White, capsule shaped biconvex tablets with dimensions 5x10 mm.
The active substance is diclofenac potassium. Each film-coated tablet contains 12.5mg diclofenac potassium.
Excipients/Inactive Ingredients: Core: Lactose monohydrate, calcium phosphate, sodium starch glycolate type A, maize starch, povidone K30, cellulose microcrystalline 101, silica colloidal anhydrous, magnesium stearate.
Coating: Opadry White OY-B-28920 (Polyvinyl alcohol, Titanium dioxide (E171), Talc, Lecithin (soya) (E322), Xanthan gum).
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.
How to take Areston: Always take this medicine exactly as described in this monograph or as the doctor or pharmacist has told the patient. Check with the doctor or pharmacist if the patients are not sure.
As a general recommendation it is important that the patient uses the lowest dose that controls pain and 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 the doctor to ensure that they are not due to another illness.
If the patient takes more Areston than they should: If the patient accidentally takes too many tablets, immediately contact the doctor or pharmacist. They 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 the patient forgets to take Areston: Do not take a double dose to make up for a forgotten dose.
Use diclofenac only when symptoms appear.
If they have any further questions on the use of this medicine, ask the doctor or pharmacist.
Do not take Areston: If the patient is allergic to diclofenac, soya oil, peanut oil or any of the other ingredients of this medicine (listed in Description). 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 the patient has established heart disease and/or cerebrovascular disease e.g. if the patient 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 the heart is reduced giving the patient exertional tiredness, palpitations and shortness of breath (heart failure).
If the patient has or has had a stomach ulcer or ulcer in the gastrointestinal tract.
If the patient has ever noticed blood in their stools or black stools (signs of gastrointestinal bleeding).
If the patient suffers from severe liver or kidney disease.
If the patient has or has had problems with their blood circulation (peripheral arterial disease).
If the patient is about 20 weeks pregnant or later.
If the patient has ever had asthma or wheezing, an extensive skin rash (urticaria), or a "hay fever"-like runny nose after taking aspirin or other NSAIDs such as ibuprofen.
If the patient has a stroke, bleeding, or other bleeding disorders.
If the patient has blood disorders.
If the patient has certain abnormalities in the bone marrow.
If any of the above applies to the patient or not sure, ask the doctor or pharmacist.
Talk to the doctor or pharmacist before taking Areston: If the patient has ever had any stomach problems or heartburn after taking painkillers or anti-inflammatory.
If the patient suffers from severe skin reactions.
If the patient suffers from asthma, hay fever or has had long-term problems of the respiratory tract, such as nasal polyps or chronic obstructive airways diseases.
If the patient has a tendency to develop allergic skin diseases, itchy skin or hives.
If the patient has a history of gastrointestinal disease, for example ulcerative colitis or Crohn's disease.
If the patient has a bleeding disorder or any other blood disorder, including a rare condition called porphyria.
If the patient has an inflammatory disease called systemic lupus erythematosus or another disease of the connective tissue.
If the patient has liver or kidney problems.
If the patient thinks they are dehydrated (e.g. due to sickness, diarrhoea, before or after major surgery).
If the patient has chickenpox (varicella).
If the patient has significant risk factors such as high blood pressure, high cholesterol, high triglycerides, diabetes, or if they smoke; they should discuss their treatment with the doctor or pharmacist.
If the patient is currently having medical treatment for a serious illness.
If the patient is taking Trimethoprim (a medicine used used to prevent or treat urinary tract infections).
If the patient is taking medicines used to treat arthritis or other pain relievers (e.g. acetylsalicylic acid,ibuprofen) or other anti-inflammatory medicines (corticosteroids).
If, at any time while taking Areston the patient experiences any signs or symptoms of problems with their heart or blood vessels such as chest pain, shortness of breath, weakness, or slurring of speech, contact the doctor immediately.
Medicines such as Areston may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment.
Make sure the doctor or pharmacist knows, before the patient takes diclofenac: If the patient smokes.
If the patient has diabetes (diabetes mellitus).
If the patient has tight, painful feeling in the chest (angina), blood clots, high blood pressure, raised cholesterol or raised levels of cholesterol or triglycerides (certain fats) in their blood.
Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.
Do not exceed the recommended dose and do not take it longer than the recommended duration (3 days for relief for fever and relief of pain).
Older people may be more sensitive to the effect of diclofenac than other adults. If the patient is older than 65 years, it is important that they follow the instructions carefully and take the lowest number of tablets that still provides sufficient relief of symptoms. It is especially important for older people to immediately report any side effects to their doctor or pharmacist.
Diclofenac may reduce the symptoms of an infection (e.g. headache, high temperature). This may therefore make it more difficult to detect or treat the infection. If the patient is not feeling well and need to visit a doctor, remember to mention that they are taking diclofenac.
Prolonged use of any type of painkiller for headaches can make headaches worse. If the patient thinks this applies to them, consult the doctor for advice.
Tell the doctor if the patient recently had or they are going to have a surgery of the stomach or intestinal tract before receiving/taking/using Areston, as diclofenac can sometimes worsen wound healing in their gut after surgery.
Areston contains lactose and soya oil: If the patient has been told by their doctor that they have an intolerance to some sugars, contact the doctor before taking this medicinal product.
If the patient is allergic to peanut or soya, do not use this medicinal product.
Driving and using machines: Usually this medicine has no influence on the ability to drive or use machines. However, in rare cases the patient may experience vision disorders, dizziness or drowsiness (see Side Effects). If the patient notices such effects, do not drive or use machines and they must immediately contact the doctor.
If the patient is pregnant or breast-feeding, think they may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Pregnancy: Do not use diclofenac during pregnancy unless the doctor recommends it.
The patient must not take diclofenac about 20 weeks of pregnancy or later because it could harm her unborn child or cause problems at delivery.
Breast-feeding: The patient should not take diclofenac if she is breast-feeding because it might be harmful for her infant.
Fertility: As with other anti-inflammatory medicines, the use of diclofenac may make it more difficult to become pregnant. The patient should not take this medicine if she is planning to become pregnant or if she has problem becoming pregnant.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some uncommon (may affect between 1 and 10 in every 1000 people) side effects, especially when taking high daily dose (150mg) for a long period of time. The frequency is expected to be lower for short-term treatment with low dose (up to 75mg daily): Palpitations, sudden and oppressive chest pain (signs of myocardial infarction or heart attack.
Breathlessness, difficulty of breathing when lying down, swelling of the feet or legs (signs of cardiac failure).
Some rare (may affect up to 1 in every 1000 people) or very rare (may affect up to 1 in every 10,000 people) side effects could be serious: Severe stomach pain.
Vomiting blood, bloody diarrhea, blood in the stools or black stools.
Allergic reaction including difficulty of breathing or swallowing, swelling of the face, mouth, tongue or throat, often associated with skin rash. Collapse.
Sudden difficulty of breathing and feeling of tightness in chest with wheezing or coughing (signs of asthma).
High blood pressure.
Sudden and severe headache, difficulty speaking, stiff neck, convulsions.
Skin rash with blisters, peeling of the skin, purple skin lesions, blistering of the eyes and mouth, skin inflammation with flaking or peeling.
Swelling of the face, feet or legs.
Any change in the colour or the amount of urine, excess of protein in urine, blood in urine.
Yellowing of the skin or eyes (signs of hepatitis/liver failure), increased liver enzymes.
Bleeding or unusual bruising, high fever or persistent sore throat, frequent infections.
Increased sensitivity of the skin to sun.
Diclofenac may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment.
Stop taking the product and contact the doctor immediately if the patient develops signs and symptoms of heart problems or stroke, such as chest pain, shortness of breath, weakness in one part or side of body, or slurring of speech.
Other side effects: The following side-effects are generally not serious and have been reported only with higher doses of the active substance diclofenac, used for longer duration. If necessary, talk to the doctor or pharmacist.
Common side effects (likely to affect 1 out of 10 people): Pain in the gut, stomach pain, diarrhoea, nausea, vomiting, flatulence, indigestion, decreased appetite; Headache, dizziness; Skin rash; Vertigo.
Rare side effects (likely to affect 1 out of 1000 people): Unusual tiredness; Itchy rash; Drowsiness.
Very rare side effects (likely to affect less than 1 out of 10,000 people): Low level of white blood cells , low levels of red blood cells.
Constipation, mouth sores, swollen, red and sore tongue, taste disorders, upper abdominal cramp.
Itching and redness of skin, hair loss.
Tingling or numbness of the hands or feet, trembling.
Visual disorders, blurred vision, ringing in the ears, hearing impaired.
Change in mood, difficulty sleeping, feeling confused.
If any of these side-effects gets worse or if the patient notices any side effects not listed in this monograph, they should inform the doctor or pharmacist.
Tell the doctor or pharmacist if the patient is taking, had recently taken or might take any other medicines.
The following medicines may, if the patient used concurrently with diclofenac, increase the risk of bleeding or ulcer. If the patient is taking any of these medicines the patient must tell the doctor: Corticosteroids (for relief of inflammation).
Anticoagulants or antiplatelet agents (blood thinners).
Selective serotonin reuptake inhibitors (SSRIs) medicines used to treat some types of depression.
Other NSAIDs, such as aspirin and ibuprofen (used to relieve inflammation/pain). Bleeding from the gastrointestinal tract or the formation of ulcers can be side effects of all NSAIDs, including diclofenac. This problem, which in older people can be more severe, may occur at any time during treatment with or without warning symptoms, or a history of severe problems of the gastrointestinal tract.
The patient should inform the doctor if they used any of the following medicine: Lithium (used, among others, for the treatment of manic depression).
Digoxin (used to treat heart problems).
Diuretics (used to increase the amount of urine).
Antihypertensive drugs such as ACE inhibitors or beta-blockers (used to treat high blood pressure or certain other heart conditions).
Medicines taken orally to treat diabetes (oral anti-diabetic).
Methotrexate (used to treat certain kinds of cancer or arthritis).
Cyclosporine (used to prevent immune reactions following organ transplants).
Quinolones (certain antibiotics), used to treat certain infections.
Sulfinpyrazone (a medicine used to treat gout) or voriconazole (a medicine used to treat fungal infections).
Phenytoin (a medicine used to treat seizures).
Colestipol and cholestyramine that can delay or decrease in absorption of diclofenac. Therefore, it is recommended to take diclofenac at least one hour before or 4 to 6 hours after administration of colestipol/cholestyramine.
Areston with food, drink and alcohol: For maximum efficacy, the tablets should preferably be taken before meals.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines the patient no longer use. These measures will help protect the environment.
Store below 30°C in the original package.
M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Areston FC tab 12.5 mg
1 × 10's;2 × 10's;3 × 10's
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