PINAVERIUM (pinaverium bromide) is contraindicated in patients with known hypersensitivity to pinaverium bromide or any of the excipients. No other contraindications have been identified at this time. WARNINGS Contact of PINAVERIUM with the oesophageal mucosa may be irritating.
Therefore, it is strongly recommended that the tablet be taken with a glass of water during mealtime. The tablet must be swallowed without being chewed or sucked. If more than three tablets are prescribed per day, the additional tablet(s) should be taken concurrently with a glass of water and a snack.
Because of a risk of oesophageal lesions, instructions on the method of administration of PINAVERIUM should be carefully adhered to (see above and ADVERSE REACTIONS). Patients with pre-existing oesophageal lesion and/or hiatus hernia should pay special attention to the correct method of administration of PINAVERIUM.
The safety and efficacy of pinaverium bromide has not been established in children and experience is limited. Therefore, PINAVERIUM is not recommended for use in children. PRECAUTIONS PINAVERIUM (pinaverium bromide) should not be administered for the relief of motility dysfunction due to underlying organic disease.
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 medication. Page 4 of 23 Use in pregnancy:3 There are no adequate data from the use of pinaverium bromide in pregnant women.
Animal studies are insufficient with respect to effects on pregnancy, embryonal/ fetal development, parturition and/ or postnatal development. The potential risk for humans is unknown. The safety of pinaverium bromide during pregnancy has not been established.
Consequently, in the pregnant patient, this drug should only be administered if, in the judgement of the physician, its use is essential to the welfare of the patient. Furthermore, the presence of bromine should be taken into account.
Theoretically, administration of pinaverium bromide at the end of the pregnancy can affect the new-born neurologically (hypotony, sedation). No such cases however have been reported with pinaverium bromide.
Use during lactation:
There is insufficient information on the excretion of pinaverium bromide in human or animal breast milk. Physico-chemical and available pharmacodynamic/ toxicological data on pinaverium bromide point to excretions in breast milk and a risk to the suckling infant cannot be excluded.
PINAVERIUM should not be used during breast-feeding. ADVERSE REACTIONS Minor adverse events were reported and listed as mild and moderate. 2%). 2%). Page 5 of 23 Post-Market Adverse Drug Reactions The following adverse reactions have been reported spontaneously during post-marketing use.
A precise frequency cannot be estimated from available data (not known). g. abdominal pain, vomiting, and dysphagia. Oesophageal lesion may occur when advised method of administration of PINAVERIUM is not followed (see WARNINGS). g. rash, pruritus, urticaria, and erythema.
Immune system disorders There have been spontaneous reports of systemic hypersensitivity reactions involving the subcutaneous tissue and other organ systems of the body such as angioedema and anaphylactic shock. DRUG INTERACTIONS 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 an anticholinergic drug may enhance spasmolysis. No interference with laboratory tests for drug level detection was observed. SYMPTOMS AND TREATMENT OF OVERDOSAGE For management of a suspected drug overdose, contact your regional Poison Control Centre.
In man, apart from diarrhoea and/or flatulence, pinaverium bromide induced no undesirable Page 6 of 23 effects in daily dosages of up to 1,200 mg. 41,42 No cases of overdosage of pinaverium bromide have been reported to date. No specific antidote is known.
However, if overdosage occurs, symptomatic treatment is recommended. DOSAGE AND ADMINISTRATION The usual adult dosage is 50 mg three times a day (total daily dose of 150 mg). The dosage may be increased up to a maximum of 100 mg taken three times a day (maximum total daily dose of 300 mg).
It is recommended that the tablet be taken with a glass of water during meals or snacks. The tablet should not be swallowed when in the lying position or just before bedtime. The duration of treatment depends on the disorders for which PINAVERIUM is given.
AVAILABILITY PINAVERIUM is available as: 50 mg Film-coated Tablets:
Each brownish-orange, round, biconvex coated tablet contains 50 mg of pinaverium bromide as active ingredient. The tablet is engraved “PIN” over “50” on one side, “APO” on the other side. Available in blisters 100’s (10 x 10) and HDPE bottles of 100 tablets.
100 mg Film-coated Tablets: Each brownish-orange, round, biconvex coated tablet contains 100 mg of pinaverium bromide as active ingredient. The tablet is engraved “PIN” over “100” on one side, “APO” on the other side. Available in blisters 100’s (10 x 10) and HDPE bottles of 100 tablets.
Page 7 of 23 PHARMACEUTICAL INFORMATION DRUG SUBSTANCE Proper name: pinaverium bromide Chemical name: 4-(6-bromoveratryl)-4-[2-[2-(6,6-dimethyl-2-norpinyl)ethoxy]ethyl]- morpholinium bromide. 42 g/mol Description: Pinaverium […]