SUMMARY CMI

DICLOFENAC-WGR

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist.

1. Why am I taking DICLOFENAC-WGR?

DICLOFENAC-WGR contains the active ingredient diclofenac sodium. DICLOFENAC-WGR is taken to treat pain and reduce inflammation (swelling and redness) that may occur in 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). For more information, see Section 1. Why am I taking DICLOFENAC-WGR? in the full CMI.

2. What should I know before I take DICLOFENAC-WGR?

Do not take DICLOFENAC-WGR if you have ever had an allergic reaction to diclofenac sodium or any of the ingredients listed at the end of this leaflet. Do not take if you have had a 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, heart bypass surgery.

Do not take DICLOFENAC-WGR during the first 6 months of pregnancy, except on doctor's advice. Do not take DICLOFENAC-WGR 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. Tell your doctor if you are breastfeeding or wish to breastfeed. Like most NSAID medicines, DICLOFENAC-WGR is not recommended for use during breastfeeding because DICLOFENAC-WGR passes into breast milk and may affect your baby.

For more information, see Section 2. What should I know before I take DICLOFENAC-WGR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with DICLOFENAC-WGR 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.

4. How do I take DICLOFENAC-WGR?

• DICLOFENAC-WGR 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.

More instructions can be found in Section 4. How do I take DICLOFENAC-WGR? in the full CMI.

5. What should I know while taking DICLOFENAC-WGR?

For more information, see Section 5. What should I know while taking DICLOFENAC-WGR? in the full CMI.

6. Are there any side effects?

There are a number of side effects associated with DICLOFENAC-WGR. It is important to be aware of them so that you can identify any symptoms if they occur. 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.

FULL CMI

DICLOFENAC-WGR

Active ingredient: diclofenac sodium

Consumer Medicine Information (CMI)

This leaflet provides important information about taking DICLOFENAC-WGR. 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 DICLOFENAC-WGR.

Where to find information in this leaflet:

1. Why am I taking DICLOFENAC-WGR?
2. What should I know before I take DICLOFENAC-WGR?
3. What if I am taking other medicines?
4. How do I take DICLOFENAC-WGR?
5. What should I know while taking DICLOFENAC-WGR?
6. Are there any side effects?
7. Product details

1. Why am I taking DICLOFENAC-WGR?

DICLOFENAC-WGR contains the active ingredient diclofenac sodium. DICLOFENAC-WGR belongs to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines can relieve the symptoms of pain and inflammation, but they will not cure your condition.

DICLOFENAC-WGR is taken to treat pain and reduce inflammation (swelling and redness) that may occur in the following:

• Different types of arthritis including rheumatoid arthritis including rheumatoid 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).

Your doctor may have prescribed this medicine for another reason.

Ask your doctor if you have any questions about why it has been prescribed for you. Your doctor may have prescribed it for another purpose.

DICLOFENAC-WGR is only available with a doctor's prescription.

This medicine is not addictive.

2. What should I know before I take DICLOFENAC-WGR?

Warnings

Do not take DICLOFENAC-WGR if:

• you are allergic (hypersensitive) to:
  - diclofenac sodium, or any of the ingredients listed at the end of this leaflet.
  - other medicines containing diclofenac sodium.
  - aspirin.
  - ibuprofen.
  - any other NSAID medicines.

If you are not sure if you are taking any of the above medicines, ask your doctor or pharmacist.

Some of the symptoms of an allergic reaction 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 take DICLOFENAC-WGR, these symptoms may be severe.

Do not take DICLOFENAC-WGR 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).
• Severe kidney or liver problems.
• Severe heart failure.
• Heart bypass surgery.

Do not take DICLOFENAC-WGR during the first 6 months of pregnancy, except on doctor's advice. Do not take 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.

Do not take DICLOFENAC-WGR if the expiry date printed on the carton has passed.

Do not take DICLOFENAC-WGR if the packaging is torn or shows signs of tampering.

Do not give DICLOFENAC-WGR to children. DICLOFENAC-WGR is not recommended for use in children, there is not enough information on its use in this age group.

Tell your doctor if you have any medical conditions, especially the following:

• Established disease of the heart or blood vessels (also called cardiovascular disease, including uncontrolled high blood pressure, congestive heart failure, established ischemic heart disease, peripheral arterial disease or atherosclerotic cardiovascular disease), as treatment with DICLOFENAC-WGR 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 DICLOFENAC-WGR, you must not increase the dose above 100 mg per day if you are treated for more than 4 weeks.
• A past 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.
• Diseases of the bowel or inflammation of the intestinal tract (Crohn's disease) or colon (ulcerative 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 care if you have any of these conditions.

It is generally important to take the lowest dose that relieves your pain and/ or swelling and for the shortest time possible in order to keep your risk for heart problems or high blood pressure as small as possible.

Tell your doctor if you currently have an infection.

If you take DICLOFENAC-WGR 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.

Tell your doctor if you are lactose intolerant.

DICLOFENAC-WGR tablets contain lactose.

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Your doctor will want to know if you are prone to allergies, especially if you get skin reaction with redness, itching or rash.

If you have not told your doctor about any of the above, tell your doctor before taking DICLOFENAC-WGR.

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 plan to become pregnant.

There is not enough information to recommend DICLOFENAC-WGR during the first 6 months of pregnancy and it must not be used during the last 3 months. This medicine may also reduce fertility and affect your chances of becoming pregnant. Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you are breastfeeding or wish to breastfeed. Like most NSAID medicines, DICLOFENAC-WGR is not recommended for use during breastfeeding because DICLOFENAC-WGR passes into breast milk and may affect your baby.

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.

You may need to take different amounts of your medicine or to take different medicines while you are taking DICLOFENAC-WGR. Your doctor and pharmacist have more information.

Some medicines may interfere with DICLOFENAC-WGR and affect how it works:

• 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 and tacrolimus, medicines used in patients who have received organ transplants.
• Trimethoprim used to 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).

4. How do I take DICLOFENAC-WGR?

How much to take

To Treat Arthritis or Other Painful Conditions

The usual starting dose of DICLOFENAC-WGR 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 DICLOFENAC-WGR 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.

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 on the carton, ask your doctor or pharmacist for help.

There are different ways to take this medicine depending upon your condition. Your doctor will tell you exactly how many tablets to take.

Elderly patients should take the minimum number of tablets that provides relief of symptoms. Elderly patients may be more sensitive to the effects of DICLOFENAC-WGR than other adults.

Do not exceed the recommended dose.

When to take DICLOFENAC-WGR

It is recommended to take DICLOFENAC-WGR 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 DICLOFENAC-WGR

DICLOFENAC-WGR tablets are usually taken in 2 or 3 doses during the day.

Swallow the tablets whole with a full glass of water. Do not chew them. The tablets have a special coating to stop them dissolving until they have passed through the stomach into the bowel. Chewing them would destroy the coating.

How long to take DICLOFENAC-WGR

Do not take DICLOFENAC-WGR for longer than your doctor says.

If you are taking DICLOFENAC-WGR for arthritis, it will not cure your disease but it should help 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 DICLOFENAC-WGR

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 the missed dose as soon as you remember, and then go back to taking your tablets 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 unwanted side effects.

Ask your doctor or pharmacist if you are not sure what to do.

If you take too much DICLOFENAC-WGR

If you think that you have taken too much DICLOFENAC-WGR, 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.

If you take too much DICLOFENAC-WGR, you may experience:

• Vomiting.
• Bleeding from the stomach or bowel.
• Diarrhoea.
• Dizziness.
• Ringing in the ears.
• Convulsions (fits).

5. What should I know while taking DICLOFENAC-WGR?

Things you should do

If you take DICLOFENAC-WGR for more than a few weeks, you should make sure you visit your doctor for regular check-ups to ensure that you are not suffering from unnoticed undesirable side effects.

If you become pregnant while taking DICLOFENAC-WGR, tell your doctor immediately. Your doctor can discuss with you the risk of taking it while you are pregnant.

Be sure to keep all your doctor's appointments so that your progress can be checked.

Your doctor will periodically re-evaluate whether you should continue treatment, 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 DICLOFENAC-WGR 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 plan to have surgery, including dental surgery, tell your doctor or dentist that you are taking DICLOFENAC-WGR. NSAID medicines can slow down blood clotting and affect kidney function.

If you get an infection while taking DICLOFENAC-WGR, tell your doctor. 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.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking DICLOFENAC-WGR. Tell any other doctors, dentists and pharmacists who are treating you that you are taking DICLOFENAC-WGR.

Things you should not do

Do not take any of the following medicines while you are taking DICLOFENAC-WGR without first telling your doctor:

• Aspirin (also called ASA or acetylsalicylic acid).
• Other salicylates.
• Other medicines containing diclofenac (e.g. Voltaren tablets, Voltaren Emulgel).
• Ibuprofen.
• Any other NSAID medicines.

If you take these medicines together with DICLOFENAC-WGR, they may cause unwanted effects.

If you need to take medicine 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-WGR to treat any other conditions unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Driving or using machines

Be careful driving, operating machinery or doing jobs that require you to be alert until you know how DICLOFENAC-WGR affects you. DICLOFENAC-WGR may cause dizziness, drowsiness, spinning sensation (vertigo) or blurred vision in some people. If you have any of these symptoms, do not drive or do anything else that could be dangerous.

Looking after your medicine

Follow the instructions on the carton on how to take care of your medicine properly.

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 may not keep well.

Store your tablets in a cool dry place where the temperature stays below 25°C. Store 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 take DICLOFENAC-WGR or it is out of date, take it to any pharmacy for safe disposal.

Do not take DICLOFENAC-WGR after the expiry date.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking DICLOFENAC-WGR.

Like all other medicines, DICLOFENAC-WGR may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment 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. Report any side effects to your doctor. As people grow older, they are more likely to get side effects from medicines.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Less serious side effects

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 DICLOFENAC-WGR contains

This medicine is gluten free.

Do not take this medicine if you are allergic to any of these ingredients.

What DICLOFENAC-WGR looks like

DICLOFENAC-WGR 25 mg Tablets

Pale yellow, round, enteric coated tablets plain on both sides. AUST R 272873.

Blister pack containing 20 or 50 tablets*.

DICLOFENAC-WGR 50 mg Tablets

Pale brown, round, enteric coated tablets plain on both sides. AUST R 272877.

Blister pack containing 10, 20 or 50 tablets*.

*Not all pack size are available.

Who distributes DICLOFENAC-WGR

Wagner Pharmaceuticals Pty Ltd
6 Albert Street
Preston VIC 3072
Tel: 1800 936 140

This leaflet was prepared in December 2024.

Published by MIMS March 2025