Advertisement
Advertisement

Norfloxacin Sandoz

norfloxacin film-coated tablets
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Norfloxacin Sandoz. It does not contain all the information that is known about Norfloxacin Sandoz. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

WHAT NORFLOXACIN SANDOZ IS USED FOR

This medicine is used to treat:
urinary tract infections
infections of the stomach or intestines (such as traveller's diarrhoea).
This medicine is also used to prevent urinary tract infections in people who get them frequently.
It contains the active ingredient norfloxacin.
Norfloxacin belongs to a group of medicines called quinolone antibiotics.
It works by killing the bacteria causing the infection.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is available only with a doctor's prescription.

BEFORE YOU TAKE NORFLOXACIN SANDOZ

When you must not take it

Do not take this medicine if you have an allergy to:
norfloxacin, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description
any other similar medicines, such as other quinolone antibiotics (e.g. ciprofloxacin).
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
muscle pain or tenderness
joint pain.
Do not take this medicine if you are pregnant.
It may affect your developing baby if you take it during pregnancy.
Do not breastfeed if you are taking this medicine.
The active ingredient in Norfloxacin Sandoz may pass into breast milk and there is a possibility that your baby may be affected.
Do not give this medicine to children or growing adolescents, unless advised by the doctor.
Safety in children and growing adolescents has not been established.
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 problems
seizures or fits
myasthenia gravis (a condition where your muscles become weak and tire easily)
heart problems
eye problems
inflammation and rupture of tendons
glucose-6-phosphate dehydrogenase deficiency.
If you have not told your doctor about any of the above, tell him/her before you start taking Norfloxacin Sandoz.

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 Norfloxacin Sandoz may interfere with each other. These include:
some antibiotics such as nitrofurantoin and erythromycin
theophylline, a medicine used to treat asthma
probenecid, a medicine used to treat gout
certain medicines that are processed by a specific liver enzyme, such as tacrine or tizanidine
glibenclamide, a medicine used to treat diabetes
cisapride, a medicine used to treat heartburn
sucralfate, a medicine used to treat duodenal or stomach ulcers
some medicines used in organ transplantation, such as cyclosporin and mycophenolic acid
NSAIDs (non-steroidal anti-inflammatory drugs), medicines used to treat pain, swelling and arthritis
ropinirole, a medicine used to treat Parkinson's disease and restless legs syndrome
multivitamins, mineral supplements and other medicines containing iron, zinc, magnesium, aluminium or calcium
tricyclic antidepressants, a group of medicines used to treat depression, such as amitriptyline and nortriptyline
clozapine, a medicine used to treat schizophrenia
antipsychotics, medicines used to treat certain mental and emotional conditions
some medicines used to treat irregular heart beats such as sotalol, amiodarone, quinidine and procainamide
didanosine (Videx), an antiviral medicine used to treat HIV infection
anticoagulants, medicines used to prevent blood clots, such as warfarin and phenindione.
These medicines may be affected by Norfloxacin Sandoz or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

HOW TO TAKE NORFLOXACIN SANDOZ

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, ask your doctor or pharmacist for help.

How much to take

Ask your doctor or pharmacist if you are unsure of the correct dose for you.
They will tell you exactly how much to take.
Follow the instructions they give you.
If you take the wrong dose, Norfloxacin Sandoz may not work as well and your problem may not improve.
The usual dose is one tablet twice a day.

How to take it

Swallow the tablets whole with a full glass of water.

When to take it

Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
Take your medicine on an empty stomach, for example, 1 hour before food or 2 hours after food.
Food can interfere with the absorption of this medicine.
If you need to take an antacid, multivitamins, supplements containing iron, calcium or zinc, didanosine (Videx) or sucralfate, take it at least 2 hours before or 2 hours after your dose of Norfloxacin Sandoz.

How long to take it

Continue taking your medicine until you finish the pack or for as long as your doctor tells you.

If you forget to take it

Take your dose as soon as you remember, and continue to take it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
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 the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Norfloxacin Sandoz. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.

WHILE YOU ARE TAKING NORFLOXACIN SANDOZ

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Norfloxacin Sandoz.
Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.
If you become pregnant while taking this medicine, tell your doctor immediately.
If you develop severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several months after Norfloxacin Sandoz 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 (e.g. Lomotil) without first checking with your doctor.
Drink plenty of water or fluids while taking Norfloxacin Sandoz.
This will help to prevent crystals forming in the urine which can cause kidney problems.

Things you must not do

Do not take Norfloxacin Sandoz to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
If you do not complete the full course prescribed by your doctor, your infection may not clear completely, or it may return.

Things to be careful of

Be careful driving or operating machinery until you know how Norfloxacin Sandoz affects you.
This medicine may cause tiredness, dizziness or light-headedness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Be careful when drinking alcohol while you are taking this medicine.
If you drink alcohol, tiredness, dizziness or light-headedness may be worse.
Avoid excessive exposure to direct sunlight.
Your skin may become more prone to sunburn.
Be careful if you consume large amounts of caffeine while you are taking Norfloxacin Sandoz.
This medicine may increase the stimulatory effects of caffeine.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Norfloxacin Sandoz.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
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:
headache
dizziness or light-headedness
feeling sick (nausea) or vomiting
tiredness
mild stomach upsets such as stomach discomfort, constipation, diarrhoea or flatulence
heartburn
dry mouth or changes in taste
disturbances to vision
discharge, itching or irritation in the vagina
difficulty sleeping.
Tell your doctor as soon as possible 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
frequent infections such as fever, severe chills, sore throat or mouth ulcers
numbness or tingling in fingers or toes
irritability, agitation, confusion, depression or hallucinations
worsening of myasthenia gravis symptoms
any changes in your hearing
changes in heart rate (faster, slower or irregular)
changes in your vision (such as seeing bright flashes of light with floaters)
development of any pain, burning, tingling, numbness and/or weakness in your arms or legs.
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:
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
wheezing or shortness of breath
severe and sudden onset of pinkish, itchy swellings on the skin (e.g. hives) not caused by sunburn
severe, watery diarrhoea, which may be bloody
yellowing of the skin and/or eyes (jaundice)
a rash together with very dry eyes and dry mouth
if you have skin rash accompanied by fever and feeling unwell
sudden and severe pain or swelling of muscles, joints or tendons
convulsions
passing little or no urine, blood in the urine, pain or tenderness around the kidney areas.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Some of side effects, such as liver, blood or kidney problems can only be found when your doctor does tests from time to time to check your progress.

AFTER TAKING NORFLOXACIN SANDOZ

Storage

Keep your medicine in the original container.
If you take it out of its original container it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store Norfloxacin Sandoz or any other 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, ask your pharmacist what to do with any medicine that is left over.

PRODUCT DESCRIPTION

What it looks like

Norfloxacin Sandoz comes in one strength:
Norfloxacin Sandoz 400mg - white, biconvex, oval, film-coated tablets.
Available in blisters of 14 tablets.

Ingredients

Active ingredients:
Norfloxacin Sandoz 400mg - 400mg norfloxacin.
Inactive ingredients:
microcrystalline cellulose
croscarmellose sodium
colloidal anhydrous silica
magnesium stearate
purified talc
hypromellose
macrogol 4000
titanium dioxide
propylene glycol
lactose.
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Norfloxacin Sandoz is supplied in Australia by:
Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Australia
Tel: 1800 634 500
 
This leaflet was revised in January 2016.
 
Australian Register Number
400mg film-coated tablet: AUST R 76899