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Fucithalmic 1% w/w Viscous Eye Drops

Active Ingredient:
fusidic acid
Company:  
ADVANZ Pharma See contact details
ATC code: 
S01AA13
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About Medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 09 Jan 2024

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 {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 20072/0242.

Fucithalmic 1% w/w Viscous Eye Drops

Package leaflet: Information for the user

Fucithalmic® 1% w/w Viscous Eye Drops

fusidic acid

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 Fucithalmic® 1% w/w Viscous Eye Drops but it will be referred to as Fucithalmic in the rest of the leaflet.

What is in this leaflet:

1. What Fucithalmic is and what it is used for
2. What you need to know before you use Fucithalmic
3. How to use Fucithalmic
4. Possible side effects
5. How to store Fucithalmic
6. Contents of the pack and other 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. What you need to know before you use Fucithalmic
Do not use Fucithalmic
  • 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 Fucithalmic

  • Do not use Fucithalmic 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 Fucithalmic for the amount of time your doctor has instructed you to use it for.

Other medicines and Fucithalmic

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.

Fucithalmic contains Benzalkonium chloride:

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 Fucithalmic, 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 Fucithalmic

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 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.

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 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 recommended 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.

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. Do not take a double dose to make up for a forgotten dose

If you stop using Fucithalmic

If you have any further questions on the use of this medicine, 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/yellowcard 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 Fucithalmic
  • 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 Fucithalmic contains
  • The active substance is fusidic acid. Fucithalmic 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 Fucithalmic looks like and contents of the pack

Fucithalmic is a white to off-white, slightly thick liquid. Fucithalmic 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
Tel: +44 (0) 208 588 9131

Manufacturer:

CENEXI HSC
2 rue Louis Pasteur
Herouville Saint-Clair
14200
France

This leaflet was last revised in November 2023.

Amdipharm is licensed to use the registered trademark Fucithalmic®.

ADVANZ Pharma
Company image
Address
Dashwood House, 69 Old Broad Street, London, EC2M 1QS, UK
Telephone
+44 (0)208 588 9131
Medical Information Direct Line
+44 (0)208 588 9131
Medical Information e-mail
[email protected]
Customer Care direct line
+44 (0)208 588 9273