Document: leaflet MAH GENERIC_PL 01502-0032 change

• leaflet MAH GENERIC_PL 01502-0032
• leaflet MAH GENERIC_PL 03265-0025

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Patient Information Leaflet

Furosemide Injection

Where to find information in this leaflet

1.    What Furosemide Injection is and what it is used for

2.    Before you are given Furosemide Injection

3.    How to use Furosemide Injection

4.    Possible side effects

5.    Storing Furosemide Injection

6.    Further information

1.    What Furosemide Injection is and what it is used for

Furosemide Injection is a powerful, quick acting diuretic which causes the body to increase the production of urine. It is used to:

•    remove large amounts of fluid that has accumulated in the tissues and lungs (oedema)

•    treat high blood pressure in emergencies

•    increase the production of urine in kidney failure

2.    Before you are given Furosemide Injection

You should NOT be given Furosemide Injection if:

•    You are sensitive or allergic to Furosemide Injection or any of the other ingredients in this injection. If you are allergic to a group of drugs called sulfonamides (e.g. Co-Trimoxazole) you may also be allergic to this injection.

•    You are dehydrated, your blood volume is low (you may feel dizzy, faint or have pale skin) or you are unable to pass urine.

•    You have low levels of potassium or sodium or an imbalance of chemicals in your blood

•    You have liver cirrhosis that is affecting your consciousness.

•    You previously received certain medicines that have damaged your kidneys.

Please tell your doctor or nurse before being given the injection if:

•    You have hypotension (low blood pressure)

•    You are an elderly patient with dementia and are also taking risperidone

•    You are elderly, if you are on other medications which can cause the blood pressure to drop and if you have other medical conditions that are risks for the drop of blood pressure.

•    You have (or potentially may have) diabetes

•    You have gout

•    You have (or have had) any problems with your liver or kidneys

•    You have difficulty in passing water, for example because of a large prostate gland

Using other medicines:

Please tell your doctor or nurse if you are taking or have recently taken any other medicines,

including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Furosemide Injection:

•    medicines to help your heart beat (e.g. digoxin)

•    medicines to help your heart beat regularly (e.g. amiodarone)

•    medicines to lower your blood pressure

particularly medicines known as ACE inhibitors or angiotensin II receptor antagonists

•    lithium

•    medicines used to treat pain or inflammation

(e.g. indometacin, ketorolac, acetylsalicylic acid)

•    antibiotics

•    cisplatin

•    methotrexate

•    ciclosporin

•    medicines to treat epilepsy e.g. phenytoin, carbamazepine

•    corticosteroids

•    chloral hydrate or triclofos

•    medicines to relax your muscles

Pregnancy or breast feeding:

Please tell your doctor or nurse before being given this injection if you are pregnant or breast feeding. The doctor will then decide if the injection is suitable for you.

Driving and using machines:

You should not drive or use machinery if you are affected by the administration of Furosemide Injection

3. How to use Furosemide Injection

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given.

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, you must tell the person giving you the injection.

During treatment with Furosemide Injection, your doctor may want you to have blood tests to show if the chemicals and fluids in your body are

balanced.

If Furosemide injection is given to a premature infant then the doctor will monitor the infant's kidneys to ensure that the Furosemide injection is not causing any problems.

4. Possible side effects

Like all medicines, Furosemide Injection can

cause side effects, although not everybody gets

them.

Tell your doctor or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment

•    If you have an allergic reaction. The signs may include inflammation of the kidney (nephritis), swollen ankles or high blood pressure, skin rashes, change in skin colour, severe blistering of the skin, being more sensitive to the sun than usual, high temperature (fever), and itching

•    Severe allergic reactions. The signs may include shock such as difficulty in breathing, cold clammy skin, pale skin colour and racing heart beat

•    Severe stomach or back pain. These could be signs of ‘pancreatitis'

•    Bruising more easily, getting more infections, feeling weak or tired more than usual. Furosemide can affect the number of blood cells, causing serious blood problems

•    Increased thirst, headache, feeling dizzy or light-headed, fainting, confusion, muscle or joint pains or weakness, cramps or spasms, stomach upsets or uneven heartbeats. These could be signs of dehydration or changes in your normal body chemicals. Severe dehydration can lead to blood clots or ‘gout'

•    You notice yellowing of your skin or eyes and your urine becomes darker in colour. These could be signs of a liver problem. In patients who already have liver problems, a more serious liver problem known as liver encephalopathy may occur. Symptoms include forgetfulness, fits, mood changes and coma

•    acute generalised exanthematous pustulosis (AGEP) (acute febrile drug eruption)

•    Blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This could be a condition called Stevens-Johnson syndrome. In a more severe form of the condition called Toxic Epidermal Necrolysis, layers of the skin may peel off to leave large areas of raw exposed skin all over the body

Tell your doctor as soon as possible if you have any of the following side effects:

•    Problems hearing or ringing in the ears (tinnitus). This especially affects people who already have problems with their kidneys

•    Tingling or feeling numb on the skin

•    Small changes in your mood such as feeling agitated or anxious

•    Dizziness, fainting and loss of consciousness (caused by symptomatic hypotension). Also headaches, loss of concentration, slower reactions, feeling sleepy or weak, problems with your sight, dry mouth. This could be due to low blood pressure

Tell your doctor or pharmacist if any of the following side effects become serious or last longer than a few days, or if you notice any side effects not listed in this leaflet

•    Feeling sick (nausea) or a general feeling of being unwell, diarrhoea and being sick

(vomiting) and constipation

•    People with bladder and prostate problems may notice pain when passing water. This is due to an increase in the amount of water passed

•    If you have diabetes you may be less able to control the levels of glucose in your blood

•    Passing more water (urine) than you usually do. This normally happens 1 or 2 hours after taking this medicine

•    Pain at the site of injection. This occurs when the medicine is injected into the muscle

•    Loss of hearing (deafness) which can sometimes be irreversible

Blood tests

Furosemide can change the levels of liver enzymes or body fats known as cholesterol and triglycerides.

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse: This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme - website: www.mhra.gov.uk/ yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    Storing Furosemide Injection

Your injection will be stored at less than 25°C and protected from light. The nurse or doctor will check that the injection is not past its expiry date before giving you the injection

6.    Further information

What Furosemide Injection contains:

This injection contains the active ingredient furosemide. Each 1 ml of solution contains 10 mg furosemide in a sterile solution for injection.

This injection contains the following inactive ingredients: sodium chloride, sodium hydroxide and sterile water for injections.

This injection contains a maximum of 4 mg of sodium per ml. To be taken into consideration by patients on a controlled sodium diet.

What Furosemide Injection looks like and contents of the pack:

Furosemide Injection is supplied in 2 ml, 5 ml and 25 ml amber glass ampoules. The injection is supplied in cartons of 1 0 ampoules. Not all ampoule sizes may be marketed.

Marketing Authorisation Holder:

hameln pharmaceuticals ltd

Gloucester

United Kingdom

Manufacturer:

hameln pharmaceuticals gmbh Langes Feld 13, 31789 Hameln, Germany

hameln rds a.s.

Horna 36, 900 01 Modra, Slovak Republic HBM Pharma s.r.o.

03680 Martin, Sklabinska, Slovak Republic

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last approved 21.12.2015

44174/52/15