What is NO-SPA forte and what is it used for?

NO-SPA forte contains drotaverine hydrochloride, which is an antispasmodic agent. It relieves spasms of the smooth muscles of the gastrointestinal tract, biliary tract, urinary tract, reproductive system and vascular system.

It is used to reduce smooth muscle spasms in the following cases:
– Gallstone disease, inflammation of the gallbladder (cholecystitis), inflammation of the bile ducts (cholangitis and papillitis);
– Kidney stone disease (nephrolithiasis), ureteral stone disease (ureterolithiasis), inflammation of the renal pelvis, inflammation of the urinary bladder and bladder spasm.

What NO-SPA forte contains

• The active substance is drotaverine hydrochloride. One film-coated tablet of NO-SPA forte contains 80 mg of drotaverine hydrochloride.

• Other ingredients are magnesium stearate, talc, povidone, corn starch, lactose drotaverine hydrochloride (Drotaverini hydrochloridum)

Additional therapy for the following conditions:
For smooth muscle spasms of the gastrointestinal tract: gastric and duodenal ulcer, gastritis, pyloric and cardia spasms, inflammation of the small intestine (enteritis), inflammation of the large intestine (colitis), spastic colitis with constipation and meteorism (flatulence)

In irritable bowel syndrome;

• Tension-type headache;

• Painful menstruation.

  
  

Do not use NO-SPA forte in the following cases:

• If you are allergic to drotaverine hydrochloride or any of the other components of this medicine

• If you have severe liver or kidney failure;

• If you have severe heart failure;

• For children under 1 year of age.

  
  

Warnings and precautions when using
Before using NO-SPA forte, consult your doctor or pharmacist:

• If you have low blood pressure;

• If you are hypersensitive to lactose, the lactose contained in the tablet may cause gastrointestinal disturbances.

  
  

Other medicines and NO-SPA forte:
Tell your doctor or pharmacist about all the medicines you are taking, have taken or may take.
When used together with levodopa, its effect in Parkinson’s disease may be reduced, i.e. rigidity of skeletal muscles and tremor may increase.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Data on the use of No-spa during pregnancy are limited.

Animal studies have not shown direct or indirect harmful effects on pregnancy and embryo/fetal development.

Do not wait — caution should be exercised when using this medicine during pregnancy.

Excretion of drotaverine into breast milk has not been studied. Therefore, its use during breastfeeding is not recommended.

Driving and using machines:
If you experience dizziness (vertigo), you should avoid driving vehicles and working with machinery.

NO-SPA fortecontains lactose
If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

How to use NO-SPA forte
Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

• The recommended dose for adults is 1 tablet of 80 mg (2–3 times) per day.

• The maximum number of tablets per day is 3 tablets (240 mg).
  The score line is intended only to facilitate breaking the tablet for easier removal from packaging.

  
  

Use in children and adolescents:
The use of drotaverine in children has not been evaluated in clinical studies.

If you take more NO-SPA forte than you should:
If you have taken more NO-SPA forte than prescribed, contact your doctor immediately.
In case of drotaverine overdose, cardiac rhythm disturbances and conduction disorders may occur, which determine the heart rhythm. Complete block of one of the branches of the conduction system and cardiac arrest may also develop, which may lead to death.

If you forget to take NO-SPA forte:
Do not take a double dose to make up for a forgotten tablet.

If you stop using NO-SPA forte:
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

 Possible side effects:

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (may affect up to 1 in 1000 people),

• Palpitations

• Hypotension (low blood pressure),

• Headache, dizziness (including vertigo), insomnia,

• Nausea, constipation,

• Allergic reaction (angioedema (swelling of the face, lips, mouth, tongue or throat), urticaria, rash, itching).

  
  

How to store NO-SPA forte

• Keep this medicine out of the sight and reach of children.

• Store at temperatures up to 25°C, in the original packaging.

  
  

Do not use after the expiry date stated on the package after “EXP”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.

The medicine is dispensed by prescription.

Marketing Authorization Holder
Opella Healthcare France SAS
157 avenue Charles de Gaulle
92200 Neuilly-sur-Seine
France

Manufacturer
Opella Healthcare Hungary Ltd.
(Opella Healthcare Hungary Limited Liability Company)
2112 Veresegyház, ulca 5
Hungary