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Drug information

Dicycloverine

POM
Read time: 1 mins
Last updated: 01 Mar 2022

Summary of product characteristics


1. Name of the medicinal product

Dicycloverine Hydrochloride 10mg Tablets


2. Qualitative and quantitative 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.


3. Pharmaceutical form

Tablets

White, round, biconvex tablets with a 'M' in two concentric circles on one side


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

Oral


4.3. 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.


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.


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 Solids


6.2. Incompatibilities

Not applicable


6.3. 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


7. Marketing authorisation holder

Zentiva Pharma UK Limited

12 New Fetter Lane

London

EC4A 1JP

United Kingdom


8. Marketing authorisation number(s)

PL 17780/0565


9. Date of first authorisation/renewal of the authorisation

19/04/2011


10. Date of revision of the text

23/02/2022

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

Oral

4.3 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.

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Disclaimer

The drug SPC information (indications, contra-indications, interactions, etc), has been developed in collaboration with eMC (www.medicines.org.uk/emc/). Medthority offers the whole library of SPC documents from eMC.

Medthority will not be held liable for explicit or implicit errors, or missing data.

Reporting of suspected adverse reactions 

Drug Licencing

Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).