Patient leaflet - FUROSEMIDE TABLETS BP 500 MG, DIURESAL 500 MG TABLETS
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
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1. WHAT FUROSEMIDE TABLETS ARE AND WHAT THEY ARE USED FOR
I ,
Furosemide Tablets are one of a group of Medicines called diuretics (water tablets). They are used to treat the abnormally low production of urine caused by kidney disorders.
2. what you need to know before you take furosemide tablets
I… ........
Do not take Furosemide Tablets ifyou:
- Are allergic to furosemide or any of the other ingredients of this medicine (listed in section 6). Signs ofan allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue
- Are allergic to amiloride, sulfonamides or sulphonamide derivatives, such as sulfadiazine or cotrimoxazole
- Have a low blood volume or are dehydrated (with or without accompanying low blood
| pressure)
- Have too little potassium or sodium in your blood (shown in blood test)
- Have severe liver problems (cirrhosis)
- Have already taken furosemide in the past to treat failure to pass urine or kidney failure or if you have kidney failure that is due to medicines or chemicals that are prone to cause kidney or liver damage or if you have kidney failure due to underlying liver disorders
- Are not passing any water (urine) or have been told by a doctor that you have kidney failure. In some types of kidney failure, it is still okay to have this medicine. Your doctor will be able to
| decide
- Have an illness called ‚Addison's Disease‘. This can make you feel tired and weak or if you are taking digoxin, used to treat heart problems
- Have digitalis poisoning (feeling or being sick, high levels of potassium in the blood, slow, fast or irregular heart beats)
- Take potassium supplements or potassium sparing diuretics for high blood pressure (e.g. amiloride or spironolactone)
- Have a disease called porphyria characterised by abdominal pain, vomiting or muscle
I weakness
- Are breast-feeding
- Are planning to undergo a procedure that
includes the use of radiocontrast (as taking
। furosemide with this may increase the risk for kidney damage)
- Are below 18 years of age.
If you have no problems with your kidneys (i.e normal kidney function), you should not take Furosemide Tablets. Talk to your doctor ifyou are unsure.
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before taking Furosemide Tablets ifyou:
- Are elderly, if you are on other medicines which
। can cause a drop in blood pressure and if you
have other medical conditions that are risks for
। a drop in blood pressure
- Have low blood pressure or feel dizzy when
। you stand up
- Feel dizzy or dehydrated. This can happen if
। you have lost a lot of water through being sick, having diarrhoea or passing water very often. It
। can also happen if you are having trouble
1 drinking or eating
- Have low blood levels of essential minerals like
1 sodium or potassium or you have acid base
। imbalance in the body identified by blood tests
- Are taking digoxin, used to treat heart problems
- Are taking any other water tablets
- Are going to have a glucose test
- Are going to give this to a baby that was born
-
1 too early.
Take special precaution ifyou:
» Are an elderly patient
- Have difficulty in passing water, for example
। because of an enlarged prostate gland (males
। only)
- Have diabetes
- Have gout (characterised by painful joints due
। to elevated uric acid levels)
- Have kidney or liver problems
- Have adrenal disease
- Have low blood protein levels as this may
। reduce the effect of the drug and increase the
' risk of ear damage
- Have raised levels of calcium in the blood;
' careful monitoring offluids and electrolyte
। levels are recommended
- Have a risk offall in blood pressure; or in case
। of premature infants as they may be more
I prone to development of kidney stones
- Are already on medicines like NSAIDs (used for I inflammation and pain) or ACE inhibitors
। (medicines used to lower blood pressure)
- Are an elderly patient with dementia and are
। also taking risperidone
- Laboratory monitoring: it is recommended to undergo regular monitoring of blood levels for sodium, potassium, kidney function tests (blood urea nitrogen and creatinine levels), glucose, magnesium, calcium, chloride, bicarbonate and uric acid.
- Regular monitoring is required to check for occurrence of blood dyscrasias (abnormal or imbalance in blood components), liver damage or any symptom that may occur particularly to you.
Your doctor may monitor you and may take blood for testing while you are taking this medicine.
Children
Furosemide Tablets are not recommended in children below 18 years ofage.
Other medicines and Furosemide Tablets
Tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicines.
Do not take this medicine and tell your doctor, if you are taking:
chloride or certain water tablets (diuretics) such1 as triamterene or potassium-sparing diuretics i such as amiloride spironolactone.
effects. These drugs include:
perindopril (called ‚ACE inhibitors‘) or losartan, candesartan, irbesartan (called ‚angiotensin II i receptor antagonists‘) or any renin inhibitors such as aliskiren. Your doctor may need to i
- Medicines such as tricyclic antidepressants, hypnotics and anxiolytics (e.g. barbiturates and i reboxetine)
moxonidine, sodium nitroprusside, amiodarone,1 disopyramide, flecainide, minoxidil, lidocaine, i prazosin, diazoxide, methyldopa, sotalol, tocainide and mexiletine i
- Digoxin used to treat heart failure. Your doctor 1 may need to change the dose of your medicine ।
- Metolazone – medicine used to pass more urine1
- Lithium – used for mental illness
- Birth control Pills or oestrogen containing drugs,
- Medicines for diabetes. These may not work as.
well when you are taking Furosemide Tablets I
- Medicines used for mental problems called ‚psychoses‘, such as risperidone, amisulpride, I sertindole, pimozide, phenothiazines and chlorpromazine. Avoid using pimozide at the same time as furosemide
- Medicines for asthma when given in high dosesi such as salbutamol, terbutaline sulphate, salmeterol, formoterol or bambuterol
- Other water tablets (diuretics) such as bendroflumethiazide. Your doctor may need to I change the dose of your medicine
- Medicines used as injections before x-ray examinations (radiocontrast agent)
- Antibiotics such as trimethoprim and cephalosporins
- Carbenoxolone – used to treat ulceration and inflammation.
Furosemide Tablets with alcohol
Avoid alcohol when taking Furosemide Tablets as iti may lead to excessive lowering of blood pressure.
Pregnancy and breast-feeding:
Pregnancy
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 passes through the placenta and hence should not be given during pregnancy unless your doctor feels it is extremely necessary. If it is given in cases of swelling or water retention, the growth ofthe baby must be regularly monitored.
^Beeast-eeeding
Furosemide passes into the milk and may inhibit secretion of milk. Hence it should be avoided in |breast-feeding women.
Driving and using machines:
Do not drive or operate machinery if you feel less alert, dizzy or have blurred vision after taking Furosemide Tablets.
Furosemide Tablets contain tartrazine (E102) and lactose
Tartrazine (E102): May cause allergic reactions. Lactose: If you have been told by your doctor that you have an intolerance to some sugars, 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.
The tablet can be divided into two halves.
The recommended dose:
Adults:
Initially 250mg (half a tablet) daily. If necessary larger doses increasing in steps of 250mg may be given every 4–6 hours to a maximum dose of 2000mg (4 tablets).
Elderly:
|The dose may be reduced in this age group.
Use in children
Not recommended.
Ifyou take more Furosemide Tablets than you should
This medicine is to be taken at regular intervals, as determined by the doctor. If you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you.
Taking too many Furosemide Tablets may make you feel confused, unable to focus, show a lack of emotion or interest in anything. You may also have dizziness, lightheadedness, fainting (due to low blood pressure), uneven heartbeat, muscle weakness or cramps and blood clots (signs include pain and swelling at the part of body that is affected). You may also have problems with your kidneys or blood.
Ifyou forget to take Furosemide Tablets
If you have forgotten to take a dose, leave out that dose completely. Take your next dose at the normal time. Do not take a double dose to make up for a forgotten dose. If you have trouble remembering to take you tablets, tell your doctor or pharmacist.
Ifyou stop taking Furosemide Tablets
Keep taking Furosemide Tablets until your doctor tells you to stop. Do not stop taking Furosemide Tablets just because you feel better.
If you have any further questions on the use of this Medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Ifyou have any ofthe following side effects while taking your medicine tell your doctor immediately or go to hospital straight away:
- Allergic reactions such as itching, skin rash with severe itching and nettle rash, fever, allergic to light, severe allergic reaction with (high) fever, red patches on the skin, joint pain and/or inflammation of the eyes, „acute generalised exanthematous pustulosis (AGEP)“ (acute febrile drug eruption) characterised by severe acute (allergic) reaction accompanied by fever and blisters on the skin/peeling skin and tiny spots from bleeding in the skin
- Sudden inflammation of the pancreas accompanied by severe pain in the upper abdomen, shifting towards the back
- Any unexplained bruising or bleeding, fever, sore throat, mouth ulcers. This could be a sign of low blood counts, agranulocytosis
- Signs of kidney inflammation e.g. pain in sides, blood in urine.
Tell your doctor or pharmacist ifyou notice any of the following side effects:
Uncommon: may affect up to 1 in 100 people
- Blurred vision
- Lowering of blood pressure, resulting in
impaired concentration and reactions, lightheadedness
- A feeling of pressure in the head, headache, dizziness, drowsiness, a feeling ofweakness, visual disturbances, dry mouth and an inability to stand upright, sensitivity to light
| (photosensitivity)
- Feelingoftiredness
- Dry mouth, thirst, disturbances of bowel like
diarrhoea, constipation or vomiting
- Raised blood levels of creatinine and urea
- Deafness (sometimes irreversible).
Rare: may affect up to 1 in 1,000 people
- Abnormal blood count (white blood cell
deficiency) accompanied by an increased susceptibility to infection
- Increase in certain substances (eosinophilic cells) in the blood
- A crawling sensation on the skin, itching or tingling without any reason
- A life-threatening form of unconsciousness
- Acute kidney failure
- Hearing disorders and ringing in the ears. These disorders are usually temporary in nature
- Inflammation of a blood vessel
- Shock (severe drop in blood pressure, extreme paleness, restlessness, weak fast pulse, clammy skin, impaired consciousness) as a result of a sudden severe dilation!
of the blood vessels due to allergy to certain substances I
- Fever
- Muscle aches
- Inability to control urination
- Increased urine production may occur i or worsen if you have a urinary tract infection I
- If you have a bladder disorder, ,__ __
enlarged prostate or narrowing of the ureters, urine production can stop suddenly
- Minor mental disturbances.
Very rare: may affect upto1 in 10,000 people
- Anaemia (a condition characterised by shortage of red blood cells)
- Very severe blood abnormality (white blood cell deficiency) accompanied by a sudden high fever, severe throat pain and ulcers in the mouth.
Not known: frequency cannot be estimated from the available data
- Certain liver function disorders or increase in certain liver enzymes
- Furosemide can cause an excessive depletion of bodily fluids (e.g. passing urine more often than normal) and minerals (sodium, potassium, magnesium, calcium). Symptoms that can occur are thirst, headache, confusion, muscle cramps, increased irritability ofthe muscles, muscular weakness, heart rhythm disturbances and gastrointestinal problems such as sensation of unease and discomfort in the stomach with an urge to vomit, or diarrhoea
- Metabolic acidosis characterized by chest pain, irregular heart beat, headache, feeling sick, vomiting, abdominal pain, altered appetite and weight gain, muscle weakness, bone pain and joint pain
- If you have a shortage of sodium (sodium deficiency):
. cramp in the calf muscles
. loss of appetite
. listlessness
. feeling of weakness
. dizziness
. drowsiness
. confusion
- If you have a shortage of potassium (potassium deficiency):. muscular weakness and inability to contract one or more muscles (paralysis)
. increased excretion of urine
. heart problems
- In the case of severe potassium deficiency:. interference with the function of the
intestine orconfusion, which can result in coma
- If you have a shortage of magnesium and calcium (magnesium and calcium deficiency):. increased irritability of the muscles
. heart rhythm disturbance
- During treatment with furosemide, the blood levels of some fats (cholesterol and triglyceride) may rise, but usually return to normal within 6 months
- In the elderly, this can lead to a low blood volume, fluid depletion and thickening ofthe blood. This can cause clots to form in the blood
- Dizziness, fainting and loss of consciousness (caused by symptomatic hypotension).
Additional side effects in children
- Increased risk or persistence of patent ductus arteriosus in premature infants
- Kidney stones in premature babies.
5. how to store furosemide tablets
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 label or carton. The expiry date refers to the last day of that month.
Store in a cool dry place and protect from light.
In case of any visible signs of deterioration, you should discard the package.
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:
Furosemide Tablets contain the active substance furosemide.
The other ingredients are: lactose (see section 2), starch, magnesium stearate, certolake tartrazine (E102) (see section 2), primojel, colloidal silicon dioxide.
What Furosemide Tablets look like and contents of the pack
Furosemide Tablets are yellow, flat bevelled edges tablets with “F3” debossed on one side and scoreline on reverse. Diameter 13.00mm.
These tablets are available in packs of 28 or 100 tablets.
Marketing Authorisation Holderand Manufacturer
Ennogen Pharma Limited,
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS. UK.
This leaflet was last revised in February 2018.