Torasemide STADA 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

TORASEMIDE STADA 10 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you consider that any of the side effects you experience is severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Torasemide STADA 10 mg tablets EFG is and what it is used for
2. Before you take Torasemide STADA 10 mg tablets EFG
3. How to take Torasemide STADA 10 mg tablets EFG
4. Possible side effects
5. How to store Torasemide STADA 10 mg tablets EFG
6. Further information

1. What TORASEMIDE STADA 10 MG TABLETS EFG is and what it is used for

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

Torasemide STADA is indicated for the treatment of:

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

2. BEFORE TAKING TORASEMIDE STADA 10 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 may precipitate 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 cardiac glycosides, as this increases the risk of cardiac arrhythmias,
• if you have gout or diabetes mellitus,
• if you have renal insufficiency or have problems urinating,
• if you have low blood pressure (hypotension).

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used 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 (medicines for the heart), antihypertensives (particularly ACE inhibitors), theophylline (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 (medicine for the treatment of cancer), lithium (antidepressant medicine), salicylates, ethacrynic acid: may increase the toxicity of these,
• non-steroidal anti-inflammatory medicines (e.g. ibuprofen, indomethacin), probenecid (anti-gout medicine), cholestyramine (medicine to reduce blood cholesterol levels): may decrease the effect of torasemide,
• medicines for the treatment of diabetes: may decrease their effect.

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 is not recommended during pregnancy.

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

Use in children

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

Driving and using machines

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

Important information about some of the components of Torasemide STADA:

This medicine contains lactose. If your doctor has informed you of 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 10 MG TABLETS EFG

Follow exactly the dosing instructions for Torasemide STADA provided by your physician. Consult your doctor or pharmacist if you have any doubts.

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 take more Torasemide STADA than recommended, you may produce a larger amount of urine and experience drowsiness, 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 take it at your usual scheduled time.

If you stop taking Torasemide STADA

Your doctor will determine the duration of your treatment with Torasemide STADA. Do not discontinue treatment before your doctor advises you to do so, 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, Torasemide STADA 10 mg can cause 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 disturbances (e.g. loss of appetite, stomach pain, nausea, vomiting, diarrhea, constipation) may appear.
• In rare cases, dry mouth and discomfort in the limbs may occur; in individual cases, visual disturbances and allergic reactions (e.g. burning sensation, redness, photosensitivity) have been observed.
• In patients with 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, along with 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 10 MG TABLETS EFG

Keep out of the reach and sight of children.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging 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 container

Torasemide STADA 10 mg are biconvex, round, white or almost white tablets, scored on one side and marked with 916 on the other.

Presented in packs 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 leaflet was approved in April 2010