Buscopan compositum 10 mg + 800 mg - disease of the gastrointestinal tract 6 suppositories

Product Description

Buscopan compositum suppositories

Indications

Paroxysmal pain in gastrointestinal tract conditions, spastic pain, dyskinesia of the urinary and biliary tract, dysmenorrhea. One coated tablet contains: Active ingredients: N-butyl hyoscine bromide 10 mg, paracetamol 500 mg Buscopan Compositum 10 mg + 800 mg suppositories One suppository contains: Active ingredients: N-butyl hyoscine bromide 10 mg, paracetamol 800 mg

Excipients

Suppositories: glyceride esters of saturated fatty acids, soy lecithin.

Contraindications

Hypersensitivity to the active ingredients, to nonsteroidal 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 causing gastrointestinal tract stenosis, paralytic ileus, ulcerative colitis, megacolon. Reflux esophagitis. Intestinal atony in the elderly and debilitated subjects. Myasthenia gravis. Paediatric age. Paracetamol-based products are contraindicated in patients with manifest glucose-6-phosphate dehydrogenase insufficiency and in those affected by severe haemolytic anaemia. Severe hepatocellular insufficiency (Child-Pugh C). Administration of the drug is not recommended during the first trimester of pregnancy and during breastfeeding (see section 4.6). The use of the product is contraindicated in case of rare hereditary conditions that may be incompatible with an excipient of the product (see section 4.4).

How to use

Suppositories 1 suppository 3-4 times a day. Do not exceed 4 suppositories per day. Duration of treatment Buscopan compositum should not be taken for a prolonged period or in doses higher than those indicated, unless prescribed by a doctor. The use of Buscopan compositum is not recommended in children under 10 years of age. The concomitant administration of other drugs containing paracetamol may increase the risk of serious side effects. require a dosage adjustment.

Warnings

In case of severe abdominal pain of unknown origin that persists, worsens or is accompanied by symptoms such as fever, nausea, vomiting, altered bowel movements, distended abdomen, low blood pressure, fainting or blood in the stool, seek medical advice immediately. To prevent overdose, make sure that other medications taken at the same time do not contain paracetamol, one of the active ingredients of Buscopan compositum. 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 patients with renal or hepatic insufficiency. In such conditions, Buscopan compositum should be administered only 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. Extensive use of analgesics, especially at high doses, can induce headache that 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. Liver damage may occur if the recommended dosage is exceeded (see section 4.9). Abrupt discontinuation of analgesics after prolonged use at high doses can cause withdrawal symptoms (e.g., headache, tiredness, nervousness), which usually resolve within a few days. Resuming analgesics should be done only after medical advice and until withdrawal symptoms have resolved. Buscopan compositum should not be taken for more than 3 days unless directed by a doctor. If pain persists or worsens, if new symptoms occur, or if redness or swelling occurs, a doctor should be consulted as these could be symptoms of a serious condition. Due to the potential risk of anticholinergic complications, it should be used with caution in patients predisposed to narrow-angle glaucoma, in patients with intestinal or urinary tract obstruction, and in those prone to tachyarrhythmia with central autonomic nervous system disorders, tachyarrhythmias, arterial hypertension, congestive heart failure, and hyperthyroidism. All antimuscarinics reduce the volume of bronchial secretions; therefore, they should be used with caution in patients with chronic inflammatory obstructive pulmonary diseases. During treatment with paracetamol, before taking any other medication, check that it does not contain the same active ingredient, since serious adverse reactions may occur if paracetamol is taken in high doses; see section 4.2. Instruct the patient to contact their doctor before combining any other medication. See also section 4.5.

Interactions

Use with extreme caution and under close supervision during chronic treatment with drugs that can induce 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 can induce a prolongation of the half-life of chloramphenicol, with the risk of increasing its toxicity. Since the clinical relevance of paracetamol interactions with warfarin and coumarin derivatives has not yet been established, long-term use of Buscopan compositum in patients undergoing oral anticoagulant therapy should only occur under medical supervision. Concomitant use of paracetamol and zidovudine (AZT or retrovir) increases the tendency to reduce leukocyte counts (neutropenia). Therefore, Buscopan compositum should be taken together with zidovudine only under medical supervision. Probenecid inhibits the binding of paracetamol to glucuronic acid, thereby reducing paracetamol clearance 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. Paracetamol administration may increase the risk of serious side effects. interfere with the determination of uric acid levels (using the phosphotungstic acid method) and blood glucose levels (using the glucose-oxidase-peroxidase method). The anticholinergic effect of drugs such as tricyclic and tetracyclic antidepressants, antihistamines, antipsychotics, quinidine, amantadine, diisopyramide, and other anticholinergics (e.g., tiotropium, ipratropium, atropine-like substances) may be potentiated by Buscopan compositum. Concomitant treatment with dopamine antagonists, such as metoclopramide, may reduce the effect of both drugs on the gastrointestinal tract. Drug-induced tachycardia

Format

6 suppositories