Each film-coated tablet contains 50 mg of Pinaverium bromide.
Excipients: Core: microcrystalline cellulose, pre-gelatinized starch, lactose monohydrate, anhydrous colloidal silica, talc, magnesium stearate.
Coating: basic butylated metacrylate copolymer, sodium laurylsulfate, stearic acid, talc, hydroxypropyl methylcellulose, iron oxide yellow, iron oxide red.
Pharmacotherapeutic Group: Other drugs for functional bowel disorders.
Pharmacology: Pharmacodynamics: Pinaverium bromide is an antispasmodic which selectively acts on the gastro-intestinal tract. It is a calcium antagonist which inhibits the influx of calcium into intestinal smooth muscle cells. In animals, Pinaverium directly or indirectly reduces 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: After oral administration Pinaverium bromide is rapidly absorbed with peak plasma concentrations occurring within one hour. The drug is extensively metabolized and eliminated via the liver. The elimination half-life is 1.5 hours.
Absolute bioavailability for the oral formulation is very low (<1%). Major route of excretion is via the feces.
Plasma protein-binding of Pinaverium bromide is high (95-97%).
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 of barium enema.
Adults: The recommended dosage is 1 tablet three times a day up to 2 tablets twice a day.
If necessary, this dosage may be increased to 2 tablets three times a day.
In preparation for a barium enema, the dosage is 2 tablets twice a day, for the 3 days before the examination.
Pediatric population: The safety and efficacy of Pinaverium bromide (Eldicet) have not sufficiently been established in children and experience is limited (see Precautions). Currently available data are described under Pharmacology: Pharmacodynamics under Actions but no recommendation on a posology can be made.
Method of Administration: The tablets must be swallowed without being chewed or sucked, with a glass of water in the middle of a meal in order to avoid contact of Pinaverium with the esophageal mucosa (risk of esophageal lesion, see Adverse Reactions).
Overdose may lead to gastrointestinal complaints, such as flatulence and diarrhea. No specific antidote is known; symptomatic treatment is recommended.
Hypersensitivity to the active substance or to any of the excipients.
Because of a risk of esophageal lesion, instructions on the method of administration should be carefully adhered to. Patients with pre-existing esophageal lesion and/or hiatus hernia should pay special attention to the correct application of Pinaverium bromide (Eldicet).
The safety and efficacy of Pinaverium bromide (Eldicet) have not sufficiently been established in children and experience is limited. Therefore, Pinaverium bromide (Eldicet) is not recommended for use in children.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effect on Ability to Drive and Use Machines: No studies on the effect on the ability to drive and use machines have been performed.
There are no adequate data from the use of Pinaverium bromide in pregnant women.
Animal studies are insufficient with respect to effects on pregnancy or embryonal/fetal development or parturition or postnatal development. The potential risk for humans is unknown. Pinaverium bromide (Eldicet) should not be used during pregnancy unless clearly necessary.
Furthermore, the presence of bromine should be taken into account. Administration of Pinaverium bromide at the end of pregnancy can affect the new-born neurologically (hypotony, sedation).
There is insufficient information on the excretion of Pinaverium bromide (Eldicet) in human or animal breast milk. Physico-chemical and available pharmacodynamic/toxicological data on Pinaverium bromide (Eldicet) point to excretion in breast milk and a risk to the suckling child cannot be excluded. Pinaverium bromide (Eldicet) should not be used during breast-feeding.
The following adverse reactions have been reported spontaneously during post- marketing use. A precise frequency cannot be estimated from available data (not known).
Gastro-intestinal disturbances have been observed, e.g., abdominal pain, diarrhea, nausea, vomiting, and dysphagia.
Esophageal lesion may occur when not applied as advised (see Dosage & Administration).
Skin and subcutaneous tissue disorders:
Cutaneous effects have been observed e.g., rash, pruritus, urticaria, and erythema.
Immune system disorders:
Clinical trials have demonstrated the absence of any interaction between Pinaverium bromide and digitalis drugs, oral anti-diabetics, insulin, oral anticoagulants and heparin.
Co-administration of anticholinergic drug may enhance spasmolysis.
No interference with laboratory tests for drug level detection was observed.
Incompatibilities: Not applicable.
Store at temperatures not exceeding 30°C. Store in the original package and keep the blister in the outer carton in order to protect from light.
Shelf-life: 3 years.
A03AX04 - pinaverium ; Belongs to the class of other drugs used for functional bowel disorders.
FC tab 50 mg (round, biconvex, yellowish-orange colored for oral administration, engraved with "50" on one side and 8 mm in diameter) x 100's.