Naflox

Package leaflet: Information for the user

NAFLOX 3 mg/ml eye drops, solution

Norfloxacin
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What NAFLOX is and what it is used for

NAFLOX contains the active substance norfloxacin and belongs to a group of medicines called fluorquinolones.
NAFLOX is indicated for the treatment of eye and ocular adnexa infections caused by bacteria sensitive to norfloxacin.

2. What you need to know before using NAFLOX

Do not use NAFLOX

• if you are allergic to norfloxacin, to any antimicrobial agent chemically related to quinolones, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using NAFLOX.
If you experience any unusual sensation in the eye, such as burning or pain after using this medicine, speak to your doctor.
Remove contact lenses before using this medicine and wait at least 15 minutes before reinserting them (see "NAFLOX 3 mg/ml eye drops, solution contains benzalkonium chloride").

Other medicines and NAFLOX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of this medicine during pregnancy and breastfeeding is not recommended.

Driving and using machines
NAFLOX does not impair the ability to drive or operate machinery.
However, some adverse effects such as burning or stinging pain reported with NAFLOX may affect your ability to drive or operate machinery (see section 4. Possible side effects).
If you experience these effects, you should not drive or operate machinery during this time.

NAFLOX contains benzalkonium chloride
NAFLOX 3 mg/ml eye drops, solution – multidose container
This medicine contains 0.025 mg of benzalkonium chloride per drop, equivalent to 0.00125 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outermost layer of the eye). If you experience any unusual sensation in the eye, such as burning or pain after using this medicine, speak to your doctor.

3. How to use NAFLOX

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose and duration of treatment.
The recommended dose is one or two drops of NAFLOX in the affected eye(s) four times a day.
Depending on the severity of the infection, one or two drops may be administered every two hours on the first day of treatment, during waking hours.

INSTRUCTIONS FOR USING THE MULTIDOSE BOTTLE
To open, press down on the closure cap and simultaneously unscrew it.
Gently squeeze the body of the container to instill the eye drops into the eye.
The solution in the bottle is sterile; therefore, it is important that the dropper tip never touches the eye and that the bottle is closed tightly after each use.
TO OPEN TO CLOSE
PUSH AND UNSCREW SCREW TIGHTLY

INSTRUCTIONS FOR USING THE SINGLE-DOSE CONTAINER

1. Separate one container from the others;
2. Open the container by twisting and pulling off the cap; the removed cap can be used, upside down, to temporarily close the container;
3. Use by gently squeezing the single-dose container to instill the eye drops into the eye.

If you use more NAFLOX than you should
If too many drops have been instilled into the eye or if the contents of the bottle have been accidentally swallowed, contact your doctor immediately.
If you forget to use NAFLOX
Do not use a double dose to make up for the missed dose.
If you stop using NAFLOX
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The most frequently reported side effect is burning or sharp pain.
Other side effects, reported rarely, are:

• swelling of the conjunctiva (chemosis)
• redness of the eyes (conjunctival hyperemia)
• excessive sensitivity of the eyes to light (photophobia)
• bitter taste in the mouth after instillation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NAFLOX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
Multi-dose bottle
Use the medicine within 30 days after first opening the bottle.
Single-dose container
Use the single-dose container within 3 months after opening the aluminium pouch.
Use the medicine immediately after opening the single-dose container. After use, discard the single-dose container, even if it has been only partially used.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What NAFLOX contains
NAFLOX 3 mg/ml eye drops, solution – Multi-dose bottle

• The active substance is norfloxacin. 1 ml of NAFLOX contains 3 mg of norfloxacin.
• The other components are: sodium acetate, benzalkonium chloride, sodium edetate, sodium chloride and water for injections.

NAFLOX 3 mg/ml eye drops, solution – Single-dose container

• The active substance is norfloxacin. Each single-dose container contains 1.5 mg of norfloxacin.
• The other components are: sodium acetate, sodium edetate, sodium chloride and water for injections.

Description of the appearance of NAFLOX and contents of the pack
NAFLOX 3 mg/ml eye drops, solution – multi-dose bottle
Box containing 1 bottle of 10 ml
NAFLOX 3 mg/ml eye drops, solution – single-dose container
Box containing 25 single-dose containers of 0.5 ml each

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DMG Italia srl, Via Laurentina km 26.700 - 00071 Pomezia (Roma)
Manufacturer
Farmigea S.p.A., via G.B. Oliva, 6/8 – 56121 Pisa (Pisa)