Product Information for the User

VIGAMOX 5mg/ml Eye Drop Solution

Moxifloxacino (as hydrochloride)

1.What is Vigamox and how is it used

2.What you need to know before starting to use Vigamox

3.How to use Vigamox

4.Possible adverse effects

5.Storage of Vigamox

6.Contents of the package and additional information

Vigamox contains the active ingredient moxifloxacino. Moxifloxacino belongs to a class of antibiotics called fluoroquinolonas that are used to treat bacterial eye infections.

Vigamox eye drops are used to treat eye infections (conjunctivitis) caused by bacteria.

Do not useVigamox

• if you are allergic (hypersensitive) to moxifloxacino, to other quinolonas, or to any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist:

• If you experience an allergic reaction to Vigamox. Allergic reactions occur infrequently and severe reactions rarely. If you experience any allergic reaction (hypersensitivity) or any adverse effect, consult section4.
• If you use contact lenses,if you present signs or symptoms of an eye infection, stop using contact lenses and use glasses. Do not use contact lenses until the signs and symptoms of infection have resolved and you have finished using the medication.
• Tendinitis and tendon rupture have been observed in people who use oral or intravenous fluoroquinolones, especially in older patientsand those treated concomitantly with corticosteroids. Discontinue Vigamox treatment if you experience tendon pain or inflammation.

Like any antibiotic, long-term use of Vigamox may lead to other infections.

Other medications and Vigamox

Inform your doctor or pharmacistif you are using, have used recently, or may need to use any other medication, including those acquired without a prescription.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

You may experience blurred vision after using Vigamox. Do not drive or operate machinery until these effects have resolved.

Follow exactly the administration instructions of this medication indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults, including elderly patients and children: 1dropin the affected eye or eyes,3times a day(in the morning, in the afternoon, and at night).

Vigamox can be used in children, in patients over 65years old, and in patients with kidney or liver problems. The information on the use of this medication in newborns is very limited and therefore it is not recommended for use in these patients.

This medication should only be applied to both eyes if your doctor has recommended it. Vigamoxshould onlybe used as eye drops.

Normally, the infection improves in 5days. If you do not see improvement, consult your doctor. You should continue using the drops for 2-3days more or for the entire period of time indicated by your doctor.

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• Take the Vigamox bottle and stand in front of a mirror
• Wash your hands
• Remove the cap
• After opening the bottle for the first time, remove the plastic ring from the seal if it is loose
• Hold the bottle, upside down, between your thumb and the rest of your fingers
• Incline your head back. Gently separate your eyelid from your eye with a finger, until a pouch forms, in which the drop should fall(figure1)
• Bring the tip of the bottle close to your eye. It may be helpful to use a mirror
• Do not touch your eye, eyelid, nearby areas, or other surfaces with the dropperbecause the drops could become infected
• Press gently on thebaseof the bottle to allow one drop of medication to fall each time(figure2)
• After using Vigamox, press the edge of your eye, near your nose with your finger for 2-3minutes(figure3). This helps to prevent the medication from passing into the rest of the body, and is especially important in young children
• If you apply drops to both eyes,wash your hands before repeating the above steps for the other eye.This prevents the spread of infection from one eye to the other
• Close the bottle tightly immediately after using the product

If a drop falls outside the eye, try again.

If more medication has been appliedthan it should, you can remove it by rinsing your eyes with warm water. Do not apply more drops until it is time for the next dose.

If you accidentally ingest Vigamox,contact your doctor or pharmacist.

If you forget to use the medication,continue with the next dose that was scheduled.Do notapply a double dose to compensate for the missed dose.

If you are using other eye drops,wait at least 5minutes between applying Vigamox and the other drops.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Vigamoxmay cause side effects, although not everyone will experience them.

Unless the side effects are severe or you suffer a severe allergic reaction,continue with the treatment as usual.

If you experience a severe allergic reaction and any of the following symptoms appear:swelling of the hands, feet, ankles, face, lips, mouth, or throat, which may cause difficulty swallowing or breathing, rash or urticaria, large blisters filled with fluid, wounds, and ulceration,stop using Vigamox immediately and contact your doctor immediately.

Common side effects

(may affect up to 1 in 10 people)

Eye effects:eye pain, eye irritation

Uncommon side effects

(may affect up to 1 in 100 people)

Eye effects:dry eye, eye itching, eye redness, inflammation or scarring of the eye surface, rupture of a blood vessel in the eye, abnormal sensation in the eye, abnormality, itching, redness, or swelling in the eyelid

Other effects:headache, bad taste

Rare side effects

(may affect up to 1 in 10,000 people)

Eye effects:corneal disorder, blurred or reduced vision, conjunctival inflammation or infection, eye fatigue, ocular swelling

Other effects:vomiting, nasal discomfort, sensation of a lump in the throat, decreased iron in the blood, abnormal liver function test values, abnormal sensation in the skin, pain, throat irritation

Frequency not known

(cannot be estimated from available data)

Eye effects:eye infection, eye surface clouding, corneal swelling, deposits on the eye surface, increased eye pressure, scratch on the eye surface, ocular allergy, eye discharge, increased tear production, light sensitivity

Other effects:shortness of breath, irregular heart rhythm, dizziness, increased allergic symptoms, itching, rash, skin redness, nausea, and urticaria

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle and on the box after “CAD”. The expiration date corresponds to the last day of the month indicated.

This medication does not require special storage conditions.

To prevent infections, discard the bottle 4 weeks after the first opening.

Medicines should not be thrown down the drains or in the trash.Deposit the packaging and unused medicines at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the packaging and unused medicines. In this way, you will help protect the environment.

Composition of Vigamox

• The active ingredientis moxifloxacino. One ml of eye drops contains 5mg of moxifloxacino (as moxifloxacino hydrochloride, 5.45mg). One drop of eye drops contains 190micrograms of moxifloxacino.
• The other components are: sodium chloride, boric acid, and purified water. Small amounts of sodium hydroxide and hydrochloric acid are added to maintain normal acidity levels (pH levels).

Appearance of the product and contents of the package

This medicationis a liquid (a transparent, yellowish-green solution) that is presented in a box containing a plastic bottle of 5ml with a screw-top cap.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Vía de les Corts Catalanes, 764

08013 – Barcelona, Spain

Responsible for manufacturing

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona, Spain

Novartis Manufacturing NV

Rijksweg 14

2870 Puurs-Sint-Amands

Belgium

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg, Germany

Siegfried El Masnou, S.A.

C/ Camil Fabra, 58

08320 El Masnou

Barcelona, Spain

This medication is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

MOXIFLOXACINO ALCON

Germany

KANAVIG

Belgium

Luxembourg

VIGAMOX

Bulgaria

Cyprus

Czech Republic

Denmark

Spain

Estonia

Finland

Greece

Hungary

Iceland

Italy

Latvia

Lithuania

Malta

Netherlands

Poland

Portugal

Romania

Slovakia

Slovenia

Sweden

MOXIVIG

United Kingdom (Northern Ireland)

Last review date of this leaflet:August 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es