Furosemide 20mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Furosemide 20 mg Tablets
(furosemide)
Read all of this 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.
- This medicine has been prescribed for you. 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, please tell. See section 4.
What is in this leaflet
1. What Furosemide Tablets are and what are they 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
1. WHAT FUROSEMIDE TABLETS ARE AND WHAT ARE THEY USED FOR
Furosemide Tablets contain furosemide as the active ingredient. This belongs to a group of medicines called diuretics (also called water tablets).
Furosemide Tablets are used to treat oedema (fluid retention) caused by heart failure, mild to moderate hypertension (high blood pressure) and certain liver and kidney disorders. They are 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 BEFQRE YOU TAKE FUROSEMIDE TABLETS Do not take Furosemide Tablets if you have:
• an allergy (hypersensitivity) to furosemide or any of the other ingredients in this medicine (listed in Section 6 )
• an allergy to any other diuretics or sulphonamides (e.g. sulphamethoxazole)
• severe kidney damage causing absence of urine production
• an electrolyte deficiency (various ions, such as potassium, sodium or chloride, required by your body)
• precoma associated with liver disease
• taken a heart medicine overdose (digitalis intoxication)
• porphyria, a metabolic disorder
• have an abnormal blood condition (blood dyscrasias)
Warnings and precautions
Talk to you doctor or pharmacist before taking Furosemide Tablets if you:
• have low blood pressure or an abnormally decreased volume of blood. Your fluid and electrolyte balance should be regularly monitored.
• take other medicines for treating high blood pressure
• suffer from gout or diabetes
• have kidney/adrenal or liver problems
• have a prostate problem or difficulty in passing urine
• are about to undergo any blood or urine tests
• are elderly
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:
• medicines used to treat high blood pressure such as ACE inhibitors, renin inhibitors, alpha blockers, calcium channel blockers, diuretics, phenothiazines
• antibiotics such as cephaloridine, gentamicin, vancomycin, colistin
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indometacin or ketorolac
• medicines to treat depression and other forms of mental illness such as lithium, pimozide, amisulpride, sertindole, tricyclic antidepressants and monoamie oxidase inhibitors
• medicines used to treat heart conditions such as digoxin, lidocaine, mexiletine and tocainide
• drugs for arrhythmias (e.g. sotalol, amiodarone, flecanide)
• nitrates (for angina)
• medicines to control diabetes such as insulin or tablets
• salicylates, for example aspirin
• muscle relaxants and antihistamines
• colestyramine or colestipol for high cholesterol
• sucralfate for stomach ulcers
• amphoterecin to treat fungal infections
• antiepileptics such as phenytoin or carbamazepine
• corticosteroids or antihistamines (to treat allergic reactions)
• medicines for attention deficit hyperactivity disorder (ADHD)
• medicines for treating cancer e.g. aldesleukin
• levodopa for Parkinson’s disease
• oral contraceptives
• alprostadil for erectile dysfunction
• treatments for asthma such as theophylline or salbutamol
• probenecid to prevent gout
• laxatives 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
Furosemide Tablets and alcohol
You should avoid drinking alcohol while taking Furosemide Tablets as this may lower your blood pressure further.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Furosemide Tablets should only be taken during pregnancy if considered essential by your doctor, and only for short-term treatment. Furosemide passes into breast milk, so inform your doctor if you are breast-feeding.
Driving and using machines
As this medicine may reduce mental alertness and cause dizziness and blurred vision, you should not drive or operate machinery until you know how the drug affects you.
Furosemide Tablets contain Lactose
Your medicine contains lactose; if you know you have an intolerance to some sugars such as lactose, contact your doctor before taking this medicine.
3. HOW TO TAKE FUROSEMIDE TABLETS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Furosemide Tablets should be swallowed with a drink of water.
The recommended dose is:
• Adults and children over 12 years:
Water retention: the usual starting dose is 40 mg in the morning, then 20 mg a day or 40 mg on alternate days. Up to 80mg a day may be given.
If you suffer from long term kidney trouble, your doctor may prescribe a starting dose of 250 mg furosemide per day which may be increased to 250 mg every 4 to 6 hours, up to a maximum of l500 mg per day.
High blood pressure: 20 - 40 mg twice a day.
• Elderly: dosage may be reduced in this age group.
• Children under 12 years: 1 - 3 mg for each kilogram of the child's body weight should be given daily. Do not exceed 40 mg per day.
Dosage adjustment may be necessary in patients with:
• hypoproteinaemia
• liver congestion/dysfunction
If you take more Furosemide Tablets than you should
If you take more medicine that your doctor has told you to, contact your doctor or nearest hospital casualty department immediately and take your Furosemide Tablets with you. Symptoms of an overdose include dehydration, changes in the levels of certain chemicals in the blood and low blood pressure.
If you forget to take Furosemide Tablets
If you miss a dose, take another as soon as you remember and carry on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking Furosemide Tablets
You should continue to take these tablets for as long as your doctor tells you to. Speak to your doctor before you stop taking Furosemide tablets.
If you have any 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 have any of the following side effects while taking your medicine, STOP taking the medicines and 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, 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. 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 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 pressure causing loss of concentration and slowed reactions, 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
• Light-headedness, sensations of pressure in the head, headache, 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
• 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 a rash fever, sweating, tiredness, and weight loss. Your doctor will perform regular blood tests to ensure no changes have occurred.
• Psychiatric disorder causing delusions, hallucinations, disorganised speech
• Feeling ‘pins and needles’ or tingling sensation
• Confusion
• Headache
• ‘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
• Tiredness, generally feeling unwell
• Fever
Very rare: may affect up to 1 in 10,000 people
• Involuntary movements of the muscle
• Inflammation or failure of the kidney which may cause back pain or changes in the amount or need to urinate
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
• Acute generalised exanthematous pustulosis (AGEP) (acute febrile drug eruption)
• Dizziness, fainting and loss of consciousness (caused by symptomatic hypotension)
• Decreased levels of potassium in the body
Additional side effects in children
• Increased risk or persistence of patent ductus arteriosus in premature infants
• Kidney stones in infants
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
Keep this medicines out of the sight and reach of children.
Do not store above 25°C.
Store in the original package/container and keep tightly closed.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Furosemide Tablets contain
The active substance is furosemide. Each tablet contains 20 mg of furosemide.
The other ingredients are lactose, magnesium stearate (E572), sodium starch glycollate, maize starch and starch paste 15%.
What Furosemide Tablets look like and contents of the pack
Furosemide 20 mg tablets are white circular flat bevelled edged tablets with 'F scoreline 20' embossed on one face and plain on the reverse.
Pack sizes: 28, 56, 100, 250, 500, 1000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Activase Pharmaceuticals Limited 11 Boumpoulinas Nicosia 1060 Cyprus
Manufacturer
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip, HA4 6QD
United Kingdom
This leaflet was last revised in November 2016.
PL 28444/0095