Buscopan Plus Tablets
1 film-coated tablet contains: Hyoscine-N-butyibromide 10mg Paracetamol 500mgCompany Name
CID/Boehringer
Therapeutic Group
ANTISPASM\ANALGESIC COMBS
Pharmaceutical form
Tablet
Package
Box of 20 tablets (2 strips of 10 tablets each)
Indications
Paroxysmal pain in diseases of the stomach or intestine, spastic pain and functional disorders in the biliary and urinary tracts and female genital organs (e.g. dysmenorrhoea).
Warning & Precautions
Buscopan Plus should be used with caution in: - Hepatic dysfunction (e.g. due to chronic alcohol abuse, hepatitis) -- Renal dysfunction -- Gilblert’s syndrome ( Meulengracht's disease) In such cases Buscopan Plus should only be used under medical supervision and, if necessary, the dose reduced or the intervals between the individual administrations prolonged . Pregnancy and lactation: Available but limited preclinical data has shown no hazard, but safety during human pregnancy has not yet been established .The usual precautions regarding the use of drugs at this time, especially during the first trimester, should be observed. Hyoscine-N-butylbromide safety during lactation has not yet been established . The active ingredient paracetamol enters breast milk, but is not likely to affect the infant when therapeutic doses are used .
Product Type
human
Dosage
Unless otherwise prescribed by the physician: For Adults: 1-2 tablets three times daily, swallowed whole with a little liquid. The total daily dose should not exceed 6 tablets. Buscopan Plus should not be taken over a prolonged period of time or in higher doses without a prescription from the doctor or dentist. The film-coated tablets are not suitable for children.
Adverse Reactions
Following administration of Buscopan Plus rubefaction may occur in rare cases, allergic reactions with exanthema in very rare cases, allergic platelet deficiency (thrombocytopenia) or reduction in leucocytes ( leucopenia ) in extremely rare cases. A reduction in granulocytes in the blood (agranulocytosis) or a reduction in cellular blood elements (pancytopenia) have been described in isolated cases in connection with paracetamol. Spasms of the bronchial muscles in the case of asthma (bronchospasm) may occur in predisposed patients (analgesic-induced asthma) in isolated cases. In Buscopan Plus overdosage there is a risk of severe liver damage due to paracetamol.
Contra Indications
-- Known genetically determined glucose-6-phosphate dehydrogenase deficiency. -- Known hypersensitivity to paracetamol.
Drug Interactions
Otherwise harmless doses of paracetamol may cause liver damage if taken together with drugs leading to enzyme induction such as certain hypnotics and anti-epileptics (e.g. glutethimide, phenobarbital, phenytoin, carbamazepin) as well as rifampicin. The same applies to alcohol abuse. Where gastric emptying is slowed down, as for instance with propantheline, the absorption rate of paracetamol may be reduced with the result that onset of action is delayed. Acceleration of gastric emptying, e.g. after administration of metoclopramide, leads to an increase in the absorption rate. Combination with chloramphenicol can prolong the half-life with the risk of increased toxicity. The clinical relevance of interactions between paracetamol and warfarin as well as coumarin derivatives cannot yet be assessed. Therefore, long-term use of paracetamol in patients being treated with oral anticoagulants is only advisable under medical supervision.
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