This information is intended for use by health professionals

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. 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

100 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 20046/0285

9. Date of first authorisation/renewal of the authorisation

24/10/2007

10. Date of revision of the text

17/01/2020