Quimox

PACKAGE LEAFLET: INFORMATION FOR THE USER

QUIMOX 5 mg/ml eye drops, solution

Moxifloxacin (as hydrochloride)
Please read this leaflet carefully before 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 others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What QUIMOX is and what it is used for

QUIMOX eye drops are used to treat eye infections (conjunctivitis) when caused by bacteria. The active substance is moxifloxacin, an ophthalmic anti-infective agent.

2. What you should know before using QUIMOX

Do not use QUIMOX

• If you are allergic (hypersensitive) to Moxifloxacin, to other quinolones, or to any of the excipients of this medicine (listed in section 6.1). Warnings and precautions Talk to your doctor or pharmacist:
• If you have an allergic reaction to QUIMOX. Allergic reactions occur not commonly, and severe reactions occur rarely. In case of allergic (hypersensitivity) reactions or any type of adverse effects, consult section 4.
• If you wear contact lenses – stop wearing them if you experience signs or symptoms of eye infection. Wear glasses instead. Do not resume wearing contact lenses until signs and symptoms of infection have disappeared and until you have stopped using the medicine.

Tendon swelling and rupture have occurred in individuals treated with oral or
intravenous fluoroquinolones, particularly in elderly patients and in patients receiving concomitant corticosteroid therapy.
Discontinue use of QUIMOX if you experience tendon pain or swelling (tendinitis).
As with any antibiotic, prolonged use of QUIMOX may lead to additional infections.
Other medicines and QUIMOX
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those not requiring a prescription.
Pregnancy, breastfeeding and fertility
Ask your doctor for advice before using QUIMOX eye drops.
Driving and using machines
You may experience blurred vision for a short period immediately after using QUIMOX. Do not drive
and do not operate machinery until this sensation has ceased.

3. How to use QUIMOX

Always use QUIMOX exactly as instructed by your doctor or pharmacist. If you have any doubts, you should
consult your doctor or pharmacist.
The recommended dose is:
Adults, including elderly patients, and children: 1 drop into the affected eye(s), 3 times a day (in the morning,
in the afternoon, and in the evening).
QUIMOX can be used in children, in patients over 65 years of age, and in patients with renal or hepatic
impairment. There is only very limited information on the use of this medicine in newborns, and its use in
newborns is not recommended.
Use the medicine in both eyes only if specifically instructed by your doctor. QUIMOX may be used only as
eye drops.
The infection usually improves within 5 days. If you do not notice any improvement, consult your doctor.
You should continue using the drops for another 2–3 days, or as long as prescribed by your doctor.

Multi-dose bottle

1. Take the QUIMOX bottle and position yourself in front of a mirror.
2. Wash your hands.
3. Unscrew the cap.
4. After removing the cap, if the safety ring has loosened, remove it before using the product.
5. Hold the bottle upside down, grasping it between your thumb and other fingers.
6. Tilt your head back. Gently pull down the lower eyelid with a clean finger to form a "pocket" between the eyelid and the eye. The drop should be instilled into this pocket (Figure 1).
7. Hold the tip of the bottle close to the eye. Looking into the mirror may be helpful.
8. Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip. This could contaminate the eye drops.
9. Gently press the bottom of the bottle to release one drop of QUIMOX at a time (Figure 2).
10. After using QUIMOX, press with a finger on the inner corner of the eye, near the nose, for 2–3 minutes (Figure 3). This helps prevent the medicine from spreading into the rest of the body and is particularly important in young children.
11. If you need to apply the eye drops to both eyes, wash your hands before repeating the steps for the other eye. This will help prevent the infection from spreading from one eye to the other.
12. Immediately after use, firmly replace the cap on the bottle.

Single-dose containers
Before use, ensure that the single-dose container is intact.
Wash your hands thoroughly before opening the container.

1. Detach the single-dose container from the strip (Fig. 1).
2. Hold the single-dose container by the base and shake downward (Fig. 2).
3. Open by twisting the top and pulling it off (Fig. 3).
4. Continue as described for the multi-dose bottle, from step 5 to step 11.

If a drop does not enter the eye, try again.
If you use more QUIMOX than you should, immediately rinse the eye with lukewarm water. Do not use the eye drops again until it is time for your next scheduled dose.
If you accidentally swallow QUIMOX, seek advice from your doctor or pharmacist.
If you forget to use the medicine, continue your treatment with the next dose as scheduled. Do not use a double dose to make up for the missed dose.
If you are using another eye drop at the same time, wait at least 5 minutes between instilling QUIMOX and the other eye drop.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, QUIMOX can cause side effects, although not everyone will experience them.
You can generally continue using the drops unless the side effects are severe or you have a serious allergic reaction.
If you experience a severe allergic reaction or any of the following side effects, stop using QUIMOX immediately and contact your doctor right away: swelling of the hands, feet, ankles, face, lips, mouth or throat causing difficulty in swallowing or breathing, skin rash or hives, large fluid-filled blisters, wounds or ulceration.

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 or scarring of the eye surface, rupture of ocular blood vessels, abnormal sensation in the eye, eyelid abnormalities, itching, redness or swelling.
General side effects: headache, bad taste.

Rare side effects
(may affect up to 1 in 1,000 people)
Eye disorders: corneal disorder, blurred or reduced vision, inflammation or infection of the conjunctiva, eye fatigue, eye swelling.
General side effects: vomiting, nasal discomfort, sensation of a lump in the throat, reduced iron in the blood, abnormal liver blood tests, abnormal skin sensation, pain, throat irritation.

Not known
(frequency cannot be estimated from available data)
Eye disorders: eye infection, clouding of the eye surface, corneal swelling, deposits on the eye surface, increased eye pressure, scratch on the eye surface, eye allergy, eye discharge, increased tearing, light sensitivity.
General side effects: shortness of breath, irregular heartbeat, dizziness, worsening of allergy symptoms, itching, skin rash, skin redness, nausea and hives.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may 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 QUIMOX

Keep out of the sight and reach of children.
Do not use the eye drops after the expiry date stated on the bottle and the carton following 'Exp'. The expiry
date refers to the last day of the month.
This medicine does not require any special storage conditions.
Multi-dose bottle
Stop using the bottle 4 weeks after first opening. This is to avoid infection.
Single-dose containers
The single-dose medicine must be used immediately after opening; any remaining medicine must be
discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What QUIMOX contains
The active substance is moxifloxacin.
Each ml of eye drops contains 5 mg of moxifloxacin (as moxifloxacin hydrochloride, 5.45 mg).
One drop of eye drops contains 190 micrograms of moxifloxacin.
The excipients are: sodium chloride, boric acid, purified water.
Small amounts of sodium hydroxide may be added to maintain normal acidity levels (pH).
Description of the appearance of QUIMOX and package contents
The medicine is a liquid (a clear, yellowish-green solution).
Multidose bottle with dropper made of low-density polyethylene and sterile tamper-evident closure cap made of polypropylene. Pack containing 1 bottle of 5 ml.
Single-dose containers made of low-density polyethylene. Pack containing 30 single-dose containers of 0.25 ml each, divided into 3 strips of 10 single-dose containers each, each strip packed in a pouch made of laminated material (PET/ALU/PE).
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder and Manufacturer
ALFA INTES Industria Terapeutica Splendore S.r.l.
Via F.lli Bandiera 26 - 80026 Casoria (NA)