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

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any 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 pack 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

Consult a doctor or pharmacist:

• If the patient has experienced allergic reactions to Vigamox. Allergic reactions occur infrequently, and serious allergic reactions occur rarely. If any allergic reactions (hypersensitivity) or other side effects occur, follow the instructions in section 4.
• If the patient wears contact lenses, they should stop wearing them when they have symptoms of eye infection. Instead, they should wear glasses. Do not wear contact lenses until the symptoms of eye infection have resolved and 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. Stop using Vigamox if the patient experiences pain or swelling of the tendons.

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

Vigamox and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, including those obtained 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. Do not drive or operate machinery until vision is clear.

3. How to use Vigamox

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose:

Adults, including the elderly and children: 1 drop into the affected eye(s) three times a day (morning, afternoon, and evening). Vigamox may be used in children, patients over 65 years, and patients with kidney and liver diseases. The use of this medicine is not recommended in newborns, as only 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 eye 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 drops should be continued for a further 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, remove it 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 (figure 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 any other surface.This could lead to contamination of the drops.
• Gently squeeze the bottom of the bottle to release one 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 rest of the 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 infection from one eye to the other.
• Replace the cap immediately after use.

If the drop does not enter the eye, repeat the attempt to administer the drop.
Using more Vigamox than recommended:rinse the eyes with warm water. Do not administer more drops until the next scheduled dose.
If Vigamox is accidentally swallowed, consult a doctor or pharmacist for advice.
Missing a dose of Vigamox:continue using the medicine, administering the next dose as scheduled. Do nottake a double dose to make up for a missed dose.
If the patient is using other eye drops, they should leave a 5-minute interval between using Vigamox and other drops.

If you have any further questions on the use of this medicine, 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 and

immediately inform their doctor:swelling of the hands, feet, ankles, face, lips, mouth, or throat, which may cause difficulty swallowing or breathing, 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, 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 the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration 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

Keep the medicine out of the 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 storage precautions.
The bottle should be discarded 4 weeks after first opening.
Medicines should 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 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/or hydrochloric acid to adjust the pH.

What Vigamox looks like and contents of the pack

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

Marketing authorization holder in Romania, the country of export:

Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg, Germany

Manufacturer:

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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in Romania, the country of export:6924/2014/01
Parallel import authorization number:199/19
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:
Ireland

Date of revision of the leaflet: 24.04.2024

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