Dicycloverine Hydrocholoride 20mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dicycloverine Hydrocholoride 20mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dicycloverine hydrochloride 20mg
3 PHARMACEUTICAL FORM
Tablet.
Dicycloverine hydrochloride 20mg Tablets are white oval biconvex tablets with ‘S176’ 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
Route of administration: Oral
Adults and children over 12 years:
1 tablet three times a day before or after meals.
4.3 Contraindications
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.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Pregnancy and lactation
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. 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.
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 woman.
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 the 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 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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 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. The principal route of elimination is via the urine.
5.3 Preclinical safety data
None stated.
List of excipients
6.1
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 Solids
6.2 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
Container: Opaque blue 250 micron PVC blisters with aluminium foil 20 micron.
Pack Size: 84 tablets.
6.6 Special precautions for disposal
None stated
7 MARKETING AUTHORISATION HOLDER
Winthrop Pharmaceuticals UK Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
United Kingdom
Trading as: Winthrop Pharmaceuticals, PO Box 611, Guildford, Surrey, GU1 4YS, UK Or
Trading as: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 17780/0566
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 13th February 1986 Date of renewal: 13 th February 1991
10 DATE OF REVISION OF THE TEXT
24/04/2014