TORASEMIDE 5 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - TORASEMIDE 5 MG 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:

/1j What Torasemide is and what it is used for
^2| Before you take Torasemide

Jj) How to take Torasemide

Possible side effects

j5) how to store torasemide

ft Further information

ft 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) 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.

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.

[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

ft Possible side effects

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

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:

Patient Information Leaflet (continued)

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)

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

Eye disorders

Frequency not known: Visual impairment

Ear and labyrinth disorders

Frequency not known: Tinnitus, Deafness

Cardiac disorders

Frequency not known: Acute myocardial infraction, Myocardial ischaemia,

Angina pertoris, Syncope, Hypotension

Vascular disorders

Frequency not known: Embolism

Gastrointestinal disorders

Common: Gastrointestinal disorder (e.g. Loss of appetite, Abdominal pain upper, Nausea, Vomiting, Diarrhoea, Constipation)

Frequency not known: Dry mouth, Pancreatitis

Hepatobiliary disorders

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

Skin and subcutaneous tissue 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)

Musculoskeletal and connective tissue disorders

Common: Muscle spasms

Renal and urinary disorders

Uncommon: Urinary retention, Bladder dilation

Rare: Blood urea increased, Blood creatinine increased

General disorders and administration site conditions

Common: Fatigue, Asthenia

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.

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).

Skin

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

Eyes and ears

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

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 or pharmacist. This includes any possible side effects not listed on this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine

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 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.

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.

What Torasemide looks like and contents of the pack

Torasemide 5mg tablets are white to off-white, round tablets marked T 5.0 and break line on one side and plain on the other side.

Torasemide tablets are supplied in blister packs of 30 tablets.

Manufacturer and Licence Holder

This medicine is manufactured by Madaus GmbH, 51101 Colonia, 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.

POM PL 15184/1474

Revision date: 04/02/20

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