Xiflodrop

Package leaflet: Information for the patient

Xiflodrop, 5 mg/ml, eye drops, solution
Moxifloxacinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, 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.

Table of contents of the leaflet

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

1. What Xiflodrop is and what it is used for

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

2. Information before using Xiflodrop

When not to use Xiflodrop:

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

Warnings and precautions
Before starting to use Xiflodrop, discuss this with your doctor or pharmacist.

• If the patient has experienced allergic reactions to Xiflodrop. Allergic reactions occur not frequently, while severe allergic reactions are rare. In case of any allergic reactions (hypersensitivity reactions) or any other adverse effects, 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. Contact lenses should not be worn until the objective and subjective symptoms of eye infection have resolved and treatment with the medicine has been completed.
• In patients receiving fluorquinolones orally or intravenously, cases of swelling and tendon rupture have been reported, particularly in elderly patients and in those concurrently treated with corticosteroids. Xiflodrop treatment should be discontinued if the patient experiences tendon pain or swelling.

As with any other antibiotic, prolonged use of Xiflodrop may lead to emergence of other infections.
Xiflodrop and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use, including those available without a prescription.
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 this medicine.
Driving and operating machinery
Vision may be blurred for a short time after instilling Xiflodrop eye drops. Until vision clears, the patient must not drive or operate machinery.

3. How to use Xiflodrop

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult your
doctor or pharmacist.
Xiflodrop is intended exclusively for instillation into the eyes.
Recommended dose:
Adults, including elderly people, and children: 1 drop into the affected eye or eyes, 3 times daily
(morning, afternoon, and evening).
Xiflodrop can 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 is only very
limited information available on its use in these patients.
This medicine should be used in both eyes only if specifically instructed by the doctor.
Xiflodrop is intended exclusively for instillation into the eyes.
Infection usually resolves within 5 days. If the patient does not observe improvement, they should
contact the doctor. The use of the drops should be continued for a further 2–3 days, or as long as
directed by the doctor.

How to use Xiflodrop

1 2 3

• Prepare the Xiflodrop bottle and stand facing 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 form a "pocket" between the eyeball and the eyelid; the drop should be placed into this pocket (Figure 1).
• Bring the tip of the bottle close to the eye. For convenience, you may use a mirror.
• Do not touch the dropper tip to the eye, eyelid, surrounding area, or any other surface. This may contaminate the drops.
• Gently press the bottom of the bottle to release a single drop of medicine at the right moment (Figure 2).
• Do not press the bottle hard. The bottle is designed so that light pressure on the bottom is sufficient.
• After instilling Xiflodrop, 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 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, close the bottle with the cap.

If the drop misses the eye, repeat the instillation attempt.
If more medicine has been instilled than recommended, rinse the eyes with warm water. Do not
instill any more medicine until the next scheduled dose.
In case of accidental ingestion of Xiflodrop, contact your doctor or pharmacist for advice.
If a dose is missed, continue treatment with the next dose as scheduled. Do not use a double
dose to make up for the missed dose.
If the patient is using other eye drops, they should wait at least 5 minutes between instilling Xiflodrop and other eye drops.
If in doubt 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 experiences them.
Treatment with eye drops can usually be continued unless the adverse reactions are severe or the patient
does not experience serious allergic reactions.
If the patient experiences a severe allergic reaction or any of the symptoms listed below, use of Xiflodrop
must be stopped immediately and the doctor must be informed 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, wounds or ulcers.
Common adverse reactions (may affect up to 1 in 10 patients)
Eye-related symptoms: eye pain, eye irritation
Uncommon adverse reactions (may affect up to 1 in 100 patients)
Eye-related symptoms: 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 symptoms: headache, unpleasant taste in the mouth.
Rare adverse reactions (may affect up to 1 in 1000 people)
Eye-related reactions: corneal disease, blurred or limited vision, conjunctival inflammation or infection,
eye fatigue, eye swelling.
General reactions: vomiting, discomfort in the nose, sensation of lumps in the throat, decreased iron levels in
the blood, abnormal liver function tests, skin sensation disorders, pain, throat irritation.
Unknown frequency (frequency cannot be estimated from available data)
Eye-related symptoms: eye infection, clouding of the eye surface, corneal swelling, deposits on the eye
surface, increased intraocular pressure, eye surface scratch, eye allergy, eye discharge, increased tear
production, light sensitivity.
General symptoms: 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 adverse reactions not listed in this leaflet, inform a doctor,
pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of
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, e-mail:
[email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Xiflodrop

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after: EXP.
The expiry date refers to the last day of the mentioned month.
This medicine does not require any special storage conditions.
To prevent contamination, the bottle must be discarded 4 weeks after first opening.
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 Xiflodrop contains

• The active substance is moxifloxacin. 1 ml of eye drops contains 5 mg moxifloxacin (as 5.45 mg moxifloxacin hydrochloride). One eye drop contains 190 micrograms of moxifloxacin.
• The other ingredients are: boric acid, sodium chloride, sodium hydroxide (to adjust pH), water for injections.

What Xiflodrop looks like and contents of the pack
Xiflodrop is a clear, yellowish-green solution, supplied in packs containing 1 plastic bottle with 5 ml of solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
BAUSCH + LOMB IRELAND LIMITED
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer
Famar S.A.
Plant A, 63 Agiou Dimitriou str.
174 56 Alimos, Athens
Greece
Pharmathen S.A.
6 Dervenakion str.
15351 Pallini, Attiki
Greece