Furosemide 500mg Tablets
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teva UK Ref: 231-30-84123-F LEA FUROSEMIDE 500mg TAB TUK |
Version: 1 |
18 December 2015 |
PAGE 1: FRONT FACE (INSIDE OF REEL)
Pharma code 277
First bar is 105mm from the top edge of the leaflet.
Package leaflet: Information for the user
Furosemide 500 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 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.
What is 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
4. Possible side effects
5. How to store Furosemide
6. Contents of the pack and other information.
^ What Furosemide is and what it is used for
Furosemide belongs to a group of medicines known as diuretics (water tablets).
You should only use this high-dose formulation if you have severely reduced kidney function (glomerular filtration rate (GFR) < 20 ml/min).
Furosemide is used to treat reduced urine production (oliguria) in chronic kidney failure.
_ 2^ What you need to know before you take Furosemide
Do not take Furosemide
• If you are allergic to furosemide, sulphonamides or any of the other ingredients of this medicine (listed in section 6),
• If you have normal or mildly to moderately reduced kidney function with a GFR greater than 20 ml/min, because of the risk of severe fluid and salt (electrolyte) loss,
• If you have kidney failure and your kidneys do not produce urine at all (anuria),
• If you have liver failure with alterations of consciousness (hepatic coma and pre-coma),
• If you have potassium deficiency,
• If you have sodium deficiency,
• If you have too little blood (hypovolaemia) or body water (dehydration),
• If you are breast-feeding (see Pregnancy and breast-feeding below),
• If you have cardiac glycoside poisoning. Cardiac glycosides (e.g. digoxin, digitoxin) are medicines used for heart failure and abnormal heart rhythms.
Warnings and precautions
Furosemide may be used in advanced or end-stage kidney failure (when dialysis is or could become necessary) with fluid retention (oedema) and/or high blood pressure, and to maintain remaining urine production (with regular monitoring).
Talk to your doctor or pharmacist before taking Furosemide :
• If you have low blood pressure (hypotension),
• If you have or suspect you may have diabetes: regular monitoring of your blood sugar levels is necessary,
• If you have gout: regular monitoring of your blood uric acid levels is necessary,
• If you have an obstruction in the urine outflow tract (e.g. if you have an enlarged prostate or narrowing of the ureter, the tube that connects the kidney and bladder): your doctor will need to monitor your condition,
• If you have low levels of protein in your blood (hypoproteinaemia), for instance if you have nephrotic syndrome (loss of protein, disturbance of fat metabolism and fluid retention): your doctor will need to adjust your dose carefully, and you must follow his/her instructions exactly,
• If you have cirrhosis of the liver (tiredness, weakness, water retention, feeling or being sick, loss of weight or appetite, yellowing skin or eyes, itch) as well as reduced kidney function,
• If you have circulation problems in the brain (cerebrovascular circulatory disorders) or heart vessels (coronary heart disease): the risks associated with a possible fall in blood pressure are higher.
• If you are elderly, if you are on other medications which can cause the drop the blood pressure and if you have other medical conditions that are risks for the drop of blood pressure.
Your doctor will want to monitor you, and may take blood for testing while you are taking this medicine.
Close monitoring is necessary if you have a high risk of developing electrolyte disturbances (e.g. if you have cirrhosis of the liver, or you take corticosteroid medicines or use laxatives a lot, or you have a limited diet) or if you lose a lot of fluids (e.g. if you experience significant vomiting, diarrhoea or intensive sweating): any blood or fluid loss (hypovolaemia or dehydration) or any electrolyte or acid-base imbalance in your body will need to be corrected, which may require your doctor to temporarily stop your treatment with Furosemide.
You should not lose more than 1 kg a day in body weight owing to the increase in urine production caused by Furosemide, regardless of how much urine you pass.
Your doctor may need to check the effect of your treatment with Furosemide periodically by temporarily stopping it.
If you are taking another medicine called risperidone at the same time as Furosemide, it is very important that you avoid becoming dehydrated. In clinical studies in elderly patients with dementia, more patients died on risperidone with furosemide than on either treatment used alone.
Tell your doctor if you are going to undergo an X-ray examination with contrast media.
Children
Furosemide may cause calcium deposits or stones in the kidneys of premature babies and increases the risk of a fetal blood vessel called the ductus arteriosus remaining open after birth when it should normally close, in premature babies with breathing difficulties. The doctor will therefore need to monitor the baby very closely.
Athletes
Furosemide may cause positive results in drugs tests.
The use of Furosemide as a performance-enhancing substance may endanger your health.
Other medicines and Furosemide
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
The following medicines may influence the effect of Furosemide:
• Glucocorticoids ("cortisone"), carbenoxolone or laxatives may increase potassium loss and therefore the risk of potassium deficiency.
• Anti-inflammatory medicines (NSAIDs e.g. indomethacin, acetylsalicylic acid) may reduce the effect of Furosemide and increase the risk of acute kidney failure in the event of blood or fluid loss (hypovolaemia or dehydration).
• Probenecid (for gout), methotrexate (for arthritis and to suppress the immune system) and other medicines excreted by the kidneys may reduce the effect of Furosemide.
• Phenytoin (for epilepsy and some forms of pain) may reduce the effect of Furosemide.
• Carbamazepine (for epilepsy and some forms of psychiatric illness) may increase sodium loss and therefore the risk of sodium deficiency.
• Sucralfate (an antacid) reduces the uptake of Furosemide from the intestines and may thus weaken its effect: you should take sucralfate and Furosemide at least 2 hours apart.
Furosemide may influence the effect of the following medicines:
• Some heart medicines (glycosides) may have a stronger effect owing to the potassium and magnesium deficiency which Furosemide may cause. Medicines which affect the heart's rhythm (e.g. terfenadine for allergies, some medicines used to treat abnormal heart rhythms) have a higher risk of causing heart rhythm abnormalities if they are used at the same time as Furosemide or in the event of electrolyte disorders.
• The side effects of high-dose salicylates (for pain) may be worsened by Furosemide.
• The side effects of some medicines on the kidneys may be worsened (e.g. antibiotics such as aminoglycosides, cephalosporins, polymyxins). Furosemide together with high doses of some cephalosporins may cause worsening of kidney function.
• Furosemide may worsen the side effects of some medicines (e.g. aminoglycosides such as kanamycin, gentamicin, tobramycin) on hearing. These side effects are not always reversible. Furosemide should therefore not be used at the same time as these medicines.
• The risk of damage to hearing may be increased when cisplatin (for cancer) and Furosemide are used together. Caution is required as the side effects of cisplatin on the kidney may also be worsened.
• The side effects of lithium (for certain forms of depression) on the heart and nervous system may be worse if Furosemide is used at the same time. Your doctor should monitor your blood lithium levels if you take these medicines together.
• Your blood pressure may fall if you take Furosemide with other medicines with the potential to lower it, such as other diuretics. Medicines called ACE inhibitors and angiotensin II receptor blockers especially may lead to a massive drop in blood pressure to the point of shock and a worsening of kidney function (in isolated cases to the point of kidney failure) when the first dose is taken or the first time a higher dose is used. Your doctor may tell you to stop taking Furosemide for at least 3 days before you start taking an ACE inhibitor or an angiotensin II receptor blocker or before the dose of these medicines is increased.
• Furosemide may reduce the removal of probenecid, methotrexate or other medicines by the kidneys, which may lead to increased blood levels and possible side effects.
• The effect of theophylline (for asthma) or curare-type muscle relaxants may be increased if they are used at the same time as Furosemide.
• Antidiabetic medicines and products that increase blood pressure (pressor amines e.g. adrenaline, noradrenaline) may not work as well with Furosemide.
• Caution is required when using risperidone at the same time as Furosemide (see Warnings and precautions above).
Joint inflammation and gout may occur if Furosemide is combined with ciclosporin A.
The kidney side effects of contrast media used in some X-ray examinations may worsen with Furosemide.
In isolated cases, the use of chloral hydrate within 24 hours after the intravenous administration of furosemide led to hot flushes, sweating, unrest, feeling sick and a fast heartbeat. Chloral hydrate should not be used at the same time as Furosemide.
Furosemide with food and drink
You should not consume large amounts of liquorice while you are taking Furosemide as it could increase your loss of potassium.
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
You should not take Furosemide if you are pregnant unless your doctor considers it to be essential: Furosemide crosses the placenta.
Top of page cut-off to middle of registration mark: 44 mm.
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TEVA UK Ref: 231-30-84123-F LEA FUROSEMIDE 500mg TAB TUK |
Version: 1 |
18 December 2015 |
PAGE 2: REAR FACE (OUTSIDE OF REEL)
You must not take Furosemide if you are breast-feeding as it will pass into your milk and inhibit your milk production. You must stop breast-feeding in order to take Furosemide.
Ask your doctor or pharmacist for advice before using any medicine. Driving and using machines
Furosemide may impair your ability to react to such a degree that it may influence your capacity to drive and use machines. This is especially true at the beginning of treatment, when the dose is increased or the medicine switched, and if you consume alcohol during treatment.
Furosemide contains lactose.
Furosemide contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
How to take Furosemide
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will decide the dose that is right for you, based mainly on how you respond to the treatment. The dose should be as low as possible to achieve the desired effect.
Adults
The starting dose of Furosemide is half a tablet (250 mg furosemide).
Your doctor will then adjust your dose gradually in steps of half a tablet (250 mg) at intervals of 4 to 6 hours, up to a usual maximum dose of 2 tablets (1,000 mg). Your doctor will periodically check your urine output and electrolyte and fluid balance.
If you have chronic kidney impairment, your doctor will adjust the dose carefully in order to reduce your fluid retention (oedema).
Use in children and adolescents
Furosemide is not recommended for use in children and adolescents under 18 years of age due to insufficient data on safety and effectiveness: other pharmaceutical forms/strengths may be more appropriate for administration to these patients.
Elderly and patients with hepatic impairment
Your doctor will carefully adjust your dose according to how you respond to the treatment.
Method of administration
The tablets should be taken in the morning without food, without chewing, with a sufficient amount of fluid (e.g. a glass of water).
Your doctor will decide how long you should keep taking Furosemide, depending on the nature and severity of your illness.
If you take more Furosemide than you should
If you take too much Furosemide, or you suspect an overdose, contact a doctor immediately. The signs of an acute overdose are related to the loss of salt and fluid: low blood pressure (hypotension), feeling dizzy or light-headed on standing up (orthostatic regulation problems), electrolyte disturbances (reduced potassium, sodium and chloride levels) or an increase in the pH value of the blood (alkalosis). Severe fluid loss may lead to dehydration and collapse from reduced blood volume with concentration of the blood and an increased risk of blood clots. In the event of rapid fluid and electrolyte loss, confusion and delirium may occur.
If you forget to take Furosemide
Carry on with the usual dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Furosemide
Do not stop taking Furosemide unless your doctor tells you to or your treatment may be unsuccessful.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
^ Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect upto 1 in 10 people):
• Electrolyte or fluid disorders which may lead to
• sodium deficiency (hyponatraemia, most frequently characterised by
apathy, leg cramps, loss of appetite, weakness, sleepiness, vomiting and confusion)
• potassium deficiency (hypokalaemia characterised most frequently by
muscle weakness, pins and needles, slight paralysis, vomiting, constipation, bloating, frequent urination, excessive thirst and abnormal heart rhythms, and, in severe cases, intestinal obstruction or altered consciousness including coma)
• calcium deficiency, sometimes leading to muscle twitching and
cramps (tetany)
• magnesium deficiency, rarely leading to muscle twitching and cramps
(tetany) or heart rhythms abnormalities
• increased blood pH (metabolic alkalosis)
• significant fluid loss may lead to circulatory disorders chiefly
associated with headache, dizziness, visual disturbances, mouth dryness and thirst, low blood pressure (hypotension) and feeling dizzy or light-headed on standing up (orthostatic regulation problems), especially in the elderly and in children. Severe fluid loss may lead to dehydration and collapse from reduced blood volume with concentration of the blood and an increased risk of blood clots.
• Raised blood uric acid levels which may lead to gout in some patients
Uncommon side effects (may affect upto 1 in 100 people):
• Low numbers of blood platelets (thrombocytopenia)
• Itching, skin and mucous membrane reactions: redness, blisters, scales (e.g. bullous exanthema, hives, purpura, erythema multiforme, bullous pemphigoid, exfoliative dermatitis), increased sensitivity to light (photosensitivity)
• Deafness (sometimes irreversible)
Rare side effects (may affect upto 1 in 1,000 people):
• High or low numbers of white blood cells (eosinophilia or leucopenia)
• Fever
• Inflammation of blood vessels (vasculitis)
• Inflammation of the kidneys (interstitial nephritis)
• Severe allergic reaction (anaphylactic shock): the first signs are a skin reaction with flushing or hives, unrest, headache, sweating, feeling sick and a bluish tinge to the skin (cyanosis)
• Pins and needles (paraesthesia)
• Usually reversible hearing disorders and/or ringing or buzzing in the ears (tinnitus)
• Digestive problems (e.g. feeling or being sick, diarrhoea)
Very rare effects (may affect up to 1 in 10,000 people):
• Anaemia due to loss (haemolytic anaemia) or reduced production (aplastic anaemia) of red blood cells, very low numbers of certain white blood cells with an increased risk of infection and severe general symptoms (agranulocytosis)
• Inflammation of the pancreas, inhibition of bile flow (intrahepatic cholestasis), increased liver function test results (transaminases)
• Certain severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
Not known (frequency cannot be estimated from the available data)
• acute generalised exanthematous pustulosis (AGEP)" (acute febrile drug eruption)
• dizziness, fainting and loss of consciousness (caused by symptomatic hypotension)
Blood glucose levels may increase during treatment with Furosemide, which may lead to worsened control of diabetes or the overt manifestation of previously silent diabetes. Blood fat (cholesterol and triglyceride), creatinine or urea levels may also increase.
Brain disease (hepatic encephalopathy) may develop in patients with advanced liver disease.
Symptoms of obstruction in the urine outflow tract (e.g. enlarged prostate or narrowing of the ureter, the tube that connects the kidney and bladder) may develop or worsen, with the potential for urine retention and associated complications.
Furosemide may cause calcium deposits or stones in the kidneys of premature babies and increases the risk of a fetal blood vessel called the ductus arteriosus remaining open after birth when it should normally close, in premature babies with breathing difficulties.
If you develop any of these side effects, please contact your doctor as soon as possible. If a side effect develops suddenly or becomes serious, please seek medical advice immediately as some side effects may under certain circumstances be life-threatening.
You must stop taking Furosemide at the first signs of an allergic (hypersensitivity) reaction.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
How to store Furosemide
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the cartons and bottle after 'EXP'. The expiry date refers to the last day of that month.
• Store in the original package in order to protect from light.
• 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.
Contents of the pack and other information What Furosemide contains
• The active substance is furosemide. Each tablet contains 500 mg furosemide.
• The other ingredients are lactose monohydrate, maize starch, silica colloidal anhydrous, talc, magnesium stearate and iron oxide yellow (E172).
What Furosemide looks like and contents of the pack
• Tablet.
• Light yellow, round flat tablets of 13 mm diameter, with bevelled edges, debossed "FUS" on one side and quartering score lines on the other. The tablet can be divided into equal doses or quarters.
• Furosemide is available in pack sizes of 20, 28, 30, 50, 60, 90 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Eastbourne BN22 9AG, United Kingdom
This leaflet was last revised in 12/2015 PL 00289/1420
84123-F 323x 200