_ _ _ _ _ _n nogen PharmaI

PACKAGE LEAFLET: INFORMATION FOR THE USER

¹ Diuresal 500mg Tablets

I Furosemide

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Read all of this leaflet carefully before you start faking this medicine because it contains important information for you.

L Keep this leaflet. You may need to read it again.

L If you have any further questions, ask your doctor or pharmacist or nurse.

L This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

L If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section

What in this leaflet:

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

2.    What you need to know before you take | Diuresal Tablets

3.    How to take Diuresal Tablets

4.    Possible side effects

5.    How to store Diuresal Tablets

6.    Contents of the pack and other information

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

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

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIURESAL TABLETS

Do not take Diuresal Tablets if you:

L Are hypersensitive (allergic) to furosemide, other sulphonamide related drugs or any of the other ingredients of Diuresal Tablets (See | section 6)

L Have low blood pressure L Have severe kidney damage which has

stopped them working properly and producing urine

•    Have liver cirrhosis (tiredness, weakness, water retention, feeling or being sick, loss of weight of appetite, yellowing skin or eyes, itch) or liver encephalopathy (confusion, altered levels of consciousness and coma as a result of liver failure)

•    Have digitalis poisoning (feeling or being sick,

I high levels of potassium in the blood, slow, fast or irregular heart beats)

L Have very low levels of potassium, sodium or other electrolytes in your blood (your doctor will advise you)

L Are dehydrated

L Take potassium supplements or potassium sparing diuretics for high blood pressure (e.g. amiloride)

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

L Are breast-feeding.

If 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 insure.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Diuresal Tablets if you:

L Are elderly, if you are on other medications which cause the blood pressure to drop and if you have other medical conditions that are risks I for the drop of blood pressure.

L Have a low blood volume (hypovolaemia)

L Have diabetes. If you are taking insulin, your doctor may need to adjust your insulin dosage L Have or have had gout (severe joint pain)

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

L Have prostate trouble or difficulty passing urine L 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

•    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.

Other medicines and Diuresal Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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, flecanide)

•    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 or foods 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) e.g. ibuprofen or naproxen 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).

Pregnancy and breast-feeding

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

Driving and using machines

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

Diuresal Tablets contain lactose

If you have been told by your doctor that you have an 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

given every 4-6 hours to a maximum dose of pOOOmg (4 tablets).

Elderly:

The dose may be reduced in this age group.

Children:

Not recommended.

|lf you 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.

|If you 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.

If you forget to take Diuresal Tablets

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.

If you have any of the following side effects while taking your medicine tell your doctor immediately or go to hospital straight away:

•    Severe allergic reaction which may include a skin rash, itching, dermatitis, peeling skin, sensitivity to sunlight or sun lamps or fever,

¹ swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing

•    Inflammation of blood vessels (vasculitis, which may cause rash, fever and joint or muscle pains) or kidney inflammation, this may change

I the number of times you pass urine or you may see blood in your urine. You may have a fever,

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

•    Blood clot (causing pain, swelling or tenderness in the legs).

Tell your doctor or pharmacist if you notice any of the following side effects:

Very common: may affect more than 1 in 10 people

•    Dehydration

•    Altered balance of fluid or chemicals in the

I body (e.g. sodium, potassium, chlorine, calcium and magnesium) causing a dry mouth, weakness, tiredness or drowsiness, restlessness, fits, muscle pain fatigue or cramps, low blood pressure, difficulty passing water, fast or irregular heart rate and feeling and being sick.

Common: may affect up to 1 in 10 people

•    Low blood volume (hypovolaemia)

•    Increased creatinine and blood urea (seen in blood tests).

Uncommon: may affect up to 1 in 100 people

•    Anaemia causing tiredness, breathlessness, unusual bleeding or bruising,

•    Changes in the body seen in tests such as levels of cholesterol, glucose, uric acid

•    Gout

•    Changes in vision including blurred or yellow vision

•    Low blood pressure causing loss of concentration and slowed reactions, light-

I headedness, sensations of pressure in the head, headache, dizziness, drowsiness, weakness, changes in vision, dry mouth

•    Irregular heartbeat

•    Muscle cramps or weakness

•    Changes in the amount or need to urinate

•    Tiredness

•    Dry mouth, thirst

•    Feeling or being sick

•    Changes in bowel movements including diarrhoea and constipation

•    Deafness (sometimes irreversible).

Rare: may affect up to 1 in 1,000 people

•    Changes in blood cells such as amount of white blood cells, reduction of platelets causing

I a rash fever, sweating, tiredness, and weight loss. Your doctor will perform regular blood tests to ensure no changes have occurred

Psychiatric disorder NOC causing delusions, hallucinations, disorganized speech Feeling 'pins and needles' or tingling sensation Confusion

Headache, dizziness 'Ringing' in the ears, loss of hearing usually reversible

Symptoms of shock such as changes in heart rate, breathlessness, cool clammy skin

Inflammation of the pancreas causing pains in your abdomen or back and nausea Changes in the liver causing yellowing of the skin or whites of the eyes)

Skin rashes

Inflammation or failure of the kidney which may cause back pain or changes in the amount or need to urinate

Tiredness, generally feeling unwell Fever.

L _

Very rare: may affect up to 1 in 10,000 people

•    Involuntary movements of the muscle.

Not known: frequency cannot be estimated

from the available data

•    Worsening of conditions where there is already balances of fluid or chemicals in the body

•    Increased levels of glucose in the body.

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

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

Additional side effects in children

•    Increased risk or persistence of patent ductus arteriosus in premature infants.

•    Kidney stones in premature babies.

Reporting of side effects

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

5. HOW TO STORE 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 of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.

Keep out of the sight and reach of children

6. CONTENTS OF THE PACK AND OTHER 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 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 of 28 or 100 tablets.

Marketing Authorisation Holder and Manufacturer

Ennogen Pharma Limited,

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS. UK.

This leaflet was last amended in December 2015.