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GENTISONE HC EAR DROPS

Active substance(s): GENTAMICIN / HYDROCORTISONE ACETATE / GENTAMICIN / HYDROCORTISONE ACETATE / GENTAMICIN / HYDROCORTISONE ACETATE

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GNE 90071

Package leaflet: Information for the user
LF-102438-01

Gentisone® HC Ear Drops

Gentamicin and Hydrocortisone acetate
Read all of this leaflet carefully before
you start using 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, pharmacist or nurse.
- This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
- If you get any side effects, talk to your
doctor, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What Gentisone HC Ear Drops are and
what they are used for
2. What you need to know before you use
Gentisone HC Ear Drops
3. How to use Gentisone HC Ear Drops
4. Possible side effects
5. How to store Gentisone HC Ear Drops
6. Contents of the pack and other
information
1. WHAT GENTISONE HC EAR DROPS
ARE AND WHAT THEY ARE USED
FOR
The name of your medicine is Gentisone HC
Ear Drops. Gentisone HC Ear Drops contain
the active ingredients gentamicin which
belongs to a group of medicines called
antibiotics and hydrocortisone acetate
which is a steroid.
Gentisone HC Ear Drops are used in adults
and children to treat eczema and bacterial
infections in the external ear, to prevent
infections in an injured ear and to treat
infected bone cavities (mastoid) behind the
ear after an operation.
2. WHAT YOU NEED TO KNOW
BEFORE YOU USE GENTISONE HC
EAR DROPS
Do not use this Gentisone HC Ear Drops :
• if you are allergic to gentamicin,
hydrocortisone or similar medicine
containing an aminoglycoside antibiotic or
steroid or to any of the other ingredients
of this medicine (listed in section 6)

• if you have or suspect you have a burst
ear drum, if you are being treated for a
problem with your external ear
• if you suffer from myasthenia gravis, a
disease causing muscle weakness.
Warnings and precautions
Talk to your doctor or pharmacist before
using Gentisone HC Ear Drops if you:
• Have any problems with your kidneys or
liver
• Are using this medicine for a long
period of time
• Have open wounds or damaged skin.
Some medicines may increase the effects
of Gentisone HC Ear Drops and your doctor
may wish to monitor you carefully if you are
taking these medicines (including some
medicines for HIV: ritonavir, cobicistat).
If any of these applies to you or if you are
not sure, tell your doctor.
Contact your doctor if you experience
blurred vision or other visual disturbances.
Other medicines and Gentisone HC Ear
Drops
Tell your doctor if you are taking, have
recently taken or might take any other
medicines, including medicines obtained
without a prescription.
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 or pharmacist
for advice before using this medicine.
Gentisone HC Ear Drops are not
recommended for use in pregnancy or
breast-feeding unless considered
appropriate by your doctor.
Driving and using machinery
This medicine should not affect your ability
to drive or use machines.
Gentisone HC Ear Drops contain
Benzalkonium chloride
Irritant, may cause skin reactions.
3. HOW TO USE GENTISONE HC EAR
DROPS
Always use this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
Shake the bottle before use. The

recommended dose is 2-4 drops three to
four times a day and at night.
Alternatively, wicks medicated with your
medicine may be placed into the external
ear or into the bone cavity behind your ear
(mastoid).
The drops should not be used continuously
for a long time as it may irritate your skin. If
your infection is severe, your doctor may
also give you antibiotics by injection.
If you swallow your ear drops
If you or someone else, accidentally
swallows some of this medicine, contact
your doctor, pharmacist or nearest hospital
emergency department immediately.
If you forget to use Gentisone HC Ear
Drops
If you forget to use your drops, use your
next dose as soon as you remember and
continue as before. Do not apply a double
dose to make up for a forgotten dose.
If you have any further questions on the use
of this medicine, ask your doctor,
pharmacist 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.
Stop using these drops and tell your
doctor immediately. These may be
signs of an allergic reaction.
Other side effects include:
Not known (frequency cannot be estimated
from the available data)
• Super infection (infection occurring
after an earlier infection)
• Hearing loss
• Burning sensation
• Stinging sensation
• Itching at the site of administration
• Blurred vision.
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. 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 GENTISONE HC
EAR DROPS
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the carton and label
after EXP. The expiry date refers to the last
day of that month.
Store your medicine in a safe place below
25°C and do not freeze or mix with other
liquids.
Do not use for more than 4 weeks after
opening.
Return any unused drops to the pharmacist.
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 Gentisone HC Ear Drops contains
- The active substances are gentamicin
sulphate 0.3% w/v gentamicin base
and 1.0% w/v hydrocortisone acetate
- The other ingredients are benzalkonium
chloride, povidone, polyethylene glycol
4000, sodium chloride, borax, disodium
edetate and purified water.
What Gentisone HC Ear Drops look like
and the contents of the pack
The ear drops are available as a white
solution in 10 ml dropper bottles.
Marketing Authorisation Holder and
Manufacturer responsible for release:
Amdipharm UK Limited,
Capital House,
85 King William Street,
London EC4N 7BL,
UK
Gentisone is the registered trade mark of
Amdipharm Mercury International Limited.
This leaflet was last revised in April
2017.

GNE 90071

Package leaflet: Information for the user
LF-102420-01

Gentisone® HC Ear Drops

Gentamicin and Hydrocortisone acetate
Read all of this leaflet carefully before
you start using 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, pharmacist or nurse.
- This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
- If you get any side effects, talk to your
doctor, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What Gentisone HC Ear Drops are and
what they are used for
2. What you need to know before you use
Gentisone HC Ear Drops
3. How to use Gentisone HC Ear Drops
4. Possible side effects
5. How to store Gentisone HC Ear Drops
6. Contents of the pack and other
information
1. WHAT GENTISONE HC EAR DROPS
ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Gentisone HC
Ear Drops. Gentisone HC Ear Drops contain
the active ingredients gentamicin which
belongs to a group of medicines called
antibiotics and hydrocortisone acetate which
is a steroid.
Gentisone HC Ear Drops are used in adults
and children to treat eczema and bacterial
infections in the external ear, to prevent
infections in an injured ear and to treat
infected bone cavities (mastoid) behind the
ear after an operation.
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE GENTISONE HC EAR DROPS
Do not use this Gentisone HC Ear Drops:
• if you are allergic to gentamicin,
hydrocortisone or similar medicine
containing an aminoglycoside antibiotic
or steroid or any of the other ingredients
of this medicine (listed in section 6)
• if you have or suspect you have a burst
ear drum, if you are being treated for a
problem with your external ear

• if you suffer from myasthenia gravis, a
disease causing muscle weakness.
Warnings and precautions
Talk to your doctor or pharmacist before
using Gentisone HC Ear Drops if you:
• Have any problems with your kidneys or
liver
• Are using this medicine for a long period
of time
• Have open wounds or damaged skin.
Some medicines may increase the effects of
Gentisone HC Ear Drops and your doctor
may wish to monitor you carefully if you are
taking these medicines (including some
medicines for HIV: ritonavir, cobicistat).
If either of these applies to you or if you are
not sure, tell your doctor.
Contact your doctor if you experience
blurred vision or other visual disturbances.
Other medicines and Gentisone HC Ear
Drops
Tell your doctor if you are taking, have
recently taken or might take any other
medicines, including medicines obtained
without a prescription.
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 or pharmacist for
advice before using this medicine.
Gentisone HC Ear Drops are not
recommended for use in pregnancy or
breast-feeding unless considered
appropriate by your doctor.
Driving and using machinery
This medicine should not affect your ability
to drive or use machines.
Gentisone HC Ear Drops contain
Benzalkonium chloride
Irritant, may cause skin reactions.
3. HOW TO USE GENTISONE HC EAR
DROPS
Always use this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not
sure.
Shake the bottle before use. The
recommended dose is 2-4 drops three to
four times a day and at night.

Alternatively, wicks medicated with your
medicine may be placed into the external
ear or into the bone cavity behind your ear
(mastoid).
The drops should not be used continuously
for a long time as it may irritate your skin. If
your infection is severe, your doctor may
also give you antibiotics by injection.
If you swallow your ear drops
If you or someone else, accidentally
swallows some of this medicine, contact
your doctor, pharmacist or nearest hospital
emergency department immediately.
If you forget to use Gentisone HC Ear Drops
If you forget to use your drops, use your next
dose as soon as you remember and continue
as before. Do not apply a double dose to
make up for a forgotten dose.
If you have any further questions on the use
of this medicine, ask your doctor, pharmacist
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.
Stop using these drops and tell your
doctor immediately. These may be signs
of an allergic reaction.
Other side effects include:
Not known (frequency cannot be estimated
from the available data)
• Super infection (infection occurring
after an earlier infection)
• Hearing loss
• Burning sensation
• Stinging sensation
• Itching at the site of administration
• Blurred vision.
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. 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 GENTISONE HC
EAR DROPS
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the carton and label
after EXP. The expiry date refers to the last
day of that month.
Store your medicine in a safe place below
25°C and do not freeze or mix with other
liquids.
Do not use for more than 4 weeks after
opening.
Return any unused drops to the pharmacist.
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 Gentisone HC Ear Drops contains
- The active substances are gentamicin
sulphate 0.3% w/v gentamicin base and
1.0% w/v hydrocortisone acetate
- The other ingredients are benzalkonium
chloride, povidone, polyethylene glycol
4000, sodium chloride, borax, disodium
edetate and water for injections.
What Gentisone HC Ear Drops look like
and the contents of the pack
The ear drops are available as a white
solution in 10 ml dropper bottles.
Marketing Authorisation Holder and
Manufacturer responsible for release:
Amdipharm UK Limited,
Capital House, 85 King William Street,
London EC4N 7BL, UK
Alternative manufacturer responsible for
release:
Famar S.A.,
Agiou Dimitriou 63, Alimos Attiki,
17456, Greece
Gentisone is the registered trade mark of
Amdipharm Mercury International Limited.
This leaflet was last revised in May
2017.

31032652

Expand Transcript

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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