Instructions for Mebsin retard capsules 200 mg No. 30
Composition
active ingredient: 1 capsule contains mebeverine hydrochloride in the form of prolonged-release pellets 200 mg;
excipients: microcrystalline cellulose, mannitol (E 421), sucrose, sodium lauryl sulfate, ethyl cellulose.
Dosage form
Capsules.
Main physicochemical properties: hard gelatin capsules No. 1, orange body, white cap, marked "S" on both parts and containing white pellets.
Pharmacotherapeutic group
Drugs used in functional gastrointestinal disorders. Synthetic anticholinergics, esterified tertiary amines.
ATX code A03A A04.
Pharmacological properties
Pharmacodynamics
Mechanism of action and pharmacodynamic effects.
Mebeverine is a myotropic antispasmodic with a selective action on the smooth muscles of the digestive tract. It eliminates spasms without inhibiting normal intestinal motility. Since this action is not mediated by the autonomic nervous system, typical anticholinergic side effects do not occur.
Clinical efficacy and safety.
The clinical efficacy and safety of different dosage forms of mebeverine have been studied in over 1500 patients. Significant relief of the predominant symptoms of irritable bowel syndrome (e.g. abdominal pain, bowel habits) was generally observed in reference and baseline-controlled clinical trials.
All formulations of mebeverine were generally safe and well tolerated at the recommended dosage regimen.
Children.
Clinical studies with tablets or capsules have only been conducted in adults. Clinical efficacy and safety data, as well as post-marketing experience with mebeverine suspension in patients aged 3 years and older, have demonstrated that mebeverine is an effective, safe and well-tolerated drug.
Clinical trials of mebeverine suspension have shown it to be effective in reducing symptoms of irritable bowel syndrome in children. Further open-label, baseline-controlled trials of mebeverine suspension have confirmed its efficacy.
The dosage regimen of tablets or capsules is calculated based on the safety and tolerability of mebeverine.
Pharmacokinetics
Absorption.
Mebeverine is rapidly and completely absorbed after oral administration in tablet form. Due to the prolonged release of the drug from the capsule, it can be taken twice a day.
Distribution.
With repeated use of Mebsin Retard®, no significant cumulation occurs.
Biotransformation.
Mebeverine hydrochloride is mainly metabolized by esterases, which in the first stage of metabolism cleave the ester bonds with the formation of veratric acid and mebeverine alcohol. In plasma, demethylcarboxylic acid (DMCA) is the main metabolite. The half-life of DMCA at steady state is 5.77 hours. With multiple use of capsules (200 mg 2 times a day), Cmax for DMCA was 804 ng/ml, and tmax was about 3 hours. The relative bioavailability of the prolonged-release capsules was optimal with an average ratio of 97%.
Breeding.
Mebeverine is not excreted unchanged, it is completely metabolized, and the metabolites are excreted almost completely. Veratric acid is excreted in the urine. Mebeverine alcohol is also excreted by the kidneys in the form of carboxylic (CC) or demethylcarboxylic acids (DMCC).
Children.
Pharmacokinetic studies in children have not been conducted.
Indication
Adults and children aged 10 and over:
· symptomatic treatment of abdominal pain and spasms, intestinal disorders and discomfort in the intestinal area in irritable bowel syndrome;
· treatment of gastrointestinal spasms of secondary genesis caused by organic diseases.
Contraindication
Hypersensitivity to the active substance or to any of the components of the drug.
Interaction with other medicinal products and other types of interactions
Interaction studies were conducted only with alcohol. In vitro and in vivo studies demonstrated the absence of any interaction between the drug and ethanol.
Application features
As the medicine contains sugar, patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Use during pregnancy or breastfeeding
The drug Mebsin Retard® is not recommended for use during pregnancy or breastfeeding.
The ability to influence the reaction speed when driving or working with other mechanisms
Studies on the effects on the ability to drive and use machines have not been conducted. The pharmacodynamic and pharmacokinetic profile, as well as post-marketing experience, do not indicate any harmful effects on the ability to drive and use machines.
Method of administration and doses
The capsules should be taken with sufficient water (at least 100 ml). It is not recommended to chew the capsules, as the capsule coating is designed for prolonged release of the drug.
Adults and children over 10 years of age should take 1 capsule 2 times a day (morning and evening).
The duration of use is unlimited. If one or more doses are missed, the patient should take the next dose as prescribed. The missed dose should not be taken in addition to the next prescribed dose.
Special patient groups.
No dosage studies have been conducted in the elderly, patients with renal and/or hepatic impairment. Based on available post-marketing data, no specific risk for the elderly, patients with renal and/or hepatic impairment has been identified. No dose adjustment is required for the above patient groups.
Children
Do not use in children under 10 years of age due to the high content of the active substance in Mebsin Retard®.
Overdose
In case of overdose, excitation of the central nervous system may theoretically occur. In cases of overdose with mebeverine, symptoms were absent or mild and resolved quickly. The symptoms of overdose that were observed were of neurological or cardiovascular origin.
Treatment. Specific antidote is unknown. Symptomatic treatment is recommended. Gastric lavage is recommended only in case of intoxication with several different drugs, which is diagnosed within 1 hour of taking the drugs. Measures to reduce absorption are not necessary.
Adverse reactions
The following adverse reactions have been reported spontaneously during post-marketing surveillance. The frequency cannot be estimated precisely from the available data.
Allergic reactions were observed, mainly on the skin.
Skin and subcutaneous tissue disorders: urticaria, angioedema, facial edema, hyperemia, skin rashes, including hemorrhagic ones.
From the nervous system: headache, dizziness, depression.
On the part of the digestive tract: diarrhea or constipation.
General disorders: hypersensitivity (anaphylactic reactions).
Expiration date
2 years.
Storage conditions
Store in the original packaging, out of the reach of children at a temperature not exceeding 30 °C.
Packaging
10 capsules in a blister. 3 blisters in a cardboard pack.
Vacation category
According to the recipe.
Producer
Mylan Laboratories Limited.
Location of the manufacturer and its business address
Plot No. S 16 & S 17, S I Z A P I A C Green Industrial Park, Polepally (V), Yedderla (M), Mahabubnagar District – 509 302, Andhra Pradesh, India.
Plot No. S 16 & S 17, SEZ APIIC Green Industrial Park, Polepally (V), Jedcherla (M), Mahaboobnagar District – 509 302, Andhra Pradesh, India.
