Package leaflet: Information for the patient

OMKASA COMOD

1 mg/ml eye drops, solution
Salicylic acid
Generic medicine
Please read all of this leaflet carefully before you start 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What OMKASA COMOD is and what it is used for

OMKASA COMOD, which contains salicylic acid, is a medicine with anti-inflammatory and decongestant properties.
OMKASA COMOD eye drops are used in adults to treat eyelid inflammations (blepharitis), non-specific conjunctivitis, and eye irritations caused by dust, smog, or sunlight.
Consult a 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 COMOD

Do not use OMKASA COMOD:

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 previously experienced allergic reactions (such as asthma, urticaria, acute rhinitis) after taking 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 COMOD.
Avoid wearing contact lenses during treatment with OMKASA COMOD.
In any case, you must remove contact lenses before applying the drops and wait 15 minutes before reinserting them.
If there is an existing infection or a risk of infection, 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 COMOD”).
Other medicines and OMKASA COMOD
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other eye drops.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, 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 to the fetus.
Driving and using machines
Like all eye drops, OMKASA COMOD may cause blurred vision for a short time immediately after application, slightly affecting the ability to drive or operate machinery. Do not drive or operate machinery until your vision is clear.

3. How to use OMKASA COMOD

Use this medicine exactly as described in this leaflet or as prescribed 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 pediatric populations under 12 years of age.

How to apply OMKASA COMOD
Wash your hands.
Take a clean cloth and gently clean around the eye (Figure 1).
Figure 1.
Remove the protective cap before use (Figure 2).
Figure 2.
When using the eye drops for the first time, turn the bottle upside down with the dropper pointing downwards and press on the bottom of the bottle to release the first drop.
Keep the bottle inverted, placing your thumb on the top of the bottle and the other fingers on its base (Figure 3).

A hand holds a tilted medicine bottle to pour its contents through an integrated dropper in the cap

Figure 3.
Support with your free hand the hand holding the bottle (Figure 4).

Two hands holding and opening a cylindrical dropper bottle to administer liquid medication

Figure 4.
Tilt your head slightly backward, gently pull down the lower eyelid, and apply a firm, quick pressure on the bottom of the bottle to release one drop (Figure 5).
Thanks to the special valve system of the COMOD device, the size and speed of drop delivery remain consistent regardless of the pressure applied.
When applying the eye drops, take care to avoid any contact between the tip of the bottle and the eye or skin.

Line drawing of two hands holding a dropper bottle to apply a drop of medicine into the

Figure 5.
After instilling the eye drop, release the lower eyelid and press with one finger on the inner corner of the eye. Open and close the eye several times to evenly distribute the eye drops. Remove any excess liquid (Figure 6).

Line drawing of a face with closed eyes and a hand gently pressing with the

Figure 6.
After use, immediately close the bottle with the cap, making sure there are no liquid residues on the dropper tip (Figure 7).

A hand holds the top part of an injection pen while the

Figure 7.
Repeat the described procedure for the other eye.

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

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

If you stop treatment with OMKASA COMOD
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 experiences them.
The following side effects may occur with OMKASA COMOD:
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 may also report side effects directly through the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OMKASA COMOD

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 which is stated on the carton after “EXP”.
The expiry date refers to the last day of that month.
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 OMKASA COMOD contains

The active substance is salicylic acid. 1 ml of solution contains salicylic acid 1 mg.
The other components are: Sorbitol (E420), Sodium Citrate, Citric Acid, Sodium Hydroxide (pH adjuster), Water for Injections.

Description of the appearance of OMKASA COMOD and contents of the pack
OMKASA COMOD eye drops solution is a clear and transparent solution contained in a multidose bottle made of LDPE with an airless pump system and a protective cap.
The pack contains one multidose bottle with 10 ml of eye drops solution.

Marketing Authorization Holder
Omikron Italia S.r.l. - Viale Bruno Buozzi, 5 - 00197 Rome, Italy
Tel: 06-80693572
Fax: 06-80665266
E-mail: [email protected]

Manufacturer responsible for batch release
Ursapharm Arzneimittel GmbH
Industriestrasse 35
66129 Saarbrücken - Germany