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.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 contains the active substance moxifloxacin. Moxifloxacin belongs to a class of antibiotics called fluoroquinolones, used to treat bacterial eye infections. Vigamox eye drops are 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

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 is using contact lenses, they should stop using them when they have symptoms of eye infection. Instead, they should use glasses. They should not wear contact lenses until the symptoms of eye infection have disappeared and they have finished using the medicine.
• In patients receiving fluoroquinolones orally or intravenously, there have been cases 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 their doctor before using Vigamox eye drops.

Driving and using machines

For a short time after using Vigamox, vision may be blurred. The patient should not drive or operate machinery until their vision is clear.

3. How to use Vigamox

This medicine should always be used exactly as the doctor or pharmacist has told you. If you are not sure, you should ask 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 can 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 there is only limited information available on its use in these patients. This medicine should be used in both eyes only if the doctor has recommended it. Vigamox is for eye use only. The infection usually clears up within 5 days. If the patient does not see an improvement, they should contact their doctor. The use of drops should be continued for another 2-3 days or as long as the doctor recommends.

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" between the eye and the eyelid; the drop should fall into this pocket (figure 1).
• Bring the tip of the bottle close to the eye. You can use a mirror to help you.
• 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 (figure 2).
• After using Vigamox, press the corner of the eye near the nose with your finger for 2-3 minutes (figure 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, you should wash your hands before repeating the above steps for the second eye. This will help prevent the transfer of infection from one eye to the other.
• Replace the cap immediately after use.

If the drop does not fall into the eye, you should try again.
Using more Vigamox than recommended:you should rinse your eyes with warm water. Do not use more medicine until it is time for your next dose.
If you accidentally swallow Vigamox, you should consult a doctor or pharmacist for advice.
Missing a dose of Vigamox:you should continue using the medicine and give 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, you should wait at least 5 minutes between using Vigamox and other drops.

If you have any further questions about using this medicine, you should ask 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 dropsunless 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 hives, 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 1,000 people)
Eye disorders:corneal disease, blurred or decreased 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

(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 hives

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. You can also report side effects directly to the Department of Adverse Reaction Monitoring 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. 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 it is first opened.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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 hydrochloric acid and/or sodium hydroxide to adjust its pH.

What Vigamox looks like and contents of the pack

The medicine is a liquid (a clear, yellowish-green solution), supplied in a LDPE bottle with a plastic dropper, a white PP cap, and a tamper-evident ring, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Novartis Farma – Produtos Farmacȇuticos, S.A.
Avenida Professor Doutor Cavaco Silva, n 10E
Taguspark, 2740-255 Porto Salvo
Portugal

Manufacturer:

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 Nürnberg, 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
Portuguese marketing authorization number:5218961

Parallel import authorization number: 1/24

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) 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:
United Kingdom (Northern Ireland)

Date of revision of the leaflet: 04.01.2024

[Information about the trademark]