Fusidic Acid 1% W/W Viscous Eye Drops
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fucithalmic® 1%w/w Viscous Eye Drops
(fusidic acid)
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.
The name of your medicine is Fucithalmic 1%w/w Viscous Eye Drops but it will be referred to as Fucithalmic throughout thi s leaflet.
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.
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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
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 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.
Do not store above 25 C.
Keep the tube tightly closed.
Discard 1 month after first opening. 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
The active substance is fusidic acid. Each gram of gel contains 10mg fusidic acid.
Also contains benzalkonium chloride, mannitol, disodium edetate, carbomer, sodium hydroxide 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, Cashel Road, Dublin 12, Ireland.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Fucithalmic® 1%w/w Viscous Eye Drops,
PL: 18799/2369
Leaflet date: 08.04.2015
Fucithalmic is a registered trademark of Leo Pharma.
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.
The name of your medicine is Fusidic acid 1%w/w Viscous Eye Drops but it will be referred to as Fusidic throughout this leaflet.
In this leaflet:
1. What Fusidic is and what it is used for
2. Before you use Fusidic
3. How to use Fusidic
4. Possible side effects
5. How to store Fusidic
6. Further information
1. WHAT FUSIDIC IS AND WHAT IT IS USED FOR
Fusidic belongs to a group of medicines called anti-infectives. It is a type of antibiotic.
Fusidic works by killing germs (bacteria) that cause infections.
Fusidic is an eye drop medicine used to treat infections of the eyes caused by germs (bacterial conjunctivitis).
2. BEFORE YOU USE FUSIDIC
Do not use Fusidic
• If you are allergic (hypersensitive) to fusidic, 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
• 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:
• 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
Fusidic 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
Always use Fusidic exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How to use Fusidic
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. 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.
Other possible side effects: Common si
affect less tt Burning,
PI ease remove any highlig0ted tex'
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How much Fusidic 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
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 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
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 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 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
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 use Fusidic 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.
Do not store above 25 C.
Keep the tube tightly closed.
Discard 1 month after first opening. 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 contains
The active substance is fusidic acid. Each gram of gel contains 10mg fusidic acid.
Also contains benzalkonium chloride, mannitol, disodium edetate, carbomer, sodium hydroxide and purified water.
What Fusidic looks like and contents of the pack
Fusidic 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, Cashel Road, Dublin 12, Ireland.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Fusidic acid 1%w/w Viscous Eye Drops,
PL: 18799/2369
Leaflet date: 08.04.2015