GenRx Norfloxacin

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Contains the active ingredient norfloxacin
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about norfloxacin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.
Ask your doctor or pharmacist:
if there is anything you do not understand in this leaflet,
if you are worried about taking your medicine, or
to obtain the most up-to-date information.
You can also download the most up to date leaflet from www.apotex.com.au.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine 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 this medicine is used for

Norfloxacin belongs to a group of antibiotics called quinolones (pronounced kwin - a - lones). Norfloxacin works by killing the bacteria causing the infection.
Norfloxacin 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.
Norfloxacin is also used for patients who get frequent urinary tract infections. Norfloxacin 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.
Your doctor may have prescribed norfloxacin for another reason.
Ask your doctor if you have any questions about norfloxacin has been prescribed for you.

Before you take this medicine

When you must not take it

Do not take this medicine if you have an allergy to:
the active ingredient, norfloxacin
other quinolone antibiotics (for example ciprofloxacin or ofloxacin)
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction 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
joint pain
Do not take this medicine if you are pregnant or breastfeeding.
Your baby may absorb this medicine in the womb or from breast milk and therefore there is a possibility of harm to the baby.
Do not give norfloxacin to children or to growing teenagers, unless advised by the doctor.
The safety of norfloxacin has not been adequately studied in these people.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
kidney disease
seizures or fits or a history of them
myasthenia gravis, a muscle disease
glucose-6-phosphate dehydrogenase deficiency
heart rhythm problems.
Arthropathy
Crystalluria
Vision disorders
Tendon inflammation
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Norfloxacin should not be used during pregnancy or while breastfeeding.
If you have not told your doctor about any of the above, tell him/her before you start taking this medicine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and GenRx norfloxacin may interfere with each other. These include:
theophylline (such as Nuelin), a medicine used to treat asthma
warfarin (such as Coumadin, Marevan), a medicine used to prevent blood clots
phenindione (such as Dindevan), a medicine also used to prevent blood clots
probenecid (Pro-Cid), a medicine used to treat gout
nitrofurantoin (Ralodantin, Macrodantin), a medicine used to treat urinary tract infections
cyclosporin (Neoral, Sandimmun, Cysporin), a medicine used to suppress the immune system
certain drugs that are metabolised by a specific enzyme: clozapine, ropinirole, tacrine, tizanidine
glibenclamide, a medicine used to treat diabetes
metronidazole (such as Flagyl, Metrogyl), a medicine used to treat various types of bacterial infections
non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis
erythromycin, a medicine used to treat infections
cisapride, a medicine used to treat gastric reflux, usually experienced as heartburn
some medicines used to treat irregular heartbeats such as sotalol, amiodarone, quinidine and procainamide
antipsychotics, medicines used to treat certain mental and emotional conditions
tricyclic antidepressants, medicines used to treat depression such as amitriptyline and nortriptyline.
These medicines may be affected by GenRx norfloxacin or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Some medicines may interfere with the absorption of GenRx norfloxacin. These include:
iron or zinc supplements, and multivitamins containing them
calcium preparations
antacids used for indigestion
sucralfate, a medicine used to treat stomach ulcers
didanosine, a medicine used to treat HIV infection.
You can still take these medicines while you are taking GenRx norfloxacin. However, you must take GenRx norfloxacin at least 2 hours before or 2 hours after taking any of these medicines to make sure there is no problem with absorption.
GenRx norfloxacin may prolong the effect of coffee and other drinks containing caffeine.
Your doctor or pharmacist will tell you if you are taking any of these and they will have more information on other medicines to be careful with or avoid while taking GenRx norfloxacin.

How to take this medicine

Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box/bottle, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
The usual dose is one tablet twice a day.
Do not stop taking your medicine or change your dosage without first checking with your doctor

How to take it

Swallow the tablets whole with a full 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 GenRx norfloxacin about 12 hours apart.
Taking GenRx norfloxacin 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 GenRx norfloxacin on an empty stomach, at least one hour before food or 2 hours after food or after taking milk and/or other dairy products
This will make sure the tablets will have a better chance of fighting the infection, because food can interfere with the absorption of GenRx norfloxacin.
Do not take GenRx norfloxacin at the same time as taking iron or zinc supplements (or multivitamins containing them), antacids, sucralfate, or didanosine (ddI).
Taking GenRx norfloxacin at the same time or even within 2 hours of taking these can interfere with the absorption GenRx norfloxacin, so that the chance of GenRx norfloxacin fighting the infection won't be as good.

How long to take it

Continue GenRx norfloxacin until you finish the pack or until your doctor recommends.
For treatment of urinary tract infections:
The length of treatment may vary from 3 to 10 days
To help stop frequent urinary tract infections from coming back:
You may need to take GenRx norfloxacin for up to 12 weeks.
For infections of the stomach or intestines: The length of treatment is usually 5 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 to take 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 medicine 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.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, 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 GenRx norfloxacin. Do this even if there are no signs of discomfort or poisoning. Keep telephone numbers of these places handy.

While you are taking this medicine

Things you must do

If you become pregnant while taking GenRx norfloxacin, tell your doctor immediately.
If you develop severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after GenRx norfloxacin 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 GenRx norfloxacin.
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 GenRx norfloxacin.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking GenRx norfloxacin.

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 GenRx norfloxacin 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 GenRx norfloxacin affects you.
GenRx norfloxacin may cause drowsiness, dizziness or light-headedness in some people. Make sure you know how you react to GenRx norfloxacin 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, your dizziness or light-headedness may be worse.
Protect your skin when you are in the sun, especially between 10 am and 3 pm.
GenRx norfloxacin 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 GenRx norfloxacin and tell your doctor.
Be careful if you consume large amounts of caffeine while you are taking GenRx norfloxacin.
GenRx norfloxacin 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.

Possible side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking GenRx norfloxacin.
GenRx norfloxacin 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.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
nausea, upset stomach, stomach pain
headache
dizziness
disturbances to vision
rash
tiredness, changes in sleep pattern
vaginal thrush - sore and itchy vagina or discharge.
The above list includes the more common side effects of your medicine. They are usually mild and short-lived.
Tell your doctor as soon as possible if you notice any of the following:
increased sensitivity of the skin to the sun, with symptoms of sunburn (redness, blistering or itching) happening more quickly than usual
confusion, depression, hallucinations
bleeding or bruising more easily than usual
signs of anaemia such as tiredness, being short of breath and looking pale
numbness or tingling in the fingers or toes
worsening of the symptoms of myasthenia gravis
decreased feeling or sensitivity, especially in the skin
changes in your hearing.
The above list includes serious side effects that may require medical attention. Serious side effects are rare.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
severe abdominal cramps or stomach cramps
watery and severe diarrhoea, which may also be bloody
skin rash, itching or hives or peeling or blistering of the skin
asthma, wheezing or shortness of breath
swelling of the face, lips tongue or throat that may cause difficulty in swallowing or breathing
yellowing of the skin or eyes
frequent infections such as fever, severe chills, sore throat or mouth ulcers
sudden and severe pain or swelling of the muscles, joints or tendons
seizures, convulsions or fits
passing little or no urine, blood in the urine.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

After you have finished taking it

Tell your doctor immediately if you notice any of the following, even if they occur several weeks after stopping treatment with GenRx norfloxacin:
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. GenRx norfloxacin 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.

Storage and disposal

Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 30°C.
Do not store any medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
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 this medicine or the expiry date has passed, your pharmacist can dispose of the remaining medicine safely.

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.

Product description

What it looks like

400 mg Tablets:
GenRx Norfloxacin 400 mg tablets are oval, scored, white film coated tablet marked "N|F" on one side and ">" on the other.
Available in bottles of 14 tablets.
* Not all strengths, pack types and/or pack sizes may be available.

Ingredients

Each tablet contains 400 mg of Norfloxacin as the active ingredient.
It also contains the following inactive ingredients:
microcrystalline cellulose
croscarmellose sodium
magnesium stearate
Opadry AMB OY-B-28920.
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Australian Registration Numbers

GenRx Norfloxacin 400 mg tablets (bottle): AUST R 155546.

Sponsor

Arrow Pharma Pty Ltd
15 - 17 Chapel Street
Cremorne VIC 3121

Distributor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
NSW 2113
GenRx is a registered trade mark of Apotex Pty Ltd.
This leaflet was last updated in:
September 2017.