- Approval Id
- 517603a531de31a1
- Drug Approval Emc Name
- Dicycloverine 10mg tablets
- Drug Name
- Dicycloverine 10mg tablets
- Company Address
- First Floor, Andrews House, College Road, Guildford, Surrey, GU1 4QB, UK
- Company Website
- https://www.zentiva.co.uk/contact/mi-form
- Company Medical Info Direct Line
- +44 (0)800 090 2408
- Company Medical Info Email
- UKMedInfo@zentiva.com
- Company Customer Care Direct Line
- +44 (0)844 8793 188
- Atc Code
- A03AA07
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Zentiva Pharma UK Limited
12 New Fetter Lane
London
EC4A 1JP
United Kingdom
- Authorisation Number
- PL 17780/0565
- Authorisation Date
- 19/04/2011
- Instruction Authorisation Holder
- Zentiva Pharma UK Limited
12 New Fetter Lane
London
EC4A 1JP
United Kingdom
- Instruction Authorisation Number
- PL 17780/0565
- Instruction Authorisation Date
- 19/04/2011
- Instruction Composition
- Each tablet contain 10 mg of dicycloverine hydrochloride
\*\*Excipients with known effect:\*\*
Each tablet contains 126.5 mg lactose, 49.50 mg sucrose and 6.10 mg glucose liquid.
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Tablets
White, round, biconvex tablets with a 'M' in two concentric circles on one side
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
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\*\*
\*Adults:\* 10-20mg three times daily before or after meals.
\*Children (2-12 years):\* 10mg three times daily.
\*\*Method of administration\*\*
Oral4.3 Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1
Known idiosyncrasy to dicycloverine hydrochloride.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.
\*\*Dicycloverine hydrochloride Tablets contain lactose, sucrose and glucose.\*\*
Patients with rare hereditary problems of fructose intolerance, rare glucose-galactose malabsorption or sucrase-isomaltase insufficency should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction
None stated.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. 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 hydrochloride. 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..
\*\*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 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 tablets. 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow 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.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
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).5.2 Pharmacokinetic properties
\*\*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.5.3 Preclinical safety data
None stated.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Lactose
Calcium Hydrogen Phosphate
Icing Sugar\\*
Maize Starch
Glucose Liquid\\*\\*
Magnesium Stearate
Purified Water
\\* mixture of Sucrose 97%
Starch 3%
\\*\\* equivalent to 4.8mg Glucose Solids6.2 Incompatibilities
Not applicable6.3 Shelf life
5 years.6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
Opaque blue 250 micron PVC blisters with aluminium foil 20 micron, or securitainers, or amber glass bottles with wadded U/F caps.
Pack size: 100 tablets.6.6 Special precautions for disposal and other handling
Not applicable
- Instruction Content
- ## Composition
Each tablet contain 10 mg of dicycloverine hydrochloride
\*\*Excipients with known effect:\*\*
Each tablet contains 126.5 mg lactose, 49.50 mg sucrose and 6.10 mg glucose liquid.
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Tablets
White, round, biconvex tablets with a 'M' in two concentric circles on one side
## Clinical Particulars
4.1 Therapeutic indications
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\*\*
\*Adults:\* 10-20mg three times daily before or after meals.
\*Children (2-12 years):\* 10mg three times daily.
\*\*Method of administration\*\*
Oral4.3 Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1
Known idiosyncrasy to dicycloverine hydrochloride.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.
\*\*Dicycloverine hydrochloride Tablets contain lactose, sucrose and glucose.\*\*
Patients with rare hereditary problems of fructose intolerance, rare glucose-galactose malabsorption or sucrase-isomaltase insufficency should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction
None stated.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. 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 hydrochloride. 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..
\*\*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 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 tablets. 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow 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.
## Pharmacological Properties
5.1 Pharmacodynamic properties
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).5.2 Pharmacokinetic properties
\*\*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.5.3 Preclinical safety data
None stated.
## Pharmaceutical Particulars
6.1 List of excipients
Lactose
Calcium Hydrogen Phosphate
Icing Sugar\\*
Maize Starch
Glucose Liquid\\*\\*
Magnesium Stearate
Purified Water
\\* mixture of Sucrose 97%
Starch 3%
\\*\\* equivalent to 4.8mg Glucose Solids6.2 Incompatibilities
Not applicable6.3 Shelf life
5 years.6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
Opaque blue 250 micron PVC blisters with aluminium foil 20 micron, or securitainers, or amber glass bottles with wadded U/F caps.
Pack size: 100 tablets.6.6 Special precautions for disposal and other handling
Not applicable
- Company Detail Path
- /organization/sanofi-ilac-sanayi-ve-ticaret-anonim-sirketi
