TORASEMIDE 2.5 MG TABLETS
Active substance(s): TORASEMIDE
Always take Torasemide 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
Packing Site Approval (where not TEVA UK Limited)
Sign & Date:
Final approval by MA Holder confirming receipt of MHRA/IMB
approval; Sign & Date:
POSSIBLE SIDE EFFECTS
Do NOT take Torasemide 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
• are breastfeeding.
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 taking Torasemide.
Taking other medicines
Talk to your doctor if you are taking any of the
• insulin or tablets for the treatment of
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:
• 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
• 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
BEFORE YOU TAKE TORASEMIDE
What Torasemide Tablets 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
What Torasemide looks like and contents of the
• 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
Marketing Authorisation holder and company
responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG.
Torasemide tablets belong to a group of
drugs called diuretics or ‘water tablets’ that
help to remove excess retained water from
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
Approved for Regulatory submission into MHRA/IMB;
Sign & Date:
WHAT TORASEMIDE IS AND WHAT IT
IS USED FOR
HOW TO STORE TORASEMIDE
Sign & Date:
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.
Sign & Date:
IN THIS LEAFLET :
1. What Torasemide is and what it is used for
2. Before you take Torasemide
3. How to take Torasemide
4. Possible side effects
5. How to store Torasemide
6. Further information
• liver problems
• dry mouth.
Rare side effects, which have been reported,
• inflammation of the pancreas, (nausea,
vomiting, abdominal pain, back pain)
• rash, itching
• photosensitivity (a skin reaction on
exposure to sunlight)
• problems with sight
• 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.
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Fonts: Univers Body text 7 pt
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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
• 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
• 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.
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,
• 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
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 take Torasemide
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.
New livery. V2 - Text update from regulatory. V3 - Text update from reg. V4 - Application of QRD
template. V5 - Text update. V6 - The word ‘Lactose’ to appear in bold. V7 - More text updates.
Reason for revision:
TEVA UK Limited
(PANTONE® is a registered trademark
of Pantone, Inc.)
PANTONE® GREEN C
TEVA UK Limited Licence, packed at TEVA Israel. (Responsible Regulatory Officer =
MA Holder & Packer: Priti Darjee).
6 December 2007
INFORMATION FOR THE USER
diabetes, as their effectiveness can be
• 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
• 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
• non-steroidal anti-inflammatory drugs
(NSAIDs), e.g. indometacin; or probenecid, a
medicine used to prevent kidney problems,
as the effect of Torasemide 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
• colestyramine, a drug used to reduce the
level of fat in your blood, as Torasemide 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 of Torasemide
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.
62106-T LEA TORASEMIDE A/S TAB TUK
TORASEMIDE 2.5 mg, 5 mg
and 10 mg TABLETS
By GrimshawB at 4:03 pm, Sep 15, 2010
This leaflet was last revised: November 2007
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.