Vigamox

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language
Vigamox
5 mg/ml, eye drops, solution
Moxifloxacin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• 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. This medicine may harm someone else even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

1. What Vigamox is and what it is used for
2. Important information 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 contains the active substance moxifloxacin. Moxifloxacin belongs to a class of antibiotics called fluoroquinolones, used to treat bacterial eye infections.
Vigamox eye drops solution is used to treat bacterial eye infections (conjunctivitis).

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 severe 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, 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 objective and subjective symptoms of eye infection have resolved and treatment with the medicine has been completed.
• In patients receiving oral or intravenous fluorquinolones, cases of tendon swelling and tendon rupture have been reported, 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 overgrowth of other infectious organisms.

Vigamox and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used by the patient, including those obtained without a prescription.

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

Driving and operating machinery
For a short time after instillation of Vigamox, vision may be blurred. Until vision clears, the patient must not drive or operate machinery.

3. How to use Vigamox

This medicine should always be used exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults, including elderly people, and children: 1 drop into the affected eye or eyes, three times a
day (in the morning, in the afternoon, and at night).
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 newborn infants, 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 your doctor.
Vigamox is intended exclusively for instillation into the eyes.
The infection usually resolves within 5 days. If no improvement is observed, the patient should
contact their doctor. Treatment with the drops should be continued for a further 2–3 days, or as
long as directed by the doctor.

1 2 3

• Prepare the Vigamox bottle and 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 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 tip of the bottle close to the eye. Using a mirror may help.
• Do not touch the dropper tip to the eye, eyelid, surrounding areas, or any other surface. This may contaminate 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 rest of the body and is particularly important in small children.
• If drops are being used in both eyes, wash your hands before repeating the above procedure for the second eye. This helps prevent spreading infection from one eye to the other.
• Immediately after use, recap the bottle tightly.

If the drop misses the eye, repeat the instillation attempt.
If more than the recommended dose of Vigamox is used: rinse the eyes with warm water. Do not
administer any additional drops until the next scheduled dose.
If Vigamox is accidentally swallowed, contact your doctor or pharmacist for advice.
If a dose of Vigamox is missed: continue using the medicine as scheduled with the next dose. Do not use a double dose to make up for the missed dose.
If you are using other eye drops, wait at least 5 minutes between instilling Vigamox and any other eye drops.
If you have any further 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 everybody will experience them.
Usually, you can continue using the drops unless the side effects are serious or
the patient experiences a severe 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,
mouth or throat which may cause difficulty in swallowing or breathing, rash or hives, large fluid-filled
blisters, sores or ulcers.

Common side effects
(may occur in less than 1 in 10 people)
Eye-related effects: eye pain, eye irritation.

Uncommon side effects
(may occur in less than 1 in 100 people)
Eye-related effects: dry eye, eye itching, eye redness, surface eye inflammation or scarring, broken blood vessel in the eye, abnormal sensation in the eye, eyelid disorders, itching, redness or swelling.
General effects: headache, unpleasant taste in the mouth.

Rare side effects
(may occur in less than 1 in 1,000 people)
Eye-related effects: corneal disorder, blurred or limited vision, conjunctivitis or conjunctival infection, eye strain, eye swelling.
General effects: vomiting, discomfort in the nose, sensation of lumps in the throat, decreased iron concentration in the blood, abnormal liver test results, skin sensation disturbances, throat pain, throat irritation.

Unknown
(frequency cannot be estimated from the available data)
Eye-related effects: eye infection, eye surface cloudiness, corneal swelling, deposits on the eye surface, increased intraocular pressure, eye surface scratch, eye allergy, eye discharge, increased tear production, light sensitivity.
General effects: shortness of breath, irregular heartbeat, dizziness, worsening of allergic symptoms, itching, rash, skin redness, nausea, and hives.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 side effects 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 conditions are required.
To prevent infection, the bottle should 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 required. These measures will help protect the environment.

6. Contents of the package 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 moxifloxacin hydrochloride).
One drop of eye drops contains 190 micrograms of moxifloxacin.
Other components are: sodium chloride, boric acid, purified water.
Additionally, small amounts of hydrochloric acid 1N and/or sodium hydroxide 1N are added to maintain normal acidity (pH).

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 LDPE bottle with a dropper, white PP screw cap, and tamper-evident ring.

For further information, please contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in Greece, country of export:
Novartis (Hellas) A.E.B.E.
12⁰ km E.O. No 1
144 51 Metamorfosi, Attica
Greece

Manufacturers:
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Alcon-Couvreur NV
Rijksweg 14
2870 Puurs
Belgium

Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany

Siegfried El Masnou, S.A.
Camil Fabra 58
El Masnou
08320 Barcelona
Spain

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in Greece, country of export:
66071/13/29-8-2016

Parallel Import Authorisation Number: 119/24

This medicine is authorised for sale in the European Economic Area and in the United Kingdom (Northern Ireland) under the following trade 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:
United Kingdom (Northern Ireland)