Furosemide 20mg/5ml Oral Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
Furosemide 20, 40 & 50 mg/5ml Oral Solution Furosemide
Read all of this leaflet carefully before you start taking this medicine.
• 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 symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Furosemide Oral Solution is and what it is used for
2. Before you take Furosemide Oral Solution
3. How to take Furosemide Oral Solution
4. Possible side effects
5. How to store Furosemide Oral Solution
6. Further information
1. What Furosemide Oral Solution is and what it is used for
Your medicine is called Furosemide 20, 40 or 50mg/5ml Oral Solution (called Furosemide Oral Solution throughout the rest of this leaflet).
Furosemide Oral Solution is one of a group of medicines called diuretics (‘water tablets’). What this medicine does
Your doctor has prescribed Furosemide Oral Solution to treat a condition called oedema where there is too much water in your body. This could be due to problems with your heart, lungs, 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.
2. Before you take Furosemide Oral Solution
Do not take Furosemide Oral Solution if you:
• are allergic (hypersensitive) to furosemide or any of the other ingredients of Furosemide Oral Solution (see section 6, Further information);
• are allergic (hypersensitive) to sulphonamides (drugs used to treat infections);
• have been told by your doctor that you have an intolerance to a sugar called fructose (see section, ‘Important information about some of the ingredients in Furosemide Oral Solution’);
• are dehydrated or have lost a lot of blood;
• are taking supplements to increase your potassium levels;
• are taking diuretics such as amiloride or triamterine which can affect your potassium levels; •have ‘Addison’s disease’ an illness affecting your adrenal glands and hormone production, causing you to feel tired, weak, loss of appetite or thirsty;
• have taken too much digoxin (for your heart);
• have kidney or liver failure, problems where your liver or kidneys are not working properly, or you have alcohol induced liver disease;
• have very low levels of potassium in your blood which will make your muscles feel weak or you may suffer paralysis;
• have very low levels of sodium in your blood which may be caused by excessive sweating, vomiting or reaction to another drug;
• are breast-feeding.
Talk to your doctor, if any of the following apply to you:
• if you are pregnant or are thinking of getting pregnant;
• if you have difficulty passing urine;
• if you have low blood pressure;
• if you have diabetes;
• if you have gout;
• if you have problems with your adrenal glands (see also section ‘Do not take Furosemide’, Addison’s disease);
• if you are dehydrated or have been vomiting (sickness);
• if you have an enzyme disorder (acute porphyria), which causes mental disturbances, seizures, stomach pains and vomiting;
• if you have kidney problems as a result of liver disease;
• if you are the parent or carer, of a premature baby, as your doctor will need to monitor your child’s kidney function;
• if you need an x-ray where a special dye (contrast medium) needs to be used;
• if you are elderly, (over the age of 65), particularly if you are taking risperidone for dementia.
Your doctor will want to monitor you, and may take blood for testing while you are taking this medicine.
Using other medicines
Make sure your doctor knows if you are taking any medicine listed here:
• Digoxin for your heart; your doctor may need to change your dose.
• Drugs to lower blood pressure, such as ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, calcium channel blockers, alpha-blockers or vasodilators: when taken with furosemide may cause your blood pressure to fall too low or affect your heart. Your doctor may need to change your dose of furosemide.
•The use of Furosemide with the following drugs may also cause your blood pressure to fall too low:
• Hypnotics and anxioletics e.g. diazepam and temazepam for sleeping problems and anxiety;
• Aldeskleukin, to treat cancer;
• Alprostadil for impotence;
• Nitrates, to treat angina;
• Moxisylyte used to treat Raynaud’s Syndrome;
• Oestrogens for Hormone Replacement Therapy (HRT) and contraception;
• Baclofen and tizanidine, used to relax your muscles;
• Anaesthetics;
• Theophylline, to treat asthma;
• Levodopa, to treat Parkinson’s disease.
• Medicines to treat mental health issues, such as pimozide, amisulpride and sertindole:
when taken with furosemide may increase the risk of damage to your heart.
• Medicines for pain and inflammation (Non-Steroidal Anti-Inflammatory Drugs -NSAIDs): may cause kidney damage when taken with furosemide. Some NSAIDs such as Indomethacin and Ketorolac may reduce the effect of furosemide.
• Ciclosporin and tacromilus, used after organ transplants: if taken with furosemide may cause gout and/or potassium levels in your blood to rise too high.
• Risperidone, to treat dementia: your doctor will decide if this is the right treatment for you.
• Drugs to treat unusual heart rhythms e.g. Amiodarone, disopyramide, flecainide, mexiletine and sotalol: when taken with furosemide increases the risk of damage to the heart.
• Aliskiren, used to lower blood pressure: when taken with furosemide may reduce the levels of furosemide in your body.
• Progestogens such as drospirenone for Hormone Replacement Therapy (HRT) and contraception: if taken with furosemide may cause the potassium levels in your blood to rise too high.
• Antibiotics for infections: some antibiotics can affect your kidneys and furosemide can make this effect worse.
• Sucralfate for stomach ulcers. Do not take furosemide within two hours of taking sucralfate as furosemide will not work as well.
• Lithium, for depression or mania: as the effect of lithium may be increased. Your doctor will check your lithium levels and may change your dose.
• Nelfinavir, ritonavir and saquinavir, used to treat viral infections: may increase the levels of furosemide in your body.
• Curare, an anaesthetic medicine: furosemide may increase the effects of curare.
• Aspirin for pain: as furosemide may increase the side effects of aspirin.
• Medicines to control diabetes or high blood pressure: these medicines may not work as well when taken with Furosemide.
• Aminoglycosides e.g. gentamycin for serious infections: the risk of side effects from genatamycin or furosemide is greater. Your doctor will only give you furosemide if it is essential.
•Antihistamines, to treat allergies: when taken with furosemide may increase the risk of damage to the heart.
•Drugs that prolong QT interval - increase the risk of side effects.
• Cisplatin to treat cancer: furosemide may increase the side effects of cisplatin. Your doctor may change your dose of furosemide.
• Phenytoin to control epilepsy (fits): furosemide may not work as well.
• Carbamazepine to control epilepsy: it may increase the side effects of furosemide if taken together.
• Corticosteroids used to treat allergic reactions: your salt balance may be altered causing your muscles to feel weak.
• Carbenoxolone to treat ulcers: your salt balance may be altered causing your muscles to feel weak.
• Medicines to treat Attention Deficit Hyperactivity Disorder (ADHD): if taken with furosemide may cause unusual heart rhythms.
• Reboxetine for depression: your salt balance may be altered causing your muscles to feel weak.
• Amphotericin for fungal infections: your salt balance may be altered causing your muscles to feel weak. It may also cause kidney damage.
• Potassium Salts, used to treat low potassium levels: if taken with furosemide may cause your potassium levels to rise too high. Avoid using potassium salts when taking furosemide.
• Sympathomimetics used to treat chronic asthma and COPD (Chronic Obstructive Pulmonary Disease): when taken with furosemide may cause levels of potassium in the blood to rise too high.
• Laxatives used over a long period of time: your salt balance may be altered causing your muscles to feel weak.
• Certain treatments for asthma when taken in large amounts: your salt balance may be altered causing your muscles to feel weak.
• Probenecid for gout: furosemide will not work as well or the effect of probenecid may be increased.
• Methotrexate for rheumatism or psoriasis: furosemide will not work as well or the effect or methotrexate may be increased.
•Warfarin (used to thin your blood) and clofiberate (used to treat high cholesterol): when taken together with furosemide, this medicine may not be as effective.
• Metozolone (another diuretic): when taken together with furosemide can increase the amount of urine you pass which, in turn, could lead to dehydration.
• Other diuretics e.g. amiloride; when taken together with furosemide your salt balance may be altered causing your muscles to feel weak.
If you need an operation tell your doctor you are taking Furosemide Oral Solution as when anaesthetics are given with furosemide your blood pressure may be lowered.
Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Taking Furosemide Oral Solution with alcohol
• Seek advice from your doctor about drinking alcohol while taking Furosemide Oral Solution.
Pregnancy and breast-feeding
Speak to your doctor before you take Furosemide Oral Solution if you are pregnant, thinking of getting pregnant, or breast-feeding.
• If you become pregnant while taking Furosemide Oral Solution, speak to your doctor as he will check the growth of your baby.
Driving and using machines
• Do not drive or operate machinery if you feel drowsy or have blurred vision after taking Furosemide Oral Solution.
Important information about some of the ingredients in Furosemide Oral Solution
• Your medicine contains alcohol. Each 5ml spoonful of your medicine contains up to 371mg of alcohol. This is about the same as drinking 10ml of beer or 4ml of wine for each 5ml dose. Take advice from your doctor before taking this medicine if you have liver disease, epilepsy, a brain injury or disease, you are pregnant, an alcoholic, or this medicine is to be taken by a child.
• Your medicine contains sodium. Each 5ml spoonful of your medicine contains less than 23mg (less than 1mmol) of sodium, i.e. it is essentially sodium free.
•If you have more than one 5ml spoonful, this will contain more than 23mg of sodium (more than 1mmol). Tell your doctor if you are on a controlled sodium diet.
• Your medicine contains maltitol; do not take Furosemide Oral Solution if you have been told by your doctor that you have an intolerance to a sugar called fructose.
3. How to take Furosemide Oral Solution
Always take Furosemide Oral Solution exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure how much to take.
Adults including elderly
• The usual starting dose is 40mg of furosemide once a day.
• Your doctor may adjust your dose gradually until you respond.
• In very bad cases your doctor may ask you to take up to 1,500mg per day.
Children
• Your doctor will tell you the exact dose for your child based on your child’s weight.
• The usual dose is between 1-3mg per kg of your child’s weight.
• The maximum dose for children is 40mg daily.
If you take more Furosemide Oral Solution than you should
• If you take more medicine than your doctor has told you to, contact a doctor or your nearest hospital casualty department immediately and take your Furosemide Oral Solution with you.
If you forget to take Furosemide Oral Solution
• If you forget to take a dose, take another as soon as you remember. Then take your next dose at the normal time.
• Do not take double the amount to make up for a forgotten dose.
If you stop taking Furosemide Oral Solution
• Speak to your doctor before you stop taking Furosemide Oral Solution.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Furosemide Oral Solution can cause side effects, although not everybody 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 red and lumpy skin rash, difficulty breathing, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away.
• purple spotting or unexpected bruising of the skin;
• increased sensitivity to touch, skin prickling, skin is sensitive to sunlight;
• spasms, muscle twitching and cramps;
• inflammation of the pancreas which may cause severe pains in your abdomen or back, nausea, vomiting and fever;
• jaundice (your skin or whites of your eyes look yellow);
• swollen kidneys. 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. If symptoms become worse you may start to feel confused or go into a coma;
•if you have problems with your liver you may experience confusion leading to unconsciousness or coma;
• kidney stones in premature babies;
Furosemide can occasionally cause changes in your blood; your doctor will perform regular blood tests to ensure no changes have occurred. The symptoms of these changes include anaemia, leading to tiredness and lethargy; unusual bleeding or bruising, blood slow to clot; ulcers in your throat, mouth or on your skin.
Other effects which may occur:
• if you have diabetes, this may not be as well controlled;
• low blood pressure causing light-headedness, headache, dizziness, drowsiness, weakness, dry mouth or problems with your eyesight;
• if taken by premature babies in the first weeks of life it may affect growth and cause shortness of breath and rapid breathing;
• skin reactions such as itching, marks on the skin, flaky or scaly skin;
• thirst, headache, confusion, muscle cramps, muscle weakness, irregular heartbeat;
• dehydration;
• gout causing pain normally in the joints of your legs;
• hearing problems or ringing in your ears (tinnitus);
• blood clots in the elderly;
• if you have problems urinating furosemide may make this worse;
• Sickness, vomiting, diarrhoea, or generally feeling unwell.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects that are 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 Oral Solution
Keep out of the sight and reach of children.
Do not store above 25°C (77°F).
Store in the original package in order to protect from light.
Once opened, do not keep Furosemide Oral Solution for more than three months.
Do not use after the expiry date stated on the carton and the bottle. The expiry date refers to the last day of that month.
Ask your pharmacist how to dispose of any medicine that is left after three months or that you no longer require. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Furosemide Oral Solution contains
- The active substance is furosemide.
- Each 5ml of Furosemide 20mg/5ml Oral Solution contains 20mg of furosemide.
- Each 5ml of Furosemide 40mg/5ml Oral Solution contains 40mg of furosemide.
- Each 5ml of Furosemide 50mg/5ml Oral Solution contains 50mg of furosemide.
- The other ingredients are ethanol 96%, sodium hydroxide, disodium hydrogen orthophosphate dodecahydrate, citric acid (monohydrate), maltitol liquid, cherry flavour, quinoline yellow ([E104] 20mg strength only) and purified water.
What Furosemide Oral Solution looks like and contents of the pack
Furosemide 20mg/5ml Oral Solution is a clear, yellow, cherry-flavoured oral solution in an amber glass bottle containing 150ml of solution.
Furosemide 40 and 50mg/5ml Oral Solutions are clear, colourless, cherry-flavoured oral solutions in amber glass bottles containing 150ml of solution.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, UK.
Tel: 01283 495 280 Fax: 01283 495 290 Email: medinfo@focuspharma.co.uk
Manufacturer
Dales Pharmaceuticals Ltd, Keighley Road, Skipton, N Yorks, BD23 2RW
For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.