Fucithalmic 10 mg/g ophthalmic gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Fucithalmic 10 mg/g eye gel
Fusidic acid
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Fucithalmic eye gel is and what it is used for
- What you need to know before using Fucithalmic eye gel
- How to use Fucithalmic eye gel
- Possible side effects
- How to store Fucithalmic eye gel
Pack contents and other information
1. What Fucithalmic is and what it is used for
Fucithalmic contains the active substance fusidic acid, which belongs to a group of medicines called ophthalmic antibiotics.
Antibiotics are used to treat bacterial infections and are not effective against viral infections. It is important to follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment. Do not store or reuse this medication. If you have leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Medicines should not be disposed of via the drain or in household waste. |
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 to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to use Fucithalmic gel.
- Do not wear contact lenses during treatment. Contact lens use may be resumed 12 hours after treatment has ended.
- You may experience blurred vision immediately after applying Fucithalmic gel. Do not drive or operate machinery until this effect has gone away.
- Follow your doctor's instructions regarding the duration of treatment. As with all antibiotics, widespread or repeated use may increase the risk of antibiotic resistance.
Using Fucithalmic gel with other medicines
Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Fucithalmic gel may only be used during pregnancy and breastfeeding if your doctor considers it necessary and according to their recommendations.
Driving and using machines
The effect of Fucithalmic on the ability to drive and use machines is none or negligible. 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 reinserting them.
Benzalkonium chloride may cause eye irritation, particularly if you have dry eye or other corneal conditions (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.
3. How to use Fucithalmic gel
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
Adults and children (0 – 17 years):
Apply 1 drop of gel into the affected eye or eyes, twice daily.
Treatment should continue for at least two days after complete resolution of the infection (when the eye returns to its normal appearance).
Contact your doctor if you do not see improvement after 7 days of treatment.
Instructions for correct administration of the medicine:
Tilt your head backward, gently pull down the lower eyelid and instill the drop into the conjunctival sac (the space between the eye and the eyelid), while looking upward. Close your eyes gently and keep them closed for a few moments.
Since this is a sterile preparation, it is recommended to follow these instructions:
- Each patient should use their own container.
- The gel should be administered with maximum hygiene; hands should be thoroughly washed, and care should be taken to avoid, as much as possible, contact of the tube's nozzle with any surface, including the eye.
- After application, close the container tightly.
- Discard 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 effect; however, consult your doctor or pharmacist.
An ocular overdose of Fucithalmic gel can be removed from the eyes with lukewarm water.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 it as soon as possible. Then continue as instructed. Do not apply a double dose to make up for missed doses.
If you stop using Fucithalmic gel
It is important that you complete the full course of treatment prescribed by your doctor, even if you start to feel better after a few days. If you stop using this medicine before the prescribed time, the infection may not be completely cured and symptoms may return or even worsen.
Antibiotic resistance may also develop, which would reduce the effectiveness of Fucithalmic gel if you need to be treated with it again in the future.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Stop using this medicine or seek medical help immediately 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 beneath the skin surface or itchy, raised, red, or skin-colored hives (angioedema or urticaria)
The following adverse effects have been observed with the use of this medicine:
- Frequent: may affect up to 1 in 10 people
Transient blurred vision
Burning sensation in the eyes
Stinging sensation in the eyes (pain at the application site)
Itching of the eyes (pruritus at the application site)
Ocular irritation/discomfort (discomfort/irritation at the application site)
- Uncommon: may affect up to 1 in 100 people
Swelling of the eyelids (palpebral edema)
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 safety profile observed in children is similar to that in adults.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 30 ºC.
Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fucithalmic gel
- The active substance 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 injections.
Appearance of the product and contents of the container
Fucithalmic is a viscous gel, white to almost white in colour.
The gel is supplied in 5-gram tubes.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Amdipharm Limited
Unit 17, Northwood House
Northwood Crescent, Northwood
Dublin 9, D09 V504, Ireland
Manufacturer
LEO Laboratories Limited, Cashel Road, Dublin 12 (Ireland).
and
CENEXI HSC, 2 rue Louis Pasteur, Herouville St Clair, 14200, France.
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Local representative:
Advanz Pharma Spain S.L.U.
Paseo de la Castellana 135, 7th floor
28046 Madrid (Spain)
Tel. +34 900 834 889
[email protected]
Date of the most recent review of this leaflet: January 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.