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Furosemide 40 Mg Tablets

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Document: leaflet MAH GENERIC_PL 06464-0207 change

UK 797-9131

Patient Information Leaflet


^SOVEREIGN

■Mb medical

Furosemide 20 mg and 40 mg Tablets


Read all of this leaflet carefully before you start taking this medicine.

•    Please keep this leaflet. You may need to read it again.

•    If you have any further questions, please 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 becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Furosemide 20 mg and 40 mg Tablets are and what they are used for

2.    Before you take Furosemide 20 mg and 40 mg Tablets

3.    How to take Furosemide 20 mg and 40 mg Tablets

4.    Possible side effects

5.    How to store Furosemide 20 mg and 40 mg Tablets

6.    Further information

1.    WHAT FUROSEMIDE 20 MG AND 40 MG TABLETS ARE AND WHAT THEY ARE USED FOR

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

This means that the name of this medicine has become Furosemide 20 mg or 40 mg Tablets (instead of Frusemide 20 mg or 40 mg Tablets). Furosemide is one of a group of drugs known as loop diuretics. Diuretics increase the amount of urine you produce by making your kidneys allow more water and salts to be removed from your body. Furosemide Tablets are used to treat oedema which is a build up of fluid in the body tissues. The oedema can be caused by heart or kidney failure, liver damage or an obstruction. In some cases the fluid may build up in your legs and hands, and in other cases in air spaces of your lungs (pulmonary oedema). Furosemide Tablets help your kidney to remove some of the excess fluid from your body.

Furosemide Tablets can also be used to treat mild to moderate high blood pressure, either on its own or in combination with other drugs.

2.    BEFORE YOU TAKE FUROSEMIDE 20 MG AND 40 MG TABLETS Do not take this medicine if:

•    you have ever had an allergic reaction (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throatwith difficulty in swallowing or breathing) to Furosemide 20 mg and 40 mg Tablets; any of the other ingredients (please refer to section 6, further information for the full list of ingredients) of this medicine or any of the other medicines that you may have taken to treat fluid build-up and swelling;

•    you have been told you have an electrolyte deficiency or low levels of salts in your body;

•    you produce reduced quantities of urine due to kidney problems;

•    you have hepatic cirrhosis (a severe form of liver disease).


Take special care with this medicine and tell your doctor or pharmacist if:

•    you have liver, kidney or adrenal gland problems;

•    you have trouble passing water (e.g. due to prostate problems);

•    you have low blood pressure or a blood disorder called hypovolaemia;

•    you have diabetes;

•    you already had a condition called "metabolic alkalosis"

(a disturbance of the acid balance of the body) before your doctor prescribed Furosemide Tablets for you, for it may get worse, leading to feelings of muscular weakness or cramp.

Taking other medicines

Tell your doctor if you are taking any other medicines, especially the following:

•    medicines to lower your blood pressure, such as ACE inhibitors (e.g. captopril), methyldopa or heart drugs such as digoxin

•    lithium (for mental illness), cephalosporin antibiotics (for infection), aminoglycoside antibiotics (e.g. gentamicin), non-steroidal anti-inflammatory agents such as indometacin or aspirin (for pain and swelling), steroids (e.g. prednisolone), antidiabetics, theophylline or other medicines for treatment of asthma, or muscle relaxants

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

Other special warnings

If you see another doctor or visit a hospital, remember to tell them what medicines you are already taking.

If you are going to have an operation please tell the anaesthetist that you are taking Furosemide Tablets as this may affect some of the drugs he/she may use.

Pregnancy and breast-feeding

Tell your doctor if you become pregnant or if you are breast-feeding. Driving and using machines

This medicine can make you feel dizzy or cause blurred vision in rare cases. Do not drive or operate machinery if you are affected.

Important information about some of the ingredients of Furosemide Tablets

Tell your doctor before taking this medicine if you have been told that you have an intolerance to some sugars. This is because Furosemide 20 mg and 40 mg Tablets contain a small amount of lactose, a type of sugar.

3. HOW TO TAKE FUROSEMIDE 20 MG AND 40 MG TABLETS

Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. He or she will tell you how many to take and how often to take them.


The usual closes of Furosemide 20 mg and 40 mg tablets are:

Adults: Usually, the initial adult dose is 40 mg (one 40 mg tablet or two 20 mg tablets) a day. Your doctor may tell you to reduce your dose to 20 mg a day or to take 40 mg on alternate days only. Some patients may require a higher dose and may be told to take up to 80 mg (two 40 mg tablets or four 20 mg tablets) or more a day, given as two or more doses during the day.

Elderly: If you are elderly, your tablets may work for longer, so your doctor may tell you to take a lower dose.

Children: If the tablets are for a child, your doctor will work out the dose depending on the child's weight. The usual daily dose for children is between 1 and 3 milligrams for each kilogram of body weight, up to a maximum total dose of 40 mg per day (i.e. two 20 mg tablets or one 40 mg tablet).

If you have kidney problems

Ask your doctor on how to proceed, and follow his/her instructions.

If you are not sure about how much medicine to take, please speak to your doctor or pharmacist.

If you take more tablets than you should

If you accidentally take too much of your medicine, tell your doctor at once or contact your nearest hospital casualty department.

Take your medicine and this leaflet with you.

If you forget to take your medicine

If you forget to take a dose, just take the next dose at the usual time. DO NOT take a double dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines Furosemide Tablets can cause unwanted side effects in some people, although it is generally well tolerated. You are unlikely to get any of the following, but if you do, tell your doctor immediately:

•    Feeling sick, stomach upset and tiredness.

•    Headaches, muscle cramps and low blood pressure which may cause sweating, light-headedness and fainting.

•    Problems with your hearing (but this is rare and hearing usually recovers after treatment is stopped).

•    Allergic reactions, such as redness, swelling and tenderness, tracking along blood vessels, skin rashes, sensitivity to light, fever or inflamed kidneys. If so, tell your doctor straight away, because he/she will need to change your treatment.

•    Allergic reactions like itching, pale or reddened skin, hives (rash) and skin haemorrhage (bruising).

•    Shock and severe pain in the upper abdomen and back. If you have received long-term treatment and you experience this, it may indicate inflammation of the pancreas and you should tell your doctor immediately.

•    Mouth ulcers, sore throat or repeated infections.

•    An increase in a type of white blood cell (eosinophilia) which may cause fever, skin rashes, breathlessness, stomach pains or frequent infections.

If you notice any side effects mentioned above, please tell your doctor or pharmacist.



Other side effects may include:

•    A temporary rise in creatinine and urea (substances that are excreted in the urine).

•    Acute renal failure has been reported.

•    Blood levels of cholesterol or triglycerides may increase when you first start treatment, but usually return to normal within six months.

•    Reduced blood levels of calcium in your blood, which in rare cases could lead to spasm and twitching of muscles (e.g. in the face, hands and feet).

•    In premature infants and very rarely in adults who have been on long term therapy, the presence of calcium deposits in the kidneys.

•    Raised levels of uric acid in the blood, which in rare cases may lead to gout (the sudden onset of pain and swelling in the joints, most commonly the big toe).

•    A decrease in the levels of calcium in the bones can occur after long term treatment, leading to a soften in g/wea kness of the bones.

•    Changes in the levels of salts and water in the blood may be experienced; symptoms of this may include increased thirst, headache, confusion, muscle weakness and reduced amounts of urine.

•    An increased production of urine may also occur; this can aggravate existing kidney and bladder conditions.

•    Changes in liver function including problems with the flow of bile. In some cases liver failure may also occur, in patients with existing liver problems.

•    Changes in blood sugar control mayoccur, particulary if you are diabetic.

•    Pins and needles may also occur.

These effects are often mild and may wear off after a few days treatment. If they are severe or last for more than a few days, tell your doctor. Older people may be at more risk of these effects, particularly at the start of treatment.

If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your docter or pharmacist immediately

5.    HOW TO STORE FUROSEMIDE 20 MG AND 40 MG TABLETS

Do not store above 25°C. Keep the container tightly closed and store in the original container. Do not use after the expiry date that is stated on the carton.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

Return any unused medicine to your pharmacist.

6.    FURTHER INFORMATION

What Furosemide 20 mg and 40 mg contain:

Each tablet contains 20 mg or 40 mg of Furosemide

The inactive ingredients are: lactose, maize starch, magnesium stearate,

povidone and sodium starch glycollate.

What Furosemide 20 mg and 40 mg Tablets look like and the contents of the pack.

Furosemide Tablets 20 mg and 40 mg are available in packs of 28 in blisters and in bulk packs of 250 (20 mg) or 1000 (40 mg).

Furosemide 20 mg Tablets are white, circular, flat tablets with a breakline and F/20 embossed on one face.

Furosemide 40 mg Tablets are white, circular, flat tablets with a breakline and F/40 embossed on one face.

Marketing Authorisation Holder and Manufacturer:

Waymade Pic trading as Sovereign Medical, Sovereign House,

Miles Gray Road, Basildon, Essex, SS14 3FR.

This leaflet does not contain all the available information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Date of preparation of the leaflet: December 2007