Vigamox
Italy
Table of Contents
Patient Information Leaflet: Information for the user
VIGAMOX 5 mg/ml eye drops, solution
Moxifloxacin hydrochloride
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What VIGAMOX is and what it is used for
- What you need to know before using VIGAMOX
- How to use VIGAMOX
- Possible side effects
- How to store VIGAMOX
- Contents of the pack and other information
1. What VIGAMOX is and what it is used for
VIGAMOX eye drops are used to treat eye infections (conjunctivitis) when caused by bacteria. The active substance is moxifloxacin, an ophthalmic anti-infective.
2. What you need to know before using VIGAMOX
Do not use VIGAMOX
- if you are allergic (hypersensitive) to moxifloxacin, to other quinolones, or to any of the excipients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist:
- If you have an allergic reaction to VIGAMOX. Allergic reactions occur uncommonly, and severe reactions occur rarely. In case of allergic reactions (hypersensitivity) or any type of adverse effects, refer to section 4.
- If you wear contact lenses – stop wearing them if you experience signs or symptoms of eye infection. Wear glasses instead. Do not resume wearing contact lenses until signs and symptoms of infection have disappeared and until you have stopped using the medicine.
- Tendon swelling and rupture have occurred in individuals treated with oral or intravenous fluoroquinolones, particularly in elderly patients and in patients receiving concomitant corticosteroid therapy. Discontinue use of VIGAMOX if you experience tendon pain or swelling (tendinitis).
As with any antibiotic, prolonged use of VIGAMOX may lead to overgrowth of other organisms.
Other medicines and VIGAMOX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using VIGAMOX eye drops.
Driving and using machines
You may experience blurred vision for a short time immediately after using VIGAMOX. Do not drive or operate machinery until this effect has cleared.
3. How to use VIGAMOX
Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults, including the elderly, and children: 1 drop in the affected eye(s), three times a day (in the
morning, afternoon, and evening).
VIGAMOX can be used in children, in patients over 65 years of age, and in patients with renal or hepatic impairment. There is only very limited information on the use of this medicine in newborns, and its use in newborns is not recommended.
Use the medicine in both eyes only if specifically instructed by your doctor. VIGAMOX must be used only as an eye drop.
The infection usually improves within 5 days. If you do not see any improvement, consult your doctor. You should continue using the drops for another 2–3 days, or as long as prescribed by your doctor.
1 2 3
Take the VIGAMOX bottle and position yourself in front of a mirror.
Wash your hands
Unscrew the cap
After removing the cap, if the safety ring has become loose, remove it before using the product
Hold the bottle upside down between your thumb and other fingers
Tilt your head backward. Pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eye. The drop should be instilled into this pocket ( Figure 1 )
Hold the tip of the bottle close to the eye. Looking in the mirror may be helpful
Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the tip of the
dropper. This could contaminate the eye drop solution
Gently press the bottom of the bottle to release one drop of VIGAMOX at a time ( Figure 2 )
After administering 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 rest of the body, which is particularly important in young children
If you need to instill the eye drop in both eyes, wash your hands before repeating the steps for the other eye. This helps prevent the infection from spreading from one eye to the other
Close the cap tightly immediately after use
If a drop misses the eye, try again.
If you use more VIGAMOX than you should, immediately rinse the eye with lukewarm water. Do not use the eye drops again until the next scheduled dose.
If you accidentally swallow VIGAMOX, consult your doctor or pharmacist for advice.
If you forget to use VIGAMOX, continue treatment with the next dose as scheduled. Do not use a double dose to make up for the missed dose.
If you are also using another eye drop at the same time, wait at least 5 minutes between instilling VIGAMOX and the other eye drop.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can generally continue using the drops, unless the side effects are severe or you have a serious allergic reaction.
If you experience a severe allergic reaction or any of the following side effects, stop using VIGAMOX immediately and contact your doctor immediately: swelling of the hands, feet, ankles, face, lips, mouth or throat causing difficulty in swallowing or breathing, skin rash or hives, large fluid-filled blisters, sores and ulceration.
Common side effects
(May affect up to 1 in 10 people)
Eye-related effects: eye pain, eye irritation
Uncommon side effects
(May affect up to 1 in 100 people)
Eye-related effects: dry eye, eye itching, eye redness, inflammation or scarring of the eye surface, broken eye blood vessels, abnormal eye sensation, eyelid abnormalities, itching, redness or swelling
General side effects: headache, bad taste
Rare side effects
(May affect up to 1 in 1,000 people)
Eye-related effects: corneal disorder, blurred or reduced vision, inflammation or infection of the conjunctiva, eye fatigue, eye swelling
General side effects: vomiting, nasal discomfort, sensation of a lump in the throat, reduced iron in the blood, abnormal liver blood tests, abnormal skin sensation, pain, throat irritation
Not known
(Frequency cannot be estimated from the available data)
Eye-related effects: eye infection, clouding of the eye surface, corneal swelling, deposits on the eye surface, increased eye pressure, scratch on the eye surface, eye allergy, eye discharge, increased tearing, light sensitivity
General side effects: shortness of breath, irregular heartbeat, dizziness, worsening of allergy symptoms, itching, skin rash, skin redness, nausea and hives
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. Reporting side effects 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 stated on the bottle and the carton after 'EXP.'. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Stop using the bottle 4 weeks after first opening. This is to avoid infection.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What VIGAMOX contains
- The active substance is moxifloxacin. One ml of eye drops contains 5 mg of moxifloxacin (as moxifloxacin hydrochloride, 5.45 mg). One drop of eye drops contains 190 micrograms of moxifloxacin.
- The other components are: sodium chloride, boric acid, purified water. Small amounts of sodium hydroxide and hydrochloric acid may be added to maintain normal acidity levels (pH).
Description of the appearance of VIGAMOX and contents of the pack
The medicine is a liquid (a clear, yellowish-green solution) supplied in a pack containing a 5 ml plastic bottle with a screw cap.
Marketing Authorization Holder
Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio (VA)
Italy
Manufacturer
Alcon Cusí, S.A.
Camil Fabra, 58
08320 El Masnou
Barcelona, Spain
Manufacturer
S.A. Alcon-Couvreur N.V.
Rijksweg 14
B-2870 Puurs
Belgium
This medicine is authorized in the European Economic Area Member States under the following
names:
MOXIFLOXACIN ALCON
Germany
KANAVIG
Belgium
Luxembourg
VIGAMOX
Bulgaria
Cyprus
Czech Republic
Denmark
Estonia
Finland
Greece
Hungary
Iceland
Italy
Latvia
Lithuania
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
MOXIVIG
United Kingdom
Ireland