FULL CMI

Pharmacy Action Diclofenac Rapid 25

Active ingredient: diclofenac potassium

Consumer Medicine Information (CMI)

This leaflet provides important information about using Pharmacy Action Diclofenac Rapid 25. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Pharmacy Action Diclofenac Rapid 25.

Where to find information in this leaflet:

1. Why am I using Pharmacy Action Diclofenac Rapid 25?
2. What should I know before I use Pharmacy Action Diclofenac Rapid 25?
3. What if I am taking other medicines?
4. How do I use Pharmacy Action Diclofenac Rapid 25?
5. What should I know while using Pharmacy Action Diclofenac Rapid 25?
6. Are there any side effects?
7. Product details

1. Why am I using Pharmacy Action Diclofenac Rapid 25?

Pharmacy Action Diclofenac Rapid 25 contains the active ingredient diclofenac potassium. Pharmacy Action Diclofenac Rapid 25 belongs to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Pharmacy Action Diclofenac Rapid 25 relieves pain and reduces inflammation (swelling and redness).

Pharmacy Action Diclofenac Rapid 25 is used for short-term treatment of following conditions:

• The relief of migraine headaches. It may also relieve accompanying symptoms, such as nausea and vomiting, which you sometimes experience when you have a migraine.
• The relief of menstrual cramps (period pain).
• The short-term treatment (up to 1 week) of painful conditions where swelling is a problem such as back or joint pain, dental pain, muscle strains or sprains and tendinitis (eg. tennis elbow).

Pharmacy Action Diclofenac Rapid 25 can relieve the symptoms of pain and inflammation, but it will not cure your condition.

2. What should I know before I use Pharmacy Action Diclofenac Rapid 25?

Warnings

Do not use Pharmacy Action Diclofenac Rapid 25 if you:

• are allergic to diclofenac potassium, or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine.
• are allergic (hypersensitive) to other medicine containing diclofenac.
• are allergic (hypersensitive) to aspirin.
• are allergic (hypersensitive) to any other anti-inflammatory medicines.
  Many medicines used to treat headache, period pain and other aches and pains contain aspirin or anti-inflammatory medicines. If you are not sure, if you are taking any of these medicines, ask your pharmacist.
  Symptoms of an allergic reaction to these medicines may include:
  - asthma, wheezing or shortness of breath;
  - swelling of the face, lips or tongue which may
  - cause difficulty in swallowing or breathing;
  - hives, itching or skin rash;
  - fainting.
  If you are allergic to aspirin or anti-inflammatory medicines and take Pharmacy Action Diclofenac Rapid 25, these symptoms may be severe. If you get an allergic reaction, stop taking and see your doctor immediately.
• currently have a stomach or intestinal ulcer, or other stomach disorder.
• have bleeding from the stomach or bowel (symptoms of which may include blood in your stools or black stools).
• have impaired kidney or severe liver disease.
• have heart failure.

Do not give this medicine to a child under 14 years of age.

There is not enough information on the use of Pharmacy Action Diclofenac Rapid 25 in children under that age.

Tell your doctor or pharmacist if any of the above apply because Pharmacy Action Diclofenac Rapid 25 is not suitable for you in these circumstances.

Do not take Pharmacy Action Diclofenac Rapid 25 during the last 3 months of pregnancy.

Use of this medicine during the last 3 months of pregnancy may affect your baby and may delay labour and birth.

Do not take Pharmacy Action Diclofenac Rapid 25 after the expiry date printed on the pack.

Do not take Pharmacy Action Diclofenac Rapid 25 if the foil seal over the tablets has been broken or shows signs of tampering. In that case, return it to your pharmacist.

Check with your doctor or pharmacist if you:

• are allergic to any other medicines, including aspirin or other NSAID medicines, foods, preservatives or dyes. They will want to know if you are prone to allergies. Talk to your doctor before taking Pharmacy Action Diclofenac Rapid 25 if you have:
• asthma or any other chronic lung disease that causes difficulty in breathing;
• have had any other 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 or peripheral arterial disease) or history of blood vessel disease;
  - significant risk factors for heart disease, such as high blood pressure, abnormally high levels of fat (cholesterol, triglycerides) in your blood, diabetes or if you smoke;
  - history of ulcers (stomach or intestinal);
  - gastrointestinal problems such as stomach ulcer, bleeding or black stools (vomiting blood or bleeding from the back passage);
  - stomach discomfort or heartburn after taking pain relievers or anti-inflammatory medicines;
  - diseases of the bowel or inflammation of the intestinal tract (Crohn's disease) or colon (ulcerative colitis);
  - liver or kidney problems;
  - a rare liver condition called hepatic porphyria;
  - bleeding disorder or other blood disorders such as anaemia;
  - diabetes;
  - dehydration (eg. by sickness, diarrhoea, before or after recent major surgery);
  - swollen feet.
  Do not exceed the recommended dose.
  Treatment with anti-inflammatory medicines, such as diclofenac, may be associated with an increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. If you have existing heart disease or risk factors for heart disease, you may be at greater risk. It is generally important to take the lowest dose of Pharmacy Action Diclofenac Rapid 25 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.
• have an infection in the present time
  If you take Pharmacy Action Diclofenac Rapid 25 while you have an infection, some of the signs of the infection may be hidden (pain, fever, swelling, redness). The tablets may hide some of the signs of an infection. You may think, mistakenly, that you are better or that the infection is not serious.
• Are pregnant or trying to become pregnant
  Unless your doctor has told you to, do not use Pharmacy Action Diclofenac Rapid 25 during the first 6 months of pregnancy. Do not use at all during the last 3 months of pregnancy.
• Are breastfeeding.
  Unless a doctor has told you to, do not use Pharmacy Action Diclofenac Rapid 25 tablet during breastfeeding.
• take any medicines for any other condition

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

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

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 that are important to mention include:

These include:

• other anti-inflammatory medicines, eg. aspirin, salicylates, or ibuprofen;
• lithium or selective serotonin reuptake inhibitors (SSRIs), medicines used to treat depression;
• digoxin, a medicine used to treat heart problems;
• ACE inhibitors or beta-blockers, medicines used to treat high blood pressure or heart conditions, glaucoma and migraine;
• diuretics, also called fluid or water tablets, used to increase the amount of urine;
• medicines used to treat diabetes, except insulin;
• prednisone, cortisone, or other corticosteroids, medicines used to provide relief for inflamed areas of the body;
• warfarin, other blood thinners or anticoagulants, medicines used to prevent blood clotting;
• methotrexate, a medicine used to treat arthritis and some cancers;
• ciclosporin or tacrolimus, medicines in patients who have received organ transplants;
• trimethoprim, a medicine used to prevent or treat urinary tract infection;
• quinolone antibacterials, medicines used to treat infections;
• 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.

These medicines may be affected by Pharmacy Action Diclofenac Rapid 25 and may affect how well it works.

You may need to take different amounts of your medicine, or you may need to take different medications.

Your pharmacist and doctor have more information on medicines to be careful with or to avoid while taking Pharmacy Action Diclofenac Rapid 25.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affects Pharmacy Action Diclofenac Rapid 25.

4. How do I use Pharmacy Action Diclofenac Rapid 25?

Follow all directions given to you by your pharmacist or doctor carefully.

These instructions may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your pharmacist or doctor for help.

How much to take / use

• Ask your pharmacist or doctor 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.
• Do not take more than the recommended dose. Take the lowest dose of Pharmacy Action Diclofenac Rapid 25 that relieves your pain and/or swelling. Stop taking as soon as your symptoms are relieved. Do not take for longer than a few days at a time.

For adults and children aged 14 years and over:

• Take 2 tablets initially, then 1 tablet every 8 hours as necessary.

How to take it

• Swallow the tablet with a glass of water.
• Follow the instructions provided with the medicine.

When to take Pharmacy Action Diclofenac Rapid 25

• Take the tablets on an empty stomach (at least half an hour before food or two hours after food). They will work more quickly if you take them on an empty stomach.
• If they upset your stomach, take the tablets with food. They will still work if you have to take them with food to prevent stomach upset.

How long to take Pharmacy Action Diclofenac Rapid 25

• Do not take Pharmacy Action Diclofenac Rapid 25 tablets for more than a few days at a time, unless a doctor has told you to. It is usually taken for a short time only.
• If symptoms persist or worsen, see your pharmacist or doctor to ensure that they are not due to a serious illness. The use of Pharmacy Action Diclofenac Rapid 25 could mask potentially serious infections.

If you use too much Pharmacy Action Diclofenac Rapid 25

If you think that you have used too Pharmacy Action Diclofenac Rapid 25, 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.

5. What should I know while using Pharmacy Action Diclofenac Rapid 25?

Things you should do

• If you become pregnant while taking Pharmacy Action Diclofenac Rapid 25, tell your pharmacist or doctor immediately. They can discuss with you the risks of using it while you are pregnant.
• If, at any time while taking Pharmacy Action Diclofenac Rapid 25 tablets 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.
• If you are about to start taking any new medicine, tell your doctor and pharmacist that you are taking Pharmacy Action Diclofenac Rapid 25 tablets.
• If you are going to have surgery, tell the surgeon and the anaesthetist that you are taking Pharmacy Action Diclofenac Rapid 25 tablets. Anti-inflammatory medicines can slow down blood clotting and affect kidney function.
• If you get an infection while taking Pharmacy Action Diclofenac Rapid 25 tablets, 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.

Remind any doctor, dentist or pharmacist you visit that you are taking Pharmacy Action Diclofenac Rapid 25.

Things you should not do

• Do not take any of the following medicines while you are taking Pharmacy Action Diclofenac Rapid 25 tablets without first telling your doctor or pharmacist:
  - aspirin or other salicylates;
  - other forms of diclofenac;
  - any other anti-inflammatory medicine.
• Do not use Pharmacy Action Diclofenac Rapid 25 tablets to treat any other complaints unless your pharmacist or doctor tells you to.
• Do not give your medicine to anyone else, even if they seem to have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Pharmacy Action Diclofenac Rapid 25 affects you.

As with other anti-inflammatory medicines, Pharmacy Action Diclofenac Rapid 25 may cause dizziness, drowsiness, spinning sensation (vertigo) or blurred vision in some people. If you have any of these symptoms, do not drive or carry out other activities that need careful attention.

Be careful if you are older than 65 years of age.

Older people may be more sensitive to the effects of Pharmacy Action Diclofenac Rapid 25 tablets than other adults. Take the lowest number of tablets that provides relief of symptoms, and report side effects promptly to your doctor or pharmacist.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Looking after your medicine

• Keep your tablets in the original packaging until it is time to take them.
• Store the tablets in a cool, dry place where the temperature stays below 25°C.
• Heat and dampness can destroy some medicines.
• A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Follow the instructions on 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.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If your pharmacist or doctor tells you to stop taking Pharmacy Action Diclofenac Rapid 25 or the tablets have passed the expiry date, ask your pharmacist what to do with any medicine that are left over.

Return any unused medicine to your pharmacist for safe disposal.

6. Are there any side effects?

Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking Pharmacy Action Diclofenac Rapid 25 tablets.

This medicine helps most people, but it may have unwanted side effects in a few peopleAll medicines can have side effects. 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 get an allergic reaction, stop taking and see your doctor immediately.

If you are over 65 years old, you should be especially careful while taking this medicine. Report any side effects promptly to your pharmacist or doctor.
As people get 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. Ask your pharmacist or doctor to answer any questions you may have.

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.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What Pharmacy Action Diclofenac Rapid 25 contains

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

What Pharmacy Action Diclofenac Rapid 25 looks like

Pharmacy Action Diclofenac Rapid 25 tablets are pink coloured, round, biconvex, film-coated tablets plain on both sides (AUST R XXXXXX).

Who distributes Pharmacy Action Diclofenac Rapid 25

Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Australia
  [email protected]
  +61 3 9809 7900
  www.generichealth.com.au

This leaflet was prepared in October 2023.

Published by MIMS November 2024