Drug Study: Eldicet

Generic name: pinaverium bromide

Brand name: Eldicet 50 mg tabler

Category: Spasmolytic

Formulation: Each film-coated tablet contains: Pinaverium bromide 50mg

Therapeutic indications:

-symptomatic treatment of pain, transit disorders and intestinal discomfort related to functional intestinal disturbances
-symptomatic treatment of pain related to functional disturbances of the biliary tract
-preparation for a barium enema

Dosage:
Adults: the recommended dosage is 3 to 4 tablets per day.
Rarely, this dosage may be increased to 6 tablets per day.

In preparation for a barium enema, the dosage is 4 tablets per day, for 3 days before the examination.

Method of Administration:
The tablets should be swallowed without chewing or sucking, with an adequate quantity of liquid (e.g. glass of water) during meals

Contraindications:

Hypersensitivity to the active substance or to any of the excipients.

Pregnancy and Lactation:
No clinical date on exposed pregnancies are available. Animal experiments have failed to show any embryotoxic, teratogenic, mutagenic or carcinogenic effects. Caution should be exercised when prescribing this product to pregnant or lactating women. Furthermore, the presence of bromide should be taken into account. Administration of pinaverium bromide at the end of the pregnancy can affect the newborn neurologically (hypotony, sedation)

Drug interactions:
None known.

Effects on ability to drive and use machines:
As far as is known, pinaverium bromide has no effect on the ability to drive or operate machines.

Undesirable effects:
Gastrointestinal disorders: rare cases of minor gastrointestinal disturbances have been observed.
Skin and subcutaneous tissue disorders: cases of cutaneous adverse effects, some being of allergic type, have been observed.

Overdose:

Currently there is no specific information on overdose related adverse reactions. Treatment should be symptomatic.

Pharmacological properties /Pharmacodynamics properties:

Pinaverium bromide is an antispasmodic selectively acting on the gastrointestinal tract. It is a calcium antagonist which inhibits the influx of calcium into intestinal smooth muscle cells. In animals, pinaverum bromide reduces directly or indirectly the effects of the stimulation of the sensitive afferences. It is free from anticholinergic effects. It is also devoid of effects on the cardiovascular system.

Pharmacokinetics properties

Less than 10% of the pinaverium bromide dose is absorbed from the gastrointestinal tract. Peak serum concentration is attained in 1 hour. The elimination half-life is 1.5 hours. The drug is extensively metabolized and eliminated via the liver. Autoradiographic studies in animals show high levels of radioactivity in the gastrointestinal tract. The drug is 97% bound to plasma proteins.

Presentation
Box of 100 tablets in blister pack

Caution:
Foods, drugs, devices, and cosmetics act prohibits dispensing without prescription

Store at temperatures not exceeding 25 degrees Celsius protect from light.

Manufactured by: Solvay Pharmaceuticals S.A.S.
01400 Chatillon-sur-Chalaronne, France


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