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TORASEMIDE 5MG TABLETS

Active substance(s): TORASEMIDE / TORASEMIDE / TORASEMIDE

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Ref: 1474/210617/1/F

Torasemide 5mg Tablets
Patient Information Leaflet
Please 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 troublesome, or if you notice any
side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Torasemide 5mg Tablets but will be referred to as
Torasemide throughout the rest of this leaflet.
Please note that the leaflet also contains information about other strengths
of the medicine, Torasemide 10mg Tablets.
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

1

What Torasemide is and what it is used for

Torasemide contains a medicine called torasemide. This belongs to a group
of medicines called ‘diuretics’ or ‘water tablets’.
* Torasemide 5 mg tablets are used to treat high blood pressure
(hypertension).
* Torasemide 5 mg and 10 mg tablets are used to treat swelling caused by
too much water in the body (oedema).
The tablets work by making you pass more water (urine).

2

Do not take Torem if you are already taking an antibiotic called an
‘aminoglycoside’ or ‘cephalosporin’ (for an infection). These medicines
include streptomycin, gentamycin, cephalexin and ceftriaxone. If this applies
to you, ask your doctor or pharmacist for advice.
It is particularly important to tell your doctor or pharmacist if you are
taking any of the following medicines:
* Other medicines to treat high blood pressure.
* Medicines called ‘ACE inhibitors’ (used to treat heart disease).
* Medicines like 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
levels of cholesterol in your blood).
* High doses of medicines called ‘salicylates’, such as aspirin.
* Medicines called ‘non-steroidal anti-inflammatory drugs’ (NSAIDs).
These include indomethacin and ibuprofen.
* Laxatives.
* Steroid medicines, such as hydrocortisone, prednisolone and
dexamethasone.
* Medicines to relax your muscles (muscle relaxants).
* Cisplatin (used to treat cancer).
* Lithium (used to treat mental health problems).
* Probenecid (used to treat gout).
* Theophylline (used to treat asthma).
Pregnancy and breast-feeding
Do not take Torasemide if you are pregnant, might become pregnant or are
breastfeeding. This is because it is not known if Torasemide will affect your
baby.
Driving and using machines
You may feel dizzy while taking Torasemide. If this happens, do not drive or
use any tools or machines.
Important information about some of the ingredients of Torasemide
This medicine contains lactose, which is a type of sugar. If you have been
told by your doctor that you cannot tolerate or digest some sugars (have an
intolerance to some sugars), talk to your doctor before taking this medicine.

Before you take Torasemide

Do not take Torasemide if you are allergic (hypersensitive) to:
* Torasemide or any of the other ingredients of Torasemide (see Section 6:
Further information).
* Similar medicines called ‘sulphonylureas’. These are used to treat diabetes
(high blood sugar). These medicines include chlorpropamide,
glibenclamide, glipizide and tolbutamide.
Do not take Torasemide if any of these apply to you. If you are not sure, talk
to your doctor or pharmacist before taking Torasemide.
Do not take Torasemide if:
* You have kidney problems (renal failure).
* You have kidney problems that have been caused by medicines.
* You have liver problems.
* You have a low volume of blood (hypovolaemia)
* You have low blood pressure (hypotension)
* You have heart beat problems (cardiac arrhythmia)
* You are taking an antibiotic called an ‘aminoglycoside’ or ‘cephalosporin’
(for an infection). These medicines include streptomycin, gentamycin,
cephalexin and ceftriaxone. See the section on ‘Taking other medicines’.
* You are pregnant or breast-feeding a baby. See the section on ‘Pregnancy
and breast-feeding
Do not take Torasemide if any of these apply to you. If you are not sure, talk
to your doctor or pharmacist before taking Torasemide.
Take special care with Torasemide
Check with your doctor or pharmacist before taking Torasemide if:
* You have low levels of potassium or sodium in your blood (shown in blood
tests).
* You have difficulty with micturition (passing urine) including prostatic
hypertrophy.
* You have diabetes (diabetes mellitus).
If any of these apply to you, or if you are not sure,talk to your doctor or
pharmacist before you take Torasemide.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines.This includes medicines that you buy without a
prescription and herbal medicines. This is because Torasemide can affect
the way some other medicines work. Also some other medicines can affect
the way Torasemide works.

3

How to take Torasemide

Always take Torasemide exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
High blood pressure
* The usual dose for adults and elderly people is between 2.5 mg and 5 mg
once a day.
Water retention (oedema)
* The usual dose for adults and elderly 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 someone else takes your Torasemide tablets by mistake, they should talk
to a doctor or go to a hospital straight away.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist

Ref: 1474/210617/1/F

Torasemide 5mg Tablets
Patient Information Leaflet (continued)

Like all medicines, Torasemide can cause side effects, although not
everyone will get them.

Stomach and gut
* Stomach upset.
* Inflammation of the pancreas causing pain in the stomach (pancreatitis).
* Changes in how your liver is working (shown by blood tests).

Within the system organ classes, adverse reactions are listed under
headings of frequency (number of patients expected to experiece the
reaction), using the following categories:

Skin
* Skin rashes and itchy skin.
* Skin being more sensitive to the sun (photo-sensitivity).

Very common (≤1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 < 1/100)
Rare (≥1/10,000 to < 1/1,000)
Vary rare (<1/10,000
Not known (cannot be estimated from available data)

Eyes and ears
* Blurred eyesight.
* Ringing in the ears (tinnitus) and loss of hearing.

4

Possible side effects

The following undesirable effects were observed whereas the frequency of
undesirable effect is not known:
See your doctor as soon as possible if you get the following side
effects:
Blood and lymphatic system disorders frequency not known:
Thrombocytopenia, Leukopenia, Anamia
Immune system disorders
Very rare: Allergic skin reactions (e.g. Pruritus, Exanthema), Photosensitivity
reaction
Frequency not known: Serious skin reactions (e.g. Stevens-Johnson
syndrome, Toxic epidermal necrolysis)
Metabolism and nutrition disorders Common: Metabolic alkalosis, Fluid and
electrolyte imbalance (e.g. Hypovolaemia, Hyponatraemia)
Nervous system disorders Common: Headache, Dizziness Frequency not
known: Cerebral ischaemia, Parenthesia, Confusional state

Other
* Feeling numb or tingling in the legs or arms.
* Dry mouth.
* Some people may have difficulty passing water (urinating).
If any of the side effects become serious or troublesome, or if you notice any
side effects not listed in this leaflet, please tell your doctor or pharmacist.
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

* Keep out of the sight and reach of children.
* This medicinal product does not require any special
storage conditions.

* Do not use after the expiry date which is stated on the bister label and

Eye disorders
Frequency not known: Visual impairment
Ear and labyrinth disorders
Frequency not known: Tinnitus, Deafness
Cardiac disorders
Frequency notknown: Acute myocardial infraction, Myocardial ischaemia,
Angina pertoris, Syncope, Hypotension
Vascular disorders
Frequency not known: Embolism

How to store Torasemide

*
*

carton. If your doctor tells you to stop using this medicine, take any
remaining medicine back to the pharmacist for safe disposal. Only keep
this medicine if your doctor tells you to.
If your medicine becomes discoloured or shows any signs of deterioration,
ask your pharmacist who will advise you what to do.
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.

6

Further information

Gastrointestinal disorders
Commo: Gastrointestinal disorder (e.g. Loss of appetite, Abdominal pain
upper, Nausea, Vomiting, Diarrhoea, Constipation)
Frequency not known: Dry mouth, Pancreatitis

What Torasemide contains
The active substance in Torasemide is torasemide.
Each tablet contains 5 milligrams of torasemide.
Other ingredients are lactose monohydrate, maize starch, colloidal silicon
dioxide and magnesium stearate.

Hepatobiliary disorders
Uncommon: Hepatic enzyme increased (e.g. Gamma-glutamyltransferase
increased)

What Torasemide looks like and contents of the pack
Torasemide 5mg tablets are white to off-white, round tablets marked
with C9 and break line on one side and BM on the other side.

Skin and subcutaneous tissue disorders Vrty rare: Allergic skin reactions
(e.g. Pruritus, Exanthema), Photosensitivity reaction Frequency not known:
Serious skin reactions (e.g. Stevens-Johnson syndrome, Toxic epidermal
necrolysis)

Torasemide tablets are supplied in blister packs of 30 tablets.

Musculoskeletal and connective tissue disorders
Common: Muscle spasms

Manufacturer and Licence Holder
This medicine is manufactured by MEDA Pharma GmbH & Co. KG,
Benzstrasse 1, 61352 Bad Homburg, Germany and procured from within the
EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.

Renal and urinary disorders
Uncommon: Urinary retention, Bladder dilation
Rare: Blood urea increased, Blood creatinine increased

POM

General disorders and administration site conditions
Common: Fatigue, Asthenia

Revision date: 21/06/17

Investigations
Uncommon: Blood uric acid increaseed, Bloood glucose increased, Lipids
increased (e.g. Blood triglycerides increased, Blood cholesterol increased)
Other possible side effects:
Blood
* An increase in the levels of certain substances in your blood, including
sugar, uric acid and fats (lipids).
Your doctor may do blood tests from time to time to make sure that
Torasemide is working safely.

PL 15184/1474

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

Expand Transcript

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.

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