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 moxifloxacin hydrochloride)
Please read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms appear identical.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. 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, 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. In case of any allergic reactions (hypersensitivity reactions) or any other adverse effects, follow the recommendations given in section 4.
• If the patient wears contact lenses – the patient should stop wearing them 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.
• Cases of 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 the development of other infections.
VIGAMOX and 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 operating machinery
Vision may be blurred for a short time after instilling VIGAMOX eye drops. Driving and operating machinery should be avoided until vision clears.

3. How to use VIGAMOX

This medicine should always be used exactly as directed by your doctor or pharmacist.
If in 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
(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 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 continue for a further 2–3 days, or as long as
directed by the doctor.

1 2 3

• Prepare the VIGAMOX medicine 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" between the eyeball and the eyelid; the drop should be placed 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 contaminate the drops.
• 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 being absorbed into the body and is particularly important in small children.
• If using drops in both eyes, wash your hands before repeating the above procedure 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.
If more than the recommended dose of VIGAMOX has been used: rinse the eyes with warm water.
Do not instill additional 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 using the medicine as scheduled. 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 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.
You can usually continue using the drops unless the adverse reactions are serious or
the patient experiences a severe 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,
mouth or throat, which may cause difficulty swallowing or breathing, rash or hives, large fluid-filled blisters,
wounds or ulcers.

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

Uncommon adverse reactions
(may affect up to 1 in 100 people)
Eye disorders: 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 disorders: headache, unpleasant taste in the mouth

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

Unknown frequency
(cannot be estimated from the available data)
Eye disorders: eye infection, eye surface clouding, corneal swelling, eye surface deposits, increased intraocular pressure,
eye surface scratch, eye allergy, eye discharge, increased tear production, photophobia
General disorders: 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, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps 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 container. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
To prevent infection, 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 in use. This will help protect the environment.

6. Contents of the package and other information

What VIGAMOX contains
The active substance is moxifloxacin.
Each 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 components are: sodium chloride, boric acid, purified water.
Small amounts of sodium hydroxide and hydrochloric acid are added to maintain the pH within normal range.

What VIGAMOX looks like and contents of the pack
VIGAMOX is a liquid (a clear, yellowish-green solution), supplied in boxes containing one LDPE bottle with a capacity of 5 ml with a cap.

For further information, contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Romania, country of export:
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg, Germany

Manufacturer:
Alcon-Couvreur N.V.
Rijksweg 14, B-2870 Puurs, Belgium
Siegfried El Masnou, S.A.
Camil Fabra, 58, 08320 El Masnou, Barcelona, Spain
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 Romania, country of export: 6924/2014/01
Parallel Import Licence Number: 175/21

This medicinal product is 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:
United Kingdom (Northern Ireland)