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Package leaflet: Information for the patient 102657/LF/2

Genticin® 80 Injectable

Gentamicin

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

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

See section 4.

What is in this leaflet:

1.    What Genticin Injectable is and what it is used for

2.    What you need to know before you are given Genticin Injectable

3.    How you will be given Genticin Injectable

4.    Possible side effects

5.    How to store Genticin Injectable

6.    Contents of the pack and other information

1.    WHAT GENTICIN INJECTABLE IS AND WHAT IT IS USED FOR

The name of your medicine is Genticin 80 mg/2 ml Injectable (will be referred to as Genticin Injectable through out the leaflet).

Genticin Injectable contains the active ingredient gentamicin which belongs to a group of medicines called antibiotics.

Genticin Injectable is used in adults and children to treat bacterial infections such as severe chest infections, urinary tract infections and septicaemia.

2.    WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GENTICIN INJECTABLE

Do not take this medicine if you:

•    Are allergic to gentamicin, any of the other ingredients of Genticin Injectable, (listed in section 6), or a similar medicine containing an aminoglycoside antibiotic

•    Suffer from myasthenia gravis,

a disease causing muscle weakness.

Warnings and precautions

Talk to your doctor or pharmacist before being given Genticin Injectable if you:

•    Have any problems with your kidneys, liver or hearing

•    Have any infections or a fever

•    Have low blood pressure or low blood volume

•    Are considered to be significantly overweight

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

The daily recommended dose in adults with normal kidney function is 3 - 6 mg/kg of body weight per day as one (preferred) up to two single doses. Your doctor may increase the dose, or frequency of doses, based on your condition.

Use in children and adolescents

The daily recommended dose in children aged 1 year and above and adolescents with normal renal function is 3 - 6 mg/kg of body weight per day as one (preferred) up to two single doses.

Use in infants after the first month of life

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.

Use in newborns

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.

Use in older people

The dose for the elderly will be adjusted accordingly.

Use in patients with kidney problems

The dose for 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.

Symptoms of overdose include dizziness, a feeling of spinning and hearing loss.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Genticin Injectable 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

•    Muscle weakness.

Infrequently:

•    Feeling or being sick

•    Sore mouth

•    Problems with your liver

•    Blood disorders.

Rarely:

•    Diarrhoea

•    Stomach pain

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AMDIPHARM

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

Extremely rarely:

•    Problems with your brain

•    Fits, confusion, hallucinations, tiredness and depression.

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. 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.    HOW TO STORE GENTICIN INJECTABLE

Keep this medicine out of the sight and reach of children.

Store your medicine in a safe place below 25°C and do not freeze.

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

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Genticin Injectable contains

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

The other ingredients are water for injection and sulphuric acid.

What Genticin Injectable looks like and the content of the pack

Genticin Injectable 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,

Capital House,

85 King William Street,

London EC4N 7BL, UK

Manufacturer and Batch Release Site:

Famar S.A.,

Agiou Dimitriou 63,

Alimos Attiki,

17456,

Greece

Genticin is the registered trade mark of Amdipharm Mercury International Limited.

This leaflet was last revised in February 2014

31018862-02