Capsules of prolonged action hard gelatinous, size 1, opaque, white, labeled "245" on the capsule; the contents of the capsules are white or almost white granules.
mebeverine hydrochloride 200 mg
Auxiliary substances: magnesium stearate - 13.1 mg, methyl methacrylate and ethyl acrylate copolymer (1: 2) - 10.4 mg, talc 4.9 mg, hypromellose 0.1 mg, methacrylic acid and ethyl acrylate copolymer (1: 1) 15.2 mg, triacetin 2.9 mg .
The composition of the capsule shell: gelatin - 75.9 mg, titanium dioxide (E171) - 1.5 mg.
Ink composition: shellac (E904), propylene glycol, aqueous ammonia, potassium hydroxide, ferric oxide black oxide (E172).
10 pieces. - blisters (3) - packs of cardboard.
15 pcs. - blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
Spasmolytic of myotropic action. Has a direct effect on the smooth muscles of the gastrointestinal tract. Eliminates spasm without affecting normal intestinal motility.
Does not possess anticholinergic action.
Mebeverin is quickly and completely absorbed after ingestion. The modified release dosage form allows the dosing regimen to be used 2 times / day.
With repeated administration of the drug, significant cumulation does not occur.
Mebeverina hydrochloride is mainly metabolized by esterases, which in the first stage split the ether into veratric acid and mebeverine alcohol. The main metabolite circulating in the plasma is the demethylated carboxylic acid. T 1/2 in the equilibrium state of the demethylated carboxylic acid is approximately 5.77 hours. With repeated administration at a dose of 200 mg 2 times / day, the C max of the demethylated carboxylic acid in the blood is 804 ng / ml, T max is about 3 hours.
The average value of the relative bioavailability of the drug in the modified release capsule is 97%.
Mebeverin in unchanged form is not excreted from the body, it is completely metabolized; its metabolites are almost completely eliminated from the body. Veratric acid is excreted by the kidneys. Mebeverine alcohol is also excreted by the kidneys, partly in the form of a carboxylic acid and partly as a demethylated carboxylic acid.
- symptomatic treatment of pain, spasms, dysfunction and discomfort in the intestines associated with irritable bowel syndrome;
- symptomatic treatment of spasms of the digestive tract, incl. caused by organic diseases.
The drug is taken orally. Capsules must be swallowed by washing with a sufficient amount of water (at least 100 ml). Capsules should not be chewed; their membrane provides a sustained release of the drug.
Assign 200 mg (1 caps.) 2 times / day for 20 minutes before meals (morning and evening).
Duration of the drug is not limited.
If the patient forgot to take one or more capsules, take the drug with the next dose. Do not take one or more missed doses in addition to the usual dose.
Reports of the following adverse events were received during the postmarketing period and were of a spontaneous nature; to accurately assess the frequency of the cases of available data is not enough.
Allergic reactions were observed mainly from the skin, but other manifestations of allergy were also noted.
From the skin: urticaria, angioedema, incl. face, exanthema.
From the side of the immune system: hypersensitivity reactions (anaphylactic reactions).
- age to 18 years (due to insufficient data on efficiency and safety);
- pregnancy (due to insufficient data);
- Hypersensitivity to any component of the drug.
PREGNANCY AND LACTATION
Data on the use of mebeverin in pregnant women is not enough. It is not recommended to use Duspatalin В® during pregnancy.
Information on the excretion of mebeverin or its metabolites with breast milk is not enough. Do not take Duspatalin В® while breastfeeding.
Clinical data on the effect of the drug on fertility in men or women are not available, however, studies in animals have not demonstrated adverse effects of the drug Duspatalin В® .
APPLICATION FOR CHILDREN
Contraindicated in children and adolescents under 18 years.
Impact on the ability to drive vehicles and manage mechanisms
Studies of the effect of the drug on the ability to drive and other mechanisms have not been carried out. The pharmacological properties of the preparation, as well as the experience of its use, do not indicate any adverse effect of mebeverine on the ability to drive and other mechanisms.
Theoretically, in case of an overdose, it is possible to increase the excitability of the central nervous system. In cases of an overdose of mebeverine, the symptoms either were absent, or were insignificant and, as a rule, quickly reversible. The symptoms of overdose were neurological and cardiovascular.
The specific antidote is unknown. Symptomatic treatment is recommended. Gastric lavage is necessary only if intoxication is detected within approximately one hour after taking several doses of the drug. Measures to reduce absorption are not required.
Only studies on the interaction of this drug with alcohol were carried out.
Studies in animals showed no interaction between the drug Duspatalin В® and ethyl alcohol.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
The information is provided for your information, do not self-medicate, it is dangerous for your health.