NO-SPA Comfort Tablets 40 Mg * 24 Sanofi ( and 12 similar items

NO-SPA COMFORT TABLETS 40 mg * 24 SANOFI PACKAGE LEAFLET: INFORMATION FOR THE USER BUT-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. 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 have to read it again. If you need further information or advice, ask your pharmacist. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. If after 3 days you do not feel better or your condition worsens, you should seek medical attention. What is in this leaflet: 1. What is NO-SPA Comfort 40 mg and what it is used for 2. What you need to know before you take No-SHPA Comfort 40 mg 3. How to take NO-SHPA Comfort 40 mg 4. Possible side effects 5. How to store NO-SHPA Comfort 40 mg 6. Contents of the pack and other information 1. What BUT Comfort 40 mg is and what it is used for BUT-SHPA Comfort 40 mg is an antispasmodic (soothing or removing spasms) product and can be used in the following diseases: spasms of smooth muscle in biliary diseases: gallstones, cholecystitis (inflammation of the gallbladder). Spasms of the smooth muscles of the urinary tract: kidney stones, urinary tract stones, inflammation of the renal pelvis, cystitis (inflammation of the bladder), spasm of the bladder. As an auxiliary therapy: In case of spasms of the smooth muscles of the stomach and intestines: ulcer of the stomach and duodenum, gastritis (inflammation of the gastric mucosa), spasm of the stomach, enteritis (inflammation of the mucous membrane 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). In tension-type headaches. In gynecological diseases: painful menstruation. 2. What you need to know before you take BUT Comfort 40 mg Do not take BUT-SHPA Comfort 40 mg: if you are hypersensitive (allergic) to the active substance (drotaverine) to any of the other ingredients (such as soy lecithin) listed in section 6, • if you suffer from severe hepatic, renal 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 can cause gastrointestinal complaints due to the lactose content of one tablet (52 mg). Due to their lactose content, patients with rare hereditary diseases such as lactose intolerance, Lapp lactase insufficiency or glucose/galactose malabsorption should not take this medicine. Children and adolescents The use of drottaverine 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 taken concomitantly with levodopa, NO-SPA Comfort 40 mg reduces the effect of levodopa in relieving symptoms of Parkinson's disease, i.e. skeletal muscle stiffness and tremor may be exacerbated. Pregnancy, breast-feeding 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. Studies in animals have not shown direct or indirect harmful effects during pregnancy and foetal development. However, caution is required when taking this medicine. Tell your doctor if you are breast-feeding or intend to breast-feed. Due to a lack of sufficient study results, the use of BUT-SHPA Comfort 40 mg during breastfeeding is not recommended. Always consult your doctor or pharmacist before taking any medicine. Driving and using machines When taken orally 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. BUT-SHPA Comfort 40 mg contains lactose BUT-SHPA Comfort 40 mg contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, ask your doctor for advice before taking this product. 3. How to take BUT Comfort 40 mg In case your doctor has not 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 trials. Do not use this medicinal product for more than 3 days without medical advice. If you take more BUT Comfort 40 mg than you should In case of overdose, contact the nearest emergency department or doctor immediately for the necessary measures to be taken for your treatment. If you forget to take BUT Comfort 40 mg Do not take a double dose to make up for a forgotten dose. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of possible adverse reactions 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) not known (cannot be estimated from the available data) Rare (affects 1 to 10 users in 10,000) Headache, dizziness, nausea and palpitations, insomnia, constipation, lowering blood pressure. allergic reactions (angioedema, urticaria, rash, itching). Not known Zamayanost Tell your doctor if the above side effects occur. Reporting of adverse reactions If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: Bulgarian Drug Agency ul. 8 Damyan Gruev Str., 1303 Sofia. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store NO-SHPA Comfort 40 mg Store in the original package at a temperature below 30C. Do not use after the expiry date stated on the carton. Keep out of the reach of children. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. 6. Contents of the pack and other information What SHO-SHPA Comfort 40 mg contains The active substance is drotaverine hydrochloride 40 mg (drotaverine hy The other ingredients are: magnesium stearate, talc, povidone, corn monohydrate. Film coating: partially hydrolyzed polyvinyl alcohol, talc, macrogol 3350, soy lecithin E322, quinoline yellow E104, yellow iron oxide E172. What NO-SHPA Comfort 40 mg looks like and contents of the pack It is available in a pack of 24 film-coated tablets in aluminium/aluminium blisters and/or in PVC/PVDC/aluminium blisters in a carton. Each PVC/PVDC/aluminium blister contains 24 film-coated tablets (1x24), respectively. Marketing Authorisation Holder and Manufacturer Marketing authorisation holder: Opella Healthcare France SAS, France Manufacturer: Opella Healthcare Hungary Ltd.