- Approval Id
- 3b1fc8a13e339120
- Drug Approval Emc Name
- Mebeverine 50mg/5ml Sugar Free Oral Suspension
- Drug Name
- Mebeverine 50mg/5ml Sugar Free Oral Suspension
- Company Name
- Chemidex Pharma Ltd
- Company Address
- 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8 RB, UK
- Company Website
- http://www.chemidex.co.uk
- Company Telephone
- +44 (0)1784 477 167
- Company Medical Info Direct Line
- +44 (0)1784 477167
- Company Medical Info Email
- info@chemidex.co.uk
- Atc Code
- A03AA04
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Chemidex Pharma Ltd
Trading as Essential Generics
8a Crabtree Road, Egham, Surrey TW20 8RN, United Kingdom
- Authorisation Number
- PL 17736/0084
- Authorisation Date
- 21 May 1997
- Instruction Authorisation Holder
- Chemidex Pharma Ltd
Trading as Essential Generics
8a Crabtree Road, Egham, Surrey TW20 8RN, United Kingdom
- Instruction Authorisation Number
- PL 17736/0084
- Instruction Authorisation Date
- 21 May 1997
- Instruction Composition
- Each 5 ml oral suspension contains 50 mg mebeverine hydrochloride (as pamoate).
Excipient(s) with known effect
Each 5 ml oral suspension contains 1 mg polyoxyl 40 hydrogenated castor oil, 10 mg sodium benzoate and 20.5 mg sodium.
For the full list of excipients, see Section 6.1.
- Instruction Dosage Form
- Oral suspension
Yellow sugar free suspension with a flavour of banana.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
1. For the symptomatic treatment of irritable bowel syndrome and other conditions usually included in this grouping, such as chronic irritable colon, spastic constipation, mucous colitis, spastic colitis. Mebeverine is effectively used to treat the symptoms of these conditions, such as colicky abdominal pain and cramps, persistent, non-specific diarrhoea (with or without alternating constipation) and flatulence.
2. For the symptomatic treatment of gastro-intestinal spasm secondary to organic diseases.4.2 Posology and method of administration
\*Adults (including the elderly) and children 10 years and over:\* 15 ml (150 mg) three times a day, preferably 20 minutes before meals.
After a period of several weeks when the desired effect has been obtained, the dosage may be gradually reduced.
\*Children under 10 years. Not applicable.\*4.3 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
\*Sodium benzoate\*
This medicinal product contains 30 mg sodium benzoate in each 15 ml spoonful of oral suspension which is equivalent to 2 mg/ml.
\*Polyoxyl 40 hydrogenated castor oil\*
This medicinal product contains 3 mg polyoxyl 40 hydrogenated castor oil in each 15 ml spoonful of oral suspension which is equivalent to 0.2 mg/ml. Castor oil may cause stomach upset and diarrhoea.
\*Sodium\*
This medicinal product contains 61.5 mg of sodium in each 15 ml spoonful of oral suspension, equivalent to 3% of the WHO recommended daily intake of 2 g sodium for an adult.4.5 Interaction with other medicinal products and other forms of interaction
None known.4.6 Fertility, pregnancy and lactation
Animal experiments have failed to show any teratogenic effects. However, the usual precautions concerning the administration of any drug during pregnancy should be observed.4.7 Effects on ability to drive and use machines
Mebeverine has no or negligible influence on the ability to drive and use machines4.8 Undesirable effects
Immune system disorders
Very rare (<1/10,000): hypersensitivity
Skin and subcutaneous tissue disorders
Very rare (<1/10,000): urticaria, angioedema, face oedema, exanthema/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 or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
On theoretical grounds it may be predicted that CNS excitability will occur in cases of overdosage. No specific antidote is known; gastric lavage and symptomatic treatment is recommended.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Synthetic anticholinergics, esters with tertiary amino group, ATC code: A03A A04
Mebeverine is a musculotropic antispasmodic with a direct action on the smooth muscle of the gastrointestinal tract, relieving spasm without affecting normal gut motility.5.2 Pharmacokinetic properties
Mebeverine is rapidly and completely absorbed after oral administration in the form of tablets or suspension. Mebeverine is not excreted as such but metabolised completely. The first step in the metabolism is hydrolysis, leading to veratric acid and mebeverine alcohol. Both veratric acid and mebeverine alcohol are excreted into the urine, the latter partly as the corresponding carboxylic acid and partly as the demethylated carboxylic acid.5.3 Preclinical safety data
None stated.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Microcrystalline cellulose
Carboxymethylcellulose sodium
Citric acid monohydrate
Sodium citrate
Polysorbate 20
Polyoxyl 40 hydrogenated castor oil
Disodium pamoate monohydrate
Sodium benzoate (E 211)
Saccharin sodium
Banana flavour
Simethicone emulsion
Purified water.6.2 Incompatibilities
Not applicable.6.3 Shelf life
5 years.6.4 Special precautions for storage
Do not store above 30°C. Keep bottle in the outer carton.6.5 Nature and contents of container
Amber glass bottle with polyethylene tamper evident cap. Each bottle contains 300 ml.6.6 Special precautions for disposal and other handling
Shake well before use. Dilution and subsequent storage not recommended. Mebeverine does not produce false positive reactions in standard diagnostic urine tests.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
- Instruction Content
- ## Composition
Each 5 ml oral suspension contains 50 mg mebeverine hydrochloride (as pamoate).
Excipient(s) with known effect
Each 5 ml oral suspension contains 1 mg polyoxyl 40 hydrogenated castor oil, 10 mg sodium benzoate and 20.5 mg sodium.
For the full list of excipients, see Section 6.1.
## Pharmaceutical Form
Oral suspension
Yellow sugar free suspension with a flavour of banana.
## Clinical Particulars
4.1 Therapeutic indications
1. For the symptomatic treatment of irritable bowel syndrome and other conditions usually included in this grouping, such as chronic irritable colon, spastic constipation, mucous colitis, spastic colitis. Mebeverine is effectively used to treat the symptoms of these conditions, such as colicky abdominal pain and cramps, persistent, non-specific diarrhoea (with or without alternating constipation) and flatulence.
2. For the symptomatic treatment of gastro-intestinal spasm secondary to organic diseases.4.2 Posology and method of administration
\*Adults (including the elderly) and children 10 years and over:\* 15 ml (150 mg) three times a day, preferably 20 minutes before meals.
After a period of several weeks when the desired effect has been obtained, the dosage may be gradually reduced.
\*Children under 10 years. Not applicable.\*4.3 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
\*Sodium benzoate\*
This medicinal product contains 30 mg sodium benzoate in each 15 ml spoonful of oral suspension which is equivalent to 2 mg/ml.
\*Polyoxyl 40 hydrogenated castor oil\*
This medicinal product contains 3 mg polyoxyl 40 hydrogenated castor oil in each 15 ml spoonful of oral suspension which is equivalent to 0.2 mg/ml. Castor oil may cause stomach upset and diarrhoea.
\*Sodium\*
This medicinal product contains 61.5 mg of sodium in each 15 ml spoonful of oral suspension, equivalent to 3% of the WHO recommended daily intake of 2 g sodium for an adult.4.5 Interaction with other medicinal products and other forms of interaction
None known.4.6 Fertility, pregnancy and lactation
Animal experiments have failed to show any teratogenic effects. However, the usual precautions concerning the administration of any drug during pregnancy should be observed.4.7 Effects on ability to drive and use machines
Mebeverine has no or negligible influence on the ability to drive and use machines4.8 Undesirable effects
Immune system disorders
Very rare (<1/10,000): hypersensitivity
Skin and subcutaneous tissue disorders
Very rare (<1/10,000): urticaria, angioedema, face oedema, exanthema/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 or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
On theoretical grounds it may be predicted that CNS excitability will occur in cases of overdosage. No specific antidote is known; gastric lavage and symptomatic treatment is recommended.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Synthetic anticholinergics, esters with tertiary amino group, ATC code: A03A A04
Mebeverine is a musculotropic antispasmodic with a direct action on the smooth muscle of the gastrointestinal tract, relieving spasm without affecting normal gut motility.5.2 Pharmacokinetic properties
Mebeverine is rapidly and completely absorbed after oral administration in the form of tablets or suspension. Mebeverine is not excreted as such but metabolised completely. The first step in the metabolism is hydrolysis, leading to veratric acid and mebeverine alcohol. Both veratric acid and mebeverine alcohol are excreted into the urine, the latter partly as the corresponding carboxylic acid and partly as the demethylated carboxylic acid.5.3 Preclinical safety data
None stated.
## Pharmaceutical Particulars
6.1 List of excipients
Microcrystalline cellulose
Carboxymethylcellulose sodium
Citric acid monohydrate
Sodium citrate
Polysorbate 20
Polyoxyl 40 hydrogenated castor oil
Disodium pamoate monohydrate
Sodium benzoate (E 211)
Saccharin sodium
Banana flavour
Simethicone emulsion
Purified water.6.2 Incompatibilities
Not applicable.6.3 Shelf life
5 years.6.4 Special precautions for storage
Do not store above 30°C. Keep bottle in the outer carton.6.5 Nature and contents of container
Amber glass bottle with polyethylene tamper evident cap. Each bottle contains 300 ml.6.6 Special precautions for disposal and other handling
Shake well before use. Dilution and subsequent storage not recommended. Mebeverine does not produce false positive reactions in standard diagnostic urine tests.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
