NO SPA Comfort 40 mg. 24 tablets

What is NO-SPA Comfort 40 mg and what it is used for
NO-SPA Comfort 40 mg is an antispasmodic (soothing or spasmodic) product and can be used for the following conditions:
Spasms of smooth muscles in bile diseases: bile stones, cholecystitis (inflammation of the gall bladder).
Spasms of the smooth muscle of the urinary tract: kidney stones, urinary stones, inflammation of the renal pelvis, cystitis (inflammation of the bladder), bladder spasm.

As an adjunct therapy:

In the case of spasms of the stomach and intestinal smooth muscle: stomach and duodenal ulcer, gastritis (inflammation of the stomach lining), stomach spasm, enteritis (inflammation of the lining of the intestine), hypersensitivity and irritability of the colon accompanied by constipation or flatulence (formation of gases in the digestive tract, mainly in the intestine);
Tension-like headache;
For gynecological diseases: painful menstruation.
2. What you need to know before you take NO-SpA Comfort 40 mg
Do not take NO-SPA Comfort 40 mg:

if you are hypersensitive (allergic) to the active substance (drotaverine) or to any of the other ingredients (such as soya lecithin), (see section 6 "Package contents and further information");
if you suffer from severe liver, kidney or heart failure;
in children under 1 year of age.
Warnings and precautions
Its use in patients with low blood pressure requires caution.
In patients sensitive to lactose, it may cause gastrointestinal complaints due to the lactose content of one tablet (52 mg).

Children and adolescents
The use of drotaverine has not been studied in children.

Other Medicines and NO-SPA Comfort 40 mg
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
When administered concomitantly with levodopa, HO-SPA Comfort 40 mg reduces the effect of levodopa on relieving the symptoms of Parkinson's disease, i. E. the stiffness of skeletal muscles and tremor may get worse.

Pregnancy, breastfeeding and fertility
Tell your doctor if you are pregnant or think you may be pregnant or if you are planning to become pregnant.
Limited data are available in pregnant patients. Animal studies do not indicate direct or indirect harmful effects during pregnancy and fetal development. However, caution should be exercised when taking this medicine.

Tell your doctor if you are breast-feeding or intend to breast-feed.
Due to the lack of sufficient results from studies, the administration of HHO-Comfort 40 mg during breast-feeding is not recommended.
Always talk to your doctor or pharmacist before taking any medicine.

Driving and using machines
For oral (oral) administration at usual doses, drotaverine does not affect the ability to drive and use machines. However, in case of dizziness occurring after taking it, avoid dangerous situations and refrain from driving and using machines.

NO-SPA Comfort 40 mg contains lactose
NO-SPA Comfort 40 mg contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.

3. How to take NO-SPA Comfort 40 mg
If your doctor does not prescribe anything else, the recommended dose is:
Adults: 3-6 tablets daily (divided into 2-3 doses).
Children: The use of drotaverine in children has not been evaluated in clinical trials.
This medicinal product should not be used for more than 7 days without medical advice.

If you take more than the required dose of NO-SpA Comfort 40 mg
In case of overdosage, contact your nearest emergency department or doctor immediately to take the necessary measures for your treatment.

If you forget to take NO-SPA Comfort 40 mg
Do not take a double dose to make up for the forgotten dose.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The frequency of possible side effects listed below is defined using the following convention:

very common (affects more than 1 user in 10);
common (affects 1 to 10 users in 100);
uncommon (affects 1 to 10 users in 1,000);
rare (affects 1 to 10 users in 10,000);
very rare (affects less than 1 user in 10,000);
not known (can not be estimated from the available data).
Rare (affects 1 to 10 users in 10,000):
Headache, vertigo, nausea and palpitations, insomnia, constipation, low blood pressure.

Rare (affects 1 to 10 users in 10,000): allergic reactions (angioedema, urticaria, rash, pruritus).

Tell your doctor if the above side effects occur.

If any of the side effects gets serious, tell your doctor, pharmacist or nurse. This includes all possible side effects not listed in this leaflet.

5. How to store NO-SpA Comfort 40 mg
Store in the original package, at temperatures below 30 ° C.
Do not use after the expiry date stated on the carton.
Keep out of the reach and sight of children.
Do not dispose of medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What does NO-SPA Comfort 40 mg contain
The active substance is drotaverine hydrochloride 40 mg (drotaverine hydrochloride).
The other ingredients are: magnesium stearate, talc, povidone, corn starch, lactose monohydrate.
Film coating: partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide E171, macrogol 3350, soy lecithin E322, quinoline yellow E104, yellow iron oxide E172.

What NO-SPA Comfort 40 mg looks like and contents of the pack
Available in a pack of 24 film-coated tablets in aluminum / aluminum blisters in a cardboard box.

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