Patient Information Leaflet

FUROSEMIDE 40MG TABLETS

Read all of this leaflet carefully because it contains important information for you.

Keep this leaflet. You may need to read it again.

Ask your doctor or pharmacist if you need more information or advice.

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.

1.    WHAT FUROSEMIDE IS AND WHAT IT IS USED FOR

Furosemide belongs to a group of medicines known as diuretics, these work on your kidneys to remove excess water from the body.

Furosemide tablets are used for the treatment of water retention (oedema) caused by heart failure, cirrhosis of the liver or certain kidney diseases. They may also be used to treat water retention due to mild to moderate high blood pressure and in the management of reduced urine production due to kidney failure.

2.    BEFORE YOU TAKE FUROSEMIDE TABLETS

Do NOT take this medicine if you:

•    are allergic (hypersensitive) to furosemide, drugs called sulfonamides (e.g. Co-Trimoxazole) or any of the other ingredients of this medicine (listed in section 6)

•    are not able to pass urine

•    have a disorder of your body salts (electrolytes) such as potassium or sodium, this may cause weakness, tiredness and muscle cramps

•    have low blood pressure (hypotension)

•    have kidney failure

•    have severe liver disease (cirrhosis)

•    have digitalis poisoning, causing nausea, vomiting and fast, slow or irregular heart beats

•    have a condition known as porphyria.

Tell your doctor before you start to take this medicine if you:

•    have serious liver or kidney problems

•    have diabetes mellitus

•    have a disease of the adrenal gland

•    have prostate problems or difficulty passing urine

•    have a history of gout.

Taking other medicines

Talk to your doctor if you are taking any of the following:

•    cardiac glycosides for heart problems e.g. digoxin

•    antiarrhythmics used to treat irregular heart rhythms, such as lidocaine, mexiletine, tocainide, amiodarone, disopryramide, flecainide and sotalol

•    medicines for lowering blood pressure such as nitrates, hydralazine or ACE Inhibitors e.g. captopril or aliskiren

•    antibiotics - medicines for infections e.g. cefuloridine, vancomycin

•    lithium - used for mental illness

•    corticosteroids e.g. prednisolone - used for inflammation

•    non-steroidal anti-inflammatory drugs such as ibuprofen, aspirin, indometacin or ketorolac, used to treat pain and inflammation

•    anti-psychotics e.g. pimozide, amisulpride, phenothiazines

•    antidepressants e.g. tricyclics, monoamine oxidase inhibitors (MAOIs)

•    sedatives or medicines used to treat anxiety

•    medicines containing platinum used to treat cancer e.g. cisplatin, carboplatin

•    other diuretics e.g. metolazone, thiazides

•    muscle relaxants e.g. baclofen, tizanidine

•    oestrogens

•    beta-sympathomimetic drugs used to treat heart problems or low blood pressure

•    general anaesthetics

•    theophylline - used for wheezing or difficulty in breathing

•    medicines for diabetes

•    antihistamines used to treat allergic reactions

•    medicines used to treat epilepsy e.g. phenytoin, carbamazepine

•    over-use of laxatives

•    probenecid used to treat gout

•    sucralfate used to treat ulcers

•    salicylates e.g. aspirin

•    amphotericin, an antifungal agent

•    atomexitine used to treat ADHD

•    levodopa, used to treat Parkinson's disease

•    aldesleukin used to treat cancer or chronic viral infections

•    alprostadil and moxisylyte (thymoxamine), used to treat erectile dysfunction

•    alcohol.

If you need to go to hospital for an operation tell the staff that you are taking furosemide, as this might interact with muscle relaxants used during surgery.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Regular monitoring of your kidneys, liver and blood should be carried out during treatment (including blood tests)

Pregnancy and breastfeeding

Talk to your doctor before taking this medicine if you are pregnant or breast-feeding.

Driving and using machines

Furosemide may affect your reactions (reduced mental alertness, dizziness and blurred vision). If you are affected do not drive, operate machinery or take part in activities where these could put yourself or others at risk.

Continued overleaf

Important information about some of the ingredients of this medicine

This medicine contains 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.

3.    HOW TO TAKE FUROSEMIDE TABLETS

Always take exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure. The tablets should be swallowed.

•    Adults: the usual initial dose is 40mg dailyreduced to 20mg daily or 40mg on alternative days. Your doctor may increase this to 80mg or more (given in divided doses), if necessary.

•    Patients with severe kidney problems: the usual daily dose is 250mg.

•    Elderly: the usual adult dose, but caution is advised as furosemide is excreted more slowly.

•    Children: the usual dose is 1-3 mg per kg body weight daily, up to a maximum total dose of 40mg per day.

If you take more than you should

If you (or someone else) accidentally take more than your prescribed dose, contact your nearest hospital casualty department, or tell your doctor immediately. Take this leaflet and any remaining tablets and the container with you.

If you forget to take a tablet take one as soon as you remember, unless it is nearly time to take the next dose. Do not take a double dose to make up for a forgotten dose.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Furosemide Tablets can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience any of the following:

•    An allergic reaction such as skin rash, itching or rarely difficulty breathing.

•    Anaemia (unusual tiredness, breathlessness and loss of colour in the lining of eyes and skin), more frequent infections, fever, unusual bruising or bleeding or pinpoint rash. These may indicate depression of your bone marrow, your doctor may decide to stop your treatment.

•    Inflammation of the pancreas (severe pain in the abdomen and back), blood vessels (rash, fever, joint or muscle pain) or kidney (changes in the frequency of urination, blood in the urine).

Common side effects:

•    Altered balance of fluid or chemicals in your body. This may cause a dry mouth, thirst, decreased production of urine, drowsiness, weakness, tiredness, restlessness, fits, muscle pain or cramps or a fast heart rate.

Other side effects may include:

•    nausea, diarrhoea, stomach upset

•    headache or dizziness

•    feeling unwell, fever

•    muscle spasm, tingling or numbness of the hands or feet

•    low blood pressure (feeling dizzy or faint on standing up)

•    liver problems (yellowing of the skin or whites of the eyes)

•    gout (severe joint paint)

•    diabetes (increased thirst, passing water more frequently, weight loss, tiredness)

•    skin rash, which may be red, itchy, swollen or scaly

•    ringing in the ears and deafness

•    photosensitivity (skin rash or spots, sunburn or itching on exposure to the sun)

•    blurred vision.

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.

5.    HOW TO STORE FUROSEMIDE TABLETS Keep out of the reach and sight of children.

Do not store above 25°C and protect from light.

Store in a cool dry place, in the original container.

Do not use the tablets after the expiry date shown on the label.

6.    FURTHER INFORMATION What these tablets contain:

The active ingredient in each tablet is furosemide 40mg.

The other ingredients are lactose, maize starch, magnesium stearate and povidone.

What these tablets look like and contents of the pack:

Furosemide 40mg tablets are flat, round and white with "M&A” logo on one side and a break line on the reverse.

They are available in blister packs of 28, 30 and100 tablets and in plastic tubs of 250, 500 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

M & A Pharmachem Ltd, Bolton BL5 2AL, UK.

Date of Approval: 01/2012

PP1206