GENTAMICIN 40MG/ML SOLUTION FOR INJECTION

Active substance: GENTAMICIN SULPHATE

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31018862-02

Patient Information Leaflet
GB727-0259LF-AM01

Genticin Injectable
Gentamicin
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 Genticin Injectable is and
what it is used for
2. 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. Further information

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
• Amphotericin (used to treat
fungal infections)

and piretanide (used to treat
heart problems)
1. WHAT GENTICIN INJECTABLE IS
• Muscle relaxants
AND WHAT IT IS USED FOR
The name of your medicine is Genticin • Medicines used to treat myasthenia
gravis such as neostigmine and
Injectable. Genticin Injectable contains
pyridostigmine
the active ingredient gentamicin which
belongs to a group of medicines called
antibiotics.
• Biphosphonates (used to treat
osteoporosis)
Genticin Injectable is used to treat
• Medicines containing oestrogens
bacterial infections such as severe
chest infections, urinary tract
infections and septicaemia.
Pregnancy and breast-feeding
2. 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, 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
other disease causing muscle
weakness

Tell your doctor before being given
Genticin Injectable if you are, or think
you may be, pregnant. Genticin is not
recommended for use in pregnancy
unless considered appropriate by your
doctor.

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, 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

6. FURTHER INFORMATION
What Genticin Injectable 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 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
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
August 2013

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)

Please tell your doctor before being
given Genticin Injectable if you are
breast-feeding. Breast-feeding is not
recommended if you are suffering
from kidney problems.

Extremely rarely:
• Problems with your brain
• Fits, confusion, hallucinations
and depression

Driving and using machinery
This medicine should not affect your
ability to drive or use machines.

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.

3. HOW YOU WILL BE GIVEN
GENTICIN INJECTABLE
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

If any of these apply to you, or if you
work out the dose which is suitable
are not sure, tell your doctor.
for you.
Your doctor may want to send you The daily recommended dose in
for blood tests from time to time to children, adolescents and adults
check the levels of gentamicin in with normal kidney function is
your blood. This is because your 3 - 6 mg/kg of body weight per day
doctor may need to keep a careful
eye on you during your treatment to doses.
prevent damage to your ears. If you
are over 65 years of age or the patient
The daily dose in infants after the
is under 1 year of age, they may also
first month of life is 4.5 - 7.5 mg/kg
monitor your hearing, your balance
and how your kidneys and liver are of body weight per day as one
working.

5. HOW TO STORE GENTICIN
INJECTABLE
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.

31018862-02

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Genticin Injection
GB727-0259LF-AM01
Leaflet
454 x 146 mm
Great Britain
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Black
08/08/2013
12 pt
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AMCo
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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