Torasemide Teva Italia

Package leaflet: Information for the user

Torasemide Teva Italia 10 mg tablets

Generic medicine
Please read all of this leaflet carefully before you take this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Torasemide Teva Italia is and what it is used for
2. What you need to know before you take Torasemide Teva Italia
3. How to take Torasemide Teva Italia
4. Possible side effects
5. How to store Torasemide Teva Italia
6. Contents of the pack and other information

1. What Torasemide Teva Italia is and what it is used for

Torasemide Teva Italia contains a medicine called torasemide. This belongs to a group of medicines called "diuretics".
Torasemide Teva Italia 10 mg tablets are used in the treatment of swelling caused by excess fluid in the body (edema).
The tablets work by increasing the amount of water removed from the body (urine).

2. What you need to know before taking Torasemide Teva Italia

Do not take Torasemide Teva Italia if:

• you are allergic to torasemide or to any of the other ingredients of this medicine (listed in section 6).
• you are allergic to medicines known as “sulfonylureas”. These are used to treat diabetes (high blood sugar).
• These medicines include chlorpropamide, glibenclamide, glipizide and tolbutamide.
• you suffer from kidney disorders (renal failure).
• you have kidney problems caused by medicines.
• you suffer from liver problems that may cause loss of consciousness, confusion and drowsiness (hepatic coma).
• you have low blood volume (hypovolemia).
• you have low blood pressure (hypotension).
• you have low levels of potassium or sodium in your blood (hyponatremia, hypokalemia).
• you have severe urination problems, for example, due to prostate enlargement (prostatic hypertrophy).
• you suffer from gout.
• you have heart rhythm problems (cardiac arrhythmia).
• you are taking an antibiotic called “aminoglycoside” or “cephalosporin” (for an infection). These medicines include streptomycin, gentamicin, cephalexin and ceftriaxone. See section “Other medicines and Torasemide Teva Italia”.
• you are pregnant or breastfeeding. See section “Pregnancy and breastfeeding”. Do not take Torasemide Teva Italia if any of these conditions apply to you. If you are unsure, consult your doctor or pharmacist before taking Torasemide Teva Italia.

Warnings and precautions:
Talk to your doctor before taking Torasemide Teva Italia if:

• you have low levels of potassium or sodium in your blood (shown by blood tests).
• you have difficulty urinating (passing urine), including prostatic hypertrophy.
• you have gout or diabetes (diabetes mellitus).

If any of these conditions apply to you, or if you are unsure, consult your doctor or pharmacist before taking Torasemide Teva Italia.

Other medicines and Torasemide Teva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is particularly important that you inform your doctor or pharmacist if you are taking any of the following medicines:

• Other medicines used to treat high blood pressure.
• Medicines called ACE inhibitors (used to treat heart conditions).
• Medicines such as digoxin or digitoxin (used to treat heart conditions).
• Adrenaline (also known as epinephrine) or noradrenaline (also known as norepinephrine). These are used to treat low blood pressure.
• Cholestyramine or other "ion-exchange resins" (used to treat high cholesterol levels in the blood).
• High doses of medicines called "salicylates", such as acetylsalicylic acid.
• Medicines called "non-steroidal anti-inflammatory drugs" (NSAIDs). These include indomethacin, naproxen, acetylsalicylic acid and ibuprofen.
• Laxatives (used to facilitate bowel movements).
• Steroid medicines such as hydrocortisone, prednisolone and dexamethasone.
• Medicines to relax muscles (muscle relaxants).
• Cisplatin (used in cancer treatment).
• Lithium (used to treat mental health conditions).
• Probenecid (used to treat gout).
• Theophylline (used to treat asthma).
• Medicines for the treatment of diabetes (high blood sugar).
• Some types of antibiotics, for example aminoglycosides (such as kanamycin, gentamicin, tobramycin, streptomycin and neomycin) and cephalosporins (such as cefuroxime, cephalexin, ceftriaxone and ceftazidime), used to treat infections (see "Do not take Torasemide Teva Italia if").
• Cumarin derivatives, e.g. fenprocumone – used to thin the blood.

Pregnancy and breastfeeding
Do not take Torasemide Teva Italia if you are pregnant, think you may be pregnant, or are breastfeeding. This is because it is not known whether Torasemide Teva Italia may affect your baby.

Driving and using machines
You may feel dizzy while taking Torasemide Teva Italia. If this happens, do not drive or operate tools or machinery.

Torasemide Teva Italia contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Torasemide Teva Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to take Torasemide Teva Italia

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Take the tablet in the morning, swallowing it with a small glass of water. Do not chew the tablet. The tablet may be divided into equal parts.

Fluid retention (edema)

• The recommended dose for adults and elderly patients is 5 mg once daily.
• Your doctor may increase the dose to 20 mg daily, if necessary.

If you take more Torasemide Teva Italia than you should

• If you take more Torasemide Teva Italia than you should, contact a doctor or go to hospital immediately. Take the medicine with you.
• If you take too many tablets, you may experience the following symptoms:
• needing to urinate very frequently,
• drowsiness,
• confusion,
• weakness or dizziness,
• low blood pressure,
• circulatory collapse,
• stomach disturbances.

If you forget to take Torasemide Teva Italia

• If you forget to take a dose, take it as soon as you remember.
• However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

If other people accidentally take your Torasemide Teva Italia tablets, they must speak to a doctor or go immediately to hospital.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Consult your doctor as soon as possible if you experience any of the following side effects:
Not known: frequency cannot be estimated from the available data

• Severe illness with skin blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Inadequate blood supply to the brain
• Heart attack, inadequate blood supply to the heart, chest pain (angina pectoris)
• Blocked blood vessel (embolism)
• Reduced platelet count in the blood, increasing the risk of bleeding or bruising (thrombocytopenia); reduced white blood cell count causing frequent infections with fever, sore throat and mouth ulcers (leucopenia); reduced red blood cell count which may cause pale skin and lead to weakness or shortness of breath (anaemia)
• Inflammation of the pancreas causing severe abdominal and back pain

Other side effects:
Common: may affect up to 1 in 10 people

• Loss of blood acidity leading to respiratory depression, general weakness, muscle contractions or cramps (metabolic alkalosis), fluid and electrolyte imbalance (e.g. low blood volume [hypovolaemia], low blood potassium levels [hypokalaemia], low sodium levels in the blood which may cause tiredness and confusion, muscle twitching, seizures and coma [hyponatraemia])
• Headache, dizziness
• Gastrointestinal disturbance (e.g. loss of appetite, abdominal pain, nausea or vomiting, diarrhoea, constipation)
• Muscle cramps
• Tiredness, feeling weak

Uncommon: may affect up to 1 in 100 people

• Increased liver enzymes (shown by blood tests)
• Inability to completely empty the bladder, enlarged bladder
• Increased levels of uric acid, sugar or fats in the blood (shown by blood tests)

Rare: may affect up to 1 in 1,000 people

• Increased levels of urea or creatinine in the blood (shown by blood tests)

Very rare: may affect up to 1 in 10,000 people

• Allergic skin reactions (e.g. itching, skin rash)
• Redness and blistering of the skin when exposed to sunlight

Not known: frequency cannot be estimated from the available data

• Tingling or numbness of the skin, confusion
• Impaired vision
• Ringing in the ears (tinnitus), hearing loss
• Fainting, low blood pressure which may be associated with weakness, dizziness and fainting
• Dry mouth

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Torasemide Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Torasemide Teva Italia contains

• The active substance is torasemide. Each tablet contains 10 mg of torasemide.
• The other ingredients are lactose monohydrate, maize starch, sodium starch glycolate type A, anhydrous colloidal silica, and magnesium stearate.

Description of the appearance of Torasemide Teva Italia and pack contents
Torasemide Teva Italia 10 mg tablets are white to off-white, round, biconvex tablets, with a score line on one side and the imprint '916' on the other.

Pack sizes: blisters containing 10, 14, 28, 30, 50, 100 and 112 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milan, Italy

Manufacturers
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Poland
Pliva Croatia Ltd., Prilaz baruna Filipovića 25, 10 000 Zagreb, Croatia