Dicycloverine Hydrochloride 20mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dicycloverine Hydrochloride 20mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains dicycloverine hydrochloride 20mg
3 PHARMACEUTICAL FORM
Tablet
White to off-white, round flat bevelled edged tablets with ‘20’ embossed on one side and scoring on the other.
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
Adults: 10-20mg three times daily before or after meals. Children (2-12 years): 10mg three times daily.
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
4.6 Fertility, 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 mother.
Effects on ability to drive and use machines
4.7
None
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 tablets 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
Not relevant
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate Maize Starch Povidone K-30 Magnesium stearate Talc
Colloidal anhydrous silica
6.2 Incompatibilities
Not applicable
6.3 Shelf life
36 months
6.4 Special precautions for storage
Do not store above 25 °C.
6.5 Nature and contents of container
84 tablets are packed in opaque blue PVC/PVdC//Aluminium blisters.
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Focus Pharmaceuticals Limited
Capital House
85 King William Street
London
EC4N 7BL
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 20046/0286
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24/10/2007
DATE OF REVISION OF THE TEXT
10
13/04/2016
11 DOSIMETRY (IF APPLICABLE)
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)