Consumer Medicine Information
The sponsor (pharmaceutical company) of this product has
advised Medsafe that this product has either been discontinued or is no
longer marketed in New Zealand.
Therefore this CMI may not be up to date.
Medsafe has elected to leave it on this web site because supplies of this
product may still be available, and consumers should continue to have access
to this product information in the interim.
You may be able to find a more current CMI containing the same medicine by
returning to the main CMI page and searching by ingredient name.
NOROXIN®
norfloxacin
400 mg tablet
What is in this leaflet
This leaflet answers some common questions about NOROXIN. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking NOROXIN against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What NOROXIN is used for
NOROXIN is an antibiotic used to treat some bacterial infections, such as:
- urinary tract infections
- infections of the stomach or intestines, such as traveller's diarrhoea
NOROXIN is also used for patients who get frequent urinary tract infections. NOROXIN may help stop these infections from coming back.
Urinary tract infections are caused by the presence of bacteria in the urinary system. The bacteria often come from the intestines where they are necessary for normal function.
In women, the most common infection involves the bladder and is called cystitis. In men, the infection may involve the prostate which is called prostatitis. In both men and women, the bacteria may travel up to the kidneys and infect them.
The symptoms of a urinary tract infection may include an urge to urinate frequently and in small amounts, and painful burning when passing urine. Urinary tract infections should be treated to avoid the kidneys being infected.
NOROXIN belongs to a group of antibiotics called quinolones (pronounced kwin-a-lones). NOROXIN works by killing the bacteria causing the infection.
Your doctor may have prescribed NOROXIN for another reason. Ask your doctor if you have any questions about why NOROXIN has been prescribed for you.
Before you take NOROXIN
When you must not take it
Do not take NOROXIN if:
- You have an allergy to NOROXIN, other quinolone antibiotics or any of
the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction to NOROXIN may include itchiness, hives, swelling of the face, lips, tongue, and/or throat (which may cause difficulty in breathing or swallowing), muscle pain or tenderness, or joint pain. - You are pregnant or breast-feeding.
Your baby may absorb this medicine in the womb or from breast milk and therefore there is a possibility of harm to the baby. - The packaging is torn or shows signs of tampering.
- The expiry date on the pack has passed.
If you take this medicine after the expiry date has passed, it may not work.
If you are not sure whether you should start taking NOROXIN, talk to your doctor.
Do not give NOROXIN to children or to growing teenagers, unless advised by the doctor.
The safety of NOROXIN has not been adequately studied in these people.
Before you start to take it
Your doctor must know about all the following before you start to take NOROXIN.
- If you intend to become pregnant or intend to breast-feed
NOROXIN should not be used during pregnancy or while breast-feeding. - If you have any medical conditions, especially the following:
- kidney disease
- seizures or fits or a history of them
- Myasthenia gravis, a muscle disease
- any heart rhythm problems
- If you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
If you have not told your doctor about any of the above, tell them before you take any NOROXIN.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and NOROXIN may interfere with each other. These include:-
- nitrofurantoin, erythromycin, other antibiotics used to treat infections
- theophylline, a medicine used to treat asthma
- clozapine, a medicine used to treat schizophrenia
- ropinirole, a medicine used to treat Parkinson's Disease
- tacrine, a medicine used to treat the symptoms of Alzheimer's Disease (not currently registered in NZ)
- tizanidine, a medicine that causes muscle relaxation (not currently registered in NZ)
- cyclosporin, a medicine commonly used in patients who have received organ transplants
- warfarin, a medicine used to stop blood clots, or other oral anticoagulants
- glibenclamide, a medicine used to treat diabetes
- probenecid, a medicine used to treat gout
- amiodarone, procainamide, sotalol, medicines used to treat an irregular heart beat
- cisapride, a medicine used to treat gastric reflux
- anti-psychotics
- tricyclic antidepressants
- non-steroidal anti-inflammatory drugs (NSAIDS)
These medicines may be affected by NOROXIN, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.
Some medicines may interfere with the absorption of NOROXIN. These include:-
- iron or zinc supplements, and multivitamins containing them
- antacids used for indigestion
- sucralfate, a medicine used to treat stomach ulcers
- didanosine (ddI), a medicine used to treat HIV infection
You can still take these medicines while you are taking NOROXIN. However, you must take NOROXIN at least 2 hours before or 2 hours after taking any of these medicines to make sure there is no problem with absorption.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking NOROXIN.
How to take NOROXIN
How much to take
Take NOROXIN only when prescribed by your doctor. Your doctor will tell you how many tablets you need to take each day.
The usual dose of NOROXIN is one tablet twice a day.
Swallow the tablets whole with a glass of water.
Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
When to take it
Take your NOROXIN about twelve hours apart.
Taking NOROXIN at evenly spaced times ensures that there is a reasonably constant amount in the blood and urine. This means that the medicine will fight the infection more effectively.
Take NOROXIN on an empty stomach, at least one hour before food or two hours after food.
This will make sure the tablets will have a better chance of fighting the infection, because food can interfere with the absorption of NOROXIN.
Do not take NOROXIN at the same time as taking iron or zinc supplements (or multivitamins containing them), antacids, or sucralfate, or didanosine (ddI).
Taking NOROXIN at the same time or even within two hours of taking these can interfere with the absorption of NOROXIN, so that the chance of NOROXIN fighting the infection won't be as good.
How long to take it
Continue taking NOROXIN until you finish the pack or until your doctor recommends.
For treatment of urinary tract infections:
The length of treatment may vary from three to ten days.
To help stop frequent urinary tract infections from coming back.
You may need to take NOROXIN for up to 12 weeks.
For infections of the stomach or intestines:
Usually for five days.
Do not stop taking your tablets because you are feeling better.
If you do not complete the full course prescribed by your doctor, some of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not clear completely or it may return.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your tablet(s) as you would normally.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
Do not take a double dose to make up for the dose that you missed.
If you have trouble remembering to take your tablets, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the National Poisons Centre (telephone 0800 POISON or 0800 764 766) for advice if you think that you or anyone else may have taken too much NOROXIN. Do this even if there are no signs of discomfort or poisoning. Keep telephone numbers of these places handy.
While you are using NOROXIN
Things you must do
If you become pregnant while taking NOROXIN, tell your doctor immediately.
If you develop severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after NOROXIN has been stopped.
Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without first checking with your doctor.
Drink plenty of water or fluids while taking NOROXIN. This will help to prevent crystals forming in the urine which can cause kidney problems. However, this is not a common problem.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking NOROXIN.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking NOROXIN.
Things you must not do
Do not stop taking your tablets because you are feeling better, unless advised by your doctor.
If you do not complete the full course prescribed by your doctor, some of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not clear completely or it may return.
Do not give NOROXIN to anyone else, even if they have the same condition as you.
Things to be careful of
Be careful driving or operating machinery until you know how NOROXIN
affects you.
NOROXIN may cause dizziness or light-headedness in some people. Make sure you
know how you react to NOROXIN before you drive a car, operate machinery, or do
anything else that could be dangerous if you are dizzy or light-headed. If you
drink alcohol, dizziness or light-headedness may by worse.
Protect your skin when you are in the sun, especially between 10 am and 3
pm.
NOROXIN may cause your skin to be much more sensitive to sunlight than it is
normally. You may get severely sunburnt even though you've only been in the
sun for a short time. Symptoms of severe sunburn include redness, itching,
pain, swelling or blistering. If outdoors, wear protective clothing and use a
15+ sunscreen. If your skin does appear to be burning, stop taking NOROXIN and
tell your doctor.
Be careful if you consume large amounts of caffeine while you are taking NOROXIN. NOROXIN may increase the chance of you getting adverse effects from caffeine, for example sleeplessness, anxiety, tremor, increased heartbeat and headache. Caffeine is contained in coffee, tea, cola drinks and some tablets.
Diarrhoea is a common problem caused by antibiotics, which usually ends when the antibiotic is discontinued. Sometimes after starting the treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Adverse Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking NOROXIN.
NOROXIN helps most people with infections of the urinary tract, stomach, or intestines but it may have unwanted adverse effects in a few people. All medicines can have adverse effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the adverse effects.
Ask your doctor or pharmacist to answer any questions you may have.
While taking it
Tell your doctor if you notice any of the following and they worry you:
- nausea
- headache
- dizziness
These are the more common adverse effects of NOROXIN. For the most part these have been mild.
Tell your doctor immediately if you notice any of the following:
- severe stomach pain
- symptoms of severe sunburn, such as redness, itching, pain, swelling or blistering
- pain, tenderness, swelling, or redness of muscles, joints or tendons
- pain, burning, tingling, numbness, and/or weakness in your arms or legs
- bleeding or bruising more easily than normal, nose bleeds
- signs of anaemia, such as tiredness, being short of breath, and looking pale
- numbness or tingling in fingers or toes
- any signs of mental disturbance, such as confusion or hallucinations
- worsening of myasthenia gravis symptoms
- visual disturbances
- changes in your hearing
- decreased feeling or sensitivity, especially in the skin
These may be serious adverse effects. You may need urgent medical attention. Serious adverse effects are rare.
If any of the following happen, stop taking NOROXIN and tell your doctor immediately or go to accident and emergency at your nearest hospital:
- watery and severe diarrhoea, which may also be bloody
- a rash together with very dry eyes and dry mouth
- swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
- sudden and severe pain or swelling of muscles, joints or tendons
- severe and sudden onset of pinkish, itchy swellings on the skin, also called hives or nettlerash (not caused by sunburn)
- convulsion
- reduced urine output, pain, tenderness around kidney area
These are all serious adverse effects. You may need urgent medical attention or hospitalisation. These adverse effects are rare.
After finishing it
Tell your doctor immediately if you notice any of the following adverse effects, particularly if they occur several weeks after stopping treatment with NOROXIN:
- severe abdominal cramps or stomach cramps
- watery and severe diarrhoea, which may also be bloody
- fever, in combination with one or both of the above
These are rare but serious adverse effects. NOROXIN can cause bacteria, which are normally present in the bowel and normally harmless, to multiply and therefore cause the above symptoms. You may need urgent medical attention. However, this adverse effect is rare.
Do not take any diarrhoea medicine without first checking with your doctor.
Other adverse effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.
Do not be alarmed by this list of possible adverse effects. You may not experience any of them.
After using NOROXIN
Storage
Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well.
Keep NOROXIN in a cool dry place where the temperature stays below 30°C. Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking the tablets, or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
Product description
What it looks like
NOROXIN is a white, capsule-shaped tablet with 'MSD 705' marked on one side.
A bottle of NOROXIN contains 100 tablets and a box contains 6 tablets.
Ingredients
Active ingredient:
- norfloxacin 400 mg per tablet
Inactive ingredients:
- cellulose - microcrystalline
- croscarmellose sodium
- hydroxypropyl cellulose
- hypromellose
- magnesium stearate
- titanium dioxide
- carnauba wax
NOROXIN does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.
Supplier
NOROXIN is supplied in New Zealand by:
Merck Sharp & Dohme (New Zealand) Limited
P O Box 99 851
Newmarket
Auckland
NEW ZEALAND
Tel: 0800 500 673
This leaflet was prepared in May 2007
CP-NRX-0507(310507)
®Registered Trademark of Merck & Co Inc., Whitehouse Station, NJ, USA