Vigamox

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
VIGAMOX
5 mg/ml, eye drops, solution
Moxifloxacin
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What VIGAMOX is and what it is 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 VIGAMOX is and what it is used for

VIGAMOX contains the active substance moxifloxacin. Moxifloxacin belongs to a class of antibiotics called fluoroquinolones, used in the treatment of bacterial eye infections.
VIGAMOX eye drops are used to treat bacterial eye infections (conjunctivitis).

2. 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 not very commonly, and severe allergic reactions are rare. In the event of any allergic reactions (hypersensitivity reactions) or any other adverse effects, follow the recommendations given in section 4.
• If the patient wears contact lenses, they should discontinue their use when objective and subjective symptoms of eye infection are present. Glasses should be used instead. Contact lenses must not be worn until objective and subjective symptoms of eye infection have resolved and treatment with the medicine has been completed.
• In patients receiving oral or intravenous fluoroquinolones, cases of tendon swelling and tendon rupture have been reported, particularly in elderly patients and those receiving concomitant corticosteroid therapy. Treatment with Vigamox should be discontinued if the patient experiences tendon pain or swelling.

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

Vigamox with other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used by the patient, including those obtained without a prescription.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using Vigamox eye drops.

Driving and using machines
Vision may be blurred for a short time after instilling Vigamox eye drops. Until vision clears, the patient must not drive or operate machinery.

3. How to use Vigamox

This medicine should always be used as directed by a physician or pharmacist. If in doubt, consult a physician or pharmacist.
Recommended dose:
Adults, including elderly individuals, and children: 1 drop in the affected eye or eyes, three times
daily (morning, afternoon, and evening).

Vigamox may be used in children, in patients over 65 years of age, and in patients with kidney or liver disease. Use of this medicine is not recommended in newborns, as there is very limited information available on its use in these patients.

This medicine should be administered to both eyes only if specifically instructed by a physician.

Vigamox is intended exclusively for ophthalmic use (instillation into the eye).

Infection usually resolves within 5 days. If no improvement is observed, the patient should contact a physician. Treatment with the drops should continue for an additional 2–3 days, or as long as directed by a physician.

1 2 3

• Prepare the Vigamox bottle and a mirror.
• Wash hands.
• Unscrew the cap.
• If the safety collar is loose after removing the cap, remove it before using the medicine.
• Hold the inverted bottle between the thumb and middle finger.
• Tilt the head backward. Using a clean finger, gently pull down the lower eyelid to create a "pocket" between the eyeball and the eyelid; the drop should be instilled into this pocket (Figure 1).
• Bring the dropper tip close to the eye. A mirror may be used to assist.
• Do not touch the dropper tip to the eye, eyelid, surrounding areas, or any other surface. This may contaminate the drops.
• Gently squeeze the bottom of the bottle to release a single drop at the appropriate moment (Figure 2).
• After instilling Vigamox, press with a finger on the inner corner of the eye near the nose for 2–3 minutes (Figure 3). This helps prevent the medicine from draining into the systemic circulation and is particularly important in small children.
• If drops are to be used in both eyes, wash hands before repeating the above procedure for the second eye. This helps prevent the spread of infection from one eye to the other.
• Immediately after use, recap the bottle tightly.

If the drop misses the eye, repeat the instillation attempt.

Using more than the recommended dose of Vigamox: rinse the eyes with warm water. Do not instill additional drops until the next scheduled dose.

In case of accidental ingestion of Vigamox, consult a physician or pharmacist for advice.

If a dose of Vigamox is missed: continue treatment by administering the next dose at the regularly scheduled time. Do not use a double dose to make up for a missed dose.

If the patient is using other eye drops, a minimum interval of 5 minutes should be maintained between instillation of Vigamox and the other drops.

If there are any further questions about the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although they do not occur in everyone.
You can usually continue using the drops unless the adverse reactions are severe or
if the patient experiences a serious allergic reaction.
If the patient experiences a severe allergic reaction or any of the symptoms listed below, stop using
Vigamox immediately and contact a doctor without delay: swelling of the hands, feet, ankles, face, lips,
oral cavity or throat causing difficulty in swallowing or breathing, rash or hives, large fluid-filled blisters,
lesions or ulcers.

Common adverse reactions
(may affect up to 1 in 10 people)
Eye-related reactions: eye pain, eye irritation.

Uncommon adverse reactions
(may affect up to 1 in 100 people)
Eye-related reactions: dry eye, eye itching, eye redness, surface eye inflammation or scarring,
broken blood vessel in the eye, abnormal sensation in the eye, eyelid abnormalities, itching, redness or swelling.
General reactions: headache, unpleasant taste in the mouth.

Rare adverse reactions
(may affect up to 1 in 1000 people)
Eye-related reactions: corneal disorder, blurred or limited vision, inflammation or infection of the conjunctiva,
eye strain, eye swelling.
General reactions: vomiting, sensation of discomfort in the nose, sensation of lumps in the throat, decreased iron concentration in blood, abnormal liver test results, disturbances in skin sensation, throat pain, throat irritation.

Unknown frequency
(cannot be estimated from the available data)
Eye-related reactions: eye infection, clouding of the eye surface, corneal swelling, deposits on the eye surface, increased intraocular pressure, eye surface scratch, eye allergy, eye discharge, increased tear production, photophobia.
General reactions: shortness of breath, irregular heartbeat, dizziness, worsening of allergic symptoms, itching, rash, skin redness, nausea, and hives.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Vigamox

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
To prevent infections, the bottle must be discarded 4 weeks after first opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Vigamox contains
The active substance is moxifloxacin.
Each ml of eye drops contains 5 mg of moxifloxacin (in the form of 5.45 mg moxifloxacin hydrochloride).
One drop of eye drops contains 190 micrograms of moxifloxacin.
Other ingredients are: sodium chloride, boric acid, purified water.
Small amounts of sodium hydroxide and/or hydrochloric acid have also been added to the product to maintain its acidity (pH) within normal limits.

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 bottle made of LDPE with a DROP-TAINER drop-dispensing system, with a PP cap and a tamper-evident ring, with a capacity of 5 ml.

For further detailed information, please contact the responsible entity or the parallel importer.

Responsible entity 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, Poland

Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw, Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing authorization number in Romania, the country of export: 6924/2014/01
Parallel import authorization number: 199/19

This medicine is authorized for sale 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