Summary of Product Characteristics (SmPC) - Dicycloverine Hydrochloride 10 mg / 5 ml oral solution
1 NAME OF THE MEDICINAL PRODUCT
Dicycloverine Hydrochloride 10mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml solution contains 10mg Dicycloverine hydrochloride This medicine contains 6 mg sodium benzoate (E211) and 1.26mg ethanol (alcohol) in each 5 ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral 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 doses (10 -20mg) three times daily before or after meals.
Children (2-12 years):
One 5ml dose (10mg) three times daily. Children (6 months - 2 years)
Half to one 5ml dose (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 water immediately prior to use.
4.3 Contraindications
Hypersensitivity to the active substance (s) or to any of the excipients listed in section
6.1.
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 oral solution 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.
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. 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 secreted 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 Website: www.mhra.gov.uk/yellowcard or search for MHRAYellow 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: 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; (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 stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium benzoate (E211), Sucralose (E955),
Citric acid monohydrate,
Chery Flavour
Raspberry Flavour
Vanilla Flavour (contains ethanol)
Blackcurrant Flavour (contains ethanol)
purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Type III amber colour glass bottle with white Polyethylene child resistant cap. Pack size: One bottle containing 120ml oral solution.
6.6 Special precautions for disposal
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Noumed Life Sciences Limited
Noumed House,
Shoppenhangers Road,
Maidenhead, Berkshire, SL6 2RB, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 44041/0091
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
02/01/2019 / 28/02/2025
10 DATE OF REVISION OF THE TEXT
28/02/2025