Omnimoxa

PACKAGE LEAFLET

Package leaflet: information for the user

Omnimoxa 5 mg/mL eye drops, solution

Moxifloxacin
Please read this leaflet carefully before using this medicine as 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 effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Omnimoxa is and what it is used for

2. What you need to know before using Omnimoxa

3. How to use Omnimoxa

4. Possible side effects

5. How to store Omnimoxa

6. Contents of the pack and other information

7. What Omnimoxa is and what it is used for
   Omnimoxa eye drops are used to treat bacterial eye infections (conjunctivitis). The active substance is moxifloxacin, an ophthalmic anti-infective.

2. What you need to know before using Omnimoxa

Do not use Omnimoxa

• if you are allergic to moxifloxacin, to other quinolones, 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 Omnimoxa:

• If you have an allergic reaction to Omnimoxa. Allergic reactions occur uncommonly, and severe reactions occur rarely. In case of allergic reactions (hypersensitivity) or any type of adverse effects, refer to section 4.
• If you wear contact lenses – stop wearing them if you experience signs or symptoms of eye infection. Wear glasses instead. Do not resume wearing contact lenses until signs and symptoms of infection have resolved and until you have stopped using the medicine.
• Tendon swelling and rupture have been reported in people treated with oral or intravenous fluoroquinolones, particularly in elderly patients and in patients receiving concomitant corticosteroid therapy. Discontinue use of Omnimoxa if you experience tendon pain or swelling (tendinitis). As with any antibiotic, prolonged use of Omnimoxa may lead to other infections.

Other medicines and Omnimoxa
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
You may experience blurred vision for a short period immediately after using Omnimoxa. Do not drive and do not operate machinery until this sensation has stopped.

3. How to use Omnimoxa

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults, including elderly patients, and children: 1 drop in the affected eye(s), 3 times a day (in the
morning, in the afternoon, and in the evening).
Omnimoxa can be used in children, in patients over 65 years of age, and in patients with
renal or hepatic impairment. There is only very limited information on the use of this medicine in
newborns, and its use in newborns is not recommended.
Method of administration
Use Omnimoxa only as an eye drop. Use the medicine in both eyes only if prescribed by your doctor.

Figure 1 Figure 2 Figure 3

• Take the Omnimoxa bottle and position yourself in front of a mirror.
• Wash your hands.
• Unscrew the cap.
• After removing the cap, if the safety ring has loosened, remove it before using the product.
• Hold the bottle upside down, grasping it between your thumb and other fingers.
• Tilt your head backward. Pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eye. The drop should be instilled into this pocket (Figure 1).
• Hold the tip of the bottle close to the eye. Looking into the mirror may be helpful.
• Do not touch the eye, eyelid, surrounding areas, or any other surface with the tip of the dropper. This could contaminate the eye drop solution.
• Gently press the bottom of the bottle to release one drop of the medicine at a time (Figure 2).
• After using Omnimoxa, press with a finger at the inner corner of the eye, near the nose, for 2–3 minutes (Figure 3). This helps prevent the medicine from spreading into the rest of the body, which is particularly important in young children.
• If you need to apply the eye drop to both eyes, wash your hands before repeating the steps for the other eye. This helps prevent the infection from spreading from one eye to the other.
• Immediately after use, firmly close the bottle cap. If a drop does not enter the eye, try again.

If you use more Omnimoxa than you should, immediately rinse the eye with lukewarm water. Do not use the eye drops again until it is time for your next scheduled dose.
If you accidentally swallow Omnimoxa, consult your doctor or pharmacist for advice.
If you forget to use Omnimoxa, continue treatment with the next dose as planned. Do not use a double dose to make up for the missed dose.
If you are also using another eye drop, wait at least 5 minutes between instilling Omnimoxa and the other eye drop.
Duration of use
The infection usually improves within 5 days. If there is no improvement, contact your doctor.
You should continue using the drops for another 2 or 3 days, or as long as your doctor has instructed you to do so.
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 everyone experiences them.
You can generally continue using the drops, unless the side effects are severe or you have a serious allergic reaction.
If you have a serious allergic reaction or if any of the following side effects occur, stop taking Omnimoxa immediately and contact your doctor immediately: swelling of the hands, feet, ankles, face, lips, mouth or throat causing difficulty in swallowing or breathing, skin rash or hives, large fluid-filled blisters, wounds and ulceration.

Common side effects (may affect up to 1 in 10 people)

• Eye-related effects: eye pain, eye irritation.

Uncommon side effects (may affect up to 1 in 100 people)

• Eye-related effects: dry eyes, itchy eyes, eye redness, inflammation or scarring of the eye surface, rupture of ocular blood vessels, abnormal sensation in the eye, eyelid abnormalities, itching, redness or swelling.
• General side effects: headache, bad taste.

Rare side effects (may affect up to 1 in 1,000 people)

• Eye-related effects: corneal disorder, blurred or reduced vision, inflammation or infection of the conjunctiva, eye fatigue, eye swelling.
• General side effects: vomiting, nasal discomfort, sensation of a lump in the throat, reduced iron levels in the blood, abnormal liver blood tests, abnormal skin sensation, pain, throat irritation.

Not known (frequency cannot be estimated from available data)

• Eye-related effects: eye infection, clouding of the eye surface, corneal swelling, deposits on the eye surface, increased eye pressure, scratch on the eye surface, eye allergy, eye discharge, increased tearing, light sensitivity.
• General side effects: shortness of breath, irregular heartbeat, dizziness, worsening of allergy symptoms, itching, skin rash, skin redness, nausea and hives.

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 via the national reporting system at 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 Omnimoxa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not use for more than 4 weeks after first opening. This is to avoid infection.
Do not dispose of any medicine 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 Omnimoxa contains

• The active substance is moxifloxacin. One mL of eye drops contains 5 mg of moxifloxacin (as moxifloxacine hydrochloride, 5.45 mg). One drop of eye drops contains 210 micrograms of moxifloxacin.
• The other components are sodium chloride, boric acid, sodium hydroxide and, if applicable, hydrochloric acid for pH adjustment, and water for injections.

Description of the appearance of X and contents of the pack
The medicine is a liquid (a clear, pale yellow solution) supplied in a transparent plastic bottle with a dropper and screw cap.
Each bottle contains 3 mL or 5 mL.
Pack sizes: box containing 1 or 3 bottles
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milan, Italy
This medicinal product is authorized in the European Economic Area countries under the
following names:
Austria Moxifloxacin Stulln 5 mg/ml Augentropfen, Lösung
Germany Moxifloxacin Stulln 5 mg/ml Augentropfen, Lösung
Greece MOFLOTREX 5 mg/ml Οφθαλμικές σταγόνες, διάλυμα
Italy Omnimoxa 5 mg/mL eye drops, solution
Netherlands Moxifloxacine Stulln 5 mg/ml oogdruppels, oplossing
Poland Moxifloxacinum Stulln
Spain Moxifloxacino Stulln 5 mg/ml eye drops, solution