Buscopan 10mg 20 tablets

Form

tableti

Dosage mg

10

Pack

20

BUSCOPAN® 10 mg film-coated tablets Opella Product Summary 1. Name of the medicinal product BUSCOPAN® 10 mg film-coated tablets 2. Qualitative and quantitative composition Active substance Hyoscine-N-butylbromide 10 mg Methyl parahydroxybenzoate 0.005 mg Propyl parahydroxybenzoate 0.002 mg Excipients Sucrose 41.187 mg For excipients, see section 6.1. See blog: Buscopan – Get rid of abdominal cramps in the shortest time 3. Pharmaceutical form White, round, biconvex, sugar-coated tablet 4. Clinical particulars 4.1. Therapeutic indications Used for spasms of the gastrointestinal tract, spasms and dyskinesia of the biliary tract, spasms of the genitourinary system. 4.2. Posology and method of administration Dosage Unless otherwise prescribed by a doctor, the recommended dosage is: Adults: 1-2 film-coated tablets 3-4 times a day. Children aged 6-12 years: 1 film-coated tablet 3 times a day. Frequency and duration of use The preparation is used with the frequency and duration determined by the doctor. Method of administration For oral use. The film-coated tablets should be swallowed whole, without chewing, with a glass of water. Additional information on special populations Renal/hepatic impairment In patients with impaired liver and kidney function, the preparation should be used with caution under medical supervision. Paediatric population Not recommended for use in children under 6 years of age. Geriatric population There is no specific information on its use in elderly patients. Volunteers over 65 years of age were also included in clinical studies, and no age-specific adverse effects were observed. 4.3. Contraindications Hypersensitivity to hyoscine-N-butylbromide or any of the excipients. Narrow-angle glaucoma, urinary retention with bladder outlet obstruction (e.g., benign prostatic hyperplasia), mechanical stenoses in the digestive tract, paralytic or obstructive ileus, tachycardia and tachyarrhythmia, megacolon, myasthenia gravis 4.4. Special warnings and precautions for use It should be used with caution in patients at risk of developing tachyarrhythmia, such as thyrotoxicosis, heart failure, and cardiac surgery. In such cases, Buscopan should only be used under medical supervision and, if necessary, the dose should be reduced or doses taken less frequently. If severe abdominal pain becomes persistent or worsens, or if severe abdominal pain is accompanied by symptoms such as fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, low blood pressure, weakness, or bloody stools, a doctor should be consulted immediately. Excipients Buscopan contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take this medicine. In addition, due to the parahydroxybenzoates it contains, it may cause allergic reactions (possibly delayed). 4.5. Interaction with other medicinal products and other forms of interaction Buscopan may enhance the anticholinergic effects of tricyclic and tetracyclic antidepressants, antihistamines, antipsychotics, quinidine, amantadine, butyrophenones, phenothiazines, disopyramide, and other anticholinergic agents (e.g., tiotropium, ipratropium, and atropine-like compounds). When used with dopamine antagonists, such as metoclopramide, the effect of both drugs on gastrointestinal motility may be reduced. Buscopan can increase the tachycardic effect of beta-adrenergic agents. Additional information on special populations No special data available. Paediatric population No special data available. 4.6. Pregnancy and lactation General advice Pregnancy Category: C. Women of reproductive potential / Contraceptives There is insufficient data on the use of Buscopan film-coated tablets in women of reproductive potential. Pregnancy There is insufficient data or experience with the use of hyoscine-N-butylbromide in pregnant women. Animal studies are insufficient regarding pregnancy/and/or embryonic/foetal development and/or birth/and/or postnatal development (see section 5.3). The potential risk to humans is unknown. As a precaution, the use of Buscopan should be avoided during pregnancy. Lactation Anticholinergic agents may inhibit lactation. It is unknown whether hyoscine-N-butylbromide or its metabolites are excreted in breast milk. Newborns have an increased response to some anticholinergic agents. A risk to newborns/infants cannot be excluded. A decision should be made whether to discontinue breastfeeding or to discontinue treatment with Buscopan, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother. Reproductive toxicity/fertility No studies have been conducted on the effect on human fertility (see section 5.3). 4.7. Effects on ability to drive and use machines There is no information on its effect on driving and operating machinery; normally, no impairment is expected in patients taking Buscopan at the recommended dose. However, if symptoms such as fatigue, dizziness, and difficulty with near vision occur, the ability to drive and operate machinery may be adversely affected. Some patients may experience impaired adaptation to near and far vision. Patients with signs of visual impairment should not drive or operate machinery. 4.8. Adverse effects The frequency of adverse effects listed below is defined as follows by system organ class: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (<1/10,000), unknown (cannot be estimated from available data). Most of the adverse effects observed during Buscopan treatment may be attributed to its anticholinergic effect. Immune system disorders Uncommon: skin reactions (e.g., urticaria and itching) Unknown: hypersensitivity reactions, dyspnea, anaphylactic reactions, anaphylactic shock with redness and hypotension, rash, erythema of the skin. Eye disorders Very rare: accommodation disorders, acute glaucoma attack, especially in hypermetropic patients, if the disorder is not corrected. Cardiac disorders Uncommon: tachycardia Vascular disorders Uncommon: low blood pressure, dizziness Gastrointestinal disorders Uncommon: dry mouth (reduced salivation), diarrhea, nausea, vomiting, stomach discomfort. Skin and subcutaneous tissue disorders Uncommon: dry skin (reduced sweating) Kidney and urinary tract disorders Rare: difficulty urinating (e.g., urinary retention and dysuria) General disorders and administration site conditions Uncommon: fatigue Reporting of suspected adverse reactions is important after the medicinal product is authorised. It allows for continuous monitoring of the benefit/risk balance of the medicinal product. 4.9. Overdose and treatment Symptoms To date, no intoxication symptoms have been observed in humans after acute overdose. Overdose may cause anticholinergic effects such as visual disturbances, tachycardia, dry mouth, urinary retention, and erythema of the skin. In animal studies, ataxia, tremor, dyspnea, and anticholinergic effects (mydriasis, dry mucous membranes, tachycardia, and reduced gastrointestinal motility with accumulation of food in the stomach and intestines) occurred after administration of extremely high doses. Respiratory arrest led to death. Treatment Since no cases of Buscopan poisoning are known to date, the precautions listed below are based on theoretical considerations: In case of oral poisoning, gastrointestinal decontamination is indicated. In case of glaucoma, topical pilocarpine should be used and an ophthalmologist should be consulted immediately. If necessary, parasympathomimetic agents (neostigmine 0.5-2.5 mg intramuscularly or IV) may be administered. Cardiovascular complications should be managed according to classical treatment principles. In case of respiratory paralysis, intubation and artificial respiration should be considered. In case of urinary retention, catheterization may be necessary. In addition, appropriate supportive measures should be taken if necessary. Pharmacological properties 5.1. Pharmacodynamic properties Pharmacotherapeutic group: Belladonna alkaloids (semi-synthetic, quaternary ammonium compounds) Hyoscine-N-butylbromide is a semi-synthetic derivative of scopolamine, which occurs naturally in plants. As a quaternary ammonium derivative, hyoscine butylbromide does not cross the central nervous system. However, it has peripheral anticholinergic effects due to the inhibition of ganglionic transmission and muscarinic receptors in smooth muscle cells. Hyoscine butylbromide administered orally or rectally has a spasmolytic effect on the smooth muscles of the gastrointestinal, biliary, and urinary tracts. The clinically proven efficacy of the preparation in spasmodic abdominal pain is due to its specific local action on nicotinic and muscarinic acetylcholine receptors in the muscular layer of the gastrointestinal tract. 5.2. Pharmacokinetic properties Absorption Due to the quaternary nitrogen atom, hyoscine-N-butylbromide is absorbed in limited amounts after oral and rectal administration. The mean absolute bioavailability of 100 mg hyoscine-N-butylbromide (e.g., administered as a film-coated tablet, suppository, or drops) is less than 1%. Results from animal studies indicate that the effect of hyoscine-N-butylbromide administered orally and rectally is a specific local effect. Distribution Hyoscine-N-butylbromide has a high affinity for muscarinic and nicotinic acetylcholine receptors and is suitable for parenteral administration. After administration, it is distributed primarily in smooth muscle cells and in the intramural ganglia of the abdominal and pelvic organs. Plasma protein binding is approximately 4.4%. Hyoscine-N-butylbromide has weak interaction with the choline transporter system in cultured human placental epithelial cells (Ki = 0.63 mM/L). Hyoscine-N-butylbromide does not cross the blood-brain barrier and has low plasma protein binding, but there is no clinical data on this effect. Biotransformation After single oral administration of 100 and 400 mg, the terminal elimination half-life ranges from 6.2 to 10.6 hours. The main metabolic pathway of hyoscine-N-butylbromide is hydrolytic cleavage of the ester bond. Elimination Hyoscine-N-butylbromide administered orally is excreted in faeces and urine. Approximately 90% of radioactivity was detected in faeces after oral administration. Radioactivity detected in urine varies depending on the route of administration but does not exceed 5%. Mean clearance values after oral doses of 100-400 mg ranged from 881 to 1420 L/min, and the volume of distribution after these doses was 6.13 to 11.3 x 105 L (considering low systemic availability). Metabolites excreted in urine are very weakly bound to muscarinic receptors and therefore are unlikely to contribute to the effect of the preparation. Linearity/non-linearity Not available. Special characteristics of patients No special characteristics are observed 5.3. Preclinical safety data Acute and chronic toxicity Acute and chronic toxicity studies have not revealed any effects related to the therapeutic use of hyoscine-N-butylbromide. In a 39-week toxicity study in dogs, the NOAEL (no observed adverse effect level) after oral administration was 30 mg/kg. Mutagenic and carcinogenic potential Hyoscine-N-butylbromide showed no mutagenic or clastogenic properties in the Ames test, an in vitro gene mutation assay in V-79 cells, or an in vitro chromosome aberration test in human lymphocytes. The preparation was not found to be genotoxic in an in vivo bone marrow micronucleus assay in rats. Long-term studies in animals investigating carcinogenic potential have not been conducted. However, two chronic toxicity studies in rats at doses up to 1000 mg/kg for 26 weeks showed no evidence of carcinogenic potential. Reproductive toxicity Hyoscine-N-butylbromide showed no teratogenic effects in rats and mice in embryotoxicity studies. Fertility was not impaired in rats. Studies on prenatal or postnatal development with hyoscine-N-butylbromide have not been conducted. Pharmaceutical properties 6.1. List of excipients Sucrose Dibasic calcium phosphate Starch Soluble corn starch Colloidal silicon dioxide Tartaric acid Stearic acid Polyvinylpyrrolidone (povidone) Talc Acacia Methyl parahydroxybenzoate Propyl parahydroxybenzoate Polyethylene glycol 6000 Carnauba wax White wax 6.2. Incompatibilities None reported 6.3. Shelf life 36 months. 6.4. Special precautions for storage Store the preparation at a temperature not exceeding 30°C, protected from light. 6.5. Dosage form and contents 20 and 50 film-coated tablets are packed in opaque PVC/aluminium blister packs. 6.6. Disposal of unused medicinal products and other special precautions Unused products or waste should be disposed of in accordance with the "Regulations on the Control of Medical Waste" and the "Regulations on the Control of Packaging Waste".