Trimspa 30s 200 mg coated tablets

The instruction for medical use


of TRIMSPA 200 medicine

the Trade name
of Trimsp 200

International unlicensed


name Trimebutin Lekarstvennaya
the Tablet form, coated, 200 mg

Structure
One tablet contains
active agent - a trimebutin a maleate of 200 mg,
excipients: cellulose microcrystalline, lactose,
tartaric acid, starch corn, sodium of a kroskarmelloz, cellulose
microcrystalline (PH 102), silicon dioxide colloidal anhydrous,
magnesium stearate,
structure regional points: a gipromelloza (5cps), diethyl phthalate, the titan dioxide (E 171), the talc purified, dichloromethane **, 2 propyl alcohol **.

The description
of the Tablet, film coated white color, round shape with a biconvex smooth surface.

Pharmacotherapeutic group
Drugs for treatment of functional disorders of a digestive tract. Synthetic holinoblokator – ethers with a tertiary amino group.
The ATX A03AA05 code

the Pharmacological

Pharmacokinetics Later properties of intake trimebutin is quickly soaked up from digestive tract, the maximum concentration in blood plasma (Cmax) is reached in
1 - 2 hour. The bioavailability is 4-6%. Extent of linking with proteins of blood plasma low – about 5%. Trimebutin in insignificant degree gets
through a placental barrier. High concentration is noted in a stomach and walls of intestines, liver and kidneys.
Trimebutin biotransformirutsya in a liver and 5-12% are removed generally with urine mainly in the form of metabolites, - with excrements. Elimination half-life of the main metabolite – the dismetil-trimebutina short also makes 4 hours.
Elimination half-life (Т½) of drug – about 12 hours.
The pharmacodynamics
Active agent of the drug Trimspa of a trimebutin a maleate, synthetic enkefalinergichesky agonist of opiate receptors, is the regulator
of a vermicular movement of a digestive tract.
Renders direct pro-kinetic effect on smooth muscle cells.
Having affinity to opiate receptors, affects u- and d-opiate
receptors of excitement at hypokinetic conditions of smooth muscles of intestines and stimulates motility, having spasmolytic effect on x - opiate receptors, at hyperkinetic states oppresses motility of intestines. Influencing enkefalinergichesky mechanisms
restores physiological physical activity, renders
the local modulating (stimulating) effect on motility of digestive tract. In this regard it can be applied at patients as at
hypo - and digestive tract hyperkinesias.
Trimspa acts throughout digestive tract, reduces gullet sphincter pressure, promotes gastric emptying and
strengthening of a vermicular movement of intestines and also promotes response of smooth muscles of a large intestine to food irritants.

Indications
as a part of complex therapy:
- a syndrome of the angry gut (spastic gut)
- pains and gripes in an abdominal cavity, enterospasms, a meteorism, diarrhea and/or a constipation
- functional digestive disturbances
- polymorphic symptomatology of gastroenterological diseases

the Route of administration and doses
to Adults and children since 12 years on 200 mg 3 times a day before food.
Maximum single dose: 200 mg.
Maximum daily dose: 600 mg a day.

Side effects
- dryness in a mouth, change of flavoring feelings, diarrhea, dyspepsia, pain in
epigastriums, nausea and a constipation
- dizziness, fatigue, feelings of cold/heat, a headache
- allergic reactions: the skin itching
- periods disorders, painful increase in the size of mammary glands
- uneasiness
- an ischuria
- disorders of hearing

of the Contraindication
- the known hypersensitivity to a trimebutin or any other
ingredient of drug
- pregnancy and the period of a lactation
- children's age up to 12 years

Medicinal interactions
of Trimsp 200 extends kurarepodobny effect, caused by d-tubocurarine. No other medicinal interactions during clinical trials were observed.

The special
instructions Use Drug strictly according to indications.
The feature influence of medicine on ability to run transport or potentially dangerous mechanisms
Should be careful when driving or potentially dangerous mechanisms demanding concentration
of attention.

Overdose
Symptoms: signs of overdose of Trimsp 200 are not described so far.
Treatment: if the patient accepted too high dose of drug inside, it is necessary to carry out gastric lavage. Symptomatic treatment.

A form of release and packing
On 6 tablets in planimetric bezjyacheykovy packing from aluminum foil.
On 5 planimetric bezjyacheykovy packs together with the instruction for medical use in the state and Russian languages place in a cardboard box.


To Store storage conditions in the dry, protected from light place at a temperature not above 25 °C
to Store out of children's reach!


2 years
not to apply a period of storage after an expiration date.

Prescription status
According to the prescription


Macleods Pharmaceuticals Limited Producer,
Indiyapretenzii 304-310, Atlanta to the Arcade, Marol Chech Road, Anderi (East), Mumbai –
400059, India

the Owner of the registration certificate
of Macleods Pharmaceuticals Limited, Indiyap

Adres of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products Branch KOO Macleods Pharmaceuticals Limited RK, Almaty, Tulebayev St. 38, office 307ATel. / fax. +7 727 2734593, 2441294E-mail: vijay9376@yahoo.com