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Furosemide 20mg Tablets

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Relon 35


Furosemide 20mg Tablets Furosemide 40mg Tablets

Furosemide (the new name for Frusemide)

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 foryou.

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 get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

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

Furosemide is a member of a group of medicines called diuretics (also called water tablets). It works by alteringthe function ofthe kidneys. They help remove excess water from the body by increasing the amount lost as urine.

Furosemide is used to treat oedema (fluid retention) caused by heartfailure, 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.

2. Before you take Furosemide Tablets

Do not take Furosemide Tablets:

•    Ifyou are allergic (hypersensitive) to furosemide, sulphonomides or any other ingredients in these tablets.

•    Ifyou are unable to pass urine

•    Ifyou have a rare condition called porphyria.

•    If you have been told that you have an electrolyte deficiency (low salt levels in the blood or low potassium levels in the blood).

•    Ifyou have suffered from precoma associated with liver disease.

Take special care with Furosemide Tablets:

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

•    If you suffer from chronic kidney trouble then your doctor may increase your dose.

•    Ifyou have liver problems.

•    Ifyouhavediabetesmellitus.

•    If you have problems with your adrenal glands.

•    Ifyou have an enlarged prostate or have difficulty passing urine.

•    If you are taking ACE inhibitors (e.g. captopril or enalapril) used for high blood pressure and heart failure.

•    If you have a history of gout.

•    ifyou are pregnant or breastfeeding. Refer to Pregnancy and Breastfeeding section below.

Taking other medicines:

Please tell your doctor if you are taking any of the

following medicines:

•    Medicines for high blood pressure e.g. methyldopa, atenolol, nifedipine.

•    Antibiotics e.g. cephaloridine.

•    Antifungals e.g itraconazole.

•    Antivirals e.g ritonavir.

•    Non-steroidal anti-inflammatory drugs e.g. ibuprofen.

•    Analgesics e.g. indometacin used with high dose aspirin, aspirin

•    Lithium used to treat depression.

•    Medicines for heart conditions e.g. digoxin, lidocaine, mexiletine and tocainide.

•    Medicines used in diabetes e.g. insulin.

•    Theophylline used to help breathing difficulties.

•    Muscle relaxants e.g. vecuronium and laxatives

•    Antihistamines

•    Glucocorticoids e.g. hydrocortisone or prednisolone.

•    Antiepileptics e.g phenytoin

•    Antipsychotics e.g pimozide

•    Stjohnswort.

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

Pregnancy and Breastfeeding:

Tell your doctor ifyou are, thinkyou might be pregnant or planning to become pregnant or if you are breast-feeding. Furosemide can be used for short-term treatment on advice of your doctor. This medicine should not be used for high blood pressure in pregnancy. Furosemide can interfere with breast milk production. Askyour doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

This medicine may reduce mental alertness and cause dizziness. Make sure you are not affected before you drive or operate machinery.

Important information about some of the ingredients of Furosemide Tablets:

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

3. How to take Furosemide Tablets

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

Adults

The usual dose is 20-40mg daily, to be taken orally with water.

If you suffer from chronic kidney trouble, your doctor may prescribe you a starting dose of 250mg furosemide per day. If necessary, you doctor may increase this to 250mg every 4to6 hours up to a maximum of I500mg a day.

Children under 12 years old

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. The doctor will work out a dose based on l-3mg for each kilogram of the child's body weight. The dose should not exceed 40mg per day.

If you take more Furosemide Tablets than you should:

If you take too many of these tablets, or someone else accidently swallows these tablets, contact your doctor, pharmacist or nearest hospital immediately.

If you forget to take Furosemide Tablets:

If you forget to take a dose then take it as soon as you remember. But never take two doses together. Then continue to take your next dose at the usual time and carry on as before.

If you stop taking Furosemide Tablets:

Do not stop taking Furosemide Tablets without first discussing it with your doctor.

If you have any further questions on the use of Furosemide Tablets ask your doctor or pharmacist.

4. Possible side effects:

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

If any of the below mentioned side effects are observed please inform your doctor immediately. Sudden signs of allergy such as rash, itching or hives on the skin, swelling ofthe face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.

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 ofthe 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.

Rare:

A reduction ofthe blood cells in the bone marrow causing tiredness, unexplained bruising and paleness. Treatment should be withdrawn if this occurs.

Very rare:

•    Inflammation of blood vessels (Vasculitis which may cause skin rash, fever and joint or muscle pain).

•    inflammation ofthe kidneys associated with blood in the urine, fever and pain in the sides

Ifyou have a urinary tract obstruction, increased urine production may occur or worsen.

Other side effects:

•    Changes in body chemicals (including calcium, cholesterol, triglycerides, creatinine or urea).

•    Low blood pressure

•    Liver disorders

•    Gout (swellingofjoints)

•    Diabetes or worsening of existing diabetes.

•    Calcium deposits forming in the kidneys of premature infants.

•    Hearing difficulty or ringing in the ears.

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

5. How to store Furosemide Tablets:

Keep out of the reach and sight of children.

Keep in the original packaging.

Do not use after the expiry date shown on the carton. The expiry date refers to the last day of that month.

Do not store above 25° C.

Medicines should not be disposed ofvia wastewater or household waste. Askyour pharmacist how to dispose of medicines no longer required. These measures will help protectthe environment.

6. Further information

What Furosemide Tablets contain:

The active substance in this medicine is called furosemide. The 20mg tablets contain 20mg furosemide and the 40mg tablets contain 40mg furosemide.

The other ingredients are lactose monohydrate, magnesium stearate, sodium starch glycollate and maize starch.

What Furosemide Tablets look like and contents of the pack:

Furosemide 20mg and 40mg tablets are white, circular tablets with a break line on one side. Furosemide 20mg tablets come as 28 tablets in strips or tubes, or 250 tablets in tubes. Furosemide 40mg tablets come as 28 tablets in strips or tubes, or 1000 tablets in tubes.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder and manufacturer is:

RelonChem Limited

27 Old Gloucester Street

London

WCI 3XX

England

PL 20395/0030    |POM

PL 20395/0031

This leaflet was last revised in August 2012