দেশ: যুক্তরাজ্য
ভাষা: ইংরেজি
সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dicycloverine hydrochloride
Teva UK Ltd
A03AA07
Dicycloverine hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01020000; GTIN: 5017007021087
PVC/PVDC/AL BLISTERS _and PVC/PVdC/PVC _ _(amber)/Al blisters:_ This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT DICYCLOVERINE HYDROCHLORIDE TABLETS CONTAINS • The active substance in Dicycloverine Hydrochloride Tablets is dicycloverine. Each Dicycloverine Hydrochloride 10 mg Tablet contains 10 mg of dicycloverine hydrochloride. Each Dicycloverine Hydrochloride 20 mg Tablet contains 20 mg of dicycloverine hydrochloride. • The other ingredients are lactose monohydrate; cellulose, microcrystalline; starch, pregelatinised (maize); magnesium stearate. WHAT DICYCLOVERINE HYDROCHLORIDE TABLETS LOOK LIKE AND CONTENTS OF THE PACK • Dicycloverine Hydrochloride 10 mg Tablets are a round, white, biconvex tablet, 6 mm in diameter, 3.15 mm in thickness, marked with A151 on one side. Available in pack sizes of: 100 tablets. • Dicycloverine Hydrochloride 20 mg Tablets are a round, white, biconvex tablet, 8 mm in diameter, 3.60 mm in thickness, marked with A203 on one side. Available in pack sizes of: 84 tablets. MARKETING AUTHORISATION HOLDER: TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom MANUFACTURER: Actavis Ltd. BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta THIS LEAFLET WAS LAST REVISED IN 05/2019. PL 00289/2162 and PL 00289/2163 The following effects may happen: headache, feeling dizzy, feeling sick, dry mouth or difficulty in swallowing, blurred eyesight and hot dry skin. IF YOU FORGET TO TAKE DICYCLOVERINE HYDROCHLORIDE TABLETS If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. IF YOU STOP TAKING DICYCLOVERINE HYDROCHLORIDE TABLETS Keep taking Dicycloverine Hydrochloride until your doctor tells you to stop. Do not stop taking Dicycloverine Hydrochloride just because y সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dicycloverine hydrochloride 10 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg dicycloverine hydrochloride Excipient with known effect: Each 10 mg tablet contains lactose monohydrate 64.50 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Each 10 mg tablet is a round, white, biconvex tablet, 6 mm in diameter, 3.15 mm in thickness, marked with A151 on one side. 4 CLINICAL PARTICULARS 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 dicycloverine hydrochloride three times daily. _Children (2-12 years) _ 10 mg dicycloverine hydrochloride three times daily. Method of administration Oral use. The tablets should be taken before or after meals. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to 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. The tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total 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 fetal abnormalities if administered during the fi সম্পূর্ণ নথি পড়ুন