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GENTICIN INJECTABLE

Active substance(s): GENTAMICIN SULPHATE

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148 mm

LF-103869-01

148 mm

31039131

Gentamicin

Read all of this leaflet carefully
before you are given this medicine
because it contains important
information for you.
- Keep this leaflet. You may need to
read it again.
- If you have any further questions,
ask your doctor or nurse.
- If you get any side effects, talk to
your doctor or nurse. 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

460 mm

60 mm

Genticin® Injectable

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
You should not be given Genticin
Injectable:
• if you are allergic to gentamicin or
a similar medicine containing an
aminoglycoside antibiotic or any of
the other ingredients of this
medicine (listed in section 6).
• if you suffer from myasthenia
gravis, a disease causing muscle
weakness.
Warnings and precautions
Talk to your doctor or nurse before
being given Genticin Injectable:
• if you have any problems with your
kidneys, liver or hearing
• if you have any infections or a fever
• if you have low blood pressure or
low blood volume
• if you are considered to be
significantly overweight
• if you have Parkinson’s disease or
any other disease causing muscle
weakness
• if you are pregnant or think you
may be pregnant.
If any of these apply to you or if you
are not sure, tell your doctor.

If you are given more Genticin
Injectable 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.
If you have any further questions on
the use of this medicine, ask your
doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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.
Tell your doctor or nurse
immediately if you experience:
• Problems with your kidney function
• Difficulty in breathing following
surgery
• Muscle weakness.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor for advice before being given
this medicine.
Pregnancy
Genticin Injectable is not
recommended for use in pregnancy
unless considered appropriate by your
doctor.
Breast-feeding
Use of Genticin Injectable whilst
breastfeeding is not recommended if
you are suffering from kidney
problems.

Rare (may affect up to 1 in 1,000
people):
• Diarrhoea
• Stomach pain
• Electrolyte disturbances
(changes in the levels of salts in
the blood).

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

Very rare (may affect up to 1 in
10,000 people):
• Problems with your brain
• Fits, confusion, hallucinations,
tiredness and depression.

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 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.

Not known (frequency cannot be
estimated from the available data):
• Symptoms of increased urination,
swelling in legs, ankles,
breathlessness, loss of appetite,
sleeping difficulty. These could be
a sign of kidney failure
• Reduction in red blood cells which
can make the skin pale and cause
weakness or breathlessness
• Symptoms of bruising,
discolouration of skin, small red
spots. These could be a sign of
purpura
• Problems with your ears that
causes a loss of balance
• Hearing loss, which is usually
reversible.

Use in children and adolescents
The 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 newborns
The daily dose in newborns is
4 - 7 mg/kg of body weight per day.

5. HOW TO STORE GENTICIN
INJECTABLE
Keep this medicine out of sight and
reach of children.
Do not use this medicine after the
expiry date which is stated on the
carton after Expiry Date. The expiry
date refers to the last day of that
month.
Do not store above 25°C. Do not
freeze.
Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the
environment.
6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Genticin Injectable contains
- The active substance is gentamicin
sulphate. Each 2 ml ampoule
contains 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 clear
colourless solution.
It is available in 2 ml clear glass
ampoules in boxes of 10 x 2 ml
ampoules.
Marketing Authorisation Holder and
Manufacturer
Amdipharm UK Limited
Capital House,
85 King William Street,
London EC4N 7BL, UK
Manufacturer
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
November 2017

31039131

LF-103869-01

AMS Component No.:
Proof Number:
Revision Date:
Product Description:
Component:
Product Code:
Country:
Vendor Name:
CRF(s):
Revised by:

1
16-Nov-2017
Genticin Injectable
Leaflet
102657
UK
Famar Alimos
PR 7471
PAT

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref.:
Print Colours:
Non-Print Colours:
Min. Font Size:

460 x 148 mm
31039131
154
N/A
Black
Cutter
12 pt

PAGE 1 OF 1

60 mm

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.

Other side effects include:
Uncommon (may affect up to 1 in
100 people):
• Feeling or being sick
• Sore mouth
• Problems with your liver
• Blood disorders.

Reporting of side effects
If you get any side effects, talk to your
doctor 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.

60 mm

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.

Use in elderly
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.

Other medicines and Genticin
Injectable
Tell your doctor or nurse if you are
taking, have recently taken or might
take any other medicines.
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).

460 mm

60 mm

Package leaflet: Information for the patient

Due to the longer half-life, newborns
are given the required daily dose in
one single dose.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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