PATIENT INFORMATION LEAFLET
Please read all of this leaflet carefully before you start taking this medicine. Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible sideeffects not listed in this leaflet. See section 4.
In this leaflet:
1. What Furosemide Tablets are and what they are used for
2. Before you take Furosemide Tablets
3. How to take Furosemide Tablets
4. Possible side effects
5. How to store Furosemide Tablets
6. Further information
1. What Furosemide Tablets are and what theyare used for
Furosemide belongs to a group of drugs known as diuretics.
These are used for reducing the amount of water in your body.
This could be due to problems with your heart, lungs, kidneys, liver, blood vessels or high blood pressure. This medicine is used to helpreduce the amount of excess water (oedema) in any part of the body.
2. Before you take Furosemide TabletsDo not take these tablets if you:
• are allergic to furosemide, amiloride, sulphonamides or any of theother ingredients (see section 6)
• are under 18 years of age
• are not producing any urine or very little urine
• have been told by a doctor that you have kidney failure; in sometypes of kidney failure, it is still okay to have this medicine - yourdoctor will be able to decide
• have liver disease
• have low blood pressure
• have digitalis poisoning (feeling or being sick, high levels ofpotassium in the blood, slow, fast or irregular heart beat)
• have an electrolyte deficiency e.g. low levels of sodium orpotassium
• have low blood volume and you are dehydrated
• have Addisons disease (long term disorder of the adrenal glands)
• have porphyria (a rare disease in which your urine becomes darkand your skin becomes extremely sensitive to the light)
• are taking other medicines that change the amount of potassiumin your blood including potassium supplements and potassiumsparing diuretics (see ‘Taking other medicines” section below)
• are breast-feeding (see “Pregnancy and breast-feeding” sectionbelow).
Check with your doctor before taking these tablets if you:
• have an enlarged prostate gland or difficulty passing urine
• have low blood volume or low blood pressure as these will needto be corrected before taking furosemide
• have or may have diabetes. If you are taking insulin your doctormay need to adjust your insulin dose
• have gout
• have liver or kidney problems
• have adrenal disease (other than Addison's disease alreadymentioned above)
• have low levels of protein in your blood (hypoproteinaemia)
• are being treated for high blood calcium levels and havedehydration, your doctor will need to correct this before givingyou furosemide
• are pregnant, think you may be pregnant or trying to get pregnant
• are elderly, if you are taking other medicines which can cause a drop in blood pressure and if you have other medical conditionsthat are risks for a drop of blood pressure.
Taking other medicines:
Check with your doctor or pharmacist before taking these tablets if you are taking other medicines, including any that you can buywithout prescription. This is particularly important if you are taking:
• potassium supplements such as potassium chloride
• any medicines to treat high blood pressure, irregular heartbeator any other heart problems
• other water tablets (diuretics) such as metolazone andacetazolamide. Do not take this medicine if you are alreadytaking other diuretics such as amiloride and spironolactone.
• medicines to treat diabetes such as insulin or gliclazide
• non-steroidal anti-inflammatory pain killers (NSAIDs) such asindometacin, ketorolac and aspirin
• antibiotics such as gentamicin, colistin, cefaloridine,vancomycin, trimethoprim, neomycin and polymixins
• general anaesthetics for use during surgery. If you are going tohave an anaesthetic please let your doctor or nurse know youare taking this medicine
• medicines to treat allergies (anti-histamines) such as cetirizine,terfenidine
• chloral or triclofos used for anxiety related disorders to help yousleep and relax
• medicines used for attention deficit hyperactivity disorder(ADHD) such as atomoxetine and methylphenidate
• methotrexate used for some cancers or autoimmune diseases
• levodopa used for Parkinson's disease
• ciclosporin, tacrolimus or aldesleukin used to stop the rejectionof organs after a transplant, and for cancer treatment
• baclofen or tizanidine (muscle relaxants)
• oestrogens and progestagens used in hormone replacementtherapy (HRT) and contraceptives such as drospirenone
• alprostadil used for impotence
• carbenoxolone and sucralfate used to treat stomach ulcers,ulcers of the intestine and inflammation of the stomach lining;sucralfate should be taken at least 2 hours before or after thismedicine
• phenytoin or carbamazepine to control epilepsy
• corticosteroids such as prednisolone or hydrocortisone usedto suppress the symptoms of some inflammatory and allergicdisorders
• cisplatin used to treat some cancers
• aminoglutethimide used in some cancers or to reduce steroidhormone levels in the blood
• moxisylyte (thymoxamine) or hydralazine to treat Raynaud’ssyndrome and high blood pressure
• medicines for asthma such as bambuterol, fenoterol, formoterol,ritodrine, salbutamol, salmeterol, terbutaline, theophylline
• amphotericin for fungal infections
• medicines to treat depression such as amitriptyline andimipramine, monoamine oxidase inhibitors (MAOIs) such asphenelzine, or reboxetine
• medicines used to treat mental illnesses or disturbances suchas lithium, pimozide, thioridazine, amisulpride, sertindole,risperidone, chlorpromazine, fluphenazine
• probenecid used for the treatment of gout
• laxatives used over a long period of time
• glychyrrizin (contained in liquorice).
Other special warnings:
Surgery: before you have any kind of surgery, tell the doctor or dentist you are taking this medicine.
Driving or using machinery: Do not drive or operate machinery if you feel dizzy or less alert or have blurred vision aftertaking this medicine.
Alcohol: Avoid drinking alcohol while you are taking these tablets, as together with this medicine it can cause your blood pressure todrop.
Pregnancy and breastfeeding: Check with your doctor before taking this medicine if you are pregnant, planning to becomepregnant or breastfeeding. Your doctor will only prescribe thismedicine if strictly necessary during pregnancy and it should not betaken if you are breastfeeding.
Tests: While you are taking this medicine your doctor may give you regular blood tests to check the levels of salts and minerals inyour blood and that your liver and kidneys are working properly.
Important information about one of the ingredients of this medicine: Contains lactose. If you have been told by yourdoctor that you have an intolerance to some sugars, contact yourdoctor before taking this medicine.
3. How to take Furosemide Tablets
The tablets should be swallowed with a drink of water.
Your doctor will decide the dose that is best for you.
The pharmacist’s label will also tell you how many tablets to take and how often.
If you are not sure about anything, ask your doctor or pharmacist.
Adults and children over 12 years:
For water retention: the usual starting dose is 40mg in the morning, then 20mg daily or 40mg on alternate days. Your doctormay increase the dose to 80mg if necessary.
For high blood pressure: 20-40mg twice a day.
Children under 12 years: The dose depends on the weight of the child, the usual dose is 1 to 3mg/kg body weight daily.
Elderly: The dose will be determined for individual patients by the doctor.
If you have taken too many tablets:
Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and thepack so that the medicine can be identified.
If you miss a dose of this medicine:
Take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with the regulardosing schedule. DO NOT DOUBLE THE DOSES.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following occur STOP taking the tablets and contact your doctor IMMEDIATELY asthese may be signs of an allergic reaction:
• swelling of the face, lips, tongue or throat, difficulty in breathing,and in severe cases shock or collapse
• skin rash, flaking, peeling, blistering, inflammation, itching,bruising due to bleeding under the skin, sensitivity to sunlight orsun lamps.
Tell your doctor straight away if you notice any of the following side effects:
■ pale skin, weakness, breathlessness, tiredness, unusualbleeding or bruising, your blood is slow to clot, fever, chills,sore throat, sores or ulcers in the mouth, generally feelingunwell, increased heart rate or frequent infections. These aresymptoms of changes in your blood/blood cell disorders
• liver problems including liver failure in patients who alreadyhave liver problems, signs include yellowing of the skin,dark urine and pale stools
• inflammation of the kidney or kidney failure which can causeswollen ankles or feet, high blood pressure, tiredness, itchyskin, weight loss, feeling sick and you may have a fever
• inflammation of blood vessels which may cause skin rash,fever, joint or muscle pains
If you notice any of the following effects, tell your doctor or pharmacist:
Uncommon effects that may happen to less than 1 in 100 people:
• upset stomach including feeling or being sick, constipation,dry mouth or feeling thirsty
• blurred or altered vision
• changes in the rhythm of your heartbeat
■ increases in the levels of cholesterol, creatinine, urea and fat inthe body
• deafness (sometimes irreversible).
Rare effects that may happen to less than 1 in 1000 people:
■ inflammation of the pancreas which causes severe pain in theabdomen and back
• ringing in the ears or hearing problems
• tiredness, fever or generally feeling unwell
• pins and needles/tingling of the skin
• minor mental disturbances
• falling into unconsciousness/coma
• drug rash with eosinophilia (elevated level of the eosinophilcount in the blood) and systemic symptoms (DRESS).
Effects of not known frequency:
• acute generalised exanthematous pustulosis (AGEP)” (a rare,acute eruption characterised by the development of numeroussmall, sterile pustules, arising on the skin)
• dizziness, fainting and loss of consciousness (caused bysymptomatic low blood pressure)
Other effects:
• changes in the amounts of water, salts or minerals in your body(e.g. sodium, potassium, calcium) causing thirst, weakness,tiredness or drowsiness, restlessness, fits, headache, low bloodpressure, feeling dizzy particularly when standing up, confusion,muscle pain, spasms, tremors, twitching or cramps, difficultypassing water, loss of appetite, abnormal heart rhythm, feelingor being sick, difficulty with breathing. If you already suffer frommetabolic alkalosis, this medicine may make your symptomsworse
• severe joint pain (gout) caused by increased amounts of uricacid in the blood
• decreased tolerance to sugars including mild diabetes. If yousuffer from diabetes, your insulin doses may need adjusting
• low blood pressure (symptoms include feeling light-headed ordizzy, loss of concentration, headache, altered vision and drymouth - these symptoms may get worse when you stand up).Low blood pressure may lead to shock, dehydration and anincreased risk of blood clots forming, particularly in the elderly
• increased amount of urine or difficulty in urinating, particularly inthose who already have bladder or prostate problems
• kidney stones in premature babies
• in premature babies with heart defects, furosemide may makethem worse.
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 the tablets in the container provided and do not store above 25°C.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not take the tablets if the expiry date on the pack has passed.
If you have any medicines that are out of date, return them to your pharmacist for safe disposal.
6. Further informationIngredients
Each Furosemide Tablet 20mg contains 20mg of furosemide.
Each Furosemide Tablet 40mg contains 40mg of furosemide.
Other ingredients are lactose, magnesium stearate, sodium starch glycollate, pregelatinised maize starch and maize starch.
What the medicine looks like:
Furosemide Tablets 20mg are white, round tablets, engraved with the company logo on one side and A328 on the other.
Furosemide Tablets 40mg are white, round tablets, engraved with the company logo on one side and a breakline and A270 on theother.
The tablets come in pack sizes of 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 and 1000 tablets. Not all pack sizes may bemarketed.
Who makes this medicine and holds the product licence:
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED
Date leaflet prepared: March 2016.
If you would like this leaflet in a different format please contact the licence holder at the aboveaddress.
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