Teva-Ciprofloxacin: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Quinolone antibiotics, like TEVA-CIPROFLOXACIN, 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 TEVA-CIPROFLOXACIN:

  ♦ 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 TEVA-CIPROFLOXACIN?” section

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

What is TEVA-CIPROFLOXACIN used for?

TEVA-CIPROFLOXACIN is used to treat certain types of bacterial infections.

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

How does TEVA-CIPROFLOXACIN work?

TEVA-CIPROFLOXACIN is an antibiotic that kills the bacteria causing the infection.

What are the ingredients in TEVA-CIPROFLOXACIN Tablets?

Medicinal ingredients: ciprofloxacin as ciprofloxacin hydrochloride

Non-medicinal ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide

TEVA-CIPROFLOXACIN Tablets come in the following dosage forms: Tablets: 250 mg, 500 mg and 750 mg.

The 250 mg tablets are white to off-white, round, film-coated, engraved with ‘novo’ on one side and ‘250' on the other.

The 500 mg tablets are white to off white, capsule-shaped, film-coated, engraved with ‘novo’ on one side and ‘500' on the other.

The 750 mg tablets are white to off-white, capsule-shaped, film-coated, engraved with ‘novo’ on one side and ‘750' on the other.

Do not use TEVA-CIPROFLOXACIN if:

• you are allergic to ciprofloxacin or other quinolone antibiotics.

• you are allergic to any other ingredient in this product (see “What are the ingredients in TEVA-

  CIPROFLOXACIN Tablets?).

• you are taking tizanidine (ZANAFLEX^®). Side effects such as drowsiness, sleepiness and low blood pressure may occur.
• you 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 TEVA-CIPROFLOXACIN. 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:

While taking TEVA-CIPROFLOXACIN:

• 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 TEVA-CIPROFLOXACIN:

• Theophylline or VIDEX^® (didanosine) chewable/buffered tablets or pediatric powder. Serious and fatal reactions have been reported in patients receiving ciprofloxacin, including TEVA-CIPROFLOXACIN and theophylline.
• Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc (see “How to take TEVA-CIPROFLOXACIN:”).
• 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 TEVA-CIPROFLOXACIN:

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

• TEVA-CIPROFLOXACIN should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone; however, TEVA-CIPROFLOXACIN may be taken with a meal that contains these products (see “The following may interact with TEVA-CIPROFLOXACIN”).
• You should avoid excessive caffeine consumption while taking TEVA-CIPROFLOXACIN.
• You should drink lots of water while taking TEVA-CIPROFLOXACIN.

• Swallow the TEVA-CIPROFLOXACIN 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 2 hours before or 6 hours after

  TEVA-CIPROFLOXACIN:

  ♦ antacids or mineral supplements containing magnesium or aluminum ♦ sucralfate

  ♦ supplements containing iron or zinc

  ♦ any product (supplement or food) with more than 800 mg calcium

• Do not use TEVA-CIPROFLOXACIN for another condition or give it to others.

You should take TEVA-CIPROFLOXACIN 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 healthcare professional about your medication or treatment.

Overdose:

If you think you have taken too much TEVA-CIPROFLOXACIN, 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 TEVA-CIPROFLOXACIN per day, even if you missed a dose.

What are possible side effects from using TEVA-CIPROFLOXACIN?

All medicines, including TEVA-CIPROFLOXACIN, can cause side effects, although not everyone gets them. These are not all the possible side effects you may feel when taking TEVA-CIPROFLOXACIN. 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 TEVA-CIPROFLOXACIN 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 TEVA-CIPROFLOXACIN if you have this condition.

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

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.

Reporting Side Effects

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:

Bottles to be stored at room temperature (between 15 – 30°C). Unit dose strips to be stored at room temperature (between 15 – 25°C) and protected from high humidity.

Keep out of reach and sight of children.

If you want more information about TEVA-CIPROFLOXACIN:

• 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://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.

Last Revised: April 5, 2018