PACKAGE LEAFLET: INFORMATION FOR THE USER    D01720

Furosemide 10mg/ml Solution for Injection / Infusion

Furosemide/Frusemide

Read all of this leaflet carefully before you are given

Furosemide Injection.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, please ask your doctor or nurse.

•    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.

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 you are given 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

Your medicine is called 'Furosemide 10mg/ml Solution for Injection/Infusion'. It will be referred to throughout this leaflet as 'Furosemide Injection'.

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 arms and legs, heart, lungs, kidney and liver. It can also be used to treat heart failure, high blood pressure (hypertension) or a reduction in the volume of urine due to kidney problems (oliguria). It is used when oral products are not suitable or for emergency treatment.

2.    Before you are given Furosemide Injection

You should not be given Furosemide Injection if:

•    you are allergic (hypersensitive) to furosemide or any of the ingredients in the product listed in section 6 of this leaflet.

•    you are allergic to a type of antibiotic known as sulphonamides

•    you are suffering from kidney failure

•    you are unable to produce and pass urine

•    you have any problems with your liver

•    you are pregnant

•    you have lack of salts in your body

•    you suffer from porphyria (a blood disease)

Take special care with Furosemide Injection:

Tell your doctor if:

•    you are suffering from a loss or likely to suffer from lack of fluids in the body

•    you are diabetic

•    you have gout

•    you have an enlarged prostate gland

•    you are breast-feeding

•    you have liver or kidney problems

•    you have problems with your adrenal glands

If any of the above applies to you or your child, please consult your doctor.

Taking other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including those obtained without prescription.

The action of Furosemide Injection may affect or be affected by a number of medicines such as the following;

•    medicines used to treat heart conditions (antiarrhythmics) e.g. mexiletine, quinidine and cardiac glycosides

•    medicines used to treat chest pain e.g. nitrates

•    medicines used to treat high blood pressure e.g. adrenergic neurone blockers, alpha blockers, beta blockers, ACE inhibitors and calcium channel blockers.

•    medicines that help you to sleep (hypnotics) such as chloral and triclofos.

•    medicines used to treat serious mental disorders e.g. lithium and phenothiazines

•    medicines used to treat schizophrenia (a serious mental disorder) e.g. amisulpride and sertindole

•    medicines used to treat epilepsy (fits) such as acetazolamide and carbamazepine

•    medicines used to treat depression e.g. tricyclic antidepressants, monoamine oxidase inhbitors (MAOI's) and reboxetine

•    medicines used to increase the volume of urine e.g. bumetanide and thiazides

•    medicines used to treat infection e.g. aminoglycosides, polymyxins and vancomycin

•    medicines used in the treatment of multiple sclerosis (MS) such as tizanidine and baclofen

•    medicines used to treat cancer e.g. aminoglutethimide, aldesleukin and platinum compounds such as oxaliplatin

•    medicines used to treat parkinsons e.g. levodopa

•    medicines used to treat inflammation such as indometacin, ketorolac, corticosteroids and NSAIDs (non-steroidal antiinflammatory drugs)

•    moxisylyte (a medicine used to improve circulation)

•    theophylline (a medicine used to treat asthma)

•    terfenadine (a medicine used to treat erectile dysfunction)

•    medicines used to treat diabetes

•    oral contraceptives (birth control) or other medicines containing oestrogen

•    general anaesthetics.

If you have any doubts about whether this medicine should be given to you, consult your doctor or nurse.

Using Furosemide Injection with food and drink

You are advised not to drink alcohol whilst you are being treated with Furosemide

Pregnancy and 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, have blurred vision or dizziness due to the Furosemide Injection, so you should not drive or operate machinery until the doctor sees how the medicine affects you.

Continued overleaf

3.    How Furosemide Injection is given

Your doctor or nurse will inject Furosemide Injection into a muscle (intramuscularly) or into a vein (intravenously). 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 intramuscular or slow intravenous 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

For the treatment of difficulty in passing urine:

250mg may be given over the first hour. If the desired response is not achieved within the next hour a further 500mg may be given over the next 2 hours. If the desired response is still not achieved within the next hour a further 1g may be given over the next four hours. If a satisfactory response is still not achieved your doctor may treat you using kidney dialysis. An effective dose up to 1g may be repeated every 24 hours.

The 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 - 1.5mg/kg body weight daily up to a maximum total daily dose of 20mg.

If you are given too much Furosemide Injection

If you are at all concerned that you have been given too much of this medicine please tell your doctor immediately.

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

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.

Most common side effects:

•    headache

•    low blood pressure

•    dry mouth

•    thirst

•    weakness

•    drowsiness

•    muscle cramps

•    tiredness

•    decrease in passing urine

•    disorders of heart rhythm may occur

Less common side effects:

•    feeling sick

•    stomach upset

•    an increase of amount of uric acid in your blood

•    gout (often felt as a severe pain in a joint)

•    high level of sugar in blood

•    increase in the amount of cholesterol and triglyceride (a type of fat) in the blood

Rare side effects:

•    skin rashes

•    sensitivity to light

•    blurred vision

•    dizziness

•    headache

•    inflammation of blood vessels, kidney or pancreas

•    very low calcium levels in the blood

•    ringing in the ears

•    loss of hearing

Side effects in premature babies:

•    build up of calcium in 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.

5.    Storing Furosemide Injection

Keep out of the reach and sight of children.

This product has an expiry date on the ampoule and carton labels. 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. Keep in the outer carton.

6.    Further Information

What Furosemide Injection contains

The active ingredient is furosemide 10mg/ml

The other ingredients are sodium chloride, water for Injections

and sodium hydroxide.

What Furosemide Injection looks like and contents of the pack

Furosemide Injection is a clear almost colourless solution presented in 2ml or 5ml clear glass ampoules in packs of 10 ampoules.

Marketing Authorisation Holder and Manufacturer

Martindale Pharmaceuticals Ltd Bampton Road Romford Essex RM3 8UG

Product licence number: PL 01883/0045 Date of revision: November 2011

Martindale A JL Pharmaceuticals fVi

Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom

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100mm Measurement Verification Bar