Cipro XL - Consumer Medicine Information
|Condition:||Bacterial Infection, Urinary Tract Infection|
|Ingredients:||ciprofloxacin, crospovidone, hypromellose, magnesium stearate, polyethylene glycol, silica colloidal anhydrous, succinic acid, and titanium dioxide|
(Ciprofloxacin hydrochloride and ciprofloxacin extended release tablets)
About this Medication
What the medication is used for
CIPRO XL is used to treat bacterial urinary tract infections and inflammation of the kidneys.
What it does
CIPRO XL is an antibiotic that kills the bacteria causing infection in the urinary tract.
When it should not be used
Do not use CIPRO XL if you:
- are allergic to ciprofloxacin, other quinolone antibiotics or to any nonmedicinal ingredients in this product (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
What the nonmedicinal ingredients are
crospovidone, hypromellose, magnesium stearate, polyethylene glycol, silica colloidal anhydrous, succinic acid, and titanium dioxide.
What dosage forms it comes in
extended release tablets: 500 mg and 1000 mg.
CIPROXL tablets are nearly white to slightly yellowish, film-coated, oblong-shaped tablets.
Warnings and Precautions
Serious Warnings and Precautions
- CIPRO XL 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 CIPRO XL.
- If you have myasthenia gravis, treatment with CIPRO XL may make your condition worse. Do not use CIPRO XL if you have this condition.
- Quinolones, including CIPRO XL, 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 XL can cause liver injury which may be fatal.
BEFORE you use CIPRO XL 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. CIPRO XL 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 CIPRO XL. 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 XL 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 CIPRO XL include:
- Theophylline or VIDEX (didanosine) chewable/buffered tablets or pediatric powder. Serious and fatal reactions have been reported in patients receiving ciprofloxacin, including CIPRO XL 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 XL and may prevent it from working. You should take CIPRO XL either 2 hours before or 6 hours after taking these products.
- Antidiabetic agents (eg, glyburide, glibenclamide, glimepiride, insulin) as the combination of ciprofloxacin with any of these agents 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 XL.
- Certain heart medications known as antiarrhythmics (e.g. 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, lanthanum carbonate
Proper Use of this Medication
- CIPRO XL should be taken as prescribed at approximately the same time each day with food or on an empty stomach.
- CIPRO XL should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone; however, CIPRO XL may be taken with a meal that contains these products. (see “Interactions with this Medication”)
- You should avoid excessive caffeine consumption while taking CIPRO XL.
- You should drink lots of water while taking CIPRO XL
- Swallow the CIPRO XL tablet whole, with water as needed. DO NOT SPLIT, CRUSH, OR CHEW THE TABLET.
Usual adult dose
Urinary tract infections: One tablet once a day for 3 days as prescribed.
Inflammation of the kidneys: One tablet once a day for 7 to 14 days as prescribed.
You should take CIPRO XL 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 XL once a day.
- Complete the course of CIPRO XL even if you are feeling better.
- Do not use CIPRO XL 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 one dose of CIPRO XL 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, indigestion
- 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 XL and contact your healthcare professional immediately.
If any of these affects you severely, tell your doctor or pharmacist.
Serious side effects, how often they happen and what to do about them
|Frequency||Symptom / effect||Talk with your doctor, nurse, or pharmacist||Stop taking drug and seek immediate medical help|
|Only if severe||In all cases|
|Common||Vaginal Yeast Infection: Itching, burning, thick white discharge||✓|
|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, and 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 XL, contact your doctor or pharmacist.
How to Store it
Store at 15°C to 30°C (56-86°F).
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 firstname.lastname@example.org.
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.