Keep out of reach of children.
Read the directions carefully before use.
For prescription only.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Drotaverine HCl ............................... 80 mg
Excipients: Lactose monohydrate, wheat starch, talc, magnesium stearate.
Tablet.
Product description: A capsule-shaped, pale yellow tablet, scored on one side, plain on the other side, undamaged edges.
Box of 2 blisters x 10 tablets.
Box of 3 blisters x 10 tablets.
Box of 6 blisters x 10 tablets.
Pharmacotherapeutic group: Drugs for functional gastrointestinal disorders.
Drotaverine is an isoquinoline derivative, which exerts its spasmodic effect directly on smooth muscle.
The inhibition of the phosphodiesterase enzyme (PDE) IV and the consequent increase of cAMP level are determinant in its mechanism of action and lead to smooth muscle relaxation through the myosin light chain kinase enzyme (MLCK) inactivation.
Drotaverine inhibits PDE IV in vitro, but not isoenzymes PDE III and PDE V. Practically, PDE IV appears to be very important in the blockage of smooth muscle contractility; suggesting that selective PDE IV inhibition might be useful in the treatment of hypermotility disorders and various diseases accompanied with gastrointestinal smooth muscle spasm. PDE III isoenzyme hydrolyses cAMP in myocardium and vascular smooth muscles; it provides an explanation, that drotaverine can be an effective spasmolytic agent without significant cardiovascular adverse effects and strong cardiovascular therapeutic activity.
Drotaverine is effective in all cases of smooth muscle spasms of both neural and muscular origin. Independently from the type of autonomous innervation, drotaverine acts equally on the smooth muscles of the gastrointestinal, biliary, urogenital, and vascular systems. Due to the vasodilator effect, drotaverine increases tissue circulation.
The effect of drotaverine is stronger than that of papaverine; its absorption is more rapid and more complete; and it bonds less to serum proteins. Another advantage is that the stimulating adverse effect on respiration observed after parenteral administration of papaverine does not occur with drotaverine administration.
Drotaverine is rapidly and completely absorbed after both oral and parenteral administration. Drotaverine is highly bound to plasma albumin (95 - 98%), gamma, and beta globulins. Serum peak concentration is reached within 45 - 60 minutes after oral administration. Following the first pass metabolism of drotaverine, 65% of the administered dose is found unchanged in the circulation.
Drotaverine is metabolized in the liver, with a biological half-life of 8 - 10 hours. Practically within 72 hours, drotaverine is eliminated from the body, in approximately 50% via the urine and about 30% in the faeces. Drotaverine is mainly excreted as metabolites; its unchanged form cannot be detected in the urine.
When administered orally at the usual doses, drotaverine does not affect the ability to drive and operate machines.
However, if you experience dizziness after intake, avoid risky situations and abstain from driving a vehicle or operating a machine.
Ask your doctor or pharmacist for advice before taking any medicine.
Based on animal and human studies, no adverse effect on the mother or foetus has been reported when used during pregnancy. However, drotaverine administration during pregnancy requires special caution.
Due to a lack of sufficient data, drotaverine administration during the period of breast-feeding is not recommended.
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
When given concomitantly with levodopa, drotaverine weakens the action in reducing the symptoms of Parkinson’s disease, so that skeletal muscle rigidity and tremor may worsen.
Like other medicines, drotaverine can cause side effects, although not everybody gets them.
Headache, dizziness, nausea, palpitation, insomnia, constipation, and hypotension may occur (rarely).
If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If you take more drotaverine tablets than you should, see your doctor or the nearest emergency unit. You should bring the package of the medicine with you.
Store in dry places, not exceeding 30°C, protect from light.
Administration of drotaverine requires special caution in patients with hypotension.
Excipients:
Lactose monohydrate: Patients with lactase insufficiency, galactose intolerance or glucose/galactose malabsorption should not take this medicine.
Wheat starch: Wheat starch in this medicine contains only very low levels of gluten and is very unlikely to cause problems if you have coeliac disease. If you have wheat allergy, you should not take this medicine.
Drotaverine is an antispasmodic medication used to relax smooth muscles for the following conditions:
- Smooth muscle spasms associated with biliary tract disorders: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, and papillitis.
- Smooth muscle spasms associated with urinary tract disorders: nephrolithiasis, ureterolithiasis, pyelitis, cystitis, and cramp of urinary bladder.
As adjuvant treatment in:
+ Smooth muscle spasms associated with gastrointestinal disorders: gastric and duodenal ulcer, gastritis, cardia and pylorus spasm, enteritis, and increased irritable colon.
+ Gynaecological diseases: dysmenorrhoea.
If you are hypersensitive to the active substance or any of the ingredients of this medicine.
In children under the age of 12 years.
If you suffer from severe insufficiency of liver, kidney, or heart.
For oral administration.
The usual dose of drotaverine for adults is 1 to 3 tablets daily (in 2 - 3 divided doses).
No clinical studies have been performed in children. If drotaverine administration is necessary for children over the age of 12 years, the dose of 1 tablet or up to 2 tablets may be given daily (in 1 - 2 divided doses). You should check with your doctor or pharmacist if you are not sure.
If you forget to take this medicine
Do not take a double dose to make up for a forgotten dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
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