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GENTAMICIN 0.3 PERCENT W-V AND HYDROCORTISONE ACETATE 1 PERCENT W-V EAR DROPS

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

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Package Leaflet: Information for the User

Gentisone® HC Ear Drops
(gentamicin sulfate / hydrocortisone acetate)
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 only. 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 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 take this medicine if you:
• Are allergic to gentamicin, hydrocortisone, any of the other ingredients
of Gentisone HC Ear Drops listed in section 6, or similar medicine
containing an aminoglycoside antibiotic or steroid
• Have or suspect you have a burst ear drum, if you are being treated for
a problem with your external ear
• 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.
If either of these applies to you or if you are not sure, tell your doctor.
Other medicines and Gentisone HC Ear Drops
Please tell your doctor if you are taking, have recently taken, or might
take any other medicines including those obtained without a prescription.
Pregnancy and breastfeeding
Tell your doctor before being given Gentisone HC Ear Drops if you are
pregnant, planning to become pregnant or if you are breastfeeding.
Gentisone HC Ear Drops are not recommended for use in pregnancy or
breastfeeding 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 the drops as your doctor or pharmacist tells you to. Check
with your doctor or pharmacist if you are not sure.
Shake the bottle and use 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.
4. Possible side effects
Like all medicines, Gentisone HC Ear Drops 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:
• Super infection (infection occurring after an earlier infection)
• Hearing loss
• Burning sensation
• Stinging sensation
• Itching at the site of administration.
Reporting of side effects
If you get any side effects, talk to your doctor or 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 out of the sight and reach of children.
Do not store above 25oC.
Do not freeze or mix with other liquids.
Do not use Gentisone HC Ear Drops after the expiry date which is
stated on the label and carton. The expiry date refers to the last day of
that month.
• Do not use for more than 4 weeks after opening.
• If your medicine shows any sign of deterioration, return it to your
pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Gentisone HC Ear Drops contain
The drops contain 0.3% w/v of gentamicin (3000 units/ml, as sulfate) and
1% w/v hydrocortisone acetate.
The other ingredients are: benzalkonium chloride, povidone (E1201),
macrogol 4000, sodium chloride, borax (E285), 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 suspension in 10ml bottles.
Manufactured by
Amdipharm UK Limited, Capital House, 85 King William Street,
London, EC4N 7BL, UK.
Famar S.A., Agiou Dimitriou 63, Alimos Attiki, 17456, Greece.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0735
POM
Leaflet dated 10th October 2016
Leaflet coded xxxxxxxxxxxx
Gentisone® is a registered trademark of Amdipharm Mercury International
Limited.

Package Leaflet: Information for the User

Gentamicin 0.3% w/v and Hydrocortisone acetate 1% w/v Ear Drops
(gentamicin sulfate / hydrocortisone acetate)
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 only. 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.
• Your medicine is called Gentamicin 0.3% w/v and Hydrocortisone
acetate 1% w/v Ear Drops but will be referred to as Gentamicin and
Hydrocortisone Ear Drops throughout this leaflet.
What is in this leaflet:
1. What Gentamicin and Hydrocortisone Ear Drops are and what they are
used for
2. What you need to know before you use Gentamicin and
Hydrocortisone Ear Drops
3. How to use Gentamicin and Hydrocortisone Ear Drops
4. Possible side effects
5. How to store Gentamicin and Hydrocortisone Ear Drops
6. Contents of the pack and other information

3. How to use Gentamicin and Hydrocortisone Ear Drops
Always use the drops as your doctor or pharmacist tells you to. Check
with your doctor or pharmacist if you are not sure.
Shake the bottle and use 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 Gentamicin and Hydrocortisone Ear Drops
If you forget to use your drops, use your next dose as soon as you
remember and continue as before.
4. Possible side effects

1. What Gentamicin and Hydrocortisone Ear Drops are and what
they are used for
The name of your medicine is Gentamicin and Hydrocortisone Ear Drops.
Gentamicin and Hydrocortisone Ear Drops contain the active ingredients
gentamicin which belongs to a group of medicines called antibiotics and
hydrocortisone acetate which is a steroid.
Gentamicin and Hydrocortisone 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 Gentamicin and
Hydrocortisone Ear Drops
Do not take this medicine if you:
• Are allergic to gentamicin, hydrocortisone, any of the other ingredients
of Gentamicin and Hydrocortisone Ear Drops listed in section 6, or
similar medicine containing an aminoglycoside antibiotic or steroid
• Have or suspect you have a burst ear drum, if you are being treated for
a problem with your external ear
• Suffer from myasthenia gravis, a disease causing muscle weakness.
Warnings and precautions
Talk to your doctor or pharmacist before using Gentamicin and
Hydrocortisone 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.
If either of these applies to you or if you are not sure, tell your doctor.
Other medicines and Gentamicin and Hydrocortisone Ear Drops
Please tell your doctor if you are taking, have recently taken, or might
take any other medicines including those obtained without a prescription.
Pregnancy and breastfeeding
Tell your doctor before being given Gentamicin and Hydrocortisone Ear
Drops if you are pregnant, planning to become pregnant or if you are
breastfeeding.
Gentamicin and Hydrocortisone Ear Drops are not recommended for use
in pregnancy or breastfeeding unless considered appropriate by your
doctor.
Driving and using machinery
This medicine should not affect your ability to drive or use machines.
Gentamicin and Hydrocortisone Ear Drops contain Benzalkonium
chloride
Irritant, may cause skin reactions.

Like all medicines, Gentamicin and Hydrocortisone Ear Drops 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:
• Super infection (infection occurring after an earlier infection)
• Hearing loss
• Burning sensation
• Stinging sensation
• Itching at the site of administration.
Reporting of side effects
If you get any side effects, talk to your doctor or 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 Gentamicin and Hydrocortisone Ear Drops





Keep out of the sight and reach of children.
Do not store above 25oC.
Do not freeze or mix with other liquids.
Do not use Gentamicin and Hydrocortisone Ear Drops after the expiry
date which is stated on the label and carton. The expiry date refers to
the last day of that month.
• Do not use for more than 4 weeks after opening.
• If your medicine shows any sign of deterioration, return it to your
pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Gentamicin and Hydrocortisone Ear Drops contain
The drops contain 0.3% w/v of gentamicin (3000 units/ml, as sulfate) and
1% w/v hydrocortisone acetate.
The other ingredients are: benzalkonium chloride, povidone (E1201),
macrogol 4000, sodium chloride, borax (E285), disodium edetate and
water for injections.
What Gentamicin and Hydrocortisone Ear Drops look like and
the contents of the pack
The ear drops are available as a white suspension in 10ml bottles.
Manufactured by
Amdipharm UK Limited, Capital House, 85 King William Street,
London, EC4N 7BL, UK.
Famar S.A., Agiou Dimitriou 63, Alimos Attiki, 17456, Greece.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0735
POM
Leaflet dated 10th October 2016
Leaflet coded xxxxxxxxxxxx

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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