Patient Medication Information: uses, side effects, how to take - Norfloxacin (Cobalt Pharmaceuticals)
ABOUT THIS MEDICATION
What the medication is used for:
NORFLOXACIN is the brand name of Cobalt Pharmaceuticals Inc. for the substance norfloxacin, available only on prescription from your physician. Norfloxacin is one of a group of medicines known as antibacterials. Antibacterials are used to treat infections caused by bacteria or germs.
Norfloxacin has been prescribed by your physician to treat an infection of the urogenital tract.
Remember: This medicine is prescribed for the particular infection you have at this time. Do not give to other people, nor use this for other infections.
Keep all medicines out of the reach of children.
Read the following information carefully. If you need any explanations, or further information, ask your physician or pharmacist.
What it does:
Norfloxacin works against a large variety of species of bacteria, killing them or preventing them from developing.
When it should not be used:
- This medicine is not recommended for children before puberty.
If you are allergic to norfloxacin or any of the
nonmedicinal ingredients in this product (see “What the nonmedicinal ingredients are” below)
- If you are allergic to any of the quinolone family of drugs
What the medicinal ingredient is:
norfloxacin
What the important nonmedicinal ingredients are: NORFLOXACIN Tablets contain: croscarmellose sodium, magnesium stearate and microcrystalline cellulose. The film coating contains: polyvinyl alcohol, soya lecithin, talc, titanium dioxide, xanthan gum.
What dosage forms it comes in:
400 mg tablets
WARNINGS AND PRECAUTIONS
BEFORE you use NORFLOXACIN talk to your physician or pharmacist if:
- You have previously taken norfloxacin or any related medicines, example, ciprofloxacin (Cipro) or nalidixic acid (NegGram), and were allergic, or had reacted badly to it.
- You suffer from kidney disease.
You have ever suffered from convulsions. • You are pregnant or intend to become pregnant or are breast-feeding or intend to breast-feed. • You have myasthenia gravis (a muscular disease) • You are anuric (cannot urinate)
- You have a condition where you cannot metabolize glucose.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with NORFLOXACIN include: corticosteroids, Sulcralfate (Sulcrate) and antacids (such as Diovol, Maalox or Amphojel). If you have to take these medications, take them at least two to three hours before or after you take NORFLOXACIN.
Inform your physician if you are taking any of the following medications: probenecid, nitrofurantoin, theophylline, cyclosporine, blood-thinning medicines, multivitamins or products containing iron, zinc, caffeine.
Also inform your physician if you are taking any other medications (prescription or nonprescription drugs).
PROPER USE OF THIS MEDICATION
Usual dose:
Take this medicine exactly as your physician ordered for the specified number of days. Do not stop even if you feel better. Stopping too soon might bring on your symptoms again.
It is best to take the tablet one hour before, or two hours after meal or milk ingestion, with a full glass of water. It is good to drink plenty of liquids–water or juice–every day, unless your physician has told you otherwise. NORFLOXACIN should not be taken within two hours of taking iron, zinc supplements or multivitamins containing them.
If you develop any new medical problem while using this medicine, or you wish to begin using any other medicine, on prescription or not, check with your physician or pharmacist.
Overdose:
If you happen to take too many tablets by accident, contact your physician or pharmacist as soon as possible.
Missed Dose:
If you forget to take a dose, take the recommended dose next time, as scheduled. Do not double the dose to make up.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Along with its intended action, any medication, including norfloxacin, may cause side effects. Most people do not have any problem when taking this medicine; but if you notice any of the following effects, check with your physician or pharmacist as soon as possible.
- Dizziness, headache, nausea.
If your experience any of the above effects, or visual
problems, avoid driving and any other activity or job that requires alertness, coordination or good vision.
Other possible effects which occur less commonly are: confusion, convulsions (seizures), swollen or inflamed joints, abdominal or stomach pain with: indigestion, gas, vomiting, diarrhea or loss of appetite; heartburn, rash; drowsiness and trouble sleeping.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
Only if severe | In all cases | |||
| Uncommon | allergic reactions / swelling of the face, lips and/or throat (with difficulty in breathing or swallowing) or hives | T | ||
| skin reactions* / severe reaction to sunlight, such as rash, redness or increased sensitivity of skin or eyes to sunlight, swelling or blistering | T | |||
| Symptom / effect (cont’d) | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
Only if severe | In all cases | |||
| Uncommon | pain in your tendons (tendinitis, tendon rupture) | T | ||
| worsening of your myasthenia gravis symptoms | T | |||
mental disturbances/ mood changes such as anxiety or depression | T | |||
* Stay our of direct sunlight, wear protective clothing and use a sunblock preparation.
This is not a complete list of side effects. For any unexpected effects while taking NORFLOXACIN, contact your doctor or pharmacist.
HOW TO STORE IT
Store your tablets at 15° - 30°C in a tightly-closed container, away from heat and direct light, and out of damp places such as the bathroom or kitchen.
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 0701C
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 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 the sponsor, Cobalt Pharmaceuticals Inc., at: 1-866-254-6111 or:
Cobalt Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, ON
L5N 2B8