Dicycloverine hydrochloride 10 mg Tablets

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

Posology

Adult population (12 years and over):

One to two 10 mg tablets, three times daily, before or after meals; alternatively, for those patients on a 20 mg dose, one 20 mg tablet, three times daily, before or after meals.

Paediatric population:

Children (2 years – 12 years):

One 10 mg tablet, three times daily, before or after meals.

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, the Lapp 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.

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.

Fertility:

Reproduction studies have been performed in rats and rabbits at doses of up to 100 times the maximum recommended dose (based on 60mg/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.

Dicycloverine Tablets has no or negligible influence on the ability to drive and use machines. In rare cases it may cause dizziness, tiredness, or sleepiness, or blurred vision, and patients should be cautioned not to drive or operate machinery if affected.

Undesirable effects seldom occur with dicycloverine. However, in susceptible individuals, undesirable effects may occur, and are summarised following.

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 at: www.mhra.gov.uk/yellowcard Or search for MHRA Yellow Card in the Google Play or Apple App Store.

Symptoms:

Symptoms of dicycloverine overdosage are headache, dizziness, nausea, dry mouth, difficulty in swallowing, dilated pupils and hot dry skin.

Treatment:

Treatment may include emetics, gastric lavage and symptomatic therapy if indicated and appropriate.

Pharmacotherapeutic group: Drugs for functional gastrointestinal disorders; Synthetic anticholinergics, esters with tertiary amino group,

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;

• a specific anticholinergic effect (antimuscarinic at the ACh – receptor sites), and;

• a direct effect upon smooth muscle (musculotropic).

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.

There is no additional information relevant to the prescriber that is not referred to elsewhere in the SmPC.

Lactose monohydrate,

Cellulose microcrystalline (E 460),

Starch, maize pregelatinised,

Magnesium stearate (E 470b).

Not applicable.

3 years.

This medicinal product does not require any special storage conditions.

Opaque, white 250 micron PVC blister with 20 micron aluminium lidding foil. Blisters containing either 7 or 10 tablets.

Packs of 50, 84, 90, 100, 168, or 180 tablets are available.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.