Torasemide

• Diuretic (water tablet)
• Used to treat high blood pressure and oedema
• Not to be used while breastfeeding
• Can cause dizziness
• Avoid drinking alcohol while taking this medicine

Torasemide belongs to a group of medicines called loop diuretics. A diuretic is a medicine which increases the amount of urine that you pass out from your kidneys.

Torasemide Sandoz 5-mg tablets are used to treat:

• High blood pressure.
• Swelling that occurs from fluid retention (oedema).

Torasemide Sandoz 10-mg tablets are used to treat:

• Swelling that occurs from fluid retention (oedema).

Torasemide Sandoz 20-mg tablets are used to treat:

• Swelling that occurs from fluid retention (oedema).

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose in adults is:

Torasemide Sandoz 5-mg tablets

Treatment of high blood pressure:

• ½ tablet once daily. If necessary, your doctor may increase this dose to one tablet a day at least two months into the treatment.

Treatment of oedema:

• One tablet once daily. If necessary, your doctor may gradually increase this dose to four tablets a day.

Torasemide Sandoz 10-mg tablets

Treatment of oedema:

• ½ tablet once daily. If necessary, your doctor may gradually increase this dose to two tablets a day.

Torasemide Sandoz 20-mg tablets

Treatment of oedema:

• ¼ tablet once daily. If necessary, your doctor may gradually increase this dose to one tablet a day.

This medicine is not suitable for use in children and adolescents under 18 years of age.

Instructions for use

The tablets should be taken in the morning. Swallow the tablets whole with 100 ml (half a glass) of water, without chewing. The tablets can be taken with or without food.

The tablets have a break line so that you can accurately break the tablet in sections, if required. Please refer to the package leaflet for instructions.

Alcohol/driving

You may feel dizzy or drowsy while taking Torasemide. This is more likely to happen when you start taking Torasemide tablets or start taking a higher dose. You should limit or stop drinking alcohol while taking this medicine as this is likely to trigger or worsen the side effects. Do not drive or operate machinery if you feel less alert after taking Torasemide tablets.

If you take more or less Torasemide than you should/stop taking Torasemide

If you have taken more Torasemide Sandoz tablets than you should, contact your doctor or pharmacist immediately.

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

Do not stop taking Torasemide without consulting your doctor first. This can be harmful to your health and make the treatment less effective.

Torasemide is not suitable for everyone. Do not take this medicine if:

• You are allergic to torasemide or any of the ingredients in this medicine (see section ‘What Torasemide contains').
• You are allergic to similar substances, such as certain medicines to treat diabetes containing active substances with names mostly ending in '-mide'.
• You have kidney problems or have any difficulties passing urine.
• You have severe liver problems, especially if you experience dizziness or syncope (loss of consciousness).
• Your blood pressure is lower than 100/60 mmHg (women) or 110/60 mmHg (men).
• You have a low blood volume (hypovolaemia).
• You are breastfeeding.

When should this medicine be used with caution?

Talk to your doctor before taking Torasemide if you have any of the following conditions:

• Gout and/or elevated uric acid levels.
• An irregular heartbeat (cardiac arrhythmia).
• A low blood volume (hypovolaemia).
• A low level of potassium or sodium in the blood.
• Acid-base abnormalities in the blood.
• Severe urinary problems due to, for example, an enlarged prostate.
• Kidney problems that have been caused by medicines.
• Diabetes.
• If you are taking certain medicines, please refer to section 'Other medicines and Torasemide’.

On long-term treatment with Torasemide, regular monitoring of cells and levels of certain substances in the blood is required.

Pregnancy and breastfeeding

Do not take Torasemide Sandoz if you are pregnant, unless your doctor says it is essential for your health. In this case, you should take the lowest possible dose.

Torasemide Sandoz should not be used while breastfeeding, as it is harmful to the baby.

Other medicines and Torasemide

Tell your doctor if you are taking, have recently taken or might take any other medicines. This is because Torasemide Sandoz can affect the way some medicines work. These medicines include:

• Other medicines for high blood pressure, in particular containing active substances with names ending in '-pril'.
• Medicines to improve heart pumping function, such as digitoxin, digoxin or methyldigoxin.
• Medicines to treat diabetes.
• Probenecid (used to treat gout).
• Medicines to treat inflammation and pain, such as acetylsalicylic acid or indomethacin.
• Medicines used to treat chronic inflammatory bowel diseases, such as sulfasalazine, mesalazine or olsalazine.
• Medicines used to treat infections, such as cefixime, cefuroxime and cefaclor.
• Cisplatin (used to treat cancer).
• Lithium (used to treat depression).
• Theophylline (used to treat asthma).
• Certain muscle relaxants containing active substances with names ending in '-curonium' or '-curium'.
• Laxatives.
• Medicines containing cortisone, such as hydrocortisone, prednisone or prednisolone.
• Colestyramine (used to treat high levels of cholesterol in the blood).
• Adrenalin or noradrenalin (used to treat low blood pressure).

Your doctor will also have a list of medicines that you should avoid mixing Torasemide with.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects that are known to be associated with this medicine include:

Common (may affect up to 1 in 10 people)

• Fluid and mineral imbalance (more likely to happen with low-salt diet).
• Alkali in the blood.
• Muscle cramps (more likely to happen when you start taking Torasemide tablets).
• Increased levels of uric acid, glucose, lipids in the blood.
• Low potassium or sodium level.
• Low blood volume (hypovolaemia).
• Gastrointestinal disorders, such as loss of appetite, abdominal pain, nausea, vomiting, diarrhoea, constipation.
• Increased hepatic enzyme level (e.g., gamma-GT).
• Headache.
• Dizziness.
• Tiredness.
• Weakness.

Uncommon (may affect up to 1 in 100 people)

• Increased levels of urea and creatinine in the blood.
• Dry mouth.
• Tingling in the arms and legs.
• Urinary problems (e.g., caused by prostatic hyperplasia).

For a list of uncommon and rare side effects, please see the package leaflet. Consult a doctor or pharmacist if you experience any side effects.

The active substance is torasemide. Each tablet contains 5 mg, 10 mg or 20 mg of torasemide.

The other active ingredients are cellulose microcrystalline, lactose monohydrate, magnesium stearate, maize starch, anhydrous colloidal silicon dioxide.

The manufacturers of Torasemide are:

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
D-39179 Barleben
Germany

LEK S.A.
50C, Domaniewska Street
02-672 Warszawa
Poland

Lek S.A.
ul. Podlipie 16
95-010 Stryków
Poland

Read the package leaflet before use.