Dicycloverine 20mg tablets

Tablets White oval biconvex tablets with 'S176'on one side.

4.1 Therapeutic indications Smooth muscle antispasmodic primarily indicated for treatment of functional conditions involving smooth muscle spasm of the gastrointestinal tract.4.2 Posology and method of administration **Posology** *Adults and children over 12 years:* 1 tablet three times a day before or after meals. **Method of administration** Oral4.3 Contraindications Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Known idiosyncrasy to dicycloverine hydrochloride.4.4 Special warnings and precautions for use Products containing dicycloverine hydrochloride should be used with caution in any patient with or suspected of having glaucoma or prostatic hypertrophy. Use with care in patients with hiatus hernia associated with reflux oesophagitis because anticholinergic drugs may aggravate the condition. **Dicycloverine contains lactose, sucrose and glucose.** Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction None stated4.6 Fertility, pregnancy and lactation **Pregnancy** Epidemiological studies in pregnant women with products containing dicycloverine hydrochloride (at doses up to 40mg/day) have not shown that dicycloverine hydrochloride increases the risk of foetal abnormalities if administered during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses of up to 100 times the maximum recommended dose (based on 60mg per day for an adult person) and have revealed no evidence of impaired fertility or harm to the foetus due to dicycloverine hydrochloride. Since the risk of teratogenicity cannot be excluded with absolute certainty for any product, the drug should be used during pregnancy only if the benefit outweighs the risk. **Breast-feeding** It is not known whether dicycloverine is secreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dicycloverine is administered during breast-feeding.4.7 Effects on ability to drive and use machines None stated.4.8 Undesirable effects Side-effects seldom occur with dicycloverine tablets. However, in susceptible individuals, dry mouth, thirst and dizziness may occur. On rare occasions, fatigue, sedation, blurred vision, rash, constipation, anorexia, nausea and vomiting, headache and dysuria have also been reported. **Reporting of suspected adverse reactions** Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose **Symptoms** of dicycloverine overdosage are headache, dizziness, nausea, dry mouth, difficulty in swallowing, dilated pupils and hot dry skin. **Treatment** may include emetics, gastric lavage and symptomatic therapy if indicated.

5.1 Pharmacodynamic properties Pharmacotherapeutic group: Drugs for functional gastrointestinal disorders, ATC code: A03AA07 Dicycloverine hydrochloride relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism; (1) a specific anticholinergic effect (antimuscarinic at the ACh-receptor sites) and (2) a direct effect upon smooth muscle (musculotropic).5.2 Pharmacokinetic properties **Distribution and Biotransformation** After a single oral 20mg dose of dicycloverine hydrochloride in volunteers, peak plasma concentration reached a mean value of 58ng/ml in 1 to 1.5 hours. 14C labelled studies demonstrated comparable bioavailability from oral and intravenous administration. **Elimination** The principal route of elimination is via the urine.5.3 Preclinical safety data None stated.

6.1 List of excipients Lactose Calcium Hydrogen Phosphate Icing Sugar\* Maize Starch Glucose Liquid\\ Magnesium Stearate Purified Water \* mixture of Sucrose 97% Starch 3% \\ equivalent to 4.8mg Glucose Solids6.2 Incompatibilities None stated.6.3 Shelf life 5 years.6.4 Special precautions for storage Do not store above 25°C.6.5 Nature and contents of container Opaque blue 250 micron PVC blisters with aluminium foil 20 micron. Pack size: 84 tablets.6.6 Special precautions for disposal and other handling Not applicable