Furosemide Tablets 40mg
FUROSEMIDE 20 mg & 40 mg TABLETS PACKAGE LEAFLET: INFORMATION FOR THE USER
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 further questions, please 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 is and what it is used for
2. Before you take Furosemide
3. How to take Furosemide
4. Possible side effects
5. How to store Furosemide
6. Further information
1. WHAT FUROSEMIDE IS AND WHAT IT IS USED FOR
• Furosemide is a diuretic ("water tablet") used to remove excess water from the body by increasing the amount of urine produced.
• Furosemide is used to treat:
• oedema (fluid retention) caused by heart failure and certain liver and kidney disorders
• high blood pressure.
2. BEFORE YOU TAKE FUROSEMIDE
DO NOT take Furosemide and tell your doctor if you:
• are allergic (hypersensitive) to any of the ingredients in your medicine
• are allergic (hypersensitive) to sulphonamides (used to treat infections) e.g. co-trimoxazole
• have severe liver disease
• have difficulty passing urine
• have kidney failure
• have severe hypovolaemia (an abnormally low volume of blood in the circulation)
• are dehydrated (you may have an increased thirst, dry lips and tongue, and pass smaller amounts of urine than usual)
• have been told that you have severe hyponatraemia (an abnormally low level of sodium in the blood)
• have been told that you have hypokalaemia (low levels of potassium in the blood)
• have been told that you have an electrolyte deficiency (low salt levels in the blood)
• are breast-feeding (see section on Pregnancy and breast-feeding).
This medicine is not recommended to the patients who are in pre-coma or coma state associated with liver disease.
Take special care with Furosemide
Tell your doctor before you start to take this medicine if you:
• have a history of gout (causes excessive uric acid in the blood and painful inflammation of the joints mainly in the feet, hands and big toe)
• have diabetes
• have prostatic hypertrophy (enlargement of the prostate gland or narrowing of the ureter, the tube that connects the kidney and bladder) and difficulty in passing water
• suffer with low blood pressure (dizziness on standing), your fluid electrolyte balance should be regularly monitored and the dose should be adjusted accordingly. 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.
• 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,
• have been told that you have hyponatraemia (low concentration of sodium in the blood)
• have hypoproteinaemia (an abnormally low level of protein in your blood)
• are elderly
Your doctor may need to do some blood tests from time to time to check the levels of sodium, potassium, creatinine and glucose in your blood. Close monitoring is necessary if 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. If you are to undergo a blood test remember to tell the doctor you are taking 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 Furosemide for a long time, you doctor may recommend you to have potassium rich diet (i.e. potatoes, bananas, tomatoes, spinach and dry fruits) or may also recommend a medical substitution of potassium.
Children
If the patient is a premature infant their kidney function will be monitored.
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.
Taking other medicines
Talk to your doctor if you are taking any of the following:
• medicines used to treat high blood pressure (e g. methyldopa), including other diuretics e g. bendroflumethazide, as your blood pressure may become too low
• medicines used to treat abnormal heart rhythm (eg. amiodarone )
• antibiotics (e.g. cefaloridine, kanamycin, gentamicin, tobramycin, cephalosporins, polymyxins), as there is an increased risk of kidney problems
• antibiotics known as an aminoglycoside, e.g. streptomycin or gentamicin
• non-steroidal anti-inflammatory drugs (e.g. aspirin, indometacin), as the effectiveness of Furosemide may be altered
• lithium, a treatment for depression, as lithium levels in the blood may be increased
• medicines used for diabetes (such as insulin or oral tablets), as the risk of “hypos” may be increased
• products that increase blood pressure (pressor amines e.g. adrenaline, noradrenaline)
• theophylline (used to help your breathing) or salicylates (e.g. aspirin), as their effectiveness may be increased
• cardiac glycosides (used for heart problems), e.g. digoxin, digitoxin, ACE inhibitors (used to treat heart and circulation problems), e.g. captopril or enalapril, sympathomimetics (used to treat asthma problems), e.g. salbutamol, or any medicines to treat low blood pressure, Angiotensin II receptor blocker e.g. losartan (used to treat high blood pressure)
• phenytoin or carbamazepine (used to treat epilepsy), aminoglutethimide (used to treat cancer), carbenoxolone (used to treat inflammation and ulceration), amphotericin (used to treat infections),
reboxetine (used to treat depression), methotrexate (used to treat leukaemia) or you are being given cisplatin (used to treat cancer)
• corticosteroids (used to reduce inflammation and allergy), e.g. prednisolone, betamethasone, drugs that may affect your kidney function, eg. probenecid, or any liquorice containing products
• laxatives used over a long period of time
• sucralfate (used to treat ulcers and inflammation of the stomach lining). Sucralfate and Furosemide must not be taken within 2 hours of one another as sucralfate may decrease the effectiveness of Furosemide
• curariform muscle relaxants (e.g. vecuronium).
If you see another doctor or go into hospital, let them or the staff know what medicines you are taking.
Furosemide may increase the effects of muscle relaxants used in operations.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast-feeding
• If you are pregnant, planning to become pregnant or are breast-feeding. ask your doctor or pharmacist for advice before taking this medicine. Furosemide should only be used in pregnancy if indicated by your doctor or physician. Furosemide passes into breast milk; therefore you must stop breastfeeding if you are taking Furosemide.
Driving and using machines
• Furosemide may cause reduced mental alertness. If you are affected, DO NOT drive or operate machinery. 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.
•
Important information about some of the ingredients of Furosemide
• Patients who are intolerant to lactose should note that Furosemide tablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE FUROSEMIDE
Always take Furosemide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The tablets should be swallowed with a drink of water. Sucralfate and Furosemide must not be taken within two hours of each other. The usual dose is:
Oedema (fluid retention) caused by heart failure and certain liver and kidney disorders:
• Adults
40 mg (two 20 mg tablets or one 40 mg tablet daily). Your doctor may adjust this to suit your needs. The maximum daily dose is 1,000 mg.
• 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 - 3 mg for each kilogram of the child's body weight should be given daily. Do not exceed 40 mg per day.
• Elderly
Dose should be same as adult dose. Your doctor will gradually adjust your dosage to suit your needs.
High blood pressure:
The usual initial dose in adults is 20-40mg daily, adjusted if necessary until an effective response is achieved. In more severe cases doses of up to 60mg per day may be required.
If you take more Furosemide than you should
If you (or someone else) take too many tablets, or if you think a child has accidentally swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
An overdose is likely to cause excessive urine production which could lead to dehydration and low salt levels in the blood. This in turn causes increased thirst, increased heartbeat and breathing, low blood pressure, blood clots, kidney problems, delirious states, feeling sick, sweating, loss of consciousness, appearance of a blue or purple coloration of the skin, tiredness, confusion and unusually pale skin. The skin may look dry and lose its elasticity.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Furosemide
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. DO NOT take a double dose to make up for a forgotten dose.
If you stop taking Furosemide
DO NOT stop taking your medicine without talking to your doctor first even if you feel better.
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 can cause side effects, although not everybody gets them.
Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens:
• an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in breathing, severe skin rash, itching or nettle rash.
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
Tell your doctor if you experience:
Furosemide may alter the levels of chemicals (glucose, fats, potassium, sodium magnesium, chlorine and calcium) present in your blood. The symptoms you may feel are like tiredness, constipation, increased thirst, headache, muscle cramp or weakness, confusion or unexplained changes to heart rate, heart problems, uncontrollable flatulence, increase in urinary frequency, increased volume of urine, apathy, involuntary contraction of muscles, loss of appetite, feeling sleepy, tingling or numbness in the hands and feet. Severe potassium losses may lead to blockage of the bowel or disturbed consciousness, with coma in extreme cases. Due to alteration of the composition of your blood and your doctor may want to do some blood tests from time to time.
The following have also been reported:
Blood disorders
Furosemide can occasionally cause changes in your blood; your doctor will perform regular blood tests to ensure no changes have occurred.
Uncommon side effects (occurring in more than 1 in 1000 patients but in less than 10 in 1000 patients):
reduction in blood platelets, which increases risk of bleeding or bruising
Rare side effects (occurring in more than 1 in 10,000 patients but in less than 10 in 10,000 patients):
Blood disorder, reduction in the number of white blood cells, which makes infections more likely
Very rare side effects (occurring in less than 1 in 10,000 patients): reduction in red blood cells and other
blood cells which can make the skin pale or yellow and cause weakness or breathlessness, bruising.
Ear disorders
Rare side effects (occurring in more than 1 in 10,000 patients but in less than 10 in 10,000 patients): hearing difficulty or ringing in the ears
Stomach and intestinal disorders:
Rare side effects (occurring in more than 1 in 10,000 patients but in less than 10 in 10,000 patients):
Stomach upset, feeling sick, being sick, frequent passing of loose or watery stools
Very rare side effects (occurring in less than 1 in 10,000 patients): Pancreatitis (inflammation of the pancreas)
Liver disorders
Very rare side effects (occurring in less than 1 in 10,000 patients): Jaundice (yellowing of the skin and whites of the eyes), abnormal result of liver function test.
Kindney disorders
Rare side effects (occurring in more than 1 in 10,000 patients but in less than 10 in 10,000 patients):
Inflammation of the kidney which can cause swollen ankles or high blood pressure, lack of ability to urinate, increased production of urine.
Skin
Uncommon side effects (occurring in more than 1 in 1000 patients but in less than 10 in 1000 patients):
itching, widespread rash, nettle rash, bruise like rash, scaling of the skin, Sensitivity to light
Very rare side effects (occurring in less than 1 in 10,000 patients): Serious illness with blistering of the
skin, mouth, eyes and genitals.
Other side effects which have been reported include:
• difficulty in controlling your blood sugar levels if you have diabetes
• worsening of the symptoms of metabolic alkalosis, a condition in which the alkalinity of body fluids and tissues is abnormally high
• dehydration and hypovolaemia (low blood volume) especially in the elderly
• excessive loss of body fluid may lead to an increased number of red blood cells in the blood. Increased number of red blood cells may lead to formation of blood clot particularly in elderly patients.
• low blood pressure (which may cause symptoms such as light-headedness, dizziness, fainting, a feeling of pressure in the head, sight problems, slow reactions, problems concentrating, dry mouth)
• bone marrow depression (causing impairment of blood cell production)
• increased blood creatinine and urea levels (this can be identified from your blood test.)
• gout
• diabetes
• a general feeling of being unwell
• fever
• shock
• in premature infants, calcium deposits in the kidneys have been reported and an increase in the persistence or the risk of patent ductus arteriosus, a heart defect
• inflammation of the blood vessels
• pins-and-needles
Levels of circulating fats in the body including cholesterol may increase, but during prolonged treatment these usually return to normal within six months.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE FUROSEMIDE
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package or container supplied and keep tightly closed. Keep the container in the outer carton.
Do not use Furosemide after the expiry date shown on the outer packaging. The expiry date refers to the last day of that month.
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 Tablets contain:
• The active ingredient is furosemide 20 mg or 40 mg.
• The other ingredients are:
• 20 mg tablets: lactose monohydrate, magnesium stearate (E572), sodium starch glycolate, maize starch and starch paste.
• 40 mg tablets: lactose monohydrate, magnesium stearate (E572), sodium starch glycolate, microcrystalline cellulose (E460), povidone and colloidal anhydrous silica (E551).
What Furosemide Tablets look like and contents of the pack:
• Furosemide 20 mg Tablets are white, circular, flat bevel edged tablets, engraved “1B2” on one side with a breakline on the reverse.
• Furosemide 40 mg Tablets are white, flat, bevel-edged tablets, engraved “F40” on one side with a breakline on the reverse.
• The 20 mg tablets are available in pack sizes of 28, 56, 100, 250, 500 and 1,000 tablets.
• The 40 mg tablets are available in pack sizes of 20, 28, 30, 50, 100, 250 and 750 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: September 2012
PL 00289/0417, PL 00289/0818.