Dicycloverine 10 mg Tablets

Tablet White to off white, circular, flat beveled edge, uncoated tablet debossed with “S10” on one side and plain on other 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: 10-20 mg three times daily before or after meals. Children (2-12 years): 10 mg three times daily. **Method of administration** Oral4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.4.4 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 hydrochloride 10 mg Tablets contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction None stated.4.6 Fertility, pregnancy and lactation **Pregnancy:** Epidemiological studies in pregnant women with products containing dicycloverine hydrochloride (at doses up to 40 mg/day) have not shown that dicycloverine hydrochloride increases the risk of foetal abnormalities if administered during the first trimester of pregnancy. **Fertility:** Reproduction studies have been performed in rats and rabbits at doses of up to 100 times the maximum recommended dose (based on 60 mg per day for an adult person) and have revealed no evidence of impaired fertility or harm to the foetus due to dicycloverine. Since the risk of teratogenicity cannot be excluded with absolute certainty for any product, the drug should be used during pregnancy only if clearly needed. **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 to a nursing mother.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 at: www.mhra.gov.uk/yellowcard.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; Synthetic anticholinergics, esters with tertiary amino group, 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 After a single oral 20 mg 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. The principal route of elimination is via the urine.5.3 Preclinical safety data None stated.

6.1 List of excipients Lactose monohydrate Maize starch Povidone Purified talc Colloidal anhydrous silica Magnesium stearate6.2 Incompatibilities None stated.6.3 Shelf life 3 years6.4 Special precautions for storage This medicinal product does not require any special storage conditions.6.5 Nature and contents of container Dicycloverine Hydrochloride 10 mg Tablets are available in cartons containing Aluminium-PVC/PVDC White opaque blister packs of 100's along with a leaflet inside.6.6 Special precautions for disposal and other handling None stated.