Fusidic Acid 1% W/W Viscous Eye Drops
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fucithalmic® 1% w/w Viscous Eye Drops
(fusidic a cid)
Please read all of this leaflet carefully before you start taking this medicine.
• 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 become serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
In this leaflet:
1. What Fucithalmic® is and what it is used for
2. Before you use Fucithalmic®
3. How to use Fucithalmic®
4. Possible side effects
5. How to store Fucithalmic®
6. Further information
1. WHAT FUCITHALMIC® IS AND WHAT IT IS USED FOR
Fucithalmic® belongs to a group of medicines called anti-infectives. It is a type of antibiotic.
Fucithalmic® works by killing germs (bacteria) that cause infections.
Fucithalmic® is an eye drop medicine used to treat infections of the eyes caused by germs (bacterial conjunctivitis).
2. BEFORE YOU USE FUCITHALMIC® Do not use Fucithalmic®
• If you are allergic (hypersensitive) to fusidic acid, or any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.
Take special care with Fucithalmic®
• Do not wear any type of contact lenses whilst using this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.
Pregnancy and breast-feeding
Please ask your doctor or pharmacist for advice before using Fucithalmic®:
• If you are pregnant, or think you are pregnant.
• If you are breast-feeding.
Tell your doctor if you become pregnant while using this medicine.
Driving and using machines
Following application of your medicine, a brief blurring of vision may occur. Do not drive or use machinery until your vision is clear. Check with your doctor if you feel any side effect that may stop you from driving or using machines.
Important information about some of the ingredients of Fucithalmic®
Fucithalmic® contains:
• Benzalkonium chloride. This is a preservative. It may cause eye irritation.
Please ask your doctor if you are worried about any of the ingredients in this medicine.
3. HOW TO USE FUCITHALMIC®
Always use Fucithalmic® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How to use Fucithalmic®
This medicine is only for use in your eyes. Do not swallow the drops. Do not put the drops inside your body or in your ears. Always wash your hands before using Fucithalmic®. Do not use if the cap seal on the tube is broken.
This diagram will help show how to use your medicine. It may be useful to look in a mirror.
Only take the cap off the tube when you are ready to use the medicine. It is important the tip of the tube does not touch your eye.
Tilt your head back. Pull your lower eyelid down gently. Hold the tube over your eye and look up.
Squeeze one drop into your lower eyelid. The drop will come out as a thick drop. It will become more liquid in your eye and you should still see clearly.
After using your medicine you may see a white powder around your eye. This can happen when the drops dry out. It is quite normal and is nothing to worry about. You can wipe the powder off with cotton wool.
If the medicine is for a child, you can put the drops in their eye while they are asleep or lying down if it is easier.
How much Fucithalmic® to use
Your doctor will tell you how many drops to use, or to give to your child. You should use your medicine twice each day. To remind you to use your medicine it may help to use it when
you do another regular action, such as brushing your teeth.
Adults, the elderly and children:
The usual dose is one drop twice each day, in the morning and in the evening.
Taking all the course of Fucithalmic®
It is very important to use all the medicine that your doctor has told you to use. You must use your medicine for at least 48 hours after you feel better and your eye looks normal. You must do this because otherwise your eye infection may come back.
What to do if you use more Fucithalmic® than you should
If you accidentally apply too many drops in the eye(s) or a small quantity of the drops are accidentally swallowed, it is unlikely to cause any harm. If a larger quantity of the drops are accidentally swallowed or you are worried contact your doctor, pharmacist or A+E department for advice.
If you forget to use Fucithalmic®
If you forget to use your medicine, use it as soon as you remember. Then next use your medicine at the usual time.
If you have any further questions about taking this medicine, please ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fucithalmic® can cause side effects, although not everybody gets them.
Important side effects to look out for: You must get urgent medical help if you have any of the following symptoms.
You may be having an allergic reaction:
• You have difficulty breathing
• Your face, especially around your eyes or your eyelids, or throat swell
• Your skin develops a severe rash
• You have burning or stinging in your eye that does not go away
Other possible side effects:
Common side effects (probably affect less than 1 in 10 people)
• Burning, stinging, discomfort, smarting, irritation, itching, soreness or dryness in the eye being treated.
• Blurring of vision in the eye being treated.
Uncommon side effects (probably affect less than 1 in 100 people)
• Watery eyes or crying on application
Side effects where the number of people affected is not known:
• Itching
• Rash
• Hives
• Conjunctivitis may get worse
If any of the side effects become serious or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
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 at: 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 FUCITHALMIC
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Keep the tube tightly closed.
• Do not keep the tube for more than one month after you first open it.
Do not use Fucithalmic after the expiry date which is stated on the tube and the carton label after 'Exp'. The expiry date refers to the last day of that month.
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. FURTHER INFORMATION What Fucithalmic contains
Each gram contains 10mg Fusidic acid (as hemihydrate). The other ingredients are: mannitol, carbomer, benzalkonium chloride, sodium edetate and purified water.
What Fucithalmic looks like and contents of the pack
Fucithalmic is a transparent to white, slightly thick liquid contained within a 5g tube, which is sealed with a tamper-evident screw cap.
Manufactured by: LEO Laboratories Limited, 285 Cashel Road, Dublin 12, Ireland.
Procured from within the EU & repackaged by Product Licence holder:
Kosei Pharma UK Limited,
956 Buckingham Avenue, Slough,
SL1 4NL, UK.
Fucithalmic® 1%w/w viscous eye drops; PL 39352/0365
Fucithalmic is a registered trademark of Amdipharm Mercury International Limited.
POM
Leaflet date: 22/09/2016
Fusidic acid 1 % w/w Viscous Eye Drops
Please read all of this leaflet carefully before you start taking this medicine.
• 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 become serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
In this leaflet:
1. What Fusidic acid is and what it is used for
2. Before you use Fusidic acid
3. How to use Fusidic acid
4. Possible side effects
5. How to store Fusidic acid
6. Further information
1. WHAT FUSIDIC ACID IS AND WHAT IT IS USED FOR
Fusidic acid belongs to a group of medicines called anti-infectives. It is a type of antibiotic.
Fusidic acid works by killing germs (bacteria) that cause infections.
Fusidic acid is an eye drop medicine used to treat infections of the eyes caused by germs (bacterial conjunctivitis).
2. BEFORE YOU USE FUSIDIC ACID Do not use Fusidic acid
• If you are allergic (hypersensitive) to fusidic acid, or any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.
Take special care with Fusidic acid
• Do not wear any type of contact lenses whilst using this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.
Pregnancy and breast-feeding
Please ask your doctor or pharmacist for advice before using Fusidic acid:
• If you are pregnant, or think you are pregnant.
• If you are breast-feeding.
Tell your doctor if you become pregnant while using this medicine.
Driving and using machines
Following application of your medicine, a brief blurring of vision may occur. Do not drive or use machinery until your vision is clear. Check with your doctor if you feel any side effect that may stop you from driving or using machines.
Important information about some of the ingredients of Fusidic acid
Fusidic acid contains:
• Benzalkonium chloride. This is a
preservative. It may cause eye irritation. Please ask your doctor if you are worried about any of the ingredients in this medicine.
3. HOW TO USE FUSIDIC ACID
Always use Fusidic acid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How to use Fusidic acid
This medicine is only for use in your eyes. Do not swallow the drops. Do not put the drops inside your body or in your ears. Always wash your hands before using Fusidic acid. Do not use if the cap seal on the tube is broken.
This diagram will help show how to use your medicine. It may be useful to look in a mirror.
Only take the cap off the tube when you are ready to use the medicine. It is important the tip of the tube does not touch your eye.
Tilt your head back. Pull your lower eyelid down gently. Hold the tube over your eye and look up.
Squeeze one drop into your lower eyelid. The drop will come out as a thick drop. It will become more liquid in your eye and you should still see clearly.
After using your medicine you may see a white powder around your eye. This can happen when the drops dry out. It is quite normal and is nothing to worry about. You can wipe the powder off with cotton wool.
If the medicine is for a child, you can put the drops in their eye while they are asleep or lying down if it is easier.
How much Fusidic acid to use
Your doctor will tell you how many drops to use, or to give to your child. You should use your medicine twice each day. To remind you to use your medicine it may help to use it when
you do another regular action, such as brushing your teeth.
Adults, the elderly and children:
The usual dose is one drop twice each day, in the morning and in the evening.
Taking all the course of Fusidic acid
It is very important to use all the medicine that your doctor has told you to use. You must use your medicine for at least 48 hours after you feel better and your eye looks normal. You must do this because otherwise your eye infection may come back.
What to do if you use more Fusidic acid than you should
If you accidentally apply too many drops in the eye(s) or a small quantity of the drops are accidentally swallowed, it is unlikely to cause any harm. If a larger quantity of the drops are accidentally swallowed or you are worried contact your doctor, pharmacist or A+E department for advice.
If you forget to use Fusidic acid
If you forget to use your medicine, use it as soon as you remember. Then next use your medicine at the usual time.
If you have any further questions about taking this medicine, please ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fusidic acid can cause side effects, although not everybody gets them.
Important side effects to look out for: You must get urgent medical help if you have any of the following symptoms.
You may be having an allergic reaction:
• You have difficulty breathing
• Your face, especially around your eyes or your eyelids, or throat swell
• Your skin develops a severe rash
• You have burning or stinging in your eye that does not go away
Other possible side effects:
Common side effects (probably affect less than 1 in 10 people)
• Burning, stinging, discomfort, smarting, irritation, itching, soreness or dryness in the eye being treated.
• Blurring of vision in the eye being treated.
Uncommon side effects (probably affect less than 1 in 100 people)
• Watery eyes or crying on application
Side effects where the number of people affected is not known:
• Itching
• Rash
• Hives
• Conjunctivitis may get worse
If any of the side effects become serious or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
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 at: 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 FUSIDIC ACID
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Keep the tube tightly closed.
• Do not keep the tube for more than one month after you first open it.
Do not use Fusidic acid after the expiry date which is stated on the tube and the carton label after 'Exp'. The expiry date refers to the last day of that month. 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. FURTHER INFORMATION What Fusidic acid contains
Each gram contains 10mg Fusidic acid (as hemihydrate). The other ingredients are: mannitol, carbomer, benzalkonium chloride, sodium edetate and purified water.
What Fusidic acid looks like and contents of the pack
Fusidic acid is a transparent to white, slightly thick liquid contained within a 5g tube, which is sealed with a tamper-evident screw cap.
Manufactured by: LEO Laboratories Limited, 285 Cashel Road, Dublin 12, Ireland.
Procured from within the EU & repackaged by Product Licence holder:
Kosei Pharma UK Limited,
956 Buckingham Avenue, Slough,
SL1 4NL, UK.
Fusidic acid 1%w/w viscous eye drops; PL 39352/0365
Leaflet date: 22/09/2016
POM