Fusidic Acid 1 Percent 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 this medicine is Fucithalmic® 1% w/w Viscous Eye Drops but it will be referred to as Fucithalmic® throughout the remainder of the 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.
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.
POM
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®
What Fucithalmic® contains
The active ingredient is fusidic acid (anhydrous) 10mg/g.
Each gram contains 10mg fusidic acid (as hemihydrate).
The other ingredients are benzalkonium chloride, disodium edetate, mannitol, carbomer, sodium hydroxide and water for injections.
What Fucithalmic® looks like and contents of the pack
Fucithalmic® is a white to off-white, slightly thick liquid.
Fucithalmic® comes in tubes of 5g.
Manufactured by
LEO Laboratories Ltd. (LEO Pharma), 285 Cashel Road, Dublin 12, Ireland.
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: 33532/0693
Leaflet dated 2nd August 2016 Leaflet coded XXXXXXXXXX
Fucithalmic® is a registered trademark of Amdipharm Mercury International Limited.
• Keep out of the sight and reach of children.
• Keep in the original packaging.
• Do not store above 25oC.
• Keep cap tightly closed.
• Discard any remaining drops 28 days after first opening.
• Do not use the drops after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.
• If your medicine becomes discoloured or shows any signs 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.
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 this medicine is Fusidic acid 1% w/w Viscous Eye Drops but it will be referred to as Fusidic acid Eye Drops throughout the remainder of the leaflet.
In this leaflet:
1. What Fusidic acid Eye Drops is and what it is used for
2. Before you use Fusidic acid Eye Drops
3. How to use Fusidic acid Eye Drops
4. Possible side effects
5. How to store Fusidic acid Eye Drops
6. Further information
1. What Fusidic acid Eye Drops is and what it is used for
Fusidic acid Eye Drops belongs to a group of medicines called anti-infectives. It is a type of antibiotic.
Fusidic acid Eye Drops works by killing germs (bacteria) that cause infections.
Fusidic acid Eye Drops is an eye drop medicine used to treat infections of the eyes caused by germs (bacterial conjunctivitis).
2. Before you use Fusidic acid Eye Drops Do not use Fusidic acid Eye Drops
• 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 Eye Drops
• 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 Eye Drops:
• 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 Eye Drops
Fusidic acid Eye Drops contains:
• Benzalkonium chloride. This is a preservative. It may cause eye irritation.
3. How to use Fusidic acid Eye Drops
Always use Fusidic acid Eye Drops 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 Eye Drops
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 Eye Drops. 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 Eye Drops 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 Eye Drops
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 Eye Drops 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 Eye Drops
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.
Like all medicines, Fusidic acid Eye Drops 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.
What Fusidic acid Eye Drops contains
The active ingredient is fusidic acid (anhydrous) 10mg/g.
Each gram contains 10mg fusidic acid (as hemihydrate).
The other ingredients are benzalkonium chloride, disodium edetate, mannitol, carbomer, sodium hydroxide and water for injections.
What Fusidic acid Eye Drops looks like and contents of the pack
Fusidic acid Eye Drops is a white to off-white, slightly thick liquid. Fusidic acid Eye Drops comes in tubes of 5g.
Manufactured by
LEO Laboratories Ltd. (LEO Pharma), 285 Cashel Road, Dublin 12, Ireland.
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: 33532/0693
Leaflet dated 2nd August 2016 Leaflet coded XXXXXXXXXX
POM
5. How to store Fusidic acid Eye Drops
• Keep out of the sight and reach of children.
• Keep in the original packaging.
• Do not store above 25oC.
• Keep cap tightly closed.
• Discard any remaining drops 28 days after first opening.
• Do not use the drops after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.
• If your medicine becomes discoloured or shows any signs 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.