Patient Medication Information: uses, side effects, how to take - Norfloxacin (AA Pharma)
Serious Warnings and Precautions
Quinolone antibiotics, including NORFLOXACIN, can cause serious side effects such as:
- Tendonitis and tendon rupture: NORFLOXACIN has caused tendonitis (inflamed tendon) and tendon rupture (partial or complete tear), which may require surgery. If you experience pain, swelling or inflammation around your joints, stop taking NORFLOXACIN and talk to your healthcare professional. This may happen while you are taking NORFLOXACIN or up to several months afterwards. The risk of tendon side effects is higher if you are taking corticosteroids.
- Peripheral neuropathy: problems in the nerves that can cause numbness and tingling in your hands and feet.
- Neurological and Mental health problems: problems in the brain such as seizures, psychosis (loss of touch with reality), confusion and other mental health symptoms. Stop taking NORFLOXACIN and get immediate medical help if you have any of these symptoms. Before you take NORFLOXACIN, tell your healthcare professional if you have a condition that may increase your chance of having a seizure or if you have a history of seizures or epilepsy.
- Heart rhythm problems: QT interval prolongation (lengthened heartbeat on an electrocardiogram (ECG) test) and arrhythmia (irregular heartbeat) can happen in patients taking NORFLOXACIN. In rare cases patients have reported a condition called torsades de pointes, which can cause sudden cardiac death. Talk to your healthcare professional before taking NORFLOXACIN if you have QT interval prolongation, or any other heart condition that affects your heart rhythm, low levels of potassium in your blood or are taking any other medications that can affect your heart rhythm.
- Myasthenia gravis: Quinolone antibiotics, including NORFOLXACIN, can make muscle weakness in people with myasthenia gravis worse. You should not take NORFLOXACIN if you have myasthenia gravis.
See the Serious side effects and what to do about them table, below for information on these and other serious side effects.
What is NORFLOXACIN used for?
NORFLOXACIN is an antibiotic used in adults to treat:
- bacterial infections of the urinary tract (bladder, prostate, kidneys).
bacterial infections (caused by 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 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 NORFLOXACIN could lead to the growth of bacteria that will not be killed by NORFLOXACIN (resistance). This means that NORFLOXACIN may not work for you in the future. Do not share your medicine.
How does NORFLOXACIN work?
NORFLOXACIN belongs to a group of antibiotics called quinolones. It works by preventing the growth of the bacteria and killing it.
What are the ingredients in NORFLOXACIN?
Medicinal ingredient: norfloxacin
Non-medicinal ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol and titanium dioxide
NORFLOXACIN comes in the following dosage forms:
Tablets: 400 mg
Do not use NORFLOXACIN if:
- you are allergic to norfloxacin, other quinolone antibiotics, or any of the non-medicinal ingredients in NORFLOXACIN (see What are the ingredients in NORFLOXACIN?).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NORFLOXACIN. Talk about any health conditions or problems you may have, including if you:
- have had seizures or have epilepsy
- have kidney problems
have risk factors for an aortic aneurysm (an abnormal bulge in a large blood vessel called the aorta) or aortic dissection (a tear in the wall of the aorta):
- have had an aortic aneurism or aortic dissection
- have, or if anyone in your family has, a condition called aneurysm disease, which is an abnormal bulge in any large blood vessel in the body
- have any of the following conditions: Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis or Behcet’s disease
- are 65 years of age or older
- have high blood pressure
- have atherosclerosis, which is a hardening of your blood vessels
- are taking corticosteroids, medicines used to treat inflammation and suppress the immune system
- have a history of depression
- have vision problems
- have diabetes or are taking anti-diabetic medication
- have glucose-6-phosphate dehydrogenase deficiency, a problem with your red blood cells
are pregnant or planning to become pregnant
- are breastfeeding or planning to breastfeed. It is not known if NORFLOXACIN passes into breastmilk. Talk to your healthcare professional about ways to feed your baby while you are taking NORFLOXACIN.
Other warnings you should know about:
- Aortic aneurism and aortic dissection: Quinolone antibiotics, including NORFLOXACIN, have been associated with aneurisms (an enlargement or “bulge” of the aorta or other large blood vessel) and aortic dissection (a tear in the wall of the aorta). Stop taking NORFLOXACIN and get immediate medical help if you experience sudden, severe pain in your abdomen, chest or back, a pulsating sensation in your abdomen, dizziness or loss of consciousness.
Sensitivity to light: Sun sensitivity (photosensitivity) can happen when taking
NORFLOXACIN after exposure to sunlight or artificial ultraviolet (UV) light (e.g. tanning beds). You should avoid excessive exposure to sunlight or artificial UV light while you are taking NORFLOXACIN. If photosensitivity skin reactions happen, with symptoms such as inflamed red skin, hives, rash, itchiness and blisters, talk to your healthcare professional.
- Blood sugar changes: Medicines like NORFLOXACIN can cause blood sugar levels to rise and drop in patients with diabetes. Serious cases of hypoglycemia (low blood sugar levels) that caused coma or death have been seen with medicines like NORFLOXACIN. If you have diabetes, check your blood sugar levels often while taking NORFLOXACIN. Blood sugar changes have also been seen in patients without diabetes.
Blood tests and monitoring: NORFLOXACIN can cause abnormal blood test results.
Your healthcare professional will decide when to perform blood tests and will interpret the results.
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 NORFLOXACIN:
- cyclosporine, used to suppress the immune system
- caffeine
- nitrofurantoin, an antibiotic used to treat urinary tract infections
- probenecid, used to treat gout
- theophylline, used to treat lung and breathing problems
- warfarin, or similar medicines, used to prevent blood clots (blood thinners)
the following should be taken either2 hours before or 2 hours after taking
NORFLOXACIN:
- antacids, used to treat heartburn and indigestion
- didanosine, used to treat HIV infection and AIDS
- multivitamins or other products that contain iron or zinc
- sucralfate, used to treat and prevent ulcers
How to take NORFLOXACIN:
- Take this medicine exactly as directed by your healthcare professional. Do not stop taking it or change your dose even if you feel better. Stopping too soon may cause your symptoms to return.
- Take NORFLOXACIN with a full glass of water, one hour before, or two hours after eating a meal or drinking milk.
- Drink plenty of liquids while you are taking NORFLOXACIN (e.g. water or juice).
Usual dose:
Adults: Your healthcare professional will decide on the dose that is right for you, and the length of time you should take NORFLOXACIN, based on the condition being treated.
Overdose:
If you think you, or a person you are caring for, have taken too much NORFLOXACIN, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you missed a dose of this medication, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.
What are the possible side effects from using NORFLOXACIN?
These are not all the possible side effects you may have when taking NORFLOXACIN. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- nausea, vomiting, diarrhea
- constipation, gas
- abdominal pain, indigestion, heartburn
- loss of appetite
- dry mouth
- bad or metallic taste in the mouthheadache
- dizziness, lightheadedness
- vertigo (sensation that you, or the environment around you, is moving or spinning)
- joint pain and stiffness
- drowsiness, fatigue
- difficulty sleeping (insomnia), abnormal dreams
- rash, itching
| Serious side effects and what to do about them | |||||||||
| Symptom / effect | Talk to your healthcare | Stop taking | |||||||
| professional | drug and get | ||||||||
| Only if | In all | immediate | |||||||
| severe | cases | medical help | |||||||
| RARE | |||||||||
| Ear problems: hearing loss, ringing in the ears | √ | ||||||||
| Eye problems: repetitive, uncontrolled movements of the eyes, redness and swelling, eye pain, irritation, vision problems, double vision | √ | ||||||||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, tenderness when touching the abdomen, fever, rapid heartbeat, nausea, vomiting | √ | ||||||||
| Neurological problems: abnormally high level of muscle tone, clumsy voluntary movements, facial paralysis, tongue or throat muscle weakness, trouble speaking, psychosis (loss of touch with reality), confusion, seizures (convulsions or fits) | √ | ||||||||
| Mental health problems: hallucinations (seeing or hearing things that are not really there), panic attacks, confusion, anxiety, depression, suicidal thoughts or actions, feeling agitated, restless or nervous, inability to think clearly or pay attention, memory loss, paranoia | √ | ||||||||
| UNKNOWN | |||||||||
| Clostridium difficile colitis (bowel inflammation): severe or persistent diarrhea (watery or bloody), stomach pain, fever, mucus in stool, nausea, vomiting | √ | ||||||||
| Liver problems: yellow skin and whites of the eyes (jaundice), nausea, fever, chills, abdominal pain, loss of appetite, dark urine, pale stool, itching, fatigue | √ | ||||||||
| Allergic reaction: hives or rash, itching, drop in blood pressure, nausea, vomiting, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, | √ | ||||||||
| Serious side effects and what to do about them | |||||||||
| Symptom / effect | Talk to your healthcare | Stop taking | |||||||
| professional | drug and get | ||||||||
| Only if | In all | immediate | |||||||
| severe | cases | medical help | |||||||
| wheezing | |||||||||
| Tendonitis (inflamed tendon) or Tendon rupture (partial or complete tear): swelling and tenderness of one or more joints, pain, inflammation, muscle aches | √ | ||||||||
| Myasthenia gravis: muscle weakness, drooping eyelid, vision changes, difficulty chewing and swallowing, trouble breathing | √ | ||||||||
Peripheral neuropathy and Guillain-Barre syndrome (problems with the nerves): pins and needle sensation in your fingers and toes, weakness in legs, unable to walk, difficulty with facial movements, severe pain, tremors, sudden, brief involuntary twitching or jerking of a muscle or group of muscles, drowsiness or strong desire to fall asleep | √ | ||||||||
| Kidney problems: increased or decreased urine output, blood in the urine, dark urine, nausea, vomiting, fever, swelling of extremities, sudden weight gain (from retaining fluid), fatigue, thirst, loss of appetite | √ | ||||||||
| Vaginal yeast infection (inflammation of the vagina): itching, burning, discharge from the vagina | √ | ||||||||
| Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (severe skin reactions): redness, blistering and/or peeling of the skin and/or inside of the lips, mouth, nose, eyes and genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands | √ | ||||||||
| Heart rhythm problems (QT interval prolongation): palpitations, fast or irregular heartbeat, chest pain, fainting, seizures (convulsions or fits) | √ | ||||||||
| Edema: unusual swelling of the arms, hands, legs, feet and ankles | √ | ||||||||
| Hypoglycemia (low blood sugar): fast heartbeat, nausea, vomiting, dizziness, rapid breathing, thirst, frequent urination, hunger, tingling, trembling, nervousness, sweating, low energy | √ | ||||||||
| Hyperglycemia (high blood sugar): increased thirst, frequent urination, dry skin, headache, blurred vision, | √ | ||||||||
| Serious side effects and what to do about them | |||||||||
| Symptom / effect | Talk to your healthcare | Stop taking | |||||||
| professional | drug and get | ||||||||
| Only if | In all | immediate | |||||||
| severe | cases | medical help | |||||||
| fatigue | |||||||||
| Increased intracranial pressure (swelling in the brain): headache, blurred or double vision, confusion, shallow breathing, high blood pressure, nausea | √ | ||||||||
| Aortic aneurysm (abnormal bulge in the aorta) or Aortic dissection (tear in the wall of the aorta): sudden, severe pain in abdomen, chest or back, pulsating sensation in the abdomen, dizziness, loss of consciousness | √ | ||||||||
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
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Store at room temperature 15°C to 30°C
- Keep container tightly closed. Protect from light.
- Keep out of reach and sight of children.
If you want more information about 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: (Drug Product Database: Access the database); the manufacturer’s website
(https://www.aapharma.ca/en/), or by calling 1-877-998-9097.