NO-SPA MAX 80mg x 24 tabl
NO-SHPA MAX tablets 80 mg * 24
LEAFLET: INFORMATION FOR THE USER
NO-SPA MAX 80 mg film-coated tablets
drotaverine hydrochloride
NO-SPA MAX 80 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.
- 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 7 days you do not feel better or your condition worsens, you should seek medical help.
What this leaflet contains:
1. What is NO-SHPA MAX 80 mg and what is it used for
2. What you should know before taking NO-SPA MAX 80 mg
3. How to take NO-SPA MAX 80 mg
4. Possible side effects
5. How to store NO-SPA MAX 80 mg
6. Contents of the package and additional information
1. What is NO-SHPA MAX 80 mg and what is it used for
NO-SHPA MAX 80 mg is an antispasmodic drug that reduces (soothes or removes) the pain caused by smooth muscle spasms.
NO-SHPA MAX 80 mg can be used in various diseases that cause contraction of the smooth muscles in the abdominal organs, which leads to painful spasms and abdominal pain.
NO-SHPA MAX 80 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 MAX 80 mg
Do not take NO-SPA MAX 80 mg:
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 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 - 104 mg in one tablet.
Children
The use of drotaverine has not been studied in children under 12 years of age.
Other medicines and NO-SHPA MAX 80 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-SPA MAX 80 mg reduces the effect of levodopa to relieve 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 is 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 a lack of sufficient data from studies, the use of HO-SPA MAX 80 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-SHPA MAX 80 mg contains lactose and soy lecithin
If your doctor has told you that you have an intolerance to some sugars, consult him before taking this product.
This medicine contains soybean oil. Do not take this medicine if you are allergic to peanuts or soy.
3. How to take NO-SPA MAX 80 mg
The recommended dose of NO-SPA MAX 80 mg is:
Adults: 1 film-coated tablet 2 or 3 times a day; the daily dose is 120 to 240 mg.
Adolescents over 12 years: 1 film-coated tablet 1 or 2 times a day; the maximum daily dose is 160 mg (no more than 2 tablets per day).
Children under 12 years of age: The use of drotaverine in children has not been evaluated in clinical studies.
This medicinal product should not be used for more than 7 days without medical advice.
The score on the tablet is only to facilitate breaking if you find it difficult to swallow the whole tablet. The break in the dividing line does not ensure uniform distribution of the dose.
If you have taken more than the required dose of NO-SPA MAX 80 mg
In case of overdose, contact the nearest emergency center or doctor immediately so that the necessary measures can be taken for your treatment. An overdose of drotaverine can lead to heart problems (rhythm and conduction disturbances) that can be fatal.
If you forgot to take NO-SPA MAX 80 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 per 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
- allergic reactions (angioedema, urticaria, rash, itching);
- headache, dizziness, insomnia;
- nausea and constipation;
- palpitations;
- lowering of blood pressure.
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 by:
Medicines Executive Agency,
Damyan Gruev St. 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 MAX 80 mg
PVC/PVDC/Al blister: To be stored at a temperature below 30°C.
Do not use after the expiration date stated on the carton. The expiration date corresponds to the last day of the specified month.
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 in additional information
What does NO-SPA MAX 80 mg contain
- The active substance is: drotaverine hydrochloride 80 mg (drotaverine hydrochloride);
- The other ingredients are:
Tablet core: magnesium stearate, talc, povidone K25, corn starch, lactose monohydrate.
Film coating: partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide E171, macrogol 3350, soy lecithin E322, quinoline yellow - aluminum varnish, E104, yellow iron oxide E172.
What NO-SPA MAX 80 mg looks like and what the package contains
Yellow, oblong, convex, film-coated tablets, debossed with “NOSPA” on one side and a score line on the other. The dividing line is only to facilitate breaking for easier ingestion, not to divide into equal doses.
Available in packs of 10, 12, 20 and 24 film-coated tablets in PVC/PVDC/aluminum blisters placed in a cardboard box.
Not all types of packaging can be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
SANOFI BULGARIA EOOD, Bulgaria.
Manufacturer:
CHINOIN Private Co. Ltd, Hungary.
Date of last revision of the leaflet: June 2019.
