Buscopan Compositum Supplement 20 Coated Tablets

Sanofi Buscopan Compositum - Food Supplement

Buscopan Compositum what it is for

How Buscopan Compositum is used

Active ingredients for Buscopan Compositum

Excipients contained in Buscopan Compositum

Contraindications with the use of Buscopan Compositum

Warnings for Buscopan Compositum

Buscopan Compositum in Pregnancy

Unwanted Effects of Buscopan Compositum

Overdose for Buscopan Compositum

Interactions with the use of Buscopan Compositum

Format

Buscopan Compositum what it is for

Buscopan Compositum is used for Paroxysmal pain in affections of the gastrointestinal tract, spastic pains, dyskinesias of the urinary and biliary tract, dysmenorrhea.

How Buscopan Compositum is used

The posology for this medicine is as follows

The following dosage is recommended for adults, unless otherwise prescribed:

We recommend 1 or 2 coated tablets 3 times a day. It is recommended not to exceed 6 tablets per day. The tablets should not be chewed, but swallowed whole with a sufficient amount of water. Duration of treatment Buscopan compositum should not be taken for more than three days unless prescribed by a doctor. Pediatric population Buscopan compositum is not recommended for use in children below 10 years of age. The concomitant administration of other paracetamol-containing drugs may require dose adjustment.

Active ingredients for Buscopan Compositum

Buscopan compositum 10 mg + 500 mg coated tablets One coated tablet contains: Active ingredients: 10 mg hyoscine butylbromide, 500 mg paracetamol.

Excipients contained in Buscopan Compositum

Coated tablets: Core: microcrystalline cellulose, carmellose sodium, corn starch, ethyl cellulose, colloidal silica, magnesium stearate. Coating: hypromellose, polyacrylates, titanium dioxide, macrogol 6000, talc, silicone – antifoam agent.

Contraindications with the use of Buscopan Compositum

Buscopan compositum must not be used in case of

• Hypersensitivity to the active substances, to non-steroidal anti-inflammatory drugs or to any of the excipients.
• Acute angle glaucoma
• Prostatic hypertrophy or other causes of urinary retention.
• Pyloric stenosis and other conditions stenosing the gastrointestinal canal, paralytic ileus, ulcerative colitis, megacolon.
• Reflux esophagitis. - Intestinal atony of the elderly and debilitated subjects.
• Myasthenia gravis
• Pediatric age.
• Paracetamol products are contraindicated in patients with manifest glucose insufficiency
• phosphate dehydrogenase and in those with severe haemolytic anemia
• Severe hepatocellular insufficiency (Child - Pugh C).

The use of Buscopan compositum is contraindicated in case of rare hereditary conditions which may be incompatible with an excipient of the product (see section 4.4). Buscopan compositum 10 mg + 800 mg suppositories should not be used in patients with a history of soy or peanut allergy.

Warnings for Buscopan Compositum

Buscopan compositum should not be taken for more than 3 days unless directed by your doctor. Instruct the patient to seek medical attention if pain persists or worsens, if new symptoms occur, or if redness or swelling develops as these could be symptoms of a serious condition. If severe abdominal pain of unknown origin persists, worsens or is accompanied by symptoms such as fever, nausea, vomiting, abnormal bowel movements, distended abdomen, drop in blood pressure, fainting or blood in stool, seek immediate medical attention. To prevent overdose, it must be ensured that any other drugs taken at the same time do not contain paracetamol, one of the active ingredients in Buscopan compositum. Liver damage may occur if the recommended dosage for paracetamol is exceeded (see section 4.9). Buscopan compositum should be used with caution in case of:

• glucose-6-phosphate dehydrogenase insufficiency
• liver dysfunction (e.g. due to chronic alcohol abuse, hepatitis
• impaired renal function
• Gilbert's syndrome
• hepatocellular insufficiency (Child - Pugh A / B)

Administer with caution in subjects with renal or hepatic insufficiency. In such conditions Buscopan compositum should only be administered under medical supervision, if necessary, by reducing the dose or prolonging the interval between individual administrations. Blood counts and renal and hepatic function should be monitored after prolonged use. The extensive use of analgesics, especially at high doses, can induce headache which should not be treated with increased doses of the drug. Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed very rarely. Treatment should be discontinued at the first signs of a hypersensitivity reaction following administration of Buscopan compositum. Abrupt discontinuation of analgesics after prolonged use in high doses may cause withdrawal symptoms (e.g. headache, fatigue, nervousness), which usually resolve within a few days. Resumption of analgesics should be subject to medical advice and remission of withdrawal symptoms. Due to the potential risk of anticholinergic complications, it should be used with caution in patients predisposed to narrow-angle glaucoma, in patients prone to obstruction of the intestinal or urinary tract and in those prone to tachyarrhythmia with disorders of the autonomic central nervous system, in tachyarrhythmias, in arterial hypertension, congestive heart failure and hyperthyroidism. All antimuscarinics reduce the volume of bronchial secretions; therefore they must be used with caution in subjects with chronic obstructive inflammatory diseases of the respiratory system. During treatment with paracetamol, before taking any other drug, check that it does not contain the same active ingredient, as serious adverse reactions can occur if paracetamol is taken in high doses. Instruct the patient to contact the physician before associating any other medication. Buscopan compositum 10 mg + 500 mg tablets contain 4.32 mg of sodium per tablet. To be taken into consideration in patients on a controlled sodium diet.

Buscopan Compositum in Pregnancy

Pregnancy There are no adequate data on the use of Buscopan compositum during pregnancy. Long experience with the two substances alone has indicated insufficient evidence of adverse effects during pregnancy in women. After the use of hyoscine butylbromide, pre-clinical studies in rats and rabbits showed neither embryotoxic nor teratogenic effects. Potential data on paracetamol overdose during pregnancy did not show an increased risk of malformations. Reproduction studies to investigate oral use have shown no signs suggesting malformations of fetotoxicity. Under normal conditions of use, paracetamol can be taken during pregnancy after careful consideration of the risk-benefit ratio. During pregnancy, paracetamol should not be taken for prolonged periods, in high doses, or in combination with other medicines as safety has not been confirmed in such cases. Therefore, Buscopan compositum is not recommended during pregnancy. Breastfeeding The safety of hyoscine butylbromide during lactation has not yet been established. Paracetamol is excreted in breast milk. However, it is expected that at therapeutic doses it will not cause undesirable effects in the newborn. The decision to continue or discontinue breastfeeding or to continue or discontinue Buscopan compositum therapy must be made considering the benefits of breastfeeding for the infant and the benefits of Buscopan compositum therapy for the mother. Fertility No studies on the effects on fertility in humans have been conducted

Unwanted Effects of Buscopan Compositum

Adverse reactions are listed below by system organ class and by frequency, according to the following categories: Very common: ≥ 1/10 Common: ≥ 1/100 1/10 Uncommon: / 1/10/1/10 1 /1,000 1/100 Rare: 1 / 10,000 1 / 1,000 Very rare: 1 / 10,000 Not known: frequency cannot be estimated from the available data. Blood and lymphatic system disorders: Not known: pancytopenia, agranulocytosis, thrombocytopenia, leukopenia. Immune system disorders, skin and subcutaneous tissue disorders: Uncommon: skin reactions, abnormal sweating, itching, nausea. Rare: erythema, decrease in blood pressure including shock. Not known: anaphylactic shock, anaphylactic reactions, skin drug reaction, dyspnoea, hypersensitivity, angioedema, urticaria, skin rash, exanthema. Very rare cases of severe skin reactions (such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and generalized exanthematous pustulosis (AGEP)) have been reported with the use of paracetamol. Cardiac disorders: Rare: tachycardia Respiratory, thoracic and mediastinal disorders: Not known: bronchial muscle spasms (especially in patients with a history of bronchial asthma or allergy). Gastrointestinal disorders: Uncommon: dry mouth. Hepatobiliary disorders: Not known: increased transaminases. Renal and urinary disorders: Not known: urinary retention. Cases of erythema multiforme have been reported with the use of paracetamol. Hypersensitivity reactions such as angioedema, edema of the larynx have been reported. In addition, the following undesirable effects have been reported: anemia, liver function abnormalities and hepatitis, kidney changes (acute renal failure, interstitial nephritis, haematuria, anuria), gastrointestinal reactions and dizziness. Somnolence, mydriasis, accommodation disturbances, increased eye tone, constipation and difficulty in urination have also been reported. Reporting of suspected adverse reactions The reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Overdose for Buscopan Compositum

Due to paracetamol overdose, elderly people, young children, patients with liver disorders, chronic alcohol consumption or chronic malnutrition, such as patients treated with enzyme-induced medicinal products, are at increased risk of intoxication, even with a fatal outcome. Symptoms N – hyoscine butylbromide Anticholinergic effects have been observed in overdose. Paracetamol In cases of chronic intoxication, hemolytic anemia, cyanosis, weakness, dizziness, paraesthesia, tremors, insomnia, headache, memory loss, irritation of the central nervous system, delirium and convulsions may occur. Symptoms usually occur during the first 24 hours and include paleness, nausea, vomiting, anorexia and abdominal pain. Patients may then experience temporary subjective improvement but mild abdominal pain possibly indicative of liver damage may persist; there may be a considerable increase in transaminases, jaundice, bleeding disorders, hypoglycemia and transition to hepatic coma. A single dose of paracetamol of approximately 6 g or more in adults or 140 mg / kg in children can cause hepatocellular necrosis. This can lead to irreversible complete necrosis and subsequently hepatocellular failure, metabolic acidosis and encephalopathy, which in turn can progress to coma and death. Concurrent elevations in hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin and an increase in prothrombin time, which occurs 12 to 48 hours after ingestion, have been observed. Clinical symptoms of liver injury are usually evident after 2 days and peak after 4 - 6 days. Acute renal failure with acute tubular necrosis can develop even in the absence of severe liver damage. Other non-hepatic symptoms have also been reported such as myocardial abnormalities and pancreatitis to be verified after an overdose with paracetamol. N – hyoscine butylbromide therapy If required, parasympathomimetic medicinal products should be administered. In cases of glaucoma an ophthalmological examination must be carried out urgently. Cardiovascular complications must be treated in accordance with the usual therapeutic principles. In case of respiratory paralysis: intubation and artificial respiration must be considered. Catheterization may be required for urinary retention. In addition, appropriate supportive measures should be used as needed. Paracetamol Where paracetamol intoxication is suspected, intravenous administration of SH group donors such as N-acetylcysteine within the first 10 hours of ingestion is indicated. Although N-acetylcysteine is most effective if administered within this period, it may still offer some degrees of protection if administered 48 hours after ingestion; in this case, it should be taken longer. The plasma concentration of paracetamol can be lowered by dialysis. Quantitative analyzes of the plasma concentration of paracetamol are recommended. Further measures will depend on the severity, nature and course of the clinical symptoms of acetaminophen intoxication and must follow standard intensive care protocols.

Interactions with the use of Buscopan Compositum

Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine) . The same situation occurs with potentially hepatotoxic substances and with alcohol abuse. Concomitant administration of chloramphenicol may induce a prolongation of the half-life of chloramphenicol, with the risk of elevating its toxicity. Since the clinical relevance of the interactions of paracetamol with warfarin and coumarin derivatives has not yet been established, long-term use of Buscopan compositum in patients on oral anticoagulant therapy should only take place under medical supervision. Concomitant use of paracetamol and zidovudine (AZT or retrovir) increases the tendency to shrink leukocytes (neutropenia). Therefore Buscopan compositum should only be taken together with zidovudine under medical supervision. Intake of probenecid inhibits the binding of paracetamol to glucuronic acid, thereby reducing the clearance of paracetamol by approximately a factor of 2. The dose of paracetamol should therefore be reduced during co-administration with probenecid. Cholestyramine reduces the absorption of paracetamol. The administration of paracetamol can interfere with the determination of uricaemia (by the phosphotungstic acid method) and with that of blood glucose (by the glucose-oxidase-peroxidase method). The anticholinergic effect of medicinal products such as tri- and tetracyclic antidepressants, antihistamines, antipsychotics, quinidine, amantadine, disopyramide and other anticholinergics (e.g. tiotropium, ipratropium, atropine-like substances) can be enhanced by Buscopan compositum. Concomitant treatment with dopamine antagonists, such as metoclopramide, may result in a reduction in the effect of both drugs on the gastrointestinal tract. Β-adrenergic drug-induced tachycardia can be potentiated by Buscopan compositum. The tachycardic effects of beta-adrenergic agents can be intensified by Buscopan compositum. In addition for oral use: Drugs that slow down gastric emptying (eg propanteline) can reduce the absorption rate of paracetamol, delaying its therapeutic effect; on the contrary, drugs that increase the gastric emptying rate (eg metoclopramide) lead to an increase in the absorption rate of paracetamol.

Format

Buscopan Compositum is sold in packs of 20 Coated Tablets.

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