Leaflet: information for the user

TORASEMIDA STADA 10 MG TABLETS EFG

Read this leaflet carefully before you start taking the 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. Do not pass it on to others even if their symptoms are the same. It may harm them.

-If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

1.What is Torasemida STADA 10 mg tablets EFG and what it is used for

2.Before taking Torasemida STADA 10 mg tablets EFG

3.How to take Torasemida STADA 10 mg tablets EFG

4.Possible side effects

5.Storage of Torasemida STADA 10 mg tablets EFG

6.Further information

Torasemida STADA is a diuretic medication (increases urine elimination) and belongs to the group of "High ceiling diuretics: sulfonamides, monodrugs".

Torasemida STADA is indicated for the treatment of:

-edema (fluid retention) due to congestive heart failure, kidney disease, or liver disease,

-hypertension.

Do not take Torasemida STADA:

-if you are allergic (hypersensitive) to torasemida or to any of the other components of Torasemida STADA.

STADA.

-if you are allergic to sulfonilureas.

-if you have anuria (absence of urine production).

Be especially careful with Torasemida STADA:

-if you have a severe liver disease, as the use of torasemida could precipitate a coma state,

-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, as it increases the risk of cardiac arrhythmias,

-if you have gout or diabetes mellitus,

-if you have kidney failure or have problems urinating,

-if you have low blood pressure (hypotension).

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

You must also inform your doctor if you are taking any of the following medications that may interact with torasemida:

-cardiac glycosides such as digoxin (heart medications), antihypertensives (particularly IECA), theophylline (asthma medication): the effect of these medications may be increased,

-mineralocorticoids, glucocorticoids, and laxatives: may increase the elimination of potassium produced by these medications,

-aminoglycoside antibiotics: may increase the toxicity to the kidneys or ears,

-cisplatin (cancer medication), lithium (antidepressant), salicylates, etacrynic acid: may increase the toxicity of these medications,

- anti-inflammatory non-steroidal medications (e.g. ibuprofen, indomethacin), probenecid (gout medication), cholestyramine (cholesterol-lowering medication): may decrease the effect of torasemida,

-diabetes medications: may decrease the effect of these medications.

Taking Torasemida STADA with food and drinks

The tablets can be taken with or without food.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

Torasemida is not recommended during pregnancy.

The passage of torasemida into breast milk is unknown, so it is not recommended to use it during breastfeeding.

Use in children

Due to the lack of established safety and efficacy of torasemida in children, the use of Torasemida in children is not recommended.

Driving and operating machinery

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

Important information about some of the components of Torasemida STADA:

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructions for Torasemida STADA as indicated by your doctor. Consult with your doctor or pharmacist if you have any doubts.

The normal dose in Adults (including elderly) is:

-Treatment of edema associated with congestive heart failure, kidney or liver disease

The initial dose ranges from 5 mg to 20 mg per day, but your doctor may increase it up to approximately twice as much if deemed necessary.

-Hypertension

The usual initial dose is 2.5 to 5 mg per day, but your doctor may increase it up to 10 mg per day or prescribe another additional antihypertensive.

Torasemida STADA is administered orally.

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

If you take more Torasemida STADA than you should

If you have taken more Torasemida STADA than you should, it may cause an increased amount of urine and appear drowsiness, confusion, weakness, and dizziness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Torasemida STADA

Do not take a double dose to compensate for the missed doses.

Take your dose as soon as you remember and take the next one at the scheduled time.

If you interrupt the treatment with Torasemida STADA

Your doctor will indicate the duration of your treatment with Torasemida STADA. Do not stop treatment before your doctor tells you to, as it may worsen your condition.

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

Like all medications, Torasemida STADA 10 mg may produce adverse effects, although not everyone will experience them.

The following adverse effects have been described:

-Prolonged treatment may lead to disturbances in hydrosaline balance.

-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 appear.

-In rare cases, dry mouth and discomfort in the extremities may appear, and in individual cases, visual disturbances and allergic reactions (e.g. itching, redness, photosensitivity) may be observed.

-In patients with difficulty urinating (e.g. due to prostate hypertrophy), increased urine flow may lead to urinary retention.

-Due to increased urine production, a decrease in blood pressure, confusion, and in exceptional cases, thrombosis, cardiac rhythm disturbances, angina pectoris, acute myocardial infarction, sudden loss of consciousness (syncope), and circulatory collapse may occur, especially if large amounts of fluid and electrolytes have been lost.

-Occasionally, elevations in blood levels of uric acid, sugar, triglycerides, and cholesterol have been observed.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

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

Do not use Torasemida STADA after the expiration date that appears on the packaging after

CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need.This will help protect the environment.

Torasemida STADA Composition

-The active ingredient is Torasemida

-The other components are: lactose monohydrate, cornstarch, carboxymethylstarch sodium (type A) (from potato), anhydrous colloidal silica, and magnesium stearate.

Product appearance and packaging contents

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

It is presented in packs of 30 tablets.

Marketing Authorization Holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

STADA ARZNEIMITTEL AG

Stadastrasse 2- 18, Bad Vilbel

D-61118 Germany

This leaflet was approved in April 2010