No-Spa (60 Tablets) is a diastolic drug that reduces pain (painful cramps) in the abdominal and pelvic organs, i.e. in the gastrointestinal tract (stomach and intestines), biliary and urinary tract, and in women also in the reproductive tract.

No-Spa contains the active substance drotaverine hydrochloride. This substance is used in the contraction of muscles of both nervous and muscular origin, most often manifested by pain in the abdominal cavity.

The relaxing effect of drotaverine does not depend on the type of innervation and the location of smooth muscles (gastrointestinal tract, urogenital system, circulatory system and biliary system). The drug is metabolized in the liver, excreted mainly in the urine and to a lesser extent through the gastrointestinal tract.

Symptoms

No-Spa is used:

• in muscle spasms associated with biliary tract diseases: cholelithiasis, cholecystitis, peritheitis, bile duct inflammation, Vater’s papillitis,
• in contractile conditions of smooth muscles of the urinary tract: kidney stones, ureterolithiasis, inflammation of the renal pelvis, cystitis, painful urge to urinate and
• auxiliary: – in contractile states of smooth muscles of the digestive tract: gastric ulcer and duodenal ulcer, gastritis, enteritis, colitis, in spasms of the stomach and pylorus, irritable colon syndrome, spastic constipation and intestinal distension, pancreatitis – in gynecological diseases: dysmenorrhea.

Active substance: Drotaverini hydrochloridum

Composition of No-Spa (60 Tablets)

The active substance of the drug is drotaverine. Each film-coated tablet contains 40 mg drotaverine hydrochloride.

The other ingredients are: tablet core: lactose monohydrate, maize starch, povidone, magnesium stearate, talc. tablet coating: Opadry II pink 85G34397, polyvinyl alcohol, talc, titanium dioxide (E171), macrogol, lecithin (soybean), carmine (E 120), tartrazine (E 102).

Dosage

Adults:

• Daily dose: 120 to 240 mg, in 2-3 divided doses.

Children:

Clinical trials have not been conducted in children. If it is necessary to use No-Spa in children:

• daily dose for children from 6 to 12 years of age: 80 mg, divided into 2 doses,
• daily dose for children over 12 years of age: 160 mg, divided into 2-4 doses.

Contraindications

Do not use No-Spa:

• if you are allergic (hypersensitive) to drotaverine or any of the other ingredients of the medicine,
• if you have severe liver, kidney and heart failure
• if you have second-third degree atrioventricular block,
• children under 6 years of age.

Contents

The package contains 60 tablets

Storage method

15°C-25°C

Manufacturer

SANOFI-AVENTIS

Warnings

Take care when taking the drug:

• in patients with hypotension,
• in children,
• in pregnant women.

Do not use the drug during childbirth.

Due to the presence of tartrazine, the drug may cause allergic reactions.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Drotaverine crosses the placenta. Do not use the drug during childbirth.

Interactions with other drugs

Tell the doctor or pharmacist about all the drugs taken by the patient now or recently, as well as about the drugs that the patient is planning to take.
Caution should be exercised with concomitant administration with levodopa (a drug used in Parkinson’s disease) due to the reduction of its anti-Parkinsonian effects and the increase in tremors and stiffness.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare (may affect up to 1 in 1,000 people):

• allergic reactions (angioedema, hives, rash, itching),
• headache and dizziness
• insomnia – palpitations,
• decrease in blood pressure – nausea, constipation.