Floxamic neo

Package leaflet: Information for the patient

Floxamic Neo, 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, 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. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Floxamic Neo is and what it is used for

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

2. Important information before using Floxamic Neo

When not to use Floxamic Neo

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

Warnings and precautions
Before starting treatment with Floxamic Neo, discuss this with your doctor, pharmacist, or
nurse.

• If the patient has experienced allergic reactions to moxifloxacin. Allergic reactions occur not frequently, and serious allergic reactions are rare. If any allergic reactions (hypersensitivity reactions) or any other adverse effects occur, follow the recommendations given in section 4.
• If the patient wears contact lenses – they should stop using them when objective and subjective symptoms of eye infection are present. Glasses should be used instead. Do not wear contact lenses until the objective and subjective symptoms of eye infection have resolved and until completion of treatment with the medicine.
• Cases of swelling and tendon rupture have been reported in patients receiving oral or intravenous fluoroquinolones, particularly in elderly patients and those concurrently treated with corticosteroids. Treatment with Floxamic Neo should be discontinued if the patient experiences tendon pain or swelling.

As with any other antibiotic, prolonged use of Floxamic Neo may lead to the development of other infections.

Floxamic Neo and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
If the patient is using other eye drops simultaneously, wait at least 5 minutes between administration of each product. Ointments should be administered last.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using any medicine.

Driving and operating machinery
For a short time after instillation of Floxamic Neo, vision may be blurred. Until vision clears, the patient must not drive or operate machinery.

3. How to use Floxamic Neo

This medicine should always be used exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
The usual dose is:
Adults, including elderly people, and children: 1 drop into the affected eye or eyes, 3 times a day (morning, afternoon, and evening).
Floxamic Neo 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 are only very limited data available on its use in these patients.
This medicine should be used in both eyes only if specifically instructed by your doctor.
Floxamic Neo is for ocular instillation only.
Infection usually resolves within 5 days. If the patient does not notice improvement, they should contact their doctor. Treatment with the drops should continue for a further 2–3 days, or as long as directed by the doctor.

Instructions for use:

• Prepare the Floxamic Neo 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. With a clean finger, gently pull the lower eyelid downward to create a "pocket" between the eyeball and the eyelid; the drop should be placed into this pocket.
• Bring the tip of the dropper close to the eye. A mirror may be used to assist.
• Do not touch the dropper tip to the eye, eyelid, surrounding area, or any other surface. This may contaminate the drops and lead to infection.
• Gently squeeze the bottle with your thumb and index finger to release a single drop at the appropriate moment.
• After instilling Floxamic Neo, press with your 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 applying 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 tightly.

If the drop misses the eye, repeat the instillation attempt.
Overdose of Floxamic Neo
Rinse the eyes with warm water. Do not administer further drops until the next scheduled dose.
Accidental ingestion of Floxamic Neo
Seek advice from your doctor or pharmacist immediately.
Missed dose of Floxamic Neo
Continue using the medicine as directed, giving the next dose at the usual scheduled time. Do not use a double dose to make up for a missed dose.
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 medicine can cause adverse reactions, although not everyone will experience them.
Usually, you can continue using the drops, unless the adverse reactions are severe or
if the patient experiences serious allergic reactions.
If the patient experiences a severe allergic reaction or any of the symptoms listed below, stop using
Floxamic Neo drops immediately and seek medical help without delay: swelling of the hands, feet, ankles, face, lips, 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, itchy eye, red eye, surface eye inflammation or scarring, broken blood vessel in the eye, abnormal sensation in the eye, eyelid disorders, itching, redness or swelling
General: headache, unpleasant taste in the mouth

Rare adverse reactions
(may occur in less than 1 in 1,000 people)
Eye-related: corneal disorder, blurred or reduced vision, inflammation or infection of the conjunctiva, eye strain, eye swelling
General: vomiting, discomfort in the nose, sensation of lumps in the throat, decreased iron concentration in blood, abnormal liver test results, skin sensation disorders, pain, throat irritation

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your 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 Warszawa
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 provide more information on the safety of this medicine.

5. How to store Floxamic Neo

There are no special requirements for storing this medicinal product.
The medicine should be stored in a place invisible and inaccessible to 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 the stated month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
After first opening the bottle – store for 28 days at a temperature below 30°C.
To prevent microbial contamination, the medicine should be discarded 28 days after first opening the bottle.
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 pack and other information

What Floxamic Neo contains

• The active substance is moxifloxacin. Each ml of solution contains 5.45 mg of moxifloxacin hydrochloride, equivalent to 5 mg of moxifloxacin. Each drop contains 0.2 mg of moxifloxacin.
• The other ingredients are: sodium chloride, boric acid, sodium hydroxide (for pH adjustment), purified water.

What Floxamic Neo looks like and contents of the pack
Floxamic Neo is a clear, yellowish-green solution, available in packs containing one 5 ml plastic bottle with a screw cap, in a cardboard box.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Warszawskie Zakłady Farmaceutyczne Polfa S.A.
Karolkowa 22/24, 01-207 Warszawa