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 (as hydrochloride)
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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, which are 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 not frequently, and serious allergic reactions are rare. If any allergic (hypersensitivity) reactions or any other adverse effects occur, 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 should not be worn until objective and subjective symptoms of eye infection have resolved and treatment has been completed.
• Tendon swelling and tendon rupture have been reported in patients receiving oral or intravenous fluoroquinolones, particularly in elderly patients and those concurrently treated with corticosteroids. VIGAMOX treatment should be discontinued if the patient experiences tendon pain or swelling.
• As with any other antibiotic, prolonged use of VIGAMOX may lead to overgrowth of other microorganisms.
• Interaction of 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 child, she should consult a doctor before using VIGAMOX eye drops.

Driving and operating machinery

Vision may be blurred for a short time after instilling VIGAMOX eye drops. Driving and operating machinery should not be performed until vision clears.

3. How to use VIGAMOX

This medicine should always be used as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose:
Adults, including elderly individuals, and children: 1 drop into the affected eye or eyes, 3 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 this patient group.

This medicine should be administered to both eyes only if specifically instructed by a doctor.
VIGAMOX is intended exclusively for instillation into the eyes.

The infection usually resolves within 5 days. If the patient does not observe improvement, they should contact their doctor. Treatment with the drops should continue for an additional 2–3 days, or as long as directed by the doctor.

1 2 3

• Prepare the VIGAMOX bottle and a mirror.
• Wash your hands.
• Unscrew the cap.
• If the protective collar is loose after removing the cap, remove it before using the medicine.
• Hold the inverted bottle between your thumb and middle finger.
• Tilt your head backward. With a clean finger, gently pull the lower eyelid downward to create a "pocket" between the eyeball and eyelid; the drop should be instilled into this pocket (Figure 1).
• Bring the tip of the bottle close to the eye. A mirror may be used to assist.
• Do not touch the dropper tip to the eye, eyelid, surrounding area, or any other surface. This may contaminate the medicine.
• Gently press the bottom of the bottle to release a single drop of medicine 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 rest of the body and is particularly important in young children.
• If administering drops to both eyes, wash your hands before repeating the above steps for the second eye. This helps prevent spreading 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 doctor or pharmacist for advice.
If a dose of VIGAMOX is missed: continue treatment as scheduled with the next dose. Do not use a double dose to make up for the missed dose.
If the patient is using other eye drops, a minimum interval of 5 minutes should be maintained between instillation of VIGAMOX and other eye drops.
If there are any further questions regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

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

Common adverse reactions
(may occur in less than 1 in 10 people)
Eye-related reactions: eye pain, eye irritation

Uncommon adverse reactions
(may occur in less than 1 in 100 people)
Eye-related reactions: dry eye, itchy eye, eye redness, surface eye inflammation or scarring,
broken blood vessel in the eye, abnormal eye sensation, eyelid disorders, itching, redness or swelling

General reactions: headache, unpleasant taste in mouth

Rare adverse reactions
(may occur in less than 1 in 1,000 people)
Eye-related reactions: corneal disorder, blurred or reduced vision, conjunctivitis or conjunctival infection,
eye fatigue, eye swelling

General reactions: vomiting, nasal discomfort, sensation of lumps in the throat, decreased iron concentration in blood,
abnormal liver test results, skin sensory disturbances, pain, throat irritation

Unknown frequency
(frequency cannot be estimated from available data)
Eye-related reactions: eye infection, eye surface clouding, corneal swelling, deposits on eye surface, increased eye pressure,
scratches on eye surface, eye allergy, eye discharge, increased tear production, light sensitivity

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 your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of 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 packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply to this medicinal product.
To prevent infection, the bottle must be discarded 4 weeks after first opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What VIGAMOX contains
The active substance is moxifloxacin.
Each 1 ml of eye drops contains 5 mg of moxifloxacin (as 5.45 mg of moxifloxacin hydrochloride). One eye drop contains 190 micrograms of moxifloxacin.
Other ingredients are: sodium chloride, boric acid, purified water.
Small amounts of sodium hydroxide and/or hydrochloric acid may also be added to maintain normal acidity (pH) of the solution.

What VIGAMOX looks like and contents of the pack
The medicine is a liquid (a clear, yellowish-green solution), supplied in boxes containing a transparent LDPE bottle with a DROP-TAINER dropper system, fitted with a PP cap and a tamper-evident ring, with a capacity of 5 ml.

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

Marketing Authorisation 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
Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in Romania, the country of export: 6924/2014/01
Parallel Import Licence Number: 84/20

This medicine is authorised for sale in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following trade 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)