TORASEMIDE 10 mg Tablet

Зміст інструкції

1. Torasemide Teva Italia 10 mg tablets
   1. What is Torasemide Teva Italia and what is it 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

Torasemide Teva Italia 10 mg tablets

Generic medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 is Torasemide Teva Italia and what is it 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 is used in the treatment of swelling caused by
too much water in the body (edema).
The tablets work by causing you to pass more water (urine).

2. What you need to know before you take 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 similar to those called “sulphonylureas”. These are used to treat diabetes (high blood sugar).
• These medicines include chlorpropamide, glibenclamide, glipizide and tolbutamide.
• you suffer from kidney problems (renal insufficiency).
• you have kidney problems caused by medicines.
• you suffer from liver problems that can cause loss of consciousness, confusion and drowsiness (hepatic coma)
• you have a 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 problems with urination, such as for example in case of prostatic hypertrophy (enlarged prostate).
• 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 not sure, ask 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 not sure, ask your doctor or pharmacist
before taking Torasemide Teva Italia.

Other medicines and Torasemide Teva Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
It is particularly important that you tell your doctor or pharmacistif you are taking any of
the following medicines:

• Other medicines used to treat high blood pressure
• Medicines called ACE inhibitors (used to treat heart disease)
• Medicines such as digoxin or digitoxin (used to treat heart disease)
• Adrenaline (also called epinephrine) or noradrenaline (also called 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 drugs called "salicylates", such as acetylsalicylic acid
• Medicines called "non-steroidal anti-inflammatory drugs" (NSAIDs). These include indometacin, 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 the treatment of cancer)
• Lithium (used to treat mental health problems)
• Probenecid (used to treat gout)
• Theophylline (used to treat asthma)
• Medicines for the treatment of diabetes (high blood sugar)
• Some types of antibiotics, such as 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").

• Coumarin derivatives, e.g. phenprocoumone - used to thin the blood.

Pregnancy and breastfeeding
Do not take Torasemide Teva Italia if you are pregnant, might become pregnant,
or if you are breastfeeding. This is because it is not known whether Torasemide Teva Italia will have effects on your
baby.

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

Torasemide Teva Italia contains lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking
this medicine.

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

For those who play sports: the use of the drug without therapeutic need constitutes doping

and may still result in positive doping tests.

3. How to take Torasemide Teva Italia

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
The tablet should be taken in the morning and swallowed with a small glass of water. Do not chew the
tablet. The tablet can be divided into equal parts.

Fluid retention (edema)

• The recommended dose in adults and the elderly is 5 mg once a day.
• The doctor may increase the dose to 20 mg per day, if necessary.

If you take more Torasemide Teva Italia than you should

• If you take more Torasemide Teva Italia than you should, consult a doctor or go to hospital immediately. Bring the medicine with you.
• If you take too many tablets, you may experience the following symptoms:
• having to urinate very frequently,
• feeling sleepy,
• feeling confused,
• weakness or dizziness.
• low blood pressure
• cardiovascular collapse
• stomach problems.

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 the next dose, skip the missed dose.
• Do not take a double dose to make up for a missed dose.

If other people were to take your Torasemide Teva Italia tablets by mistake,
they should talk to a doctor or go to hospital immediately.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Consult your doctor as soon as possible if you experience the following side effects:

Not known: frequency cannot be estimated from available data

• Severe illness with blistering of the skin (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)
• Reduction of platelets in the blood, which increases the risk of bleeding or bruising (thrombocytopenia), reduction of white blood cells causing frequent infections with fever, sore throat and mouth ulcers (leukopenia), reduction of red blood cells which can make the skin pale and causes weakness or shortness of breath (anemia)
• Inflammation of the pancreas causing severe pain in the abdomen and back

Other side effects:

Common: may affect up to 1 in 10 people

• Loss of acid from the blood causing respiratory depression, general weakness, muscle twitching or cramps (metabolic alkalosis), electrolyte imbalance (e.g. low blood volume [hypovolemia], low blood potassium levels [hypokalaemia], low sodium levels in the blood which can cause fatigue and confusion, muscle contraction, seizures and coma [hyponatraemia])
• Headache, dizziness
• Gastrointestinal discomfort (e.g. loss of appetite, abdominal pain, nausea or vomiting, diarrhoea, constipation)
• Muscle cramps
• Fatigue, feeling weak

Uncommon: may affect up to 1 in 100 people

• Increased liver enzymes (shown by blood tests)
• Inability to completely empty the bladder, dilated 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 available data

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly through 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 at a temperature above 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Torasemide Teva Italia contains

• The active ingredient is torasemide. Each tablet contains 10 mg of torasemide.
• The other ingredients are lactose monohydrate, corn starch, sodium starch glycolate type A, anhydrous colloidal silica and magnesium stearate. Description of the appearance of Torasemide Teva Italia and contents of the packTorasemide Teva Italia 10 mg tablets are tablets of colour from white to off-white, round, biconvex, with a notch on one side and with the inscription ‘916’ on the other.

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

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milan
Manufacturer
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