Dicycloverine

Dicycloverine Hydrochloride 20mg Tablets

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.

Tablet

White to off-white, round flat bevelled edged tablets with '20' embossed on one side and scoring on the other.

Smooth muscle antispasmodic primarily indicated for treatment of functional conditions involving smooth muscle spasm of the gastrointestinal tract.

Posology

Adults: 10-20mg three times daily before or after meals.

Children (2-12 years): 10mg three times daily.

Method of administration

Oral

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Known idiosyncrasy to dicycloverine hydrochloride

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.

No interaction studies have been performed.

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.

Not relevant

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

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.

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.

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).

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.

Not relevant

Lactose monohydrate

Maize Starch

Povidone K-30

Magnesium stearate

Talc

Colloidal anhydrous silica

Not applicable

36 months

Do not store above 25°C.

84 tablets are packed in opaque blue PVC/PVdC//Aluminium blisters.

Not applicable

Focus Pharmaceuticals Limited

Dashwood House

69 Old Broad Street

London

EC2M 1QS

UK

PL 20046/0286

24/10/2007

19/01/2024

DOSIMETRY

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INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

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