NOFLAM
Naproxen 250mg and 500mg tablets
What is in this leaflet
This leaflet answers some common questions about NOFLAM tablets. 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 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 NOFLAM is used for
NOFLAM contains the active ingredient naproxen.
NOFLAM relieves pain and reduces inflammation (swelling, redness and heat) associated with:
- different types of arthritis including rheumatoid arthritis, osteoarthritis
- arthritis in children (juvenile arthritis)
- ankylosing spondylitis (a disease of the joints in the spine)
- muscle and bone ailments such as sprains, strains, lower back pain (lumbago), rheumatism and tendonitis (eg. tennis elbow)
- gout (a disease with painful swollen joints)
- pain following surgery
- period pain
NOFLAM belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (or NSAIDs). There are many different types of NSAIDs used to treat pain and inflammation. Although NOFLAM can relieve the symptoms of pain and inflamation, it will not cure your condition.
Your doctor, however, may have prescribed NOFLAM for another purpose.
Ask your doctor if you have any questions why NOFLAM has been prescribed for you.
There is no evidence that NOFLAM is addictive.
NOFLAM is available only with a doctor's prescription.
Before you take NOFLAM
When you must not take it
Do not take NOFLAM if:
- you are allergic to NOFLAM, or any ingredients listed at the end of this leaflet or you have had an allergic reaction to aspirin or any other NSAID medicine, including other naproxen containing medicines such as Synflex®, Naprosyn R Naxen® Sonaflam® or Naprogesic®.
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 which may cause difficulty in swallowing or breathing
- hives, itching or skin rash
- fainting
If you are allergic to aspirin or NSAID medicines and take NOFLAM, these symptoms may be severe.
- aspirin or other NSAIDs have given you asthma, nasal polyps or rhinitis (hayfever symptoms such as runny nose, stuffiness, watery eyes, sneezing, itchy nose, throat and eyes) in the past
- you are vomiting blood or material that looks like coffee grounds
- you are bleeding from the rectum (back passage), have black sticky bowel motions (stools) or bloody diarrhoea
- you have a peptic ulcer (i.e. stomach or duodenal ulcer)
- you have a tendency to spontaneously bleed or bleed when incurring minor accidents (haemorrhagic diathesis)
- you have liver disease
- you have asthma
- the package is torn or shows signs of tampering
- the expiry date printed on the pack has passed
If you take this medicine after the expiry date has passed, it may not work as well.
If the pharmacist has repacked the medicine for you, there may not be an expiry date on the pack.
If you are not sure if you should be taking NOFLAM, talk to your doctor.
Do not give NOFLAM to children under 2 years of age.
The safety and effectiveness in children under 2 have not been established.
Before you start to take it
Tell your doctor if:
- you are pregnant or plan to become pregnant
NOFLAM may make it more difficult to fall pregnant and is not recommended in women trying to fall pregnant. NOFLAM may affect your developing baby if you take it during pregnancy. If it is necessary for you to take NOFLAM, your doctor will discuss the risks and benefits of taking it during pregnancy.
Do not take NOFLAM if you are in labour as it may harm you and/or affect the baby. - you are breast-feeding or plan to breast-feed
NOFLAM 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 NOFLAM if you are breast-feeding. - you have or have had any other health problems, especially the following:
- rhinitis, nasal polyps
- heartburn, indigestion, stomach ulcers or other stomach problems
- kidney or liver disease
- heart problems, including high blood pressure or heart failure
- fluid retention or swelling of the hands, ankles or feet
- you are or have been dependent on alcohol
- a tendency to bleed easily
- you are on a low sodium diet
- you have low salt levels in your blood
- suffer from hypovolaemia - a blood disorder consisting of a decrease in the volume of circulating blood
- you have a history of allergies resulting in swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
- are or have been a smoker
- you currently have an infection
If you take NOFLAM while you have an infection, the tablets may hide some of the signs of an infection (e.g. pain, fever). This may make you think mistakenly, that you are better or that your infection is not serious. - you plan to have surgery
NOFLAM can prolong bleeding. - you are allergic to any other medicines, foods, dyes or preservatives.
If you have not told your doctor about any of the above, tell them before you start taking NOFLAM.
Taking other medicines
Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or health food shop.
Some medicines may interfere with NOFLAM. These medicines include:
- aspirin, salicylates or other NSAID medicines
- antacids and cholestyramine
- lithium, a medicine used to treat some types of depression
- probenecid, a medicine used to treat gout
- frusemide, a diuretic, also called fluid or water tablets.
- phenytoin, a medicine used to treat epilepsy
- methotrexate, a medicine used to treat arthritis, and some cancers
- warfarin, a medicine used to stop blood clots
- a group of medicines called beta-blockers used to treat high blood pressure
- certain antibiotics called sulphonamides
- some medicines used to treat diabetes called sulphonylureas
These medicines may be affected by NOFLAM, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking NOFLAM.
Ask your doctor or pharmacist if you are not sure about this list of medicines.
How to take NOFLAM
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
How much to take
Take NOFLAM exactly as your doctor has prescribed.
Your doctor will tell you how many NOFLAM tablets you should take each day. Your doctor may give you a lower dose if you are older or have certain health problems.
Adults
The usual dose is 500mg to 1000mg a day depending upon your condition.
Children
The usual dose for children over 5 years is 10mg/kg/day given as two divided doses at 12 hour intervals. Therapy in children under 5 years of age is not recommended.
Elderly patients and those with liver or kidney problems may require smaller doses.
How to take it
Swallow NOFLAM tablets whole with a glass of water.
When to take it
Take NOFLAM at about the same time each day.
If you take NOFLAM after food this may help reduce the possibility of an upset stomach.
Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take the tablets.
How long to take it
Continue taking NOFLAM until your doctor tells you to stop.
Depending on your condition, you may need to take NOFLAM only once, for a few days, a few weeks or longer periods.
As with other NSAID medicines, if you are using NOFLAM for arthritis, it will not cure your condition but it should help to control pain, swelling and stiffness. If you have arthritis, NOFLAM should be taken every day for as long as your doctor prescribes.
For pain, sprains and strains, NOFLAM is usually needed for shorter periods.
For period pain (menstrual cramps), NOFLAM is usually taken during each menstrual cycle as soon as period pains begin and continued for up to 5 days, if necessary.
For gout, NOFLAM is usually taken until the attack has passed.
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 continue taking it as you would normally.
Do not double a dose to make up for the one you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering your dose, ask your pharmacist for some hints.
In case of overdose
Immediately telephone your doctor or National Poisons Information Centre (telephone 0800 POISON or 0800 764 766) for advice, or go to your nearest Accident and Emergency Centre if you think that you or anyone else may have taken too much NOFLAM. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
The following are some symptoms, which may or may not occur.
- drowsiness, dizziness
- pain or tenderness in the stomach
- stomach upset including nausea (feeling sick), vomiting, heartburn, indigestion or cramps
- convulsions (fits)
- confusion
- unable to breathe
Keep telephone numbers for these places handy.
If you are not sure what to do, contact your doctor or pharmacist.
While you are taking NOFLAM
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you are taking NOFLAM.
Tell your doctor if you become pregnant while taking NOFLAM.
If you are going to have surgery, tell your doctor you are taking NOFLAM.
Tell your doctor you are taking NOFLAM if you are going to have any laboratory tests. NOFLAM can affect the results of some of these tests.
If you get an infection while using NOFLAM, tell your doctor. NOFLAM may hide some of the signs of an infection such as pain, fever, redness and swelling. You may mistakenly think that you are better or that it is not serious.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Tell your doctor if you feel the tablets are not helping your condition.
Visit your doctor regularly so they can check on your progress.
Things you must not do
Do not stop taking NOFLAM or change the dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give NOFLAM to anyone else even if they have the same condition as you.
Do not use NOFLAM to treat other complaints unless your doctor says to.
Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting a pharmacist.
Things to be careful of
Be careful driving or operating machinery until you know how NOFLAM affects you.
NOFLAM may cause dizziness, light-headedness, drowsiness or a spinning sensation (vertigo) in some people. Make sure you know how you react to NOFLAM before you drive a car, operate machinery, or do anything else that could be dangerous.
Side Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking NOFLAM.
NOFLAM helps most people but it may have unwanted side effects.
All medicines can have side effects. Sometimes they are serious. 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 if you notice any of the following and they worry you:
- stomach upset including nausea (feeling sick), heartburn, indigestion
- constipation, diarrhoea, pain in the stomach
- dizziness, light-headedness, drowsiness
- spinning sensation (vertigo)
- headache
- buzzing or ringing in the ears
- sore or dry mouth or tongue (stomatitis)
- feeling thirsty
These are the more common side effects of NOFLAM. Mostly these are mild.
Tell your doctor immediately, or go to your nearest Accident and Emergency Centre, if you notice any of the following:
- severe pain or tenderness in any part of the stomach
- eye problems such as blurred vision
- fast or irregular heartbeats, also called palpitations
- difficulty hearing, deafness
- bleeding or bruising more easily than normal, reddish-purplish or blue-black blotches under the skin
- unusual weight gain, swelling of ankles or legs
- vomiting blood or material that looks like coffee grounds
- bleeding from the back passage (rectum), black sticky bowel motions (stools) or bloody diarrhoea, or blood in the urine
- 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 or skin hypersensitivity
- symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur more quickly than normal
- fainting, seizures or fits
- depression (feelings of deep sadness and unworthiness)
- inability to sleep (insomnia), difficulty concentrating
- yellowing of the skin or eyes
- shooting pain from the stomach to the back (pancreatitis)
These are serious side effects. You may need urgent medical attention. Serious side effects are rare.
This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Ask your doctor or pharmacist if you don't understand anything in this list.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After taking NOFLAM
Storage
Keep your tablets in the original container and protect from light until it is time to take them.
If you take the medicine out of its container it may not keep well.
Keep NOFLAM tablets in a cool dry place where the temperature stays below 25°C.
Do not store it, or any other medicine, in a bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep NOFLAM 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.
Do not keep your tablets in the refrigerator.
Disposal
If your doctor tells you to stop taking NOFLAM, or the medicine has passed its expiry date, ask your pharmacist what to do with any tablets that are left over.
Product Description
What Noflam looks like
NOFLAM 250 mg tablets are yellow round tablets. They are marked with "NP/250" on one side.
NOFLAM 500 mg tablets are yellow capsule shaped tablets. They are marked "NP 500" on one side with a bisect on the other side.
Each NOFLAM tablet contains the active ingredient naproxen.
Each NOFLAM 250mg and 500mg tablet also contain povidone, lactose, maize starch, sodium starch glycollate, talc, magnesium stearate, polysorbate 80, quinoline yellow.