This information is intended for use by health professionals

1. Name of the medicinal product

Dicycloverine Hydrochloride 10 mg Tablets

2. Qualitative and quantitative composition

Each tablet contains 10 mg dicycloverine hydrochloride.

Excipient(s) with known effect

Each tablet contains 37.90 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Tablet

White to off white, round, biconvex tablets, engraved with “10” on one side and plain 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.

Paediatric population

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

Method of administration Oral.

4.3 Contraindications

Hypersensitivity to dicycloverine hydrochloride or any of the excipients listed in Section 6.1.

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.

Dicycloverine Hydrochloride 10 mg Tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Fertility, pregnancy and lactation

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 hydrochloride. Since the risk of teratogenicity cannot be excluded with absolute certainty for any product, the drug should be used during pregnancy only if the benefit outweighs the risk.

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 during breast-feeding.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

Side-effects seldom occur with dicycloverine tablets. However, in susceptible individuals, dry mouth, thirst and dizziness may occur. On rare occasions, fatigue, sedation, blurred vision, rash, constipation, anorexia, nausea and vomiting, headache and dysuria have also been reported. 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 of Dicycloverine overdosage are headache, dizziness, nausea, dry mouth, difficulty in swallowing, dilated pupils and hot dry skin. 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

Mechanism of action

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

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.

5.3 Preclinical safety data

None stated.

6. Pharmaceutical particulars
6.1 List of excipients

Povidone K30

Maize Starch

Calcium Hydrogen Phosphate Anhydrous

Lactose Monohydrate (140 M)

Magnesium Stearate

6.2 Incompatibilities

None stated.

6.3 Shelf life

18 months

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

Blisters of opaque PVC/PVDC lidded with aluminium foil.

Each blister contains 10 tablets.

Pack size: 100 tablets.

6.6 Special precautions for disposal and other handling

None stated.

7. Marketing authorisation holder

Creo Pharma Limited

Felsted Business Centre,

Felsted,

Essex,

CM6 3LY,

United Kingdom

8. Marketing authorisation number(s)

PL 31862/0024

9. Date of first authorisation/renewal of the authorisation

16/10/2018

10. Date of revision of the text

16/10/2018