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Spazmolizin

An antispasmodic medicine (it relaxes smooth muscle), used for spasms associated with:

Active substances:

the active substance drotaverine hydrochloride 40 mg.

Patient information

Spazmolizin

Overview

Spazmolizin

Rectal suppositories, 40 mg

COMPOSITION

Each suppository contains the active substance drotaverine hydrochloride 40 mg.

Excipient: semi-synthetic solid glycerides.

WHAT IT IS USED FOR

An antispasmodic medicine (it relaxes smooth muscle), used for spasms associated with:

biliary tract disorders: gallstones, cholangiolithiasis, cholecystitis, cholangitis, papillitis;

urinary tract disorders: kidney or ureteral stones, pyelitis, cystitis, bladder spasms.

As adjuvant treatment: for spasms of the gastrointestinal tract (gastric or duodenal ulcer, gastritis, enteritis, colitis, irritable bowel with bloating), for tension-type headache and for dysmenorrhoea (menstrual pain).

HOW IT WORKS

Drotaverine relaxes the smooth muscle of the biliary and urinary tracts, the gastrointestinal tract and the blood vessels, reducing spasm and the associated pain. Its effect is stronger and longer-lasting than that of papaverine, without serious cardiovascular effects.

HOW TO USE

Administered rectally. Adults: 1–2 suppositories 2–3 times a day. The maximum single dose is 80 mg and the maximum daily dose is 240 mg.

If symptoms do not improve after 3 days, stop treatment and consult your doctor. Not for use in children and adolescents.

WHEN IT SHOULD NOT BE USED

hypersensitivity to drotaverine hydrochloride or to any of the excipients;

severe hepatic failure;

severe renal failure;

severe heart failure (low cardiac output syndrome);

breast-feeding;

children and adolescents.

Important to know

Use with caution in patients with low blood pressure and in pregnant women. In patients with porphyria, use is not safe (drotaverine has been associated with acute porphyria attacks).

Tell your doctor if you are taking levodopa (for Parkinson's disease): drotaverine may reduce its effect, worsening rigidity and tremor. If dizziness occurs, avoid driving and operating machinery. Read the package leaflet carefully before use.

Possible side effects

Rare: allergic reactions (angioedema, urticaria, skin rash, itching), headache, dizziness, insomnia, palpitations, lowered blood pressure, nausea, constipation.

If side effects occur, stop using the product and consult a doctor or pharmacist.

STORAGE

Store below 25 °C. Do not freeze. Keep out of the reach of children. Shelf life: 36 months.

QUESTIONS AND CONTACTS

For questions about the medicine, please consult your doctor or pharmacist. Manufacturer: FARMAPRIM SRL, 5 Crinilor str., Porumbeni village, Criuleni district, Republic of Moldova, MD-4829. Pharmacovigilance: safety@farmaprim.md.

Brief information prepared on the basis of the approved Summary of Product Characteristics. It does not replace consultation with a doctor or pharmacist and does not contain all information about the medicine. Always read the package leaflet.