Buscopan compositum 20 coated tablets

BUSCOPAN COMPOSITUM * 20CPR RIV

Therapeutic indications

Paroxysmal pains in affections of the gastrointestinal tract, spastic pains, dyskinesias of the biliary tract.

Dosage and method of use

The following dosage is recommended for adults, unless otherwise prescribed:Coated tablets1-2 tablets 3 times a day. Do not exceed 6 tablets per day. The tablets should not be chewed, but swallowed whole with a sufficient amount of water.Suppositories1 suppository 3-4 times a day. Do not exceed 4 suppositories per day.Duration of treatmentBuscopan Compositum should not be taken for more than three days unless prescribed by a doctor (see section 4.4). Pediatric population Buscopan Compositum is not recommended for use in children below 10 years of age. Co-administration of other paracetamol-containing drugs may require dose adjustment, see section 4.4.

Contraindications

Buscopan Compositum is contraindicated in case of: - hypersensitivity to the active substances (hyoscine N-butylbromide and paracetamol), to non-steroidal anti-inflammatory drugs or to any of the excipients listed in section 6.1; - acute angle glaucoma; - prostatic hypertrophy or other causes of urinary retention; - mechanical stenosis of the gastrointestinal tract; - pyloric stenosis and other conditions stenosing the gastrointestinal canal; - paralytic or obstructive ileus; - megacolon; - Ulcerative colitis; - reflux esophagitis; - intestinal atony of the elderly and debilitated subjects; - myasthenia gravis; - pediatric age; - paracetamol-based products are contraindicated in patients with manifest insufficiency of glucose-6-phosphate dehydrogenase and in those suffering from 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.

Side effects

Adverse reactions are listed below by system organ class and frequency, according to the following categories: Very common: ≥ 1/10 Common: ≥ 1/100, Blood and lymphatic system disorders Not known: pancytopenia, agranulocytosis, thrombocytopenia, neutropenia , leukopenia, haemolytic anemia.Immune system disorders, skin and subcutaneous tissue disordersUncommon: skin reactions, abnormal sweating, pruritus, nausea. Rare: erythema, decrease in blood pressure including shock. Very rare: urticaria, rash, rash, severe skin reactions (such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and generalized exanthematous pustulosis (AGEP)). Not known: anaphylactic shock, anaphylactic reactions, drug skin reaction, dyspnoea, hypersensitivity, angioedema, fixed drug eruption.Cardiac pathologies. 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, cytolytic hepatitis which can lead to acute liver failure.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, larynx edema 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.Further adverse reactions only for suppositories Gastrointestinal disorders. Not known: anorectal discomfort.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

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 of 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 (eg due to chronic alcohol abuse, hepatitis); • chronic use of alcohol even in case of recent cessation • impaired renal function; • Gilbert's syndrome; • mild to moderate hepatocellular insufficiency (Child - Pugh A / B); • low reserves of glutathione.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 by extending 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. Serious skin reactions: Life-threatening reactions such as Stevens-Johnson syndrome (SSJ) and toxic epidermal necrolysis (NET) have been reported with the use of Buscopan Compositum. Patients should be informed about the signs and symptoms and monitored closely for skin reactions. If symptoms or signs of Stevens-Johnson syndrome, toxic epidermal necrolysis (e.g. progressive rash associated with blisters or mucosal lesions) occur, the patient should immediately discontinue treatment with Buscopan Compositum and consult a physician. Hepatotoxicity may occur with paracetamol even at therapeutic doses, after short-term treatment and in patients with no pre-existing hepatic dysfunction (see section 4.8). 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 intestinal or urinary tract obstructions 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 if paracetamol is taken in high doses, serious adverse reactions may occur, see section 4.2. Instruct the patient to contact the physician before associating any other medication. See also section 4.5. Buscopan Compositum 10 mg + 500 mg tablets contains 4.32 mg sodium per tablet, ie less than 1mmole (23 mg) sodium, so it is essentially 'sodium-free'.

Pregnancy and breastfeeding

PregnancyThere 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 N-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. Epidemiological studies of neurodevelopmental in children exposed to paracetamol in utero show inconclusive results. If clinically necessary, 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.Feeding timeThe safety of hyoscine N-butylbromide during breastfeeding 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 baby and the benefits of Buscopan Compositum therapy for the mother.FertilityNo studies on the effects on fertility in humans have been conducted (see section 5.3).

Expiry and retention

Coated tablets: Store below 25 ° C. Suppositories: store below 30 ° C.

Interactions with other drugs

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, hypnotic antiepileptics such as glutethimide, phenobarbital, carbamazepine , phenytoin). 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. Paracetamol may increase the risk of bleeding in patients taking warfarin and other vitamin K antagonists. Patients taking paracetamol and vitamin K antagonists should be monitored for appropriate clotting and for bleeding. Co-administration of flucloxacillin with paracetamol may lead to metabolic acidosis in patients with risk factors for glutathione depletion. 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 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.Interference with laboratory testsThe intake of paracetamol can affect the determination of uric acid by the method of phosphotungstic acid and of blood glucose by the method of glucose oxidase-peroxidase.Additionally for oral use: Drugs that slow down gastric emptying (eg propantheline) can reduce the absorption rate of paracetamol, delaying its therapeutic effect; on the contrary, drugs that increase the gastric emptying rate (eg metoclopramide or domperidone) lead to an increase in the absorption rate of paracetamol.

Overdose

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 drugs, are at increased risk of intoxication, even with a fatal outcome. Symptoms Hyoscine N-Butylbromide Anticholinergic effects have been observed in case of 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, gastrointestinal bleeding, metabolic acidosis, encephalopathy and disseminated intravascular coagulation which can in turn progress to coma and death. Concurrent elevations of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin with reduced prothrombin levels and an increase in prothrombin time, occurring 12 to 48 hours after ingestion, have been observed. Clinical symptoms of liver damage are usually evident after 2 days and reach a maximum 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 such as myocardial abnormalities, pancytopenia and pancreatitis have also been reported to be verified after an overdose with paracetamol. Therapy Hyoscine N-Butylbromide 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 according to 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 when administered within this period, it may still offer some degrees of protection when 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.

Active principles

Buscopan Compositum 10 mg + 500 mg coated tabletsOne coated tablet contains:Active principles:Hyoscine N-Butylbromide 10mg, Paracetamol 500mgBuscopan Compositum 10 mg + 800 mg suppositoriesOne suppository contains:Active principles:Hyoscine N-Butylbromide 10 mg, Paracetamol 800 mg Excipient with known effect: sodium. For the full list of excipients, see section 6.1.

Excipients

Coated tablets:Nucleus: microcrystalline cellulose, sodium carmellose, corn starch, ethyl cellulose, colloidal silica, magnesium stearate.Coating: hypromellose, polyacrylates, titanium dioxide, macrogol 6000, talc, silicone-antifoam agent.Suppositories: glyceride esters of saturated fatty acids, soy lecithin.