Consumer Information for: SANDOZ CIPROFLOXACIN

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

Sandoz Ciprofloxacin is used to treat corneal ulcers and conjunctivitis caused by bacterial infections of the eye

Antibacterial drugs like Sandoz Ciprofloxacin treat only bacterial infections. They do not treat viral infections.

What it does

Sandoz Ciprofloxacin is an antibiotic that stops the growth of bacteria.

When it should not be used
  • Allergic to ciprofloxacin or any of the other ingredients in Sandoz Ciprofloxacin.
  • Allergic to other quinolone antibiotics, including nalidixic acid.
What the medicinal ingredient is

Ciprofloxacin hydrochloride

What the non-medicinal ingredients are

acetic acid, benzalkonium chloride (as a preservative), edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH) mannitol, purified water and sodium acetate.

What dosage form it comes in

0.3% ophthalmic solution (eye drops)

Warnings and precautions

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

  • Notice your symptoms get worse or suddenly return. You should contact your healthcare professional. You may become more susceptible to infections especially after prolonged use.
  • Develop another infection, your healthcare professional will prescribe another medicine to treat that infection.
  • Have a skin rash or any other allergic reaction, including hives, itching or breathing problems. You should stop treatment and immediately contact your healthcare professional. You may need emergency treatment.
  • Feel pain, swelling or inflammation of the tendons while, or soon after taking Sandoz Ciprofloxacin. You should stop treatment and contact your healthcare professional.
  • Are pregnant or planning to become pregnant.
  • Are breastfeeding or planning to breastfeed.
  • Are elderly or if you are taking corticosteroids. You are more likely to get pain or swelling in your tendons during treatment with Sandoz Ciprofloxacin.

Other warnings you should know about:

  • Only use Sandoz Ciprofloxacin in children younger than 1 year if prescribed by your healthcare professional.
  • Do NOT wear contact lenses while using Sandoz Ciprofloxacin unless otherwise instructed by your healthcare professional.
  • Your vision may be temporarily blurry after using Sandoz Ciprofloxacin. Do not drive or use machines until your vision is clear.
  • The preservative in Sandoz Ciprofloxacin, benzalkonium chloride, may cause eye irritation and discolour contact lenses

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

Proper use of this medication

  • Only use Sandoz Ciprofloxacin in your eyes.
  • Get the Sandoz Ciprofloxacin bottle and a mirror (if needed).
  • Wash your hands.
  • Twist off the cap.
  • Hold the bottle, pointing down, between your thumb and fingers.
  • Tilt your head back. Pull down your eyelid with a clean finger, until there is a ‘pocket’ between the eyelid and your eye. The drop will go in here (picture 1).
  • Bring the bottle close to the eye. Use the mirror if it helps.
  • Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could contaminate the drops.
  • Gently press on the base of the bottle to release one drop of Sandoz Ciprofloxacin at a time (picture 2). Do not squeeze the bottle. It is designed so that a gentle press on the bottom of the bottle is all that it needs.
  • If you take drops in both eyes, repeat the steps for your other eye.
  • Close the bottle cap firmly immediately after use.
  • If you are using other eye medicines, the medicines must be used at least 5 minutes apart. Eye ointments should be administered last.

Although you may feel better early in treatment, Sandoz Ciprofloxacin should be used exactly as directed.

Misuse or overuse of Sandoz Ciprofloxacin could lead to the growth of bacteria that will not be killed by Sandoz Ciprofloxacin (resistance). This means that Sandoz Ciprofloxacin may not work for you in the future.

Do not share your medicine.

Usual dose

Conjunctivitis (Adults and Children 1 year and older):
Days 1 and 2: Apply 1 or 2 drops in the eye(s) every 2 hours while you are awake.
Days 3 to 7: Apply 2 drops in the eye(s) every 4 hours while you are awake.

Corneal Ulcer (Adults and Children 12 years and older):
Day 1: Apply 2 drops in the eye(s) every 15 minutes for the first 6 hours. Then apply 2 drops in the eye(s) every 30 minutes for the rest of the day.
Day 2: Apply 2 drops in the eye(s) every hour.
Days 3 to 14: Apply 2 drops in the affected eye(s) every 4 hours.
If your eye(s) do not get better after 14 days, talk to your healthcare professional.

Overdose

If you think you have applied too much Sandoz Ciprofloxacin, rinse it all out with warm water. Do not apply any more Sandoz Ciprofloxacin until it is time for your next dose.

If you or your child accidentally ingest Sandoz Ciprofloxacin, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

  • If you forget to apply a dose of Sandoz Ciprofloxacin, take it as soon as you remember.
  • However, if it is almost time for your next dose, do not take the missed dose. Instead, continue with your next scheduled dose.
  • Do not use a double dose to make up for a missed dose.
Side effects and what to do about them

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

Side effects may include:

In the eye:

  • white deposits on the eye surface (cornea)
  • eye discomfort such as stinging, burning, irritation, itching
  • staining of the eye surface (cornea)
  • dry eye
  • tearing (watering of the eye)
  • eye discharge
  • eyelid crusting
  • eyelid scales
  • eyelid redness
  • eye redness
  • damage of the eye
  • eye inflammation
  • sensitivity to light
  • eye pain
  • reduced or blurred vision
  • double vision
  • decreased eye sensation
  • bump on the eyelid (stye)
  • tired eyes

Other areas of your body:

  • bad taste
  • headache
  • dizziness
  • ear pain
  • nasal sinus discharge
  • diarrhea
  • abdominal pain

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
UNKNOWN
Allergic reaction: swelling of face, lips or tongue; difficulty breathing; hives; itchy skin    
Tendon disorder: pain or swelling in tendons    

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 the bottle in the carton at room temperature (2° C-30° C).

Keep out of reach and sight of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information
  • 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 (health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.sandoz.ca, or by calling 1-800-363-8883.

This leaflet was prepared by Sandoz Canada Inc.

Last Revised: August 17, 2018