This information is intended for use by health professionals

1. Name of the medicinal product

Dicycloverine Hydrochloride 10mg/5ml Oral Solution

2. Qualitative and quantitative composition

Dicycloverine Hydrochloride 10mg

3. Pharmaceutical form

Oral Solution

4. Clinical particulars
4.1 Therapeutic indications

Dicycloverine is a smooth muscle antispasmodic primarily indicated for treatment of functional conditions involving smooth muscle spasm of the gastrointestinal tract. The commonest of these are irritable colon (mucous colitis, spastic colon).

4.2 Posology and method of administration

Adults

One to two 5ml spoonfuls (10 - 20mg) three times daily before or after meals.

Children (2-12 years):

One 5ml spoonful (10mg) three times daily.

Children (6 months - 2 years)

5 - 10mg three or four times daily, 15 minutes before feeds. Do not exceed a daily dose of 40mg. If it is necessary to dilute Dicycloverine Syrup this may be done using Syrup or if diluted immediately prior to use with water.

4.3 Contraindications

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

Known idiosyncrasy to dicycloverine hydrochloride.

Infants under 6 months of age.

Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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. There are reports of infants, 3 months of age and under, administered dicycloverine hydrochloride syrup who have evidenced respiratory symptoms (breathing difficulty, shortness of breath, breathlessness, respiratory collapse, apnoea) as well as seizures, syncope, asphyxia, pulse rate fluctuations, muscular hypotonia and coma. The above symptoms have occurred within minutes of ingestion and lasted 20-30 minutes. The symptoms were reported in association with dicycloverine hydrochloride syrup therapy but the cause and effect relationship has neither been disproved or proved. The timing and nature of the reactions suggest that they were a consequence of local irritation and/or aspiration, rather than to a direct pharmacological effect. Although no causal relationship between these effects, observed in infants and dicycloverine administration has been established, dicycloverine hydrochloride is contra-indicated in infants under 6 months of age.

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 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.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 at: www.mhra.gov.uk/yellowcard.

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

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

Invert Syrup Medium

Citric Acid Monohydrate

Sodium Benzoate

Raspberry Flavour

Cherry Flavour (contains ethanol)

Blackcurrant Essence (contains ethanol)

Vanilla Essence (contains ethanol)

Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25'C. Should be stored and dispensed in amber glass bottles.

6.5 Nature and contents of container

Type III, EP amber glass bottles sealed with a polyethylene screw cap equiped with a polyethylene seal and pilferproof closure.

Pack sizes:

1 bottle containing 500ml syrup.

1 bottle containing 120ml syrup.

6.6 Special precautions for disposal and other handling

None stated.

7. Marketing authorisation holder

Zentiva Pharma UK Limited

12 New Fetter Lane

London

EC4A 1JP

United Kingdom

8. Marketing authorisation number(s)

PL 17780/0564

9. Date of first authorisation/renewal of the authorisation

16-03-2011

10. Date of revision of the text

22/06/2020