Dicycloverine Hydrochloride 10mg/5ml Oral Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dicycloverine Hydrochloride 10mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 10 mg dicycloverine hydrochloride.
Excipients with known effect:
Sodium benzoate (E 211): 6.0 mg/5 ml Invert syrup: 4.25 g/5 ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution.
Clear to pale yellow coloured liquid, with a characteristic odour and taste.
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):
5 to 10 ml (10 mg - 20 mg), three times daily, before or after meals.
Paediatric population :
Children (2 years - 12 years):
5 ml (10 mg), three times daily, before or after meals.
Children (6 months - 2years):
5 mg - 10 mg three or four times daily, 15 minutes before feeds. Do not exceed a daily dose of 40 mg.
Infants (6 months or younger):
Dicycloverine is contraindicated in infants less than six (6) months of age (see section 4.3).
Method of administration For oral administration.
Directions for opening the bottle and using the pipette for Dicycloverine Oral Solution
Instructions for opening the bottle and using the dosing syringe
• Remove cap from the bottle.
• Fit the adaptor into the neck of the bottle, it is not necessary to remove after use.
• While the bottle is sitting on a firm, flat surface, hold it steady with one hand.
With the other hand insert the tip of the syringe into the adaptor.
• Invert the bottle (turn upside-down).
• Slowly pull back the plunger of the syringe until the mark that matches the number of mg or ml to be taken is just visible.
• If large bubbles can be seen in the syringe, slowly push the plunger back into the syringe. This will force the medicine back into the bottle. Repeat the above step again.
• Return the bottle to its original position, and remove the dosing syringe.
• The contents of the syringe may be emptied directly into the mouth by slowly pushing down the plunger of the syringe.
• Close the bottle.
• Rinse the dosing syringe with water.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Infants aged six months or younger. 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.
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 fructose intolerance, glucose galactose malabsorption or sucrase - isomaltase insufficiency should not take this medicine.
This product contains sodium benzoate; which mayresult in increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).
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 40 mg/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 60 mg/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 Oral Solution 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
Invert Syrup,
Citric acid monohydrate (E 330),
Sodium benzoate (E 211),
Cherry flavour (contains acetic acid (E 260), propylene glycol (E 1520) and triethyl citrate (E 1505)),
Vanilla flavour (contains propylene glycol (E 1520)),
Blackcurrant flavour (contains propylene glycol (E 1520)),
Raspberry flavour (contains acetic acid (E 260), propylene glycol (E 1520), triacetin (E 1518)),
Purified water.
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf life
2 years.
Discard 6 months after opening.
6.4 Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Keep the bottle in the outer carton.
6.5 Nature and contents of container
Amber, type III glass bottles with white opaque HMHDPE Roll on Pilfer Proof (ROPP) child resistant closure with LDPE wad.
Amber Polyethylene Terephthalate (PET) bottles with white opaque HMHDPE (ROPP) Roll on Pilfer Proof child resistant closure with LDPE wad.
Pack sizes: 100 ml, 120 ml and 150 ml with a dosing pipette. Not all pack sizes may be marketed.
Special precautions for disposal
6.6
7
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
MARKETING AUTHORISATION HOLDER
Morningside Healthcare Ltd 115 Narborough Road Leicester LE3 0PA United Kingdom
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MARKETING AUTHORISATION NUMBER(S)
PL 20117/0255
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14/07/2016
DATE OF REVISION OF THE TEXT
14/07/2016