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Package leaflet: Information for the user

Furosemide 10 mg/ml solution for Injection

Furosemide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.    What Furosemide Injection 10 mg/ml is and what it is used for

2.    What you need to know before you use Furosemide Injection 10 mg/ml

3.    How to use Furosemide Injection 10 mg/ml

4.    Possible side effects

5.    How to store Furosemide Injection 10 mg/ml

6.    Contents of the pack and other information

1. What Furosemide Injection 10 mg/ml is and what it is used for

Furosemide is one of a group of medicines called diuretics. A diuretic helps get rid of excess fluid in the body by causing more urine to be passed.

Furosemide Injection 10 mg/ml is used to remove excess fluid from the body.

It may also be used when your kidneys are not functioning properly and not producing normal amounts of urine.

2. What you need to know before you use Furosemide Injection 10 mg/ml

Do not use Furosemide Injection 10 mg/ml:

•    if you are allergic to furosemide or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

•    if you are allergic to amiloride, sulfonamides or sulphonamide derivatives, such as sulfadiazine or co- trimoxazole.

•    if you 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.

•    if you have severe liver problems (cirrhosis).

•    if your doctor has told you that you have a low blood volume or are dehydrated (with or without accompanying low blood pressure).

•    if you are not passing any water (urine).

•    if you have too little potassium or sodium in your blood (shown in blood test),

•    if you have an illness called 'Addison's Disease'. This can make you feel tired and weak

•    if you are breast-feeding (see “Pregnancy and breast-feeding” section below)

•    if you are taking digoxin, used to treat heart problems

Do not take Furosemide Injection 10 mg/ml if any of the above applies to you. If you are not sure, talk

to your doctor or pharmacist before taking Furosemide Injection 10 mg/ml.

Warnings and precautions:

Tell your doctor or pharmacist before taking Furosemide Injection 10 mg/ml

•    if you have low blood pressure or feel dizzy when you stand up.

•    if you have diabetes .

•    if you are 65 years of age or older

•    if you have difficulty in passing water (urine), particularly if you have an enlarged prostate gland

•    if you have low levels of protein in your blood (hypoproteinaemia)

•    if you suffer from acute porphyria symptoms of which may include severe stomach, back or thigh pain. Nausea, vomiting or constipation may also present along with weakness in arms and legs.

•    if you have liver or kidney problems

•    if you have diabetes

•    if you are an elderly patient (above 65) with dementia and are also taking risperidone

•    if you have prostate problems

•    if you have gout

•    if you 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 drinking or eating

•    if you are going to give this medicine to a baby that was born too early

•    if you have an abnormal heart rhythm or have a history of heart problems

•    if you are going to have a glucose test

•    if you are taking any other water tablets

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Furosemide Injection 10 mg/ml.

Other medicines and Furosemide Injection 10 mg/ml:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Furosemide Injection 10 mg/ml can affect the way some other medicines work. Also some medicines can affect the way Furosemide Injection 10 mg/ml work.

Do not take this medicine, if you are taking:

Medicines which change the amount of potassium in your blood. These include potassium

supplements such as potassium chloride or certain water tablets (diuretics) such as triamterene.

The following medicines can affect the way Furosemide Injection 10 mg/ml work and increase

the chance of you getting side effects:

•    Medicines used to treat high blood pressure such as ramipril, enalapril, perindopril (called 'ACE inhibitors') or losartan, candesartan, irbesartan (called 'angiotensin II receptor antagonists'). Your doctor may need to change the dose of your medicine or ask you to stop taking them.

•    Medicines for high blood pressure or heart problems such as aliskiren or hydralazine. Your doctor may need to change the dose of your medicine.

•    Medicines used to treat high blood pressure or prostate problems known as alpha-blockers, such as prazosin and medicines used to treat high blood pressure and other medicines used to remove water from the body known as diuretics, such as amiloride, spironolactone, acetazolamide and metolazone

•    medicines used to treat unusual heart beats, such as amiodarone, disopyramide, flecainide, lidocaine sotalol and mexiletine

•    Medicines to help you sleep and relax such as chloral hydrate and triclofos

•    Medicines used as a general anaesthetic for relaxing your muscles during surgery. If you are going to have an anaesthetic please ensure that the doctor or nurse knows you are taking furosemide

•    Medicines for diabetes. These may not work as well when you are taking Furosemide Injection 10 mg/ml.

•Theophylline - used for wheezing or difficulty in breathing.

•    Phenytoin - used for epilepsy. This can lower the effect of Furosemide Injection 10 mg/ml.

•    medicines used for mental problems called 'psychoses', such as risperidone, amisulpride, sertindole, pimozide and chlorpromazine. Avoid using pimozide at the same time as furosemide

The following medicines can increase the chance of side effects when taken with Furosemide Injection 10 mg/ml:

•    Lithium - used for mental illnesses. To help stop side effects your doctor may need to change the dose of your lithium and check the amount of lithium in your blood.

•    Cisplatin - used for some cancers.

•    Digoxin - used for heart problems. Your doctor may need to change the dose of your medicine.

•    Non-steroidal anti-inflammatory drugs (NSAIDS) - used for pain and inflammation such as aspirin, ibuprofen, ketoprofen or indometacin.

•    Carbamazepine - used for epilepsy.

•Aminoglutethimide - used for breast cancer.

•    Medicine used to stop the rejection of organs after a transplant such as tacrolimus, ciclosporin, aldesleukin

•    Moxisylyte used to treat Raynaud's syndrome

•    Clofibrate, used to treat high cholesterol

•    Medicines used to treat angina that you spray or dissolve under your tongue such as glyceryl trinitrate or isosorbide dinitrate

•    Methotrexate - used for cancers of the skin, joint or bowel diseases.

•    Carbenoxolone and sucralfate - used for ulcers of the foodpipe (gullet).

•    Medicines used for depression, such as reboxetine, amitriptyline and phenelzine.

•Amphotericin - used for fungal infections if used for a long time

•    Corticosteroids - used for inflammation such as prednisolone •Atomoxetine used to treat Attention Deficit Hyperactivity Disorder (ADHD)

•    Medicines to relax muscles such as baclofen and tizanidine •Antihistamines, used to treat allergies such as cetirizine.

•Alprostadil, used to treat male impotence

•    Oestrogen and drospirenone, used as contraceptives or in hormone replacement therapy (HRT)

•    Liquorice - often used in cough medicines if taken in large amounts

•    Probenecid (used with another HIV medicine)

•    Medicines for infection such as gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin, trimethoprim or high doses of cephalosporins (such as cephaloridine, ceftriaxone)

•    Medicines used as injections before X-ray examinations (radiocontrast agent)

•    Medicines used for constipation (laxatives) if used for a long time such as bisacodyl or senna

•    Medicines for asthma when given in high doses such as salbutamol, terbutaline sulphate, salmeterol, formoterol or bambuterol

•    Medicines used to treat blocked noses, such as ephedrine and xylometazoline

•    Potassium salts used to treat low potassium in the blood

•    Medicines used to treat Parkinson's disease such as levodopa

•    Other water tablets (diuretics) such as bendroflumethiazide. Your doctor may need to change the dose of your medicine

Furosemide Injection 10 mg/ml with food, drink and alcohol

You should avoid drinking alcohol while taking Furosemide Injection 10 mg/ml as this may lower your blood pressure further.

Pregnancy and breast-feeding:

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.

Do not take Furosemide Injection 10 mg/ml if you are pregnant.

Do not breast-feed if you are taking Furosemide Injection 10 mg/ml. This is because small amounts may pass into the mother's milk. Talk to your doctor before taking this medicine if you are breast-feeding or planning to breast-feed.

Driving and using machines:

You may feel dizzy or unwell after taking Furosemide Injection 10 mg/ml. If this happens, do not drive or use any tools or machines.

Furosemide Injection 10 mg/ml contains Sodium

Furosemide Injection contains less than 1 mmol sodium (23 mg) per ml i.e. essentially 'sodium free'.

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3. How to use Furosemide Injection 10 mg/ml

Your medicine will be given to you by a doctor or nurse. This is because it can only be given by injection. The injection may be given into a muscle (intramuscular) or slowly into a vein (intravenous). Your doctor will decide on the most suitable dose for you, and how the medicine will be given. The dosage and frequency of repeated doses may change depending on how you respond to treatment.

Adults: The initial dose may vary from 20 mg to 250 mg depending on how you respond.

Elderly: Furosemide is generally cleared from the body more slowly in the elderly. If you are elderly, your doctor may decide to start with a low dose and increase the dose gradually according to your response. Children: The doctor will decide on the dosage, depending on how severely the kidneys are affected and on the response to initial doses.

Whilst you are receiving treatment with this medicine, your doctor may want to take blood for testing which will show if you have the right balance of fluid and chemicals in the body.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you use more Furosemide Injection 10 mg/ml than you should

It is most unlikely that you will be given too much of this medicine by the nurse or doctor. Symptoms of an overdose could include weakness, muscle cramps and palpitations or an irregular heart-beat. If you notice these or any symptoms after you receive your medicine, tell the doctor or nurse.

If you forget to use Furosemide Injection 10 mg/ml

If you think you may have missed a dose, tell the doctor or nurse.

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.

If any of the below mentioned side effects are observed please inform your doctor immediately

•    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, 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.

The other possible side effects are listed under headings of frequency, using the following categories: Common (may affect up to 1 in 10 people)

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 of the muscles , muscular weakness, heart rhythm disturbances and gastrointestinal problems such as sensation of unease and discomfort in stomach with an urge to vomit, or diarrhoea.

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 the 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 or confusion, 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 disturbances.

•    Lowering of blood pressure, resulting in impaired concentration and reactions, light-headedness, a feeling of pressure in the head, headache, dizziness, drowsiness, a feeling of weakness, visual disturbances, dry mouth and an inability to stand upright

Uncommon (may affect up to 1 in 100 people)

•    abnormal blood count accompanied by bruising and a tendency to bleed

•    sensitivity to light (photosensitivity).

•    involuntary leakage of urine

•    in the elderly, this can lead to a low blood volume, fluid depletion and thickening of the blood. This can cause clots to form in the blood .

Rare (may affect up to 1 in 1,000 people)

•    abnormal blood count (white blood cell deficiency) accompanied by a 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

•    hearing disorders & ringing in the ears. These disorders are usually temporary in nature

•    inflammation of a blood vessel

•    acute kidney failure

•    inflammation of the kidneys associated with blood in the urine, fever and pain in the sides

•    if you have a urinary tract obstruction, increased urine production may occur or worsen.

•    if you have a bladder disorder, enlarged prostate or narrowing of the ureters, urine production can stop suddenly •shock (severe drop in blood pressure, extreme paleness , restlessness, weak fast pulse, clammy

skin, impaired consciousness) as a result of a sudden severe dilatation of the blood vessels due to allergy to certain substances •fever

•minor mental disturbances

Very rare (may affect up to 1 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

•    certain liver function disorders •increase in certain liver enzymes

During treatment with furosemide, the blood levels of some fats (cholesterol and triglyceride) may rise, but usually return to normal within 6 months.

After injection into a muscle, pain may occur at the spot where the injection is given.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

By reporting side effects you can help provide more information on the safety of this medicine.

For UK - You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

For Ireland - You can also report side effects directly via HPRA Pharmacovigilance,

Earlsfort Terrace, IRL -Dublin 2;

Tel: +353 1 6764971, Fax: +353 1 6762517 Website: www.hpra.ie, e-mail: medsafety@hpra.ie

5. How to store Furosemide Injection 10 mg/ml

Keep this medicine out of the sight and reach of children. Do not store above 25° C.

Do not refrigerate.

Keep the ampoule / vial in the outer carton in order to protect from light.

Furosemide Injection is for single use only. Use the product immediately after opening. Discard any unused contents.

Do not use this medicine after the expiry date (EXP) which is stated on the pack. The expiry date refers to the last day of that month.

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 Injection 10 mg/ml contains

The active substance is furosemide.

Each 2 ml sterile solution for injection contains 20 mg of furosemide (10 mg/ml).

Each 4 ml of sterile solution for injection contains 40 mg furosemide (10 mg/ml). Each 5 ml of sterile solution for injection contains 50 mg of furosemide(10 mg/ml). Each 25 ml of sterile solution for injection contains 250 mg furosemide (10 mg/ml).

The other ingredients are sodium chloride, sodium hydroxide and water for injections.

What Furosemide Injection 10 mg/ml looks like and contents of the pack

Furosemide Injection 10 mg/ml is a colourless or almost colourless sterile solution for injection.

20 mg in 2 ml: amber coloured ampoule with two white ring and white OPC dot containing 2 ml solution. 40 mg in 4 ml: amber coloured 5 ml ampoule with white snap off and blue band containing 4 ml solution. 50 mg in 5 ml: amber coloured 5 ml ampoule with white snap off and white band containing 5 ml solution. 250 mg in 25 ml: Type I amber glass vial sealed with a chlorobutyl rubber stopper and aluminium seal and a red flip off cap containing 25 ml solution.

Pack sizes:

For 20 mg in 2 ml: ampoule of 2 ml capacity. Each pack contains 10 ampoules

For 40 mg in 4 ml: ampoule of 5 ml capacity. Each pack contains 1, 5 or 10 ampoules

For 50 mg in 5 ml: ampoule of 5 ml capacity. Each pack contains 10 ampoules For 250 mg in 25 ml:

vial of 25 ml capacity. Each pack contains 1, 5 or 10 vials Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex HA1 4HF, United Kingdom

For any further information about this medicinal product, please contact the marketing authorisation holder, Accord Healthcare Limited

This leaflet was last revised in 08/2014.