Diuresal Tablets 40mg
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PACKAGE LEAFLET: INFORMATION FORTHE USER
_ -I
nogen Pharmal
|Read all ofthis leaflet carefully before you start taking this medicine because it contains (important information for you.
• Keep this leaflet. You may need to read it | again.
• 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,
I or pharmacist or nurse. This includes any
I possible side effects not listed in this leaflet.
I See section 4.
What is in this leaflet:
i1. WhatFurosemideTabletsareandwhat they are used for
|2. What you need to know before you take Furosemide Tablets |3. How to take Furosemide Tablets 4. Possible side effects |5. How to store Furosemide Tablets 6. Contents of the pack and other information
iFurosemide Tablets is one of a group of medicines called diuretics (water tablets).
Your doctor has prescribed Furosemide Tablets to treat a condition called oedema where there is too much water in your body. This could be due to problems with your heart, kidneys, liver, blood vessels or high blood pressure. Furosemide helps your 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 them working properly and producing urine
L Have very low levels of potassium, sodium or other electrolytes 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
I weight or appetite, yellowing skin or eyes, itch)
I or liver encephalopathy (confusion, altered
I levels of consciousness and coma as result of
1 liver failure)
• Are not producing any urine
'• Have digitalis poisoning (feeling or being sick, high levels of potassium in the blood, 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. amiloride or spironolactone)
I* Are dehydrated.
Warnings and precautions
Talk to your doctor, or pharmacist or nurse before
taking Furosemide Tablets ifyou:
CHave low blood volume (hypovolaemia)
Have low blood pressure (hypotension)
• Have diabetes. If you are taking insulin, your I doctor may need to adjust your insulin dosage • Have had gout (severe joint pain)
L Have Metabolic acidosis (too much acid in I the body)
Have Prostate trouble or difficulty passing | urine
• Are hypersensitive to sulphonamide type drugs like Furosemide (see section 4: Side Effects)
• Are elderly
|* Have low levels of protein in the blood (hypoproteinaemia) as a result of kidney damage
• Have kidney problems
• 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 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, alpha blockers, calcium channel blockers, diuretics
• Drugs to treat mental illness (e.g. pimozide, amisulpride)
• Drugs for arrhythmias (e.g. sotalol, amiodarone, flecanide)
• Digoxin foryourheart
• Moxisylte for Raynaud's syndrome
• Nitrates (forangina)
• Lithium for depression or mania
• Colestyramine or colestipol for high cholesterol
• Non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen or naproxen
• 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
• Antiepileptics e.g. phenytoin or carbamazepine
• Corticosteroids or antihistamines (to treat allergic reactions)
• DrugsforADHD
• Drugs treating cancer
• Levodopa (for Parkinson's disease)
• Oral contraceptives
• Alprostadil for erectile dysfunction
• Certain treatments for asthma such as theophylline or salbutamol
• Probenecid to prevent gout
• Laxatives used over a long period of time
• 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
• Drugs that cause QT prolongation (e.g. amiodarone)
• Renin inhibitors used to treat high blood pressure (e.g.aliskiren)
• Chelating agents such as sucralfate used to treat duodenal ulcers
• Immunomodulators such as aldesleukin used to treat certain types of cancer
• Tricyclic antidepressants used to treat depression (e.g. imipramine)
• Alcohol.
Pregnancy and breastfeeding
Ask your doctor 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:
iThe usual starting dose is 40mg in the morning; then 20mg a day or 40mg on alternate days. Up to |80mg may be given.
Elderly:
The dose may be reduced in this age group. Children:
|lmg to 3mg/kg daily up to maximum total dose of 40mg/day. A more suitable dosage form e.g. oral bolution, may be appropriate.
Ilfyou take more Furosemide Tablets than you should
This medicine is to be taken at regular intervals, as determined by the physician. Ifyou take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you.
^Ifyou stop taking Furosemide Tablets
Keep taking Furosemide Tablets until your doctor tells you to stop. Do not stop taking Furosemide [Tablets just because you feel better.
[Ifyou forget to take Furosemide Tablets
If you have forgotten to take a dose, leave out that pose completely. Take your next dose at the normal time. If you have trouble remembering to |take the tablets, tell your doctor or pharmacist.
Rare: may affect uptol in 1,000
people
• Changes in blood cells such as amount ofwhite blood cells, reduction of platelets causing a rash fever, sweating, tiredness, and weight loss.
Your doctorwill perform regular blood tests to ensure no changes have occurred
• Mental illness 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 ofthe 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side pffects, although not everyone gets them.
.Ifyou have any ofthe following side effects while taking your medicine tell your doctor .immediately or go to hospital straight away:
L Severe allergic reaction which may include a i skin rash, itching, dermatitis, peeling skin,
1 sensitivity to sunlight or sun lamps or fever,
| 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 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. ofthe ankles |* Blood clot (causing pain, swelling or tenderness in the legs).
Tell your doctor or pharmacist ifyou notice any lof the following side effects:
Very common: may affect more than 1 in 10 people
C Dehydration
Altered balance offluid or chemicals in the I body (e.g. sodium, potassium, chlorine, calcium I and magnesium) causing a dry mouth, i weakness, tiredness or drowsiness,
1 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
I* Anaemia causing tiredness, breathlessness, unusual bleeding or bruising L Changes in the body seen in tests such as levels ofcholesterol, glucose, uric acid l Gout
• Changes in vision including blurred or yellow I vision
• Low blood pressure causing loss of I concentration and slowed reactions, light-I headedness, sensations of pressure in the 1 head, headache, dizziness, drowsiness,
| weakness, changes in vision, dry mouth, dizziness when standing [• 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.
Very rare: may affect uptol 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 offluid or chemicals in the body
• Increased levels of glucose in the body.
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: 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 FUROSEMIDE TABLETS
Check the expiry date printed on the label or side of the box. Do not use after the 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 ofvia 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 Furosemide Tablets contain:
Furosemide 20mg and 40mg Tablets contain the 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 marketed.
Marketing Authorisation Holderand Manufacturer
Ennogen Pharma Limited,
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS. UK.
This leaflet was last revised in December 2014.