— I Furosemide ' l Furosemide

_ _ [furosemide]

HB

20mg

40mg

Tablets

Tablets

C^nnogen Pharmal

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

|» Keep Ibis leaflet. You may need to read it again.

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

|» 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.

|> If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any I possible side effects not listed in this leaflet.

I See section <1.

What is in this leaflet:

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

12. What you need to know before you take Furosemide Tablets b. How to take Furosemide Tablets 4. Possible side effects 6. How to store Furosemide Tablets . Contents of the pack and other information

I⁶’

., WHAT FUROSEMIDE TABLETS ARE AND WHAT THEY ARE USED FOR

furosemide Tablets is one of a group of medicines called diuretics (water tablets).

Your doctor has prescribed Furosemide Tablets to treat a condition called oedema v/here there is too much water in your body. This could be due lo

emblems with your heart, kidneys, liver, blood essels or high blood pressure. Furosemide helps r/our kidneys to get rid of the extra water that is not needed in your body.

Do not take Furosemide Tablets if you:

•    Are allergic to furosemide, other sulphonamide | related drugs or any of the other ingredients of

Furosemide Tablets (see section 6)

]• Have low blood pressure

•    Have severe kidney damage which has

| stopped Ihem working properly and producing urine

{• Have very low levels of potassium, sodium or other eleclrolytes in your blood or low blood | volume (your doctor will be able to advise you)

•    Have liver cirrhosis (tiredness, weakness,

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

•    Are not producing any urine

]> Have digitalis poisoning (feeling or being sick, high levels of potassium in the blood,

I slow, fast or Irregular heart beats)

•    Are breastfeeding

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

!• Take potassium supplements or potassium sparing diuretics for high blood pressure (e.g.

I amiloride or spironolactone)

•    Are dehydrated.

Warnings and precautions

Talk to your doctor, or pharmacist or nurse before

rng Furosemide Tablets if you:

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

Have low blood volume (hypovolaemia)

CHave low blood pressure (hypotension)

Have diabetes. If you are taking insulin, your doclor may need lo adjust your insulin dosage Have had gout (severe joint pain)

Have Metabolic acidosis (too much acid in the body)

Have Prostate trouble or difficulty passing urine

Are hypersensitive to sulphonamide type drugs like Furosemide (see section 4: Side Effects) Have low levels of protein in the blood (hypoproteinaemia) as a result of kidney damage

o Have kidney problems o Have liver congestion (slowed blood flow through the vessels) or other liver problems.

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

Other medicines and Furosemide Tablets Tell your doclor 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:

s Drugs to lower blood pressure, such as ACE inhibitors, alpha blockers, calcium channel blockers, diuretics

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

•    Drugs for arrhythmias (e.g. sotalol, amiodarone, decanide)

•    Dlgoxin for your heart

•    Moxisylte for Raynaud's syndrome

•    Nitrates (for angina)

e Lithium for depression or mania

•    Colestyramine or colestipol for high cholesterol

•    Non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen or naproxen

e Aspirin for pain

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

•    Amphoterecin (to treat fungal Infections)

•    Chloral hydrate (to treat insomnia)

•    Antidepressants (e.g. monoamine oxidase inhibitors (MAOIs))

•    Medicines to control diabetes such as insulin or tablets

o Antiepileptics e.g. phenyloin or carbamazepine

•    Corticosteroids or antihistamines (to treat allergic reactions)

•    Drugs for ADHD

•    Drugs treating cancer

•    Levodopa (for Parkinson's disoase) o Oral contraceptives

e Alprostadil for erectile dysfunclion o Certain treatments for asthma such as theophylline or salbutamol

•    Probenecid to prevent gout

•    Laxatives used over a long period of time

•    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

•    Drugs lhat cause QT prolongation (e.g. amiodarone)

•    Renin Inhibitors used to treat high blood pressure (e.g.aliskiren)

•    Chelating agents such as sucralfate used lo treat duodenal ulcers

a Immunomodulators such as aldesleukin used to treat certain typos of cancer a Tricyclic antidepressants used to treat depression (e.g. Imipramine) a Alcohol.

Pregnancy and breastfeeding Ask your doclor or pharmacist for advice if you are pregnant, planning on becoming pregnant before taking this medicine.

Driving and using machines

Do not drive or operate machinery if you feel less

alert after taking Furosemide Tablets.

Furosemide Tablets contains 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.

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

The usual dose:

Adults:

|The usual starling dose is 40mg in the morning; then 20mg a day or 40mg on alternate days. Up to pOmg may be given.

Elderly:

The dose may be reduced in Ihis age group. ^Children:

jlmg to 3mg/kg daily up to maximum total dose ol 40mg/day. A more suitable dosage form e.g. oral Solution, may be appropriate.

|f you take more Furosemide Tablets than you should

[This medicine is to be taken at regular intervals, as determined by the physician. 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.

|f you stop taking Furosemide Tablets Keep taking Furosemide Tablets until your doctor lells you to stop. Do not stop taking Furosemide Tablets Just because you feel betler.

If you forget to take Furosemide Tablets Ilf you have forgotten to lake a dose, leave out that dose completely. Take your next dose at the normal time. If you have Irouble remembering to take the tablets, tell your doctor or pharmacist.

o Mental illness causing delusions, hallucinations, disorganized speech

•    Feeling 'pins and needles' or tingling sensalion

•    Confusion o Headache, dizziness e 'Ringing' in the ears, loss of hearing

usually reversible

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

•    Inflammation of Ihe pancreas causing pains in your abdomen or back and nausea

•    Changes in tire liver causing yellowing of Ihe skin or whites of the eyes

» Skin rashes

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

o Tiredness, generally feeling unwell t> Fever.

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

•    Involuntary movements of the muscle.

.ike all medicines, this medicine can cause side rffects, although not everyone gels 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 Ihe face, lips, tongue or throat, or I difficulty breathing or swallowing

•    Inflammation of blood vessels (vasculitis, which I may cause rash, fever and joint or muscle

pains) or kidney inflammation, ihls may change | the number of times you pass urine or you may ¹ see blood In your urine. You may have a fever,

I feel drowsy, or notice swelling e.g. of the ankles » Blood clot (causing pain, swelling or | tenderness in the legs).

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

Very common: may affect more than 1 in 10 people

Dehydralion

» Altered balance of fluid or chemicals In the | 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

0    Low blood volume (hypovolaemia)

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

1

Uncommon: may affect up to 1 In 100 people

|» Anaemia causing tiredness, breathlessness, unusual bleeding or bruising |» Changes in Ihe body seen In tests such as levels of cholesterol, glucose, uric acid li Gout

•    Changes In vision Including blurred or yellow I vision

•    Low blood pressure causing loss of

I concentration and slowed reactions, lightheadedness, sensations of pressure in the I head, headache, dizziness, drowsiness,

. weakness, changes in vision, dry mouth l Irregular heartbeat

C Muscle cramps or weakness

Changes in the amount or need to urinate » Tiredness l Dry mouth, thirst

C Feeling or being sick

Changes in bowel movements Including ■ diarrhoea and constipation

Deafness (sometimes irreversible).

taare: may affect up to 1 In 1,000 people

a Changes In blood cells such as amount of ' white blood cells, reduction of platelets causing I a rash fever, sweating, tiredness, and weight ¹ loss. Your doctor will perform regular blood | tests to ensure no changes have occurred

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 Ihe body.

•    Acute generalised exanthematous pustulosis (AGEP) (acule 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 possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: vrww.mhra.gov.uk/yellowcard By reporting side effecls you can help provide more information on Ihe safely of this medicine.

S. HOW TO STORE FUROSEMIDE TABLETS

Check the expiry date printed on the label or side of Ihe box. Do not use after Ihe expiry date stated on the label.

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 wasle. 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_l.

What Furosemide Tablets contain: Furosemide 20mg and 40mg Tablets contain Ihe active substance furosemide 20mg and 40mg respectively In each tablet.

The other ingredients are; lactose, maize starch, magnesium stearate, pregelatinised starch, talc, microcrystalline cellulose.

What Furosemide Tablets look like and contents of the pack

Furosemide 20mg Tablets are plain on one side and scored with a F20 on the other side. Furosemide 40mg Tablets are plain on one side and have a breakline on the other side.

The 20mg Tablets are available in packs of 28, 100, 250,500, 1000.

The 40mg Tablets are available in packs of 28.

Not all pack sizes may be markeled.

Marketing Authorisation Holder and Manufacturer

Ennogen Pharma Limited,

UnitG4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS. UK.

This leaflet was last revised in December 2015.