Airtal 100 mg
Film-coated tablets
Aceclofenac
Composition per tablet:
Aceclofenac (INN) 100 mg
Excipients: microcrystalline cellulose, croscarmellose sodium, glycerol palmitostearate, povidone, hypromellose, polyoxyl 40 stearate and titanium dioxide.
Pharmaceutical form and contents of container
Film-coated tablets for oral administration. Pack of 20 tablets.
Pharmacological properties
Aceclofenac is a non-steroidal synthesis product with potent analgesic and anti-inflammatory action.
Pharmacokinetic properties
Following oral administration, aceclofenac is rapidly and fully absorbed in the form of an unaltered drug. Peak plasma concentrations are reached approximately 1.25 to 3.0 hours after ingestion. Aceclofenac penetrates the synovial fluid, where its concentrations reach approximately 57% of plasma concentrations. The volume of distribution is approximately 25 liters. Plasma half-life is about 4 hours. Aceclofenac exhibits high protein binding (> 99%). Aceclofenac primarily circulates in the form of an unchanged
drug. The main metabolite detected in plasma is 4'-hydroxyaceclofenac. Approximately two-thirds of the administered dose is excreted in urine, mainly in the form of hydroxymetabolites. No alterations in the pharmacokinetics of aceclofenac have been found in elderly patients.
Pharmacodynamic properties
The mechanism of action of aceclofenac is largely based on inhibition of prostaglandin synthesis. Aceclofenac is a potent inhibitor of the enzyme cyclooxygenase, which is involved in prostaglandin production.
Therapeutic indications
Airtal is indicated for the treatment of inflammatory and painful conditions such as
lumbago, toothache, scapulohumeral periarthritis, and extra-articular rheumatism, and for the long-term treatment of osteoarthritis,
rheumatoid arthritis, and ankylosing spondylitis.
Contraindications
Do not take Airtal:
• If you are in the third trimester of pregnancy or are breastfeeding your child.
• If you are allergic (hypersensitive) to aceclofenac or to any of the other ingredients of the medicinal product.
• If acetylsalicylic acid or other non-steroidal anti-inflammatory drugs have given you asthma, rhinitis or urticaria or any other allergic reaction.
• If you have had a stomach or duodenal ulcer or bleeding or have suffered a perforation in your gastrointestinal tract.
• If you have bleeding or a blood clotting disorder (you bleed easily).
• If you have severe kidney failure.
• If you have severe liver failure.
• If you have an established heart condition and/or cerebrovascular disease, for example if you have had a heart attack, stroke, TIA or blocked blood vessels in the heart or brain or an operation to eliminate any obstruction or a coronary by-pass.
• If you present or have had problems with blood circulation (peripheral arterial disease).
Precautions for use
Take special care with Airtal:
• If you are planning to become pregnant or suspect that you are pregnant.
• If you have had or develop an ulcer, bleeding or perforation in the stomach or duodenum, symptoms of which are severe or persistent abdominal pain and/or black stools. There may even be no prior warning symptoms.
This risk is greater when using high doses and prolonged treatments, in patients with a history of peptic ulcer and in elderly patients. In these cases, your doctor may consider also giving you medication to protect your stomach. The incidence of side effects, bleeding and gastrointestinal perforations in particular (in some cases fatal), is higher in elderly patients.
• If you have liver disease.
• If you have kidney failure.
• If you have heart problems or have had a cerebrovascular accident (stroke, brain hemorrhage).
• If you are a smoker.
• If you have diabetes.
• If you have angina, blood clots, high blood pressure, raised cholesterol or triglycerides.
Medicines like Airtal could be associated with an increase in the risk of suffering heart attacks ("myocardial infarctions"). The adverse effects can be minimised by using the lowest effective dose for the shortest possible time. Do not exceed the recommended dose or duration of treatment. These types of medicines can also cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).
• If you have a blood disorder.
• If at the same time you are taking medication which alters blood clotting such as oral anticoagulants like warfarin or antiplatelet drugs like acetylsalicylic acid, tell your doctor. You should also mention the use of other medicines which could increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medicines like Airtal can make these conditions worse.
• If you are convalescing from a serious operation (surgery).
• If you have ever had or still have bronchial asthma.
• If you have chickenpox this medicine should not be used, as in rare cases, severe skin infections have been related to its use.
• Hypersensitivity reactions and, very rarely, very severe allergic reactions can occur. The risk is greater during the first month of treatment. At the first sign of skin rash, sores in the mucous membranes or other signs of hypersensitivity, stop the treatment immediately. Ask your doctor, even if any of the above has happened to you before.
Warnings
Pregnancy, breast-feeding and fertility
Pregnancy
As the administration of medicines like Airtal have been associated with an increased risk of suffering congenital abnormalities/miscarriages, its administration is not recommended in the first and second trimesters of pregnancy unless it is absolutely necessary. In such cases, the dose and duration should be reduced to a minimum. The administration of Airtal is contraindicated in the third trimester.
Breast-feeding
You should not take Airtal if you are breast-feeding.
Fertility
Women of childbearing age should take into account that medicines like Airtal have been associated with a reduction in the ability to conceive.
Effects on ability to drive and use machines
If you suffer from dizziness, fainting, vertigo or any other central nervous system disorder, do not use dangerous tools or machinery while you are taking Airtal.
Use in elderly patients
Caution should be taken when treating elderly patients as they are generally more prone to the side effects and are more likely to have cardiovascular problems or impaired liver or kidney function and to be taking concomitant medication.
Interactions
Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. Some medicines may interact with Airtal. In such cases, it may be necessary to change the dose or stop
the treatment with some of these medicines. This is particularly important if you take lithium, digoxin, diuretics, antihypertensive drugs, anticoagulants, antiplatelet drugs, antidiabetic drugs, methotrexate, corticosteroids, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors (SSRI antidepressants), ciclosporin, tacrolimus or zidovudine.
Incompatibilities
Not applicable
Posology and method of administration
Adults: 200 mg a day, in two 100 mg doses, one tablet in the morning and another at night.
Children: There are no clinical data on the use of Airtal in children and it is not therefore recommended for use in this population.
Elderly patients: Your doctor will tell you how much to take and should monitor you regularly.
Kidney failure or heart failure: your doctor will tell you how much to take and should monitor you regularly.
Liver failure: the dose of Airtal should be reduced to 1 tablet per day in patients with liver problems. Long-term treatment As a precaution, all patients receiving long-term treatment with non-steroidal anti-inflammatory drugs should be monitored (e.g. renal and liver function and blood count).
Instructions for the correct administration of the product
The tablets should be swallowed whole with a sufficient amount of liquid. Airtal can be taken with food.
Overdose
There is no information concerning the consequences of an overdose of Airtal in humans. In the event of overdose, absorption of the drug should be prevented as far as possible with gastric lavage and treatment with activated charcoal. The treatment for acute poisoning essentially consists of supportive and symptomatic measures for complications such as gastrointestinal irritation, kidney failure, hypotension, respiratory depression and seizures.
Side effects
Like all medicines, Airtal can cause side effects, although not everybody gets them.
The side effects which may appear with Airtal are:
Common (affecting up to 1 in every 10 people)
• Gastrointestinal distress, abdominal pain, nausea and diarrhoea.
• Dizziness.
• Elevated liver enzyme levels.
Uncommon (a ecting up to 1 in every 100 people)
• Wind, inflammation of the stomach, constipation, vomiting and mouth ulcers.
• Itching, skin rash and inflammation (dermatitis) and hives.
• Increased urea, increased creatinine.
Rare (affecting up to 1 in every 1,000 people)
• Blood in the stools, gastrointestinal bleeding, gastrointestinal ulcer.
• Inflammation of the face.
• Heart failure, raised blood pressure.
• Anaemia.
• Severe allergic reaction, allergies.
• Visual disturbances.
• Difficulty breathing.
Very rare (affecting up to 1 in every 10,000 people)
• Inflammation of the mucous membranes in the mouth, inflammation of the pancreas, intestinal perforation, vomiting with blood. Worsening of ulcerative colitis and Crohn's disease has also been observed.
• Purplish blotches on the skin, severe skin reactions. On very rare occasions, medicines like Airtal may be associated with very severe reactions affecting the skin and mucous membranes such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
• Palpitations, reddening, hot flushes, inflammation of the blood vessels (vasculitis).
• Liver damage (including hepatitis), increased alkaline phosphatase.
Medicines like Airtal may be associated with liver disorders that cause the skin and eyes to turn yellow, sometimes with high fever or swelling and sensitivity of the upper abdomen. If you experience any of the following reactions, stop the treatment and tell your doctor IMMEDIATELY: yellowing of skin or eyes.
• Reduced white blood cell count, reduced platelet count, bone marrow depression, haemolytic
anaemia.
• Increased potassium in the blood.
• Depression, sleep disorders, trouble falling asleep.
• Tingling, drowsiness, headache, altered sense of taste, tremors.
• Vertigo, ringing in the ears (tinnitus).
• Noisy breathing, bronchospasm.
• Leg cramps.
• Impaired kidney function (nephrotic syndrome), kidney failure.
• Fatigue, fluid retention (oedema).
• Weight gain.
Severe skin infections have occurred on very rare occasions in patients with chickenpox.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Do not use this medicine after the expiry date stated on the package.
Storage conditions
Store below 30ºC
THIS IS A MEDICAMENT
Medicament is a product, which a ects your health and its consumption contrary to instructions is
dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of
the pharmacist who sold the medicament.
The doctor and the pharmacist are the experts in medicines, their benefits and risks.
Do not by yourself interrupt the period of treatment prescribed.
Do not repeat the same prescription without consulting your doctor.
Keep all medicaments out of reach of children.
For sale with a medical prescription
Medicines must be kept out of the sight and reach of children
Manufacturer
Industrias Farmacéuticas Almirall, S.A.
Ctra. de Martorell 41-61
08740 Sant Andreu de la Barca - Barcelona (Spain)
Marketing authorisation holder
Almirall, S.A.
General Mitre, 151
08022 Barcelona (Spain)
Date of the last revision of the text: 07/2014
