diclofenac sodium enteric-coated tablets
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Diclofenac Sandoz.
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 DICLOFENAC SANDOZ IS USED FOR
Diclofenac Sandoz is used to treat the symptoms of inflammatory and degenerative forms of rheumatism, rheumatoid arthritis and osteoarthritis. It is also used to relieve states of acute or chronic pain in which there is an inflammatory component, as well as for the symptomatic treatment of menstrual pain (period pain).
It contains the active ingredient diclofenac sodium.
Diclofenac sodium belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It works by reducing pain and inflammation (swelling and redness).
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
There is no evidence that this medicine is addictive.
BEFORE YOU TAKE DICLOFENAC SANDOZ
When you must not take it
Do not take this medicine if you have an allergy to:
diclofenac sodium, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description.
any other similar medicines, such as aspirin or other NSAIDs.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take this medicine if you have or have had any of the following medical conditions:
stomach or intestinal ulcer
bleeding from the stomach or bowel (symptoms of which may include blood in your stools or black stools)
severe kidney or liver problems
severe heart failure.
Do not take this medicine during the last three months of pregnancy. It may affect your developing baby if you take it during the last three months of pregnancy.
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 you doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
history of ulcers (stomach or intestinal)
gastrointestinal problems such as stomach ulcer, bleeding or black stools, or have experienced stomach discomfort or heartburn after taking anti-inflammatory medicines in the past
Crohn’s disease or ulcerative colitis, which are diseases of the bowel
a tendency to bleed or other blood problems such as anaemia
history of haemorrhoids (piles) or irritation of the rectum (back passage)
any heart problems, including disease of the heart with shortness of breath, and swelling of the feet or lips due to fluid build-up
problems with your liver or kidney function
asthma or any other chronic lung disease that causes difficulty in breathing
seasonal allergies (e.g. hay fever)
repeated chest infections
polyps in the nose
recent major surgery
high blood pressure.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.
Tell your doctor if you are lactose intolerant. Diclofenac Sandoz tablets contain lactose.
Tell your doctor if you 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 him/her before you start taking Diclofenac Sandoz.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicine, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Diclofenac Sandoz may interfere with each other. These include:
aspirin, salicylates, ibuprofen, or other NSAID medicines
anticoagulants such as warfarin, medicines used for thinning the blood or stop blood clots
digoxin, a medicine used to treat heart problems
lithium or selective serotonin-reuptake inhibitors (SSRIs), medicines used to treat some types of depression
diuretics, also called fluid or water tablets, 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
corticosteroids, medicines such as prednisone and cortisone, used to reduce the activity of your immune system
antidiabetic agents, medicines used to treat diabetes
methotrexate, a medicine used to treat arthritis, as well as some types of cancers
cyclosporin, a medicine used in patients who have received organ transplants
glucocorticoids, a group of anti-inflammatory medications, used to treat arthritis
certain antibiotics called quinolones
voriconazole, a medicine used to treat fungal infections.
These medicines may be affected by Diclofenac Sandoz, 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 this medicine.
HOW TO TAKE DICLOFENAC SANDOZ
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How much to take
The usual starting dose is 75mg to 150mg per day. For long-term treatment, 75mg to 100mg daily is usually sufficient.
In period pain, the usual starting dose is 50mg to 100mg per 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 increased over several menstrual cycles up to a maximum of 200mg per day.
Ask your doctor or pharmacist if you are unsure of the correct dose for you.
They will tell you exactly how much to take.
Follow the instructions they give you.
If you take the wrong dose, Diclofenac Sandoz may not work as well and your problem may not improve.
How to take it
Swallow the tablets whole with a full glass of water or other liquid.
Do not chew them. These tablets have a special coating to stop them dissolving until they have gone through the stomach and into the intestines, where they can start to work. If you chew them, the coating is destroyed.
When to take Diclofenac Sandoz
It is recommended to take the tablets before meals. You may take them with, or immediately after food in order to reduce the chance of stomach upset.
How long to take Diclofenac Sandoz
Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition but does not cure it.
If you forget to take it
Take your dose as soon as you remember, and continue to take it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
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 (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much Diclofenac Sandoz. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms of an overdose may include:
bleeding from the stomach or bowel
ringing in the ears
WHILE YOU ARE TAKING DICLOFENAC SANDOZ
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Diclofenac Sandoz.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It can slow down blood clotting and affect kidney function.
If you become pregnant while taking this medicine, tell your doctor immediately.
Tell your doctor if you get an infection while taking this medicine.
This medicine 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.
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor may do some tests (check your kidneys, liver and blood) from time to time to prevent unwanted side effects.
Things you must not do
Do not take any of the following medicines while you are taking Diclofenac Sandoz without first telling your doctor:
aspirin (also called ASA or acetylsalicylic acid)
other medicines containing diclofenac
any other NSAID medicine.
If you take these medicines together with Diclofenac Sandoz, they may cause unwanted side effects.
If you need to take something for headache or fever, it is usually okay to 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.
This medicine does not replace exercise or rest programs or the use of heat/cold treatments.
Do not take Diclofenac Sandoz to treat any other complaints unless your doctor tells you to.
Do not give your medicine 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 Diclofenac Sandoz affects you.
This medicine may cause dizziness or light-headedness in some people.
Elderly patients should take the minimum number of tablets that provides relief of symptoms.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Diclofenac Sandoz.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
If you are over 65 years of age you may have an increased chance of getting side effects.
Do not be alarmed by the following list of 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 pain including nausea (feeling sick), vomiting, indigestion, loss of appetite, weight loss, wind, abdominal cramps
skin rashes, skin inflammation with flaking or peeling
dizziness, spinning sensation
drowsiness, disorientation, forgetfulness
sore mouth or tongue
altered taste sensation
feeling depressed, anxious or irritable
strange or disturbing thoughts or moods, nightmares, sleeplessness, shakiness
tingling or numbness of the hands or feet
feeling fast or irregular heart beat
unusual weight gain or swelling of ankles or legs due to fluid build up
symptoms of sunburn that happen more quickly than usual (redness, itching, swelling, blistering of the lips, eyes, mouth and/or skin)
blurred or double vision
difficulty hearing, buzzing or ringing of the ears
hair loss or thinning.
If any of the following happen, tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:
red or purple skin
severe pain or tenderness in the stomach, vomiting blood or material that looks like coffee grounds, bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea
rash, itching or hives on the skin, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
persistent nausea, loss of appetite, unusual tiredness, vomiting, pain in the upper right abdomen, yellowing of the skin/or eyes, dark urine or pale bowel motions
constant “flu-like” symptoms (chills, fever, sore throat, aching joints, swollen glands, tiredness or lack of energy), bleeding or bruising more easily than normal
development of painful red areas, large blisters, peeling of skin, bleeding lips, eyes, mouth, nose or genitals which may be accompanied by fever and chills, aching muscles and generally feeling unwell
sudden and severe headache, stiff neck, severe nausea, dizziness, numbness, difficulty in speaking, paralysis, fainting, convulsions/seizures (fits)
change in the colour or amount of urine passed, blood in the urine, burning feeling when passing urine and frequent need to urinate
chest pains which may be a sign of a heart attack.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some people.
AFTER TAKING DICLOFENAC SANDOZ
Keep your medicine in the original container.
If you take it out of its original container it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store Diclofenac Sandoz 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.
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
What it looks like
Diclofenac Sandoz tablets come in two strengths:
Diclofenac Sandoz 25mg - round, brown-yellow enteric-coated tablets.
Diclofenac Sandoz 50mg - round, brown-yellow enteric-coated tablets.
Available in blisters or bottles of 50 tablets.
Diclofenac Sandoz 25mg - 25mg diclofenac sodium
Diclofenac Sandoz 50mg - 50mg diclofenac sodium
calcium hydrogen phosphate
sodium starch glycollate
colloidal silicon dioxide
methacrylic acid copolymer
yellow ferric oxide.
Sandoz Pty Ltd
ABN 60 075 449 553
Level 4, 100 Harris St
Pyrmont NSW 2009
Tel: 1800 634 500 1800 634 500
Novartis New Zealand Ltd
Private Bag 65904 Mairangi Bag
Tel: 0800 354 335 0800 354 335
This leaflet was revised in February 2010.
Australian Register Numbers:
Diclofenac Sandoz 25mg - AUST R 63664 (blisters)
Diclofenac Sandoz 25mg - AUST R 61297 (bottles)
Diclofenac Sandoz 50mg - AUST R 63661 (blisters)
Diclofenac Sandoz 50mg - AUST R 61298 (bottles)
Published by MIMS/myDr May 2010
Consumers should be aware that the information provided by the Consumer Medicines Information (“CMI”) search (“CMI Search”) is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. All copyright and responsibility for CMI is that of the relevant pharmaceutical company. UBM Medica Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource (e.g. “Published by MIMS/myDr January 2007”), the CMI provided was complete to the best of UBM Medica Australia’s knowledge. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. UBM Medica Australia, its servants and agents shall not be responsible for the continued currency of the CMI, or for any errors, omissions or inaccuracies in the CMI and/or the CMI Search whether arising from negligence or otherwise or from any other consequence arising there from