Monafox

Package Leaflet: Information for the Patient

Monafox, 5 mg/mL, Eye Drops, Solution

Moxifloxacin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Monafox and what is it used for

Monafox eye drops are used to treat bacterial eye infections (conjunctivitis).

2. Important information before using Monafox

When not to use Monafox:

• if you are allergic to moxifloxacin, other quinolones (a type of antibiotic), or any of the other ingredients of this medicine (listed in section 6).

If you have any further questions, ask your doctor.

Warnings and precautions

Before starting to use Monafox, discuss it with your doctor or pharmacist.

• If you have experienced allergic reactions to Monafox. Allergic reactions occur not very often, and severe allergic reactions occur rarely. If you experience any allergic reactions (hypersensitivity) or any other side effects, follow the instructions in section 4.
• If you wear contact lenses, you should stop wearing them when you have signs and symptoms of an eye infection. Instead, use glasses. Do not wear contact lenses until the signs and symptoms of the eye infection have disappeared and you have finished using the medicine.
• In patients receiving fluoroquinolones orally or intravenously, there have been reports of swelling and tendon rupture, especially in elderly patients and those treated with corticosteroids at the same time. You should stop using Monafox if you experience pain or swelling of the tendons.

As with any other antibiotic, long-term use of Monafox may lead to the development of other infections.

Monafox and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take, including those obtained without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

For a short time after using Monafox, your vision may be blurred. Do not drive or operate machinery until your vision is clear.

3. How to use Monafox

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Monafox is for use in the eye only.
Recommended dose
Adults, including the elderly and children: 1 drop into the affected eye(s) 3 times a day (morning, afternoon, and evening).
Monafox can be used in children, patients over 65 years old, and patients with kidney and liver diseases. The use of this medicine is not recommended in newborns because there is only limited information available on its use in these patients.
This medicine should be used in both eyes only if your doctor has recommended it.
The infection usually clears up within 5 days. If you do not see an improvement, you should contact your doctor. You should continue using the drops for a further 2-3 days or as long as your doctor recommends.

How to use Monafox

1 2 3

• Prepare the Monafox bottle and a mirror

Wash your hands

• Remove the cap
• If the protective collar is loose after removing the cap, it should be removed before using the medicine
• Hold the inverted bottle between your thumb and middle finger
• Tilt your head back. With a clean finger, pull the lower eyelid down to create a "pocket"; the drop should fall into this pocket (see picture 1.)
• Bring the tip of the bottle close to your eye. You can use a mirror to help.
• Do not touch the dropper to the eye or eyelid, or to any other surfaces.This could lead to contamination of the drops.
• Gently squeeze the bottom of the bottle to release one drop of medicine (see picture 2.)
• Do not squeeze the bottle too hard. It is designed so that a gentle squeeze on the bottom is enough.
• After using Monafox, press the corner of your eye (near your nose) with your finger for 2-3 minutes (see picture 3.)
• 3.)This will help prevent the medicine from getting into the rest of your body, which is especially important in small children.
• If you are using the drops in both eyes, wash your hands before repeating the above steps for the other eye. This will help prevent transferring infection from one eye to the other.
• Replace the cap on the bottle immediately after use.
• Use one bottle before opening the next.

If the drop does not enter the eye, try again.
If you use more Monafox than you should, rinse your eyes with warm water. Do not use any more drops until it is time for your next dose.
If you accidentally swallow Monafox, contact your doctor or pharmacist for advice.
If you miss a dose of Monafox, continue with the next dose as planned. Do nottake a double dose to make up for a forgotten dose.
If you are using other eye drops, leave at least 5 minutes between using Monafox and the other drops.
If you have any questions about using Monafox, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Monafox can cause side effects, although not everybody gets them.
You can usually continue using the drops unless the side effects are serious or you experience severe allergic reactions.

If you experience a severe allergic reaction or any of the following symptoms, stop using Monafox and

immediately tell your doctor:swelling of the hands, feet, ankles, face, lips, mouth, or throat, which may cause difficulty in swallowing or breathing, rash or hives, large blisters, sores, or ulcers.
Common side effects(may affect up to 1 in 10 people)
Eye symptoms:eye pain, eye irritation
Uncommon side effects(may affect up to 1 in 100 people)
Eye symptoms:dry eye, itchy eye, red eye, inflammation of the surface of the eye or scarring, broken blood vessel in the eye, abnormal sensation in the eye, eyelid problems, itching, redness, or swelling
General symptoms:headache, unpleasant taste in the mouth
Rare side effects(may affect up to 1 in 1,000 people)
Eye symptoms:corneal disease, blurred or decreased vision, conjunctivitis, eye infection, eye fatigue, swelling of the eye
General symptoms:vomiting, discomfort in the nose, feeling of lumps in the throat, decreased iron levels in the blood, abnormal liver test results, abnormal sensation on the skin, pain, throat irritation
Unknown(frequency cannot be estimated from the available data)
Eye symptoms:eye infection, clouding of the surface of the eye, swelling of the cornea, deposits on the surface of the eye, increased pressure in the eye, scratching on the surface of the eye, eye allergy, eye discharge, increased tear production, sensitivity to light
General symptoms:shortness of breath, irregular heartbeat, dizziness, worsening of allergic symptoms, itching, rash, redness of the skin, nausea, and hives

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Monafox

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 bottle and carton after: EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
To prevent infections, the bottle should be discarded 4 weeks after it is first opened.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Monafox contains

• The active substance is moxifloxacin. 1 ml of eye drops contains 5 mg of moxifloxacin (as 5.45 mg of moxifloxacin hydrochloride). One drop contains 190 micrograms of moxifloxacin.
• The other ingredients are: boric acid, sodium chloride, sodium hydroxide 1N, water for injections.

What Monafox looks like and contents of the pack

Monafox is a clear, yellowish-green solution, supplied in packs containing 1 plastic bottle of 5 ml solution.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Pharmathen S.A.
6 Dervenakion str.
15351 Pallini, Attiki
Greece
Famar S.A
Plant A, 63 Agiou Dimitriou Street
174 56 Alimos, Athens
Greece
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

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

Poland
Monafox

Date of last revision of the leaflet: February 2024