Vigamox

Leaflet attached to the packaging: information for the user

VIGAMOX, 5 mg/ml, eye drops, solution

Moxifloxacin (in the form of hydrochloride)

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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 packaging 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 eye drops are 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 not very often, and serious allergic reactions occur rarely. If any allergic reactions (hypersensitivity) or any other side effects occur, follow the instructions in section 4.
• If the patient wears contact lenses, they should stop wearing them when they experience 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 cases of swelling and tendon rupture, especially in elderly patients and those treated with corticosteroids at the same time. Stop using VIGAMOX if the patient experiences pain or swelling of the tendons.

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

VIGAMOX and other medicines

Tell the 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 a doctor before using VIGAMOX eye drops.

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 the 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 old, and patients with kidney and liver diseases. The use of this medicine is not recommended in newborns, as there is only limited information 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 clears up within 5 days. If the patient does not notice an improvement, they should contact their doctor. The use of drops should be continued for a further 2-3 days or as long as the doctor advises.

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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 the head back. With a clean finger, pull the lower eyelid down to form a "pocket"; the drop should fall into it (diagram 1).
• Bring the tip of the bottle close to the eye. For ease of use, a mirror can be used.
• Do not touch the dropper to the eye or eyelid, or surrounding areas.This may lead to contamination of the drops.
• Gently squeeze the bottom of the bottle to release a single drop of medicine (diagram 2).
• After administering VIGAMOX, press the corner of the eye near the nose for 2-3 minutes (diagram 3). This will help 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 will help prevent the transfer of infection from one eye to the other.
• Close the bottle immediately after use.

If the drop does not get into the eye, try again.
If more VIGAMOX is used than recommended:rinse the eyes with warm water.
Do not administer more drops until the next normal dose is due.
If VIGAMOX is accidentally swallowed, consult a doctor or pharmacist for advice.
If a dose of VIGAMOX is missed:continue using the medicine, giving the next dose at the scheduled time. Do notgive a double dose to make up for a missed dose.
If the patient is using other eye drops, they should leave a 5-minute interval between administering VIGAMOX and 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 immediately:swelling of the hands, feet, ankles, face, lips, mouth, or throat, which may cause difficulty swallowing or breathing, rash or urticaria, 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 eye surface 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 side effects

(may affect up to 1 in 1,000 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

(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, skin redness, nausea, and urticaria.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and carton, after "EXP". The expiry date refers to the last day of that month.
There are no special precautions for storage.
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 required. This will help protect the environment.

6. Contents of the packaging 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, small amounts of sodium hydroxide and hydrochloric acid are added to adjust the pH.

What VIGAMOX looks like and contents of the pack

The medicine is a liquid (clear, greenish-yellow solution), supplied in cartons containing a 5 ml plastic bottle with a screw cap.

Marketing authorisation holder

Novartis Poland Sp. z o.o., ul. Marynarska 15, 02-674 Warsaw, tel. +48 22 37 54 888

Manufacturer

Siegfried El Masnou, S.A., Camil Fabra 58, El Masnou, 08320 Barcelona, Spain
Novartis Manufacturing NV, Rijksweg 14, 2870 Puurs-Sint-Amands, Belgium
Novartis Farmacéutica, S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nürnberg, Germany
This medicine is authorised 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 last revision of the leaflet:11/2024