TORASEMIDE TARBIS 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

TORASEMIDA TARBIS 5 mg tablets EFG

Read the package leaflet carefully before starting to take this medicine.

• Keep this package 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. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Contents of the package leaflet:

1. What TORASEMIDA TARBIS 5 mg tablets are and what they are used for
2. Before taking TORASEMIDA TARBIS 5 mg tablets
3. How to take TORASEMIDA TARBIS 5 mg tablets
4. Possible side effects
5. Storage of TORASEMIDA TARBIS 5 mg tablets
6. Further information

1. What TORASEMIDA TARBIS 5 mg tablets are and what they are used for

Torasemide is a diuretic medicine (increases urine production) and belongs to the group of medicines called "High-ceiling diuretics". Torasemide 5 mg is indicated for:

• Treatment of high blood pressure
• Treatment of edema (swelling due to fluid retention) as a result of altered heart function (e.g. due to heart failure)
• Treatment of edema of hepatic or renal origin.

2. Before taking TORASEMIDA TARBIS 5 mg tablets

Do not take TORASEMIDA TARBIS 5 mg:

• If you are allergic (hypersensitive) to torasemide or any of the other ingredients of TORASEMIDA TARBIS 5 mg.
• If you are allergic to sulfonylureas
• If you have anuria (absence of urine production).

Be cautious when taking TORASEMIDA TARBIS 5 mg:

• If you have low blood pressure (hypotension)
• If you have renal failure with absence of urine production.
• If you have severe liver function impairment
• If you have low sodium or potassium levels in your blood or low blood volume (hypovolemia)
• If you have gout or diabetes mellitus.

Use of other medicines:

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

Also, inform your doctor if you are taking any of the following medicines that may interact with torasemide:

• Cardiac glycosides such as digoxin (heart medicines), antihypertensives (especially ACE inhibitors), theophylline (asthma medicine): 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 (cancer medicine), lithium (antidepressant), salicylates, ethacrynic acid: may increase the toxicity of these medicines.
• Non-steroidal anti-inflammatory medicines (e.g. ibuprofen, indomethacin), probenecid (gout medicine), cholestyramine (cholesterol-lowering medicine): may decrease the effect of torasemide.
• Diabetes medicines: may decrease the effect of these medicines.

Taking TORASEMIDA TARBIS 5 mg with food and drinks

The tablets can be taken with or without food. They should be taken in the morning, without chewing, with a little liquid.

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.

Use in elderly

No differences in efficacy or safety have been observed according to the patient's age.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before taking any medicine.

Torasemide is not recommended during pregnancy.

It is not known whether torasemide passes into breast milk, so its use is not recommended during breastfeeding.

Driving and using machines:

This medicine may affect your ability to drive or use machines. The effect is increased if taken simultaneously with alcohol.

Important information about some of the ingredients of TORASEMIDA TARBIS 5 mg

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

This medicine does not contain gluten.

3. How to take TORASEMIDA TARBIS 5 mg tablets

Follow exactly the administration instructions of TORASEMIDA TARBIS 5 mg indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. Remember to take your medicine.

Your doctor will indicate the duration of your treatment with TORASEMIDA TARBIS 5 mg. Do not stop treatment before, as it may worsen your condition.

Torasemide tablets are for oral administration.

The tablets can be taken with or without food. They should be taken in the morning, without chewing, with a little liquid.

Adults

Treatment of edema associated with congestive heart failure, renal or hepatic disease.

The initial dose ranges from 5 mg to 20 mg per day, but your doctor may increase it up to approximately double 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 an additional antihypertensive.

If you take more TORASEMIDA TARBIS 5 mg than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone (91) 562.04.20, indicating the medicine and the amount taken.

In case of overdose, increased urine production may occur, and drowsiness, confusion, weakness, and dizziness may appear.

If you forget to take TORASEMIDA TARBIS 5 mg:

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

Take your dose as soon as you remember and, the next day, take it at the corresponding time.

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

4. Possible side effects

Like all medicines, TORASEMIDA TARBIS 5 mg can cause side effects, although not everybody gets them.

Adverse reactions may occur with the following frequency:

Very common: Affects more than 1 in 10 patients treated.

Common: Affects between 1 and 10 in 100 patients treated.

Uncommon: Affects between 1 and 10 in 1,000 patients treated.

Rare: Affects between 1 and 10 in 10,000 patients treated.

The following side effects have been reported:

-With prolonged treatment, alterations in water and salt balance in the body may occur.

-Occasionally at the start of treatment: headache, dizziness, fatigue, weakness, muscle cramps, and gastrointestinal disorders (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, 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), the increased urine flow may lead to urinary retention.

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

-Occasionally, increases in blood uric acid, sugar, triglycerides, and cholesterol have been observed.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

5. Storage of TORASEMIDA TARBIS 5 mg tablets

Keep out of the reach and sight of children.

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

Expiry date:

Do not use TORASEMIDA TARBIS 5 mg after the expiry date stated on the package 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 no longer required. This will help protect the environment.

6. FURTHER INFORMATION

Composition of TORASEMIDA TARBIS 5 mg:

• The active ingredient is torasemide. Each tablet contains 5 mg of torasemide.

• The other ingredients (excipients) are: lactose monohydrate, corn starch, sodium starch glycolate (type A), colloidal anhydrous silica, and magnesium stearate.

Appearance and packaging of the product

TORASEMIDA TARBIS 5 mg are biconvex, round, white or almost white tablets, scored on one side and marked with 915 on the other. They are available in packs of 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Manufacturer:

TEVA OPERATIONS POLAND SP.Z.O.O.

Ul. Mogilska 80

(Krakow) - 31-546 - Poland

or

PLIVA HRVATSKA D.O.O.

Prilaz Baruna Filipovica 25

ZAGREB 10000 Croatia

This package leaflet was last revised in March 2010