Dicycloverine Hydrochloride 10mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dicycloverine Hydrochloride 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dicycloverine hydrochloride 10 mg.
Excipient with known effect:
Dicycloverine Hydrochloride 10mg Tablets contain 59 mg lactose monohydrate/tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white flat, beveled edged, round, 6.5mm diameter tablets with “D1” debossed on one side.
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.
4.2 Posology and method of administration
Posology
Adult population (12 years and over):
One to two 10 mg tablets, three times daily, before or after meals; alternatively, for those patients on a 20 mg dose, one 20 mg tablet, three times daily, before or after meals.
Paediatric population:
Children (2years - 12 years):
One 10 mg tablet, three times daily, before or after meals.
Method of administration Oral.
4.3 Contraindications
Hypersensitivity to the active substance or to 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.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
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.
Breast-feeding:
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 to a nursing mother.
Fertility:
Reproduction studies have been performed in rats and rabbits at doses of up to 100 times the maximum recommended dose (based on 60mg/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.
4.7 Effects on ability to drive and use machines
Dicycloverine Tablets has no or negligible influence on the ability to drive and use machines. In rare cases it may cause dizziness, tiredness, or sleepiness, or blurred vision, and patients should be cautioned not to drive or operate machinery if affected.
4.8 Undesirable effects
Undesirable effects seldom occur with dicycloverine. However, in susceptible individuals, undesirable effects may occur, and are summarised following.
|
Organ Class |
Uncommon |
Rare |
|
(> 1 / 1,000 to < 1 / 100) |
(> 1 / 10,000, < 1 / 1,000) | |
|
Eye Disorders |
Blurred vision | |
|
Gastrointestinal |
Dry mouth |
Constipation |
|
System Disorders |
Nausea | |
|
Vomiting | ||
|
General Disorders |
Fatigue | |
|
Metabolic Disorders |
Thirst |
Anorexia |
|
Nervous System |
Dizziness |
Headache |
|
Disorders |
Sedation | |
|
Renal and Urinary System Disorders |
Dysuria | |
|
Skin Disorders |
Rash |
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:
Symptoms of dicycloverine overdosage are headache, dizziness, nausea, dry mouth, difficulty in swallowing, dilated pupils and hot dry skin.
Treatment:
Treatment may include emetics, gastric lavage and symptomatic therapy if indicated and appropriate.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for functional gastrointestinal disorders; 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;
• a specific anticholinergic effect (antimuscarinic at the ACh - receptor sites), and;
• 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
There is no additional information relevant to the prescriber that is not referred to elsewhere in the SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate,
Cellulose microcrystalline (E 460),
Starch, maize pregelatinised,
Magnesium stearate (E 470b).
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
Opaque, white 250 micron PVC blister with 20 micron aluminium lidding foil. Blisters containing either 7 or 10 tablets.
Packs of 50, 84, 90, 100, 168, or 180 tablets are available.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Morningside Healthcare Ltd,
115, Narborough Road,
Leicester, LE 3 0PA, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 20117/0256
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14/07/2016
10 DATE OF REVISION OF THE TEXT
14/07/2016