Contains the active ingredient, diclofenac sodium
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 . It does not contain all the information that is known about . 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 diclofenac is used for
The name of your medicine is Apo-Diclofenac. It contains the active ingredient, diclofenac sodium.
It is used to treat the symptoms of:
Rheumatism
Rheumatoid arthritis
Osteoarthritis
Pain with swelling (back pain, muscle damage and tendonitis)
Painful periods (dysmenorrhoea)
How it works
Diclofenac belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It also has analgesic (painkilling) and antipyretic (fever reducing) properties.
Diclofenac acts by reducing pain (at rest and on movement), morning stiffness and swelling of the joints associated with rheumatic diseases, as well as improving function.
In addition, it has been shown to relieve period pain (dysmenorrhoea).
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed diclofenac for another reason.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
Use in children
There is not enough information to recommend the use of this medicine in children.
Before you take diclofenac
When you must not take it
Do not take this medicine if you have had an allergic reaction to:
diclofenac
aspirin or any other NSAIDs
any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; muscle pain or tenderness or joint pain or rash, itching or hives on the skin.
Do not take this medicine if you are intolerant or allergic to lactose.
These tablets contain a small amount of lactose.
Do not take this medicine if you suffer from a stomach or duodenal ulcer and/or bleeding from the stomach or bowel (black, sticky motions).
Do not take this medicine if you suffer from severe heart, liver or kidney problems.
Do not take this medicine if you are in the last 3 months (last trimester) of pregnancy.
Diclofenac may affect your developing baby, and may delay labour and birth, if you take it at this stage of your pregnancy.
Do not take this medicine after the expiry date (EXP) printed on the pack.
If you take this medicine after the expiry date has passed, it may not work as well.
Do not take this medicine if the packaging is torn, shows signs of tampering or if it does not look quite right.
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 or pharmacist.
Before you start to take it
Tell your doctor if:
1. You have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
2. You have, or have had in the past, any medical conditions, especially the following:
problems with your heart, liver or kidney
asthma, rhinitis, nasal polyps or lung disease or other breathing problems
repeated chest infections
problems with blood clotting or other blood disorders
high blood pressure
diabetes
dehydration (e.g. by sickness or diarrhoea, before or after recent major surgery)
intolerance or allergy to lactose.
a stomach or duodenal ulcer, severe attacks of indigestion, or any other stomach or bowel disorder (e.g. ulcerative Colitis or Crohn's Disease).
problems with fluid retention
3. You are pregnant or planning to become pregnant
If you are trying to become pregnant your doctor will advise you whether to keep taking this medicine, as it may affect your chances of becoming pregnant
If you are in the first 6 months of pregnancy your doctor will discuss with you the risks and benefits of taking this medicine.
You must not take this medicine in the last 3 months of pregnancy.
4. You are breast-feeding or planning to breast-feed
This medicine passes into breast milk. Your doctor will discuss with you the benefits and risks of taking it whilst breast-feeding. It is not recommended that you take this medicine whilst breast-feeding.
Diclofenac can cover up some of the symptoms of infections so that you may think the infection is not serious.
6. You are about to have, or have just had, an operation.
Diclofenac can slow down blood clotting and may affect kidney function, or the healing process.
7. You smoke or drink large amounts of alcohol.
This can increase the chances of you having stomach problems or ulcers whilst taking this medicine.
If you have not told your doctor about any of the above, tell them before you start taking this medicine.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and diclofenac may interfere with each other. These include:
Lithium, and medicines called Selective-Serotonin Reuptake Inhibitors (SSRIs),used to treat some types of depression
Digoxin, a heart tablet
Antibiotic medicines called quinolones (e.g. ciprofloxacin or norfloxacin). The combination with diclofenac may cause convulsions
Anticoagulants (e.g. warfarin) and other medicines for thinning the blood
Antidiabetic medicines (tablets or injections) for diabetes
Methotrexate, a medicine used to treat rheumatoid arthritis, as well as some types of cancers
Cyclosporin, a medicine used after organ transplants, as well as to treat rheumatoid arthritis
Corticosteroids (anti-inflammatory medicines), especially the group called glucocorticoids (e.g. hydrocortisone and prednisolone)
Aspirin or any other anti-inflammatory (NSAID or COX-2 inhibitor) medications
Medicines for blood pressure and heart problems, such as beta-blockers or ACE inhibitors
Diuretics, also called fluid or water tablets
Voriconazole, a medicine used to treat serious fungal infections
Sulfinpyrazone, a medicine used to treat gout
Phenytoin, a medicine used to treat seizures
These medicines may be affected by diclofenac or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Note especially that the combination of diclofenac, ACE inhibitors and certain diuretics may seriously damage your kidneys.
Your doctor and pharmacist can tell you if you are taking any of these medicines. They may also have more information on medicines to be careful with or avoid while taking diclofenac.
Other interactions not listed above may also occur.
How to take this medicine
Follow all directions given to you by your doctor or pharmacist carefully.
They may be different to the information in this leaflet.
If you do not understand any written instructions, ask your doctor or pharmacist for help.
How much to take
Your doctor or pharmacist will tell you how many tablets you will need to take. This depends on your condition and whether or not you are taking any other medicines.
The initial dosage for arthritis and other painful inflammatory conditions is 75 to 150 mg per day.
For long-term treatment, 75 to 100 mg daily may be all that is needed.
The daily dose should generally be divided into two or three doses taken during the day.
For period pain, the daily dosage is generally 50 to 150 mg. The starting dose is normally 50 to 100 mg and, if necessary, can be increased over several months to a maximum of 200 mg/day. Treatment should be started when the period pain starts, and stopped after it goes away.
How to take it
The tablets should be swallowed whole with liquid.
Do not break, crush or chew the tablets.
When to take it
Take it at about the same time each day.
Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take it.
You may take it with, or immediately after food in order to reduce the chance of stomach upset.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
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 go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you experiencing side effects.
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 (Tel: 13 11 26 for Australia) for advice, or go to the Accident and Emergency department at the nearest hospital, if you think that you or anyone else may have taken too much diclofenac.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too much diclofenac, you may experience vomiting, diarrhoea, bleeding from the stomach or bowel, dizziness, ringing in the ears and/or convulsions (fits).
While you are taking diclofenac
Things you must do
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking diclofenac.
Tell your doctor immediately if you become pregnant.
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
If you are about to start taking a new medicine, remind your doctor and pharmacist that you are taking diclofenac.
Go to your doctor regularly for a check-up.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.
Things you must not do
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not take your medicine to treat any other complaints unless your doctor tells you to.
Do not stop taking your medicine, or change the dosage, without checking with your doctor.
Things to be careful of
Be careful while driving or operating machinery until you know how diclofenac affects you.
Diclofenac may cause dizziness or light-headedness in some people.
Side effects of diclofenac
All medicines may have some side effects. Sometimes they are serious, but most of the time, they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking diclofenac.
Ask your doctor or pharmacist to answer any questions you may have.
Following is a list of possible side effects. Do not be alarmed by this list. You may not experience any of them.
Tell your doctor or pharmacist if you notice any of the following:
stomach pain
feeling of fullness and/or heartburn after eating, nausea, vomiting
constipation, diarrhoea
abdominal cramps
flatulence (wind)
loss of appetite
sore mouth or tongue
strange taste
skin rashes
itching
giddiness (vertigo) or dizziness
headache
hair loss or thinning
The above list includes the more common side effects. Mostly, these are mild.
Tell your doctor as soon as possible if you notice any of the following:
drowsiness, disorientation, forgetfulness
feeling depressed, anxious or irritable
strange or disturbing thoughts or moods
shakiness, sleeplessness, nightmares
tingling or numbness of the hands or feet
feeling of fast and irregular heartbeat
sharp pains in your abdomen
unusual weight gain or swollen ankles or legs due to fluid build-up
sunburn that happens after only a short time in the sun
blurred or double vision
buzzing or ringing in the ears, problems hearing
signs of a possible blood problem such as persistent flu-like symptoms (sore throat, fever, swollen glands, aches), or bleeding or bruising more than normal.
These may be serious side effects. You may need medical attention. Most of these side effects are rare.
If any of the following happen, stop taking your medicine and either tell your doctor immediately or go to Accident and Emergency department at your nearest hospital:
rash, itching, hives on the skin, swelling of the face, lips, mouth or throat, difficulty swallowing or breathing (signs of an allergic reaction)
peptic ulceration and gastrointestinal bleeding may occur in some patients. You may feel unusually weak and tired, or notice blood in your faeces or have black, sticky faeces. You may vomit blood or material that looks like coffee grounds and may have severe stomach pain or tenderness.
liver problems such as nausea, loss of appetite, tiredness, vomiting, pain in the upper right abdomen, yellow skin and/or eyes, dark urine, pale faeces (signs of liver problems)
serious skin reactions such as painful red areas, large blisters, peeling skin, bleeding lips, eyes, mouth, nose or genitals
sudden and severe headache, and/or nausea, stiff neck, dizziness, numbness, problems speaking, paralysis, convulsions (fits) (possible signs of stroke or brain problem)
kidney problems indicated by a change in the colour or amount of urine passed, a need to urinate more often, burning feeling when urinating, blood in the urine
fainting
convulsions (fits)
chest pain (possible sign of a heart attack).
These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.
Other side effects not listed above may occur in some patients.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
After taking this medicine
Storage
Keep your medicine in its original packaging until it is time to take them.
If you take the tablets out of their original bottle they may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, 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 or pharmacist tells you to stop taking this medicine or it has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.
Where to go for further information
Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.
Product description
What Apo-Diclofenac looks like
Apo-Diclofenac 25 mg Tablets:
Round, brown-yellow film coated tablets.
Apo-Diclofenac 50 mg Tablets:
Round, brown-yellow film coated tablets.
Ingredients
Each tablet 25 or 50 mg of diclofenac as the active ingredient.
It also contains the following inactive ingredients:
In addition the tablets contain the following inactive ingredients:
lactose
calcium hydrogen phosphate
microcrystalline cellulose
maize starch
sodium starch glycollate
magnesium stearate
colloidal silicon dioxide
methacrylic acid copolymer
triethyl citrate
talc
titanium dioxide
yellow ferric oxide.
This medicine is gluten-free, sucrose-free, tartrazine-free and other azo dyes-free.
Australian Registration Numbers
Apo-Diclofenac 25 mg tablets:
Blister packs of 50 tablets.
AUST R 160729.
Apo-Diclofenac 50 mg tablets:
Blister packs of 50 tablets.
AUST R 160730.
Not all strengths, pack types and/or pack sizes may be available.
Sponsor
Apotex Pty Ltd
66 Waterloo Road
North Ryde NSW 2113
Australia
Apotex Pty Ltd is the licensee of the registered trade marks APO and APOTEX from the registered proprietor, Apotex Inc.
This leaflet was prepared in:
December 2010.
