- Approval Id
- 84652535e429b7a4
- Drug Approval Emc Name
- Dicycloverine hydrochloride 10 mg Tablets
- Drug Name
- Dicycloverine hydrochloride 10 mg Tablets
- Company Name
- Blackrock Pharmaceuticals Limited
- Company Address
- The Old Barrel Store, Brewery Courtyard, Draymans Lane, Marlow, SL7 2FF, UK
- Company Website
- https://www.blackrockpharma.com
- Company Telephone
- 0330 133 3713
- Company Medical Info Direct Line
- +44 8000 668348
- Company Medical Info Email
- safety.uk@lambda-cro.com
- Atc Code
- A03AA07
- Legal Category
- Prescription only medicine
- Authorisation Holder
- \*\*Blackrock Pharmaceuticals Ltd\*\*
The Old Barrel Store, Brewery Courtyard
Draymans Lane, Marlow, SL7 2FF, UK
- Authorisation Number
- PL 33271/0013
- Authorisation Date
- 19/02/2025
- Instruction Authorisation Holder
- \*\*Blackrock Pharmaceuticals Ltd\*\*
The Old Barrel Store, Brewery Courtyard
Draymans Lane, Marlow, SL7 2FF, UK
- Instruction Authorisation Number
- PL 33271/0013
- Instruction Authorisation Date
- 19/02/2025
- Instruction Composition
- Each tablet contains 10 mg of dicycloverine hydrochloride.
Excipient(s) with known effect
Each tablet contains 74 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Tablet
Round, white to off-white, uncoated tablet with a 'V' debossed 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 and children over 12 years:\* 10-20 mg three times daily before or after meals.
\*Children (2-12 years):\* 10 mg three times daily. Dicycloverine Hydrochloride Syrup is also available for this age group.
Method of administration
For oral use.4.3 Contraindications
Hypersensitivity to the active substance or to 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.
Contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total 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 40 mg/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 60 mg 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
Dicycloverine Hydrochloride 10 mg Tablets may affect the ability to drive and use machines. If patients experience dizziness, fatigue, sedation or blurred vision, they should not drive or use any tools or machines.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 the Yellow Card Scheme at: 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 over dosage 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 20 mg dose of dicycloverine hydrochloride in volunteers, peak plasma concentration reached a mean value of 58 ng/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 Monohydrate
Povidone K90
Maize Starch
Colloidal Anhydrous Silica
Talc
Magnesium Stearate6.2 Incompatibilities
Not applicable.6.3 Shelf life
24 months.6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
Opaque PVC/aluminium foil blister pack containing 10 tablets.
The blister packs are packed in an outer cardboard carton containing 100 tablets.6.6 Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
- Instruction Content
- ## Composition
Each tablet contains 10 mg of dicycloverine hydrochloride.
Excipient(s) with known effect
Each tablet contains 74 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Tablet
Round, white to off-white, uncoated tablet with a 'V' debossed 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 and children over 12 years:\* 10-20 mg three times daily before or after meals.
\*Children (2-12 years):\* 10 mg three times daily. Dicycloverine Hydrochloride Syrup is also available for this age group.
Method of administration
For oral use.4.3 Contraindications
Hypersensitivity to the active substance or to 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.
Contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total 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 40 mg/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 60 mg 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
Dicycloverine Hydrochloride 10 mg Tablets may affect the ability to drive and use machines. If patients experience dizziness, fatigue, sedation or blurred vision, they should not drive or use any tools or machines.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 the Yellow Card Scheme at: 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 over dosage 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 20 mg dose of dicycloverine hydrochloride in volunteers, peak plasma concentration reached a mean value of 58 ng/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 Monohydrate
Povidone K90
Maize Starch
Colloidal Anhydrous Silica
Talc
Magnesium Stearate6.2 Incompatibilities
Not applicable.6.3 Shelf life
24 months.6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
Opaque PVC/aluminium foil blister pack containing 10 tablets.
The blister packs are packed in an outer cardboard carton containing 100 tablets.6.6 Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
