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Furosemide 20mg Tablets

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Document: leaflet MAH GENERIC_PL 39484-0021 change

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PACKAGE LEAFLET: INFORMATION FOR THE USER

FUROSEMIDE 20mg & 40mg TABLETS

Furosemide


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

•    lf any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.


In this Ieaflet:

1.    What Furosemide Tablets are and what they are used for

2.    Before you take Furosemide Tablets

3.    How to take Furosemide Tablets

4.    Possible side effects

5.    How to store Furosemide Tablets

6.    Further information


1. WHAT FUROSEMIDE TABLETS ARE AND WHAT THEY ARE USED FOR


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The name of your medicine is Furosemide 20mg Tablets or Furosemide 40mg Tablets. They contain the active ingredient called Furosemide.

Furosemide belongs to a group of medicines called diuretics (also called water tablets). lt works by interfering with the filtration process of the kidneys to reduce the amount of sodium and water taken back into the blood stream, thus increasing the volume of urine produced. The tablets are used to treat oedema (fluid retention) caused by heart failure, and certain liver and kidney disorders. lt is also used to manage a condition called oliguria, where the body produces an abnormally small amount of urine, due to kidney disease.


2. BEFORE YOU TAKE FUROSEMIDE TABLETS


Do not take Furosemide Tablets if you:

•    are alergic to Furosemide or any of the other ingredients of Furosemide Tablets

•    are a patient with hypovolaemia (state of decreased blood volume; more specifically decrease in volume of blood plasma) or are suffering from dehydration

•    are unable to pass urine (water)

•    have kidney failure caused by certain drugs or liver disease

•    have been told you have severe liver problems with cirrhosis of the liver

•    have, or have previously had, low blood potassium or sodium

•    have porphyria (blood disorder)

•    have digitalis intoxication

•    are allergic to Sulphonamides

Take special care with Furosemide Tablets:

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

•    are elderly

•    have prostate problems or difficulty in passing water (urine)

•    are suffering from diabetes

•    have liver or kidney problems

•    are a patient with a history of gout

•    have low blood pressure

Taking other medicines

You should tell your doctor if you are taking or have taken any of the


following medicines as they may interact with your Furosemide Tablets:

•    Medicines used to treat high blood pressure such as ACE inhibitors like captopril, alpha-blockers (e.g. Prazosin), beta-blockers and calcium channel blockers

•    Antibiotics including cephalosporins & aminoglycosides

•    Non-steroidal anti-inflammatory drugs used for pain and inflammation such as lndomethacin, Acetylsalicylic acid

•    Medicines used to treat epilepsy like carbamazipine

•    Medicines used to treat depression Iike MAOls

•    Laxative drugs used in constipation

•    Medicines used to relieve anxiety and reduce tension and irritability

•    Medicines like vasodilators used for high blood pressure or heart problems

•    Medicines used as a general anaesthetic for relaxing your muscles during surgery

•    Medicines like corticosteroids used for inflammation

•    Lithium and Reboxetine, used for treating mental illnesses

•    Medicines used to treat heart condition like cardiac glycosides (e.g. digitalis preparations)

•    Medicines used for diabetes

•    Theophylline, which is used to help your breathing

•    Curare type muscle relaxants and antihistamines

•    Probenecid, a medicine used for the prevention of gout

•    Cisplatin or aminoglutethimidine used in cancer therapy

•    Phenytoin used for epilepsy

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

•    B2 sympathomimetics (e.g. asthma treatment)

•    Carbenoxolone, used in ulcer healing

•    Amphotericin, used to treat fungal infections

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

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

Furosemide passes into breast milk and may inhibit lactation. Women must not breast-feed if they are treated with Furosemide.

Tell your doctor if you are pregnant before taking this medicine.

Driving and using machines

Do not drive or operate machines as this medicine may reduce mental alertness and cause dizziness.


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3. HOW TO TAKE FUROSEMIDE TABLETS


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4. POSSIBLE SIDE EFFECTS


Important information about some of the ingredients of Furosemide Tablets

These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take Furosemide Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Method of Administration

The tablet should be swallowed with a glass of water.

The usual dose is:

Adults: The usual dose is 20-40mg daily

lf you suffer from chronic kidney problem, your doctor may prescribe a starting dose of 250 mg Furosemide per day. If necessary, your doctor may increase this to 250 mg every 4 to 6 hours upto a maximum of 1500 mg per day. In exceptional cases up to 2000mg per day may be given.

Eld e rly : The usual adult dose, but caution is advised as Furosemide is excreted more slowly in the elderly.

C h i l dren : lf Furosemide tablets are prescribed for a child make sure that the tablets are taken as instructed by the doctor. The dosage is worked out depending on the child's weight.

A dose of 1 -3 mg for each kilogram of the child's body weight should be given daily. Do not exceed 40mg per day.

If you take more Furosemide Tablets than you should

If you or anyone else has swallowed a lot of the tablets all together, contact your nearest hospital casualty department or doctor immediately.

If you forget to take Furosemide Tablets

lf you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten tablet.

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

Tell a doctor straight away if you notice any of the following serious side effects you may need urgent medical treatment

•    If you have an allergic reaction. The signs may include inflammation of the kidney (nephritis), swollen ankles or high blood pressure, skin rashes, change in skin colour, severe blistering of the skin, being more sensitive to the sun than usual, high temperature (fever), and itching

•    Severe allergic reactions. The signs may include shock such as difficulty in breathing, cold clammy skin, pale skin colour and racing heart beat

•    Low body level of salts such as sodium or potassium or dehydration. Symptoms of this include: Headache, drowsiness & dizziness, dry mouth & thirst, Increased sweating, Passing lots of water, weakness & tiredness, confusion, skin problems including itching or peeling, sensitivity to light, muscle weakness & muscle cramps and Irregular heart beat.

•    Inflammation of pancreas, with severe pain in the abdomen & back

•    Stomach upset or diarrhoea

Tell a doctor as soon as possibile if you have any of the following side effects:

•    Hearing difficulties or ringing in the ears

•    Low blood pressure - Headaches, feeling dizzy or light-headed when standing up quickly. Also loss of concentration, slower reactions, feeling sleepy or weak, problems with your sight or dry mouth.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet

•    Blurred vision

•    Feeling sick

•    Sore throat or repeated infections

•    Gout

•    Feeling of general discomfort or uneasiness

•    Diabetes

•    Increase in blood creatinine and urea levels will be detected by blood test

•    Production of blood cells is affected (This can mean decrease in white blood cells to fight infection; decrease of platelets to clot the blood or decrease in red cells to carry oxygen)

•    Effects on the bone marrow (causing anaemia, increased bruising, nose bleeds or infections)

•    Very low protein level in blood

•    Low calcium level in the serum

•    Change in the levels of liver enzymes or body fats known as cholesterol and triglycerides shown up on blood tests

•    Abnormally high alkalinity in the blood and body fluids

•    Kidney or liver disorders

•    Unwanted and involuntary muscle contractions

•    ln premature infants, if administered during the first weeks of life, it may cause heart problems

•    Glucose tolerance may decrease Blood Tests:

•    May occasionally alter the composition of your blood and your doctor may want to do some blood tests from time to time. If you are to undergo a blood test remember to tell the doctor of your treatment with Furosemide

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.    HOW TO STORE FUROSEMIDE TABLETS

Keep out of the sight and reach of children.

Do not use Furosemide Tablets after the expiry date which is stated on the label after Exp. The expiry date refers to the last date of that month. Do not store above 25oC. Keep the container tightly closed. Store in the original package/container.

6.    FURTHER INFORMATION

What Furosemide Tablets contain

Each tablet contains the active ingredient furosemide. This is the new name for frusemide. The ingredient itself has not changed.

The tablet also contains the inactive ingredients lactose, magnesium stearate, sodium starch glycollate and maize starch.

What Furosemide Tablets look like and contents of pack

Furosemide 20 mg tablets BP: White, circular, flat bevelled edge round tablets marked with FL on one side. Each tablet contains 20mg of Furosemide.

Furosemide 40 mg tablets BP: White, circular, flat bevelled edge round

tablets marked with FL on one side. Each tablet contains 40mg of _

Furosemide.

Pack sizes: 20mg - 28, 56, 100, 250, 500 and 1000 tablets.

40mg - 28, 56,100, 250, 500, 504, 1000 and 1008 tablets.

Also available in blister packs of 28, 56 & 1008 tablets.

Not all pack sizes may be marketed.

Maketing Authorisation Holder

Fourrts (UK) Pharmacare Ltd

First Floor, 2 Victoria Road, Harpenden, Hertfordshire,

AL5 4EA, United Kingdom.

Manufacturer:

Rx Farma Limited, Unit 3 colonial Way, Watford, Hertfordshire, WD24 4YR, UK.

This leaflet was last revised in: December 2014 PL 39484/0021 PL 39484/0022

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Name of the artwoik Printed leaflet 245 x 180mm Furosemide 20mg and 40mg tablets