Summary of Product Characteristics (SmPC) - Dicycloverine Hydrochloride 10 mg tablets
1 NAME OF THE MEDICINAL PRODUCT
Dicycloverine Hydrochloride 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains dicycloverine hydrochloride 10mg
Excipient(s) with known effect
Each tablet contains 50.5mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off-white, round flat bevelled edged tablets with ‘10’ embossed 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: 10-20mg three times daily before or after meals.
Children (2-12 years): 10mg three times daily.
Method of administration
Oral
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.
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
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
Pregnancy
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.
Breast-feeding
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.
4.7 Effects on ability to drive and use machines
Not relevant
4.8 Undesirable effects
The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention:
Rare (≥1/10,000 to <1/1,000)
Not known: frequency cannot be estimated from the available data
| MedDRA system organ class database | Frequency | Adverse reactions |
| Nervous system disorders | Rare | Sedation, headache |
| Not known | Dizziness may occur | |
| Metabolism and nutrition disorders | Rare | Anorexia |
| Eye disorders | Rare | Blurred vision |
| Gastrointestinal disorders | Not known | Dry mouth |
| Rare | Constipation, nausea, vomiting | |
| Renal and urinary disorders | Rare | Dysuria |
| Skin and subcutaneous tissue disorders | Rare | Rash |
General disorders and administration site conditions | Rare | Fatigue |
| Not known | Thirst |
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
Symptoms of dicycloverine tablets overdosage are headache, dizziness, nausea, dry mouth, difficulty in swallowing, dilated pupils and hot dry skin.
Management
Treatment may include emetics, gastric lavage and symptomatic therapy if indicated.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for functional gastrointestinal disorders, ATC code: A03AA07
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
Distribution and Biotransformation
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.
Elimination
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
100 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
Dashwood House
69 Old Broad Street
London
EC2M 1QS
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 20046/0285
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06/06/2025
10 DATE OF REVISION OF THE TEXT
06/06/2025