Дицетел®

General characteristics. Structure:

Active agent: a pinaveriya bromide — 50 mg (for a dosage of 50 mg), 100 mg (for a dosage of 100 mg).
Excipients: silicon dioxide colloid — 1,00 mg (2,00 mg), cellulose microcrystallic — 79,35 mg (158,70 mg), talc — 3,00 mg (6,00 mg), magnesium stearate — 1,50 mg (3,00 mg), starch prezhelatinizirovanny — 17,00 mg (34,00 mg), lactoses monohydrate — 18,15 mg (36,30 mg).
Film covering: butylmethacrylate copolymer the main — 8,176 mg (16,352 mg), sodium lauryl sulfate — 0,818 mg (1,636 mg), talc — 6,473 mg (12,946 mg), stearic acid — 1,192 mg (2,384 mg), сеписперс dry 3203 — 0,341 mg (0,682 mg) (a gipromelloza (Е 464) — 55,0-65,0%, cellulose microcrystallic (Е 460) — 5,0-15,0%, titanium dioxide (Е 171) — 20,0-30,0%, dye a sunset yellow (a varnish aluminum) (Е 110) — 3,0%).

Description
Tablets of 50 mg
Round biconvex tablets, film coated orange color, with an engraving "50" on one party and the  badge under the letter "S" on other party.
Tablets of 100 mg
 Round biconvex tablets, film coated orange color, with an engraving "100" on one party and the  badge under the letter "S" on other party.

Pharmacological properties:

Pharmacodynamics. An antispasmodic with the selection action on digestive tract. Inhibits intake of calcium in cells of smooth muscles of intestines. Researches on animals showed that the pinaveriya bromide reduces effects of stimulation of sensitive neurons. Does not possess
 anticholinergic action. Does not exert impact on cardiovascular system.

Pharmacokinetics. After intake a pinaveriya bromide is quickly soaked up and reaches the maximum concentration in plasma in one hour of Pinaveriya bromide has high ability of linkng with proteins of plasma (95-96%).
Drug is actively metabolized in a liver. The elimination half-life makes 1,5 h.
Absolute bioavailability very low (less than 1%). It is brought out of an organism mainly with a stake.

Indications to use:

Symptomatic treatment of the pains, disturbances of transit of intestinal contents and discomfort connected with functional disorders of work of intestines;
Symptomatic treatment of the pains connected with functional disorders of biliary tract;
Preparation for X-ray inspection of digestive tract using sulfate barium.

Route of administration and doses:

Drug is intended for intake.
Pill is taken during food entirely, without chewing and not rassasyvy, washing down with a glass of water to prevent contact a bromide pinaveriya with a mucous membrane of a gullet (see the section "Special Instructions"). Дицетел®, tablets, film coated, 50 mg.
The recommended daily dose — on 1 tablet 3 times a day or on 2 tablets 2 times a day.
If it is necessary, the daily dose can be increased to 2 tablets 3 times a day.
By preparation for X-ray inspection — on 2 tablets 2 times a day within 3 days before a research.
Дицетел®, tablets, film coated, 100 mg.
The recommended daily dose — on 1 tablet 2 times a day.
If it is necessary, the daily dose can be increased to 1 tablet 3 times a day.
By preparation for X-ray inspection — on 1 tablet 2 times a day within 3 days before a research.

Features of use:

Due to the risk of injury of a mucous membrane of a gullet it is necessary to adhere to recommendations about use carefully. Patients with an esophagitis and/or hernia of an esophageal opening have to pay special attention to the correct use of drug.

Influence on ability to driving and other mechanisms
Researches on influence of drug on ability to driving and other mechanisms were not conducted.

Side effects:

During post-marketing use it was reported about the following undesirable phenomena. Messages had spontaneous character, and for exact assessment of frequency of cases of the available data it is not enough.
Disturbances from digestive tract:
Pain in a stomach, diarrhea, nausea, vomiting, a dysphagy.
At the wrong administration of drug injury of a mucous membrane of a gullet is possible (see the section "Special Instructions").
Disturbances from skin and hypodermic fabrics:
Rash, itch, urticaria, erythema.
Disturbances from immune system:
Hypersensitivity.

Interaction with other medicines:

Clinical trials did not reveal any interactions a bromide pinaveriya with cardiac glycosides, peroral hypoglycemic means, insulin, peroral anticoagulants and heparin.
The concomitant use of anticholinergics can strengthen stopping of spasms.
Influence of drug on results of laboratory tests by definition of concentration of medicines was not noted.

Contraindications:

Hypersensitivity to any of drug components.
Deficit of lactase, intolerance of a galactose, glyukozo-galaktozny malabsorption.

Due to the insufficiency of data on efficiency and safety use of drug for children up to 18 years is not recommended.

Pregnancy and period of a lactation
There are no sufficient data of use a bromide pinaveriya by pregnant women. The potential risk for the person is unknown. Use of drug during pregnancy is allowed if the advantage of use for mother exceeds potential risk for a fruit.
Besides, it is necessary to take into account that bromine is a part of drug. In this regard appointment the bromide pinaveriya at the end of pregnancy can cause neurologic frustration (a lowering of arterial pressure, sedation) in the newborn.
There is no sufficient information about drug Ditsetel® excretion with maternal milk. Physical and chemical and available data on a pharmacodynamics and toxicology of the drug Ditsetel® indicate drug excretion with mother's milk in this connection, the risk for the baby cannot be excluded.
Дицетел® it is not necessary to apply during a lactation.

Overdose:

Symptoms: the overdose can lead to gastrointestinal frustration, such as a meteorism and diarrhea.
Treatment: the special antidote is unknown; the symptomatic treatment is recommended.

Storage conditions:

List B. To store in the dry, protected from light place at a temperature not above 30 °C. To store in the place, unavailable to children! Period of validity of 5 years. Drug cannot be used after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Tablets film coated 50 mg.
On 20 tablets in PVC/Alya the blister. On 1 blister together with the application instruction in a pack cardboard.
Tablets film coated 100 mg.
On 15 or 20 tablets in PVC/Alya the blister. On 1 blister (on 20 tablets) or on 2 blisters (on 15 tablets) together with the application instruction in a pack cardboard.