Flomixa

Package leaflet: Information for the user

Flomixa, 5 mg/ml, eye drops, solution
Moxifloxacinum (as hydrochloride)
Please read the entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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.

Leaflet contents

1. What Flomixa is and what it is 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 Flomixa is and what it is used for

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

2. Important information before using Flomixa

When not to use Flomixa:

• if the patient is allergic to the active substance moxifloxacin, other quinolones, or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions This medicine is intended for ocular use only and must not be administered by injection.
• If the patient has experienced allergic reactions to Flomixa, treatment should be discontinued and medical advice sought. Allergic reactions occur not frequently, and serious allergic reactions are rare. In the event 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 wearing them when objective and subjective symptoms of eye infection occur. Glasses should be used instead. Contact lenses should not be worn until objective and subjective symptoms of eye infection have resolved and treatment with the medicine has been completed.
• In patients receiving oral or intravenous fluorquinolones, cases of swelling and tendon rupture have been reported, particularly in elderly patients and those concurrently treated with corticosteroids. If the patient experiences pain or swelling of the tendons, Flomixa should be discontinued and medical advice sought.
• As with any other antibiotic, prolonged use of Flomixa 5 mg/ml eye drops, solution may lead to the development of other infections.

Flomixa and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.
If more than one topical ophthalmic medicinal product is being used, the products should be administered at least 5 minutes apart. Ointments should be applied last.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and using machines
Vision may be blurred for a short time after instilling Flomixa eye drops. Until vision clears, the patient must not drive or operate machinery.

3. How to use Flomixa

This medicine should always be used exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist.
The usual dose for adults, including elderly people, and children is: 1 drop in the affected eye or eyes, 3 times daily (in the morning, afternoon and evening).
Flomixa may be used in children, in patients aged over 65 years, and in patients with impaired kidney or liver function. Information on the use of this medicine in newborns is very limited, and its use is not recommended in newborns.
This medicine should be administered to both eyes only if specifically instructed by the doctor.
Flomixa is intended for instillation into the eyes only.

Instructions for use

• Wash your hands.
• Prepare the Flomixa bottle and stand in front of a mirror.
• Unscrew the cap.
• If the safety 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 backwards. Gently pull down the lower eyelid with a clean finger to form a "pocket" between the eyeball and the eyelid. The drop should be instilled into this pocket.
• Bring the tip of the bottle close to the eye. A mirror may be helpful. Do not let the dropper tip touch the eye, eyelid, surrounding areas or any other surface. This may contaminate the drops.
• Gently squeeze the bottom of the bottle to release a single drop of the medicine.
• After instilling Flomixa, press gently with a finger on the inner corner of the eye near the nose for 2–3 minutes. This helps prevent the medicine from draining into the rest of the body and is particularly important in small children.
• If using drops in both eyes, wash your hands before repeating the above steps for the second eye. This helps prevent spreading infection from one eye to the other.
• Immediately after use, tightly recap the bottle.

If a drop misses the eye, repeat the instillation attempt.
Missed dose of Flomixa: continue using the medicine as scheduled with the next dose. Do not use a double dose to make up for a missed dose.
If the patient is using other eye drops: allow at least a 5-minute interval between instillation of Flomixa and other eye drops.
Duration of treatment
Infection usually resolves within 5 days.
If there is no visible improvement, consult your doctor. Continue using the drops for another 2–3 days, or as long as your doctor has advised.
Accidental overdose of Flomixa: rinse the eyes with warm water. Do not instill any more medicine until the next scheduled dose. If Flomixa is accidentally swallowed, contact your doctor or pharmacist for advice.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everybody experiences them.
Usually, you can continue using the drops unless the adverse reactions are severe or the patient develops a serious allergic reaction.
If the patient experiences a severe allergic reaction or any of the symptoms listed below, stop using Flomixa immediately and inform a doctor without delay: swelling of the hands, feet, ankles, face, lips, or swelling of the mouth or throat which may make swallowing or breathing difficult, rash or hives, large fluid-filled blisters, sores or ulcers.

Common adverse reactions (may occur in less than 1 in 10 people)
Eye-related: eye pain, eye irritation

Uncommon adverse reactions (may occur in less than 1 in 100 people)
Eye-related: dry eye, eye itching, eye redness, surface eye inflammation or scarring, broken blood vessel in the eye, abnormal sensation in the eye, eyelid abnormalities, itching, redness or swelling
General: headache, unpleasant taste in the mouth

Rare adverse reactions (may occur in less than 1 in 1000 people)
Eye-related: corneal disorder, blurred or restricted vision, conjunctivitis (inflammation or infection of the conjunctiva), eye strain, eye swelling, eyelid pain
General: vomiting, discomfort in the nose, sensation of lumps in the throat, decreased iron concentration in the blood, abnormal liver test results, skin sensation disturbances, pain, throat irritation

Frequency not known (frequency cannot be estimated from available data)
Eye-related: eye infection, corneal clouding, corneal edema, deposits on the eye surface, increased intraocular pressure, corneal abrasion, eye allergy, eye discharge, increased tear production, photophobia (light sensitivity)
General: shortness of breath, irregular heartbeat, dizziness, worsening of allergic symptoms, itching, rash, skin redness, nausea, and urticaria (hives).

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Flomixa medicine

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and the cardboard
pack after "EXP". The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicinal product.
From a microbiological point of view, after opening, the product may be stored for a maximum of
28 days at a temperature of 25°C. For any other storage period and conditions, the user is
responsible.
Medicines must 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 package and other information

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

What Flomixa looks like and contents of the pack
Flomixa is a liquid (clear, yellow solution) supplied in cardboard boxes containing a 5 ml plastic bottle with a screw cap.

Marketing Authorisation Holder Importer
Farmak International Sp. z o.o. Farmak International Sp. z o.o.
ul. Koszykowa 65 ul. Chełmżyńska 249
00-667 Warsaw 04-458 Warsaw
tel. +48 22 822 93 06 Poland
e-mail: [email protected]