Vigamox

Leaflet attached to the packaging: 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

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Vigamox and what is it 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 packaging and other information

1. What is Vigamox and what is it used for

Vigamox eye drops are used to treat bacterial eye infections (conjunctivitis).
The active substance of the medicine is moxifloxacin, an ophthalmic anti-infective agent.

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

You should consult a doctor or pharmacist:

• If the patient has experienced allergic reactions to Vigamox. Allergic reactions occur not very often, and serious allergic reactions occur rarely. If any allergic reactions (hypersensitivity) or any other side effects occur, you should follow the instructions given in section 4.
• If the patient uses contact lenses- they should stop using them when they experience objective and subjective symptoms of eye infection. Instead, they should use glasses. Do not wear contact lenses until the objective and subjective symptoms of eye infection have resolved and until the use of the medicine has been completed.
• In patients receiving fluoroquinolones orally or intravenously, there have been reports of swelling and tendon rupture, especially in elderly patients and those treated with corticosteroids at the same time. You should stop using Vigamox if the patient experiences pain or swelling of the tendons.

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

Vigamox and other medicines

You should tell your doctor or pharmacist about all medicines the patient is taking, including those that are available without a prescription.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before using Vigamox eye drops.

Driving and using machines

For a short time after using Vigamox, vision may be blurred. Do not drive or operate machines until vision has cleared.

3. How to use Vigamox

This medicine should always be used exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Recommended dose:

Adults, including the elderly and children: 1 drop into the affected eye(s) 3 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 and liver diseases. The use of this medicine is not recommended in newborns, as only very limited information is available on its use in these patients.
This medicine should be used in both eyes only if instructed to do so by a doctor.
Vigamox is for ophthalmic use only.
The infection usually resolves within 5 days. If the patient does not notice an improvement, they should contact their doctor. The use of the drops should be continued for a further 2-3 days or as directed by the doctor.

1 2 3

• Prepare the Vigamox bottle and a mirror.
• Wash your hands.
• Remove the cap.
• If the protective collar is loose after removing the cap, it should be removed before using the medicine.
• Hold the inverted bottle between the thumb and middle finger.
• Tilt your head back. With a clean finger, pull down the lower eyelid to create a "pocket"; the drop should fall into it (picture 1).
• Bring the tip of the bottle close to the eye. You can use a mirror to help.
• Do not touch the dropper to the eye or eyelid, or to other surfaces.This may lead to contamination of the drops.
• Gently squeeze the bottom of the bottle to release a single drop of medicine (picture 2).
• After using Vigamox, press the corner of the eye near the nose with your finger for 2-3 minutes (picture 3). This will help prevent the medicine from entering the entire body, which is especially important in small children.
• If using drops in both eyes, wash your hands before repeating the above steps for the other eye. This will help prevent transferring the infection from one eye to the other.
• Replace the cap immediately after use.

If the drop does not get into the eye, try again.
Using more Vigamox than recommended:rinse your eyes with warm water. Do not use more medicine until the next normal dose.
If you accidentally swallow Vigamox, consult a doctor or pharmacist for advice.
Missing a dose of Vigamox:continue using the medicine, giving the next dose at the scheduled time. Do notuse a double dose to make up for a missed dose.
If you are using other eye drops, wait at least 5 minutes between using Vigamox and other drops.

If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vigamox can cause side effects, although not everybody gets them.
It is usually possible to continue using the drops, unless the side effects are serious or if the patient experiences severe allergic reactions.

If the patient experiences a severe allergic reaction or any of the following symptoms, they should stop using Vigamox immediately and

inform their doctor right away:swelling of the hands, feet, ankles, face, lips, mouth, or throat, which may make swallowing or breathing difficult, rash or urticaria, large blisters, sores, or ulcers.

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 of the surface of the eye or scarring, broken blood vessel in the eye, abnormal sensation in the eye, eyelid problems, itching, redness, or swelling
General disorders:headache, unpleasant taste

Rare side effects

(may affect up to 1 in 1000 people)
Eye disorders:corneal disease, blurred or impaired vision, conjunctivitis or eye infection, eye strain, eye swelling
General disorders:vomiting, discomfort in the nose, feeling of lumps in the throat, decreased iron levels in the blood, abnormal liver test results, skin sensation disorders, pain, throat irritation

Unknown frequency

(frequency cannot be estimated from the available data)
Eye disorders:eye infection, clouding of the surface of the eye, corneal swelling, deposits on the surface of the eye, increased pressure in the eye, scratching on the surface of the eye, eye allergy, eye discharge, increased tear production, sensitivity to light
General disorders:shortness of breath, irregular heartbeat, dizziness, worsening of allergic symptoms, itching, rash, redness of the skin, nausea, and urticaria

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vigamox

The medicine should be stored in a place 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 month.
There are no special precautions for storage.
The bottle should be discarded 4 weeks after first opening.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Vigamox contains

The active substance ismoxifloxacin.
One ml of eye drops contains 5 mg of moxifloxacin (as 5.45 mg of moxifloxacin hydrochloride). One drop contains 190 micrograms of moxifloxacin.
The other ingredients are:sodium chloride, boric acid, purified water.
Additionally, the medicine contains small amounts of sodium hydroxide and hydrochloric acid to adjust its pH.

What Vigamox looks like and contents of the pack

The medicine is a liquid (clear, yellowish-green solution), supplied in cardboard boxes containing a 5 ml LDPE bottle with a DROP-TAINER dosing system, a PP cap, and a tamper-evident ring.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Greece, the country of export:66071/13/29-8-2016

Parallel import authorization number: 57/23

This medicinal product has been authorized 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
Date of leaflet approval: 28.03.2023
[Information about the trademark]