Furosemide 20 Mg Tablets Bp
FUROSEMIDE PIL 16.05.2016:FUROSEMIDE 0042030516-01.. 180 X 297mm 5/16/16 4:40 PM Page 1
PATIENT INFORMATION LEAFLET
FUROSEMIDE 20MG & 40MG TABLETS
Read all of this leaflet carefully before you starts taking this medicine because it contains important information for you.
• Keep the leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Furosemide is and what it is used for
2. What you need to know before you take Furosemide
3. How to take Furosemide Tablets
4. Possible side effects
5. How to store Furosemide Tablets
6. Contents of the pack and other information
1. WHAT FUROSEMIDE IS AND WHAT IT IS USED FOR
• Furosemide is a member of a group of medicines called diuretics (also called water tablets).
• It works by interfering with the filtration process of the kidneys to reduce the amount of sodium and water taken back into the bloodstream, thus increasing the volume of urine produced.
• Furosemide is used to treat oedema (fluid retention) caused by heart failure, 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FUROSEMIDE
DO NOT take this medicine and talk to your doctor if you:
• have previously had an allergic reaction to Furosemide, other diuretics or sulphonamides (e.g. sulphamethoxazole trimethoprim, sulfadiazine, etc)
• are allergic to any of the other ingredients of this tablets (See section 6)
• are pregnant, planning to become pregnant or breast-feeding
• have liver cirrhosis (tiredness, weakness, water retention, feeling or being sick, loss of weight or appetite, yellowing skin or eyes)
• have severe kidney damage which has stopped them working properly and producing urine
• have very low levels of potassium, sodium or other electrolytes in your blood (your doctor will be able to advice you)
• have the rare condition called porphyria which can affect the skin and nervous system
• are suffering from digitalis toxicity (harmful effects of the drug digoxin)
• have been told that you have a low volume of fluid in the body or a low blood pressure
• have Addison’s disease (low levels of corticosteroid hormones secreted)
Warnings and precautions
Take special care and check with your doctor or pharmacist before taking these tablets if you have:
• low levels of protein in the blood (hypo- proteinaemia) as a result of kidney damage
• liver congestion (slowed blood flow through the vessels) or other liver problems
• diabetes, kidney problems
• prostate trouble or difficulty passing urine
• have an abnormal blood condition
• or had gout (causes excess uric acid in the blood and painful inflammation of the joints, mainly in the feet and hands and especially in the big toe)
• are about to undergo any blood or urine tests
Talk to your doctor or pharmacist before taking Furosemide Tablets: if you are elderly, if you are on other medications which can cause the drop of the blood pressure and if you have other medical conditions that are risks for the drop of blood pressure.
Other medicines and Furosemide tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially:
• medicines used to treat high blood pressure such as ACE inhibitors, alpha blockers, diuretics (e.g. methyldopa, captopril)
• antibiotics (for infection) such as cephaloridine, cephalothin, gentamycin and neomycin
• digoxin used to increase the force of the heart muscle, and medicines to correct abnormal heart beats, eg amiodarone
• non-steroidal anti-inflammatory drugs (to relieve the pain or inflammation in the joints or to lower a high temperature) such as aspirin, piroxicam and ibuprofen
• corticosteroids (such as prednisolone) for allergic or inflammatory conditions such as asthma or arthritis
• medicines for diabetes, eg insulin
• theophylline used to treat asthma
• antihistamines, eg cetrizine
• curare-type muscle relaxing drugs such as tubocurarine
• lithium, a treatment for depression
• medicines used to treat other heart condition (e.g. lignocaine, mexiletine and tocainide)
• drugs to treat mental illness (e.g. pimozide, amisulpride)
• amphotericin (to treat fungal infection)
• chloral hydrate (to treat insomnia)
• antidepressants (e.g. monoamino oxidase inhibitors MAOIs)
• colestyramine or colestipol for high cholesterol
• moxisylte for Raynaud’s syndrome
• antiepileptics (e.g. phenytoin or carbamazepine)
• drugs for ADHD (Attention Deficit Hyperactivity Disorder)
• drugs treating cancer (e.g. cisplatin)
• levodopa (for Parkinson’s disease)
• oral contraceptives
• alprostadil for erectile dysfunction
• probenecid to prevent gout
• laxative used over a long period of time
• medicines or food containing liquorice
If you are already taking or receiving one of these medicines, speak to you doctor before you start furosemide tablets.
Pregnancy and breast-feeding
Tell your doctor before you are given this medicine if you are or think you may be pregnant or are planning to become pregnant, or are breast feeding. Furosemide should only be given in pregnancy and while breast feeding, if the doctor thinks that it is absolutely necessary.
Driving and using machines
Furosemide may cause some patients to be less alert which could interfere with the ability to drive or to operate machines. If you notice that you are not as alert as usual, do not drive or operate machinery and ask your doctor for advice. Furosemide tablets contains lactose
This medicine contains lactose, if you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE FUROSEMIDE
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Swallow the tablets with a drink of water.
Adult
• The initial dose is 40mg a day, reduced to 20mg daily or 40mg on alternate days, depending on how you respond.
• If you suffer from chronic kidney trouble, your doctor may prescribe a starting dose of 250 mg of Furosemide per day.
If necessary your doctor may increase this to 250mg every 4 to 6 hours up to a maximum of 1500mg per day.
Children
• 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.
• A dose of 1-3mg for each kilogram of the child’s body weight should be given daily. Do not exceed 40 mg per day.
Elderly
Furosemide is generally cleared from the body more slowly in the elderly. If you are elderly, your doctor may decide to start with a low dose and increase the dose gradually according to your response.
If you take more tablets than you should
If you or anyone else has swallowed a lot of the tablets all together contact your nearest hospital casualty department or doctor immediately.
If you forget to take a dose
If you forget to take a dose, take it as soon as you remember, but do not take two doses together. Then go on as before.
If you have further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, furosemide tablets can cause side-effects, although not everyone gets them.
If you experience any of the following tell your doctor immediately:
• severe allergic reaction which may include a skin rash, itching, dermatitis, peeling skin, sensitivity to sunlight, difficulty breathing, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint
• 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 may pass urine or you may see blood in your urine.
• sore throat or repeated infections
Furosemide may cause other unwanted effects:
Very common (may affect more than 1 in 10 people):
• dehydration, low blood pressure causing loss of concentration and slowed reactions, light-headedness, sensations of pressure in the head, headache, dizziness, drowsiness, weakness, changes in vision, dry mouth, dizziness when standing
• 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):
• low blood volume (hypovolaemia)
• increased creatinine and blood urea (seen in blood tests)
Uncommon (may affect up to 1 in 100 people):
• a reduction of the blood cells in the bone marrow causing tiredness, unexplained bruising and paleness
• changes in the body seen in tests such as levels of cholesterol, glucose, uric acid
• stomach upset, diarrhoea, abdominal pain
• blurred vision or yellow vision
• deafness (sometimes irreversible)
• gout (causing a swollen painful joint or joints)
• diabetes
Rare (may affect up to 1 in 1,000 people):
• hearing difficulty or ringing in the ears
• over-sensitivity to light, pins and needles
• sudden constant pain in the upper part of your tummy (this may suggest inflammation of a gland called the pancreas)
• abnormal liver function which may cause jaundice (yellowing of the skin or whites of the eyes)
• psychiatric disorder causing delusions, hallucinations, disorganized speech
• symptoms of shock such as changes in heart rate, breathlessness, cool clammy skin
Very rare (may affect up to 1 in 10,000 people):
• muscular spasm
Not known (frequency cannot be estimated from the available data):
• acute generalized exanthematous pustulosis (AGEP) (acute febrile drug eruption)
• headache, dizziness, confusion, fainting and loss of consciousness (caused by symptomatic hypotension)
During the treatment with furosemide, the blood levels of some fats (cholesterol and triglyceride) may rise, but these usually return to normal within six months. Deposits calcium salts in the kidneys have been reported in premature babies following treatment with furosemide. Furosemide may occasionally alter the composition of your blood and your doctor may want to do some blood tests from time to time. If you are to undergo a blood test remember to tell the doctor of your treatment with Furosemide.
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
• Do not use this medicine after the expiry which is stated on the label, carton after ‘EXP’. The expiry date refers to last date of that month.
• Do not store above 25°C.
• Keep the container tightly closed (for plastic bottles).
• Store in the original container (for plastic bottles).
• Keep blister in the outer carton (for blister packs).
Keep all medicines out of the sight and reach of children.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What furosemide tablets contain
• The active ingredient is 20mg or 40mg of Furosemide. The other ingredients are
• Furosemide tablets 20 mg:
Lactose monohydrate, magnesium stearate, sodium starch glycollate and maize starch.
• Furosemide tablets 40 mg:
Lactose, talc, magnesium stearate, maize starch and colloidal silica.
What Furosemide tablets look like and contents of the pack:
• Furosemide 20mg tablets:
White, circular tablets embossed ‘PV’ on one face and F/20 on the other.
• Furosemide 40mg tablets:
White, circular tablets embossed ‘PV’ on one face and F/40 on the other
• Pack sizes: Furosemide 20mg & 40mg tablets are available in the pack sizes of 28, 56, 100, 250, 500 &1000 into plastic containers and 28 & 56 in blister packs. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex, UB6 7HQ.
Telephone: 0208 997 5444
Fax:_0208 997 5433_
To request a copy of this leaflet in large print or audio format or additional copies, please contact the licence holder at the address (or telephone, fax) above.
PL 04556 / 0042 & 04556 / 0003
Reference: 0042030516/01
Date leaflet last revised: May 2016
