Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dicycloverine hydrochloride
Thame Laboratories Ltd
A03AA07
Dicycloverine hydrochloride
2mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01020000; GTIN: 5055935100023 5055935100030 5055935100047
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. ► Keep this leaflet. You may need to read it again. ► If you have any further questions, ask your doctor or pharmacist. ► This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. ► If you get any side effects, talk to your doctor or pharmacist. This inc ludes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Dicycloverine Hydrochloride 10mg/5ml Oral Solution but it will be referred as Dicycloverine throughout this leaflet. WHAT IS IN THIS LEAFLET? 1. WHAT DICYCLOVERINE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICYCLOVERINE 3. HOW TO TAKE DICYCLOVERINE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DICYCLOVERINE 6. CO NTENTS OF THE PACK AND OTHER INFORMATION Dicycloverine contains the active substance dicycloverine hydrochloride. This belongs to a group of medicines called antispasmodics. Dicycloverine is used to treat: Cramps Pain in the stomach or intestine (gut) Stomach or intestine (gut) problems – such as irritable bowel. HOW DICYCLOVERINE WORKS Dicycloverine works by relaxing the muscles in your stomach and gut (intestine). It stops sudden musc le contractions (spasms). In doing this, it relieves cramps, pain, bloating, wind and discomfort. DO NOT TAKE DICYCLOVERINE IF: ► You are allergic (hypersensitive) to dicycloverine or any of the other ingredients of this medicine (listed in section 6) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING DICYCLOVERINE IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING CONDITIONS: ► You have glaucoma (signs include painful eyes with blurred vision) ► You have an enlarged prostate ► You have indigestion or heart burn caused by a ‘hia Aqra d-dokument sħiħ
OBJECT 1 DICYCLOVERINE HYDROCHLORIDE 10MG/5ML ORAL SOLUTION Summary of Product Characteristics Updated 02-Feb-2018 | Thame Laboratories 1. Name of the medicinal product Dicycloverine Hydrochloride 10mg/5ml Oral Solution 2. Qualitative and quantitative composition Dicycloverine Hydrochloride Oral Solution contains the active ingredient, dicycloverine hydrochloride. Each 5ml solution contains 10mg dicycloverine hydrochloride. Excipients with known effect: Each 5ml solutioncontains 14.735mg of propylene glycol (E1520) and 3.696gof mixture of fructose, glucose and sucrose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral solution Clear, light yellow to yellow solution with a strawberry flavour 4. Clinical particulars 4.1 Therapeutic indications Dicycloverine Hydrochloride is a smooth muscle antispasmodic primarily indicated for treatment of functional conditions involving smooth muscle spasm of the gastrointestinal tract. The commonest of these are irritable colon (mucous colitis, spastic colon). 4.2 Posology and method of administration Adults 5-10ml (10 - 20mg) three times daily before or after meals. Children (2-12 years): 5ml (10mg) three times daily. Children (6 months - 2 years) 2.5-5ml (5 - 10mg) three or four times daily, 15 minutes before feeds. Do not exceed a daily dose of 20ml (40mg). Children (0 – 6 months) Do not give this medicine to children under 6 months of age METHOD OF ADMINISTRATION: ► Use the 2.5-5ml double-ended spoon supplied in the pack (see below) to measure the required dose. ► Swallow the solution. ► Wash the spoon with clean water after taking every dose. DOUBLE-ENDED SPOON 4.3 Contraindications Known idiosyncrasy to dicycloverine hydrochloride. Infants under 6 months of age. This medicine contains invert sugar. Patients with rare hereditary problems of fructose intolerance or glucose galactose malabsorption should not take this medicine. This medicine contains 3.696g of a mixture of fructose, glucose and sucrose per dose (5ml). This should be taken in Aqra d-dokument sħiħ