Torasemide Stada 5 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

TORASEMIDE STADA 5 MG TABLETS EFG

Read the entire leaflet carefully before you start taking this medicine

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet Contents:

1. What Torasemide STADA 5 mg tablets EFG is and what it is used for
2. Before taking Torasemide STADA 5 mg tablets EFG
3. How to take Torasemide STADA 5 mg tablets EFG
4. Possible side effects
5. How to store Torasemide STADA 5 mg tablets EFG
6. Further information

1. What TORASEMIDA STADA 5 MG TABLETS EFG is and what it is used for

Torasemida STADA is a diuretic medicine (increases urine elimination) belonging to the group known as "High-ceiling diuretics: sulfonamides, single active substance".

Torasemida STADA is indicated for the treatment of:

• edema (fluid retention) due to congestive heart failure, renal or hepatic disease,
• hypertension.

2. BEFORE TAKING TORASEMIDE STADA 5 MG TABLETS

EFG Do not take Torasemide STADA:

• if you are allergic (hypersensitive) to torasemide or to any of the other components of Torasemide STADA,
• if you are allergic to sulfonylureas,
• if you have anuria (absence of urine production).

Take special care with Torasemide STADA:

• if you have severe liver disease, as the use of torasemide could precipitate a coma,
• if you have low blood levels of sodium or potassium or low blood volume,
• if you have heart problems, especially if you are being treated with digitalis glycosides, since this increases the risk of cardiac arrhythmias,
• if you have gout or diabetes mellitus,
• if you have renal insufficiency or have difficulty urinating,
• if you have low blood pressure (hypotension).

Use of other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

You should also inform your doctor if you are taking any of the following medicines that may interact with torasemide:

• cardiac glycosides such as digoxin (heart medications), antihypertensives (particularly ACE inhibitors), theophylline (a medicine for the treatment of asthma): the effect of these medicines may be increased,
• mineralocorticoids, glucocorticoids, and laxatives: may increase potassium loss caused by these medicines,
• aminoglycoside antibiotics: may increase kidney or ear toxicity,
• cisplatin (a medicine for the treatment of cancer), lithium (an antidepressant medicine), salicylates, etacrynic acid: may increase the toxicity of these,
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen, indomethacin), probenecid (a medicine for gout), cholestyramine (a medicine to reduce blood cholesterol levels): may reduce the effect of torasemide,
• medicines for the treatment of diabetes: may reduce the effect of these.

Taking Torasemide STADA with food and drinks

The tablets may be taken with or without food.

Pregnancy and Breast-feeding

Consult your doctor or pharmacist before using any medicine.

The use of torasemide during pregnancy is not recommended.

It is unknown whether torasemide passes into breast milk; therefore, its use during breast-feeding is not recommended.

Use in children

Since the safety and efficacy of torasemide in children have not been established, the use of Torasemide in children is not recommended.

Driving and use of machines

This medicine may affect your ability to drive and operate machinery, especially if taken simultaneously with alcohol.

Important information about some of the components of Torasemide STADA:

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially "sodium-free".

3. HOW TO TAKE TORASEMIDE STADA 5 MG TABLETS EFG

Follow exactly the dosing instructions for Torasemide STADA provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

The usual dose in Adults (including elderly patients) is:

• Treatment of edema associated with congestive heart failure, renal or liver disease

The initial dose ranges from 5 mg to 20 mg daily. However, your doctor may increase it up to approximately double if considered appropriate.

• Hypertension

The usual initial dose is 2.5 to 5 mg daily. Your doctor may increase it up to 10 mg daily or prescribe an additional antihypertensive agent.

Torasemide STADA is administered orally.

Swallow the tablets whole, without chewing, with a sufficient amount of liquid in the morning. The tablets may be taken with or without food.

If you take more Torasemide STADA than you should

If you have taken more Torasemide STADA than you should, you may experience increased urine output and may develop somnolence, confusion, weakness, and dizziness.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Torasemide STADA

Do not take a double dose to make up for missed doses.

Take your dose as soon as you remember, and the following day resume your regular dosing schedule at the usual time.

If you stop taking Torasemide STADA

Your doctor will determine the duration of your treatment with Torasemide STADA. Do not discontinue treatment before being instructed to do so by your doctor, as your condition may worsen.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Torasemida Stada 5 mg can produce adverse effects, although not everyone will experience them.

The following adverse effects have been reported:

• With prolonged treatment, disturbances in water and electrolyte balance may occur.
• Occasionally, especially at the beginning of treatment, headache, dizziness, fatigue, weakness, muscle cramps, and gastrointestinal discomfort (e.g. loss of appetite, stomach pain, nausea, vomiting, diarrhea, constipation) may occur.
• In rare cases, dry mouth and discomfort in the extremities may occur; in individual cases, visual disturbances and allergic reactions (e.g. itching, redness, photosensitivity) may be observed.
• In patients who have difficulty urinating (e.g. due to prostate enlargement), increased urine flow may lead to urinary retention.
• Due to increased urine production, a drop in blood pressure may occur, as well as confusion, and, exceptionally, thrombosis, cardiac rhythm disturbances, angina pectoris, acute myocardial infarction, sudden loss of consciousness (syncope), and circulatory collapse, especially if large amounts of fluid and salts have been lost.
• Occasionally, increases in blood levels of uric acid, glucose, triglycerides, and cholesterol have been observed.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of TORASEMIDE STADA 5 MG TABLETS EFG

Keep out of the reach and sight of children.

Do not store above 30°C. Store in the original container.

Do not use Torasemide STADA after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Torasemide STADA

• The active substance is Torasemide.
• The other components are: monohydrate lactose, corn starch, sodium carboxymethyl starch (type A) (from potato), colloidal anhydrous silica and magnesium stearate.

Appearance of the product and contents of the pack

Torasemide STADA 5 mg are biconvex, round, white or almost white tablets, scored on one side and marked with 915 on the other.

Packaged in containers of 30 tablets.

Marketing Authorization Holder

Laboratorio STADA, S.L. Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA ARZNEIMITTEL AG

Stadastrasse 2-18, Bad Vilbel

D-61118 Germany

This patient information leaflet was approved in April 2010