Package Leaflet: Information for the user

Furosemide 20mg/2ml

solution for injection lFurosemide)

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 any further questions, ask your doctor or nurse.

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 nurse. This includes any possible side effects not listed in this

leaflet. See section 4.

What is in this leaflet:

1.    What Furosemide is and what it is used for

2.    What you need to know before you use Furosemide

3.    How to use Furosemide

4.    Possible side effects

5.    How to store Furosemide

6.    Contents of the pack and other information

1.    WHAT FUROSEMIDE IS AND WHAT IT IS USED FOR

Furosemide belongs to a group of medicines called diuretics. Furosemide increases the amount of urine produced by your body.

Furosemide is used to rid the body of too much fluid (also called oedema). Too much fluid can be caused by:

•    heart problems

•    liver problems

•    kidney problems Furosemide is also used:

•    in periods with extremely high blood pressure that may lead to life-threatening conditions (hypertensive crisis).

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE FUROSEMIDE

Do not use Furosemide if:

■    You are allergic to furosemide, or any of the other ingredients of this medicine (listed in section 6)

■    You are allergic to sulphonamide antibiotics

■    You are severely dehydrated (you have lost lots of body fluid for example by suffering from severe diarrhoea or being sick)

■    You have kidney failure and are not producing urine, despite treatment with furosemide

■    You have kidney failure as a consequence of poisoning with kidney or liver toxic substances

■    You have very low levels of potassium or sodium in your blood

■    The patient is in a coma caused by liver failure

■    You are breastfeeding

If you are uncertain, whether you can use this medicine or not, ask your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or nurse before using Furosemide if:

■    You normally have problems passing water due to an obstruction (such as an enlarged prostate)

■    You have diabetes

■    You have a low blood pressure or sometimes have sudden falls in blood pressure (your blood vessels in your heart or brain are too narrow).

•    You have liver disease (such as cirrhosis)

■    You have kidney problems (such as nephrotic syndrome)

■    You are dehydrated (you have lost body fluids - by suffering from severe diarrhoea or being sick), this might lead to collapse or blood clotting

■    You have gout (painful or inflamed joints) due to high levels of uric acid (by-product of metabolism) in your blood

■    You have the inflammatory disease called “systemic lupus erythematosus (SLE)”

■    You have hearing problems

■    You are using sorbitol (sugar substitute for people with diabetes)

■    You are taking medicines that cause life-threatening irregular heart beat (QT interval prolongation)

■    You are taking lithium

•    You have porphyria (disease where the production of the oxygen binding molecule of the red blood cells is disrupted and urine is purple-coloured)

■    Your skin has an increased sensitivity to sunlight (photosensitivity)

■    You are an athlete; this medicine might give a positive result in doping tests

If given to premature babies furosemide can cause kidney stones or calcification If any of these apply to you, your doctor may want to change your treatment or give you special advice. While you are using Furosemide, your doctors may recommend regular blood tests of your blood sugar

levels or your blood uric acid levels. They will also check your blood levels of important body salts such as potassium and sodium which are particularly important if you are being sick or have diarrhoea.

Other medicines and Furosemide

Tell your doctor or nurse if you are using or have recently used or might use any other medicines. This is important because some medicines should not be taken together with Furosemide.

In particular, tell your doctor or pharmacist if you are taking:

■    Lithium - for mood disorders, as its effect and side effects may be increased by furosemide. Your doctor will prescribe this medicine to you only if absolutely necessary and he will then check your lithium levels and may change your dose

•    Heart medicines, like digoxin; your doctor may need to change your dose

■    Any medicines for high blood pressure, including thiazide diuretics (like bendroflumethiazide or hydrochlorothiazide), ACE inhibitors (like lisinopril), angiotensin II antagonists (like losartan) as furosemide may cause your blood pressure to fall too low. Your doctor may need to change your dose of furosemide

■    Cholesterol or lipid-lowering medicines like fibrates, such as clofibrate, fenofibrate or bezafibrate, as the effect of furosemide may be increased.

■    Diabetes medicines, like metformin and insulin, as your sugar levels may be increased

•    Anti-inflammatory medicines, including NSAIDS (like aspirin or celecoxib) as they can reduce the effects of furosemide; high doses of pain killers (salicylates) may increase the side effects of furosemide

■    Anti-inflammatory or anti-allergic medicines like corticosteroids, medicines to treat stomach ulcers like carbenoxolone, or laxatives, as in combination with furosemide they will affect your sodium and potassium levels. Liquorice has the same effect as carbenoxolone.Your doctor will check your potassium levels

■    Injections given during operations, including tubocurarine, curarine derivates and succinylcholine

■    Chloral hydrate - for sleeping problems (in isolated cases, the intravenous administration (injection into a vein) of furosemide in a 24 hour period prior to chloral hydrate administration may lead to flushing, increased sweating, anxiety, nausea, increase in blood pressure and faster heart beat). Therefore, the simultaneous administration of furosemide and chloral hydrate is not recommended.

■    Phenytoin or phenobarbital - for epilepsy, as the effect of furosemide may be decreased

■    Theophylline - for asthma, as its effect may be increased by furosemide

■    Antibiotics like cephalosporins, polymyxins, aminoglycosides or quinolones or other drugs which may affect your kidneys like immunosuppressants, iodinated contrast media, foscamet or pentamidine as furosemide can make this worse

■    Probenecid - used with some other medicines to protect the kidney, as it may reduce the effects of furosemide

■    Organoplatins - used in some cancers, as furosemide may increase the side effects of these drugs

■    Methotrexate - used in some cancers and for severe arthritis, as it may reduce the effects of furosemide

■    Drugs to raise your blood pressure (Pressor amines), as they may not work as well when you take them with furosemide

■    Aminoglutethimide - used to suppress corticosteroid production (Cushing's syndrome), as it may increase the side effects of furosemide

■    Carbamazepine - used to treat epilepsy or schizophrenia, as it may increase the side effects of furosemide

■    Ciclosporin - used to prevent rejection of transplants, as you are at risk of gouty arthritis (painful joints).

■    Drugs that will alter your heart beat such as amiodarone, sotalol, dofetilide, ibutilide, as their effect may be increased by furosemide

Furosemide with food and drink and alcohol

You can eat and drink as usual when taking Furosemide. You do not need to change your diet unless suggested by a doctor.

Pregnancy and breast feeding and fertility

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 can pass from mother to baby

•    So this medicine is only given to pregnant women if absolutely necessary.

Do not use Furosemide if you are breast-feeding

•    This is because this medicine passes into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Furosemide may make you less alert than usual. If you are affected do not drive or use machines (see section 4 “Possible side effects”).

Furosemide contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per ampoule, i.e. essentially ‘sodium-free’.

3. HOW TO USE FUROSEMIDE

Always use this medicine exactly as described in this leaflet or as your doctor or nurse have told you. Check with your doctor or nurse if you are not sure. Furosemide is normally given by a doctor or nurse. It is given:

■    as a slow injection into a vein (intravenous) or

■    exceptionally into a muscle (intramuscular).

The following information is intended for healthcare professionals only:

Administration

Intravenous administration of furosemide must be slow; a rate of 4 mg per minute must not be exceeded and should never be given in association with other medicinal products in the same syringe.

Intramuscular administration must be restricted to exceptional cases where neither oral nor intravenous administrations are feasible. It must be noted that intramuscular injection is not suitable for the treatment of acute conditions such as pulmonary oedema.

The initial dose recommended for adults and adolescents over 15 years, is of 20 to 40 mg (1 or 2 ampoules) by intravenous (or in exceptional cases intramuscular) administration; the maximum dose varying according to individual response. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours.

In adults, the recommended maximum daily dose of furosemide is 1500 mg.

Incompatibilities

Furosemide injection may be mixed with neutral and weak alkaline solution with pH between 7 and 10, such

Your doctor will decide on the dose. The dose depends on your particular condition, how bad it is, and how long you are treated for.

■    The recommended first dose for adults (including teenagers over 15) is 20 to 40 mg.

■    If your doctor thinks a higher dose is needed, you may be given further 20 mg injections. This is usually given every 2 hours, until the desired fluid loss occurs.

■    In some cases, insteadofinjections,yourdoctormay recommend this medicine is given by continuous infusion into a vein (a drip).

■    For children (children below 15 will only be treated in exceptional cases), the dose depends on the child's weight. The first dose is 0.5 to 1 mg/kg a day.

■    Older people are usually given 20 mg/day at first. This can be gradually increased until the desired fluid loss occurs.

Weight loss by loss of body fluid should not be more than 1 kg of body weight per day.

If you need to keep using Furosemide, your doctor will probably recommend a switch from injections to an oral (tablet) form of this medicine, as soon as possible.

If you use more Furosemide than you should

If you think you have been given too much of this medicine, tell your doctor straight away.

Signs which may occur if you have been given too much of this medicine are dryness of the mouth, increased thirst, irregular heartbeat, mood changes, muscle cramps or pain, feeling or being sick, unusual tiredness or weakness, a weak pulse or loss of appetite.

If you think you have missed an injection, speak to your doctor or nurse.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines this medicine can cause side effects, although not everybody gets them. Contact your doctor or seek medical help immediately if you experience any of the following:

-    Allergic reactions {anaphylaxis}. The signs may include swelling of the throat face, lips and mouth, difficultly in breathing or swallowing and loss of consciousness.

-    Effects to blood composition, including very low white blood cell levels. The symptoms of this include anaemia, leading to tiredness, lethargy, ulcers in your throat, mouth, or on your skin; sore throat or repeated infections.

Uncommon (affects 1 to 10 users in 1,000)

■    Skin rashes (including itching, redness, peeling), a tendency to bruising or your skin being sensitive to sunlight

■    Blood cell changes can lead to failure of blood clotting (with increased risk of bleeding)

Rare (affects 1 to 10 users in 10,000):

■    Feeling or being sick, diarrhoea, constipation, loss of appetite, discomfort in the mouth and stomach.

■    Hearing problems (more common in patients with kidney failure) and tinnitus (ringing in the ears).

•    Kidney damage (interstitial nephritis)

■    Muscle problems, including leg cramps or muscle weakness

■    Pain or discomfort where the injection is given (particularly after injection into muscle)

■    The inflammatory disease lupus erythematosus may occur or get worse

■    Changes in blood test results (fat-like substances in your blood)

■    A numb feeling, tingling or feeling dizzy

■    High temperature

■    Blurred eye-sight, confusion, sleepiness

■    Dry mouth

Very rare (affects less than 1 user in 10,000):

■    Severe muscle problems including twitching, spasms, cramps (also called “tetanus”).

•    Blood cell changes can lead to anaemia, inability to fight infection

■    Pancreatitis (severe tummy pain) due to inflammation of the pancreas

The following may also occur:

■    Low blood pressure making you feel faint or dizzy. It may also cause the feeling of pressure in the head, joint pain, blood clot formation, or collapse of your circulation (shock)

•    Low potassium levels in the blood. This can cause muscle weakness, tingling and numbness, slight inability to move a body part, being sick, obstipation, increased gas in your gut, increased urine production, increased urge to drink, or slow or irregular heart rhythm. These problems are more likely if you have other diseases like liver or heart problems or too little potassium in your diet or if you take other medicines (see “Taking other medicines”). Extreme potassium losses can cause a transiently reduced movement of your intestine or a reduced awareness, with deep extended reduced consciousness in extreme cases. Regular blood checks and potassium supplements may be needed

•    Low sodium, calcium and magnesium levels in the blood. This may occur due to increased loss of sodium, calcium and magnesium with your urine. Low sodium levels typically cause a lack of interest, cramp in the calf, reduced appetite, weakness, sleepiness, being sick and confusion. Low calcium levels may cause cramps of your muscles. These cramps of your muscles or an irregular heart beat can also be caused by low magnesium levels in your body.

■    Gout may occur or get worse

■    Existing problems passing water may be made worse

• Diabetes may occur or get worse

■    Liver problems or changes in the blood may cause jaundice (yellow skin, dark urine, tiredness)

■    Reduced volume of body fluid especially in elderly patients. Severe fluid loss may lead to increased concentration of the blood with a tendency for the development of blood clots

■    Premature babies may get kidney stones or calcification

■    In premature babies the channel between the lung artery and the aorta which is open in the unborn baby might stay open

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly.

For UK: via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

For IE: via:

HPRA Pharmacovigilance Earlsfort Terrace IRL- Dublin 2 Tel: +3531 6764971 Fax: +3531 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie

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

What Furosemide looks like and contents of the pack:

Furosemide is a clear colourless to almost colourless solution.

The pack may contain 5,50 or 100 x 2 ml amber glass ampoules containing Furosemide 20 mg/2 ml solution for injection.

Marketing Authorisation holder and manufacturer:

marketing Authorisation holder

Fresenius Kabi Limited Cestrian Court, Eastgate Way,

Manor Park, Runcorn, Cheshire WA71 NT, UK

Manufacturer:

LABESFAL - Laboratories Almira S.A.

(Fresenius Kabi Group)

Lagedo, 3465-157 Santiago de Besteiros, Portugal Tel: +351 232 831100

This leaflet was last revised in 12/2014

5.    HOWTO STORE FUROSEMIDE

■    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 after EXP. The expiry date refers to the last day of that month.

■    Keep the ampoules in the outer carton in order to protect from light.

■    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 contains:

Each ampoule of Furosemide contains 20 mg of furosemide as the active substance in 2 ml of solution for injection. Other ingredients are sodium chloride, sodium hydroxide, water for injections.

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as 0.9% sodium chloride and Ringer's lactate solution.

Furosemide should not be mixed with strong acid solutions (pH lower than 5.5), such as solutions containing ascorbicacid, noradrenaline and adrenaline, due to the risk of precipitation.

Product containing visible particles should not be used.

For single use only, discard any remaining contents after use.

Shelf life

Shelf life of the finished medicinal product:

3 years

After first opening: Once opened the product should be used immediately

After dilution:

Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C protected from light.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

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