Patient Information Leaflet

OMKASA

1 mg/ml eye drops, solution
Salicylic acid
Equivalent medicine
Please read all of 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, ask 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What OMKASA is and what it is used for
What you need to know before using OMKASA
How to use OMKASA
Possible side effects
How to store OMKASA
Contents of the pack and other information

1. What OMKASA is and what it is used for

OMKASA, containing salicylic acid, is a medicine with anti-inflammatory and decongestant properties.
OMKASA eye drops are used in adults to treat eyelid inflammations (blepharitis), non-specific conjunctivitis, and eye irritations caused by dust, smog, or sunlight.
Consult your doctor if you do not feel better or if you feel worse after 24–36 hours.

2. What you need to know before using OMKASA

Do not use OMKASA:

If you are allergic to salicylic acid, salicylates in general, or to any of the other ingredients of this medicine (listed in section 6).
If you have experienced allergic reactions (asthma, hives, acute rhinitis) after previous use of medicines containing acetylsalicylic acid or non-steroidal anti-inflammatory drugs (medicines used to treat inflammation).
In children under 12 years of age.

If you are pregnant or breastfeeding, see section “Pregnancy and Breastfeeding”.
Warnings and precautions
Talk to your doctor or pharmacist before using OMKASA.
Avoid wearing contact lenses during treatment with OMKASA.
In any case, you must remove your lenses before applying the drops and wait 15 minutes before reinserting them.
If an infection is present or suspected, your doctor may prescribe an antibiotic medicine to be used at the same time.
Children and adolescents
Salicylic acid is contraindicated in pediatric patients under 12 years of age (see section “Do not use OMKASA”).
Other medicines and OMKASA
Tell your doctor or pharmacist if you are currently using, have recently used, or might use any other eye drops.
If you are taking coumarin anticoagulants (medicines used to thin the blood), your doctor will prescribe OMKASA with caution.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Your doctor will carefully evaluate the benefits of the medicine for the mother against any potential risks for the fetus.
Driving and using machines
Like all eye drops, OMKASA may cause blurred vision for a short time immediately after application, slightly affecting your ability to drive or operate machinery. Do not drive or use machinery until your vision is clear.

3. How to use OMKASA

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one drop 1 to 4 times daily, instilled into the conjunctival sac, according to medical prescription.

Use in children and adolescents
Salicylic acid is contraindicated in the pediatric population under 12 years of age.

If you use more OMKASA than you should
In case of accidental ingestion/absorption of OMKASA eye drops, inform your doctor immediately or go to the nearest hospital.

If you forget to use OMKASA
Do not use a double dose to make up for the missed dose.

If you stop using OMKASA
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur with OMKASA:
Rare (may affect up to 1 in 1,000 people): local allergic reactions.
Very rare (may affect up to 1 in 10,000 people): itching, eye redness (ocular hyperemia), and blurred vision immediately after instillation.

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 www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OMKASA

Store below 25°C.
The shelf life after first opening the bottle is 28 days. Any remaining product should be discarded.
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 that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What OMKASA contains

The active substance is salicylic acid. 1 ml of solution contains 1 mg of salicylic acid.
The other components are: chlorhexidine digluconate; boric acid; sodium tetraborate; sodium chloride; sodium edetate; water for injections.

Description of the appearance of OMKASA and the contents of the pack
OMKASA eye drops, solution, is a clear and transparent solution in a polyethylene bottle with dropper. Each bottle contains 10 ml of eye drops, solution.
Marketing Authorization Holder
Omikron Italia S.r.l. – Viale Bruno Buozzi 5, 00197 Roma
Manufacturer
Ursapharm Arzneimittel GmbH
Industriestrasse 35
66129 Saarbrucken - Germany