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Furosemide Tablets 40mg

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Document: leaflet MAH GENERIC_PL 04569-0114 change

FUROSEMIDE TABLETS


KEEP ALL MEDICINES OUT OF REACH AND SIGHT OF CHILDREN. BEFORE YOU TAKE YOUR MEDICINE PLEASE READ THIS LEAFLET CAREFULLY.

This leaflet contains a summary of the information about your medicine, Furosemide Tablets.

YOUR MEDICINE


Your medicine is in the form of a tablet. There are two different strengths of tablet available. Each tablet contains either 20 mg or 40 mg of the active ingredient Furosemide. Each tablet also contains lactose, microcrystalline cellulose, sodium starch glycollate, magnesium stearate, maize starch, silicon dioxide and talc.

The active ingredient in this medicine is Furosemide. This is the new name for Frusemide. The Ingredient itself has not changed._


Furosemide Tablets 20 mg and 40 mg are white; the 20 mg tablets are marked ‘FE20’ on one side and “G” on the other whilst the 40 mg tablets are marked ‘FE 40’ on one side and “G” on the other. Furosemide Tablets are available in containers of 1000 tablets. Your pharmacist will dispense the number of tablets prescribed by your doctor.

HOW DOES YOUR MEDICIINE WORK?


Your medicine contains Furosemide which belongs to a group of drugs called DIURETICS (or water tablets). Diuretics work by reducing the amount of water in the body by acting on the kidneys to increase the flow of urine.

Product Licence Holder and Manufacturer: Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL.

WHY DO YOU NEED TO TAKE YOUR MEDICINE?


Furosemide Tablets can be used to treat high blood pressure or the build up of fluid in the body caused by heart failure, liver or kidney disease.

Furosemide Tablets can also treat a build up of fluid, usually in the arms and legs caused by pressure or blockage of a blood vessel (vein).

WHAT SHOULD YOU DO BEFORE TAKING YOUR MEDICINE?


Do not take this medicine and tell your doctor if:

•    You are pregnant or intend to become pregnant

•    You are breast-feeding

•    You are unable to pass urine

•    You have taken Furosemide, a sulphonamide, or a similar medicine before and suffered an unpleasant or allergic reaction including asthma, skin rash or an itchy, runny nose.

•    You suffer from shakiness and confusion caused by liver disease.

•    You are being treated for Digoxin overdose

•    There is a family history of a rare condition called porphyria

•    You are on a low sodium diet or if you have low blood levels of ions such as potassium.

Tell your doctor or Pharmacist if:

   You have low blood pressure or blood volume

•    You have liver or kidney problems

• You have prostate problems

• You have diabetes mellitus

•    You have a disease of the adrenal glands

•    You have difficulty passing urine

•    You suffer from gout

•    You are elderly

•    You are taking other medicines which can cause a drop in blood pressure

•    You have other medical conditions that are risks for a drop in blood pressure

•    You are already taking any of the following other medicines:

* medicine to treat a heart condition or high blood pressure eg. Digoxin, Methyldopa, an ACE inhibitor (such as Captopril), Mexilitine, Tocainide, Lidocaine *medicines used to raise blood pressure eg. Ephedrine, Methoxamine * antibiotics such as Cefaloridine, Gentamicin * Non steroidal anti-inflammatory drugs e.g. Indometacin, Aspirin

corticosteroids eg. Prednisolone * laxatives * Lithium, to treat mental illness * antidiabetic medicine including insulin * Theophylline * antihistamines, to help relieve allergies.

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.

WHILST TAKING YOUR TABLET


Do not drive or operate machines if Furosemide Tablets make you feel dizzy or your vision becomes blurred. If you need to have an operation when muscle relaxants may be given with the anaesthetic, tell the doctor that you are taking Furosemide Tablets. Your doctor will give you regular blood tests and monitor your condition.

HOW SHOULD YOU TAKE YOUR TABLETS?


ADULTS

The usual starting dose is 40mg of Furosemide a day. This dose may be reduced to 20 mg Furosemide a day or 40 mg Furosemide every other day. Some patients may need a dose of 80 mg (taken in divided doses) or more of Furosemide a day. Elderly patients may need lower doses than those stated above.

CHILDREN

The dose of Furosemide for a child depends upon the weight of the child. The usual dose is 1-3 mg/kg body weight a day. The maximum dose is 40 mg Furosemide a day/

If you forget to take your dose of Furosemide Tablets, unless it is almost time for your next dose, take it as soon as you remember. Otherwise, if you miss a dose do not double the next dose, just carry on as before.

If you take too much of your medicine contact your doctor immediately.

CAN YOUR MEDICINE HAVE ANY SIDE EFFECTS?


Furosemide tablets may cause the body to pass too much water and change the sodium or potassium levels. This may lead to the following side effects:

•    Dehydration

•    Feeling sick

•    Diarrhoea

•    Blurred vision

•    Dizziness

•    Headache

Other side effects which rarely occur include sensitivity of the skin to sunlight, red swollen skin, skin rash, yellowing of the skin or whites of the eyes, abdominal pain with sickness, kidney problems in premature babies, difficulty in passing urine (a temporary rise in creatinine levels in the blood may occur), loss of calcium from the body, dizziness on standing up, muscle spasm, tingling or numbness in the arms or legs, gout, sore throat, fever, feeling unusually tired, ringing in the ears and deafness (sometimes irreversible (uncommon)) a temporary rise in cholesterol and fats in the blood. If a skin rash starts, stop taking Furosemide tablets and speak to your doctor. Patients prone to diabetes may notice the symptoms of diabetes eg. Thirst loss of weight, passing more urine than usual and diabetics on Insulin may find they need to increase their daily dose. Patients suffering from metabolic alkalosis may notice a worsening of their symptoms such as painful cramps in their hands and feet, facial twitches, spasm of the larynx, convulsions. Very rarely, when you take this medicine, your bone marrow may produce fewer cells than normal. As a result you may feel tired and become more susceptible to infections (e.g. colds, throat infections) or bruising. If you experience these side-effects, stop taking this medicine and consult your doctor. Furosemide tablets may occasionally cause changes in the blood and your doctor may want to perform blood tests. If any doctor performs a blood test remember to tell them you are taking this medicine.

Not known (frequency cannot be estimated from the available data):

•    acute generalised exanthematous pustulosis (AGEP) (acute febrile drug eruption)

•    dizziness, fainting and loss of consciousness (caused by symptomatic hypotension)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE SHOWN ON THE LABEL.

REMEMBER this medicine was prescribed by your doctor for you. DO NOT give it to others. It may harm them.

Protect from light. Store in a dry place below 25°C.

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