Torasemide 10mg Tablets
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER Torasemide 5mg Tablets Torasemide 10mg Tablets
Read all of 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 Tablets are and what they are used for
2. What you need to know before you take Torasemide Tablets
3. How to take Torasemide Tablets
4. Possible side effects
5. How to store Torasemide Tablets
6. Contents of the pack and other information
1 What Torasemide Tablets are and what they are used for
Torasemide is a ty pe of m edicine called a diur etic, which incr eases the amount of water (urine) passed. It is used when your body is retaining too much water (oedema) due to heart failure. You will be given a dose of torasemide that will make you pass more water.
2What you need to know before you take Torasemide Tablets Do not take Torasemide Tablets if:
• You are allergic (hypersensitive) to torasem ide, or any of the other ingredients of Torase mide Tablets
• You are all ergic (hypersensitive) to similar medicines called sulphonylureas (e.g. chlorpromamide, glibenclamide, glipizide)
• You have severe kidney problems where there is no production or passing of urine
• You have a liver dis ease that ca uses you to beco me unconscious, confused and drows y (precomatose)
• You have been told you have very low blood pressure
• You are breast-feeding
Warnings and precautions:
Talk to your doctor before taking Torasemide tablets
• You have been told by your doctor that you have low blood potassium or so dium levels or a low volume of blood in your body. These conditions need to be corrected before you can start taking this medicine
• You suffer from gout or diabetes. Your doctor will need to monitor you carefully while you are taking this medicine
• You have any kidney p roblems or problem s pass ing uri ne e.g. Benign Pro static Hy perplasia -enlarged prostate. This medicine may not be suitable for you
• You have been told that you suffer fro m irregular heart beat. This medicine may not be suitable fo r you
• You are under 12 years old. There is not enoug h experience of use of th is medicine in youn g children
• You have a condition which causes too much acid or base in your blood or tissues
If you are going to be taking this medicine for a lo ng period of tim e you will need to be monitored more closely and your doctor will carry out extra blood tests.
Other medicines and Torasemide tablets
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Some medicines may not work well together. One medicine may stop another from working properly or the effects of some medicines taken together may make you feel unwell.
Talk to your doctor befo re taking To rasemide Tablets if you are taking any of the f ollowing medicines. Your doctor needs to know if you are taking any of these medicines, so that the right dose of Torasemide Tablets can be given to you. You may also need to be monitored more closely and blood tests taken.
• Certain types of antibiotics e.g. aminogylcosides (such as gentamicin, streptomycin and neomycin) and cephalosporins (such as cefuroxime, cefalexin and ceftazidime) - used to treat infections
• Digoxin or digitoxin - used to treat heart failure
• Medicines used to treat high blood pressure, especially ACE-inhibitors e.g. enalapril. The starting dose of the ACE-inhibitor or Torase mide may have to be reduce d when these medicines are given together
• Medicines used to treat low blood pressure e.g. noradrenaline or adrenaline
• laxatives
• Steroids - used to treat inflammation
• Non-steroidal anti-inflammatory medicines e.g. ibuprofen, naproxen, aspirin, indomethacin
• Theophylline - used to treat asthma
• Anti-diabetic medicines
• Muscle relaxants (which contain curare - used in general aneasthesia)
• Probenecid - a medicine used to treat gout
• Cholestyramine - used to lower blood fats
• Cisplatin - used to treat cancer
• Lithium - used to treat depression
Please tell your doctor or pharmacist if you are taking or have r ecently taken any other medicines, including medicines obtained without a prescription.
Torasemide Tablets with food, drink and alcohol
Drinking alcohol while taking this medicine may make you dizzy or drowsy.
Pregnancy, breast-feeding and fertility
Talk to your doctor before taking this medicine if you are pregnant or think you are pregnant.
Do not take this medicine if you are breast-feeding.
Driving and using machines
This medicine may make you feel dizzy or drowsy. This is more likely to happen when you first start taking this medicine, your doctor increases your dose or if you drink alcohol.
Do not drive and do not use any tools or machines if you feel dizzy or drowsy.
Torasemide Tablets
contains lactose monohydrate
This medicine contains lactose monohydrate, a t ype of sugar. If you have be en 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 Tablets
Always take Torasem ide Tablets exactly as your doctor has told you. You sh ould check with your doctor or pharmacist if you are not sure.
The tablets should be taken in the morning and swallowed whole with a small glass of water. Do not chew the tablets.
Adults and Older people
The usual dose is 5 mg daily, but your doctor may prescribe a higher dose. The maximum dose is 20mg a day.
Use in Children
There is no experience of treatment of children with torasemide.
Patients with liver and kidney disease
There is li mited information on dosage adj ustments in patients w ith liver or kidne y disease s. Your doctor will monitor you closely and adjust your dose as necessary.
If you take more Torasemide Tablets than you should
If y ou or so meone else takes too many Torasem ide Tablets y ou may experience the following symptoms:
• pass a lot of water (urine)
• confusion
• dizziness
• sleepiness
• weakness
• upset stomach
You should contact your doctor, pharmacist or hospital emergency department immediately. Always take any tablets left over with you and also the bo x, as this will allow easier identification of the tablets.
If you forget to take Torasemide Tablets
If you forget to take a dose, take it as soon as y ou remember unless it is near ly time for your next dose. Do not take a double dose to make up for a forgotten tablet.
4 Possible side effects
Like all medicines, Torasemide Tablets can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following:
You may need medical attention, have your medicine stopped or the dose altered.
• Low level s of potassium or sodiu m in your bloo d which cause dry mouth, drowsiness, confusion, fast or irregular heat beat, muscle cramps, nausea or vo miting, unusual tiredness. These eff ects may happen if your medicine makes you pass too much water (urine). This may happen if you are elderly or when you first start taking this medicine
• Low blood pressure (dizziness when getting up from a sitting or lying position)
• Difficulty in passing water
• Decreases in red and white blood cells or clotting disorders, which can so metimes lead to angina, changes in the heart beat or other problems with your heart (e.g. heart attack)
• Allergic reactions such as a severe skin rash, itching or increased sensitivity of the skin to light
• Numbness or tingling in the legs or arms
• Inflammation of the pancreas which causes severe pain in the abdomen and back (pancreatitis)
• Ringing or buzzing in the ears or any loss of hearing
• Visual disturbances e.g. blurred eyesight
Tell you doctor if you experience any of the following and they are bothersome or do not improve:
You may need medical attention only if they continue or becom e bothersome. There is usually no need for your medicine to be stopped.
• Headache
• Dizziness
• Feeling or being sick
• Stomach upset (e.g. loss of appetite, stomach pain), diarrhoea, constipation
The levels of potassiu m, sodium, sugar, uric acid, creatinine and lipids (fats) in your blood may be affected by this medicine and your doctor may wish to test your bl ood. Changes in so me liver enzymes may also occur.
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 Tablets
Keep out of the sight and reach of children.
Do not use Torasemide Tablets after the expiry date which is stated on the carton after EXP. Th e expiry date refers to the last day of that month.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharm acist how to throw away medicines no longer used. These measures will help protect the environment.
6 Contents of the pack and other information What Torasemide Tablets contain
The active substance is torasemide. Each tablet contains either 5mg or 10mg of torasemide.
The other ingredients are lactose monohydrate, maize starch, sodium starch gly colate Type A, silica colloidal anhydrous and magnesium stearate.
What Torasemide Tablets look like and contents of pack
Torasemide 5mg Tablets are white to alm ost-white, round, biconvex tablets with a break lin e on one side and marked with ‘915’ on the other.
Torasemide 10mg Tablets are white to almost-white, round, biconvex tablets with a break line on one side and marked with ‘916’ on the other.
Pack sizes: Blister packs of 14, 28, 30, 50, 100 or 112 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
PLIVA Pharma Ltd.,
Ridings Point,
Whistler Drive,
Castleford,
West Yorkshire, WF10 5HX Manufacturer
Teva Operations Poland Sp. z.o.o., ul. Mogilska 80,
31-546 Krakow,
Poland.
This leaflet was last revised in September 2013.
PL 10622/0098 PL 10622/0099
Only the paragraph containing the details of the current batch release site will be included in the printed version of the PIL