Consumer Information for: APO-MOXIFLOXACIN

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

APO-MOXIFLOXACIN est un antibiotique utilisé pour traiter l’infection bactérienne de l’œil (« œil rose »).

What it does

APO-MOXIFLOXACIN est un antibiotique qui stoppe la croissance des bactéries. Il tue les bactéries et réduit les infections oculaires.

When it should not be used

Ne prenez pas APO-MOXIFLOXACIN si vous êtes:

  • Allergic to moxifloxacin or any of the ingredients in APO-MOXIFLOXACIN (see What are the ingredients in APO-MOXIFLOXACIN?).
  • Allergic to other quinolones.
What the medicinal ingredient is

Ingrédients médicinaux : Moxifloxacine à 0,5 % p/v (sous forme de chlorhydrate de moxifloxacine)

What the non-medicinal ingredients are

Ingrédients non médicinaux : Acide borique, Chlorure de sodium, et Eau pour injection. Peut aussi contenir Acide chlorhydrique / Hydroxyde de sodium pour ajuster le pH.

What dosage form it comes in

APO-MOXIFLOXACIN est un liquide (une solution) fourni dans un flacon blanc translucide en polyéthylène à basse densité de 5 mL, qui contient 3 mL de solution d’APO-MOXIFLOXACIN. APO-MOXIFLOXACIN est une solution jaune transparente.

Warnings and precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-MOXIFLOXACIN. Talk about any health conditions or problems you may have, including if you:

  • Develop an allergic reaction (see Serious side effects and what to do about them). Stop taking APO-MOXIFLOXACIN and get immediate medical help.
  • Notice your infection gets worse. Stop taking APO-MOXIFLOXACIN and get immediate medical help. As with any antibiotic, use of APO-MOXIFLOXACIN for a long time may lead to other infections. Do NOT use APO-MOXIFLOXACIN longer than your doctor tells you to.
  • Develop pain or swelling in your tendons. Stop taking APO-MOXIFLOXACIN and get immediate medical help. This is more likely to happen if you are elderly or taking corticosteroids at the same time as APO-MOXIFLOXACIN.

Other warnings you should know about:

  • APO-MOXIFLOXACIN can be used in children as young as 1 year of age. APOMOXIFLOXACIN should not be used in children younger than 1 year of age.
  • Do NOT wear contact lenses if you have an eye infection.
  • Your vision may be temporarily blurry after using APO-MOXIFLOXACIN. Wait until your vision clears before driving or using machinery.
  • If you are pregnant or planning to become pregnant or are breast- feeding or planning to breastfeed, talk to your doctor or pharmacist before using APO-MOXIFLOXACIN.
  • Antibacterial drugs like APO-MOXIFLOXACIN treat only bacterial infections. They do not treat viral infections, such as the common cold. Although you may feel better early in treatment, APO-MOXIFLOXACIN should be taken exactly as directed. Misuse or overuse of APO-MOXIFLOXACIN could lead to the growth of bacteria that will not be killed by APO-MOXIFLOXACIN (resistance). This means that APO-MOXIFLOXACIN may not work for you in the future. Do not share your medicine.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication

The following may interact with APO-MOXIFLOXACIN:

  • Tell your doctor or pharmacist if you are:
    • taking or have recently taken any prescription or non-prescription medicines,
    • using any other eye products,
    • taking corticosteroids as this may increase your chance of developing pain or swelling of your tendons.
Proper use of this medication

How to take APO-MOXIFLOXACIN:

  1. Get the bottle of APO-MOXIFLOXACIN and a mirror.
  2. Wash your hands.
  3. Twist off the cap.
  4. Hold the bottle, pointing down, between your thumb and fingers.
  5. Tilt your head back.
  6. Pull down your eyelid with a clean finger, until there is a “pocket” between your eyelid and eye. The drop will go in there.
  7. Bring the bottle close to the eye. Use the mirror if it helps.
  8. Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could contaminate the drops.
  9. Gently squeeze the bottle to release one drop of APO-MOXIFLOXACIN solution.
  10. If the drop misses you eye, wipe it up and try again.
  11. If you need drops in both eyes, repeat the steps for your other eye.
  12. Keep the bottle tightly closed when not in use.

Usual Dose

Apply one drop in the affected eye(s) three times a day (morning, afternoon and at night) unless your doctor tells you otherwise.

Use APO-MOXIFLOXACIN for seven days or as long as your doctor tells you to.

Overdose

If you use too much APO-MOXIFLOXACIN, rinse it out of your eyes with warm water. Do not put any more drops of APO-MOXIFLOXACIN in until it’s time for your next dose.

If you accidentally swallow APO-MOXIFLOXACIN, talk to your doctor or pharmacist.

If you think you have taken too much APO-MOXIFLOXACIN, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss a dose, apply the missed dose as soon as possible and then go back to your regular dosing schedule. If the drop misses your eye, try again.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking APO-MOXIFLOXACIN. If you experience any side effects not listed here, contact your healthcare professional.

Common eye side effects while using APO-MOXIFLOXACIN include:

  • mild temporary burning or stinging,
  • itching or redness.

Other less common eye side effects include:

  • dryness,
  • sensation of pressure, discomfort, corneal inflammation, broken blood vessels in the white part of the eye, swelling of the eye or eyelid,
  • blurry vision,
  • temporary reduction of vision,
  • pain, inflammation of the eye surface or eyelid, tired eyes, redness of the eyelid,
  • watery eyes, sensitivity to light, eye discharge.

You may also experience reactions in other areas of your body, including:

  • bad taste,
  • headache,
  • throat pain,
  • abnormal liver blood tests,
  • abnormal skin sensation,
  • vomiting,
  • nose discomfort,
  • dizziness,
  • irregular heart rhythm,
  • shortness of breath,
  • nausea,
  • allergic reaction,
  • skin redness or itching,
  • rash or hives.
Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and get immediate medical help
UNKNOWN
Severe allergic reaction:
  • swelling of hands
  • feet
  • ankles
  • face
  • lips
  • mouth or throat
  • difficulty breathing
  • fever
  • rash or hives
  • large fluid-filled blisters
  • sores
    ✔

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How to store

Store at 4°C to 25°C. Discard 28 days after opening. Keep out of the reach and sight of children.

Do not use APO-MOXIFLOXACIN after the expiry date (shown as EXP on the package.)
Discard 28 days after opening

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about APO-MOXIFLOXACIN:

  • Talk to your healthcare professional.
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drugproducts/drug-product-database.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Last revised: December 31,2018

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