Vigamox

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

VIGAMOX

5 mg/ml, eye drops, solution

Moxifloxacin (in the form of hydrochloride)

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 uses contact lenses, they should stop using them when they experience objective and subjective symptoms of eye infection. Instead, they should use glasses. They should not wear contact lenses until the objective and subjective symptoms of eye infection have disappeared and until 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. You should stop using VIGAMOX if the patient experiences pain or swelling of the tendons.

Just like with any other antibiotic, long-term use of VIGAMOX may lead to the occurrence of other infections.

VIGAMOX and other medicines

You should tell your doctor or pharmacist about all the 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 administering VIGAMOX, vision may be blurred. Until vision returns to normal, the patient should not drive or operate machinery.

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 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 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 disappears within 5 days. If the patient does not notice 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 the lower eyelid down to create a "pocket"; the drop should fall into it (diagram 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, the area around the eyes, or other surfaces. This may lead to contamination of the drops.
• Gently squeeze the bottom of the bottle to release a single drop of medicine (diagram 2).
• After administering VIGAMOX, press the corner of the eye near the nose with your finger for 2-3 minutes (diagram 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 procedure 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 get into the eye, you should repeat the attempt to administer the drop.
Using more VIGAMOX than recommended:rinse your eyes with warm water.
Do not administer more drops until the next scheduled dose.
If VIGAMOX is accidentally swallowed, you should consult a doctor or pharmacist for advice.
Missing a dose of VIGAMOX:you should continue using the medicine, giving the next dose according to the scheduled dosing regimen. Do nottake a double dose to make up for a missed dose.
If the patient is using other eye drops, they should leave at least a 5-minute interval between administering VIGAMOX and other drops.

If you have any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, VIGAMOX can cause side effects, although not everybody gets them.
Usually, you can 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 of the eyelids
General disorders:headache, unpleasant taste

Rare side effects

(may affect up to 1 in 1000 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

(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 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, 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 stated.
There are no special precautions for the storage of the medicinal product.
To prevent infections, 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 of VIGAMOXis moxifloxacin.
One ml of eye drops contains 5 mg of moxifloxacin (in the form of 5.45 mg of moxifloxacin hydrochloride). One drop of eye drops contains 190 micrograms of moxifloxacin.
The other ingredients of VIGAMOX are:sodium chloride, boric acid, purified water.
In addition, small amounts of sodium hydroxide and/or hydrochloric acid are added to the medicine to adjust its acidity (pH).

What VIGAMOX looks like and contents of the pack

The medicine is a liquid (a clear, yellowish-green solution), supplied in cartons containing a transparent LDPE bottle with a DROP-TAINER dosing system, with a PP cap and a protective ring, with a capacity of 5 ml.
For more detailed information, you should contact the marketing authorization holder or the 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Romania, the country of export: 6924/2014/01
Parallel import authorization number: 84/20

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 approval of the leaflet: 20.01.2025

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