Below is a text only representation of the Patient Information Leaflet (ePIL).
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PL 20072/0242.
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.
The name of your medicine is Fusidic acid 1% w/w Viscous Eye Drops but it will be referred to as Fusidic acid Eye Drops in the rest of the leaflet.
What is in this leaflet:
1. What Fusidic acid Eye Drops are and what they are used for 2. What you need to know 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. Contents of the pack and other information
1. What Fusidic acid Eye Drops are and what they are 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. What you need to know before you use Fusidic acid Eye Drops
Do not use Fusidic acid Eye Drops
if you are allergic to fusidic acid or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Fusidic acid Eye Drops
Do not use Fusidic acid Eye drops for a long time as the bacteria may no longer be killed by the antibiotic
Do not wear any type of contact lenses whilst using this medicine
Always use Fusidic acid eye drop for the amount of time your doctor has instructed you to use it for.
Other medicines and Fusidic acid Eye Drops
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This includes any medicines which you have bought 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 taking 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.
This medicine contains 0.55 mg benzalkonium chloride in each 5 g tube which is equivalent to 0.11 mg/g.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Contact lenses should not be used during treatment with Fusidic acid eye drop , see section "Warnings and Precautions"
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
Please ask your doctor if you are worried about any of the ingredients in this medicine.
3. How to use Fusidic acid Eye 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.
How to administer 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.
Use in children
If this 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 recommended 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.
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. Do not take a double dose to make up for a forgotten dose
If you stop using Fusidic acid Eye Drops
If you have any further questions on the use of this medicine, please ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine 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 (may affect up to 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 (may affect up to 1 in 100 people)
Watery eyes or crying on application
Swelling of the eyelids
Rash.
Rare (may affect up to 1 in 1000 people):
Hives
Your eye infection 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/yellow card or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Fusidic acid Eye 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 tube after EXP. The expiry date refers to the last day of that month
Do not keep the tube for more than one month after you first open it
Store below 25°C. Keep the tube tightly closed.
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 Fusidic acid Eye Drops contains
The active substance is fusidic acid. Fusidic acid Eye Drops contains 10 milligrams of fusidic acid in each gram of drops
The other ingredients are benzalkonium chloride, disodium edetate, mannitol, carbomer, sodium hydroxide and water for injections.
You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet.
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 5 g.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Amdipharm UK Limited Dashwood House 69 Old Broad Street London EC2M 1QS United Kingdom