Each tablet contains dicycloverine hydrochloride 20mg
Excipient(s) with known effect
Each tablet contains 101.0 mg 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 '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
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. Pharmacological properties
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
84 tablets are packed in opaque blue PVC/PVdC//Aluminium blisters.
6.6 Special precautions for disposal and other handling
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
10. Date of revision of the text
17/01/2020
11. DOSIMETRY
IF APPLICABLE
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
IF APPLICABLE
ADVANZ Pharma
Address
Dashwood House, 69 Old Broad Street, London, EC2M 1QS, UK