Teva-Norfloxacin: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is TEVA-NORFLOXACIN used for?

• Norfloxacin is an antibiotic used to treat:

  • infection of the urinary tract.

  • bacterial infection (Neisseria gonorrhea) of:

    • the urethra (tube from the bladder to the penis or vaginal opening).
    • or cervix (lower part of the uterus).

Antibacterial drugs like TEVA-NORFLOXACIN treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment,

NORFLOXACIN should be used exactly as directed. Misuse or overuse of TEVA-NORFLOXACIN could lead to the growth of bacteria that will not be killed by TEVA-NORFLOXACIN (resistance).

This means that TEVA-NORFLOXACIN may not work for you in the future. Do not share your medicine.

How does TEVA-NORFLOXACIN work?

Norfloxacin works by:

• preventing the bacterial DNA from working, thereby preventing growth.
• kills bacteria.

What are the ingredients in TEVA-NORFLOXACIN?

Medicinal ingredients: Norfloxacin

Non-medicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, titanium dioxide, triethyl citrate, polyethylene glycol and talc.

TEVA-NORFLOXACIN comes in the following dosage forms:

Tablets 400 mg

Do not use TEVA-NORFLOXACIN if:

• You are allergic to norfloxacin, or any ingredients in this product or any other quinolone antibacterial agents

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-NORFLOXACIN. Talk about any health conditions or problems you may have, including if you:

• have had seizures.
• have had tendon problems after using of quinolone antibiotics.
• have kidney disease.

• are pregnant or planning to become pregnant.

• are breastfeeding or planning to breastfeed.
• are taking any other prescription or non-prescription products.

Other warnings you should know about:

• If vision is affected with the use of TEVA-NORFLOXACIN, talk to your eye specialist immediately.
• Avoid excessive exposure to the sun when taking TEVA-NORFLOXACIN. Photosensitivity skin reactions can occur with symptoms such as inflamed red skin, hives, rash, itchiness and blisters. Talk to your doctor if this occurs.
• you have defects in the glucose-6-phosphate dehydrogenase enzyme. Using quinolone antibiotics, such as TEVA-NORFLOXACIN, can rarely destroy blood cells. Discuss with your doctor.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with TEVA-NORFLOXACIN:

• Probenecid (gout medication).
• Theophylline (lung disease medication).
• Cyclosporine (skin and joint pain medication).
• Oral anticoagulant warfarin or its derivatives (blood thinner medication).
• Multivitamins.
• Products containing iron or zinc.
• Antacids (heartburn and indigestion medication).
• Sucralfate (intestinal disease medication).
• Caffeine.
• Nitrofurantoin (urinary tract infection medication).

How to take TEVA-NORFLOXACIN:

• Take this medicine exactly as directed by your physician. Do not stop even if you feel better. Stopping too soon may cause your symptoms to return.
• It is best to take the tablet with a full glass of water, one hour before, or two hours after eating a meal or drinking milk.
• Drink plenty of liquids every day during TEVA-NORFLOXACIN treatment (e.g. water or juice) to avoid potential side effects (e.g. crystalluria- cloudy urine).
• TEVA-NORFLOXACIN should not be taken within two hours of taking iron, zinc supplements or multivitamins containing them.

Usual dose:

Adults

The recommended dosage of TEVA-NORFLOXACIN for urinary tract infections is one 400 mg tablet twice a day for 7 to 10 days.

For women with a mild urinary tract infection, the recommend dosage can be decreased to 3 days.

For adults with gonococcal infection of the urethra or cervix, the recommended dosage of

TEVA-NORFLOXACIN is two 400 mg tablets (800 mg) given as a single dose.

Elderly

The recommended dosage of TEVA-NORFLOXACIN in elderly patients with normal renal function for their age is the same as given for adults above.

Overdose:

Missed Dose:

If you forget to take a dose, take the next recommended dose as scheduled. Do not double the dose to make up for the missed dose. If you happen to take too many tablets by accident, contact your physician or pharmacist immediately.

What are the possible side effects from using TEVA-NORFLOXACIN?

These are not all the possible side effects you may have when taking TEVA-NORFLOXACIN. If you have a side effect not shown here, contact your doctor.

Stop taking TEVA-NORFLOXACIN and contact your doctor right away if:

1. a)

   You have pain, swelling or rupture of your tendon and:

   • rest
   • avoid physical exercise

Fluoroquinolones, like TEVA-NORFLOXACIN, have been associated with these effects.

1. b)

   You have problems in your nerves (neuropathy) with symptoms such as:

   • pain, burning, tingling, numbness or weakness

Fluoroquinolones, like TEVA-NORFLOXACIN, have been associated with this condition.

Fluoroquinolones, like TEVA-NORFLOXACIN, have been associated with effects such as:

• confusion, tremors, headache.
• seeing things, depression, agitation.
• difficulty sleeping, anxiety, nervousness and suicidal thoughts.
• •

Contact your doctor right away if you have suicidal thoughts.

Common side effects that may occur include:

• nausea, headache and dizziness

Other side effects that may occur include:

• rash, itching, muscle pain
• vomiting, upset stomach, diarrhea, constipation
• poor appetite

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

• Store at room temperature 15°C to 30°C
• Store your tablets in a tightly closed container, away from direct light, and out of damp places such as the bathroom or kitchen.

Keep out of reach and sight of children.

If you want more information about TEVA-NORFLOXACIN:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.

Last Revised: October 12, 2018