diclofenac sodium 25 mg & 50 mg enteric coated tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions about DINAC. 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 DINAC 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 want to read it again.
What DINAC Tablets are used for
The name of your medicine is DINAC. It contains the active ingredient diclofenac sodium.
DINAC is used for treating 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 dysmenorrhoea (heavy, painful periods).
Your doctor may have prescribed DINAC for another reason. Ask your doctor if you have any questions about why DINAC was prescribed for you.
DINAC belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It also has analgesic and antipyretic 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 pain in dysmenorrhoea.
There is no evidence that DINAC is addictive.
Before you take DINAC Tablets
When you must not take DINAC Tablets
DINAC tablets should not be used by children. In adults, they should not be taken if:
- You are allergic to the active ingredient or any of the inactive ingredients mentioned at the end of this leaflet under Product Description.
- You have had allergic reactions (such as asthma, itchy rash or severe hay fever) after taking aspirin or any other NSAIDs.
- You suffer from a stomach ulcer, bleeding from the stomach or bowel.
- It has passed its expiry date or the packaging appears to have been tampered with.
- You are pregnant or breast feeding, or if there is a possibility that pregnancy may occur.
Before you start to take DINAC Tablets
Tell your doctor if you plan on becoming pregnant or will be breast feeding while you are using DINAC.
Tell your doctor if you have any medical conditions, especially the following:
- problems with your heart, liver or kidney function.
- any infection.
- a stomach ulcer, severe attacks of indigestion, or any other stomach or bowel disorder in the past.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.
In particular, tell your doctor if you take any of the following:
- Lithium, a medicine used to treat some types of depression
- Digoxin, a heart tablet
- Diuretics, also called fluid or water tablets
- Medicines which lower blood pressure
- Aspirin or any other anti-inflammatory (NSAID or COX-2 inhibitor) medications
- Anticoagulants, tablets for thinning the blood
- Antidiabetic agents, for diabetes
- Methotrexate, a medicine used for treatment of rheumatoid arthritis, as well as some types of cancers
- Cyclosporin, a medicine used after organ transplants, as well as in the treatment of rheumatoid arthritis
- Glucocorticoids, a group of anti-inflammatory medications
These medicines may be affected by DINAC, 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.
Tell your doctor or pharmacist if you are currently taking a diuretic and other medicine(s) to help lower blood pressure at the same time. Sometimes diuretics and certain blood pressure lowering drugs are combined in the one product. If you are taking these drug combinations, your doctor may advise a blood test to check your kidney function before you start to take DINAC.
How to take DINAC Tablets
The daily dose should generally be prescribed in two or three divided doses. The prescribed dose should be swallowed whole with a glass of water. You may take it with or immediately after food in order to reduce the chance of stomach upset.
The dosage and duration of treatment will be determined for you by your doctor.
If you forget to take your dose
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 you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you take too much
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) or go to accident and emergency at your nearest hospital, if you think that you or anyone else has taken too much DINAC.
Do this even if there are no signs of discomfort or poisoning.
While you are using DINAC Tablets
Things you must do
- Always follow your doctor’s instructions carefully.
- Tell your doctor if you become pregnant while taking DINAC.
- If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking DINAC.
Things you must not do
- Do not use DINAC to treat any other complaint unless your doctor says so.
- Do not give this medication to anyone else, even if their symptoms seem similar to yours.
Things to be careful of
Be careful driving or operating machinery until you know how DINAC affects you. DINAC may cause dizziness or light-headedness in some people.
Side effects
All medicines can have unwanted effects. Sometimes they are serious, most of the time they are not. Do not be alarmed by this list of possible side effects. You may not experience any of them.
The most common side effects seen in patients taking diclofenac preparations are:
- stomach pain
- nausea, vomiting, diarrhoea
- abdominal cramps
- flatulence
- anorexia
- rashes
- dizziness
- headache
- vertigo
These are the more common side effects of DINAC. Mostly, these are mild and short-lived.
If any of the following happen, stop taking DINAC, and tell your doctor immediately, or go to accident and emergency at your nearest hospital:
- swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
- peptic ulceration and gastrointestinal bleeding.
If you feel unusually weak and tired, or notice blood in your faeces, together with severe stomach pain, stop taking the tablets and see your doctor immediately.
These are very serious side effects. You may need urgent medical attention or hospitalisation.
Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.
After using DINAC
Storage
Keep DINAC in the original packaging until you need to take it.
Store below 25 de C in a dry place, out of the reach of children.
Disposal
Return any unused or out of date medicine to your pharmacist.
Product Description
What DINAC Tablets look like
DINAC 25 mg: round, brown-yellow film coated tablets. They are available in bottles of 50 tablets.
DINAC 50 mg: round, brown-yellow film coated tablets. They are available in bottles of 50 tablets.
Ingredients
Active Ingredient is diclofenac sodium. DINAC also contains some inactive ingredients. These are lactose, calcium hydrogen phosphate, microcrystalline cellulose, maize starch, sodium starch glycollate, magnesium stearate, colloidal silicon dioxide, methacrylic acid copolymer, triethyl citrate, talc, titanium dioxide and yellow ferric oxide.
Supplier
DINAC is supplied in Australia by:
Douglas Pharmaceuticals Australia Ltd
3/10 Inglewood Place
Norwest Business Park
BAULKHAM HILLS NSW 2153
Australian Registration Numbers:
25 mg tablets:
Bottles- AUST R 68941
50 mg tablets:
Bottles- AUST R 68943
Date of leaflet preparation: 20 April 2005
Published by MIMS December 2005