Summary of Product Characteristics (SmPC) - Mebeverine Hydrochloride 150 mg/5 ml oral suspension
1 NAME OF THE MEDICINAL PRODUCT
Mebeverine hydrochloride 150mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml oral suspension contains 150 mg mebeverine hydrochloride (as pamoate).
Excipient(s) with known effect
Each 5 ml oral suspension contains 10 mg sodium benzoate, 215 mg Macrogolglycerol Hydroxystearate, 6.5 mg Propylene glycol (E 1520) and 41.90 mg sodium.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
Yellow coloured suspension with a flavour of banana.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
- 1. Mebeverine is indicated 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
Posology
Adults (including the elderly) and children 10 years and over: 5 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.
Method of administration
For oral administration only.
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
Shake well before use
Excipient Warnings
Sodium benzoate (E 211)
This medicine contains 10.00mg sodium benzoate (E 211) in each 5ml which is equivalent to 2.00mg/ml of oral suspension.
Macrogolglycerol 40 Hydroxystearate
May cause stomach upset and diarrhea.
Propylene glycol (E 1520)
This medicinal product contains 6.5mg propylene glycol in each 5ml dose which is equivalent to 1.3mg/ml.
Sodium
This medicinal product contains 41.90 mg sodium per 5ml, equivalent to 2.095% of the WHO recommended maximum 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 machines.
4.8 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 Website: 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.
5 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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium benzoate (E 211)
Simeticone emulsion
Microcrystalline cellulose and carmellose sodium
Sodium Citrate (E 331)
Citric acid monohydrate (E 330)
Polysorbate 20 (E 432)
Macrogolglycerol 40 Hydroxystearate
Saccharin Sodium (E 954)
Pamoic Acid Disodium Salt Monohydrate
Banana flavour [contains propylene glycol (E1520)]
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
24 Months.
Discard 30 days after first opening.
6.4 Special precautions for storage
Do not store above 25ºC.
Do not refrigerate or freeze.
6.5 Nature and contents of container
Bottle: Type III amber glass
Closure: Tamper evident, child-resistant white plastic (polyethylene/polypropylene) cap with (EPE) liner
Dosing Device: A 5ml oral syringe with 0.1ml intermediate graduation and a syringe adaptor.
Pack size: 125ml
6.6 Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Syri Limited t/a SyriMed
Unit 4, Bradfield Road,
Ruislip, Middlesex
HA4 0NU, UK.
8 MARKETING AUTHORISATION NUMBER(S)
PL 39307/0139
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
11/12/2024
10 DATE OF REVISION OF THE TEXT
11/12/2024