Antispasmin Forte, 20 tablets, Biofarm

Indications:
Antispasmin FORTE 80 mg tablets contain the active substance drotaverine hydrochloride, which is an antispasmodic drug.
This medicine is used for the symptomatic treatment of smooth muscle spasm:
-associated with biliary tract diseases - gallstones, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis;
-associated with urinary tract diseases - renal lithiasis, ureteral lithiasis, pyelitis, cystitis and spasm of the bladder sphincters.
This medicine is used in combination with other medicines in the treatment of:
-smooth muscle spasm associated with gastrointestinal tract diseases: gastric or duodenal ulcer, gastritis, spasms of the cardia and pyloric sphincters, enteritis, colitis, spastic colitis accompanied by constipation and forms of irritable colon accompanied by meteorism (bloating);
-headaches with a feeling of intracranial tension;
-dysmenorrhea (painful menstruation), uterine spasm associated with gynecological diseases.

Composition:
-The active substance is drotaverine hydrochloride. Each tablet contains 80 mg drotaverine hydrochloride.
-The other ingredients are: lactose monohydrate, corn starch, povidone K 25, sodium starch glycolate (type A), magnesium stearate, talc.

Method of administration:
Always take this medicine exactly as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure.
Unless your doctor has advised you otherwise, the usual dose for adults is 1 tablet 2-3 times a day.
You should contact your doctor if your symptoms do not improve after 3 days of treatment.
Use in children and adolescents:
The use of drotaverine in children and adolescents has not been evaluated in clinical trials. Antispasmin FORTE should not be administered to children and adolescents due to the high amount of active substance they contain.

Contraindications:
Do not use Antispasmin FORTE:
- if you are allergic to drotaverine hydrochloride or any of the other ingredients of this medicine.
- if you have severe liver, kidney or heart problems (severe liver failure, severe kidney failure or severe heart failure).
-in children and adolescents.

Precautions:
Before using Antispasmin FORTE, talk to your doctor, pharmacist or nurse if:
-Do you have low blood pressure.
- you have porphyria. The use of drotaverine has been associated with acute attacks of porphyria.
Children and adolescents:
The use of drotaverine in children and adolescents has not been evaluated in clinical trials. Antispasmin tablets
FORTE should not be administered to children and adolescents due to the large amount of active substance they contain.

Pregnancy, lactation and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
There is limited information on the use of drotaverine in pregnant women. In animal studies, no toxic effects on pregnancy or fetal development were observed when this drug was administered during pregnancy. The use of drotaverine during pregnancy requires caution.
The excretion of drotaverine in breast milk has not been studied in animals. A risk to the newborn/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from drotaverine therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Driving and using machines:
When administered orally and in recommended doses, drotaverine hydrochloride does not affect the ability to drive or use machines. However, if you notice a feeling of lack of balance in space or spinning of surrounding objects after taking this medicine, avoid potentially hazardous activities, driving or using machines.

Presentation:
20 tablets

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.