a

nogen PharmaI

PACKAGE LEAFLET: INFORMATION FORTHE USER

Diuresal 500mg Tablets

Furosemide

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

I* Keep this leaflet. You may need to read it again.

•

doctor or pharmacist.

L This medicine has been prescribed for you. Do I not pass it on to others. It may harm them,

I even if their symptoms are the same as yours.

• 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.

iln this leaflet:

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

2.    Before you take Diuresal Tablets |3. How to take Diuresal Tablets

4. Possible side effects

|5. How to store Diuresal Tablets

6. Further information

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

biuresal Tablets are one of a group of medicines called diuretics (water tablets). They are used to treat the abnormally low production of urine caused

2. BEFORE YOU TAKE DIURESAL TABLETS

iDo not take Diuresal Tablets ifyou:

•

other sulphonamide related drugs or any of the other ingredients of Diuresal Tablets (See | section 6)

•    Have low blood pressure

|* Have severe kidney damage which has

stopped them working properly and producing | urine

•

water retention, feeling or being sick, loss of weight or appetite, yellowing skin or eyes)

•

high levels ofpotassium in the blood, slow, fast or irregular heart beats)

•    Have very low levels of potassium, sodium or other electrolytes in your blood (your doctor will

I advise you)

L Are dehydrated

•    Take potassium supplements or potassium

' sparing diuretics for high blood pressure (e.g. i amiloride)

•    Have Addison's disease (low levels of corticosteroid hormones secreted)

•    Are breast-feeding

|lf you have no problems with your kidneys (i.e normal kidney function), you should not take |Diuresal Tablets. Talk to your doctor if you are unsure.

I

Take special care with Diuresal Tablets

|Consult your doctor before taking Diuresal Tablets if you:

are at risk of developing low blood pressure doctor may need to adjust your insulin dosage.

•    Have metabolic acidosis (too much acid in the body)

•    Have prostate trouble or difficulty passing urine

•    Have low levels of protein in the blood (hypoproteinaemia) as a result of kidney damage

•    Have liver congestion (slowed blood flow through the vessels) or other liver problems

•    Have kidney problems

•    Are elderly

•    Have an abnormal blood condition

•    Are about to have blood or urine tests.

Your doctor may monitor you and may take blood for testing while you are taking this medicine.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

In particular tell your doctor if you are taking any of the following:

•    Drugs to lower blood pressure, such as ACE inhibitors, beta-blockers, calcium channel blockers, alpha-blockers

•    Drugs to treat mental illness (e.g. pimozide, amisulpride)

•    Drugs used in the treatment of heart arrhythmias (e.g. sotalol, amiodarone)

•    Nitrates for the treatment of angina

•    Colestyramine or colestipol used for the treatment of high cholesterol

•    Drugs for the treatment of ADHD (Attention Deficit Hyperactivity Disorder)

•    Drugs used to treat cancer

•    Levodopa used to treat Parkinson's disease

•    Probenacid for treatment of gout

•    Medicines orfoods containing liquorice

•    If you are about to undergo a procedure where curariform muscle relaxants (e.g. vercuronium) or anaesthetics may be used, tell your anaesthetist/dentist or healthcare professional.

•    Non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin used for the treatment of pain

•    Digoxin for the treatment of heart conditions

•    Alprostadil for the treatment impotence

•    Antidepressants including tricyclics, MAOIs or reboxetine for the treatment of depression

•    Antiepileptics (e.g. carbamazepine, phenytoin)

•    Corticosteroids or antihistamines used to treat allergic reactions

•    Laxatives used over a long period of time

•    Drugs for asthma such as bambuterol, fenoterol, formoterol, ritodrine, salbutamol, salmeterol, terbutaline, theophylline

•    Moxisylyte used to treat Raynaud's Syndrome

•    Oestrogens or progesterones for Hormone Replacement Therapy (HRT) and contraception

•    Amphotericin for the treatment of fungal infections

•    Antibiotics that affect your kidneys or ears (e.g cefaclor, colistin, gentamicin, vancomycin)

•    Lithium for the treatment of depression or mania

•    Medicines used to control diabetes such as insulin

•    Anxiolytics and hypnotics (e.g. Chloral hydrate for the treatment of insomnia).

L

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice if you are pregnant, planning on becoming pregnant or are preastfeeding before taking this medicine.

Driving and using machines

Do not drive or operate machinery if you feel less plert after taking Diuresal Tablets.

|lmportant information about some of the ingredients

|This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have pn intolerance to some sugars, talk to your doctor before taking this medicine.

3. HOW TO TAKE DIURESAL TABLETS

Always take Diuresal Tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

The usual dose:

Adults:

Initially 250mg (half a tablet) daily. If necessary larger doses increasing in steps of 250mg may be ^iven every 4-6 hours to a maximum dose of 2000mg (4 tablets).

Elderly:

The dose may be reduced in this age group.

Children:

.Not recommended.

.Ifyou take more Diuresal Tablets than you should

This medicine is to be taken at regular intervals, as determined by the doctor. If you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you.

ilfyou stop taking Diuresal Tablets

Keep taking Diuresal Tablets until your doctor tells you to stop. Do not stop taking Diuresal Tablets just because you feel better.

Ifyou forget to take Diuresal Tablets

Ilf you have forgotten to take a dose, leave out that 'dose completely. Take your next dose at the pormal time. If you have trouble remembering to take the tablets, tell your doctor or pharmacist.

•    Changes in your blood: your doctor will perform regular blood tests to ensure no changes have occurred.

The symptoms of these changes include anaemia, leading to tiredness and lethargy, unusual bleeding or bruising, blood slow to clot, ulcers in the throat, mouth or on your skin.

•    Metabolism: changes in levels of body chemicals (glucose, fats or calcium)

•    Heart: low blood pressure, inflammation of blood vessels (vasculitis, which may cause rash fever and joint or muscle pains)

•    Nervous system: headache, dizziness, confusion

•    Liver: jaundice (yellowing of the skin or whites of the eyes)

•    Muscles and joints: muscle tension or weakness, gout

•    Stomach and intestines: stomach irritation, feeling sick or thirsty

•    Pancreas: inflammation of the pancreas (pancreatitis) which may cause severe pains in your abdomen or back, nausea, vomiting and fever

•    Urinary and genital: kidney stones in premature babies

•    Senses: hearing problems or ringing in your ears (tinnitus), pins and needles or tingling, blurred or yellow vision

•    Other: generally feeling unwell, fever, risk of patent ductus arterious (heart defect) in premature infants.

If any of the side effects gets serious or you notice

any side effects not listed, please tell yourdoctor

or pharmacist.

5. STORING DIURESAL TABLETS

Check the expiry date printed on the label or side of the box. This will be the last day of the month stated. Do not use after the expiry date stated.

Do not store above 25°C. Store in the original package.

In case of any visible signs of deterioration, you should discard the package.

Medicines should not be disposed ofvia waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.

4. POSSIBLESIDEEFFECTS

Keep out of the reach and sight of children

Like all medicines, Diuresal Tablets can cause side Effects, although not everyone gets them.

|lfyou experience any ofthe following then STOP taking the medicine and contact a doctor Immediately •

symptoms such as rash, itching, swelling ofthe face, wheeziness, shortness of breath, tightness in the chest, fever, low blood pressure and feeling dizzy particularly when standing up.

•

may cause fever, rash and joint or muscle pains) or kidney inflammation, this may change the number of times you pass urine or you may see blood in your urine. You may have a fever,

I feel drowsy, or notice a swelling e.g. of the I ankles.

bell your doctor or pharmacist ifyou notice any of the following side effects:

•

I body (e.g sodium, potassium, chlorine and ' magnesium) causing a dry mouth, weakness,

I tiredness or drowsiness, restlessness, fits,

¹ muscle pain, fatigue or cramps, low blood | pressure, difficulty passing water, fast heart beat and feeling and being sick

6. FURTHER INFORMATION

What Diuresal Tablets contain:

Diuresal Tablets contain the active substance furosemide.

The other ingredients are: lactose, starch, magnesium stearate, certolake tartrazine, primojel

What Diuresal Tablets look like and contents of the pack

Diuresal 500mg Tablets are yellow, flat bevelled edges tablets with “F3” debossed on one side and breakline on reverse. Diameter 13.00mm.

These tablets are available in packs of28 or 100 tablets.

Marketing Authorisation Holderand Manufacturer

Ennogen Pharma Limited,

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS. UK.

This leaflet was last amended in February 2013.

J