Ribomicin

Package leaflet: Information for the patient

RIBOMICIN 0.3% eye drops, solution, 0.3% ophthalmic ointment

Gentamicin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What RIBOMICIN is and what it is used for
2. What you need to know before using RIBOMICIN
3. How to use RIBOMICIN
4. Possible side effects
5. How to store RIBOMICIN
6. Contents of the pack and other information

1. What RIBOMICIN is and what it is used for

RIBOMICIN contains the active substance gentamicin, which belongs to a class of medicines called antibiotics used for bacterial eye infections.
RIBOMICIN eye drops are indicated for the treatment of short-term or somewhat prolonged infections of the front part of the eye, including those affecting the eyelashes, caused by bacteria, including Pseudomonas and/or Proteus. It is also used to prevent infections before eye surgery or following the removal of foreign bodies from the eye.
If you do not feel better or if you feel worse after using RIBOMICIN, speak to your doctor.

2. What you need to know before using RIBOMICIN

Do not use RIBOMICIN

• If you are allergic to gentamicin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using RIBOMICIN.
If you use this medicine for a prolonged period, you may develop microorganisms that are no longer sensitive, such as fungi. If this occurs, or if irritation or an allergic reaction to any component develops, stop using the medicine and consult your doctor to establish appropriate therapy.
Paediatric population
In very early infancy, this product should only be administered when clearly necessary and under direct medical supervision.
Other medicines and RIBOMICIN
No interactions with other medicines are known.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
In pregnant women, this product should only be administered when clearly necessary and under direct medical supervision.
Driving and using machines
RIBOMICIN eye drops, solution and eye ointment do not affect the ability to drive or operate machinery.
RIBOMICIN contains parahydroxybenzoates and benzalkonium chloride
RIBOMICIN eye ointment contains parahydroxybenzoates
May cause allergic reactions (including delayed reactions).
RIBOMICIN eye drops, solution contains benzalkonium chloride
This medicine contains 0.011 mg of benzalkonium chloride per dose (2 drops equal to 0.1 ml), equivalent to 0.11 g/L. Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, particularly if you have dry eye or corneal disorders (the transparent outermost layer of the eye). If you experience any unusual sensation, burning or pain in the eye after using this medicine, speak to your doctor.

3. How to use RIBOMICIN

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage, method and duration of administration

RIBOMICIN eye drops, solution
Instill 2 drops into the conjunctival sac (the space between the lower eyelid and the eyeball) every 1–2 hours during the day at the beginning of therapy, then gradually reduce the frequency to 1–2 times daily for 2–3 days after the clinical symptoms have disappeared, as prescribed by your doctor.

RIBOMICIN ophthalmic ointment
Apply half to one centimeter of ointment into the small fold at the inner corner of the eye next to the nose (conjunctival fornix), preferably in the evening, or as otherwise prescribed by your doctor.

Instructions for using the single-dose container

1. Separate one container from the others;
2. Open the container by twisting and removing the cap;
3. Use immediately after opening: after use, discard the container even if partially used.

If you use more RIBOMICIN than you should
Symptoms of overdose have not been reported.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
RIBOMICIN eye drops, solution
Transient local irritation
RIBOMICIN ophthalmic ointment
Occasionally a burning or stinging sensation
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store RIBOMICIN

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack after "Exp". The expiry date refers to the product in its original unopened packaging, correctly stored.
The eye drops in the multidose bottle must not be used more than 30 days after first opening the container.
The eye drops in the single-dose container do not contain preservatives: after administration, the unit must be discarded even if only partially used.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What RIBOMICIN contains
RIBOMICIN eye drops, solution – multidose bottle

• The active substance is gentamicin sulfate. 100 ml of solution contain 0.3 g of gentamicin.
• The other components are: Disodium phosphate; Monosodium phosphate; Sodium chloride; Sodium metabisulfite; Edetate sodium; Benzalkonium chloride (see section 2 “RIBOMICIN eye drops, solution contains benzalkonium chloride”); Water for injections.

RIBOMICIN eye drops, solution – single-dose container

• The active substance is gentamicin sulfate. 100 ml of solution contain 0.3 g of gentamicin.
• The other components are: Disodium phosphate; Monosodium phosphate; Sodium chloride; Sodium metabisulfite; Edetate sodium; Water for injections.

RIBOMICIN ophthalmic ointment

• The active substance is gentamicin sulfate. 100 g of ointment contain 0.3 g of gentamicin.
• The other components are: Sodium metabisulfite; Methyl p-hydroxybenzoate; Propyl p-hydroxybenzoate (see section 2 “RIBOMICIN ophthalmic ointment contains parahydroxybenzoates”); Liquid paraffin; White soft paraffin.

Description of the appearance of RIBOMICIN and contents of the pack
Eye drops, solution. Carton containing 1 bottle of 10 ml; Carton containing 5 single-dose containers of 0.5 ml.
Ophthalmic ointment. Carton containing 1 tube of 5 g.
Marketing Authorization Holder
PHARMANUTRA SpA, Via Campodavela, 1 - 56122 Pisa
Manufacturer
FARMIGEA SpA, Via G. B. Oliva 8, 56121 – Pisa