Vigamox

Patient Information Leaflet

Warning! Please keep this leaflet. Information on the immediate packaging is in a foreign language.
Vigamox, 5 mg/ml, eye drops, solution
Moxifloxacinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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 eye drops are used to treat bacterial eye infections (conjunctivitis).
The active substance is moxifloxacin, an ophthalmic antibacterial agent.

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 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 stop using them when objective and subjective symptoms of eye infection are present. Instead, glasses should be used. Contact lenses should 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 swelling and tendon rupture have been reported, 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 the 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. Driving and operating machinery should not be undertaken until vision is clear again.

3. How to use Vigamox

This medicine should always be used exactly as directed by your doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
Recommended dose:
Adults, including elderly people, and children: 1 drop into the affected eye or eyes, 3 times a
day (in the morning, in the afternoon, and at night).
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 used in both eyes only if specifically instructed by your doctor.
Vigamox is intended exclusively for instillation into the eyes.
Infection usually resolves within 5 days. If the patient does not observe improvement, they should
contact their doctor. Treatment with the drops should be continued 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 safety 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 form a "pocket"; 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 areas, or any other surface. This may lead to contamination of the drops.
• Gently squeeze the bottom of the bottle to release a single drop of medicine at the appropriate moment ( Figure 2 ).
• After instilling Vigamox, press gently 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 especially important in young children.
• If using drops in both eyes, wash your hands before repeating the procedure described above for the second eye. This helps prevent spreading infection from one eye to the other.
• Immediately after use, replace the cap on the bottle.

If the drop misses the eye, repeat the instillation attempt.
Use of more than the recommended dose of Vigamox: rinse the eyes with warm water. Do not
instill any more drops until the next scheduled dose.
In case of accidental ingestion of Vigamox, contact your 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, at least a 5-minute interval should be maintained between
instillation of Vigamox and other eye drops.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The use of drops can usually be continued unless the adverse reactions are severe or
if the patient develops a serious allergic reaction.
If the patient experiences a severe allergic reaction or any of the symptoms listed below, stop using
Vigamox immediately and inform a doctor without delay: swelling of the hands, feet, ankles, face, lips,
oral cavity or throat causing difficulty in swallowing or breathing, rash or urticaria, large fluid-filled blisters,
wounds 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, eye itching, eye redness, surface eye inflammation or scarring,
broken blood vessel in the eye, abnormal sensation in the eye, eyelid disorders, itching, redness or swelling
General reactions: headache, unpleasant taste in the mouth

Rare adverse reactions
(may occur in less than 1 in 1,000 people)
Eye-related reactions: corneal disease, blurred or limited vision, conjunctival inflammation or infection,
eye strain, eye swelling
General reactions: vomiting, nasal discomfort, sensation of lumps in the throat, decreased iron levels 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, 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 urticaria.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
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 this 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 conditions are required.
To prevent infection, the bottle should 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 required. These measures will help protect the environment.

6. Contents of the package 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 drop of eye drops contains 190 micrograms of moxifloxacin.
Other ingredients are: sodium chloride, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.

What Vigamox looks like and contents of the pack
Vigamox is a liquid (a clear, yellowish-green solution) supplied in cartons containing one 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 more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Greece, the country of export:
Novartis (Hellas) A.E.B.E., 12 km National Highway No 1, 144 51, Metamorfosi, Attiki, Greece

Manufacturer:
Novartis Farmacéutica, S.A., Gran Via de les Corts Catalanes, 764 08013 Barcelona, Spain

Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing Authorisation Number in Greece, the country of export: 66071/13/29-8-2016
Parallel Import Authorisation Number: 143/23

This medicinal product has been authorised for marketing in EU Member States 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