Patient Medication Information: uses, side effects, how to take - Q-Ciprofloxacin
ABOUT THIS MEDICATION
What the medication is used for:
Q-CIPROFLOXACIN is used to treat certain types of bacterial infections.
What it does:
Q-CIPROFLOXACIN is an antibiotic that kill the bacteria causing the infection.
When it should not be used:
Do not use Q-CIPROFLOXACIN
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:
Q-CIPROFLOXACIN tablets: ciprofloxacin as ciprofloxacin hydrochloride.
What the nonmedicinal ingredients are:
Q-CIPROFLOXACIN tablets: Microcrystalline cellulose NF, corn starch NF, colloidal silicon dioxide NF, crospovidone NF, magnesium stearate NF, pregelatinized starch NF, and opadry II white Y-22-7719.
What dosage forms it comes in:
Q-CIPROFLOXACIN tablets: 250 mg, 500 mg and 750 mg.
Q-CIPROFLOXACIN 250 mg: each white, round, biconvex, film-coated tablet is embossed with “ CF 250” on one side and “G” on the other side. HDPE bottles of 100's.
Q-CIPROFLOXACIN 500 mg: each white, capsule-shaped, biconvex, film-coated tablet is embossed with “CF 500” on one side and “G” on the other side. Unit dose packages of 10 (cartons of 100's), and HDPE bottles of 100's and 500's.
Q-CIPROFLOXACIN 750 mg: each white, capsule-shaped, biconvex, film-coated tablet is embossed with “CF 750” on one side and “G” on the other side. HDPE bottles of 100's.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
- 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 Ciprofloxacin.
- If you have myasthenia gravis, treatment with Q-CIPROFLOXACIN may make your condition worse. Do not use Q-CIPROFLOXACIN if you have this condition.
- Quinolones, including 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.
- Q-CIPROFLOXACIN can cause liver injury which may be fatal.
| IMPORTANT: PLEASE READ |
BEFORE you use Q-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,
or if you are breast feeding. Q-
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 Q-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 Q-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 Q-CIPROFLOXACIN include:
Theophylline or VIDEX® (didanosine)
chewable/buffered tablets or pediatric powder. Serious and fatal reactions have been reported in patients receiving ciprofloxacin, including Q-
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 Q-CIPROFLOXACIN and may prevent them from working. You
should take Q-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 Q-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
Q-CIPROFLOXACIN should be taken as prescribed at approximately the same time each day with food or on an empty stomach.
Q-CIPROFLOXACIN should not be taken with dairy products (like
milk or yogurt) or calcium-fortified juices alone; however, Q-CIPROFLOXACIN may be taken with a meal that contains these products (see Interactions With This Medication).
You should avoid excessive caffeine consumption while taking Q-
CIPROFLOXACIN
| IMPORTANT: PLEASE READ |
You should drink lots of water while taking
Q-CIPROFLOXACIN
Swallow the Q-CIPROFLOXACIN tablets whole.
DO NOT SPLIT, CRUSH, OR CHEW THE TABLET.
You should take Q-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 Q-CIPROFLOXACIN as
prescribed
Complete the course of Q-CIPROFLOXACIN
even if you are
feeling better.
Do not use Q-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 Q-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)
- Dizziness, fainting
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 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 emergency medical attention | ||
| 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 | ✓ | |||
| IMPORTANT: PLEASE READ |
| 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 | ✓ | |||
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 Q-CIPROFLOXACIN contact your doctor or pharmacist.
HOW TO STORE IT
Store between 15oC and 30oC.
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 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 MedEffect™ Canada Web site at
www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, QD Pharmaceuticals ULC at: 1-800-661-3429
QD Pharmaceuticals ULC
Etobicoke, Ontario M8Z 2S6
www.qdpharmaceuticals.ca
Revised on: April 8, 2014.