This information is intended for use by health professionals

1. Name of the medicinal product

Dicycloverine Oral Solution

2. Qualitative and quantitative composition

Dicycloverine Hydrochloride 10mg/5ml

3. Pharmaceutical form

Solution

4. Clinical particulars
4.1 Therapeutic indications

Dicyloverine 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 Dicyloverine Oral Solution this may be done using Syrup or if diluted immediately prior to use with water.

4.3 Contraindications

Known idiosyncrasy to dicycloverine hydrochloride. Infants under 6 months of age.

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 oral solution 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.

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

4.5 Interaction with other medicinal products and other forms of interaction

None

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. 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.

It is not known whether dicycloverine is secreted in human milk. Because many drugs are secreted 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

None

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 Website: 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

Not relevant.

6. Pharmaceutical particulars
6.1 List of excipients

Sodium benzoate

Sucrose (40-80#)

Citric acid monohydrate

Sodium Citrate

Flavour Cherry – ST4545/25

Flavour Raspberry – AF – 2283

Flavour Vanilla – AF – 2268

Flavour Blackcurrant – AF – 2285

6.2 Incompatibilities

Not applicable

6.3 Shelf life

24 months

6.4 Special precautions for storage

Do not store above 25°C. Store in the original container.

6.5 Nature and contents of container

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

Pack size: 1 bottle containing 120ml syrup.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Marketing authorisation holder

Focus Pharmaceuticals limited

Capital House

85 King William Street

London

EC4N 7BL

UK

8. Marketing authorisation number(s)

PL 20046/0287

9. Date of first authorisation/renewal of the authorisation

18/05/2009

10. Date of revision of the text

01/10/2015

11 Dosimetry

IF APPLICABLE

12 Instructions for preparation of radiopharmaceuticals

IF APPLICABLE