Crysanal

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

Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

Why am I using CRYSANAL?

CRYSANAL contains the active ingredient naproxen sodium. CRYSANAL is used to relieve pain and reduces inflammation (swelling, redness and soreness) that may occur with different types of arthritis, in muscle and bone injuries, after setting broken or dislocated bones, with menstrual cramps (period pain), due to migraine headache, following surgery, or due to dental pain. For more information, see Section 1. Why am I using CRYSANAL? in the full CMI.

What should I know before I use CRYSANAL?

Do not use if you have ever had an allergic reaction to naproxen sodium, aspirin or any other NSAID medicines, or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use CRYSANAL? in the full CMI.

What if I am taking other medicines?

Some medicines may interfere with CRYSANAL and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

How do I use CRYSANAL?

Take CRYSANAL exactly as your doctor has prescribed. Your doctor will tell you how many CRYSANAL tablets to take each day. More instructions can be found in Section 4. How do I use CRYSANAL? in the full CMI.

What should I know while using CRYSANAL?

Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using CRYSANAL.
Tell your doctor if you get an infection while using CRYSANAL.
Tell your doctor if you feel the tablets are not helping your condition.
Call your doctor straight away if you become pregnant while taking CRYSANAL.
Things you should not do
Do not give CRYSANAL to anyone else, even if they have the same condition as you.
Do not use CRYSANAL to treat other complaints unless your doctor tells you to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how CRYSANAL affects you.
CRYSANAL may cause dizziness or light-headedness in some people. If this occurs, do not drive.
Drinking alcohol
Tell your doctor if you drink alcohol. If you drink alcohol, dizziness or light-headedness may be worse.
Looking after your medicine
Keep the tablets in a cool dry place away from moisture, heat or sunlight. Store below 30°C.
Do not keep your tablets in the refrigerator.
For more information, see Section 5. What should I know while using CRYSANAL? in the full CMI.

Are there any side effects?

Tell your doctor immediately if you notice any of these serious side effects: difficulty hearing, deafness, severe or persistent headache, yellowing of the skin or eyes, bleeding or bruising more easily than normal, reddish or purplish blotches under the skin, fast or irregular heartbeats, eye problems such as blurred vision, unusual weight gain, swelling of ankles or legs. Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these very serious side effects: vomiting blood or what looks like coffee grounds, bleeding from the back passage, black sticky bowel motions or bloody diarrhoea, severe dizziness, spinning sensation, severe pain or tenderness in any part of the stomach, swelling of the face, lips or tongue which may cause difficulty in swallowing, difficulty breathing, wheezing or shortness of breath, sudden or severe itching, skin rash or hives, fainting, seizures or fits, pain or tightness in the chest, flu-like symptoms with a rash on the face then an extended rash with a high temperature and enlarged lymph nodes. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
Active ingredient: naproxen sodium
Consumer Medicine Information (CMI)
This leaflet provides important information about using CRYSANAL. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using CRYSANAL.
Where to find information in this leaflet:

Why am I using CRYSANAL?

CRYSANAL contains the active ingredient naproxen sodium. CRYSANAL belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (or NSAIDs).
CRYSANAL is used to relieve pain and reduces inflammation (swelling, redness and soreness) that may occur:
in different types of arthritis including rheumatoid arthritis, osteoarthritis and ankylosing spondylitis
in muscle and bone injuries such as sprains, strains, lower back pain (lumbago), rheumatism and tendonitis, such as tennis elbow
from swelling and pain after setting broken or dislocated bones
with menstrual cramps (period pain)
due to migraine headache
following surgery
due to dental pain
Although CRYSANAL can relieve the symptoms of pain and inflammation, it will not cure your condition.
Your doctor may have prescribed CRYSANAL for another reason.
Ask your doctor if you have any questions why CRYSANAL has been prescribed for you.

What should I know before I use CRYSANAL?

Warnings

Do not use CRYSANAL if:

you have an allergy to naproxen sodium, aspirin or any other NSAID medicine, or 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 doctor or pharmacist. If you are allergic to aspirin or NSAID medicines and use CRYSANAL, these symptoms may be severe. 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
Always check the ingredients to make sure you can use this medicine.
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 currently have a peptic ulcer (i.e. stomach or duodenal ulcer), or have had one before
you have severe liver disease
you have recently had or are about to have heart bypass surgery
you are taking other medications which contain naproxen sodium or naproxen sodium (e.g. Naprogesic®, Naprosyn®, Anaprox® or Inza®)
you have severe heart failure
Do not give CRYSANAL to a child under the age of 2 years. The safety and effectiveness of CRYSANAL in children under 2 years of age has not been established.
If you are not sure if you should start taking CRYSANAL, talk to your doctor.

Check with your doctor if you:

have allergies to any other substances, such as foods, preservatives or dyes
have or have had any medical conditions, especially the following:
heartburn, indigestion, stomach ulcers or other stomach problems
vomiting blood or bleeding from the back passage
bowel or intestinal problems such as ulcerative colitis
kidney or liver disease
heart failure
high blood pressure or heart problems
swelling of the ankles or feet
a tendency to bleed or other blood problems, such as anaemia
currently have an infection. If you take CRYSANAL while you have an infection, the signs may be hidden (e.g. pain, fever). This may make you think, mistakenly, that you are better or that it is not serious.
you plan to have surgery. CRYSANAL can prolong bleeding.
You are on a strict salt (or sodium) restricted diet. CRYSANAL contains a small amount of sodium.
If you have not told your doctor about any of the above, tell them before you take any CRYSANAL.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or intend to become pregnant.
CRYSANAL may affect your developing baby if you use it during pregnancy. If it is necessary for you to be given CRYSANAL, your doctor will discuss the risks and benefits of receiving it during pregnancy.
CRYSANAL may impair fertility and is not recommended in women attempting to conceive.
Tell your doctor if you are breastfeeding or intend to breastfeed.
CRYSANAL passes into breast milk. The effect on the baby is not known.

Use in children

There is no specific information available to recommend the use of CRYSANAL in children under 5 years.

Use in people over 65 years

Older people may be at more risk of developing stomach ulcers and hence your doctor may prescribe a lower dose.

What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with CRYSANAL and affect how it works. These include:
antacids, medicines used to treat indigestion and heartburn
aspirin, salicylates or other NSAID medicines
diuretics, also called fluid or water tablets
lithium, a medicine used to treat some types of depression
probenecid, a medicine used to treat gout
phenytoin, a medicine used to treat epilepsy
methotrexate, a medicine used to treat arthritis and some cancers
warfarin, a medicine used to prevent blood clots
heparin, a medicine used to prevent blood clots
medicines used to treat high blood pressure including ACE inhibitors, angiotensin receptor antagonists and beta-blockers
certain antibiotics called sulphonamides
some medicines used to treat diabetes
steroids, medicines used to treat inflammation
serotonin reuptake inhibitors, also known as SSRIs, medicines used to treat some types of depression
zidovudine, a medicine used to treat HIV infection
sodium bicarbonate, a medicine used to treat stomach upset or ulcers
You may need to use different amounts of your medicine, or you may need to use different medicines. Your doctor will advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect CRYSANAL.

How do I use CRYSANAL?

How much to take

Take CRYSANAL exactly as your doctor has prescribed.
Your doctor will tell you how many CRYSANAL tablets to take each day.
The dose your doctors recommends depends on both the type and severity of pain and/or inflammation you have.
Follow the instructions provided and use CRYSANAL until your doctor tells you to stop. They may differ from the information contained in this leaflet.

Sprains, strains, and period pain

The recommended dose is 550 mg (one tablet) given initially, then 275 mg (half-a-tablet) every 6 to 8 hours as needed. The total dose in one day should not be more than 1375 mg (two and a half tablets).

Migraine headache

The recommended dose is 825 mg (one and a half tablets) taken at the first sign of a migraine. An additional dose of 275 mg (half a tablet) to 550 mg (one tablet) can be taken at least one hour after the initial dose, if required. The total dose in one day should not be more than 1375 mg (two and a half tablets).

Different types of arthritis

The recommended dose is 550 mg (one tablet) to 1100 mg (two tablets) a day (divided in two doses).
Your doctor may recommend lower doses than these, it is always best to use the lowest effective dose for your condition.

When to take CRYSANAL

Take the tablets during or immediately after food with a full glass of water or milk. This may help reduce the possibility of an upset stomach.

How long to take CRYSANAL

Do not take CRYSANAL for longer than your doctor says.
Depending on your condition, you may need to use CRYSANAL, only once, for a few days, a few weeks or for longer periods.
For sprains and strains, CRYSANAL is usually only needed for a few days. 
As with other NSAID medicines, if you are taking CRYSANAL for arthritis, it will not cure your condition but it should help to control pain, swelling and stiffness. If you have arthritis, CRYSANAL should be taken every day for as long as your doctor prescribes.
For menstrual cramps (period pain), CRYSANAL is usually taken during each period as soon as the cramps begin and continued for a few days until the pain goes away.
Ask your doctor if you are not sure how long to take CRYSANAL for.

If you forget to take CRYSANAL

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 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 have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you use too much CRYSANAL

If you take too much CRYSANAL, you may experience drowsiness, pain or tenderness in the stomach, stomach upset including nausea (feeling sick), vomiting, heartburn, indigestion or cramps. If you think that you have used too much CRYSANAL, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.

What should I know while using CRYSANAL?

Things you should do

Ask your doctor or pharmacist before you start taking any new medicines.
Tell your doctor you are taking CRYSANAL if you are going to have surgery
Tell your doctor you are taking CRYSANAL if you are going to have any laboratory tests. CRYSANAL can affect the results of some of these tests.
Tell your doctor if you get an infection while using CRYSANAL. CRYSANAL may hide some of the signs of an infection and may make you think, mistakenly, that you are better or that it is not serious. Signs of an infection may include fever, pain, swelling and redness.
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.

Call your doctor straight away if you:

become pregnant while taking CRYSANAL
Remind any doctor, dentist or pharmacist you visit that you are using CRYSANAL.

Things you should not do

Do not give CRYSANAL to anyone else, even if they have the same condition as you.
Do not use CRYSANAL to treat other complaints unless your doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how CRYSANAL affects you.
As with other NSAID medicines, CRYSANAL may cause dizziness or light-headedness in some people. If this occurs do not drive.

Drinking alcohol

Tell your doctor if you drink alcohol.
If you drink alcohol, dizziness or light-headedness may be worse.

Looking after your medicine

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 will not keep well.
Keep the tablets in a cool dry place where the temperature stays below 30°C.
Do not keep your tablets in the refrigerator.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.

Are there any side effects?

All medicines can have side effects. CRYSANAL helps most people with pain due to inflammation, but it may have unwanted side effects in a few people.
If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.

Less serious side effects

Less serious side effects
What to do
Gut related:
stomach upset including nausea (feeling sick) and heartburn
loss of appetite
constipation, diarrhoea, pain in the stomach
 
Head related:
dizziness, light-headedness
headache, drowsiness
buzzing or ringing in the ears
sore or dry mouth or tongue
feeling thirsty
 
Skin related:
itching or mild skin rashes
 
Other:
fluid retention or shortness of breath
Speak to your doctor if you have any of these less serious side effects and they worry you. These side effects of CRYSANAL are usually mild.

Serious side effects

Serious side effects
What to do
Head related:
difficulty hearing, deafness
severe or persistent headache
 
Skin related:
yellowing of the skin
 
Bleeding related:
bleeding or bruising more easily than normal, reddish or purplish blotches under the skin
Heart related:
fast or irregular heartbeats, also called palpitations
 
Eye related:
eye problems such as blurred vision
yellowing of the eyes
Other:
unusual weight gain, swelling of ankles or legs
Tell your doctor immediately if you notice any of these serious side effects. You may need urgent medical attention. Serious side effects are rare.

Very serious side effects

Very serious side effects
What to do
Gastrointestinal or gut related:
vomiting blood or what looks like coffee grounds
bleeding from the back passage (rectum), black sticky bowel motions (stools) or bloody diarrhoea

Head related:
severe dizziness, spinning sensation

Pain related:
severe pain or tenderness in any part of the stomach

Allergic reaction related:
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
difficulty breathing, wheezing or shortness of breath
sudden or severe itching, skin rash or hives
fainting, seizures or fits
pain or tightness in the chest
flu-like symptoms with a rash on the face then an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these very serious side effects. You may need urgent medical attention or hospitalisation. These very serious side effects are rare.
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

Product details

This medicine is only available with a doctor's prescription.
CRYSANAL is not addictive.

What CRYSANAL contains

Active ingredient
(main ingredient)
each CRYSANAL tablet contains 550mg of naproxen sodium
Other ingredients
(inactive ingredients)
Microcrystalline cellulose
Magnesium stearate
Purified water
Povidone
Purified talc
Opadry Blue YS-1R-4216 ARTG PI No. 3174
Potential allergens
CRYSANAL tablets are lactose and gluten free
Do not take this medicine if you are allergic to any of these ingredients.

What CRYSANAL looks like

CRYSANAL is a dark blue capsule-shaped tablet with 'NPS 550' on one side.
CRYSANAL comes in packs of 50 tablets (Aust R 67927).

Who distributes CRYSANAL

CRYSANAL is supplied in Australia by:
Clinect Pty Ltd
120 - 132 Atlantic Drive
Keysborough VIC 3173
Australia
Customer enquiries: 1 800 899 005
Sponsor:
Atnahs Pharma Australia Pty Ltd
Level 10
10 Shelley Street,
SYDNEY, NSW, 2000, Australia
This leaflet was prepared in September 2021.