Summary of Product Characteristics (SmPC) - Dicycloverine Hydrochloride 20 mg tablets
1 NAME OF THE MEDICINAL PRODUCT
Dicycloverine Hydrochloride 20 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg dicycloverine hydrochloride.
Excipient(s) with known effect
Each tablet contains 75.80 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off white, round, biconvex tablets, engraved with “20” on one side and plain 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
Posology
Adults and children over 12 years: 1 tablet three times a day before or after meals.
Method of administration
Oral.
4.3 Contraindications
Hypersensitivity to dicycloverine hydrochloride or 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. Lactose
Dicycloverine Hydrochloride 20 mg Tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactose 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
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 hydrochloride. Since the risk of teratogenicity cannot be excluded with absolute certainty for any product, the drug should be used during pregnancy only if the benefit outweighs the risk.
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 during breast-feeding.
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
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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
Pharmacotherapeutic group: Drugs for functional gastrointestinal disorders, ATC code: A03AA07
Mechanism of action
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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Povidone K30
Maize Starch
Calcium Hydrogen Phosphate Anhydrous
Lactose Monohydrate (140 M)
Magnesium Stearate
6.2 Incompatibilities
None stated.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
Blisters of opaque PVC/PVDC lidded with aluminium foil.
Each blister contains 14 tablets.
Pack size: 84 tablets.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Zentiva Pharma UK Limited
12 New Fetter Lane
London
EC4A 1JP
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 17780/0987
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
21/02/2025
10 DATE OF REVISION OF THE TEXT
21/02/2025