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PATIENT INFORMATION LEAFLET

FUROSEMIDE 20MG TABLETS FUROSEMIDE 40MG TABLETS

What you need to know about Furosemide:

Your doctor has decided that you need this medicine to help treat your condition.

Please read this leaflet carefully before you start to take your medicine. It contains important information.

Keep the leaflet in a safe place because you may want to read it again.

If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.

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 pharmacist.

In this leaflet:

1.    What is Furosemide and what is it used for?

2.    Before you take Furosemide

3.    How to take Furosemide Tablets

4.    Possible side effects

5.    How to store Furosemide Tablets

6.    Further information

0 WHAT IS FUROSEMIDE AND WHAT IS IT USED FOR:

•    Furosemide is a member of a group of medicines called diuretics (also called water tablets).

•    It works by interfering with the filtration process of the kidneys to reduce the amount of sodium and water taken back into the bloodstream, thus increasing the volume of urine produced.

•    Furosemide is used to treat oedema (fluid retention) caused by heart failure, and certain liver and kidney disorders.

•    It is also used to manage a condition called oliguria, where the body produces an abnormally small amount of urine, due to kidney disease.

21 BEFORE YOU TAKE FUROSEMIDE:

If the answer to any of the following questions is YES,

DO NOT take this medicine without consulting your doctor.

•    Have you previously had an allergic reaction to Furosemide other diuretics or sulphonamides (e.g. sulphamethoxazole trimethoprim, sulfadiazine, etc.)

•    Are you allergic to any of the other ingredients? (See section 6).

•    Are you pregnant, planning to become pregnant or breastfeeding?

•    Do you have liver (cirrhosis), kidney or prostate trouble or difficulty passing urine?

•    You have very low levels of potassium, sodium or other electrolytes in your blood (your doctor will be able to advice you).

•    Do you have the rare condition called porphyria which can affect the skin and nervous system?

•    Do you suffer from gout, diabetes or adrenal disease?

•    Have you been told that you have electrolyte deficiency (low salt levels in the blood)?

•    You are suffering from digitalis toxicity (harmful effects of the drug digoxin).

•    You have difficulty in passing water, for example because of an enlarged prostate gland (males only).

•    You have been told that you have a low volume of fluid in the body or a low blood pressure.

•    Do you have gout (causes excess uric acid in the blood and painful inflammation of the joints, mainly in the feet and hands and especially in the big toe).

If you are elderly you may be more sensitive to the effects of Furosemide tablets.

As this medicine may reduce mental alertness and cause dizziness, you should not drive or operate machinery until you know how the drug affects you.

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

Pregnancy and breast-feeding:

Tell your doctor before you are given this medicine if you are or think you may be pregnant or are planning to become pregnant, or are breast feeding. As with all drugs furosemide should only be given in pregnancy and when breast feeding if the doctor thinks that it is absolutely necessary.

Driving and using machines:

Furosemide may cause some patients to be less alert which could interfere with the ability to drive or to operate machines. If you notice that you are not as alert as usual, do not drive or operate machinery and ask your doctor for advice.

Important information about some of the ingredients of furosemide Tablets 40mg.

This medicine contains lactose, if you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

Taking other medicines?

You should consult your doctor before taking any other medicines, particularly any of the following:

A large number of drugs can interact with furosemide which can significantly alter their effects. These drugs include:

•    Medicines used to treat high blood pressure (e.g. methyldopa).

•    Antibiotics (for infection) such as cephaloridine, cephalothin, gentamycin and neomycin.

•    Digoxin used to increase the force of the heart muscle, and medicines to correct abnormal heart beats, eg amiodarone.

•    Tablets for high blood pressure (including medicines called ACE inhibitors such as captopril).

•    Non-steroidal anti-inflammatory drugs (to relieve the pain or inflammation in the joints or to lower a high temperature) such as piroxicam and ibuprofen.

•    Corticosteroids (such as prednisolone) for allergic or inflammatory conditions such as asthma or arthritis.

•    Medicines for diabetes, eg insulin.

•    Theophylline used to treat asthma.

•    Antihistamines, eg cetrizine.

•    Curare-type muscle relaxing drugs such as tubocurarine.

•    Lithium, a treatment for depression.

•    Medicines used to treat a heart condition (e.g. digoxin, lignocaine, mexiletine and tocainide).

•    Medicines used for diabetes.

•    Salicylates (e.g. aspirin).

•    Muscle relaxants and antihistamines (e.g. Cetrizine).

If you are already taking or receiving one of these medicines, speak to you doctor before you start furosemide tablets 40mg.

31 HOW TO TAKE FUROSEMIDE:

You should take your medicine as directed by your doctor. The pharmacist’s label should tell you how much to take and how often. If it does not or you are not sure ask your doctor or pharmacist.

Adult:

•    The initial dose is 40mg a day, reduced to 20mg daily or 40mg on alternate days, depending on how you respond.

•    If you suffer from chronic kidney trouble, your doctor may prescribe a starting dose of 250 mg of Furosemide per day. If necessary your doctor may increase this to 250mg every 4 to 6 hours up to a maximum of 1500mg per day.

Children:

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

•    Swallow the tablets with a drink of water.

Elderly:

Furosemide is generally cleared from the body more slowly in the elderly. If you are elderly, your doctor may decide to start with a low dose and increase the dose gradually according to your response.

What if you forget to take a dose?

If you forget to take a dose, take it as soon as you remember, but do not take two doses together. Then go on as before.

What if you have taken too many tablets? (Over dose)

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

4JPOSSIBLE SIDE EFFECTS:

Like all medicines, furosemide tablets can sometimes cause side-effects, although not everyone gets them.

All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips should be reported to your doctor immediately.

If you experience any of the following tell your doctor immediately.

•    Skin rashes or itching.

•    Sore throat or repeated infections

Furosemide may cause other unwanted effects including:

•    Hearing difficulty or ringing in the ears.

•    Nausea (feeling sick), feeling discomfort.

•    Dizziness.

•    Stomach upset, diarrhoea.

•    Blurred vision.

•    Headache, weakness, faintness or muscle cramp from changes of chemicals in the blood.

•    Abdominal pain.

•    Over-sensitivity to light.

•    Muscle cramps.

•    Pins and needles.

•    Gout (causing a swollen painful joint or joints).

•    Sudden, constant pain in the upper part of your tummy (this may suggest inflammation of a gland called the pancreas).

•    A reduction of the blood cells in the bone marrow causing tiredness, unexplained bruising and paleness.

•    Abnormal liver function which may cause jaundice (yellowing of the skin or whites of the eyes).

•    Diabetes.

•    Allergic reactions causing skin rash, excessive skin sensitivity to sunlight, fever, or kidney inflammation

•    Low blood pressure.

•    Inflammation of blood vessels.

During the treatment with furosemide, the blood levels of some fats (cholesterol and triglyceride) may rise, but these usually return to normal within six months. Deposits calcium salts in the kidneys have been reported in premature babies following treatment with furosemide.

Furosemide 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.

If you experience any of the above or are concerned about anything or you notice anything unusual contact your doctor.

5.    HOW TO STORE FUROSEMIDE:

This medicine should not be used after the expiry date printed on the pack.

•    Do not store above 25°c.

•    Keep the container tightly closed (for plastic bottles).

•    Store in the original container (for plastic bottles).

•    Keep blister in the outer carton (for blister packs).

Keep all medicines out of the reach and sight of children. Remember: This medicine has been prescribed for you. Do not give it to anybody even if their symptoms appear to be the same as yours, since it may be harmful to them. Please take the unused and leftover tablets to the pharmacist for safe disposal. Medicines should not be disposed of via wastewater or household waste.

6.    FURTHER INFORMATION:

What furosemide tablets contain:

   The active substance (the ingredient that makes the tablet work) each tablet contains 20mg or 40mg of Furosemide.

The other ingredients are

   Furosemide tablets 20 mg;

Lactose monohydrate, magnesium stearate, sodium starch glycollate and maize starch.

   Furosemide tablets 40 mg:

Lactose, talc, magnesium stearate, maize starch and colloidal silica.

What Furosemide tablets look like and contents of the pack:

   Furosemide 20mg tablets:

White, circular tablets embossed ‘PV’ on one face and F/20 on the other.

   Furosemide 40mg tablets:

White, circular tablets embossed ‘PV’ on one face and F/40 on the other

   Pack sizes: Furosemide 20mg & 40mg tablets are available in the pack sizes of 28, 56, 100, 250, 500 &1000 into plastic containers and 28 & 56 in blister packs.

The Marketing Authorization holder and company responsible for manufacture:

Pharmvit Ltd, 177 Bilton Road, Perivale, Greenford, Middlesex, UB6 7HQ.

“Is this leaflet hard to see or read,

Phone 0208 997 5444 for help”

Date leaflet last revised: December 2010.

PL 04556 / 0042 & 0003 Reference: 0042/031210