Dicetel, 50 mg 20 pcs.

Pharmacodynamics.

Spasmolytic agent with selective action on the gastrointestinal tract. Inhibits the entry of calcium into the cells of the smooth muscles of the intestine.

Animal studies have shown that pinaverium bromide reduces the effects of stimulation of sensitive neurons. It has no anticholinergic effect. It has no effect on the cardiovascular system.

Pharmacokinetics.

After oral administration pinaverium bromide is rapidly absorbed and reaches maximum plasma concentration after one hour. Pinaverium bromide has high plasma protein binding capacity (95-96%). The drug is actively metabolized in the liver.

The elimination half-life is 1.5 hours. Absolute bioavailability is very low (less than 1%). It is excreted mainly with feces.

Indications

Active ingredient

Composition

1 film-coated tablet contains:

The active ingredient:

pinaverium bromide – 50 mg.

Excipients:

colloidal silicon dioxide – 1.00 mg,

microcrystalline cellulose – 79.35 mg,

talc – 3.00 mg,

How to take, the dosage

The drug is intended to be taken orally.

The tablets are taken with meals in whole, without chewing or swallowing, with a glass of water to prevent contact of pinaverium bromide with the esophageal mucosa.

Sheet film-coated tablets 50 mg are indicated in a daily dose of 1 tablet 3 times daily or 2 tablets 2 times daily. If necessary, the daily dose can be increased to 2 tablets 3 times a day.

In preparation for gastrointestinal X-ray examination, 2 tablets 2 times a day for 3 days before the examination.

The film-coated tablets 100 mg are prescribed in a daily dose of 1 tablet 2 times a day. If necessary, the daily dose can be increased to 1 tablet 3 times a day.

In preparation for X-ray examination, 1 tablet 2 times a day for 3 days before the examination.

Interaction

Special Instructions

Due to the risk of damage to the esophageal mucosa, the recommendations for use should be carefully followed.

Patients with esophagitis and/or esophageal hernia should pay special attention to the correct use of the drug.

Synopsis

Contraindications

Side effects

Overdose

Symptoms: Overdose may lead to gastrointestinal disorders such as flatulence and diarrhea.

Treatment: no specific antidote is known; symptomatic treatment is recommended.

Pregnancy use

There are insufficient data on the use of pinaverium bromide in pregnant women. The potential risk to humans is unknown. The use of the drug during pregnancy is allowed if the benefit to the mother exceeds the potential risk to the fetus. Besides, it should be taken into account that the drug contains bromine. In this regard, the prescription of pinaverium bromide at the end of pregnancy may cause neurological disorders (decreased blood pressure, sedation) in the newborn.

There is no sufficient information about excretion of Dicetel® with maternal milk. Physicochemical and available data on pharmacodynamics and toxicology of Dicetel® indicate excretion of the drug with the mother’s milk, therefore, the risk to the infant cannot be excluded. Dicetel® should not be used during lactation

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