NO-SPA COMFORT 40mg x 24 tabl
NO-SPA Comfort 40 mg film-coated tablets
drotaverine hydrochloride
NO-SPA Comfort 40 mg film-coated tablets
drotaverine hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
This medicine is available without a prescription. However, in order to get the best results from the treatment, you must carefully follow the instructions for use of the medicinal product.
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 three days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains:
1. What is NO-SPA Comfort 40 mg and what is it used for
2. What you should know before taking NO-SPA Comfort 40 mg
3. How to take NO-SHPA Comfort 40 mg
4. Possible side effects
5. How to store NO-SPA Comfort 40 mg
6. Contents of the package and additional information
1. What is NO-SPA Comfort 40 mg and what is it used for
NO-ShPA Comfort 40 mg is an antispasmodic (relieving 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 large intestine, 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 should know before taking 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 soy lecithin), (see item 6 Contents of the package and additional information);
if you suffer from severe liver, kidney or heart failure;
in children under 1 year.
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 those obtained without a prescription.
When taken simultaneously with levodopa, NO-SHPA Comfort 40 mg 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
Tell your doctor if you are pregnant or think you may be pregnant or if you intend to become pregnant.
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.
Inform your doctor if you are breast-feeding or intend to breast-feed.
Due to lack of sufficient results of studies, the use of NO-SPA Comfort 40 mg during breastfeeding 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 machinery. However, in case of dizziness occurring after taking it, avoid dangerous situations and refrain from driving and operating machinery.
NO-SPA Comfort 40 mg contains lactose
NO-SPA Comfort 40 mg contains 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-SHPA Comfort 40 mg
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. Do not use this medicinal product for more than 7 days without medical advice.
If you have taken more than the required dose of NO-SPA Comfort 40 mg
In case of overdose, immediately contact the nearest emergency department or doctor so that the necessary measures can be taken for your treatment.
If you forgot to take NO-SPA Comfort 40 mg
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 (an estimate cannot be made from the available data).
Rare (affects 1 to 10 users in 10,000):
Headache, dizziness, nausea and palpitations, insomnia, constipation, lowering of blood pressure.
Allergic reactions (angioedema, urticaria, rash, itching).
Inform your doctor if the above side effects occur.
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all possible side effects not described in this leaflet.
5. How to store NO-SPA Comfort 40 mg
To be stored in the original packaging, at a temperature below 30°C.
Do not use after the expiry 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 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, iron oxide yellow E172.
What NO-SPA Comfort 40 mg looks like and what the package contains
It is available in a pack of 24 film-coated tablets in aluminium/aluminium blisters and/or in PVC/PVDC/aluminium blisters placed in a cardboard box.
Each PVC/PVDC/aluminum blister contains respectively 24 film-coated tablets (1 x 24).
Marketing Authorization Holder:
SANOFI BULGARIA EOOD, Bulgaria.
Manufacturer:
CHINOIN Private Co. Ltd, Hungary.
