Monafox

Package leaflet: Information for the patient

Monafox, 5 mg/mL, eye drops, solution
Moxifloxacinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Monafox is and what it is 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 Monafox is and what it is 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 the patient is 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, please consult your doctor.
Warnings and precautions
Before starting treatment with Monafox, discuss it with your doctor or pharmacist.

• If the patient has experienced allergic reactions to Monafox. Allergic reactions occur not frequently, while severe allergic reactions are rare. In case of any allergic (hypersensitivity) reactions or other adverse effects, follow the recommendations given in section 4.
• If the patient wears contact lenses – they should stop using them when experiencing subjective or objective signs of eye infection. Glasses should be used instead. Contact lenses should not be worn until subjective and objective symptoms of eye infection have resolved and treatment with the medicine has been completed.
• In patients receiving fluorquinolones orally or intravenously, cases of tendon swelling and tendon rupture have been reported, particularly in elderly patients and those concurrently treated with corticosteroids. Monafox treatment should be discontinued if the patient experiences pain or swelling in tendons.

As with any other antibiotic, prolonged use of Monafox may lead to development of other infections.
Monafox and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used, including those available without prescription.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
For a short time after instillation of Monafox, vision may be blurred. Until vision clears, the patient must not drive or operate machinery.

3. How to use Monafox

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult your
doctor or pharmacist.
Monafox is intended for ocular instillation only.
Recommended dose
Adults, including elderly patients, and children: 1 drop into the affected eye or eyes, 3 times daily
(morning, afternoon, and evening).
Monafox may be used in children, in patients over 65 years of age, and in patients with kidney or
liver disease. Use of this medicine is not recommended in newborns, as there is very limited information
available on its use in this patient group.
This medicine should be administered to both eyes only if specifically instructed by the doctor.
The infection usually resolves within 5 days. If no improvement is observed, the patient should
contact the doctor. Treatment with the drops should be continued for a further 2–3 days, or as long as
directed by the doctor.
How to use Monafox

1 2 3

• Prepare the Monafox bottle and a mirror
• Wash your hands
• Unscrew the cap
• If the safety collar is loose after removing the cap, remove it before using the medicine
• Hold the inverted bottle between your thumb and middle finger
• Tilt your head backward. Gently pull the lower eyelid downward with a clean finger to form a "pocket" between the eyeball and eyelid; the drop should be instilled into this pocket (figure 1.)
• Bring the tip of the bottle close to the eye. A mirror may be used to assist.
• Do not touch the eye, eyelid, surrounding areas of the eye, or any other surface with the dropper tip. This may lead to contamination of the drops.
• Gently press the bottom of the bottle to release a single drop of medicine at the appropriate moment (figure 2.)
• Do not press the bottle firmly. The bottle is designed so that gentle pressure on the bottom is sufficient.
• After instilling Monafox, press with a finger on the inner corner of the eye near the nose for 2–3 minutes (figure 3.) This helps prevent the medicine from draining into the systemic circulation and is particularly important in small children.
• If administering drops to both eyes, wash your hands before repeating the above procedure for the second eye. This helps prevent spreading infection from one eye to the other.
• Immediately after use, replace the cap on the bottle.
• Use the entire contents of one bottle before opening a new one.

If the drop misses the eye, repeat the instillation attempt.
If more medicine has been instilled than recommended, rinse the eyes with lukewarm water. Do not
instill any additional drops until the next scheduled dose.
In case of accidental ingestion of Monafox, contact a doctor or pharmacist for advice.
If a dose is missed, continue treatment by administering the next dose at the scheduled time. Do not
administer a double dose to make up for the missed dose.
If the patient is using other eye drops, an interval of at least 5 minutes should be maintained between instillation of Monafox and the other eye drops.
In case of any doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Treatment with the eye drops can usually be continued unless the adverse reactions are severe or the patient
does not experience serious allergic reactions.
If the patient experiences a severe allergic reaction or any of the symptoms listed below, Monafox
should be discontinued immediately and the doctor should be informed without delay: swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing, rash or hives, large fluid-filled blisters, sores or ulcers.
Common adverse reactions (may affect up to 1 in 10 patients)
Eye-related symptoms: eye pain, eye irritation
Uncommon adverse reactions (may affect up to 1 in 100 patients)
Eye-related symptoms: dry eye, eye itching, eye redness, surface eye inflammation or scarring, eye blood vessel rupture, abnormal sensation in the eye, eyelid abnormalities, itching, redness or swelling
General symptoms: headache, unpleasant taste in the mouth
Rare adverse reactions (may affect up to 1 in 1,000 patients)
Eye-related symptoms: corneal disease, blurred or reduced vision, conjunctivitis or conjunctival infection, eye strain, eye swelling
General symptoms: vomiting, nasal discomfort, sensation of lumps in the throat, decreased iron concentration in the blood, abnormal liver test results, skin sensation disturbances, pain, throat irritation or discomfort
Unknown frequency (cannot be estimated from available data)
Eye-related symptoms: eye infection, corneal opacity, corneal edema, deposits on the eye surface, increased intraocular pressure, corneal abrasion, eye allergy, eye discharge, increased tear production, photophobia
General symptoms: shortness of breath, irregular heartbeat, dizziness, worsening of allergic symptoms, itching, rash, skin redness, nausea, and urticaria
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Monafox

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after: EXP.
The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
To prevent infection, the bottle must be discarded 4 weeks after first opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Monafox contains

• The active substance is moxifloxacin. 1 ml of eye drops contains 5 mg moxifloxacin (as 5.45 mg moxifloxacin hydrochloride). One eye drop contains 190 micrograms of moxifloxacin.
• 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 packaging containing 1 plastic bottle with 5 ml of solution.
Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names:
Poland: Monafox