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Details for: PRIVA-CIPROFLOXACIN

Company: PHARMAPAR INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02445344PRIVA-CIPROFLOXACINCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)500 MGTABLETORAL
Search Reported Side Effects Report a Side Effect

Summary Reports

Summary Safety Review - Fluoroquinolones - Assessing the potential risk of persistent and disabling side effects
Summary Safety Review - Oral FLUOROQUINOLONES - Assessing the Potential Risk of Retinal Detachment
Summary Safety Review - Fluoroquinolones - Assessing the potential risk of aneurysm (a balloon-like bulge) and dissection (a separation or tear in the layers of the wall) of the aorta (a major blood vessel)
Summary Safety Review - Systemic and Inhaled Fluoroquinolone Antibiotics - Assessing the Potential Risk of Heart Valve Regurgitation

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

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

What it does

Priva-CIPROFLOXACIN is antibiotic that kill the bacteria causing the infection.

When it should not be used

Do not use Priva-CIPROFLOXACIN if you:

  • are allergic to ciprofloxacin, other quinolone antibiotics or to any non-medicinal ingredients in these products (see What the Nonmedicinal ingredients are).
  • are currently taking tizanidine (ZANAFLEX®) for the management of spasticity. Tizanidine concentrations may increase and cause further side effects such as drowsiness, sleepiness and low blood pressure.
What the medicinal ingredient is

ciprofloxacin as ciprofloxacin hydrochloride.

What the non-medicinal ingredients are

Colloidal Anhydrous Silica, Crospovidon, Hypromellose, Magnesium Stearate, Maize starch, Microcrystalline Cellulose, Pregelitinized starch, Polyethlene Glycol, Purified Talc, and Titanium Dioxide.

What dosage form it comes in

Priva-CIPROFLOXACIN 500 mg Tablets: White to off-white, capsule shaped, biconvex, film-coated tablets, with score line on one side and plain on other side. Bottles of 100 and 500 tablets.

Warnings and precautions

Serious Warnings and Precautions

  • Priva-CIPROFLOXACIN has been shown to lengthen the heartbeat on an electrocardiogram test (QT interval prolongation).
  • Serious hypersensitivity (allergic) reactions have been reported in some patients receiving quinolone therapy, including Priva- CIPROFLOXACIN.
  • If you have myasthenia gravis, treatment with Priva-CIPROFLOXACIN may make your condition worse. Do not use Priva- CIPROFLOXACIN if you have this condition.
  • Quinolones, including Priva- CIPROFLOXACIN, are associated with an increased risk of tendinitis and tendon rupture in all ages. Speak to your doctor to determine if this medication is suitable for you.
  • Seizures and toxic psychoses may occur with quinolone therapy. Tell your doctor if you have any central nervous system problems (ie, epilepsy). Your doctor will determine whether you should use this medication.
  • Priva-CIPROFLOXACIN can cause liver injury which may be fatal.

BEFORE you can use Priva-CIPROFLOXACIN talk to your doctor or pharmacist if you:

  • Have a history of seizures
  • Have a heart condition known as “QT prolongation”
  • Have low levels of potassium in your blood
  • Have liver or kidney disease or damage
  • Are pregnant, planning to become pregnant, breast feeding or planning to breast-feed. Priva- CIPROFLOXACIN is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.
  • Are less than 18 years of age.
  • Have a history of tendon problems associated with the use of a quinolone antibiotic.
  • Have a condition known as myasthenia gravis.

You may become sensitive to the sun and ultraviolet light while taking Priva-CIPROFLOXACIN. Exposure to sunlight and ultraviolet light , such as that used in tanning salons, should be minimized until you know how you respond.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to Priva-CIPROFLOXACIN as it can cause dizziness.

Interactions with this medication

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

Drugs that may interact with Priva-CIPROFLOXACIN include:

  • Theophylline or VIDEX® (didanosine) chewable/buffered tablets or pediatric powder. Serious and fatal reactions have been reported in patients receiving ciprofloxacin, including Priva- CIPROFLOXACIN, and theophylline.
  • Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc, all of which can interfere with the absorption of Priva-CIPROFLOXACIN and may prevent them from working. You should take Priva-CIPROFLOXACIN either 2 hours before or 6 hours after taking these products.
  • Antidiabetic agents (eg, glyburide, glibenclamide, glimepiride, insulin) as the combination of any of these agents with ciprofloxacin may cause lower blood sugar.
  • Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)
  • Caffeine (e.g. coffee) and other xanthine derivatives (e.g. pentoxifylline). Excessive caffeine intake should be avoided while taking Priva- CIPROFLOXACIN.
  • Certain heart medications known as antiarrhythmics (eg, quinidine, procainamide, amiodarone, sotalol)
  • Other medications including oral anticoagulants (like warfarin and acenocoumarol), phenytoin, duloxetine, tizanidine, methylxanthines, sevelamer, sucralfate, clozapine, ropinirole, lidocaine, sildenafil, probenecid, methotrexate, metoclopramide, cyclosporine, and lanthanum carbonate
Proper use of this medication
  • Priva-CIPROFLOXACIN should be taken as prescribed at approximately the same times each day with food or on an empty stomach.
  • Priva-CIPROFLOXACIN should not be taken with dairy products (like milk or yogurt) or calciumfortified juices alone; however, Priva- CIPROFLOXACIN may be taken with a meal that contains these products (see Interactions With This Medication).
  • You should avoid excessive caffeine consumption while taking Priva-CIPROFLOXACIN.
  • You should drink lots of water while taking Priva- CIPROFLOXACIN
  • Swallow the Priva-CIPROFLOXACIN tablets whole, with water as needed. DO NOT SPLIT, CRUSH, OR CHEW THE TABLET.

You should take Priva-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.

Remember:

  • Take your dose of Priva-CIPROFLOXACIN as prescribed
  • Complete the course of Priva-CIPROFLOXACIN even if you are feeling better.
  • Do not use Priva-CIPROFLOXACIN for another condition or give it to others.

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

Overdose

In case of drug overdose, contact a health care practitioner, 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 Priva-CIPROFLOXACIN per day, even if you missed a dose.

Side effects and what to do about them

Side effects may include:

  • Nausea and vomiting
  • Diarrhea
  • Rash, blistering of skin
  • Stomach pain/discomfort, gas
  • Cramping
  • Coordination problems (unsteady walk)
  • Feeling unwell
  • Increased muscle tone, inflammation of joints, muscle pain
  • Loss of appetite
  • Loss of hearing (tinnitus)
  • Migraine
  • Sleeping problems
  • Problems with smell and taste
  • Sweating
  • Visual disturbances (eyesight problems)

If your eyesight worsens or changes in any way, consult your doctor and eye specialist immediately.

If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking Priva- CIPROFLOXACIN and contact your healthcare professional immediately.

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

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 seek immediate medical help
Rare
Allergic Reaction: rash, hives (skin eruptions), swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, rapid heartbeat    
Central Nervous System Disorders: Seizures/ convulsions, confusion, tremors, hallucinations, depression, suicidal thoughts or psychotic reactions    
Photosensitivity Reaction: Sensitivity to light, blistering of skin    
Tendon pain, inflammation, or rupture    
Increased Blood Sugar: frequent urination, thirst, hunger, tiredness, blurred vision, headache, trouble concentrating    
Low Blood Sugar: dizziness, weakness, headache, sweating, hunger    
Unknown
Severe Bowel Disorder: Persistent diarrhea, bloody or watery diarrhea, abdominal or stomach pain/cramping, blood/mucus in stool    
Nerve Disorder (Neuropathy): Pain, burning, tingling, numbness, weakness    
Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite, pale stools    
Heart Disorder (QT Prolongation): Irregular heartbeat    

This is not a complete list of side effects. For any unexpected effects while taking Priva- CIPROFLOXACIN, contact your doctor or pharmacist.

How to store

Tablets: Store at room temperature 15°C- 30°C in a dry place.

Keep out of reach and sight of children.

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

This document plus the full product monograph, prepared for health professionals can be found by contacting Pharmapar Inc.

This leaflet was prepared by:
Pharmapar Inc.
100-5950, Ch. de la Côte de Liesse
Mont-Royal
Qc, H4T 1E2

Phone# (514) 731-2003; Fax: (514) 731-2004

Date of Revision: August 22, 2019

Date modified: