Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**3\. How to take Areston** Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. As a general recommendation it is important that you use the lowest dose that controls your pain and that you do not take diclofenac for longer than necessary. **Adults and adolescents aged 14 years and over** Take an initial dose of 2 tablets when symptoms appear. If needed, continue with 1 tablet every 4 to 6 hours. Do not take more than 6 tablets in 24 hours, except if prescribed by a doctor. Swallow the whole tablet with a drink of water, preferably before meals. Do not exceed the recommended dose. **Use in children and adolescents** Do not give Areston 12.5mg film-coated tablets to children younger than 14 years. **Elderly** In frail elderly patients use the lowest dose that controls the pain. Do not take diclofenac for more than 3 days for relief of pain and relief of fever. If symptoms persist or worsen, tell your doctor to ensure that they are not due to another illness. **If you take more Areston than you should** If you accidentally take to many tablets, immediately contact your doctor or pharmacist. You may need medical attention. Symptoms of an overdose may include vomiting, diarrhoea, dizziness, ringing in the ears (tinnitus), convulsions/ seizures, severe stomach pain or bloody or black stools. **If you forget to take Areston** Do not take a double dose to make up for a forgotten dose. Use diclofenac only when symptoms appear. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
ORAL
Medical Information
**1\. What Areston is and what it is used for** Areston is a painkiller, which also reduce inflammation (swelling) and lower body temperature. Areston is used in the short-term treatment (i.e. maximum 3 days) of pain in the joints and ligaments, muscular pain, headache, dental pain, menstrual pain, acute lower back pain, pain and fever associated with the flu, sore throat and colds.
**2\. What you need to know before you take Areston** If this medicine has been prescribed by a doctor, follow carefully the instructions of the doctor. These instructions may differ from the general information in this leaflet. **Do not take Areston:** - If you are allergic to diclofenac, soya oil, peanut oil or any of the other ingredients of this medicine (listed in section 6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash or any other allergic type reaction. - If you have established heart disease and/or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages; or the pumping power of your heart is reduced giving you exertional tiredness, palpitations and shortness of breath (heart failure). - If you have or have had a stomach ulcer or ulcer in the gastrointestinal tract. - If you have ever noticed blood in your stools or black stools (signs of gastrointestinal bleeding). - If you suffer from severe liver or kidney disease. - If you have or have had problems with your blood circulation (peripheral arterial disease). - If you are about 20 weeks of pregnancy or later. - If you have ever had asthma or wheezing, extensive skin rash (urticaria) or “hay fever”-like runny nose after taking aspirin or other NSAIDs such as ibuprofen. - If you have a stroke, a bleeding or other bleeding disorders. - If you have blood disorders. - If you have certain abnormalities in the bone marrow. If any of the above applies to you or you are not sure ask your doctor or pharmacist.
M01AB05
diclofenac
Manufacturer Information
MEDOCHEMIE SINGAPORE PTE. LTD.
MEDOCHEMIE LTD (CENTRAL FACTORY)
MEDOCHEMIE LTD - FACTORY AZ (Primary & Secondary Packager)
Active Ingredients
Documents
Patient Information Leaflets
Areston PIL.pdf
Approved: May 4, 2023