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PATIENT INFORMATION LEAFLET

Please read all of this leaflet carefully before you start taking this medicine.

Keep the leaflet, you may need to read it again.

This medicine has been prescribed for you personally and you should not pass It on to others.

It may harm them, even if their symptoms are the same as yours.

If you have any further questions, please ask your doctor or pharmacist.

Dose:

Adults and elderly:

The usual dose is one or two tablets first thing in the morning. Your doctor will tell you how many tablets to take.

Children and adolescents (under 18 years of age):

Not recommended as safety in this age group has not yet been established.

If you are taking sucralfate (a medicine for stomach ulcers). Do not take sucralfate at the same time as Furosemide Tablets. Take your dose at least 2 hours before or after Furosemide Tablets. This is because it can affect the way your medicine works.

If you take more Furosemide Tablets than you should:

If you think you may have taken more Furosemide Tablets than you should or if a child has swallowed any of these tablets, contact your doctor or pharmacist or hospital emergency department immediately.

Always take any tablets left over with you, also the box and leaflet as this will allow easier identification of the tablets. Taking too much Furosemide Tablets may make you feel confused, unable to focus, show a lack emotion or interest in anything. You may also have dizziness, light headedness, fainting (due to low blood pressure), uneven heartbeat, muscle weakness or cramps and blood clots (signs include pain and swelling at the part of body that is affected). You may also have problems with your kidneys or blood.

If you forget to take Furosemide Tablets:

If you forget to take a dose, take it as soon as you remember. Then continue the following morning as normal. Do not take a double dose to make up for a forgotten dose.

If you stop taking Furosemide Tablets:

Keep taking Furosemide tablets until your doctor tells you to stop taking it.

Blood tests

Your doctor may carry out blood tests to check that the levels of some salts in the blood are at the correct levels.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines Furosemide Tablets can cause side effects, although not everybody gets them. STOP TAKING this medicine and tell your doctor immediately if you suffer from any of the following

•    allergic reactions such as itching, skin rash with severe itching and nettle rash, fever, allergic to light, severe allergic reaction with (high) fever, red patches on the skin, joint pain and/or inflammation of the eyes, severe, acute (allergic) reaction accompanied by fever and blisters on the skin/peeling skin and tiny spots from bleeding in the skin.

•    sudden inflammation of the pancreas accompanied by severe pain in the upper abdomen, shifting towards the back.

The other possible side effects are listed under headings of frequency, using the following categories: Common (affects 1 to 10 users in 100)

Uncommon (affects 1 to 10 users in 1,000)

Rare (affects 1 to 10 users in 10,000)

Very rare (affects less than 1 user in 10,000)

Common

Furosemide can cause an excessive depletion of bodily fluids (e.g. passing urine more often than normal) and minerals (sodium, potassium, magnesium, calcium). Symptoms that can occur are thirst, headache, confusion, muscle cramps, increased irritability of the muscles , muscular weakness, heart rhythm disturbances and gastrointestinal problems such as sensation of unease and discomfort in stomach with an urge to vomit, or diarrhoea.

If you have a shortage of sodium (sodium deficiency):

•    cramp in the calf muscles

•    loss of appetite

•    listlessness

•    feeling of weakness

•    dizziness

•    drowsiness

•    confusion.

If you have a shortage of potassium (potassium deficiency):

•    muscular weakness and the inability to contract one or more muscles (paralysis)

•    increased excretion of urine

•    heart problems

•    in the case of severe potassium deficiency: interference with the function of the intestine or confusion, which can result in coma.

If you have a shortage of magnesium and calcium (magnesium and calcium deficiency):

•    increased irritability of the muscles

•    heart rhythm disturbances.

•    Lowering of blood pressure, resulting in impaired concentration and reactions, light-headedness, a feeling of pressure in the head, headache, dizziness, drowsiness, a feeling of weakness, visual disturbances, dry mouth and an inability to stand upright

Uncommon

•    abnormal blood count accompanied by bruising and a tendency to bleed

•    sensitivity to light (photosensitivity).

•    involuntary leakage of urine

•    in the elderly, this can lead to a low blood volume, fluid depletion and thickening of the blood. This can cause clots to form in the blood .

Rare

•    abnormal blood count (white blood cell deficiency) accompanied by a increased susceptibility to infection

•    increase in certain substances (eosinophilic cells) in the blood

•    a crawling sensation on the skin, itching or tingling without any reason

•    a life-threatening form of unconsciousness

•    hearing disorders & ringing in the ears. These disorders are usually temporary in nature

•    inflammation of a blood vessel

•    acute kidney failure

•    inflammation of the kidneys associated with blood in the urine, fever and pain in the sides.lf you have a urinary tract obstruction, increased urine production may occur or worsen.

•    if you have a bladder disorder, enlarged prostate or narrowing of the ureters, urine production can stop suddenly

•    shock (severe drop in blood pressure, extreme paleness,, restlessness, weak fast pulse, clammy skin, impaired consciousness) as a result of a sudden severe dilatation of the blood vessels due to allergy to certain substances

•    fever

•    minor mental disturbances Very rare

•    anaemia (a condition characterised by shortage of red blood cells)

•    very severe blood abnormality (white blood cell deficiency) accompanied by a sudden high fever, severe throat pain and ulcers in the mouth

•    certain liver function disorders

•    increase in certain liver enzymes

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or

| Storing the tablets |

Keep out of the reach and sight of children.

Blisters: Do not store above 25°C. Store in the original package (blister carton).

Tablet Containers: Do not store above 25°C. Keep the container tightly closed.

Do not use the tablets after the expiry date as shown on the blister, label or carton. The expiry date refers to the last day of that month.

Unless your doctor tells you to, do not keep any tablets that you no longer need. Give them back to your pharmacist.

| Further Information |

What Furosemide Tablets look like and contents of the pack

-    Furosemide 20mg tablets are round, white to off-white tablets marked ‘F20’ on one side and ‘BL’ on the other.

-    Furosemide 40mg tablets are round, white to off-white, tablets marked ‘F40’ separated by a break line on one side and ‘BL’ on the other.

-    The tablets are supplied in blister packs containing 28, 30, 50, 56, 84, 98 and 100 tablets and containers containing 100, 250, 500 & 1000 tablets.

Not all pack sizes may be marketed.

Name and address: Brillpharma Limited

Unit 3, Canalside, Northbridge Road,

Berkhamsted, Hertfordshire, HP4 1 EG,

United Kingdom

Telephone: 01442 200 922

Fax: 01442 873 717

Email: infd@brillpharma-labs.co.uk

This leaflet was revised in November 2013

PL 40496/0043 - Furosemide 20mg Tablets BP

PL 40496/0044 - Furosemide 40mg Tablets BP

The name of this medicine is

FUROSEMIDE 20mg TABLETS BP or FUROSEMIDE 40mg TABLETS BP

The active ingredient in this medicine is furosemide. This is the new name for frusemide. The ingredient itself has not changed.

The tablets are available in two strengths and contain either 20 mg or 40 mg of the active ingredient furosemide. The tablets also contain lactose monohydrate, maize starch, pregelatinized maize starch, magnesium stearate and sodium starch glycollate.

The manufacturer is Bristol Laboratories Ltd., Unit 3, Canalside, Northbridge Road, Berkhamsted, Herts, HP4 1EG UK.

| What the tablets are and what they are used for |

Furosemide belongs to a group of medicines called diuretics, which increase the amount of urine passed by the kidneys, helping to remove excess fluids from the body. Diuretics are also known as ‘water tablets’.

Furosemide Tablets are used in the treatment of oedema (fluid retention) caused by disorders of the heart, kidneys or liver alone or in combination with other anti-hypertensive agents.The tablets may also be used to treat pulmonary oedema (build up of fluid in the lungs) and mild to moderate hypertension (high blood pressure).

| Before you take the tablets |

Do not take this medicine and tell your doctor If:

you are allergic (hypersensitive) to Furosemide and/or any of the other ingredients of Furosemide tablets. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

•    you are allergic to amiloride, sulfonamides or sulphonamide derivatives, such as sulfadiazine or co-trimoxazole.

•    you have been told by a doctor that you have kidney failure. In some types of kidney failure, it is still okay to have this medicine. Your doctor will be able to decide.

•    you have severe liver problems (cirrhosis).

•    your doctor has told you that you have a low blood volume or are dehydrated (with or without accompanying low blood pressure).

•    you are not passing any water (urine).

•    you have too little potassium or sodium in your blood (shown in blood test),

•    you have an illness called ‘Addison’s Disease’. This can make you feel tired and weak

•    you are breast-feeding (see “Pregnancy and breast-feeding” section below)

•    you are taking other medicines which change the amount of potassium in your blood (see Taking other medicines” section below)

•    you are children and adolescents under 18 years of age. Furosemide tablets are not suitable for children.

Do not take Furosemide Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Furosemide Tablets.

Take special care with Furosemide Tablets:

Check with your doctor or pharmacist before taking If:

•    you have low blood pressure, or feel dizzy when you stand up.

•    you have diabetes (high blood sugar)

•    you are 65 years of age or older

•    you have difficulty in passing water (urine)

•    you have gout

•    you have liver or kidney problems

•    you have low level of protein in your blood (hypoproteinaemia)

•    you suffer from acute porphyria symptoms of which may include severe stomach, back or thigh pain. Nausea, vomiting or constipation may also present along with weakness in arms and legs.

•    you are an elderly patient with dementia and are also taking risperidone

•    you have prostate problems

•    you feel dizzy or dehydrated. This can happen if you have lost a lot of water through being sick, having diarrhoea or passing water very often. It can also happen if you are having trouble drinking or eating

•    you are going to have a glucose test

•    you are taking any other water tablets

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking furosemide tablets.

Taking other medicines

Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines. This is because Furosemide tablets can affect the way some other medicines work. Also some medicines can affect the way Furosemide tablets work.

The following medicines can affect the way Furosemide Tablets work and Increase the chance of you getting side effects:

•    Medicines such as ramipril, enalapril, perindopril (called ‘ACE inhibitors’) or losartan, candesartan, irbesartan (called ‘angiotensin II receptor antagonists’). Your doctor may need to change the dose of your tablets or ask you to stop taking them.

•    Medicines for high blood pressure or heart problems. Your doctor may need to change the dose of your medicine.

•    Medicines to help you sleep and relax such as chloral hydrate

•    Medicines used as a general anaesthetic for relaxing your muscles during surgery. If you are going to have an anaesthetic please ensure that the doctor or nurse knows you are taking furosemide

•    Medicines for diabetes. These may not work as well when you are taking Furosemide Tablets.

•    Theophylline - used for wheezing or difficulty in breathing.

•    Phenytoin - used for epilepsy. This can lower the effect of Furosemide Tablets.

•    Risperidone - an antipsychotic drug.

The following medicines can Increase the chance of side effects when taken with Furosemide Tablets:

•    Lithium - used for mental illnesses. To help stop side effects your doctor may need to change the dose of your lithium and check the amount of lithium in your blood.

•    Platinum compounds/Cisplatin - used for some cancers.

•    Digoxin - used for heart problems. Your doctor may need to change the dose of your medicine.

•    Non-steroidal anti-inflammatory drugs (NSAIDS) - used for pain and inflammation such as aspirin, ibuprofen, ketoprofen or indometacin.

•    Carbamazepine - used for epilepsy.

•    Aminoglutethimide - used for breast cancer.

•    Ciclosporin - used to stop the rejection of organs after a transplant.

•    Methotrexate - used for cancers of the skin, joint or bowel diseases.

•    Carbenoxolone and sucralfate - used for ulcers of the foodpipe (gullet).

•    Reboxetine - used for depression.

•    Amphotericin - used for fungal infections if used for a long time

•    Corticosteroids - used for inflammation such as prednisolone

•    Liquorice - often used in cough medicines if taken in large amounts

•    Probenecid (used with another HIV medicine)

•    Medicines for infection such as gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin or high doses of cephalosporins

•    Medicines used as injections before X-ray examinations (radiocontrast agent)

•    Medicines used for constipation (laxatives) if used for a long time such as bisacodyl or senna

•    Medicines for asthma when given in high doses such as salbutamol, terbutaline sulphate, salmeterol, formoterol or bambuterol

•    Other water tablets (diuretics) such as bendroflumethiazide. Your doctor may need to change the dose of your medicine

Pregnancy and breast feeding and fertility

•    Do not take Furosemide Tablets if you are pregnant. Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you might be pregnant. Do not breast-feed if you are taking Furosemide Tablets. This is because small amounts may pass into the mothers milk. Talk to your doctor before taking this medicine if you are breast feeding or planning to breast-feed.

•    Ask your doctor or pharmacist for further advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

•    This medicine may make you feel dizzy or unwell. Do not drive or operate machinery if this happens

Furosemide tablets contain Lactose

This medicine contains lactose. If you have been told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine.

Taking your medicine

•    Always take these tablets exactly as advised by your doctor. You should check with your doctor or pharmacist if you are not sure.

•    The number of tablets you need will depend on your condition. The tablets should be swallowed whole with a glass of water |

•    You should take the tablets at approximately the same time each day before a meal or 8 as directed by your doctor R

^Hack ■ Textused

SAME SIZE ARTWORK 120 mmx 400 mm