Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Fucithalmic 1% w/w Viscous Eye Drops
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Fusidic acid hemihydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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).
What you need to know before you take it
e 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
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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.
How to take it
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 2
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.
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.
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By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
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.
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 Email :[email protected] 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 ®.
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Frequently asked questions about Fucithalmic 1% w/w Viscous Eye Drops
How do I take Fucithalmic 1% w/w Viscous Eye Drops?
Fucithalmic 1% w/w Viscous Eye Drops comes as eye drops. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Fucithalmic 1% w/w Viscous Eye Drops?
The active substance in Fucithalmic 1% w/w Viscous Eye Drops is fusidic acid hemihydrate.
Are there equivalent medicines to Fucithalmic 1% w/w Viscous Eye Drops?
Medicines with the same active substance, strength and form include: Fusidic Acid 1% Viscous Eye Drops. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Fucithalmic 1% w/w Viscous Eye Drops, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Fucithalmic 1% w/w Viscous Eye Drops without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: fusidic acid hemihydrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Fusidic acid eye drops are indicated for the topical treatment of bacterial conjunctivitis where the organism is known to be sensitive to the antibiotic.
4.2. Posology and method of administration
Posology:
For all ages: One Fusidic acid eye drop to be instilled into the eye twice daily. Treatment should be continued for at least 48 hours after the eye returns to normal.
Method of administration:
For ophthalmic use only.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Contact lenses should not be worn/used when Fusidic acid eye drops are used. The microcrystalline fusidic acid may cause scratches in the contact lens or cornea. Contact lenses are kept out until all symptoms of the infection have gone.
Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.
Fusidic acid eye drops contain benzalkonium chloride, which may cause eye irritation and discolour soft contact lenses.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Systemic interactions are unlikely since systemic exposure after application of Fusidic acid eye drops is negligible.
4.6. Fertility, pregnancy and lactation
Pregnancy
No effects during pregnancy are anticipated, since systemic exposure to Fusidic acid eye drops is negligible. Fusidic acid eye drops can be used during pregnancy.
Breast-feeding
No effects on the breast-fed new-born/infant are anticipated since the systemic exposure of the breast-feeding woman to fusidic acid is negligible. Fusidic acid eye drops can be used during breast-feeding.
Fertility
There are no clinical studies with Fusidic acid eye-drops regarding fertility. No effects on women of childbearing potential are anticipated, since systemic exposure to Fusidic acid eye-drops is negligible.
4.7. Effects on ability to drive and use machines
Fusidic acid eye drops has no or negligible influence on the ability to drive or use machines. Fusidic acid eye drops may, however, cause a blurring of vision following application and patient should take this into account.
4.8. Undesirable effects
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and spontaneous reporting.
Based on pooled data from clinical studies, including 2,499 patients with eye infections including acute conjunctivitis, who received Fucithalmic eye drops, the frequency of undesirable effects was 11.3%.
The most frequently reported adverse reactions during treatment are various application site reactions such as pain, pruritus and irritation/discomfort in/around the eyes, which occurred in approximately 8.5% of patients, followed by blurring of vision, which occurred in approximately 1.2% of patients. Angioedema has been reported in a few patients post marketing.
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common (≥1/10)
Common (≥1/100 and <1/10)
Uncommon (≥1/1,000 and <1/100)
Rare (≥1/10,000 and <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
System organ class
Frequency
Undesirable effects
Immune system disorders
Uncommon
Hypersensitivity
Eye disorders
Common
Vision blurred (transient)
Uncommon
Eyelid oedema, Lacrimation increased
Rare
Conjunctivitis aggravated
Skin and subcutaneous tissue disorders
Uncommon
Rash
Angioedema
Rare
Urticaria
General disorders and administration site conditions
Common
Application site pain (including eye burning and eye stinging)
Application site pruritus
Application site discomfort/irritation
Paediatric population
The observed safety profile is similar in children and adults.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
The total quantity of fusidic acid in one 5 g tube of Fucithalmic eye drops (50 mg) does not exceed the approved total daily oral dose of fusidic acid contain-ing products. The concentration of the excipients is too low to constitute a safety risk. Therefore, overdose is unlikely to occur.
💬 Ask about this leaflet
Ask anything about Fucithalmic 1% w/w Viscous Eye Drops. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.