Buscopan Compositum 10mg + 500mg 20 coated tablets

Buscopan Compositum 10mg + 500mg 20 coated tablets is a drug formulated for the treatment of paroxysmal pains associated with conditions of the gastrointestinal tract and spastic pain. Each coated tablet contains two active ingredients: Hyoscine N-butylbromide (10 mg) e paracetamol (500 mg), which act synergistically to relieve pain and reduce muscle spasms. This product is indicated to deal with dyskinesias of the biliary tract and other conditions that require an antispasmodic and analgesic action. The tablets are designed to be swallowed whole, ensuring optimal release of the active ingredients. Buscopan Compositum is an effective solution for those seeking rapid and targeted relief from painful symptoms related to gastrointestinal disorders. 

INDICATIONS

Why is Buscopan Compositum 10mg + 500mg 20 coated tablets used? What is it for?

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

ACTIVE INGREDIENTS AND EXCIPIENTS

What is the composition of Buscopan Compositum 10mg + 500mg 20 coated tablets?

Composition

Buscopan Compositum 10 mg + 500 mg coated tablets One coated tablet contains: Active ingredients: Hyoscine N-butylbromide 10 mg, paracetamol 500 mg Buscopan Compositum 10 mg + 800 mg suppositories One suppository contains: Active ingredients: Hyoscine N-butylbromide 10 mg, paracetamol 800 mg Excipient with known effects: sodium.

Excipients

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

DOSAGE

How is Buscopan Compositum 10mg + 500mg 20 coated tablets taken?

The following dosage is advisable for adults, unless otherwise prescribed by a doctor: Coated tablets 1-2 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. Suppositories 1 suppository 3-4 times a day. Do not exceed 4 suppositories per day. Duration of treatment Buscopan Compositum must not be taken for more than three days unless following a medical prescription ((see the section "What are the warnings of Buscopan Compositum 10mg + 500mg 20 coated tablets?")). Pediatric population The use of Buscopan Compositum is not recommended in children under 10 years of age. The simultaneous administration of other drugs containing paracetamol may require a dosage adjustment (see the section "What are the warnings of Buscopan Compositum 10mg + 500mg 20 coated tablets?").

CONTRAINDICATIONS AND SIDE EFFECTS

When should Buscopan Compositum 10mg + 500mg 20 coated tablets not be used and what side effects can it cause?

Contraindications

Buscopan Compositum is contraindicated in case of: - hypersensitivity to the active ingredients (hyoscine N-butylbromide and paracetamol), to non-steroidal anti-inflammatory drugs or to any of the excipients (see the section "What is the composition of Buscopan Compositum 10mg + 500mg 20 coated tablets?"); - acute angle glaucoma; - prostatic hypertrophy or other causes of urinary retention; - mechanical stenosis of the gastrointestinal tract; - pyloric stenosis and other conditions that stenose the gastrointestinal tract; - paralytic or obstructive ileus; - megacolon; - ulcerative colitis; - reflux esophagitis; - intestinal atony in 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 hemolytic anemia; - severe hepatocellular insufficiency (Child - Pugh C). The use of Buscopan Compositum is contraindicated in cases of rare hereditary conditions that may be incompatible with an excipient of the product ((see the section "What are the warnings of Buscopan Compositum 10mg + 500mg 20 coated tablets?")). 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, less than 1/10 Uncommon: ≥ 1/1,000, less than 1/100 Rare: ≥ 1/10,000, less than 1/1,000 Very rare: less than 1/10,000 Not known: frequency cannot be estimated from the available data. Blood and lymphatic system disorders Not known: pancytopenia, agranulocytosis, thrombocytopenia, neutropenia, leukopenia, haemolytic anemia. Immune system disorders, skin and subcutaneous tissue disorders Uncommon: skin reactions, abnormal sweating, itching, nausea. Rare: erythema, decrease in blood pressure including shock. Very rare: urticaria, rash, exanthema, severe skin reactions (such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and generalized exanthematous pustulosis (AGEP)). Not known: anaphylactic shock, anaphylactic reactions, cutaneous drug reaction, dyspnoea, hypersensitivity, angioedema, fixed drug eruption. Cardiac diseases. 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 may 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, laryngeal edema have been reported. Furthermore, the following side effects have been reported: anemia, alterations in liver function and hepatitis, alterations affecting the kidney (acute renal failure, interstitial nephritis, hematuria, anuria), gastrointestinal reactions and dizziness. Drowsiness, mydriasis, accommodation disorders, increased ocular tone, constipation and difficulty urinating have also been reported. Additional adverse reactions only for suppositories Gastrointestinal disorders. Not known: anorectal discomfort. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance 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.

INTERACTIONS

Which medicines or foods can modify the effect of Buscopan Compositum 10mg + 500mg 20 coated tablets?

Use with extreme caution and under strict control during chronic treatment with drugs that can cause the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example, rifampicin, cimetidine, hypnotics and antiepileptics such as glutetimide, phenobarbital, carbamazepine, phenytoin). The same situation occurs with potentially hepatotoxic substances and alcohol abuse. Concomitant administration of chloramphenicol may induce a prolongation of the half-life of chloramphenicol, with the risk of increasing its toxicity. Paracetamol may increase the risk of bleeding in patients taking warfarin and other vitamin K antagonists. Patients taking acetaminophen and vitamin K antagonists should be monitored for appropriate clotting and 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 reduce leukocytes (neutropenia). Therefore Buscopan Compositum should be taken together with zidovudine only under medical supervision. Taking 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 concomitant administration with probenecid. Cholestyramine reduces the absorption of paracetamol. The anticholinergic effect of medicines such as tri- and tetracyclic antidepressants, antihistamines, antipsychotics, quinidine, amantadine, disopyramide and other anticholinergics (e.g. tiotropium, ipratropium, atropine-like substances) can be potentiated 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. Tachycardia induced by β-adrenergic drugs can be potentiated by Buscopan Compositum. The tachycardic effects of beta-adrenergic agents may be intensified by Buscopan Compositum. Interference with laboratory tests The intake of paracetamol can influence the determination of uric acid by the phosphotungstic acid method and blood sugar by the glucose oxidase-peroxidase method. In addition for oral use: Drugs that slow gastric emptying (e.g. propantheline) can reduce the speed of absorption of paracetamol, delaying its therapeutic effect; on the contrary, drugs that increase the speed of gastric emptying (e.g. metoclopramide or domperidone) lead to an increase in the speed of absorption of paracetamol.

PREGNANCY AND BREASTFEEDING

Can Buscopan Compositum 10mg + 500mg 20 coated tablets be used during pregnancy and breastfeeding?

Pregnancy There are no adequate data on the use of Buscopan Compositum during pregnancy. The long experience with the two substances in monotherapy 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. During pregnancy, potential data on paracetamol overdose have not shown an increased risk of malformations. Reproduction studies to investigate oral use have shown no signs suggesting malformations of foetotoxicity. Epidemiological studies on neurodevelopment 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 a careful examination of the risk-benefit ratio. During pregnancy, paracetamol should not be taken for prolonged periods, at 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 N-butylbromide during breastfeeding has not yet been established. Paracetamol is excreted in breast milk. However, it is foreseeable that at therapeutic doses it does not cause side effects in the newborn. The decision to continue or discontinue breastfeeding or to continue or discontinue therapy with Buscopan Compositum must be made considering the benefits of breastfeeding for the child and the benefits of therapy with Buscopan Compositum for the mother. Fertility No studies on the effects on fertility in humans have been conducted.

WARNINGS

What are the warnings of Buscopan Compositum 10mg + 500mg 20 coated tablets?

Warnings and precautions

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 occurs because these may be symptoms of a serious condition. If you experience severe abdominal pain of unknown origin that persists, worsens, or is accompanied by symptoms such as fever, nausea, vomiting, change in bowel movements, distended abdomen, drop in blood pressure, fainting, or blood in the stool, contact your doctor immediately. To prevent overdose, you must ensure that other medicines 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. Buscopan Compositum must be used with caution in case of: • glucose-6-phosphate dehydrogenase insufficiency; • liver dysfunction (e.g. due to chronic alcohol abuse, hepatitis); • chronic use of alcohol even in case of recent cessation; • impaired renal function; • Gilbert syndrome; • mild to moderate hepatocellular insufficiency (Child - Pugh A/B); • low glutathione reserves. Administer with caution in subjects with renal or hepatic insufficiency. In such conditions Buscopan Compositum must be administered only under medical supervision, if necessary, reducing the dose or prolonging the interval between individual administrations. Blood counts and renal and liver function should be monitored after prolonged use. The extensive use of analgesics, especially at high doses, can induce headache which must not be treated with increased doses of the medicine. 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: Potentially fatal reactions such as Stevens-Johnson syndrome (SSJ) and toxic epidermal necrolysis (TEN) have been reported with the use of Buscopan Compositum. Patients should be informed about the signs and symptoms and monitored carefully for skin reactions. If symptoms or signs of Stevens-Johnson syndrome, toxic epidermal necrolysis occur (e.g. progressive skin rash associated with blisters or mucosal lesions), the patient should immediately discontinue treatment with Buscopan Compositum and consult a doctor. Hepatotoxicity may occur with paracetamol even at therapeutic doses, after short-term treatment and in patients without pre-existing liver dysfunction ((see the section "When should Buscopan Compositum 10mg + 500mg 20 coated tablets not be used and what side effects can it cause?")). Abrupt discontinuation of analgesics after prolonged use at high doses may cause withdrawal symptoms (e.g. headache, tiredness, nervousness), which usually resolve within a few days. The resumption of analgesics must be subject to medical advice, and to the remission of withdrawal symptoms. Due to the potential risk of anticholinergic complications, it should be used with caution in patients predisposed to angle-closure glaucoma, in patients subject to intestinal or urinary tract obstructions and in those prone to tachyarrhythmia with autonomic central nervous system disorders, tachyarrhythmias, 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 medicine, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions may occur (see the section "How is Buscopan Compositum 10mg + 500mg 20 coated tablets taken?"). Invite the patient to contact the doctor before combining any other drug. See also (see section "Which medicines or foods can modify the effect of Buscopan Compositum 10mg + 500mg 20 coated tablets?"). Buscopan Compositum 10 mg + 500 mg tablets contains 4.32 mg sodium per tablet, i.e. less than 1 mmol (23 mg) sodium, therefore it is essentially “sodium-free”.

Overdose

Due to overdose of paracetamol, elderly people, young children, patients with liver disorders, chronic alcohol consumption or chronic malnutrition, as well as patients treated with enzyme-inducing medicines are subjected to an increased risk of intoxication, even with fatal outcome. Symptoms Hyoscine N-butylbromide In case of overdose, anticholinergic effects have been observed. Paracetamol In cases of chronic intoxication, hemolytic anemia, cyanosis, weakness, dizziness, paraesthesia, tremors, insomnia, headache, memory loss, irritative phenomena of the central nervous system, delirium and convulsions may occur. Symptoms usually appear 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 perhaps indicative of liver damage may persist; there may be a considerable increase in transaminases, jaundice, coagulation 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 may induce complete irreversible necrosis and subsequently hepatocellular failure, gastrointestinal bleeding, metabolic acidosis, encephalopathy and disseminated intravascular coagulation which may in turn progress to coma and death. Concurrent increases in hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin with reduction in prothrombin levels and an increase in prothrombin time have been observed, occurring 12 - 48 hours after ingestion. Clinical symptoms of liver injury are normally 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 occur after overdose with acetaminophen. 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 usual therapeutic principles. In case of respiratory paralysis, intubation and artificial respiration should be considered. Catheterization may be necessary 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 for longer. The plasma concentration of paracetamol can be lowered by dialysis. Quantitative analyzes of plasma paracetamol concentration are recommended. Further measures will depend on the severity, nature and course of the clinical symptoms of paracetamol intoxication and should follow standard intensive care protocols.

Driving vehicles and using machinery

No studies on the effects on the ability to drive and use machines have been performed. However, anticholinergics can induce visual accommodation disorders and drowsiness, which should be taken into account by those who drive vehicles or machinery or carry out jobs which require a high level of vigilance.

CONSERVATION

How is Buscopan Compositum 10mg + 500mg 20 coated tablets stored?

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

FORMAT

What is the format of Buscopan Compositum 10mg + 500mg 20 coated tablets?

20 coated tablets

DRUG LEGAL TEXT

Content responsibility

This sheet contains information that is not intended to replace a doctor's diagnosis or advice, as only the doctor can draw up any prescription and give therapeutic indications. All contents must be understood and are of an exclusively informative nature and aimed exclusively at bringing to the attention of customers or potential customers in the pre-purchase phase of the products sold through this site. In case of pathologies, disorders or allergies it is always best to consult your doctor first.

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