General Information
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Inza.
It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking Inza against the benefits they expect it will have for you. If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What Inza is used for Inza is used to treat the symptoms of:
different types of arthritis including rheumatoid arthritis, osteoarthritis and ankylosing spondylitis
muscle and bone injuries such as sprains, strains and lower back pain
menstrual cramps (period pain)
pain due to inflammation
acute migraine headaches.
Inza belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by relieving pain and inflammation (swelling, redness and soreness). Although Inza can relieve the symptoms of pain and inflammation, it will not cure your condition. Your doctor may have prescribed Inza for another reason. Ask your doctor if you have any questions about why Inza has been prescribed for you. Inza is available only with a doctor's prescription. There is no evidence that Inza is addictive. Before you take Inza When you must not take it
Do not take Inza if you are allergic to:
medicines containing naproxen, aspirin or any other NSAID medicine
any of the ingredients listed at the end of this leaflet.
Many medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAID medicines. If you are not sure if you are taking any of these medicines, ask your pharmacist. Symptoms of an allergic reaction to these medicines may include:
asthma, wheezing or shortness of breath
swelling of the face, lips or tongue, difficulty in swallowing or breathing
hives, itching or skin rash
fainting.
If you are allergic to aspirin or NSAID medicines and take Inza, these symptoms may be severe. Do not take Inza if you:
have, or have had, a peptic ulcer (ulcer of the stomach or duodenum)
are vomiting blood or material that looks like coffee grounds
are bleeding from the rectum (back passage), have black sticky bowel motions (stools) or bloody diarrhoea
have chronic and severe attacks of indigestion or other stomach trouble.
Do not give Inza to children under 5 years of age.
The safety of Inza in this age group 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 are allergic to:
any other medicines including aspirin or other NSAID medicines
any other substances such as foods, dyes or preservatives.
Tell your doctor if you are pregnant or plan to become pregnant.
Inza is not recommended for use during pregnancy, as it may affect your baby. Inza may also reduce fertility and affect your chances of becoming pregnant. If there is a need to consider Inza during your pregnancy your doctor will discuss the risks and benefits involved. Tell your doctor if you are breastfeeding or wish to breastfeed.
Inza passes into breast milk. Therefore there is a possibility that the breastfed baby may be affected. Your doctor will discuss the risks and benefits of taking Inza when breastfeeding. Tell your doctor if you have, or have had, any medical conditions, especially the following:
asthma
kidney problems
liver problems
high blood pressure or heart problems
peptic ulcer (ulcer of the stomach or duodenum)
heartburn, indigestion or other stomach problems
vomiting blood or bleeding from the back passage
a tendency to bleed or other blood problems, such as anaemia
swelling of the ankles or legs (oedema).
Tell your doctor if you currently have an infection.
If you take Inza while you have an infection, it may hide some of the signs of the infection (such as pain, fever, swelling or redness). This may make you mistakenly think that you are better or that your infection is not serious. If you have not told your doctor about any of the above, tell him/her before you start taking Inza.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and Inza may interfere with each other. These include:
other medicines used to treat high blood pressure or heart conditions, including ACE inhibitors, angiotensin receptor blockers or betablockers
diuretic tablets - also called fluid or water tablets, particularly thiazide diuretics
aspirin, salicylates or other NSAID's, medicines used to relieve pain, swelling and other symptoms of inflammation
medicines used to prevent blood clots such as warfarin and heparin
sulfonylureas, medicines used to treat diabetes
probenecid, a medicine used to treat gout
lithium, a medicine used to treat some types of depression
phenytoin, a medicine used to treat epilepsy
methotrexate, a medicine used to treat arthritis and some types of cancer
sulfonamide antibiotics (e.g. Bactrim, Septrin)
medicines containing sodium bicarbonate such as antacids or urinary alkalisers
zidovudine, a medicine used to treat patients with HIV.
These medicines may be affected by Inza 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 Inza. How to take Inza Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet. If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.
How much to take
Your doctor will tell you how many tablets you need to take each day and when to take them. This depends on your condition and whether or not you are taking any other medicines.
For different types of adult arthritis, the usual starting dose is 500 mg. The maintenance dose ranges from 375 mg to 1000 mg per day, taken in two divided doses. For sprains, strains and period pain, 500 mg is the usual starting dose, followed by 250 mg every six to eight hours as needed. The maximum dose per day is 1250 mg. For migraine headache, the usual starting dose is 750 mg, followed by 250 mg to 500 mg one hour later, if needed. The maximum daily dose is 1250 mg. Elderly patients and those with liver or kidney problems may require smaller doses. How to take Inza
Swallow the tablets with a full glass of water or milk.
The 250 mg tablet can be divided in half along the score line if needed. When to take it
Take Inza during or immediately after food.
This will reduce the chance of a stomach upset. How long to take it for
Do not take Inza for longer than your doctor recommends.
Depending on your condition, you may need to take Inza only once, for a few days, a few weeks or longer periods. If you are taking Inza for arthritis, it will not cure your condition but it should help control pain, swelling and stiffness. If you have arthritis, Inza should be taken every day for as long as your doctor prescribes. For sprains and strains, Inza is usually only needed for a few days. For menstrual cramps (period pain), Inza is usually taken during each period as soon as the cramps begin and continued for a few days until the pain goes away. 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 the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
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 you or anyone else may have taken too much Inza. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention. Symptoms of an overdose may include dizziness, drowsiness, disorientation, stomach pain, indigestion, nausea (feeling sick) or vomiting. While you are taking Inza Things you must do
Before starting any new medicine, tell your doctor or pharmacist that you are taking Inza.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking Inza.
If you become pregnant while taking Inza, tell your doctor immediately.
If you get an infection while taking Inza, tell your doctor.
Inza may hide some of the signs of an infection (such as pain, fever, redness, swelling). You may mistakenly think that you are better or that your infection is not serious. If you plan to have surgery, including dental surgery, tell your doctor or dentist that you are taking Inza.
If you need to have any tests, tell your doctor that you are taking Inza.
Inza may affect the results of some tests. Keep all of your doctor's appointments so that your progress can be checked.
You may need to have regular tests to check your eyes, liver, kidneys and blood. Things you must not do
Do not use Inza to treat any other conditions unless your doctor tells you to.
Do not give Inza 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 Inza affects you.
Inza may cause drowsiness, dizziness, lightheadedness and blurred vision in some people. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous. If you drink alcohol, dizziness or light-headedness may be worse. Side effects Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Inza.
Like all other medicines, Inza may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Do not be alarmed by this list of possible 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:
stomach upset including nausea (feeling sick), vomiting, indigestion, heartburn
constipation, diarrhoea, stomach pain or cramps
thirst
skin rash, itching
increased sweating
dizziness, drowsiness, lightheadedness
headache
buzzing or ringing in the ears or other hearing disturbances.
The above list includes the more common and mild side effects. Tell your doctor as soon as possible if you notice any of the following:
severe pain or tenderness in the stomach
bleeding or bruising more easily than normal, reddish or purple blotches under the skin
signs of frequent infections such as fever, chills, sore throat or mouth ulcers
tiredness, being short of breath when exercising, looking pale
dark coloured urine
yellowing of the eyes or skin (jaundice)
fast or irregular heart beat
eye problems such as blurred or double vision
unusual weight gain, swelling of the ankles or legs
symptoms of sunburn (such as redness, swelling, blistering) which may occur more quickly than normal.
The above list includes serious side effects. You may need medical attention. Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:
fever with nausea, headache and sore, stiff neck
vomiting blood or material that looks like coffee grounds
bleeding from your back passage (rectum), black sticky stools or bloody diarrhoea
passing little or no urine, with nausea, vomiting, loss of appetite and weakness
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
asthma, wheezing, shortness of breath
sudden or severe itching, skin rash, hives, peeling of the skin
fainting, seizures or fits (convulsions)
pain or tightness in the chest.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. Tell your doctor if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people. After taking Inza Storage
Keep Inza 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. Keep your tablets in the bottle until it is time to take them.
If you take the tablets out of the bottle, they may not keep well. Keep your tablets in a cool dry place where the temperature stays below 30 °C.
Do not store Inza or any other medicine in the bathroom or near a sink. Do not leave Inza in the car or on window sills.
Heat and dampness can destroy some medicines. Disposal
If your doctor tells you to stop taking Inza, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
Product description What it looks like
Inza comes in 2 strengths of tablets:
Inza 250 - round, white, scored tablet marked NP/250 and G
Inza 500 - oblong, white tablet marked NP 500 and G.
Each bottle contains 50 tablets. Ingredients
The active ingredient in Inza is naproxen:
each Inza 250 tablet contains 250 mg of naproxen
each Inza 500 tablet contains 500 mg of naproxen.
The tablets also contain the following inactive ingredients:
lactose
cellulose-microcrystalline
starch-maize
talc-purified
silica-colloidal anhydrous
starch-pregelatinised maize
sodium starch glycollate
magnesium stearate.
The tablets are gluten free. Manufacturer
Inza is made in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Chase Building 2
Wentworth Park Road
Glebe NSW 2037
Phone: (02) 9298 3999
www.alphapharm.com.au
Medical Information
Phone: 1800 028 365
Australian registration numbers:
Inza 250 - Aust R 40927
Inza 500 - Aust R 40929
This leaflet was prepared on
30 April 2007.