NOROXIN®

Norfloxacin

Consumer Medicine Information

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.

1. if you intend to become pregnant or intend to breast-feed

NOROXIN should not be used during pregnancy or while breast-feeding.

2. if you have or have had any medical conditions, especially the following:

• kidney disease
• seizures or fits or a history of them
• Myasthenia gravis, a muscle disease
• heart rhythm problems

3. 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, another antibiotic used to treat urinary tract infections
• certain medicines that are metabolised by a specific enzyme in the liver such as: caffeine, clozapine, ropinirole, tacrine, theophylline, tizanidine
• theophylline, a medicine used to treat asthma
• cyclosporin, a medicine commonly used in patients who have received organ transplants
• warfarin, a medicine used to stop blood clots
• probenecid, a medicine used to treat gout
• glibenclamide, a medicine used to treat diabetes
• non-steroidal anti-inflammatory drugs, known as NSAIDS
• erythromycin, another antibiotic used to treat & in some cases prevent infection
• cisapride, a medicine used to treat discomfort due to the stomach acid flowing the wrong way up the oesophagus ( also called the food pipe).
• some medicines used to treat irregular heart beats such as sotalol, amiodarone, quinidine, and procainamide,
• antipsychotics, a group of medicines used to treat certain mental & emotional conditions
• tricyclic antidepressants, a group of medicines used to treat depression such as amitriptyline & nortriptyline.

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, 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 Poisons Information Centre (telephone 13 11 26) 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 months 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 side effects from caffeine, for example sleeplessness, anxiety, tremor, increased heartbeat and headache. Caffeine is contained in coffee, tea, cola drinks and some tablets.

Side 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 side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side 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
• disturbances to vision

These are usually mild side effects of NOROXIN.

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
• 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
• if you develop any changes in your hearing
• if you develop any pain, burning, tingling, numbness and/or weakness in your arms or legs.

These may be serious side effects. You may need urgent medical attention. Serious side 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)
• convulsions
• passing little or no urine, pain or tenderness around kidney area

These are all serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

After finishing it

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several months 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 side 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 side effect is rare.

Do not take any diarrhoea medicine without first checking with your doctor.

Other side 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 side 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 and scored on the other side.

A box of NOROXIN contains 6 or 14 tablets.

Ingredients

Active ingredient:

norfloxacin 400mg 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 Australia by:
Merck Sharp & Dohme (Australia) Pty Limited
A.B.N. 14 000 173 508
54-68 Ferndell Street
SOUTH GRANVILLE NSW 2142

This leaflet was reviewed in June 2007.

Australian Register Number:

AUST R 10503
WPC-NRX-T- 052007

® Registered Trademark of Merck & Co., Inc. Whitehouse Station, N.J., U.S.A.

Published by MIMS/myDr October 2008

Consumers should be aware that the information provided by the Consumer Medicines Information (“CMI”) search (“CMI Search”) is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. All copyright and responsibility for CMI is that of the relevant pharmaceutical company. UBM Medica Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource (e.g. “Published by MIMS/myDr January 2007”), the CMI provided was complete to the best of UBM Medica Australia’s knowledge. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. UBM Medica Australia, its servants and agents shall not be responsible for the continued currency of the CMI, or for any errors, omissions or inaccuracies in the CMI and/or the CMI Search whether arising from negligence or otherwise or from any other consequence arising there from.