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

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

2. Important information before using VIGAMOX

When not to use VIGAMOX

Warnings and precautions

Consult a doctor or pharmacist:

• If the patient has experienced allergic reactions to VIGAMOX.Allergic reactions occur infrequently, and serious allergic reactions occur rarely. If any allergic reactions (hypersensitivity) or other side effects occur, follow the instructions in section 4.
• 4.
• If the patient wears contact lenses- they should stop wearing them when they have symptoms of eye infection. Instead, they should wear glasses. Do not wear contact lenses until the symptoms of eye infection have resolved and the use of the medicine has been completed.
• In patients receiving fluoroquinolones orally or intravenously, there have been reports of swelling and tendon rupture, especially in elderly patients and those treated with corticosteroids. Stop using VIGAMOX if the patient experiences pain or swelling of the tendons.

As with any other antibiotic, long-term use of VIGAMOX may lead to the development of other infections.

VIGAMOX and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, including those obtained without a prescription.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using VIGAMOX.

Driving and using machines

For a short time after administering VIGAMOX, vision may be blurred. Do not drive or operate machinery until vision returns to normal.

3. How to use VIGAMOX

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose:

Adults, including the elderly and children: 1 drop into the affected eye(s), 3 times a day (morning, afternoon, and evening). VIGAMOX can be used in children, patients over 65 years, and patients with kidney and liver diseases. The use of this medicine is not recommended in newborns, as only limited information is available on its use in these patients. This medicine should be used in both eyes only if advised by a doctor. VIGAMOX is for eye use only. The infection usually resolves within 5 days. If the patient does not observe improvement, they should contact their doctor. The use of drops should be continued for a further 2-3 days or as advised by the doctor.

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2
3

• Prepare the VIGAMOX bottle and a mirror.
• Wash your hands.
• Remove the cap.
• If the protective collar is loose after removing the cap, it should be removed before using the medicine.
• Hold the inverted bottle between the thumb and middle finger.
• Tilt your head back. Pull the lower eyelid down with a clean finger to create a "pocket"; the drop should fall into this pocket (figure 1).
• Bring the tip of the bottle close to the eye. You can use a mirror to help.
• Do not touch the dropper to the eye or eyelid, or to other surfaces.This may cause infection of the drops.
• Gently squeeze the bottom of the bottle to release a single drop of medicine (figure 2).
• After administering VIGAMOX, press the corner of your eye with your finger for 2-3 minutes (figure 3). This helps prevent the medicine from entering the entire body, which is especially important in small children.
• If using drops in both eyes, wash your hands before repeating the above steps for the second eye. This helps prevent the transfer of infection from one eye to the other.
• Replace the cap immediately after use.

If the drop does not get into the eye, try again.
If you use more VIGAMOX than you should:rinse your eyes with warm water. Do not put in another drop until it is time for your next regular dose.
If you accidentally swallow VIGAMOX, consult your doctor or pharmacist for advice.
If you miss a dose of VIGAMOX:continue using the medicine as planned. Do notuse a double dose to make up for a missed dose.
If you are using other eye drops, wait at least 5 minutes between using VIGAMOX and the other drops.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, VIGAMOX can cause side effects, although not everybody gets them.
It is usually possible to continue using the drops, unless the side effects are serious or if the patient experiences severe allergic reactions.

If the patient experiences a severe allergic reaction or any of the following symptoms, they should stop using VIGAMOX immediately and

inform their doctor right away:swelling of the hands, feet, ankles, face, lips, mouth, or throat, which may cause difficulty swallowing or breathing, rash or hives, large blisters, wounds, or ulcers.

Common side effects

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

Uncommon side effects

(may affect up to 1 in 100 people)
Eye disorders:dry eye, eye itching, eye redness, inflammation of the surface of the eye or scarring, broken blood vessel in the eye, abnormal sensation in the eye, disorders of the eyelids, itching, redness, or swelling
General disorders:headache, unpleasant taste

Rare side effects

(may affect up to 1 in 1000 people)
Eye disorders:corneal disease, blurred or impaired vision, conjunctivitis or eye infection, eye strain, eye swelling
General disorders:vomiting, discomfort in the nose, feeling of lumps in the throat, decreased iron levels in the blood, abnormal liver test results, skin sensation disorders, pain, throat irritation

Unknown frequency

(cannot be estimated from the available data)
Eye disorders:eye infection, clouding of the eye surface, corneal swelling, deposits on the eye surface, increased eye pressure, scratching on the eye surface, eye allergy, eye discharge, increased tear production, sensitivity to light
General disorders:shortness of breath, irregular heartbeat, dizziness, worsening of allergic symptoms, itching, rash, redness of the skin, nausea, and hives.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Medicinal Product Monitoring, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VIGAMOX

Keep the medicine out of the 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 month.
There are no special storage precautions.
To prevent infections, the bottle should be discarded 4 weeks after it is first opened.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What VIGAMOX contains

The active substance ismoxifloxacin.
One ml of eye drops contains 5 mg of moxifloxacin (as 5.45 mg of moxifloxacin hydrochloride). One drop contains 190 micrograms of moxifloxacin.
The other ingredients are:sodium chloride, boric acid, purified water.
Additionally, the medicine contains small amounts of sodium hydroxide and/or hydrochloric acid to adjust its pH.

What VIGAMOX looks like and contents of the pack

The medicine is a liquid (clear, yellowish-green solution), supplied in cartons containing a 5 ml LDPE bottle with a screw cap.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization 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 by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Portuguese marketing authorization number, country of export: 5218961

Parallel import authorization number: 396/24

This medicine is authorized 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)

Date of revision of the leaflet: 15.11.2024

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