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

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

Symptoms

Smooth muscle contractions associated with diseases of the bile ducts: cholelithiasis, cholecystitis, peritheitis, bile duct inflammation, Vater’s papillitis;

Urinary tract smooth muscle contractions: kidney stones, ureterolithiasis, inflammation of renal pelvis, cystitis, painful urge to urinate.

As supportive therapy, it can be used safely and with the desired effect:

• in contractile states of smooth muscles of the gastrointestinal tract: gastric and duodenal ulcer disease, gastritis, enteritis, colitis, spasms of the gastric tab and pylorus, irritable colon syndrome, spastic constipation and intestinal distension, pancreatitis;
• in gynecological diseases: dysmenorrhea;
• in tension headaches.

Active substance: Drotaverini hydrochloridum

Composition of No-Spa Max

Each film-coated tablet contains 80 mg of drotaverine hydrochloride (Drotaverini hydrochloridum)

Dosage

Adults: The daily dose is 120 to 240 mg in 2-3 divided doses.

Children: Clinical trials have not been conducted in children.

In case of necessity to use the medicinal product NO-SPA Forte 80 mg

In children: the daily dose for children over 12 years of age is 160 mg, divided into 2 – 4 doses.

Contraindications

Hypersensitivity to the active substance or any of the excipients of the product.

Severe liver and kidney failure, circulatory failure.

Second-third degree AV block.

Do not use in children under 12 years of age.

Contents

The package contains 20 coated tablets

Storage

Below 25°C

Manufacturer

SANOFI-AVENTIS

Warnings

Due to the lactose content, the medicinal product may cause gastrointestinal discomfort in lactose intolerant patients.

The product should not be used in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Due to the presence of quinoline yellow, the product may cause allergic reactions.

The product should be used with caution in patients with hypotension.

The product should be used with caution in children, as drotaverine has not been studied in this patient group.

Caution should be exercised when using drotaverine in pregnant women.

Drotaverine should not be used during labor.

Pregnancy and lactation

Due to the lack of sufficient research, the product should be used in pregnant or lactating women only when the benefits of its use outweigh the risk factors.

The active substance crosses the placenta.

A clinical trial found an increased risk of postpartum haemorrhage in patients receiving drotaverine during labor. Therefore, drotaverine should not be used during labor.

It is not known whether drotaverine is excreted in human milk. The use of drotaverine during breastfeeding is not recommended.

Driving vehicles

At therapeutic doses, orally administered drotaverine has no influence on the ability to drive and use machines.

Patients should be advised that if they feel dizzy they should avoid potentially hazardous activities such as driving or operating machinery.

Overdosage

There are no known cases of overdosage with drotaverine.

In the event of overdose, the patient should be carefully monitored and treatment instituted symptomatically.

Interactions with other drugs

Caution should be exercised with concomitant administration with levodopa due to the reduction of its anti-Parkinsonian effect and the increase in tremors and stiffness.

Side effects

Like any drug, this drug can cause side effects, although not everybody gets them.
Rare (affects 1 to 10 users in 10,000):

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