Package Insert: Information for the Patient

Fucithalmic 10 mg/g Ophthalmic Gel

Fusidic Acid

Read this entire package insert carefully before starting to use the medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

Fucithalmic contains the active ingredient fusidic acid, belonging to a group of medications called ocular antibiotics.

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

Do not use Fucithalmic

- if you are allergic to fusidic acid or to any of the other ingredients of this medicine (included in section 6).

Warnings and precautions

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

• Do not use contact lenses during treatment. Contact lens use may be resumed 12 hours after treatment has finished.
• You may notice blurred vision immediately after administration of Fucithalmic gel. Do not drive or use machines until this effect has disappeared.
• Follow your doctor's instructions regarding the duration of treatment. As with all antibiotics, general or repeated use may increase the risk of antibiotic resistance.

Use of Fucithalmic gel with other medicines

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

Pregnancy, breastfeeding and fertility

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

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

Driving and operating machines

The influence of Fucithalmic on the ability to drive and use machines is negligible. However, you may notice 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, which is equivalent to 0.11 mg of benzalkonium chloride in each gram of Fucithalmic gel.

Benzalkonium chloride may be absorbed by soft contact lenses, altering their color. You should remove your contact lenses before using this medicine and reinsert them 15 minutes later.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children (0 – 17 years):

Apply 1 drop of gel in the affected eye or eyes, two times a day.

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

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

Instructions for correct administration of the medication:

With the head tilted back, separate the lower eyelid downwards and let the drop fall into the conjunctival sac (space between the eye and the eyelid) while looking upwards. Close the eyes gently and keep them closed for a few moments.

As this is a sterile preparation, it is recommended to follow the following instructions:

• Each patient will use their own container.
• The application of the gel should be carried out with maximum hygiene, therefore, wash hands carefully and avoid, as far as possible, the cannula of the tube coming into contact with any surface, including the eye.
• After application, close the container tightly.
• Dispose of the container once treatment is completed.

If you use more Fucithalmic gel than you should

If more Fucithalmic gel has been applied than recommended, it is unlikely to cause an overdose, nonetheless, consult your doctor or pharmacist.

Fucithalmic gel eye overdose can be eliminated from the eyes with warm water.

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

If you forgot to use Fucithalmic gel

In case of forgotten dose, apply another as soon as possible. Then continue as instructed. Do not apply a double dose to compensate for the 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 feeling better after a few days. If you stop using this medication before the indicated time by your doctor, it is possible that the infection has not been fully cured and symptoms may return or worsen.

Resistance to the antibiotic may also be generated, which will reduce the effectiveness of Fucithalmic gel in case you need to be treated again in the future.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

• Difficulty breathing, hives, 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's surface or itchy, elevated, red, or skin-colored hives (angioedema or urticaria)

The following adverse effects have been observed with the administration of this medication:

• Frequent:may affect up to 1 in 10 people

Transient blurred vision

Burning sensation in the eyes

Itching sensation in the eyes (eye discomfort)

Itching sensation in the eyes (application site pruritus)

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

• Infrequent:may affect up to 1 in 100 people

Swelling of the eyelids (blepharitis)

Excessive tearing (watery eyes)

Swelling of the face or throat

Rash

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

Worsening of conjunctivitis

Other adverse effects in children

The observed safety profile is similar in children and adults.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Fucithalmic gel

• The active ingredient is fusidic acid.

Each gram of gel contains 10 mg of fusidic acid.

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

Appearance of the product and contents of the packaging

Fucithalmic is a viscous gel of white to almost white color.

The gel is presented in 5-gram tubes.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Responsible manufacturer

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

and

CENEXI HSC, 2 rue Louis Pasteur, Herouville St Clair, 14200, France.

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona

Last review date of this leaflet: January 2022

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.