FUCITHALMIC 10 mg/g OPHTHALMIC GEL

Introduction

Leaflet: information for the patient

Fucithalmic 10 mg/g eye gel

fusidic acid

Read the entire leaflet carefully before starting to use the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Fucithalmic gel is and what it is used for
2. What you need to know before using Fucithalmic gel
3. How to use Fucithalmic gel
4. Possible side effects
5. Storage of Fucithalmic gel

Contents of the pack and additional information

1. What Fucithalmic is and what it is used for

Fucithalmic contains the active ingredient fusidic acid, which belongs to a group of medicines called antibiotics for ophthalmic use.

Fucithalmic gel is indicated for the treatment of conjunctivitis (superficial eye infections) caused by bacteria sensitive to fusidic acid.

2. What you need to know before using Fucithalmic gel

Do not use Fucithalmic

• if you are allergic to fusidic acid or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Fucithalmic gel.

• Do not wear contact lenses during treatment. You can restart wearing contact lenses 12 hours after completing the treatment.
• You may experience blurred vision immediately after administering Fucithalmic gel. Do not drive or use machines until this effect has disappeared.
• Follow your doctor's instructions regarding treatment duration. As with all antibiotics, widespread or repeated use may increase the risk of developing antibiotic resistance.

Using Fucithalmic gel with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Fucithalmic gel should only be used during pregnancy and breastfeeding if your doctor considers it necessary and follows their recommendations.

Driving and using machines

Fucithalmic has no or negligible influence on the ability to drive and use machines. However, you may experience blurred vision immediately after application. Do not drive or use machines until this effect has disappeared.

Fucithalmic gel contains benzalkonium chloride

This medicine contains 0.01% benzalkonium chloride, equivalent to 0.11 mg of benzalkonium chloride per gram of Fucithalmic gel.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. You should remove your contact lenses before using this medicine and wait 15 minutes before putting them back on.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer on the front of the eye). Consult your doctor if you experience any unusual sensation, itching, or pain in the eye after using this medicine.

3. How to use Fucithalmic gel

Follow the administration instructions for this medicine exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children (0-17 years)

Apply 1 drop of gel to the affected eye(s) twice a day.

Treatment should be continued for at least 2 days after complete resolution of the infection (when the eye returns to its normal appearance).

Consult your doctor if you do not observe improvement after 7 days of treatment.

Instructions for correct administration of the medicine:

With your head tilted back, pull down the lower eyelid and drop the gel into the conjunctival sac (the space between the eye and the eyelid) while looking up. Gently close your eyes and keep them closed for a few moments.

As this is a sterile preparation, follow these instructions:

• Each patient will use their own container.
• Apply the gel with maximum hygiene, washing your hands carefully and avoiding contact between the tube nozzle and any surface, including the eye.
• Close the container tightly after application.
• Discard the container after completing the treatment.

If you use more Fucithalmic gel than you should

If you have applied more Fucithalmic gel than you should, it is unlikely to cause an overdose effect. However, consult your doctor or pharmacist.

An overdose of Fucithalmic gel can be removed from the eyes with lukewarm water.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used or ingested.

If you forget to use Fucithalmic gel

If you miss a dose, apply another as soon as possible. Then continue as indicated. Do not apply a double dose to make up for missed doses.

If you interrupt treatment with Fucithalmic gel

It is essential to complete the treatment cycle indicated by your doctor, even if you start to feel better after a few days. If you stop using this medicine before your doctor indicates, the infection may not be fully cured, and symptoms may return or worsen.

This may also lead to antibiotic resistance, reducing the effectiveness of Fucithalmic gel if you need to be treated again in the future.

If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Stop using this medicine or seek urgent medical attention if you experience the following:

• Difficulty breathing, rash, itching, or swelling of the eyelids, face, or lips, which may be signs of an allergic reaction (hypersensitivity)
• Swelling with a red rash under the skin or hives that itch, raised, red, or skin-colored (angioedema or urticaria)

The following side effects have been observed with the administration of this medicine:

• Frequent:may affect up to 1 in 10 people

Transient blurred vision

Burning sensation in the eyes

Itching sensation in the eyes (pain at the application site)

Itching in the eyes (pruritus at the application site)

Eye irritation/discomfort (discomfort/irritation at the application site)

• Uncommon:may affect up to 1 in 100 people

Swelling of the eyelids (eyelid edema)

Watery eyes (tearful eyes)

Swelling of the face or throat

Rash

• Rare:may affect up to 1 in 1,000 people

Worsening of conjunctivitis

Other side effects in children

The observed safety profile is similar in children and adults.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fucithalmic

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the container after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Place the container and any unused medicine in the SIGRE collection point at the pharmacy. If you have any questions, ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Fucithalmic gel

• The active ingredient is fusidic acid.

Each gram of gel contains 10 mg of fusidic acid.

• The other ingredients are benzalkonium chloride, carbomer, mannitol, disodium edetate, sodium hydroxide, and water for injectable preparations.

Appearance of the product and contents of the pack

Fucithalmic is a viscous white to almost white gel.

The gel is presented in 5-gram tubes.

Marketing authorization holder and manufacturer

Marketing authorization holder

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Manufacturer

LEO Laboratories Limited, Cashel Road, Dublin 12 (Ireland).

and

CENEXI HSC, 2 Luis Pasteur Street, Herouville St Clair, 14200, France.

You can request more information about this medicine from the local representative of the marketing authorization holder:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona

Date of the last revision of this leaflet: January 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.