2. What should I know before I take FENAC EC?
Do not take if you have ever had an allergic reaction to FENAC EC 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.
3. What if I am taking other medicines?
Some medicines may interfere with FENAC EC and affect how it works.
4. How do I take FENAC EC?
Swallow the tablets whole with a full glass of water or other liquid. Do not chew
them.
5. What should I know while taking FENAC EC?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking FENAC EC.
If you become pregnant while taking FENAC EC, tell your doctor immediately.
Be sure to keep all of your doctor's appointments so that your progress can be checked.
If you get an infection while taking FENAC EC, tell your doctor.
|
|
Things you should not do
|
Do not stop any other forms of treatment for arthritis that your doctor has told you
to follow.
Do not give FENAC EC to anyone else, even if their condition seems similar to yours.
Do not take it to treat any 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 FENAC
EC affects you.
|
|
Looking after your medicine
|
Keep FENAC EC in the original container until it is time to take it.
Keep your tablets below 25°C.
|
6. Are there any side effects?
If you are over 65 years of age, you should be especially careful while taking FENAC
EC. Report any side effects promptly to your doctor. NSAIDs, including diclofenac,
may be associated with increased risk of gastro-intestinal anastomotic leak. Close
medical surveillance and caution are recommended when taking FENAC EC after gastrointestinal
surgery. If symptoms of vision disorders occur during treatment with FENAC EC, contact
your doctor as an eye examination may be considered to exclude other causes. 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(s):
diclofenac sodium
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking FENAC EC. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking FENAC EC.
Where to find information in this leaflet:
1. Why am I taking FENAC EC?
FENAC EC contains the active ingredient diclofenac sodium. FENAC EC belongs to a group of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which are used to treat pain and reduce
inflammation (swelling and redness).
FENAC EC is used to treat:
different types of arthritis including rheumatoid arthritis and osteoarthritis
other painful conditions where swelling is a problem such as back pain, rheumatism,
muscle strains, sprains and tendonitis (e.g. tennis elbow)
menstrual cramps (period pain)
relieve pain in children after they have had an operation.
It can relieve the symptoms of pain and inflammation, but it will not cure your condition.
Ask your doctor if you have any questions about why FENAC EC has been prescribed for
you.
Your doctor may have prescribed it for another purpose.
FENAC EC is not addictive.
2. What should I know before I take FENAC EC?
Warnings
Do not take FENAC EC:
if you are allergic (hypersensitive) to:
diclofenac or any of the other ingredients listed at the end of this leaflet
other medicines containing diclofenac
aspirin
ibuprofen
any other NSAID
If you are not sure if you are taking any of the above medicines, ask your doctor
or pharmacist.
Symptoms of an allergic reaction to these medicines may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue, throat, and/or extremities (signs of angioedema)
rash, itching or hives on the skin.
Many medicines used to treat headache, period pain and other aches and pains contain
aspirin or NSAID medicines.
If you are allergic to aspirin or NSAID medicines and you use FENAC EC, these symptoms
may be severe.
always check the ingredients to make sure you can take this medicine.
if you have had any of the following medical conditions:
a stomach or intestinal ulcer
bleeding from the stomach or bowel (symptoms of which may include blood in your stools
or black stools)
kidney or liver problems
severe heart failure
heart bypass surgery
during the first 6 months of pregnancy, except on doctor's advice. Do not take this
medicine during the last three months of pregnancy.
Use of this medicine during the last 3 months of pregnancy may affect your baby and
may delay labour and birth.
Use of non-aspirin NSAIDs can increase the risk of miscarriage, particularly when
taken close to the time of conception.
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.
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes.
Your doctor will want to know if you are prone to allergies, especially if you get
skin reactions with redness, itching or rash
take any medicines for any other condition
have, or have had, any of the following medical conditions:
established disease of the heart or blood vessels (also called cardiovascular disease,
including uncontrolled high blood pressure, congestive heart failure, established
ischemic heart disease, or peripheral arterial disease, or atherosclerotic cardiovascular
disease) as treatment with FENAC EC is generally not recommended
established cardiovascular disease (see above) or significant risk factors such as
high blood pressure, abnormally high levels of fat (cholesterol, triglycerides) in
your blood, diabetes, or if you smoke, and your doctor decides to prescribe FENAC
EC, you must not increase the dose above 100 mg per day if you are treated for more
than 4 weeks
current or past history of gastrointestinal problems such as stomach or intestinal
ulceration, bleeding or black stools, and/or stomach discomfort or heartburn after
taking anti-inflammatory medicines in the past
diseases of the bowel or inflammation of the intestinal tract (Crohn's disease) or
colon (ulcerative or ischemic colitis)
past history of haemorrhoids (piles) or irritation of the rectum (back passage)
liver or kidney problems
a rare liver condition called porphyria
bleeding disorders or other blood disorders (e.g. anaemia)
asthma or any other chronic lung disease that causes difficulty in breathing
hay fever (seasonal allergic rhinitis)
repeated chest infections
polyps in the nose
diabetes
dehydration (e.g. by sickness, diarrhoea, before or after recent major surgery)
swollen feet
Your doctor may want to take special precautions if you have any of the above conditions.
It is generally important to take the lowest dose of FENAC EC that relieves your pain
and/or swelling and for the shortest time possible in order to keep your risk for
cardiovascular side effects as small as possible.
currently have an infection
If you take FENAC EC while you have an infection, some of the signs of the infection
such as pain, fever, swelling and redness may be hidden. You may think, mistakenly,
that you are better or that the infection is not serious.
are lactose intolerant
FENAC EC tablets contain lactose.
are planning to give this medicine to a child.
Safety and effectiveness in children have not been established.
If you have not told your doctor about any of the above, tell them before you start
taking FENAC EC.
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 trying to become pregnant.
There is not enough information to recommend the use of FENAC EC during the first
6 months of pregnancy and it must not be used during the last 3 months. FENAC EC may
also reduce fertility and affect your chances of becoming pregnant. Your doctor can
discuss the risks and benefits involved.
Tell your doctor if you are breastfeeding or plan to breastfeed.
Breast feeding is not recommended while taking FENAC EC. The active ingredient, diclofenac,
passes into breast milk and may affect your baby. Your doctor will discuss the risks
and benefits of taking FENAC EC when breastfeeding.
Children
There is not enough information to recommend the use of FENAC EC tablets in children.
3. 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 FENAC EC and affect how it works. These include:
other anti-inflammatory medicines e.g. aspirin, salicylates or ibuprofen
warfarin or other "blood thinners" (medicines used to prevent blood clotting)
digoxin (a medicine for heart problems)
lithium or selective serotonin-reuptake inhibitors (SSRIs), a medicine used to treat
some types of depression
diuretics (medicines used to increase the amount of urine)
ACE inhibitors or beta-blockers (medicines used to treat high blood pressure, heart
conditions, glaucoma and migraine)
prednisone, cortisone, or other corticosteroids (medicines used to provide relief
for inflamed areas of the body)
medicines (such as metformin) used to treat diabetes, except insulin
methotrexate (a medicine used to treat arthritis and some cancers)
ciclosporin, tacrolimus (a medicine used in patients who have received organ transplants)
trimethoprim (a medicine used to prevent or treat urinary tract infections)
some medicines used to treat infection (quinolone antibacterials)
glucocorticoid medicines, used to treat arthritis
sulfinpyrazone (a medicine used to treat gout)
voriconazole (a medicine used to treat fungal infections)
phenytoin (a medicine used to treat seizures)
rifampicin (an antibiotic medicine used to treat bacterial infections)
You may need to take different amounts of your medicines or to take different medicines
while you are using FENAC EC. Your doctor and pharmacist have more information.
If you have not told your doctor about any of these things, tell him/ her before you
start using FENAC EC.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect FENAC EC.
4. How do I take FENAC EC?
How much to take
Follow all directions given to you by your doctor and pharmacist carefully. These
instructions may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
There are different ways to take FENAC EC tablets depending on your condition. Your
doctor will tell you exactly how many tablets to take.
Do not exceed the recommended dose.
To treat arthritis or other painful conditions:
The usual starting dose of FENAC EC tablets is 75 mg to 150 mg each day. After the
early stages of treatment, it is usually possible to reduce the dose to 75 mg to 100
mg each day.
To treat menstrual cramps (period pain):
The tablets are usually taken during each period as soon as cramps begin and continued
for a few days until the pain goes away.
The usual starting dose of FENAC EC tablets is 50 mg to 100 mg each day, beginning
as soon as cramps begin and continuing until the pain goes away, but for no longer
than 3 days.
If necessary, the dose can be raised over several menstrual periods to a maximum of
200 mg each day.
When to take FENAC EC
It is recommended to take the tablets before meals or on an empty stomach. If they
upset your stomach, you can take them with food or immediately after food.
They will work more quickly if you take them on an empty stomach, but they will still
work if you have to take them with food to prevent stomach upset.
How to take FENAC EC
FENAC EC tablets are usually taken in 2 or 3 doses during the day.
Swallow the tablets whole with a full glass of water or other liquid. Do not chew
them.
The tablets have a special coating to keep them from dissolving until they have passed
through the stomach into the bowel. Chewing the tablets would destroy the coating.
How long to take it for
Do not take FENAC EC for longer than your doctor says.
If you are taking FENAC EC for arthritis, it will not cure your disease, but it should
help to control pain and inflammation. It usually begins to work within a few hours
but several weeks may pass before you feel the full effects of the medicine.
If you forget to take FENAC EC
If it is almost time for your next dose (e.g. within 2 or 3 hours), 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 it as you would
normally.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you take too much FENAC EC
If you think that you or anyone else has taken too much FENAC EC, urgent medical attention
maybe needed.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26) for advice, 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.
Symptoms of an overdose may include vomiting, bleeding from the stomach or bowel,
diarrhoea, dizziness, ringing in the ears or convulsions (fits).
5. What should I know while taking FENAC EC?
Things you should do
If you take FENAC EC for more than a few weeks, you should make sure to visit your
doctor for regular check-ups to ensure that you are not suffering from unnoticed undesirable
effects.
Be sure to keep all of your doctor's appointments so that your progress can be checked.
Your doctor will periodically reevaluate whether you should continue treatment with
FENAC EC, if you have established heart disease or significant risks for heart disease,
especially in case you are treated for more than 4 weeks.
Your doctor may want to check your kidneys, liver and blood from time to time to help
prevent unwanted side effects.
If, at any time while taking FENAC EC you experience any signs or symptoms of problems
with your heart or blood vessels such as chest pain, shortness of breath, weakness,
or slurring of speech, contact your doctor immediately. These may be signs of cardiovascular
toxicity.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
FENAC EC.
NSAID medicines can slow down blood clotting and affect kidney function.
If you get an infection while taking FENAC EC, tell your doctor.
FENAC EC may hide some of the signs of an infection (pain, fever, swelling, redness).
You may think, mistakenly, that you are better or that the infection is not serious.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking FENAC EC.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
FENAC EC.
Call your doctor straight away if you:
become pregnant while taking this medicine
Your doctor can discuss with you the risks of taking FENAC EC while you are pregnant.
Remind any doctor, dentist or pharmacist you visit that you are taking FENAC EC.
Things you should not do
Do not take any of the following medicines while you are taking FENAC EC without first
checking with your doctor or pharmacist:
aspirin (also called ASA or acetylsalicylic acid)
other salicylates
other medicines containing diclofenac
ibuprofen
any other NSAID medicines.
If you take these medicines together with FENAC EC, they may cause unwanted side effects.
If you need to take something for headache or fever, it is recommended that you take
paracetamol. If you are not sure, your doctor or pharmacist can advise you.
Do not stop any other forms of treatment for arthritis that your doctor has told you
to follow.
FENAC EC does not replace exercise or rest programs or the use of heat/cold treatments.
Do not give FENAC EC to anyone else, even if their condition seems similar to yours.
Do not take it to treat any other complaints unless your doctor tells you to.
Things to be careful of
Elderly patients should take the minimum number of tablets that provides relief of
symptoms.
Elderly patients, especially those with a low body weight, may be more sensitive to
the effects of FENAC EC than other adults.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how FENAC
EC affects you.
FENAC EC may cause dizziness, drowsiness, spinning sensation (vertigo) or blurred
vision in some people. If any of these occur, do not drive, use machine or do anything
else that could be dangerous.
Looking after your medicine
Keep your medicine in the original container until it is time to take it.
If you take the tablets out of the blister pack, they may not keep well.
Keep your tablets below 25°C.
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.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and a- half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take FENAC EC or it is out of date, take it to any pharmacy
for safe disposal.
Do not take FENAC EC after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
If you are over 65 years of age, you should be especially careful while taking FENAC
EC. Report any side effects promptly to your doctor.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
NSAIDs, including diclofenac, may be associated with increased risk of gastro-intestinal
anastomotic leak.
Close medical surveillance and caution are recommended when taking FENAC EC after
gastrointestinal surgery.
*If symptoms of vision disorders occur during treatment with FENAC EC, contact your
doctor as an eye examination may be considered to exclude other causes.
Serious side effects
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.
7. Product details
This medicine is only available with a doctor's prescription.
What FENAC EC contains
|
Active ingredient
(main ingredient)
|
25 mg or 50 mg diclofenac sodium per tablet
|
|
Other ingredients
(inactive ingredients)
|
colloidal anhydrous silica
microcrystalline cellulose
lactose monohydrate
magnesium stearate
maize starch
povidone
hypromellose
iron oxide yellow
iron oxide red (50 mg tablet only)
titanium dioxide
sodium starch glycollate type A
purified talc
PEG-40 hydrogenated castor oil
methacrylic acid - ethyl acrylate copolymer (1:1)
triethyl citrate
|
|
Potential allergens
|
sugars as lactose
|
Do not take this medicine if you are allergic to any of these ingredients.
What FENAC EC looks like
FENAC EC 25 mg: round, pale yellow, enteric coated tablets plain on both sides
(AUST R 272882).
Available in blister packs of 50 tablets.
FENAC EC 50 mg: round, pale brown, enteric coated tablets plain on both sides
(AUST R 272871).
Available in blister packs of 50 tablets.
Who distributes FENAC EC
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in December 2025.
FENAC® is a Viatris company trade mark
FENAC EC_cmi\Dec25/00