Floxamic Neo

Package Leaflet: Information for the Patient

Floxamic Neo, 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Floxamic Neo and what is it 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 is Floxamic Neo and what is it 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 you are allergic to moxifloxacin, other quinolones or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Floxamic Neo, discuss it with your doctor, pharmacist or nurse.

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

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

Floxamic Neo and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
If you are using other eye drops at the same time,keep a gap of at least 5 minutes between the applications of the two eye drops. 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 Floxamic Neo, your vision may be blurred. Do not drive or use machines until your vision is clear.

3. How to use Floxamic Neo

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The usual dose is:

Adults, including the elderly and children: 1 drop into the affected eye(s), 3 times a day (morning, afternoon and evening).
Floxamic Neo can be used in children, in patients over 65 years of age and in patients with kidney and liver diseases. The use of this medicine is not recommended in newborns, as only very limited data are available on its use in these patients.
This medicine should be used in both eyes only if your doctor has recommended it.
Floxamic Neo is for eye use only.
The infection usually resolves within 5 days. If you do not notice an improvement, you should contact your doctor. The use of the drops should be continued for a further 2-3 days, or as long as your doctor recommends.

Instructions for use:

• Prepare the bottle with Floxamic Neo and a mirror.
• Wash your hands.
• Remove the cap.
• If the protective 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 back. With a clean finger, gently pull the lower eyelid down to create a "pocket"; the drop should fall into this pocket.
• Bring the tip of the bottle close to your eye. You can use a mirror to help.
• Do not touch the dropper tip to your eye or eyelid, or to any other surface. This could contaminate the drops.
• Gently squeeze the bottle with your thumb and index finger to release one drop of the medicine.
• After using Floxamic Neo, press the corner of your eye (near your nose) with your finger for 2-3 minutes. This helps prevent the medicine from draining into your tear duct and 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 immediately after use.

If the drop does not get into your eye, try again.

Using more Floxamic Neo than you should

Rinse your eyes with warm water. Do not put in any more drops until it is time for your next normal dose.
If you accidentally swallow Floxamic Neo, contact your doctor or pharmacist for advice.

Forgetting to use Floxamic Neo

Continue to use the medicine at the next scheduled dose. Do not use a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can usually continue to use 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 Floxamic Neo immediately

and seek medical help: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 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

Rare side effects

(may affect up to 1 in 1,000 people)
Eye disorders: corneal disease, blurred or decreased vision, inflammation or infection of the conjunctiva, eye strain, eye swelling
General disorders: vomiting, unpleasant sensation in the nose, sensation of lumps in the throat, decreased iron levels in the blood, abnormal liver test results, abnormal skin sensation, pain, throat irritation

Unknown 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 of 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 Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, 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 Floxamic Neo

There are no special storage instructions for this medicine.
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 carton and bottle after EXP. The expiry date refers to the last day of that month.
The inscription on the packaging after the abbreviation EXP means the expiry date and after the abbreviation Lot means the batch number.
After first opening the bottle - store for 28 days below 30°C.
To prevent microbial contamination, the medicine should be discarded 28 days after first opening the bottle.
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 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 (to adjust pH), purified water.

What Floxamic Neo looks like and contents of the pack

The medicine is a clear, greenish-yellow solution available in packs containing one plastic bottle of 5 ml with a screw cap, in a cardboard box.

Marketing Authorisation Holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer

Polfa Warszawa S.A.
Karolkowa 22/24, 01-207 Warsaw
Date of last revision of the leaflet:January 2022