Composition:

Each Spasmopinaver film-coated tablet contains pinaverium bromide 50 mg or 100 mg.

Pharmacodynamics:

Spasmopinaver, pinaverium, is a calcium antagonist which inhibits the calcium influx by blocking the voltage-dependent calcium channel at the smooth muscle cell level.

It possesses a high degree of selectivity for the intestinal smooth muscle.

Pharmacokinetics:

Pinaverium bromide is poorly absorbed from the gastro-intestinal tract after oral administration (4 to 7% of the administered dose).

Maximum serum concentration is reached after 1 hour.

Pinaverium bromide is 97% bound to plasma proteins.

It is rapidly metabolized by the liver.

 Elimination half-life is approximately 1.5 hours.

Pinaverium bromide is mainly eliminated by the biliary route.

Therapeutic Indications:

Treatment and relief of symptoms associated with irritable bowel syndrome: abdominal pain, bowel disturbances and intestinal discomfort.

Treatment of symptoms related to functional disorders of the biliary tract.

Dosage and Administration:

Adult:

One tablet of 50 mg to be taken three times daily with a glass of water during meals or snacks.  The tablet should not be swallowed when in the lying position or just before bedtime.

In exceptional cases, the dosage may be increased up to three tablets of 100 mg daily.

The duration of treatment depends on the disorders for which pinaverium is given.

Drug-Drug Interactions:

No reported drug-drug interactions with pinaverium bromide.

Precautions:

Should not be administered for the relief of motility dysfunction due to underlying organic disease.

Contact with pinaverium with the esophageal mucosa may be irritating.  

Therefore, it is strongly recommended that the tablet be taken with a glass of water during mealtime.  

-If more than 3 tablets are prescribed daily, the additional tablet should be taken concurrently with a glass of water and a snack.

Contraindications:

Patients with known hypersensitivity to pinaverium or any ingredient of the product.

Pregnancy:

Reproductive studies performed in animals have not revealed the presence of teratogenic effects.

 However, the safety of pinaverium 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.

Lactation:

As no controlled studies are available for nursing women; therefore, the drug should be avoided during lactation.

Adverse Reactions:

Mainly minor digestive disorders that may related to the disease, such as epigastric pain and/or fullness, nausea, constipation, heartburn, distension and diarrhea.

Other side effects such as headache, dryness of the mouth, drowsiness, vertigo and skin allergy.

Presentation & Storage:

Spasmopinaver 50 film-coated tablets are supplied in boxes of 10 tablets each.

Spasmopinaver 100 film-coated tablets are supplied in boxes of 10 tablets each.

Store at temperature of 30°C, in a dry place.