Torasemide 5 Mg Tablets
PACKAGE LEAFLET: INFORMATION FORTHE USER
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Read all of this leaflet carefully before you start
taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
INTHIS LEAFLET:
1. WhatTorasemide is and what it is used for
2. Before you takeTorasemide
3. How to takeTorasemide
4. Possible side effects
5. How to storeTorasemide
6. Further information
• WHATTORASEMIDE IS AND WHAT IT IS USED FOR
• Torasemide tablets belong to a group of drugs called diuretics or 'water tablets' that help to remove excess retained water from the body.
• Torasemide 2.5 mg and 5 mg tablets are used to treat high blood pressure.
• Torasemide 5 mg and 10 mg tablets are used to treat oedema (fluid retention) caused by heart failure.
DO NOT takeTorasemide if you:
• are allergic (hypersensitive) to torasemide or any of the other ingredients of this medicine
• are allergic to sulphonylureas (medicines used to treat diabetes, e.g. glibenclamide)
• have severe kidney or liver problems
• suffer from low blood pressure (feeling faint or dizzy)
• are pregnant or breast-feeding
• are taking an antibiotic known as a cephalosporin or aminoglycoside
• have developed kidney problems due to taking medicines which cause kidney damage.
Take special care with Torasemide
Tell your doctor before you start to take this
medicine if you:
• suffer from diabetes
• suffer from gout
• have been told you have low sodium and/or potassium levels in your blood
• have hypovolaemia (an abnormally low volume of blood in the circulation)
• have any problems passing urine
• have an abnormal heart beat.
If you are to have an operation and anaesthetic (including at the dentist) tell your doctor or dentist that you are takingTorasemide.
Taking other medicines
Talk to your doctor if you are taking any of the following:
• insulin or tablets for the treatment of diabetes, as their effectiveness can be reduced
• other drugs to reduce blood pressure such as diuretics ("water tablets"), e.g. amiloride or beta blockers, e.g. propanolol, as your blood pressure may become too low
• ACE inhibitors used to treat heart disease and high blood pressure, e.g. captopril, as you may temporarily suffer from low blood pressure
• any digitalis drug (to treat heart problems), e.g. digoxin, as the sensitivity of the heart to these drugs is increased
• corticosteroids, e.g. prednisolone, used to treat inflammation in diseases such as rheumatoid arthritis; or laxatives, e.g. bisacodyl, as the level of potassium in your blood may become too low
• lithium, a treatment for depression; salicylates, used as painkillers and to reduce inflammation, e.g. aspirin; cisplatin, which is used to treat cancer; or aminoglycoside antibiotics, e.g. gentamicin, as the chance of side effects may be increased
• antibiotics, e.g. cefalexin, as there is an increased risk of kidney problems
• muscle-relaxing drugs, e.g. tubocurarine; or theophylline, which is used to help breathing problems, as their effectiveness may be increased
• non-steroidal anti-inflammatory drugs (NSAIDs), e.g. indometacin; or probenecid, a medicine used to prevent kidney problems, as the effect ofTorasemide may be reduced
• sympathomimetic drugs, e.g. adrenaline, noradrenaline and ephedrine, as their effectiveness may be decreased. Ephedrine may be present in medicines for colds and nasal stuffiness
• colestyramine, a drug used to reduce the level of fat in your blood, asTorasemide may not be as effective.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Torasemide is not recommended if you are breast-feeding. If you are pregnant, planning to become pregnant or breast-feeding, ask your doctor for advice before taking any medicine.
Driving and using machines
Torasemide may cause dizziness. If affected do not drive or operate machinery.
Important information about some of the ingredients ofTorasemide
Patients who are intolerant to lactose should note that Torasemide contain a small amount of 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.
^ HOWTOTAKETORASEMIDE
Always takeTorasemide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Torasemide can be taken with or without food. The tablets should be swallowed with a drink of water.
The usual dose is:
Adults including the elderly:
• High blood pressure
One 2.5 mg tablet a day.Your doctor may increase your dose up to 5 mg once a day, if necessary.
• Oedema (fluid retention)
One 5 mg tablet once a day. If necessary your doctor may increase your dose up to 20 mg once a day.
Your doctor will monitor you during treatment and this may include blood tests.
Children under 12 years of age
Torasemide is not recommended for use in children.
If you take more Torasemide than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause drowsiness, confusion, excessive urine production, dizziness or faintness due to low blood pressure and stomach upset. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to takeTorasemide
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.
If you stop taking Torasemide
You should continue to take these tablets for as long as your doctor tells you to. If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines,Torasemide can cause side effects, although not everybody gets them.
If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or nettle rash).
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
The most frequent side effects are:
• headache
• dizziness
• weakness
• drowsiness
• muscle cramps
• loss of appetite
• low blood pressure (feeling dizzy and faint)
• if you suffer from alkalosis (a change in the acid/base balance of the body) this may be worsened
• confusion
• stomach pain.
Other side effects are:
• nausea, vomiting, diarrhoea or constipation
• changes in the blood chemistry, e.g. in the levels of sugars and fats
• any urinary problems may be further complicated and lead to a failure to pass urine
• liver problems
• dry mouth.
• tinnitus (ringing in the ears) or hearing loss
• 'pins-and-needles' or numbness in your arms, legs, hands or feet
• problems with blood including its clotting ability and circulation/flow. A decrease in the number of red and white blood cells and platelets in the blood may occur.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
HOWTO STORETORASEMIDE
Keep out of the reach and sight of children. Do
not transfer to another container. Do not use Torasemide after the expiry date that is stated on the outer packaging.The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.
FURTHER INFORMATION
WhatTorasemideTablets contain:
• Each tablet contains either 2.5 mg, 5 mg or 10 mg of the active ingredient torasemide.
• The other ingredients are lactose anhydrous, crospovidone, povidone (k-30), microcrystalline cellulose and magnesium stearate.
WhatTorasemide looks like and contents of the pack:
• The 2.5 mg tablets are white to off white, round, flat tablets with the letters 'TSD' indented on one side and the numbers '2.5' indented on the other.
• The 5 mg tablets are white to off white, oval shaped tablets, scored and indented with '9' and '3' on each side of the score and indented with '7127' on the other side.
• The 10 mg tablets are white to off white, oval shaped tablets, scored and indented '9' and '3' on each side of the score and with '7128' indented on the other side.
• The 2.5 mg is available in pack sizes 20, 28, 50, 56, and 100 tablets.
• The 5 and 10 mg is available in pack sizes of 20, 28, 30, 50, 56, 100 and 400 tablets.The
10 mg product is also available in a pack size of 14 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture:
TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: 09/2010
PL 00289/0443-0445
Rare side effects, which have been reported, include:
• inflammation of the pancreas, (nausea, vomiting, abdominal pain, back pain)
• rash, itching
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TEVA UK LIMITED
• photosensitivity (a skin reaction on exposure to sunlight)
• problems with sight