Vigamox

Patient Information Leaflet

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

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm others, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What VIGAMOX is and what it is used for
2. What you need to know 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 is used to treat bacterial eye infections (conjunctivitis).

2. Important information before using the medicine 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 uncommonly, 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 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 with the medicine has been completed.
• In patients receiving oral or intravenous fluorochinolones, cases of swelling and tendon rupture have been reported, particularly in elderly patients and those concurrently treated with corticosteroids. 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 overgrowth of other pathogens.
VIGAMOX and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, 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.
Driving and operating machinery
For a short time after instillation of VIGAMOX, vision may be blurred. Until vision clears, driving and operating machinery should not be undertaken.

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, 3 times
daily (in the morning, afternoon, and at night).

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

This medicine should be used in both eyes only if specifically instructed by a physician.

VIGAMOX is intended exclusively for ophthalmic instillation (eye drops).

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

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 down the lower eyelid to form a "pocket" between the eyeball and the 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 areas, or any other surface. This may contaminate the drops.
• Gently press 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 especially 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, 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 administer 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 as scheduled with the next dose. Do not
administer a double dose to make up for the missed dose.

If the patient is using other eye drops, they should wait at least 5 minutes between instilling VIGAMOX and other eye drops.

If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Usually, you can continue using the drops unless the adverse reactions are severe or
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 eye drops immediately and contact a doctor without delay: swelling of the hands, feet,
ankles, face, lips, swelling of the mouth or throat which may cause 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, 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 disorder, blurred or reduced vision, conjunctivitis (inflammation or
infection of the conjunctiva), eye strain, eye swelling
General reactions: vomiting, nasal discomfort, sensation of lumps in the throat, decreased iron
concentration in blood, abnormal liver function tests, disturbances in skin sensation, pain, throat
irritation

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

Reporting of adverse reactions
If any adverse effects 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 Warszawa
Tel.: + 48 22 49 21 301
Faks: + 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 stated month.
No special storage conditions are required.
To prevent infections, 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 pack 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/or hydrochloric acid may also be added to maintain the normal acidity (pH) of the product.

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

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

Marketing authorisation holder in Portugal, the country of export:
Novartis Farma – Produtos Farmacêuticos, S.A.
Avenida Professor Doutor Cavaco Silva, n.º 10E, Taguspark
2740-255 Porto Salvo, Portugal

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 Portugal, the country of export: 5218961
Parallel import authorisation number: 396/24

This medicinal product is authorised for marketing 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)