- Approval Id
- 9995771517acbcf5
- Drug Approval Emc Name
- Dicycloverine 10 mg Tablets
- Drug Name
- Dicycloverine 10 mg Tablets
- Company Name
- Flamingo Pharma (UK) Ltd
- Company Address
- The BLOC, 38 Springfield Way, Kingston Upon Hull, HU10 6RJ, UK
- Company Website
- http://www.flamingopharma.co.uk
- Company Telephone
- +44 (0) 7784240228
- Company Medical Info Direct Line
- 00 800 890 13370
- Atc Code
- A03AA07
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Flamingo Pharma UK Ltd.
Ist floor, Kirkland House,
11-15 Peterborough Road,
Harrow, Middlesex,
HA1 2AX, United Kingdom.
- Authorisation Number
- PL 43461/0041
- Authorisation Date
- 02/10/2018
- Instruction Authorisation Holder
- Flamingo Pharma UK Ltd.
Ist floor, Kirkland House,
11-15 Peterborough Road,
Harrow, Middlesex,
HA1 2AX, United Kingdom.
- Instruction Authorisation Number
- PL 43461/0041
- Instruction Authorisation Date
- 02/10/2018
- Instruction Composition
- Each tablet contains 10 mg of Dicycloverine hydrochloride.
Excipient(s) with known effect:
Each tablet contains 67.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Tablet
White to off white, circular, flat beveled edge, uncoated tablet debossed with “S10” on one side and plain on other 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: 10-20 mg three times daily before or after meals.
Children (2-12 years): 10 mg three times daily.
\*\*Method of administration\*\*
Oral4.3 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.
Dicycloverine hydrochloride 10 mg Tablets contains lactose monohydrate. 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
None stated.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.
\*\*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 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 excreted in human milk, caution should be exercised when dicycloverine is administered to a nursing mother.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 at: www.mhra.gov.uk/yellowcard.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; 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 20 mg 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
None stated.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Lactose monohydrate
Maize starch
Povidone
Purified talc
Colloidal anhydrous silica
Magnesium stearate6.2 Incompatibilities
None stated.6.3 Shelf life
3 years6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.6.5 Nature and contents of container
Dicycloverine Hydrochloride 10 mg Tablets are available in cartons containing Aluminium-PVC/PVDC White opaque blister packs of 100's along with a leaflet inside.6.6 Special precautions for disposal and other handling
None stated.
- Instruction Content
- ## Composition
Each tablet contains 10 mg of Dicycloverine hydrochloride.
Excipient(s) with known effect:
Each tablet contains 67.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Tablet
White to off white, circular, flat beveled edge, uncoated tablet debossed with “S10” on one side and plain on other 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: 10-20 mg three times daily before or after meals.
Children (2-12 years): 10 mg three times daily.
\*\*Method of administration\*\*
Oral4.3 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.
Dicycloverine hydrochloride 10 mg Tablets contains lactose monohydrate. 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
None stated.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.
\*\*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 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 excreted in human milk, caution should be exercised when dicycloverine is administered to a nursing mother.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 at: www.mhra.gov.uk/yellowcard.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; 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 20 mg 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
None stated.
## Pharmaceutical Particulars
6.1 List of excipients
Lactose monohydrate
Maize starch
Povidone
Purified talc
Colloidal anhydrous silica
Magnesium stearate6.2 Incompatibilities
None stated.6.3 Shelf life
3 years6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.6.5 Nature and contents of container
Dicycloverine Hydrochloride 10 mg Tablets are available in cartons containing Aluminium-PVC/PVDC White opaque blister packs of 100's along with a leaflet inside.6.6 Special precautions for disposal and other handling
None stated.
