Irbeprex may be available in the countries listed below.
Ingredient matches for Irbeprex
Irbesartan
Irbesartan is reported as an ingredient of Irbeprex in the following countries:
- Colombia
International Drug Name Search
Wednesday, 28 September 2016
Bendroflumethiazide Tablets BP 2.5mg
1. Name Of The Medicinal Product
BENDROFLUMETHIAZIDE TABLETS BP 2.5mg
2. Qualitative And Quantitative Composition
Each tablet contains 2.5mg Bendroflumethiazide PhEur.
3. Pharmaceutical Form
White uncoated tablets.
4. Clinical Particulars
4.1 Therapeutic Indications
Bendroflumethiazide is indicated for:
1. Cases where the reduction of fluid retention by diuresis is required; oedema of cardiac, renal or hepatic origin and iatrogenic oedema
2. Bendroflumethiazide produces a moderate but usefully prolonged fall of blood pressure in hypertensive patients. It may be used as the sole antihypertensive agent, or, as an adjunct to other drugs whose action it potentiates. In non-oedematous patients, there may be little noticeable diuretic effect.
4.2 Posology And Method Of Administration
Posology
It is recommended that the tablets should be taken in the morning to avoid nocturia.
Adults and children aged 12 years and over:
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Hypertension: 2.5-5mg once daily. When Bendroflumethiazide is used concurrently with other specific hypotensive agents, the dosage of such agents should be reduced and then adjusted as necessary.
Children under 12 years: Initial dose of 400micrograms/kg of body weight daily reducing to the maintenance dose of 50-100micrograms/kg daily.
A more appropriate dosage form may be required.
Elderly: Dosage may need to be reduced in the elderly, especially where there is impairment of renal function.
Method of Adminstration
For oral administration.
4.3 Contraindications
• Hypersensitivity to thiazides and any other ingredient in bendroflumethiazide tablets.
• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Severe renal or hepatic insufficiency.
• Hypercalcaemia; refractory hypokalaemia; hyponatraemia; symptomatic hyperuricaemia.
• Addison's disease.
4.4 Special Warnings And Precautions For Use
• Bendroflumethiazide may raise serum uric acid levels with consequent exacerbation of gout in susceptible patients.
• Thiazide diuretics should be used with caution in patients with mild or moderate renal or hepatic dysfunction. Renal function should be monitored during bendroflumethiazide therapy. Thiazides can cause electrolyte imbalance which is more severe in patients with hepatic and renal impairment and in those receiving higher or prolonged doses. Elderly patients and those on long term treatment need regular blood tests to monitor electrolyte levels. Hypokalaemia should be corrected by adding potassium supplements to the regimen. The risk of hypomagnesaemia is increased in alcoholic cirrhosis.
• Systemic lupus erythematosus (SLE) may be exacerbated by bendroflumethiazide.
• Diabetes Mellitus may be aggravated by bendroflumethiazide.
• Caution is required when treating patients with porphyria.
• Patients taking pimozide or thioridazine. (see section 4.5)
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
• Allopurinol: Bendroflumethiazide may antagonise the action of allopurinol by causing retention of urate in the kidney. Caution is advised when using this combination.
• Anion exchange resins: Colestyramine and colestipol reduce absorption of bendroflumethiazide. This can be prevented by leaving an interval of two hours between doses of bendroflumethiazide and the anion exchange resin.
• Antiarrhythmics: The cardiotoxicity of disopyramide, amiodarone, flecainide and quinidine is increased if hypokalaemia occurs following the administration of bendroflumethiazide. The actions of lidocaine and mexiletine are antagonised by hypokalaemia.
• Antidepressants: There is an increased risk of postural hypotension if bendroflumethiazide is given with tricyclic antidepressants. There may also be a risk of hypokalaemia if thiazides are given with reboxetine. Concomitant use with MAOIs may result in an enhanced hypotensive effect.
• Antidiabetics: Bendroflumethiazide antagonises the hypoglycaemic effects of sulfonylureas, with a potential loss of diabetic control.
• Antiepileptics: There is an increased risk of hyponatraemia when bendroflumethiazide and carbamazepine are take concurrently.
• Antifungals: The risk of hypokalaemia is increased when amphotericin and bendroflumethiazide are taken concurrently.
• Antihypertensives: Bendroflumethiazide may enhance the antihypertensive effect of ACE inhibitors and angiotensin-II antagonists. There is an increased risk of first dose hypotension if prazosin is given to a patient taking bendroflumethiazide.
• Antipsychotics: Hypokalaemia increases the risk of ventricular arrhythmias with pimozide or thioridazine so concomitant use should be avoided.
• Calcium salts: Bendroflumethiazide reduces urinary excretion of calcium so there is an increase risk of hypercalcaemia when calcium salts are taken concurrently. Serum calcium levels should be monitored to ensure that they do not become excessive.
• Calcium channel blockers and peripheral vasodilators: The hypotensive effect of calcium channel blockers and moxisylyte may be enhanced when co-administered with bendroflumethiazide.
• Corticosteroids: Corticosteroids may exacerbate hypokalaemia associated with bendroflumethiazide and its diuretic activity may be antagonised.
• Cytotoxics: Concomitant use with cisplatin can lead to an increased risk of nephrotoxicity and ototoxicity.
• Digoxin: The hypokalaemic effect of bendroflumethiazide may enhance sensitivity to digoxin when taken concurrently. Patients should be monitored for signs of digoxin intoxication, especially arrhythmias. The dose of digoxin should be reduced and potassium supplements given, should digoxin toxicity develop.
• Hormone antagonists: There is an increased risk of hyponatraemia when bendroflumethiazide is used concomitantly with aminoglutethamide. Bendroflumethiazide can cause an increased risk of hypercalcaemia when co-administered with toremifene.
• Lithium: Bendroflumethiazide inhibits the tubular elimination of lithium, resulting in an elevated plasma lithium concentration and risk of toxicity. Plasma lithium concentrations must be monitored when these drugs are given concurrently.
• Muscle relaxants: The hypotensive activity of bendroflumethiazide may be increased by baclofen and tizanidine. Bendroflumethiazide may enhance the neuromuscular blocking activity of non-depolarising muscle relaxants, such as tubocurarine, gallamine, alcuronium and pancuronium.
• NSAIDs: Bendroflumethiazide may enhance the nephrotoxicity of NSAIDs. Indometacin and ketorolac antagonise the diuretic effect of bendroflumethiazide, this occurs to a lesser extent with ibuprofen, piroxicam and naproxen. The effects of concurrent use should be monitored and the dose of bendroflumethiazide modified if necessary.
• Oestrogens and progestogens: Oestrogens and combined oral contraceptives antagonise the diuretic effect of bendroflumethiazide.
• Sympathomimetics: Sympathomimetics can cause hypokalaemia. The risk of serious heart arrhythmias in asthmatic patients may be increased if bendroflumethiazide is added to their medication.
• Theophylline: Concomitant administration of theophylline and bendroflumethiazide increases the risk of hypokalaemia.
• Ulcer healing drugs: There is an increased risk of hypokalaemia and a decrease in diuretic activity when carbenoxolone and bendroflumethiazide are taken together. Patients should be monitored and given potassium supplements when required.
• Vitamins: The risk of hypercalcaemia is increased if bendroflumethiazide is given with vitamin D.
4.6 Pregnancy And Lactation
Bendroflumethiazide is best avoided for the management of oedema or hypertension in pregnancy as it crosses the placenta and its use may be associated with hypokalaemia, increased blood viscosity and reduced placental perfusion.
There is insufficient evidence of safety in human pregnancy and foetal bone marrow depression, thrombocytopenia and neonatal jaundice have been described.
Bendroflumethiazide suppresses lactation and, although the amounts passing into breast milk are small, it should be avoided in breast feeding mothers.
4.7 Effects On Ability To Drive And Use Machines
As bendroflumethiazide can cause dizziness, patients should make sure they are not affected before driving or operating machinery.
4.8 Undesirable Effects
• Effects on blood
Rarely, blood dyscrasias, including agranulocytosis, aplastic anaemia, thrombocytopenia and leucopenia, have been reported.
• Hypersensitivity reactions
Rashes (including exfoliative dermatitis), photosensitivity, pneumonitis and pulmonary oedema have been reported occasionally.
• Metabolic effects
Bendroflumethiazide may lower carbohydrate tolerance and the insulin dosage of some diabetic patients may require adjustment. Care is required when bendroflumethiazide is administered to patients with a known predisposition to diabetes. Bendroflumethiazide may raise serum uric acid levels and exacerbate gout in susceptible individuals. Plasma lipids may be altered in patients taking bendroflumethiazide.
• Effects on electrolytes
Bendroflumethiazide administration may cause hypokalaemia, hypomangnesaemia, hyponatraemia, hypercalcaemia and hypochloraemic alkalosis. Hypokalaemia may result in polyuria, malaise, muscle weakness or cramp, dizziness, nausea, anorexia or vomiting.
• Gastrointestinal effects
Nausea, vomiting, diarrhoea, constipation and gastric irritation have all been reported.
• Other reactions
Pancreatitis, intrahepatic cholestasis and impotence (reversible on discontinuing the drug) have been reported. Postural hypotension or dizziness may also occur.
4.9 Overdose
Symptoms: Nausea, vomiting, diarrhoea, dehydration, dizziness, weakness, muscle cramps, diuresis, increased frequency of micturition with polyuria and thirst. Extreme cases may show depletion of intravascular volume, hypotension and peripheral circulatory failure. Hypokalaemia and mild hypoglycaemia are likely to be present if diuresis is profound. CNS depression (eg drowsiness, lethargy and coma) may occur without cardiovascular or respiratory depression.
Treatment: Activated charcoal may help reduce absorption of substantial amounts if given within one hour of ingestion. Treatment should be symptomatic and directed at fluid and electrolyte replacement which should be monitored together with the blood pressure and renal function. Hyponatraemia should be treated with water deprivation rather than by the administration of sodium chloride. Cathartics should be avoided.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC CODE; C03A A01
Bendroflumethiazide is a thiazide diuretic.
The mechanism whereby the thiazides exert their antihypertensive effect has not been clearly established.
Bendroflumethiazide inhibits the renal tubular absorption of salt and water by its action at the beginning of the distal convoluted tubule. Sodium and chloride ions are excreted in equivalent proportions. Because potassium excretion is promoted, metabolic alkalosis may occur secondary to hypokalaemia. There is no important effect upon carbonic anhydrase. Bendroflumethiazide exerts its diuretic effect in about 2 hours and this lasts for 12 to 18 hours or longer.
5.2 Pharmacokinetic Properties
Absorption: Bendroflumethiazide has been reported to be completely absorbed from the gastrointestinal tract. Diuresis is initiated in about 2 hours and lasts for 12-18 hours or longer.
Distribution: Bendroflumethiazide is more than 90% bound to plasma proteins.
Metabolism: There are indications that it is fairly extensively metabolised. Peak plasma levels are reached in 2 hours and a plasma half- life of between 3 and 8.5 hours on average.
Elimination: About 30% is excreted unchanged in the urine with the remainder excreted as uncharacterized metabolites.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Also contains: lactose, magnesium stearate, maize starch, pregelatinised maize starch, stearic acid, water.
6.2 Incompatibilities
None known.
6.3 Shelf Life
Shelf-life
Three years from the date of manufacture.
Shelf-life after dilution/reconstitution
Not applicable.
Shelf-life after first opening
Not applicable.
6.4 Special Precautions For Storage
Store below 25°C in a dry place.
6.5 Nature And Contents Of Container
The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps and polyfoam wad or cotton wool.
Pack sizes: 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s
The product may also be supplied in blister packs in cartons:
a) Carton: Printed carton manufactured from white folding box board.
b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-7g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.
Pack sizes: 28s, 30s, 56s, 60s, 84s
Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.
Maximum size of bulk packs: 50,000.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
Administrative Data
7. Marketing Authorisation Holder
Actavis UK Limited
(Trading style: Actavis)
Whiddon Valley
BARNSTAPLE
N Devon EX32 8NS
8. Marketing Authorisation Number(S)
PL 0142/0380
9. Date Of First Authorisation/Renewal Of The Authorisation
27.6.94
10. Date Of Revision Of The Text
February 2007
Beechams Powders Capsules
1. Name Of The Medicinal Product
Beechams Powders Capsules
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Capsule
4. Clinical Particulars
4.1 Therapeutic Indications
Symptomatic relief of symptoms of influenza, feverishness, chills and colds including feverish colds.
The symptomatic relief of nasal congestion and difficult breathing arising from this, sinusitis and its associated pain, acute nasal catarrh.
4.2 Posology And Method Of Administration
Recommended Dose and Dosage Schedule
Adults (including elderly) and children aged 12 years and over:
2 capsules every 4 to 6 hours as required, but no more than 12 capsules in any 24 hours.
Do not take continuously for more than 7 days without medical advice
Children under 12 years of age
Not to be given under the age of 12
4.3 Contraindications
Concomitant use of other sympathomimetic decongestants
Phaeochromocytoma
Closed angle glaucoma
Known hypersensitivity to paracetamol or any of the other ingredients. Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, and heart disease.
Patients taking tricyclic antidepressants, or beta blocking drugs and those who are taking or who have taken within the last two weeks monoamine oxidase inhibitors (see section 4.5).
4.4 Special Warnings And Precautions For Use
Medical advice should be sought before using this product in patients with these conditions:
An enlargement of the prostate gland
Occlusive vascular disease (e.g. Raynaud's phenomenon)
Cardiovascular disease
This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) (see interactions).
Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.
Keep out of the reach and sight of children
Contains Paracetamol
Do not exceed the stated dose
If symptoms persist consult your doctor
If you are under the care of your doctor or receiving prescribed medicines consult your doctor before taking this product.
Do not take other flu, cold or decongestant medicines or other paracetamol-containing medicines, with this product.
Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Special Label Warnings
Do not take with any other paracetamol-containing products. Do not take with other flu, cold or decongestant products.
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Special Leaflet Warnings
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Enzyme-inducing drugs may increase hepatic damage, as does excessive intake of alcohol. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. These interactions are considered to be of unlikely clinical significance in acute usage at the dosage regimen proposed.
Medical advice should be sought before taking paracetamol-caffeine phenylephrine in combination with the following drugs:
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4.6 Pregnancy And Lactation
This product is not recommended for use in pregnancy due to the phenylephrine and caffeine content. There is a potential increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption during pregnancy.
This product should not be used while breast-feeding without medical advice.
Caffeine in breast milk may have a stimulating effect on breast-fed infants.
Phenylephrine may be excreted in breast milk.
4.7 Effects On Ability To Drive And Use Machines
Patients should be advised not to drive or operate machinery if affected by dizziness.
4.8 Undesirable Effects
Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. The frequency of these adverse events is not known (cannot be estimated from available data).
Paracetamol
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* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Caffeine
Adverse reactions identified through post-marketing use with caffeine are listed below. The frequency of these reactions is unknown.
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When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.
Phenylephrine
The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.
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Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown.
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4.9 Overdose
Paracetamol
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors:
If the patient
a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
Or
b, Regularly consumes ethanol in excess of recommended amounts.
Or
c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms:
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management:
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
Caffeine
Symptoms and signs
Overdose of caffeine may result in epigastric pain, vomiting, diurese, tachycardia or cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).
It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related liver toxicity.
Treatment
No specific antidote is available, but supportive measures may be used.
Phenylephrine
Symptoms and signs
Phenylephrine overdosage is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include hypertension, and possibly reflex bradycardia. In severe cases confusion, hallucinations, seizures and arrhythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than that required to cause paracetamol-related liver toxicity.
Treatment
Treatment should be as clinically appropriate. Severe hypertension may need to be treated with alpha blocking drugs such as phentolamine.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Paracetamol: An analgesic and antipyretic.
Caffeine: A mild stimulant
Phenylephrine hydrochloride: A sympathomimetic decongestant.
The active ingredients are not known to cause sedation.
5.2 Pharmacokinetic Properties
Paracetamol: is readily absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine, mainly as glucoronide and sulphate conjugates.
Caffeine: is absorbed readily after oral administration, maximal plasma concentrations are achieved within one hour and the plasma half-life is about 3.5 hours. 65-80% of administered caffeine is excreted in the urine as 1-methyluric acid and 1-methylxanthine.
Phenylephrine Hydrochloride: is irregularly absorbed from the gastrointestinal tract and undergoes first-pass metabolism by monoamine oxidase in the gut and liver; orally administered phenylephrine thus has reduced bioavailability. It is excreted in the urine almost entirely as the sulphate conjugate.
5.3 Preclinical Safety Data
Pre-clinical safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use of the product and which have not already been mentioned elsewhere in this Summary.
The toxicity of paracetamol has been extensively studied in numerous animal species. Pre-clinical studies in rats and mice have indicated single dose oral LD50 values of 3.7 g/kg and 338 mg/kg, respectively. Chronic toxicity in these species at large multiples of the human therapeutic dose, occurs as degeneration and necrosis of hepatic, renal and lymphoid tissue, and blood count changes. The metabolites believed responsible for these effects have also been demonstrated in man. Paracetamol should not, therefore, be taken for long periods of time, and in excessive doses. At normal therapeutic doses, paracetamol is not associated with genotoxic or carcinogenic risk. There is no evidence of embryo-or foetus-toxicity from paracetamol in animal studies.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lactose
Colloidal silica
Dimeticone
Shell capsule (G dye/100g capsule part)
Amaranth (E123)
Erthyrosine (E127)
Sunset yellow (E110)
Titanium dioxide (E171)
Gelatin
Shell body (G dye/100G capsule part)
Gelatin
Titanium dioxide (E171)
6.2 Incompatibilities
None known
6.3 Shelf Life
Five years
6.4 Special Precautions For Storage
None stated
6.5 Nature And Contents Of Container
Opaque blisters of polyvinyl chloride (PVC)/polyvinylidene chloride (PVdC) backed with aluminium foil. Ten or 16 capsules are blistered and packed into boxboard cartons.
6.6 Special Precautions For Disposal And Other Handling
Not applicable
7. Marketing Authorisation Holder
Beecham Group Plc
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.
8. Marketing Authorisation Number(S)
PL 00079/0205
9. Date Of First Authorisation/Renewal Of The Authorisation
1.7.82 / 1.7.97
10. Date Of Revision Of The Text
May 2010.
Tuesday, 27 September 2016
Benylin Tickly Coughs Non-Drowsy
1. Name Of The Medicinal Product
Benylin Tickly Coughs Non-Drowsy
2. Qualitative And Quantitative Composition
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For excipients see 6.1.
3. Pharmaceutical Form
Oral liquid
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of irritating, tickling dry coughs and sore throats.
4.2 Posology And Method Of Administration
For oral administration.
Adults and children over 5 years: 10 ml
Children 1 - 5 years: 5 ml
The dose may be repeated three or four times a day.
Children under one year: Not to be given to children under 1 year.
Elderly: There is no need for dosage reduction in the elderly.
4.3 Contraindications
Hypersensitivity or intolerance to any of the ingredients.
4.4 Special Warnings And Precautions For Use
Diabetics should take note of the carbohydrate content of this product.
Do not give to children under one year.
Keep all medicines out of the reach of children.
Information relating specifically to excipients in the formulation.
This medicine contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose.
This medicine contains sucrose and glucose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No clinically significant interactions known.
4.6 Pregnancy And Lactation
The safety of this product during pregnancy and lactation has not been established, but is not considered to constitute a hazard during these periods.
4.7 Effects On Ability To Drive And Use Machines
Not applicable.
4.8 Undesirable Effects
No adverse effects would be anticipated.
4.9 Overdose
Overdosage would not be expected to cause any problems and treatment would be merely symptomatic and supportive.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Glycerol and sucrose have demulcent properties and will soothe irritated sore throats and possibly block sensory cough receptors within the respiratory tract.
5.2 Pharmacokinetic Properties
Glycerol is readily absorbed from the gastrointestinal tract and undergoes extensive metabolism principally in the liver. It may be used in the synthesis of lipids, and is metabolised to glucose or glycogen or oxidised to carbon dioxide and water. It may also be excreted in the urine unchanged.
Sucrose is hydrolysed in the small intestine by the enzyme sucrase to glucose and fructose which are then absorbed.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Citric acid monohydrate
Sodium benzoate (E211)
Cough syrup 513277 flavour (containing anise oil, liquorice, propylene glycol, ethanol (alcohol)
Black treacle
Liquid glucose
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
No special precautions for storage.
6.5 Nature And Contents Of Container
A white flint glass bottle with an aluminium roll-on pilfer proof cap with a flowed in liner, or a triseal (LDPE/EPE/LDPE) liner.
Alternative cap: A wadless polypropylene tamper evident cap.
Pack size: 200ml.
or
An amber glass bottle with an aluminium roll-on pilfer proof cap with a triseal LDPE/EPE/LDPE) liner.
Pack size: 125ml and 150ml
or
An amber PET bottle with a child resistant polypropylene cap fitted with an expanded polyethylene liner.
Pack size: 150ml or 300ml.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
Administrative Data
7. Marketing Authorisation Holder
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire SL6 3UG
United Kingdom
8. Marketing Authorisation Number(S)
PL 15513/0142
9. Date Of First Authorisation/Renewal Of The Authorisation
11th January 2005
10. Date Of Revision Of The Text
6th August 2010
Balneum Bath Oil
1. Name Of The Medicinal Product
Balneum
2. Qualitative And Quantitative Composition
Soya oil, 84.75% w/w
3. Pharmaceutical Form
Oily liquid for external use.
4. Clinical Particulars
4.1 Therapeutic Indications
Dry skin conditions including those associated with dermatitis and eczema.
4.2 Posology And Method Of Administration
Topical
The liquid should be added to bath water.
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In particularly dry skin, 2-3 times the above quantities can be used
Generally, 2-3 baths should be taken weekly. For babies and infants a daily bath is recommended.
4.3 Contraindications
• Hypersensitivity to the active ingredient or to any of the excipients listed in section 6.1 .
• Hypersensitivity to peanut or soya.
4.4 Special Warnings And Precautions For Use
None.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
Not known.
4.7 Effects On Ability To Drive And Use Machines
Not applicable.
4.8 Undesirable Effects
None.
4.9 Overdose
Not applicable.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Balneum was developed in response to the need for a suitable non-irritant cleansing agent for patients with eczema. As the skin in this condition requires the application of large amounts of fat, cleansing properties as well as greasing properties were combined. Balneum is a mixture of plant oils having a high proportion of unsaturated fatty acid (linolic acid up to 60%). The emulsifier used is a mixture of fatty acid amides with aliphatic alcohol and readily dispersible polyoxyethylene lauryl ester. Butylhydroxytoluene is added as an antioxidant.
5.2 Pharmacokinetic Properties
Not applicable.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Polyoxyethylene lauryl ether (4mol EO), oleic acid diethanolamide, perfume oil DV5171, propylene glycol, butylated hydroxytoluene, ascorbyl palmitate, citric acid monohydrate.
6.2 Incompatibilities
None.
6.3 Shelf Life
HDPE bottle - 5 years
Foil Laminate sachet - 5 years
Blister pack (20ml) - 2 years
6.4 Special Precautions For Storage
None.
6.5 Nature And Contents Of Container
Container: HDPE bottle with polyethylene or polypropylene cap and with or without LDPE dispensing insert.
Contents: Each bottle contains one of the following amounts; - 20ml, 95ml, 100ml, 150ml, 200ml,225ml, 250ml, 300ml, 500ml, 2x500ml, 600ml, 1000ml.
Also
Container: Foil laminate sachets.
Contents: Each sachet contains one of the following amounts: 10ml, 20ml.
Also
20ml blister pack, consisting of blister foil (PET/PB) and cover foil (PET/aluminum/PE)
6.6 Special Precautions For Disposal And Other Handling
None.
ADMINISTRATIVE DATA
7. Marketing Authorisation Holder
Almirall Hermal GmbH
Scholtzstrasse 3
D-21465,
Reinbek
Germany
8. Marketing Authorisation Number(S)
PL 33016/0008
9. Date Of First Authorisation/Renewal Of The Authorisation
31 July 1998
10. Date Of Revision Of The Text
17 November 2011
Amp Equine
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Amp Equine
Ampicillin
Ampicillin sodium salt (a derivative of Ampicillin) is reported as an ingredient of Amp Equine in the following countries:
- United States
International Drug Name Search
Beechams Cold and Flu Hot Blackcurrant
1. Name Of The Medicinal Product
Beechams Cold & Flu Hot Blackcurrant
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Powder
4. Clinical Particulars
4.1 Therapeutic Indications
The relief of symptoms of influenza, feverishness, chills and feverish colds including headache, sore throat pain, aches and pains, nasal congestion, sinusitis and its associated pain, and acute nasal catarrh.
4.2 Posology And Method Of Administration
Directions for use
Empty contents of sachet into beaker. Half fill with very hot water. Stir well. Add cold water as necessary and sugar if desired.
Recommended Dose and Dosage Schedule
Adults (including elderly) and children aged 12 years and over:
One sachet to be taken every four hours, if necessary, up to a maximum of six sachets in any 24 hours.
Do not take continuously for more than 7 days without medical advice.
Not to be given to children under 12 years of age except on medical advice
4.3 Contraindications
Hypersensitivity to paracetamol or any of the other constituents.
Concomitant use of other sympathomimetic decongestants
Phaeochromocytoma
Closed angle glaucomaHypertensive patients or those taking or have taken in the last two weeks monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers (see section 4.5).
Hepatic or renal impairment, diabetes, hyperthyroidism and cardiovascular disease.
4.4 Special Warnings And Precautions For Use
Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Medical advice should be sought before taking this product in patients with these conditions:
• An enlargement of the prostate gland
• Occulusive Vascular disease (e.g. Raynaud's Phenomenon)
This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Do not exceed the stated dose.
Patients should be advised not to take other paracetamol-containing or other cold, flu or decongestant products concurrently.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Special label warnings
Do not take with other flu, cold or decongestant products. Do not take with any other paracetamol-containing products.
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Special leaflet warnings
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding, occasional doses have no significant effect.
Phenylephrine should be used with caution in combination with the following drugs as interactions have been reported
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4.6 Pregnancy And Lactation
Due to the phenylephrine content this product should not be used in pregnancy or whilst breast-feeding without medical advice. Phenylephrine may be excreted in breast milk.
4.7 Effects On Ability To Drive And Use Machines
Patients should be advised not to drive or operate machinery if affected by dizziness.
4.8 Undesirable Effects
Paracetamol
Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
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* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Phenylephrine
The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.
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Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare.
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4.9 Overdose
Paracetamol
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors
If the patient
a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
Or
b, Regularly consumes ethanol in excess of recommended amounts.
Or
c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
Phenylephrine
Symptoms and signs
Phenylephrine overdosage is likely to result in effects similar to those listed under advserse reactions. Additional symptoms may include hypertension and possibly reflux bradycardia. In severe cases confusion, hallucinations, seizures and arrythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than required to cause paracetamol-related toxicity.
Treatment
Treatment should be as clinically appropriate. Severe hypertension may need to be treated with an alpha blocking drug such as phentolamine.
Ascorbic acid
Symptoms and signs
High doses of ascorbic acid (>3000 mg) may cause transient osmotic diarrhoea and gastrointestinal effects such as nausea and abdominal discomfort. Effects of overdose of ascorbic acid would be subsumed by severe liver toxicity caused by paracetamol overdose.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Paracetamol: Provides the analgesic and antipyretic actions.
Phenylephrine Hydrochloride is a sympathomimetic agent and provides relief from nasal congestion due to its vasoconstrictor action.
Ascorbic Acid is commonly included in combination cold products to compensate for vitamin C losses that may occur in the initial stages of acute viral infections, including the common cold.
5.2 Pharmacokinetic Properties
Paracetamol - Is readily absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine, mainly as glucuronide and sulphate conjugates.
Ascorbic Acid - Is readily absorbed from the GI tract and is widely distributed in the body tissues, 25% bound to plasma proteins. Ascorbic acid in excess of the body's needs is eliminated in the urine as metabolites.
Phenylephrine Hydrochloride - Due to irregular absorption and first pass metabolism by monoamine oxidase in the gut and liver, phenylephrine has reduced bioavailability from the gastrointestinal tract. It is excreted in the urine almost entirely as the sulphate conjugate.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sucrose Ph Eur, Sodium citrate Ph Eur, Citric acid Ph Eur, Sodium cyclamate NF, Saccharin sodium BP, Blackcurrant Juice, Blackcurrant Polvaromas, Blackcurrant Flavour, Natural Grapeskin (E163).
6.2 Incompatibilities
None stated.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Store below 25°C.
6.5 Nature And Contents Of Container
The product is packed in laminate sachets comprising paper / polythene / aluminium foil / polythene. Five or ten sachets may be contained in a box board carton.
6.6 Special Precautions For Disposal And Other Handling
None
7. Marketing Authorisation Holder
Beecham Group Plc
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as GlaxoSmithKline Consumer Healthcare
Brentford
TW8 9GS
U.K.
8. Marketing Authorisation Number(S)
PL 00079/0282
9. Date Of First Authorisation/Renewal Of The Authorisation
21.11.91 / 10.11.97
10. Date Of Revision Of The Text
June 2010.
Monday, 26 September 2016
Baclofen Tablets BP 10mg (Actavis UK Ltd)
1. Name Of The Medicinal Product
BACLOFEN TABLETS BP 10mg
2. Qualitative And Quantitative Composition
Each tablet contains 10mg Baclofen PhEur.
3. Pharmaceutical Form
White to off-white uncoated tablets.
White to off-white, circular, biconvex uncoated tablets impressed “C” on one face, and the identifying letters “B” “L” on either side of a central division line on the reverse.
4. Clinical Particulars
4.1 Therapeutic Indications
Baclofen is indicated for:
1) The relief of spasticity of voluntary muscle resulting from disorders such as multiple sclerosis and other spinal lesions, including tumours of the spinal cord, motor neurone disease, syringomyelia, transverse myelitis and traumatic partial section of the spinal cord.
2) Adults and children in the relief of spasticity of voluntary muscle arising from conditions such as cerebral palsy, cerebrovascular accidents, traumatic head injury and meningitis.
Treatment with Baclofen should not be initiated until the spastic state has become stabilised and it should be administered selectively; it is most likely to be of benefit to patients whose spasticity constitutes a handicap to activities or physiotherapy.
Paediatric population
Baclofen is indicated in patients 0 to <18 years for the symptomatic treatment of spasticity of cerebral origin, especially where due to infantile cerebral palsy, as well as following cerebrovascular accidents or in the presence of neoplastic or degenerative brain disease.
Baclofen is also indicated for the symptomatic treatment of muscle spasms occurring in spinal cord diseases of infectious, degenerative, traumatic, neoplastic, or unknown origin such as multiple sclerosis, spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia or paraparesis, and compression of the spinal cord.
4.2 Posology And Method Of Administration
Posology
Before commencing treatment the overall extent of clinical improvement that the patient may be expected to achieve must be realistically assessed. Careful titration of dosage is essential (particularly in the elderly) until the patient is stabilised. If the initial dosage is too high or if the dosage is increased too rapidly, side-effects may occur. This is particularly relevant if the patients is ambulant in order to minimise muscle weakness in the unaffected limbs or where spasticity is necessary for support.
Adults:
The following gradually incremented dosage regime is suggested but may need adjustment to suit individual patient requirements.
5mg three times daily for three days.
10mg three times daily for three days.
15mg three times daily for three days.
20mg three times daily for three days.
Satisfactory control of symptoms is usually obtained with doses up to 60mg daily but a careful adjustment is often necessary to meet the requirements of each individual patient. Dosage may be slowly increased where necessary to a maximum daily dose of not more than 100mg unless the patient is in hospital under careful medical supervision. Small frequent dosage regimes may prove to be more beneficial in some cases than larger spaced doses. Additionally, some patients may benefit from the administration of Baclofen at night only in order to counteract painful flexor spasm. Similarly, a single dose given approximately 1 hour prior to the performance of specific tasks such as washing, shaving, dressing and physiotherapy will often improve mobility.
Once the maximum recommended dosage has been reached and a therapeutic effect is not apparent within 6 weeks a decision should be made whether to continue treatment with Baclofen.
Paediatric population (0 to <18 years):
Treatment should usually be started with a very low dose (corresponding to approximately 0.3 mg/kg a day), in 2-4 divided doses (preferably in 4 divided doses).
The dosage should be raised cautiously, at about 1 week intervals, until it becomes sufficient for the child's individual requirements. The usual daily dosage for maintenance therapy ranges between 0.75 and 2 mg/kg body weight. The total daily dose should not exceed a maximum of 40 mg/day in children below 8 years of age. In children over 8 years of age a maximum daily dose of 60 mg/day may be given.
Baclofen tablets are not suitable for use in children below 33 kg body weight.
Elderly:
Elderly patients may be more susceptible to side-effects, especially during initial therapy. Small doses should therefore be used at the start of treatment, the dose being titrated gradually against the response under careful supervision. There is no evidence that the eventual average maximum dosage differs from that in younger patients.
Patients with impaired renal function:
In patients with impaired renal function or undergoing chronic haemodialysis, a particularly low dosage of Baclofen should be selected ie approximately 5mg daily.
Patients with spastic states of cerebral origin:
Unwanted effects are more likely to occur in these patients. It is therefore recommended that a very cautious dosage schedule be adopted and that patients be kept under appropriate surveillance.
Method of Administration
For oral administration.
4.3 Contraindications
• Hypersensitivity to Baclofen or any of the excipients.
• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Active peptic ulceration as Baclofen stimulates gastric acid secretion.
• Porphyria.
4.4 Special Warnings And Precautions For Use
• Severe psychiatric disorders may be exacerbated by treatment with Baclofen. Patients suffering from these conditions should therefore be treated cautiously and kept under close surveillance.
• Baclofen may also exacerbate epileptic manifestations but can be employed provided appropriate supervision and adequate anticonvulsive therapy are maintained.
• Baclofen should be used with extreme care in patients already receiving antihypertensive therapy (see “Interactions”).
• Baclofen should be used with caution in patients suffering from cerebrovascular accidents or from respiratory, hepatic or renal impairment.
• Baclofen stimulates gastric acid secretion and should be used with caution in patients with a history of peptic ulceration.
• Since under treatment with Baclofen neurogenic disturbances affecting emptying of the bladder may show an improvement, whereas in patients with pre-existing sphincter hypertonia acute retention of urine may occur, the drug should be used with caution in such patients.
• Since in rare instances elevated SGOT, alkaline phosphatase and glucose levels in serum have been recorded, appropriate laboratory tests should be performed in patients with liver diseases or diabetes mellitus in order to ensure that no drug induced changes in these underlying diseases have occurred.
• Withdrawal: Anxiety and confusional states, hallucinations, psychotic, manic or paranoid states, convulsions (status epilepticus), tachycardia and as rebound phenomenon temporary aggravation of spasticity have been reported with abrupt withdrawal of Baclofen, especially after long term medication. Treatment should always (unless serious adverse effects occur) therefore, be gradually discontinued by successively reducing the dosage over a period of about 1-2 weeks.
There is very limited clinical data on the use of Baclofen in children under the age of one year. Use in this patient population should be based on the physician's consideration of individual benefit and risk of therapy.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
• Alcohol, anxiolytics and hypnotics: Alcohol and other CNS depressants may exacerbate the CNS effects of baclofen (daytime sedation, drowsiness) and should be avoided.
• Anaesthetics: Pre-treatment with baclofen may prolong the duration of fentanyl anaesthesia.
• Antidepressants, tricyclic: Tricyclic antidepressants can enhance the muscle relaxant effects of baclofen, resulting in profound muscle hypotonia so caution should be used if baclofen and tricyclic antidepressants are used concomitantly. In addition, tricyclic antidepressants can cause sedation and drowsiness which may be additive to the side effects of baclofen.
• Antihypertensives and diuretics: The hypotensive activity of baclofen may be potentiated by concomitant treatment with antihypertensive agents and diuretics. It may be necessary to adjust the dosage if baclofen is given to patients receiving antihypertensive therapy.
• Dopaminergics: It is recommended that levodopa and baclofen should not be given concomitantly. Reports of hallucination, confusion, headache and nausea developing in patients with parkinsonism shortly after baclofen was added to their medication. The interaction was thought to be due to an exacerbation of the side effects due to baclofen.
• Lithium: Patients receiving lithium and baclofen concomitantly should be monitored for severe aggravation of hyperkinetic symptoms, especially in patients with Huntington's chorea.
• Memantine: Memantine may modify the effects of baclofen.
• NSAIDs: Because of their potential adverse effect on renal function, NSAIDs may indirectly be associated with decreased excretion of baclofen. (See section 4.2-patients with impaired renal function).
4.6 Pregnancy And Lactation
Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. However, during pregnancy, especially in the first 3 months, Baclofen should only be employed if its use is of vital necessity. The benefits of the treatment for the mother must be carefully weighed against the possible risks for the child. Baclofen crosses the placental barrier.
In mothers taking Baclofen in therapeutic doses, the active substance passes into breast milk, but in quantities so small that no undesirable effects on the infant are to be expected.
4.7 Effects On Ability To Drive And Use Machines
Baclofen may cause sedation, decreased alertness, dizziness and light-headedness. Patients should be warned that if affected they should not drive, operate machinery or take part in activities where these may put themselves or others at risk.
4.8 Undesirable Effects
Unwanted effects occur mainly at the start of treatment, if the dosage is raised too rapidly, if large doses are employed, or in elderly patients. They are often transitory and can be attenuated or eliminated by reducing the dosage; they are seldom severe enough to necessitate withdrawal of the medication.
• Central nervous system: Particularly at the start of treatment, unwanted effects such as daytime sedation, drowsiness, and nausea may frequently occur. Also occasionally encountered are dryness of the mouth, respiratory depression, light-headedness, lassitude, exhaustion, mental confusion, dizziness, retching, vomiting, headache and insomnia.
Should nausea persist following a reduction in dosage, it is recommended that Baclofen be ingested with food or a milk drink.
• Neurological and/or psychiatric manifestations which have occasionally or rarely been reported include: euphoria, depressive states, paraesthesia, myalgia, muscular weakness, ataxia, tremor, nystagmus, accommodation disorders, hallucinations, nightmares. It is often difficult to distinguish between these manifestations and those of the disease under treatment. Lowering of the convulsion threshold and attacks of convulsions may possibly occur, particularly in epileptic patients.
• Gastrointestinal tract: Frequently nausea. Occasionally, mild gastrointestinal disturbances (constipation, diarrhoea).
• Cardiovascular system: Occasionally, hypotension, cardiovascular depression.
• Urogenital system: Occasionally or rarely, dysuria, frequency of micturition and enuresis are reported frequently. It is often difficult to distinguish between these manifestations and those of the disease under treatment.
• Other unwanted effects: In rare or isolated cases visual disturbances, alterations in the taste sensation, hyperhidrosis, skin rash, deterioration in liver function tests. There have been rare reports of hypothermia.
Certain patients have shown increased spasticity as a paradoxical reaction to the medication.
An undesirable degree of muscular hypotonia - making it more difficult for patients to walk or fend for themselves - may occur and can usually be relieved by re-adjusting the dosage (ie by reducing the doses given during the day and possibly increasing the evening dose).
4.9 Overdose
Symptoms: Prominent features are signs of central nervous depression eg drowsiness, impairment of consciousness, respiratory depression, coma. Also liable to occur are confusion, hallucinations, agitation, accommodation disorders, absent pupillary reflex; generalised muscular hypotonia, myoclonia hyporeflexia or areflexia; convulsions; peripheral vasodilation, hypotension, bradycardia; nausea, vomiting, diarrhoea, hypersalivation; elevated LDH, SGOT and AP values.
A deterioration in the condition may occur if various substances or drugs acting on the CNS eg alcohol, diazepam, tricyclic antidepressants, have been taken at the same time.Symptoms may occur at lower dosages in patients with impaired renal function or in the elderly.
Treatment: No specific antidote is known. Elimination of the drug from the gastrointestinal tract (induction of vomiting, gastric lavage; comatose, drowsy or hyporeflexic patients should be intubated prior to gastric lavage), administration of activated charcoal; if necessary, saline aperient; in respiratory depression, administration of artificial respiration, also measures in support of cardiovascular functions; inducing artificial or assisted respiration and possibly aggressive maintenance of cardiovascular function. Since the drug is excreted chiefly via the kidneys, generous quantities of fluid should be given, possibly together with a diuretic. In the event of convulsions diazepam should be administered cautiously iv.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC CODE: M03B X01
Baclofen, a GABA (gamma-aminobutyric acid) derivative, is chemically unrelated to other antispastic agents and acts at spinal level, reducing spasticity and spasm.
Baclofen depresses monosynaptic and polysynaptic reflex transmission, probably by simulating the GABAB-receptors, this simulation in turn inhibiting the release of the excitatory amino acids glutamate and aspartate. Neuromuscular transmission is unaffected by Baclofen. Baclofen also exerts an antinociceptive effect. Baclofen may act at supraspinal sites producing CNS depression.
5.2 Pharmacokinetic Properties
• Absorption
Baclofen is rapidly and almost completely absorbed from the gastrointestinal tract. The peak plasma concentration occurs about from 1 to 3 hours following ingestion.
• Distribution
Baclofen crosses the blood-brain barrier and concentrations in the CSF are about 12% of those in plasma. Protein binding is about 30%.
• Metabolism
Baclofen is metabolised by deamination to a small extent. The main metabolite, β-(p-chlorophenyl)-4-hydroxobutyric acid, is pharmacologically inactive.
• Elimination
The elimination half-life of baclofen is about 3 to 4 hours in plasma and about 5 hours in CSF. This half life may increase to 35 hours in overdose. About 70 to 80% of a dose is excreted in the urine mainly as unchanged drug and about 15% is metabolised in the liver.
5.3 Preclinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Baclofen increases the incidence of omphaloceles (ventral hernias) in the foetuses of rats at high doses.
A dose related increase in the incidence of ovarian cysts, and less marked increase in enlarged and/or haemorrhagic adrenals have been observed in female rats treated for 2 years. No teratogenic effects have been noted in mice or rabbits. The clinical relevance of these findings is not known.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Also contains: lactose, pregelatinised maize starch, maize starch, magnesium stearate, water.
6.2 Incompatibilities
None known.
6.3 Shelf Life
Shelf-life
Three years from the date of manufacture.
Shelf-life after dilution/reconstitution
Not applicable.
Shelf-life after first opening
Not applicable.
6.4 Special Precautions For Storage
Store below 25°C.
Protect from light.
6.5 Nature And Contents Of Container
The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene tablet containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass bottles with screw caps and polyfoam wad or cotton wool. An alternative closure for polyethylene containers is a polypropylene, twist on, push down and twist off child-resistant, tamper-evident lid.
The product may also be supplied in blister packs in cartons:
a) Carton: Printed carton manufactured from white folding box board.
b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-7g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.
Pack sizes: 28s, 30s, 50s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s.
Product may also be supplied in bulk packs for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material.
Maximum size of bulk packs: 50,000.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
Administrative Data
7. Marketing Authorisation Holder
Actavis UK Limited
(Trading style: Actavis)
Whiddon Valley
BARNSTAPLE
N Devon EX32 8NS
8. Marketing Authorisation Number(S)
PL 0142/0344
9. Date Of First Authorisation/Renewal Of The Authorisation
June 1993; September 1998
10. Date Of Revision Of The Text
March 2011
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