Furosemide Injection 10mg In 1ml
PACKAGE LEAFLET: INFORMATION FOR THE USER
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(Furosemide/Frusemide)
Read all of this leaflet carefully before you use Furosemide
Injection.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The active ingredient in this medicine is Furosemide. This is the new name for Frusemide. The ingredient itself has not changed.
In this leaflet
1. What Furosemide Injection is and what it is used for
2. Before having Furosemide Injection
3. How Furosemide Injection is given
4. Possible side effects
5. Storing Furosemide Injection
6. Further information
1. What Furosemide Injection is and what it is used for
Furosemide belongs to a group of medicines called loop diuretics which remove water from the tissues by increasing the amount of urine passed.
Furosemide Injection is used to remove excessive amounts of fluid present in the heart, lungs, kidneys and liver.
2. Before having Furosemide Injection
You should not be given Furosemide Injection if you are:
• allergic (hypersensitive) to Furosemide or any of ingredients listed in section 6 of this leaflet
• allergic to a type of antibiotic known as sulphonamides
• suffering from kidney failure
• unable to produce and pass urine
• suffering from any problems with your liver
• pregnant
• suffering from low blood volumes
• suffering from a loss or lack of water in your body tissues (dehydration)
Take special care with Furosemide Injection if you are:
• suffering from a loss or likely to suffer from a lack of fluids in the body
• suffering from an enlarged prostate gland
• diabetic
• suffering from gout
• suffering from problems in passing urine
• suffering from low blood pressure
• suffering from a decrease in the amount of proteins in your blood
• breast-feeding
Special care should be taken if your premature baby is given this medicine.
If any of the above applies to you or your child, please consult your doctor.
The following medicines may affect or be affected by the action of Furosemide Injection:
• medicines used to treat bacterial infections (antibiotics) e.g. neomycin, vancomycin or any of the cephlosporins
• medicines for pain relief (non-steroidal anti-inflammatory agent) e.g. aspirin and ibuprofen
• medicines to reduce inflammation and pain (corticosteroids) e.g. betamethasone, hydrocortisone and prednisolone
• carbamazepine, used to treat a number of disorders including epilepsy and certain mental conditions
• aminoglutethimide, used to treat breast cancer
• medicines to treat diabetes
• medicines to treat tumours eg. cisplatin
• medicines used to raise low blood pressure (pressor amines) e.g. tyramine, dopamine, serotonin and noradrenaline
The activity of the following medicines may be increased by Furosemide Injection:
• salicylates, used to treat muscle and joint disease
• phenytoin, used in the treatment of epilepsy
• theophylline, used to treat asthma
• curare type muscle relaxants, used during major surgical procedures
If you have any doubts about whether this medicine should be administered to you, consult your doctor or nurse.
Pregnancy & breast-feeding
Furosemide Injection should not be used if you are pregnant. It should be used with special care if you are breast-feeding. If you are pregnant, think you may be pregnant or you are breastfeeding, you should consult your doctor if you are to be given or have been given this medicine.
Effects on the ability to drive and use machines
You may be less alert than usual due to the Furosemide Injection, so you should not drive or operate machinery until the doctor sees how the medicine affects you.
3. How Furosemide Injection is given
Your doctor or nurse will administer the injection into a vein. Furosemide will always be injected slowly.
Adults
Your doctor or nurse will decide on the correct dose for you, but usual initial doses are 20 - 50mg by injection. If larger doses are required the injection will be given to you as a slow infusion (drip). An infusion rate of 4mg per minute should not be exceeded. Your doctor or nurse will adjust the dose according to its effects.
Elderly
The recommended dose is the same as for adults. Your doctor or nurse may adjust your dose until the required effect is achieved as this drug leaves the body more slowly in the elderly.
Children
Usual dosage ranges from 0.5 to 1.5mg/kg body weight daily up to a maximum total daily dose of 20mg
Patients with severe kidney problems
It is recommended that an infusion rate of 2.5mg/min is not exceeded.
Taking other medicines If you are given too much Furosemide Injection:
If you are at all concerned that you have been given too much of Please tell your doctor or nurse if you are taking or have recently this medicine please tell your doctor immediately. taken any other medicines, including those obtained without prescription
Other medicines which may interact with Furosemide Injection:
The dose of the following medicines may need to be adjusted if taken together with Furosemide Injection:
• medicines used to treat heart conditions (cardiac glycosides) eg. digoxin
• medicines used to lower blood pressure e.g. hydralazine, methyldopa
• lithium, a drug used to treat mood disorders
The dose of Furosemide Injection may need to be reduced or stopped before using:
• ACE inhibitors to lower your blood pressure e.g. ramipril.
Continued overleaf
4. Possible side effects
Like all medicines, Furosemide Injection can cause side effects, although not everybody gets them:
Side effects which you need to tell your doctor about immediately:
• fever
• bruising easily
• sore throat
• repeated infections
• skin rashes,
• inflammation in your kidneys
• shock.
The above are signs of an allergic (hypersensitive) reaction and a condition called bone marrow depression. If you experience any of the above tell your doctor immediately as your treatment with Furosemide should be discontinued.
Mild side-effects that do not normally require you to stop your medicine.
• feeling sick (nausea)
• feeling unwell
• stomach upset
Other side effects include:
• itching
• red skin rash with itching (urticaria)
• skin raised with little water sacs (bullous lesions)
• abnormal redness of the skin(erythema multiforme)
• red scaling of the skin (exfoliative dermatitis)
• discoloration in the skin (purpura)
• decrease in the number of platelets in the blood (thrombocytopenia)
• low blood pressure
• increase in the amount of cholesterol and triglyceride (a type of fat) in the blood
• an altered blood sugar level. In diabetics this may lead to a worsening of blood sugar control. Undiagnosed diabetes may be triggered
• hearing disturbances (auditory hallucinations)
• inflammation of the pancreas
• a change in the amount of creatinine and urea (waste products) in urine (short lived change)
• an increase of amount of uric acid in your blood
• loss of body water (dehydration)
• decrease in the amount of blood in the body
• decrease in the amount of calcium in the body
• metabolic alkalosis, metabolic disturbance where the pH of the blood is abnormally high.
• discomfort passing urine in patients with bladder emptying disorders such as enlarged prostate gland or narrowing of the urethra (tube that carries urine outside the body from the bladder)
5. Storing Furosemide Injection
Keep out of the reach and sight of children.
This product has an expiry date on the syringe label and container label. The doctor or nurse will check that the product has not passed this date. Any product that has passed this date must be returned to a pharmacist for safe disposal.
Do not store above 25°C and store in the original container.
6. Further Information
What Furosemide Injection contains
The active ingredient is furosemide 10mg in 1ml.
The other ingredients are water for injections, sodium chloride, sodium hydroxide and nitrogen.
What Furosemide Injection looks like and the contents of the pack
The injection is supplied as a sterile solution in a glass 10ml prefilled syringe. Each prefilled syringe contains 8ml of the solution. The prefilled syringes are supplied in single units.
Product Licence Holder:
Aurum Pharmaceuticals Ltd Bampton Road Harold Hill
Romford Essex RM3 8UG
Manufacturer:
Federa SC
Avenue Jean Jaures 71 B-1030 Brussels Belgium
Product licence numbers: PL 12064/0076 Furosemide Injection 10mg in 1ml Leaflet approved: November 2008 Date of revision: September 2007
Rare side effects include:
• sensation of burning and prickling (paraesthesiae)
• gout
• decrease in the number of circulating white blood cells in the blood (leucopenia)
• severe reduction in number of white blood cells (agranulocytosis)
• failure to produce sufficient new cells to replenish blood cells by bone morrow (aplastic anaemia)
• abnormal breakdown of red blood cells (haemolytic anaemia)
• very low calcium levels in the blood (tetany)
Side effects in premature babies
• continuation of a condition known as patent ductus arterious if Furosemide Injection is given to premature babies in the first weeks of their life. Your paediatrician will detect this condition and corrective measures will be taken.
• build up of calcium in the kidney has been reported.
Other side effects
You may not know if you have some of the side effects. Your doctor may need to do tests.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom
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