Flomixa

Package Leaflet: Information for the User

Flomixa, 5 mg/ml, Eye Drops, Solution

Moxifloxacin(as hydrochloride)

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, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

1. What is Flomixa and what is it used for

Flomixa eye drops are used to treat bacterial eye infections (conjunctivitis).
The active substance is moxifloxacin, an ophthalmic antibacterial agent.

2. Important information before using Flomixa

When not to use Flomixa:

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

Warnings and precautions

This medicine is for use in the eyes only and must not be injected.

• If you experience allergic reactions to Flomixa, stop using the medicine and consult your doctor. Allergic reactions are not very common, and serious allergic reactions are rare. 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 if you experience signs of eye infection. Instead, wear glasses. Do not wear contact lenses until the signs of eye infection have resolved and you have finished using the medicine.
• In patients taking fluoroquinolones orally or intravenously, there have been reports of tendonitis and tendon rupture, especially in elderly patients and those treated with corticosteroids. Stop using Flomixa if you experience pain or swelling of the tendons and consult your doctor.
• As with any other antibiotic, long-term use of Flomixa 5 mg/ml eye drops, solution may lead to other infections.

Flomixa and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, including those obtained without a prescription.
If you are using more than one eye medicine, leave at least a 5-minute interval between each application. Apply eye ointments last.

Pregnancy and breastfeeding

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

Driving and using machines

For a short time after using Flomixa, your vision may be blurred. Do not drive or use machines until your vision is clear.

3. How to use Flomixa

Use this medicine exactly as your doctor has told you.
If you are not sure, ask your doctor or pharmacist.
The usual dose for adults, including the elderly, and children is: 1 drop into the affected eye(s), 3 times a day (morning, afternoon, and evening).
Flomixa can be used in children, in patients over 65 years of age, and in patients with kidney or liver problems. There is limited experience with the use of this medicine in newborns, and its use is not recommended in newborns.
Use this medicine in both eyes only if your doctor has told you to do so.
Flomixa is for use in the eyes only.

Method of administration

• Wash your hands.
• Prepare the Flomixa bottle and stand in front of a mirror.
• Remove the cap.
• If the protective collar is loose after removing the cap, remove it before using the medicine. Turn the bottle upside down and hold it between your thumb and middle finger. Tilt your head back. With a clean finger, gently pull down the lower eyelid to create a "pocket" between the eye and the eyelid. The drop should fall into this pocket.
• Bring the tip of the bottle close to the eye. You can use a mirror to help. Do not touch the dropper to the eye or eyelid, or to any other surface, as this may contaminate the drops.
• Gently squeeze the bottom of the bottle to release a single drop of medicine.
• After using Flomixa, press the corner of your eye (near your nose) for 2-3 minutes. This will help prevent the medicine from draining 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.

If a drop misses your eye, try again.
Missing a dose of Flomixa:continue using the medicine as scheduled. Do not use a double dose to make up for a missed dose.
If you are using other eye drops, wait at least 5 minutes between using Flomixa and the other drops.

Duration of treatment

The infection usually clears up within 5 days.
If there is no improvement, consult your doctor. Continue using the drops for a further 2-3 days or as long as your doctor tells you.
Using more Flomixa 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 Flomixa, consult your doctor or pharmacist for advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Flomixa 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 Flomixa and tell your doctor immediately: swelling of the hands, feet, ankles, face, lips, mouth, or throat, which may cause difficulty swallowing or breathing, rash, or hives, large blisters, sores, or ulcers.
Common side effects (may affect up to 1 in 10 people)
Eye disorders: eye pain, eye irritation
Uncommon side effects (may affect up to 1 in 100 people)
Eye disorders: dry eye, eye itching, eye redness, 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 disorders: headache, unpleasant taste in the mouth
Rare side effects (may affect up to 1 in 1,000 people)
Eye disorders: corneal disease, blurred or decreased vision, conjunctivitis, eye fatigue, eye swelling, eyelid pain
General disorders: vomiting, discomfort in the nose, feeling of grit in the throat, decreased iron levels in the blood, abnormal liver test results, skin sensation disorders, pain, throat irritation
Frequency not known (frequency cannot be estimated from the available data)
Eye disorders: eye infection, clouding of the surface of the eye, corneal swelling, 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 disorders: 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, tell your doctor or pharmacist. You can also report side effects directly to the Department of Pharmacovigilance, 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.
You can also report side effects 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 Flomixa

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 the carton after "EXP". The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
From a microbiological point of view, the product can be stored for a maximum of 28 days at 25°C. The user is responsible for the storage conditions.
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 Flomixa contains

The active substance is moxifloxacin.
1 ml of eye drops contains 5 mg of moxifloxacin (as moxifloxacin hydrochloride).
The other ingredients are: sodium chloride, boric acid, water for injections.
Sodium hydroxide and hydrochloric acid may be added to adjust the pH of the solution.

What Flomixa looks like and contents of the pack

The medicine is a liquid (clear, yellow solution), supplied in cartons containing a 5 ml plastic bottle with a screw cap.

Marketing Authorization Holder and Importer

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel. +48 22 822 93 06
e-mail: biuro@farmakinternational.pl
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Date of last revision of the leaflet:May 2025