BUT - SPA tablets 40 mg * 24 SANOFI

BUT - SPA tablets 40 mg * 24 SANOFI
Leaflet: user information
NO-SPA 40 mg tablets
NO-SPA 40 mg tablets
dritaverine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist. If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
If after 3 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains:
1. What NO-SPA tablets are and what they are used for
2. What you need to know before you take NO-SPA tablets
3. How to take NO-SPA tablets
4. Possible side effects
5. How to store NO-SPA tablets
6. Contents of the package and additional information

1. What is NO-SPA tablets and what is it used for
NO-SHPA tablets is an antispasmodic (soothing or relieving spasms) product and can be used for the following diseases:
Smooth muscle spasms in biliary diseases: gallstones, cholecystitis (inflammation of the gallbladder).

Spasms of the smooth muscles of the urinary tract: kidney stones, stones in the urinary tract, inflammation of the renal pelvis, cystitis (inflammation of the bladder), spasm of the bladder.

As adjunctive therapy:
In case of spasms of the smooth muscles of the stomach and intestines: ulcer of the stomach and duodenum, gastritis (inflammation of the lining of the stomach), spasm of the stomach, 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 intestines).
In tension-type headache.
In gynecological diseases: painful menstruation.
2. What you need to know before taking NO-SPA tablets
Do not take No-SPA tablets:
if you are hypersensitive (allergic) to the active substance (drotaverine) or to any of the other ingredients (such as soy lecithin) listed in point 6).
if you suffer from severe liver, kidney or heart failure
in children under one 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).

Due to the lactose content, patients with rare hereditary diseases such as lactose intolerance, the Lapp lactase deficiency or glucose/galactose malabsorption should not take this medicine.

Talk to your doctor or pharmacist or nurse before taking NO-SPA.

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

Other medicines and NO-SPA tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
When taken at the same time as levodopa, HO-SPA reduces the effect of levodopa in relieving the symptoms of Parkinson's disease, i.e. skeletal muscle stiffness and tremors may worsen.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

A limited amount of data are available in pregnant patients. Animal studies do not indicate direct or indirect harmful effects during pregnancy and fetal development. However, caution is required when taking this medicine.

Due to the lack of sufficient results of studies, the use of NO-SPA during breast-feeding is not recommended.

Always consult your doctor or pharmacist before using any medicine.

Driving and using machines
When taken orally (by mouth) in usual doses, drotaverine does not affect the ability to drive and operate machines. However, in case of dizziness occurring after taking it, avoid dangerous situations and refrain from driving and operating machinery.

Important information about some of the ingredients of No-shpa tablets
No-shpa tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, consult him before taking this product.

3. How to take NO-SPA tablets
Unless your doctor has prescribed otherwise, 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 studies.
If you have taken more than the required dose of No-Shpa tablets
In case of overdose, contact the nearest emergency department or doctor immediately so that the necessary measures can be taken for your treatment.

If you have forgotten to take NO-SPA tablets
Do not take a double dose to make up for a missed dose.

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

The frequency of possible side effects listed below has been determined 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)
with an unknown frequency (cannot be estimated from the available data)

Rare:
headache, dizziness, nausea and palpitations, insomnia, constipation, lowering of blood pressure.
allergic reactions (angioedema, urticaria, rash, itching)
With an unknown frequency
dizziness
Inform your doctor if the above side effects occur.

Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly via

Executive Agency for Medicines,
"Damyan Gruev" Street No. 8,
1303 Sofia,
Tel.: +35 928903417,
website: www.bda.bg.

By reporting side effects, you can contribute to getting more information about the safety of this medicine.

5. How to store NO-SPA tablets
To be stored in the original packaging, at a temperature below 25°C.
For the plastic packaging with a tablet dispenser x 60 tablets, the storage conditions are:
Store in the original packaging, at a temperature below 25°C

Do not use after the expiration date stated on the carton.
Keep out of the reach of children.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What does NO-SPA tablets contain?
The active substance is drotaverine hydrochloride 40 mg (drotaverine hydrochloride);
The other ingredients are: magnesium stearate, talc, povidone, corn starch, lactose monohydrate.
What NO-SPA tablets look like and what the package contains
It is available in a package of 20 tablets NO-SPA in PVC/aluminum blisters x 20 tablets in a blister in a cardboard box
and/or in a package of 24 tablets NO-SPA in PVC/aluminum blisters x 24 tablets in a blister in a cardboard box
and/or in a package of 60 NO-SPA tablets in a plastic package with a tablet dispenser in a cardboard box.

Before using the package of 60 tablets in a plastic package, remove the protective stickers from the button and the bottom of the plastic tube.

Not all types of packaging can be put on sale.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Opella Healthcare France SAS, France

Manufacturer:
Opella Healthcare Hungary Ltd. Hungary
Opella Healthcare Poland Sp. z o. o. Poland

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