ARESTON INSTANT12.5 mg. 20 tablets

What Areston Instant is and what it is used for
Arreston Instant is a pain-relieving medicinal product that also reduces inflammation (swelling) and lowers body temperature.
Arreston Instant is used to treat rheumatic pain, muscle pain, headache, toothache, period pain, acute low back pain, pain and fever associated with flu, sore throat and colds.

2. What you need to know before you take Areston Instant
If this medicine has been prescribed for you by a doctor, follow all his instructions carefully. They may differ from the general information contained in this leaflet.

Do not take Areston Instant:
If you are allergic to diclofenac, soybean oil or any of the other ingredients of this medicine (listed in section 6). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), trouble breathing, chest pain, runny nose, skin rash, or some other allergic-type reaction.
If you have established heart disease and/or cardiovascular disease, for example, if you have had a heart attack, stroke, mini-stroke or blockage of a blood vessel in the heart or brain, or have had an operation to unblock blood vessels or a bypass; or if your heart's pumping of blood is reduced, causing excessive tiredness, palpitations or shortness of breath (heart failure).
If you have or have had a stomach or gastrointestinal ulcer
If you have noticed blood in your stools or black stools (a symptom of gastrointestinal bleeding).
If you suffer from severe liver or kidney disease.
If you have or have had circulation problems (peripheral arterial disease)
If you are in the last three months of pregnancy.
If you have ever had asthma or wheezing, a widespread skin rash (hives) or hay fever - such as a runny nose after taking aspirin or another NSAID such as ibuprofen.
If you have a stroke, bleeding or other bleeding disorders. If you have blood disorders.
If you have certain bone marrow abnormalities.
If any of the above applies to you or you are not sure, ask your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking Areston Instant:

If you have ever had stomach problems after taking painkillers or anti-inflammatory medicines.
If you suffer from severe skin reactions.
If you suffer from asthma, hay fever or have long-term breathing problems such as nasal polyps or chronic obstructive airways disease.
If you have a tendency to develop allergic skin diseases, itchy skin and urticaria.
If you have a history of gastrointestinal disease, such as ulcerative colitis or Crohn's disease.
If you suffer from a bleeding disorder or other blood disorder, including a rare condition called porphyria.
If you suffer from an inflammatory disease called systemic lupus erythematosus or other
connective tissue disease.
If you suffer from liver or kidney problems.
If you think you are dehydrated (eg due to illness, diarrhoea, before or after
major surgery).
If you have measles (chicken pox).
Medicines such as Arreston Instant may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and long-term treatment.

Make sure your doctor or pharmacist is informed before taking diclofenac:

If you smoke.
If you suffer from diabetes (diabetes mellitus).
If you have tightness, chest pain (angina), blood clots, high blood pressure, high cholesterol or high levels of cholesterol or triglycerides (certain fats) in your blood.
Side effects can be minimized by using the lowest effective dose for the shortest possible time.

Do not exceed the recommended dose and the recommended duration of treatment (3 days for high fever relief and 5 days for pain relief).

Elderly people may be more sensitive to the effects of diclofenac than other adults. If you are over the age of 65, it is important to follow the directions carefully and take the smallest possible number of tablets that provides sufficient relief of symptoms. It is especially important for older people to report any side effects to their doctor or pharmacist immediately.

Diclofenac can reduce the symptoms of an infection (eg headache, high fever). Because of this, detection and treatment of infection can be difficult. If you feel unwell and need to see a doctor, be sure to let him know that you are taking diclofenac.

Long-term use of all types of headache pain relievers can make headaches worse. If you think this applies to you, talk to your doctor.

Tell your doctor if you have recently had or are about to have stomach or bowel surgery before taking
Arreston Instant with food, drinks and alcohol
It is not recommended to take diclofenac during or immediately after a meal, as the rate of absorption of diclofenac is reduced when the tablets are taken with food.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Do not take diclofenac during pregnancy unless your doctor has recommended it.
You should not take diclofenac during the last 3 months of pregnancy, as it may harm your unborn baby or cause problems at birth.

Breastfeeding
You should not take diclofenac if you are breast-feeding, as it may harm your baby. Fertility

Like all anti-inflammatory drugs, the use of diclofenac can make it difficult to get pregnant. You should not take this medicine if you are planning to become pregnant or if you are having trouble getting pregnant.

Driving and using machines
This medicine does not normally affect the ability to drive or use machines. However, in rare cases you may experience visual disturbances, dizziness or drowsiness (see section 4). If you notice such effects, do not drive or operate machinery and contact your doctor immediately.

Areston Instant contains lactose and soybean oil.
If your doctor has told you that you have an intolerance to certain types of sugars, contact your doctor before taking this medicinal product. If you are allergic to soy, do not take this medicinal product.

3. How to take Areston Instant
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

As a general recommendation, it is important to take the lowest dose that controls pain and not to take diclofenac for longer than necessary.

Adults and adolescents aged 14 and over
Take an initial dose of 2 tablets when symptoms appear. If necessary, continue with 1 one tablet every 4 to 6 hours. Do not take more than 6 tablets in 24 hours. Swallow the tablet whole with a little water, preferably before a meal. Do not exceed the recommended dose.

Use in children and adolescents
Do not give Arreston Instant 12.5 mg film-coated tablets to children under 14 years of age.

Elderly patients
In frail elderly patients, use the lowest dose for pain control.

Do not take diclofenac for longer than 5 days for pain relief and 3 days for high fever relief.

If symptoms persist or worsen, inform your doctor to make sure they are not due to another condition.

If you have taken more than the required dose of Arreston Instant
If you accidentally take too many tablets, contact your doctor or pharmacist immediately. You may need medical attention. Overdose symptoms may include vomiting, diarrhea, dizziness, ringing in the ears (tinnitus), seizures/fits, severe abdominal pain, or bloody or black stools.

If you forget to take Areston Instant
Do not take a double dose to make up for a missed dose.

If you have stopped taking Arreston Instant
Take diclofenac only when symptoms occur.

If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Within each frequency grouping, adverse reactions are listed in descending order of seriousness.

The following side effects also include those reported with long-term use of high-dose diclofenac.

Common (may affect up to 1 in 10 people)
Headache, dizziness.
Disturbance of balance associated with nausea (vertigo).
Nausea, vomiting, diarrhea, abdominal pain, flatulence, loss of appetite.
Changes in liver function (for example, in the level of transaminases).
A rash.
Rare (may affect up to 1 in 1,000 people)
Hypersensitivity, allergic reactions, including hypotension and shock (low blood pressure, pallor, restlessness, weak rapid pulse, clammy skin, decreased consciousness).
Drowsiness.
Sudden difficulty breathing and chest tightness with wheezing or coughing (signs of asthma), including shortness of breath.
Inflammation of the stomach, bleeding in the gastrointestinal tract, vomiting blood, black or bloody diarrhea, gastrointestinal ulcers (with or without bleeding/perforation). Inflammation of the liver (hepatitis), yellowing of the skin or eyes (jaundice), liver disorder.
Rash with severe itching and hives (urticaria).
Swelling of the hands, hands, feet and ankles (edema).
Very rare (may affect up to 1 in 10,000 people)
Blood disorders, including thrombocytopenia (low platelet count) associated with bruising and bleeding tendency; leukopenia (below
Sudden accumulation of fluid in the skin and mucous membranes (for example, swelling of the throat, tongue or face), difficulty breathing and/or rash and itching, often as an allergic reaction (angioedema).
Disorientation, depression, insomnia, nightmares, irritability, severe mental reactions, taking control of the patient's own behavior and actions (psychotic disorder), anxiety.
Numbness or numbness of hands and feet (paresthesia), memory impairment, convulsions/seizures, tremors, neck stiffness (a sign of meningitis, including aseptic meningitis), taste disturbances, sudden and severe headache, nausea, dizziness, stiffness, inability for speaking or difficulty speaking, paralysis (signs of stroke).
Impaired vision, blurred vision, double vision.
Ringing in the ears (tinnitus), hearing disorders.
Palpitations, chest pain, insufficient pumping power of heart failure), heart attack (myocardial infarction).
High blood pressure (hypertension), inflammation of the blood vessels (vasculitis).
Pneumonia (pneumonitis).
Colitis, including hemorrhagic colitis (inflammation of the colon with bloody diarrhea) and Crohn's disease (chronic inflammation of the small intestine and/or large intestine), constipation, inflammation of the oral mucosa (stomatitis), inflammation of the tongue (glossitis), diseases of esophagus, strictures of the digestive tract, inflammation of the pancreas, accompanied by severe pain in the upper abdomen that spreads to the back, nausea and vomiting (pancreatitis).
Very rapidly progressive inflammation of the liver, necrosis of liver tissue, liver failure.
Blisters, eczema, reddening of the skin (erythema), rash with red irregular spots (erythema multiforme), severe hypersensitivity reaction with high fever, red spots on the skin, joint pain and/or eye inflammation (Stevens-Johnson Syndrome) , severe, sudden hypersensitivity reaction with high fever and skin blistering/skin peeling (toxic epidermal necrolysis), severe inflammation of the skin with loss of epidermis and hair (exfoliative dermatitis), hair loss, hypersensitivity to sunlight (photosensitivity), bruising (including allergic purpura), itching (pruritus).
Kidney failure (insufficient kidney function), blood in the urine, excess protein in the urine, a disorder in which the kidneys cannot filter blood properly (nephrotic syndrome), inflammation of the kidneys associated with blood in the urine, high fever and pain in the waist (interstitial nephritis), necrosis of kidney tissue (renal papillary necrosis).
The most common side effects are gastrointestinal. Gastric ulcers, perforation or gastrointestinal bleeding may occur, sometimes fatal, especially in elderly patients (see section 2). Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, blood in the stool, vomiting of blood, inflammation of the oral mucosa with ulcers, worsening of colitis or Crohn's disease (chronic inflammation of the small and/or colon) (see section 2). Less commonly, inflammation of the stomach wall has been observed.

Diclofenac may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke.

Tell your doctor right away if you notice chest pain, which could be a sign of a potentially serious allergic reaction called Kunis syndrome.
5. How to store Areston Instant
Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date corresponds to the last day of the month stated.

To be stored below 30°C.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What Areston Instant contains:
The active substance is diclofenac potassium. Each film-coated tablet contains 12.5 mg diclofenac potassium.
The other ingredients are:
Core: lactose monohydrate, calcium phosphate, sodium starch glycolate type A, corn starch, povidone KZO, microcrystalline cellulose 101, silicon dioxide, colloidal anhydrous, magnesium stearate;
Coating: Opadry white OY-B-28920 (poly(vinyl alcohol), titanium dioxide (E171), talc, lecithin (soy) (E322), xanthan gum).

What Areston Instant looks like and contents of the pack:
White, oblong, biconvex tablets with dimensions of 5x10 mm.
Areston Instant is packed in aluminum/aluminum blisters containing 10 tablets.
Packs of 10, 20, 30 and 40 tablets are available.

Not all types of packaging can be put on sale.

 

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