Torasemide 10mg Tablets
Package leaflet: Information for the patient [Torasemide] 10mg Tablets
Torasemide
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist . This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What [Torasemide] is and what it is used for
2. What you need to know before you use [Torasemide]
3. How to use [Torasemide]
4. Possible side effects
5. How to store [Torasemide]
6. Contents of the pack and other information
1. What [Torasemide] is and what it is used for?
[Torasemide] contains a medicine called torasemide. This belongs to a group of medicine called ‘diuretics’ or ‘water tablets’.
• [Torasemide] 10mg tablets are used to treat swelling caused by too much water in the body.
The tablets work by making you pass more water (urine).
2. What you need to know before you use [Torasemide].
DO NOT take [Torasemide] if you:
• are allergic to torasemide or any of the other ingredients of this medicine (listed in section 6).
• are allergic to similar medicines called ‘sulphonylureas’. These are used to treat diabetes (high blood sugar). These medicines include chlorpropamide, glibenclamide, glipizide and tolbutamide.
• have kidney problems (renal failure).
• have kidney problems that have been caused by medicines.
• have liver problems
• have low blood pressure (hypotension).
• have heart beat problems
• are taking an antibiotic called an ‘aminoglycoside’ or ‘cephalosporin’ (for an infection). These medicines include streptomycin, gentamycin, cephalexin and ceftriaxone. See the section on ‘Other medicines and [Torasemide]’.
• are you pregnant or breast-feeding a baby. See the section on ‘Pregnancy and breast-feeding’.
• are aged 12 years or younger.
Do not take [Torasemide] if any of these apply to you.
Warnings and precautions
Check with your doctor or pharmacist before taking [Torasemide] tablets if you:
• have low levels of potassium or sodium in your blood (shown in blood tests).
• have diabetes (diabetes mellitus).
• have difficulty passing water (urinating).
• have a low volume of blood (hypovolaemia).
• have gout or high levels of uric acid in your blood.
If you are not sure, talk to your doctor or pharmacist before taking [Torasemide]. Other medicines and [Torasemide]:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because [Torasemide] can affect the way some other medicines work. Also some other medicines can affect the way [Torasemide] works.
It is particularly important to tell your doctor or pharmacist if you are taking any of the following medicines:
• Cisplatin (used to treat cancer)
• Lithium (used to treat mental health problems)
• Medicines like digoxin or digitoxin (used to treat heart beat problems ).
• Steroid medicines, such as hydrocortisone prednisolone and dexamethasone.
• Other medicines to treat high blood pressure such as ACE-inhibitors.
• Laxatives
• Theophylline (used to treat asthma)
• Medicines called ‘ non-steroidal anti-inflammatory drug (NSAIDs). These include indomethacin and ibuprofen
• Cholestyramine, or other ‘ion exchange resins’ (used to treat high levels of cholesterol in your blood).
• Antidiabetics such as metformin, insulin
• High doses of medicines called ‘salicylates’, such as aspirin.
• Medicines to relax your muscles (muscle relaxants).
• Adrenaline (also called epinephrine) or noradrenaline (also called norepinephrine). These are used to treat low blood pressure
• Probenecid (used to treat gout).
• Antibiotics such as streptomycin, gentamycin, cephalexin and ceftriaxone
[Torasemide] with food and drink
You can take [Torasemide] with or without food
Pregnancy and breast-feeding
Do not take [Torasemide] if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. This is because it is not known if [Torasemide] will affect your baby.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may feel dizzy while taking [Torasemide]. If this happens, do not drive or use any tools or machines.
This medicine contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
3. How to take [Torasemide]
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The tablets should be swallowed whole with water.
Water retention (oedema)
• The usual dose for adults and older people is 5 mg once a day.
• Your doctor may increase the dose to 20 mg a day if needed.
If you take more [Torasemide] than you should
• If you take more [Torasemide] than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
• If you take too many tablets, you may pass a lot of urine, become sleepy, or feel confused, faint or dizzy. You may also have stomach upset.
If you forget to take [Torasemide]
• If you forget to take a dose, take it as soon as you remember it.
• However, if it is nearly time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
If you stop taking [Torasemide]
If you have any further questions on the use of this medicine or wish to stop your treatment, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side-effects, although not everybody gets them.
Serious side effects
Stop taking the medicine and seek medical advice IMMEDIATELY if you get the following side effects:
• Blood problems causing unusual bleeding or bruising, or frequent infections with fever, sore throats, and mouth ulcers
• Skin inflammation, peeling and blistering
• Blockage of blood flow through the brain and lungs causing clots
• Chest pain, particularly with pain radiating down the left arm and pale, clammy skin
• Fainting or loss of consciousness
• Hypotension
• Inflammation of the pancreas causing pain in the stomach (Pancreatitis) Other possible side effects:
• Stomach problems (e.g. loss of appetite, abdominal pain, feeling and being sick, diarrhoea, constipation)
• Changes in how your liver is working (shown by blood tests).
• Low blood salt levels causing tiredness, weakness, feeling and being sick, headache, muscle cramps, muscle spasms
• Headache
• Dizziness
• Drowsiness
• Confusional state
• An increase in the levels of certain substances in your blood, including sugar, uric acid, creatinine and fats (lipids). Your doctor may do blood tests from time to time to make sure that [Torasemide] is working safely
• Some people may have difficulty passing water (urinating)
• Skin rashes and itchy skin
• Skin being more sensitive to the sun (photo-sensitivity)
• Dry mouth
• Blurred eyesight
• Ringing in the ears (tinnitus) and loss of hearing
• Feeling numb or tingling in the legs or arms
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store [Torasemide]
Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Store your tablets in the original package.
Do not use this medicine after the expiry date which is stated on the carton and blister foil after ‘EXP’. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What [Torasemide] contains
The active substance in your tablets is torasemide.
Other ingredients are: lactose monohydrate, maize starch, sodium starch glycollate Type A, silica, colloidal anhydrous and magnesium stearate.
What [Torasemide] looks like and contents of the pack
These are white to off-white, round, biconvex tablets with a break line on one side and marked with ‘916’ on the other.
[Torasemide] lOmg Tablets are available in blister packs of 14, 28, 30, 50, 100 or 112 tablets.
Marketing Authorisation Holder
The marketing authorisation holder for [Torasemide] lOmg Tablets:
Pharmathen S.A.
Dervenakion 6, Pallini, Attiki, 153 51,
Greece.
Manufactuer
The tablets are manufactured by:
PLIVA Hrvatska d.o.o.
Prilaz baruna Filipovica 25, 10 000 Zagreb,
Croatia
and
AWD pharma GmbH&Co.KG,
Leipziger Str.7.13, 01097 Dresden,
Germany
This leaflet was last revised in
05/2015