Torasemide Tarbis 5 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

TORASEMIDE TARBIS 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, ask your doctor or pharmacist.

• This medicine has been prescribed for you personally; do not give it to others, even if they have the same symptoms as you, because 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 TARBIS 5 mg tablets are and what they are used for
2. Before taking TORASEMIDE TARBIS 5 mg tablets
3. How to take TORASEMIDE TARBIS 5 mg tablets
4. Possible side effects
5. How to store TORASEMIDE TARBIS 5 mg tablets
6. Further information

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

Torasemide is a diuretic medicine (increases urine elimination) belonging to the group of medicines known as "high-ceiling diuretics". Torasemide 5 mg is indicated for:

• The treatment of arterial hypertension
• The treatment of oedema (swelling due to fluid retention) resulting from impaired cardiac function (e.g. due to heart failure)
• The treatment of oedema of hepatic or renal origin.

2. BEFORE TAKING TORASEMIDE TARBIS 5 mg TABLETS

Do not take TORASEMIDE TARBIS 5 mg:

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

Take special care with TORASEMIDE TARBIS 5 mg:

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

Use of other medicines:

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

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

• 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.
• Antibiotics of the aminoglycoside group: may increase kidney or ear toxicity.
• Cisplatin (a medicine for the treatment of cancer), lithium (an antidepressant medicine), salicylates, ethacrynic acid: may increase the toxicity of these.
• Non-steroidal anti-inflammatory medicines (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 TORASEMIDA TARBIS 5 mg with food and drink

The tablets may be taken with or without food. They should be taken in the morning, without chewing, with a small amount of liquid.

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.

Use in the elderly

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

Pregnancy and breastfeeding:

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 breastfeeding is not recommended.

Driving and use of machines:

This medicine may impair your ability to drive and operate machinery. The effect is intensified if taken simultaneously with alcohol.

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

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 does not contain gluten.

3. HOW TO TAKE TORASEMIDE TARBIS 5 mg TABLETS

Follow exactly the administration instructions for TORASEMIDE TARBIS 5 mg given by your doctor. If you have any doubts, consult your doctor or pharmacist. Remember to take your medication.

Your doctor will indicate how long you should take TORASEMIDE TARBIS 5 mg. Do not stop treatment earlier, as this could worsen your condition.

Torasemide tablets are for oral use.

The tablets may be taken with or without food. They should be taken in the morning, without chewing, with a small amount of liquid.

Adults

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

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

Hypertension.

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone (91) 562.04.20, indicating the medication and the amount ingested.

In case of overdose, increased urine output may occur, along with somnolence, confusion, weakness, and dizziness.

If you forget to take TORASEMIDE TARBIS 5 mg:

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

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

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

4. Possible adverse effects

Like all medicines, TORASEMIDE TARBIS 5 mg can cause adverse effects, although not everyone experiences them.

Adverse reactions may occur with the following frequency:

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

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

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

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

The following adverse effects have been reported:

- With prolonged treatment, disturbances in the body's water and electrolyte balance may occur.

- Occasionally 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 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 arrhythmia, angina pectoris, acute myocardial infarction, sudden loss of consciousness (syncope), and circulatory collapse, especially if large amounts of fluid and electrolytes 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 TORASEMIDA TARBIS 5 mg tablets

Keep out of the reach and sight of children.

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

Expiry:

Do not use TORASEMIDA TARBIS 5 mg after the expiry date stated on the packaging after EXP. The expiry date refers to 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 packaging that you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of TORASEMIDE TARBIS 5 mg:

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

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

Appearance of the product and contents of the pack

TORASEMIDE 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

Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona, Spain

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 leaflet has been reviewed in March 2010