Ciprofloxacin Tablets: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Quinolone antibiotics, like CIPROFLOXACIN TABLETS, are related to disabling and possibly long lasting effects such as:

  • inflamed tendon (tendonitis), tendon rupture.
  • nerve damage (peripheral neuropathy).

  • problems in the brain such as:

    • convulsions
    • nervous breakdown
    • confusion
    • and other symptoms

• Quinolone antibiotics, like CIPROFLOXACIN TABLETS:

  • have lengthened the heartbeat (QT prolongation)
  • have led to serious allergic reactions, including death
  • may be related to increased tendonitis (inflamed tendon)
  • may worsen myasthenia gravis (a muscle disease)
  • may lead to seizures and nervous breakdowns. Tell your doctor if you have brain or spinal cord problems (such as epilepsy)
  • may cause liver injury which may lead to death

• For further information and symptoms see:

  • the “To help avoid side effects and ensure proper use, …” section

  • the “What are possible side effects from using CIPROFLOXACIN TABLETS?”

    section

Talk to your doctor to see if CIPROFLOXACIN TABLETS is right for you.

What is CIPROFLOXACIN TABLETS used for?

CIPROFLOXACIN TABLETS is used to treat certain types of bacterial infections.

Antibacterial drugs like CIPROFLOXACIN TABLETS treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, CIPROFLOXACIN TABLETS should be taken exactly as directed. Misuse or overuse of CIPROFLOXACIN TABLETS could lead to the growth of bacteria that will not be killed by CIPROFLOXACIN TABLETS. This means that CIPROFLOXACIN TABLETS may not work for you in the future. Do not share your medicine.

How does CIPROFLOXACIN TABLETS work?

CIPROFLOXACIN TABLETS is an antibiotic that kills the bacteria causing the infection.

What are the ingredients in CIPROFLOXACIN TABLETS?

Medicinal ingredients: ciprofloxacin as ciprofloxacin hydrochloride

Non-medicinal ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, starch (corn) and talc. The coating of the tablet also contains hypromellose, polyethylene glycol, and titanium dioxide.

CIPROFLOXACIN TABLETS comes in the following dosage forms:

CIPROFLOXACIN TABLETS: 250 mg, 500 mg and 750 mg.

Do not use CIPROFLOXACIN TABLETS if:

• you are allergic to ciprofloxacin or other quinolone antibiotics.
• you are allergic to any other ingredient in these products (see “What are the ingredients in CIPROFLOXACIN TABLETS?”).
• you are taking tizanidine (ZANAFLEX^®). Side effects such as drowsiness, sleepiness and low blood pressure may occur.
• are currently taking agomelatine^a. Agomelatine concentrations may increase and may cause further side effects such as liver toxicity.

^a Currently not marketed in Canada

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

• have a history of seizures.
• have an irregular heart rhythm (such as QT prolongation).
• have low potassium blood levels.
• have liver or kidney disease or damage.

• are pregnant, planning to become pregnant, breast feeding or planning to breast feed.

• are less than 18 years of age.
• have a history of tendon problems (such as pain, swelling or rupture of a tendon) related to the use of quinolone antibiotics.
• have myasthenia gravis (a muscle disease).

Other warnings you should know about:

Blood Sugar Changes

Medicines like CIPROFLOXACIN TABLETS can cause blood sugar levels to rise and drop in patients with diabetes. Serious cases of hypoglycemia (low blood sugar levels) that caused coma or death have been seen with medicines like CIPROFLOXACIN TABLETS. If you have diabetes, check your blood sugar levels often while taking CIPROFLOXACIN TABLETS.

While taking CIPROFLOXACIN TABLETS:

• Avoid too much sunlight or artificial ultraviolet light (such as sunlamps).

  • Contact your doctor if a sunburn or rash occurs.

• Do not drive or use machinery if you feel dizzy or lightheaded.

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

The following may interact with CIPROFLOXACIN TABLETS:

• Theophylline or VIDEX^® (didanosine) chewable/buffered tablets or pediatric powder. Serious and fatal reactions have been reported in patients receiving ciprofloxacin, including ciprofloxacin tablet USP and theophylline.
• Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc (see “How to take CIPROFLOXACIN TABLETS:”).
• Antidiabetic agents (such as glyburide, glibenclamide, glimepiride, insulin); the combination of any of these agents with ciprofloxacin may cause lower blood sugar.
• Nonsteroidal Anti-Inflammatory Drugs (NSAIDS).
• Caffeine (such as coffee) and other xanthine derivatives (such as pentoxifylline).

• Certain heart medications known as antiarrhythmics (such as quinidine,

  procainamide, amiodarone, sotalol).

• Other medications including:

  • oral anticoagulants (like warfarin and acenocoumarol),
  • phenytoin, duloxetine, methylxanthines, sevelamer,
  • sucralfate, clozapine, ropinirole, lidocaine, sildenafil, probenecid,

  • methotrexate, metoclopramide, cyclosporine, lanthanum carbonate,

    zolpidem.

How to take CIPROFLOXACIN TABLETS:

• CIPROFLOXACIN TABLETS should be taken as prescribed at almost the same times each day with food or on an empty stomach.

• CIPROFLOXACIN TABLETS should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone; however CIPROFLOXACIN TABLETS may be taken with a meal that contains these products (see “The following may interact with CIPROFLOXACIN TABLETS”).

• You should avoid excessive caffeine consumption while taking

  CIPROFLOXACIN TABLETS.

• You should drink lots of water while taking CIPROFLOXACIN TABLETS.

• Swallow the CIPROFLOXACIN TABLETS tablets whole, with water as needed.

  DO NOT SPLIT, CRUSH, OR CHEW THE TABLET.

• If you are taking the following medicines, take them at least 6 hours before or 2 hours after CIPROFLOXACIN TABLETS:

  • antacids or mineral supplements containing magnesium or aluminium
  • sucralfate
  • supplements containing iron or zinc
  • any product (supplement or food) with more than 800 mg calcium
• Do not use CIPROFLOXACIN TABLETS for another condition or give it to others.

You should take CIPROFLOXACIN TABLETS for as long as your doctor prescribes it, even after you start to feel better. Stopping an antibiotic too early may result in failure to cure your

infection.

Usual dose:

Your doctor (healthcare provider) will tell you how much of the medicine to take and for how long.

This information does not take the place of discussions with your doctor or health care professional about your medication or treatment.

Overdose:

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

Missed Dose:

Should you forget to take it at the usual time, you may take your dose later in the day. Do not take more than two doses of CIPROFLOXACIN TABLETS per day, even if you missed a dose.

What are possible side effects from using CIPROFLOXACIN TABLETS?

All medicines, including CIPROFLOXACIN TABLETS, can cause side effects, although not everyone gets them.

These are not all the possible side effects you may feel when taking CIPROFLOXACIN TABLETS. If you have any side effects not listed here or if conditions worsen or do not improve then:

• contact your healthcare professional.
• see the “To help avoid side effects and ensure proper use,…” section.

Stop taking CIPROFLOXACIN TABLETS and contact your doctor if:

1. a)

   you have symptoms of an allergic reaction such as:

   • rash, hives, blistering or other skin reaction
   • swelling of the face, lips, tongue or throat
   • difficulty breathing
   • irregular or rapid heartbeat, or fainting spells
2. b) you have sunburn-like skin reaction when exposed to sunlight or ultraviolet light.
3. c)

   you have pain, swelling or rupture of a tendon. You should:

   • rest
   • avoid physical exercise
4. d)

   you have neuropathy (damage to the nerves) with symptoms such as:

   • pain, burning, tingling, numbness or weakness
5. e)

   you have severe diarrhea (bloody or watery) with or without:

   • fever
   • stomach pain or tenderness

You may have Clostridium difficile colitis (bowel inflammation). See your doctor right away.

1. f)

   you have mental problems such as:

   • confusion, headache, shaking
   • hallucinations, depression, agitation
   • difficulty sleeping, anxiety, nervousness, suicidal thoughts

Contact your doctor if you have suicidal thoughts.

Other side effects include:

• your eyesight worsens or changes. See your doctor or eye specialist right away.
• nausea, dizziness, unsteady walk
• gas, cramping, feeling unwell,
• loss of hearing, problems of smell and taste, loss of appetite
• migraine, sweating
• worsening of myasthenia gravis (a muscle disease) with symptoms such as:
• weakness
• difficulty walking, swallowing, drooping eyelids

Do not use CIPROFLOXACIN TABLETS if you have this condition.

Self-Limiting Side Effects:

• feeling lightheaded
• insomnia (difficulty sleeping)
• nightmares

If any of these affect you severely, tell your doctor or pharmacist.

Serious Side Effects and What to do About Them

Serious Side Effects and What to do About Them

Serious Side Effects and What to do About Them

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 IT

Reporting Side Effects

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

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

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.

Storage:

Tablets: Store at 15° C to 30° C.

Keep out of reach and sight of children.

If you want more information about CIPROFLOXACIN TABLETS:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by contacting the sponsor, Ranbaxy Pharmaceuticals Canada Inc. at: 1-866-840-1340

RANBAXY

Ranbaxy Pharmaceuticals Canada Inc.

Brampton, Ontario

L6T 1C1

Last revised: September 16, 2019

All other trademarks are the property of their respective owners.