Vigamox

Patient Information Leaflet

Warning! Keep this leaflet! Information on the outer packaging in a foreign language.
VIGAMOX, 5 mg/ml, eye drops, solution
Moxifloxacin
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Vigamox is and what it is used for

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

2. Important information before using Vigamox

When not to use Vigamox

• 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
Consult a doctor or pharmacist:

• If the patient has experienced allergic reactions to Vigamox. Allergic reactions occur not very 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 – should discontinue their use when objective and subjective symptoms of eye infection are present. Glasses should be used instead. Contact lenses should not be worn until objective and subjective symptoms of eye infection have resolved and until completion of treatment with the medicine.
• Cases of tendon swelling and tendon rupture have been reported in patients receiving oral or intravenous fluorquinolones, particularly in elderly patients and those concurrently treated with corticosteroids. Vigamox treatment should be discontinued if the patient experiences tendon pain or swelling.

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

Vigamox and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using Vigamox eye drops.

Driving and operating machinery
Vision may be blurred for a short time after instilling Vigamox eye drops. Until vision clears, the patient must not drive or operate machinery.

3. How to use Vigamox

This medicine should always be used as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose:
Adults, including elderly individuals, and children: 1 drop into the affected eye or eyes, three times a day (morning, afternoon, and evening).

Vigamox 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 is very limited information available on its use in these patients.
This medicine should be administered to both eyes only if specifically instructed by a doctor.
Vigamox is intended exclusively for ophthalmic instillation (eye drops).

Infection usually resolves within 5 days. If no improvement is observed, the patient should contact a doctor. Treatment with the drops should continue for an additional 2–3 days, or as long as directed by a physician.

1 2 3

• Prepare the Vigamox bottle and a mirror.
• Wash 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 the thumb and middle finger.
• Tilt the head backward. With a clean finger, gently pull down the lower eyelid to create a "pocket" between the eyeball and the eyelid; the drop should be instilled into this pocket (Figure 1).
• Bring the dropper tip close to the eye. A mirror may be used to assist.
• Do not touch the dropper tip to the eye, eyelid, surrounding areas, or any other surface. This may result in contamination of the drops.
• Gently squeeze the bottom of the bottle to release a single drop at the appropriate moment (Figure 2).
• After instilling Vigamox, 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 systemic circulation and is particularly important in small children.
• If administering drops to both eyes, wash hands before repeating the above procedure for the second eye. This helps prevent the spread of infection from one eye to the other.
• Immediately after use, recap the bottle tightly.

If the drop misses the eye, repeat the instillation attempt.
Accidental overdose of Vigamox: rinse the eyes with warm water. Do not instill any additional drops until the next scheduled dose.
If Vigamox is accidentally swallowed, seek advice from a doctor or pharmacist immediately.
If a dose of Vigamox is missed: continue treatment as scheduled. Do not use a double dose to make up for a missed dose.
If the patient is using other eye drops, a minimum interval of 5 minutes should be maintained between instillation of Vigamox and the other drops.
If there are any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this product may cause adverse reactions, although not everyone experiences them.
Usually, you may continue using the drops unless the adverse reactions are severe or
the patient develops a serious allergic reaction.
If the patient experiences a severe allergic reaction or any of the symptoms listed below,
stop using Vigamox immediately and contact a doctor without delay: swelling of the hands, feet, ankles, face, lips, or inside the mouth or throat causing difficulty in swallowing or breathing, rash or hives, large fluid-filled blisters, sores or ulcers.

Common adverse reactions
(may affect up to 1 in 10 people)
Eye-related reactions: eye pain, eye irritation

Uncommon adverse reactions
(may affect up to 1 in 100 people)
Eye-related reactions: 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 reactions: headache, unpleasant taste in the mouth

Rare adverse reactions
(may affect up to 1 in 1,000 people)
Eye-related reactions: corneal disorder, blurred or limited vision, conjunctival inflammation or infection, eye fatigue, eye swelling
General reactions: vomiting, nasal discomfort, sensation of lumps in the throat, decreased iron concentration in blood, abnormal liver test results, skin sensory disturbances, pain, throat irritation

Unknown frequency
(frequency cannot be estimated from available data)
Eye-related reactions: eye infection, eye surface clouding, corneal swelling, deposits on the eye surface, increased intraocular pressure, eye surface scratch, eye allergy, eye discharge, increased tear production, light sensitivity
General reactions: 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 a 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 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Vigamox

Keep this medicine out of 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 the stated month.
No special storage instructions apply.
To prevent infection, discard the bottle 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 required. This will help protect the environment.

6. Contents of the pack and other information

What Vigamox contains
The active substance is moxifloxacin.
Each ml of eye drops contains 5 mg of moxifloxacin (as 5.45 mg of moxifloxacin hydrochloride).
Each eye drop contains 190 micrograms of moxifloxacin.
Other components are: sodium chloride, boric acid, purified water.
Small amounts of sodium hydroxide and hydrochloric acid have also been added to maintain the
normal acidity (pH) of the product.

What Vigamox looks like and contents of the pack
The medicine is a liquid (a clear, yellowish-green solution), supplied in cardboard boxes containing a 5 ml bottle made of LDPE with a DROP-TAINER dropper system, a PP cap, and a tamper-evident ring.

For further detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Greece, country of export:
Novartis (Hellas) A.E.B.E.
12 km National Highway No 1
144 51, Metamorfosi, Attiki, Greece

Manufacturer:
Alcon Couvreur NV, Rijksweg 14, 2870 Puurs, Belgium
Novartis Farmacéutica, S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Siegfried El Masnou, S.A., Camil Fabra 58, El Masnou, 08320 Barcelona, Spain

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in Greece, country of export: 66071/13/29-8-2016
Parallel Import Licence Number: 57/23

This medicinal product has been authorised for marketing in EU Member States under the following names:

MOXIFLOXACIN ALCON:
Germany

KANAVIG:
Belgium, Luxembourg

VIGAMOX:
Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Iceland, Latvia, Lithuania, Malta, Netherlands, Poland, Portugal, Romania, Spain, Slovakia, Slovenia, Sweden, Hungary, Italy

MOXIVIG:
Ireland