Cipro - Consumer Medicine Information
|Ingredients:||ciprofloxacin as ciprofloxacin hydrochloride, crospovidone, hypromellose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, silica colloidal anhydrous and titanium dioxide; ciprofloxacin, hypromellose, lecithin, magnesium stearate, medium chain triglycerides, poly acrylate dispersion, polysorbate 20, polyvidone 25, strawberry flavouring, sucrose and water|
(Ciprofloxacin tablet USP)
CIPRO ORAL SUSPENSION
(Ciprofloxacin oral suspension)
About this Medication
What the medication is used for
CIPRO and CIPRO ORAL SUSPENSION are used to treat certain types of bacterial infections.
What it does
CIPRO and CIPRO ORAL SUSPENSION are antibiotics that kill the bacteria causing the infection.
When it should not be used
Do not use CIPRO or CIPRO ORAL SUSPENSION if you:
- are allergic to ciprofloxacin, other quinolone antibiotics or to any nonmedicinal 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
CIPRO tablets: ciprofloxacin as ciprofloxacin hydrochloride.
CIPRO ORAL SUSPENSION: ciprofloxacin.
What the nonmedicinal ingredients are
CIPRO tablets: crospovidone, hypromellose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, silica colloidal anhydrous and titanium dioxide.
CIPRO ORAL SUSPENSION: hypromellose, lecithin, magnesium stearate, medium chain triglycerides, poly acrylate dispersion, polysorbate 20, polyvidone 25, strawberry flavouring, sucrose and water.
What dosage forms it comes in
CIPRO tablets: 250 mg, 500 mg and 750 mg.
The 250 mg tablets are round and white to slightly yellow in colour. One side is engraved with “CIP 250” and a score-line, and the other side has the Bayer cross.
The 500 mg tablets are oblong and white to slightly yellow in colour. One side is engraved with “CIP 500” and a score-line, and “BAYER” on the other side.
The 750 mg tablets are oblong and white to slightly yellow in colour. One side is engraved with “CIP 750” and “BAYER” on the other.
CIPRO ORAL SUSPENSION: 10 g/100 mL.
Warnings and Precautions
Serious Warnings and Precautions
- CIPRO and CIPRO ORAL SUSPENSION have 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 CIPRO and CIPRO ORAL SUSPENSION.
- If you have myasthenia gravis, treatment with CIPRO or CIPRO ORAL SUSPENSION may make your condition worse. Do not use CIPRO or CIPRO ORAL SUSPENSION if you have this condition.
- Quinolones, including CIPRO and CIPRO ORAL SUSPENSION, 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.
- CIPRO and CIPRO ORAL SUSPENSION can cause liver injury which may be fatal.
BEFORE you use CIPRO or CIPRO ORAL SUSPENSION talk to your doctor or pharmacist if you:
- Have hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency as CIPRO ORAL SUSPENSION contains sucrose.
- 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. CIPRO and CIPRO ORAL SUSPENSION are 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 CIPRO or CIPRO ORAL SUSPENSION. 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 CIPRO or CIPRO ORAL SUSPENSION as they 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 CIPRO and CIPRO ORAL SUSPENSION include:
- Theophylline or VIDEX (didanosine) chewable/buffered tablets or pediatric powder. Serious and fatal reactions have been reported in patients receiving ciprofloxacin, including CIPRO and CIPRO ORAL SUSPENSION, and theophylline.
- Antacids, multivitamins, and other dietary supplements containing magnesium, calcium, aluminum, iron or zinc, all of which can interfere with the absorption of CIPRO or CIPRO ORAL SUSPENSION and may prevent them from working. You should take CIPRO or CIPRO ORAL SUSPENSION 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 CIPRO and CIPRO ORAL SUSPENSION.
- 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
- CIPRO or CIPRO ORAL SUSPENSION should be taken as prescribed at approximately the same times each day with food or on an empty stomach.
- CIPRO and CIPRO ORAL SUSPENSION should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone; however, CIPRO or CIPRO ORAL SUSPENSION may be taken with a meal that contains these products (see Interactions With This Medication).
- You should avoid excessive caffeine consumption while taking CIPROand CIPRO ORAL SUSPENSION.
- You should drink lots of water while taking CIPRO or CIPRO ORAL SUSPENSION.
- Swallow the CIPRO tablets whole, with water as needed. DO NOT SPLIT, CRUSH, OR CHEW THE TABLET.
- Shake CIPRO ORAL SUSPENSION vigorously each time before use for approximately 15 seconds. Swallow the prescribed amount of suspension. Do not chew the microcapsules. Reclose the bottle completely after use and store it in an upright position.
You should take CIPRO or CIPRO ORAL SUSPENSION 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.
- Take your dose of CIPRO or CIPRO ORAL SUSPENSION as prescribed.
- Complete the course of CIPRO or CIPRO ORAL SUSPENSION even if you are feeling better.
- Do not use CIPRO or CIPRO ORAL SUSPENSION 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.
|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|
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 CIPRO or CIPRO ORAL SUSPENSION per day, even if you missed a dose.
Side Effects and what to do about them
Side effects may include:
- Nausea and vomiting
- Rash, blistering of skin
- Stomach pain/discomfort, gas
- Coordination problems (unsteady walk)
- Dizziness, fainting
- Feeling unwell
- Increased muscle tone, inflammation of joints, muscle pain
- Loss of appetite
- Loss of hearing (tinnitus)
- Sleeping problems
- Problems with smell and taste
- 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 CIPRO or CIPRO ORAL SUSPENSION 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||Stop taking drug and seek immediate medical help|
|Only if severe||In all cases|
|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 CIPRO or CIPRO ORAL SUSPENSION, contact your doctor or pharmacist.
How to Store it
Tablets: Store below 30°C (86°F).
Oral Suspension: Can be kept for 14 days when stored in the refrigerator or at room temperature (5°C-25°C). Store in an upright position.
Keep out of reach and sight of children.
Reporting Suspected 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 3 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
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Website 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.
For more information, please contact your health professional or pharmacist first, or Bayer Medical Information at 1-800-265-7382 or email@example.com.
This document plus the full Product Monograph, prepared for health professionals can be found at: http://www.bayer.ca or by contacting the manufacturer at the above-mentioned phone number and email address.