Package leaflet: Information for the patient. Torarese 2.5 mg tablets Torarese 5 mg tablets Torarese 10 mg tablets Torarese 20 mg tablets.

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1 Package leaflet: Information for the patient Torarese 2.5 mg tablets Torarese 5 mg tablets Torarese 10 mg tablets Torarese 20 mg tablets Torasemide Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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. What is in this leaflet 1. What Torarese is and what it is used for 2. What you need to know before you take Torarese 3. How to take Torarese 4. Possible side effects 5. How to store Torarese 6. Contents of the pack and other information 1. What Torarese is and what it is used for Torarese 2,5 mg tablets are used to treat: high blood pressure Torarese 5mg tablets are used to treat: high blood pressure swelling caused by too much water in the body (oedema) Torarese 10 mg tablets are used to treat: swelling caused by too much water in the body (oedema) Torarese 20 mg tablets are used to treat: swelling caused by too much water in the body (oedema) Torasemide is a diuretic, which is a medicine that increases the urine output. 2. What you need to know before you take Torarese Do not take Torarese if you are/have allergic to: torasemide or any of the other ingredients of this medicine (listed in section 6) chemical analogue medicines such as certain medicines to treat diabetes, containing active substances with names mostly ending in -mide kidney failure with insufficient urine production severe liver disorders with loss of consciousness blood pressure lower than 100/60 mmhg (women) or 110/60 mmhg (men) decreased blood volume

2 breast-feeding Warnings and precautions Talk to your doctor before taking Torarese if any of the following apply to you: gout and/or an increase in uric acid levels in the blood an irregular heart beat reduced blood volume reduced potassium or sodium levels in the blood abnormal changes in the amount of acid and base in the body severe urinary flow disorders caused for example by an enlarged prostate gland reduced kidney function due to medicines which cause kidney damage diabetes taking any medicines See Other medicines and Torarese If you continuously use torasemide your doctor will check your blood regularly regarding cells and levels of certain substances, particularly if you use other medicines. Children and adolescents Torarese is not recommended for children and adolescents below 18 years of age. Other medicines and Torarese Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The following medicines can affect or be affected by Torarese: medicines to treat high blood pressure, particularly medicines with active substances ending in -pril medicines to encourage the heart s pumping strength, such as digitoxin, digoxin or methyldigoxin medicines to treat diabetes probenecid, a medicine to treat gout medicines to treat inflammation and pain, such as acetyl salicylic acid or indometacin sulfasalazine, mesalazine or olsalazine, medicines to treat chronic inflammatory bowel diseases medicines to treat infections, such as cefixime, cefuroxime, cefaclor, cefalexin, cefadroxil, cefpodoxime proxetil, kanamycin, neomycin, gentamycin, amikacin or tobramycin cisplatin, a medicine to treat cancer lithium, a medicine to treat depression theophylline, a medicine to treat asthma some muscle-relaxant medicines with active substances ending in -curonium or -curium all medicines to treat constipation medicines containing cortisone, such as hydrocortisone, prednisone or prednisolone colestyramine, a medicine to reduce blood fat levels adrenaline or noradrenaline, medicines to increase blood pressure Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Only take Torarese during pregnancy if your doctor indicates that it is absolutely necessary. The lowest possible dose should be used in this case. Breast-feeding Torarese is not recommended for women who are breastfeeding as it may harm the baby.

3 Driving and using machines Dizziness or drowsiness may occur when taking Torarese particularly at the beginning of treatment, when increasing the dosage, changing the preparation or when concomitantly ingesting alcohol. If your attention is decreased, do not drive or operate machines. Torarese contains lactose This medicine contains lactose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 3. How to take Torarese Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Torarese 2.5 mg tablets Treatment of high blood pressure 1 tablet once daily If necessary, your doctor may increase the dose to 2 tablets once daily after two months treatment at the earliest. Torarese 5 mg tablets Treatment of high blood pressure ½ tablet once daily If necessary, your doctor may increase the dose to 1 tablet once daily after two months treatment at the earliest. Treatment of swelling caused by too much water in the body (oedema) 1 tablet once daily If necessary, your doctor may gradually increase the dose to 4 tablets once daily. Dividing the tablet: The tablet can be divided into equal doses. Place the tablet on a hard, flat surface with the break-line facing upwards. Press with a finger on the middle of the tablet and the tablet breaks into two equal halves. Torarese 10 mg tablets Treatment of swelling caused by too much water in the body (oedema) ½ tablet once daily If necessary, your doctor may gradually increase the dose to 2 tablets once daily. Dividing the tablet: The tablet can be divided into equal doses. Place the tablet on a hard, flat surface with the break-line facing upwards. Press with one finger each on the left and the right side of a single break-line and the tablet breaks into two equal halves.

4 Torarese 20 mg tablets Treatment of swelling caused by too much water in the body (oedema) ¼ tablet once daily If necessary, your doctor may gradually increase the dose to 1 tablet once daily. Dividing the tablet: The tablet can be divided into equal doses. Place the tablet on a hard, flat surface with the break-line facing upwards. Press with a finger on the middle of the tablet and the tablet breaks into four equal parts. Use in children and adolescents There is insufficient experience on the use of torasemide in children and adolescents thus this medicine is not recommended for children and adolescents below 18 years of age. Reduced liver function which is not severe Your doctor will treat you carefully as the torasemide level might increase. Kind of administration Take the tablets each morning independent of meals, unchewed, with 100 ml of water, equivalent to a half glass. Duration of use To be decided by your attending doctor. Torarese can be continuously used for some years or until excess tissue fluid has disappeared. If you take more Torarese than you should Contact your doctor immediately. An overdose is likely to cause pass a lot of water (urine), sleepiness, confusion, weakness, dizziness, hypotension, circulatory collapse, upset stomach. Always take any tablets left over with you and also the box, as this will allow easier identification of the tablets. If you forget to take Torarese Take the forgotten dose as soon as possible at the same day or take the next dose normally the next day. Do not take a double dose to make up for a forgotten dose. If you stop taking Torarese Do not stop Torasemide use without your doctors permission, as this can seriously harm you and reduce the therapy effect. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

5 4. Possible side effects Like all medicines this medicine can cause side effects, although not everybody gets them. Side effects can occur with the following frequencies: Common: may affect up to 1 in 10 people disturbances in the amount of body water and minerals, particularly when there is clearly limited salt intake excessive alkaline in the body muscle cramps, especially when beginning treatment increased blood concentrations of uric acid, sugar and fats reduced potassium and sodium levels in blood reduced blood volume stomach and/or bowel disorders, such as loss of appetite, stomach pain, nausea, vomiting, diarrhoea, constipation increase of certain liver enzyme levels, such as gamma-gt headache dizziness tiredness weakness Uncommon: may affect up to 1 in 100 people increase of blood concentrations in the substances urea and creatinine dry mouth creeping sensation or tingling in arms and legs difficulty in passing water (urine) (e.g. due to prostatic hyperplasia) Very rare: may affect up to 1 in 10,000 people narrowed or constricted blood vessels caused by blood thickening lower blood pressure than normal circulation problems, especially when standing up irregular heart beat angina pectoris, a condition often marked by severe chest pain heart attack fainting confusion inflammation of the pancreas allergic reactions with itching and rash increased light sensitivity severe skin reactions reduction in red and white blood cells and platelets problems with sight ringing or buzzing in the ears hearing loss Reporting of side effects 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 [the national reporting system; to be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Torarese Keep this medicine out of the sight and reach of children.

6 Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. Do not store above 25 C. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Torarese contains - The active substance is torasemide. Each tablet contains 2.5 mg of torasemide Each tablet contains 5 mg of torasemide. Each tablet contains 10 mg of torasemide. Each tablet contains 20 mg of torasemide. - The other ingredients are: microcrystalline cellulose, lactose monohydrate, magnesium stearate, maize starch, colloidal anhydrous silica What Torarese looks like and contents of the pack Torarese 2.5 mg tablets Torarese 2.5 mg is around, white to off-white tablet Torarese 5 mg tablets Torarese 5 mg is around, white to off-white tablet with break notch. Torarese 10 mg tablets Torarese 10 mg is around, white to off-white tablet with cross break notch. Torarese 20 mg tablets Torarese 20 mg is a round, white to off-white tablet with cross break notch. Pack sizes: 10, 14, 20, 28, 30, 50, 56, 60, 70, 80, 90, 100, 400 (20 x 20) tablets Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer [To be completed nationally] This medicinal product is authorised in the Member States of the EEA under the following names: [To be completed nationally] This leaflet was last revised in [To be completed nationally]