Patient Information Leaflet GB 727-1380-APIL

31018862-02

O

Gentamicin 40mg/ml

Solution for Injection

AMDIPHARM

Read all of this leaflet carefully before you start taking this medicine.

-    Please keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass

it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Gentamicin 40mg/ml Solution for Injection is and what it is used for

2.    Before you are given Gentamicin 40mg/ml Solution for Injection

3.    How you will be given Gentamicin 40mg/ml Solution for Injection

4.    Possible side effects

5.    How to store Gentamicin 40mg/ml Solution for Injection

6.    Further information

1.    WHAT GENTAMICIN 40MG/ML SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR

The name of your medicine is Gentamicin 40mg/ml Solution for Injection. Gentamicin 40mg/ml Solution for Injection contains the active ingredient gentamicin which belongs to a group of medicines called antibiotics. Gentamicin 40mg/ml Solution for Injection is used to treat bacterial infections such as severe chest infections, urinary tract infections and septicaemia.

2.    BEFORE YOU ARE GIVEN GENTAMICIN 40MG/ML SOLUTION FOR INJECTION

Do not take this medicine if you:

•    Are allergic to gentamicin, any of the other ingredients of Gentamicin 40mg/ml Solution for Injection, or a similar medicine containing an aminoglycoside antibiotic

•    Suffer from myasthenia gravis, a

disease causing muscle weakness

Take special care if you:

•    Have any problems with your kidneys or liver

•    Have any infections or a fever

•    Have low blood pressure or low blood volume

•    Are considered to be significantly overweight

•    Have Parkinson’s disease or any other disease causing muscle weakness

If any of these apply to you, or if you are not sure, tell your doctor.

Your doctor may want to send you for blood tests from time to time to check the levels of gentamicin in your blood. This is because your doctor may need to keep a careful eye on you during your treatment to prevent damage to your ears. If you are over 65 years of age or the patient is under 1 year of age, they may also

monitor your hearing, your balance and how your kidneys and liver are working.

Taking other medicines

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

This is especially important if you are taking:

•    Agalsidase alpha and beta, used to treat a rare condition called Fabry disease. These two medicines should not be used together

•    Antibiotics such as penicillin, cephalosporins,vancomycin, colistin, teicoplanin and capreomycin

•    Ciclosporin and tacrolimus (used to stop the body rejecting bone marrow or organ transplants)

•    Cisplatin and fludarabine (chemotherapy drugs)

•    Amphotericin (used to treat fungal infections)

•    Furosemide (frusemide), digoxin and piretanide (used to treat heart problems)

•    Muscle relaxants

•    Medicines used to treat myasthenia gravis such as neostigmine and pyridostigmine

•    Indometacin (an anti-inflammatory)

•    Biphosphonates (used to treat osteoporosis)

•    Medicines containing oestrogens (used for contraception)

Pregnancy and breast-feeding

Tell your doctor before being given Gentamicin 40mg/ml Solution for Injection if you are, or think you may be, pregnant. Gentamicin is not recommended for use in pregnancy unless considered appropriate by your doctor.

Please tell your doctor before being-given Gentamicin 40mg/ml Solution for Injection if you are breast-feeding. Breast-feeding is not recommended if you are suffering from kidney problems.

Driving and using machinery

This medicine should not affect your ability to drive or use machines.

3. HOW YOU WILL BE GIVEN GENTAMICIN 40mg/ml SOLUTION FOR INJECTION

This medicine will be given to you by a doctor or nurse as an injection into a muscle or vein. It can also be given as a drip (infusion). Your doctor will work out the dose which is suitable for you.

The daily recommended dose in children, adolescents and adults with normal kidney function is 3 - 6 mg/kg of body weight per day as one (preferred) up to two single doses.

The daily dose in infants after the first month of life is 4.5 - 7.5 mg/kg of body weight per day as one (preferred) up to two single doses.

The daily dose in newborns is 4-7 mg/kg of body weight per day. Due to the longer half-life, newborns are given the required daily dose in one single dose.

The dose for the elderly, children under 12 years and patients with kidney problems will be adjusted accordingly.

If you are given more medicine than you should

Overdosing is unlikely. If it does happen the doctor will treat any symptoms that follow.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Gentamicin 40mg/ml Solution for Injection can cause side effects, although not everybody gets them.

If you notice:

•    itching or skin rashes

•    swelling of the face, lips or throat

•    difficulty in breathing or wheeziness

tell your doctor immediately. These may be signs of an allergic reaction.

Side effects may include:

•    Hearing loss, which is usually reversible

•    Problems with your kidney function

•    Problems with your ears that causes a loss of balance

•    Difficulty in breathing following surgery

Infrequently:

•    Feeling or being sick

•    Sore mouth

•    Problems with your liver

•    Blood disorders

Rarely:

•    Diarrhoea

•    Stomach pain

•    Electrolyte disturbances (changes in the levels of salts in the blood)

Extremely rarely:

•    Problems with your brain

•    Fits, confusion, hallucinations and depression

If any of these side effects becomes severe, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist immediately.

5.    HOW TO STORE GENTAMICIN 40mg/ml SOLUTION FOR INJECTION

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN

Store your medicine in a safe place below 25^oC and do not freeze.

This medicine must not be used after the expiry date printed on the pack.

6.    FURTHER INFORMATION What Gentamicin 40mg/ml Solution for Injection contains

Each 2ml ampoule contains the active ingredient gentamicin sulphate (equivalent to 80mg gentamicin base).

The other ingredients are water for injection and sulphuric acid.

What Gentamicin 40mg/ml Solution for Injection looks like and the content of the pack

Gentamicin 40mg/ml Solution for Injection is a colourless to pale yellow liquid. It is available in 2 ml clear glass ampoules in boxes of 10 x 2 ml ampoules.

Marketing Authorisation Holder and Manufacturer responsible for release:

Amdipharm UK Limited

Regency House

Miles Gray Road

Basildon

Essex

SS14 3AF

United Kingdom

Manufacturer and Batch Release Site:

Famar S.A.,

Agiou Dimitriou 63,

Alimos Attiki,

17456,

Greece

This leaflet was last revised in October 2013

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. By reporting side effects you can help provide more information on the safety of this medicine. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at

www.mhra.gov.uk/yellowcard Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

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AMDIPHARM

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