Dicycloverine

Dicycloverine Oral Solution

Dicycloverine Hydrochloride 10mg/5ml

Excipient(s) with known effect

Each 5ml of oral solution contains

Sucrose: 2.33g

Sodium benzoate: 1.25mg

For the full list of excipients, see section 6.1

Solution

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).

Posology

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.

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. Infants under 6 months of age.

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

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 secreted 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 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.

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

Not applicable

24 months

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

No special requirements.

Focus Pharmaceuticals limited

Dashwood House

69 Old Broad Street

London

EC2M 1QS

UK

PL 20046/0287

18/05/2009

18/01/2024

DOSIMETRY

IF APPLICABLE

INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

IF APPLICABLE