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GENTICIN INJECTABLE

Active substance(s): GENTAMICIN SULPHATE

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31018862-03

Package leaflet: Information for the patient

102657/LF/158/03

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

Monitoring during treatment
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.
Other medicines and Genticin
Injectable
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:
• Antibiotics such as penicillin,
ticarcillin, clindamycin,
lincomycin, cephalosporins,
vancomycin or other
aminoglycoside antibiotics
• Ciclosporin (used to stop the
body rejecting bone marrow or
organ transplants)
• Cisplatin and fludarabine
(chemotherapy drugs)
• Amphotericin (used to treat
fungal infections)
• Furosemide (frusemide), and
piretanide (used to treat heart
problems)
• Muscle relaxants
• Medicines used to treat
myasthenia gravis such as
neostigmine and pyridostigmine
• Indomethacin (an
anti-inflammatory)
• Biphosphonates (used to treat
osteoporosis).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice
before being given this medicine.
Genticin is not recommended for
use in pregnancy unless considered
appropriate by your doctor.
Use of Genticin Injectable whilst
breastfeeding 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
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 as a drip (infusion). Your
doctor will work out the dose which
is suitable for you.
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.

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

102657/LF/158/03

Version No.:
Product Name:
Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:
CRF:

Genticin Injectable
10 x 2ml
Leaflet
102657
UK
Famar
3
06/10/2015
ADD
AMCo.CRF.004.2015

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

454 x 146 mm
31018862-03
N/A
N/A
N/A
Black

Non-Print Colours: Cutter
Tech App. Date:
Min. Font Size:

08/10/2015
12 pt

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APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc.) and that Amdipharm have
license approval to distribute this component for
sale in the relevant market.

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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
September 2015

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).

31018862-03

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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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