OMNIMOXA 5 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Omnimoxa 5 mg/ml Eye Drops Solution

Read the entire package leaflet carefully before starting to use the medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Omnimoxa and what is it used for
2. What you need to know before taking Omnimoxa
3. How to use Omnimoxa
4. Possible side effects
5. Storage of Omnimoxa
6. Package Contents and Additional Information

1. What is Omnimoxa and what is it used for

This medicine is used to treat eye infections (conjunctivitis) caused by bacteria. The active ingredient is moxifloxacin, an ophthalmic anti-infective.

Antibiotics are used to treat bacterial infections and are not effective against viral infections.

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

2. What you need to know before taking Omnimoxa

Do not use Omnimoxa

If you are allergic (hypersensitive) to moxifloxacin, other quinolones, or any of the other components of this medicine (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before using this medicine:

• If you experience an allergic reaction to this medicine.Allergic reactions are rare and severe reactions are very rare. If you experience any allergic reaction (hypersensitivity) or side effect, see section 4.

• If you use contact lenses –if you experience signs or symptoms of an eye infection, stop using contact lenses and wear glasses. Do not use contact lenses until the signs and symptoms of infection have resolved and you have finished using the medicine.

• Tendon inflammation and rupture have been observed in people using oral or intravenous fluoroquinolones, especially in older patients and those treated concurrently with corticosteroids. Discontinue treatment with this medicine if you experience pain or inflammation of the tendons (tendinitis).

As with any antibiotic, long-term use of this medicine may lead to other infections.

Other Medicines and Omnimoxa

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine, including those obtained without a prescription.

Pregnancy, Breastfeeding, and Fertility

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

Driving and Using Machines

You may experience blurred vision immediately after using this medicine. Do not drive or use machines until these effects have resolved.

3. How to Use Omnimoxa

Follow your doctor's instructions for administering this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

Adults, including elderly patients and children: 1 drop in the affected eye(s), 3 times a day(morning, afternoon, and evening).

This medicine can be used in children, patients over 65 years old, and patients with kidney or liver problems. Information on the use of this medicine in newborns is very limited, and therefore, its use is not recommended in these patients.

Method of Administration

This medicine should only be used as eye drops. It should only be applied to both eyes if your doctor has recommended it.

Figure 1 Figure 2 Figure 3

• Take the bottle of this medicine and stand in front of a mirror.
• Wash your hands.
• Remove the cap.
• After opening the bottle for the first time, remove the plastic ring from the seal if it is loose.
• Hold the bottle, upside down, between your thumb and the rest of your fingers.
• Tilt your head back. Gently pull the lower eyelid down to form a pouch, where the drop should fall (Figure 1).
• Bring the tip of the bottle close to the eye. You may find it helpful to look in the mirror.
• Do not touch the eye, eyelid, or surrounding areas with the dropperbecause the drops may become infected.
• Gently squeeze the base of the bottle to release one drop of medicine at a time (Figure 2).
• After using this medicine, press the edge of the eye, next to the nose, for 2-3 minutes (Figure 3). This helps prevent the medicine from entering the rest of the body and is especially important in young children.
• If you are applying drops to both eyes, wash your hands before repeating the above steps for the other eye.This helps prevent the spread of infection from one eye to the other.
• Close the bottle tightly immediately after use.

If a drop falls outside the eye, try again.

If you have applied more moxifloxacin than you should, you can rinse your eyes with warm water. Do not apply more drops until it is time for the next dose.

If you accidentally swallow this medicine, contact your doctor or pharmacist.

If you forget to use this medicine, continue with the next scheduled dose. Do notapply a double dose to make up for the missed dose.

If you are using other eye drops, wait at least 5 minutes between applying this medicine and the other drops.

Duration of Use

The infection usually improves within 5 days. If you do not see an improvement, consult your doctor. You should continue using the drops for 2-3 days more or for the entire period indicated by your doctor.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Generally, you can continue using the dropsunless the effects are severe or you experience a severe allergic reaction.

If you experience a severe allergic reaction and any of the following symptoms appear, stop using this medicine immediately and contact your doctor:swelling of the hands, feet, ankles, face, lips, mouth, or throat that may cause difficulty swallowing or breathing, rash or hives, large blisters filled with fluid, wounds, and ulcers.

Common Side Effects(may affect up to 1 in 10 people)

• Eye Effects:eye pain, eye irritation

Uncommon Side Effects(may affect up to 1 in 100 people)

• Eye Effects:dry eye, eye itching, eye redness, inflammation or scarring of the eye surface, rupture of a blood vessel in the eye, abnormal sensation in the eye, abnormality, itching, redness, or swelling of the eyelid

• Other Effects:headache, bad taste

Rare Side Effects(may affect up to 1 in 1,000 people)

• Eye Effects:corneal disorder, blurred or reduced vision, conjunctival inflammation or infection, eye fatigue, eye swelling

• Other Effects:vomiting, nasal discomfort, sensation of a lump in the throat, decreased iron in the blood, abnormal liver function test values, abnormal sensation on the skin, pain, throat irritation

Frequency Not Known(cannot be estimated from available data)

• Eye Effects:eye infection, clouding of the eye surface, corneal swelling, deposits on the eye surface, increased pressure in the eye, scratching of the eye surface, eye allergy, eye discharge, increased tear production, sensitivity to light

• Other Effects:shortness of breath, irregular heartbeat, dizziness, increased allergic symptoms, itching, rash, skin redness, nausea, and hives

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Omnimoxa

Keep out of sight and reach of children.

Do not use the eye drops after the expiration date stated on the bottle and carton after "EXP". The expiration date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

Do not use for more than 4 weeks after first opening. This is to prevent infections.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Omnimoxa

• The active ingredient is moxifloxacin. One milliliter of eye drops contains 5 mg of moxifloxacin (as moxifloxacin hydrochloride, 5.45 mg). One drop of eye drops contains 210 micrograms of moxifloxacin.
• The other ingredients are: sodium chloride, boric acid, hydrochloric acid, and/or sodium hydroxide (to adjust the pH) and water for injections.

Appearance of the Product and Package Contents

This medicine is a liquid (clear, pale yellow solution) supplied in a transparent plastic bottle with a dropper and screw cap.

Each bottle contains 3 ml or 5 ml.

Package sizes: carton with 1 or 3 bottles.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

OmniVision GmbH

Lindberghstraße 9

82178 Puchheim

Germany

Manufacturer

Pharma Stulln GmbH

Werksstrasse 3

92551 Stulln

Germany

You can obtain further information about this medicine by contacting the local representative of the marketing authorization holder:

OmniVision Farma España S.L.

C/ Josep Irla i Bosch, 1-3

Pl: 6 Pt: 2

08034 Barcelona

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

AustriaMoxifloxacin Stulln 5 mg/ml Augentropfen, Lösung

GermanyMoxifloxacin Stulln 5 mg/ml Augentropfen, Lösung

GreeceMOFLOTREX 5 mg/ml Οφθαλμικ?ς σταγ?νες, δι?λυμα

ItalyOmnimoxa 5 mg/mL collirio, soluzione

NetherlandsMoxifloxacine Stulln 5 mg/ml oogdruppels, oplossing

PolandMoxifloxacinum Stulln

SpainOmnimoxa 5 mg/ml colirio en solución

Date of the Last Revision of this Package Leaflet:December 2022.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es