5 mg/ml eye drops, solution
moxifloxacin
What Vigamox is and what it is used for
Vigamox eye drops are used to treat infection in the eye ( conjunctivitis ) caused by bacteria. The active ingredient is moxifloxacin, an antibacterial agent for ophthalmic use.
The moxifloxacin contained in Vigamox may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Vigamox
Do not use Vigamox
- If you are allergic to moxifloxacin, to other quinolones, or to any other ingredient in this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Vigamox.
If you have an allergic reaction to Vigamox. Allergic reactions occur in less common cases and serious reactions are rare. If you get an allergic (hypersensitivity) reaction or a side effect, see section 4.
- If you wear contact lenses – stop using the lenses if you have signs or symptoms of an eye infection. Use your glasses instead. Do not start wearing the lenses again until the signs and symptoms of infection have passed and you have stopped using the medicine.
- People who have taken fluoroquinolones by mouth or intravenously have been affected by swollen tendons and ruptures, especially in elderly patients and in those treated with corticosteroids at the same time. Stop taking Vigamox if you experience pain in a tendon or if it begins to swell. Like all antibiotics, long-term use of Vigamox can lead to other infections.
Other medicines and Vigamox
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
You may notice that your vision is blurred for a short time right after using Vigamox. Do not drive or use machinery until your vision is back to normal.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How to use Vigamox
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Recommended dose:
Adults, including the elderly, and children: 1 drop in the affected eye(s), 3 times a day (in the morning, in the afternoon, and the evening).
Vigamox can be used in children, in patients over 65 years of age, and in patients with kidney or liver problems. There is only very limited information on the use of this medicine in neonates, and therefore use in neonates is not recommended.
Use this medicine in both eyes only if your doctor has told you to. Vigamox should only be used for ophthalmic use.
Infection usually improves within 5 days. You should continue using the drops for another 2-3 days or as directed by your doctor. If you do not notice any improvement after 5 days, contact the doctor.
- Take out the bottle of Vigamox and stand in front of a mirror
- Wash your hands
- Twist off the lid
- If the safety-sealed lid collar is loose after the lid is removed, it must also be removed before using the product.
- Hold the bottle upside down between your thumb and fingers
- Tilt your head back. Pull down the lower eyelid with a clean finger until a “pocket” is formed between the eyelid and the eye. Where the drop should be placed (picture 1)
- Hold the dropper tip of the bottle close to the eye. Use the mirror as a guide.
- Avoid touching the eye or eyelid, surrounding areas, or other surfaces with the dropper tip. Then the drops can become infected.
- Press lightly on the bottom of the bottle to squeeze out one drop of the medicine at a time (picture 2)
- After using Vigamox, press with a finger in the corner of the eye by the nose for 2-3 minutes (picture 3). This prevents the medicine from getting out into the rest of the body, which is especially important for young children.
- If you use the drops in both eyes, wash your hands before repeating the same steps for the other eye. It helps prevent infection from spreading from one eye to the other.
- Close the bottle cap immediately after use.
If a drop misses the eye, try again.
If you have used too much Vigamox, rinse everything out with lukewarm water. Do not instill more drops until it is time for your next regular dose.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you accidentally swallow Vigamox, consult a doctor or pharmacist.
If you forget to use Vigamox, continue with the next dose as scheduled. Do not take a double dose to make up for a missed dose.
If you use other eye preparations, wait at least 5 minutes between using Vigamox and the other eye preparations.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can usually continue to take the drops unless the side effects are severe or you have a severe allergic reaction.
If you have a severe allergic reaction and any of the following happen, stop taking Vigamox immediately and contact your doctor immediately: Swelling of the hands, feet, ankles, face, lips, mouth, or throat, which may make it difficult to swallow or breathe, rash or hives, large fluid-filled blisters, sore spots, and sores.
Common side effects are
(may affect up to 1 in 10 users)
Side effects in the eye: Eye pain, eye irritation.
Less common side effects are
(may affect up to 1 in 100 users)
Side effects in the eye: Dry eyes, itchy eyes, eye redness, inflammation or scarring on the surface of the eye, ruptured blood vessels in the eye, abnormal sensation in the eye, eyelid problems, itching, redness or swelling
General side effects: Headache, bad taste in the mouth
Rare side effects ar
(may affect up to 1 in 1000 users)
Side effects in the eye: Corneal disorder, blurred vision or impaired vision, inflammation or infection of the conjunctiva, eye fatigue, eye swelling
General side effects: Vomiting, nasal discomfort, feeling of lumping in the throat, decreased iron in the blood, abnormal liver test results, abnormal skin sensation, pain, throat irritation
Has been reported:
(occurs in an unknown number of users)
Side effects in the eye: Infection in the eye, clouding of the surface of the eye, swelling of the cornea, deposits on the surface of the eye, increased pressure in the eye, scratches on the surface of the eye, eye allergy, secretion from the eye, increased tear production, sensitivity to light.
General side effects: Shortness of breath, irregular heartbeat, dizziness, worsening allergic symptoms, itching, rash, skin redness, nausea, and hives.
How to store Vigamox
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the bottle and carton after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Discarded 4 weeks after opening. This is done to prevent infection.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is moxifloxacin.
One ml of the eye drops contains 5.45 mg moxifloxacin hydrochloride equivalent to 5 mg moxifloxacin. One eye drop contains 190 micrograms of moxifloxacin.
- Other ingredients are sodium chloride, boric acid, and purified water.
Very small amounts of sodium hydroxide and hydrochloric acid can be added to adjust acidity levels ( pH levels).
Appearance and package sizes of the medicine
This medicine is a liquid (a clear, green-yellow solution) supplied in a package containing a 5 ml plastic bottle with a screw cap.
Marketing Authorisation Holder
Novartis Farmacéutica, SA
Gran Via de Les Corts Catalanes, 764
08013 Barcelona
Spain
Alcon-Couvreur NV
Rijksweg 14
2870 Puurs
Belgium
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Siegfried El Masnou, SA
Camille Fabra 58
El Masnou
08320 Barcelona
Spain
This medicine is approved in the European Economic Area under the following names:
MOXIFLOXACIN ALCON
Germany
KANAVIG
Belgium
Luxembourg
VIGAMOX
Bulgaria
Cyprus
Denmark
Estonia
Finland
Greece
Iceland
Italy
Latvia
Lithuania
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
The Czech Republic
Hungary
MOXIVIG
Ireland
UK