Label: information for the user

Airtal 100 mg powder for oral suspension

aceclofenac

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Label contents:

1. What Airtal is and for what it is used
2. What you need to know before starting to take Airtal
3. How to take Airtal
4. Possible side effects
5. Storage of Airtal
6. Container contents and additional information

Airtal contains aceclofenac which has analgesic, anti-inflammatory and antirheumatic activity.

Your doctor will prescribe this medication for the treatment of inflammatory and painful processes such as lower back pain (lumbalgia), toothache (odontalgia), and joint pain (periarthritis of the shoulder and elbow and extra-articular rheumatism). Airtal is also indicated for the chronic treatment of pain and inflammation associated with chronic joint processes: osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

It is essential to use the smallest effective dose to alleviate or control pain and not to take this medication for longer than necessary to control your symptoms.

Do not take Airtal

• If you are in the third trimester of pregnancy or breastfeeding your child.
• If you are allergic to aceclofenac or any of the other components of this medication (listed in section 6).
• If NSAIDs, including acetylsalicylic acid, have caused asthma, rhinitis, urticaria, or other allergic reactions in you.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the digestive tract.
• If you have bleeding or coagulation problems (bleed easily).
• If you have severe kidney failure.
• If you have severe liver failure.
• If you have established cardiovascular disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA), or blockages in the coronary or cerebral vessels, or coronary bypass surgery.
• If you have or have had peripheral arterial disease.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication:

• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is higher with high doses and prolonged treatment, especially in patients with a history of peptic ulcer disease and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protector medication.

Elderly patients have a higher incidence of adverse effects, specifically gastrointestinal bleeding and perforation (in some cases fatal).

• If you have liver disease.
• If you have kidney failure.
• If you have heart problems or have had a stroke (cerebral hemorrhage).
• If you smoke.
• If you have diabetes.
• If you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides.

This medication may be associated with an increased risk of heart attacks ("myocardial infarctions"). Adverse effects can be minimized by using the lowest effective dose for the shortest possible period. Do not exceed the recommended dose or treatment duration.

Additionally, this medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

• If you have blood disorders.
• If you are taking anticoagulant medications such as warfarin, or antiplatelet agents like acetylsalicylic acid, inform your doctor. You should also mention the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease or ulcerative colitis, as this medication may worsen these conditions.
• If you are recovering from a major surgical operation.
• If you have a history of bronchial asthma.
• In the case of chickenpox, avoid using this medication as it may cause severe skin infections in rare cases.
• May cause hypersensitivity reactions and, very rarely, severe allergic reactions (see section 4. Possible adverse effects). The risk is higher during the first month of treatment. Discontinue treatment immediately if you experience the first symptoms of skin rash, mucosal lesions, or other signs of hypersensitivity.

Consult your doctor, even if any of the above circumstances have occurred at any time.

Other medications and Airtal

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Certain medications may interact with this medication. In these cases, you may need to adjust the dose or discontinue treatment with one of the medications.

This is especially important if you are taking lithium, digoxin, diuretics, antihypertensives, anticoagulants, antiplatelet agents, hypoglycemic agents, methotrexate, corticosteroids, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs (NSAIDs), selective serotonin reuptake inhibitors (SSRIs), cyclosporine, tacrolimus, or zidovudine.

Airtal with food and beverages

This medication can be taken with or without food.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy and fertile women

Do not take Airtal if you are in the last 3 months of pregnancy, as it may harm your unborn child or cause complications during delivery. It may cause kidney and heart problems in your newborn. It may affect your tendency and that of your newborn to bleed and make labor longer or more difficult than expected. Do not take Airtal during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while trying to become pregnant, use the lowest dose for the shortest possible time. If taken for more than a few days after 20 weeks of pregnancy, this medication may cause kidney problems in your newborn that may lead to low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (patent ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

For fertile women, consider that this medication has been associated with a decrease in the ability to conceive.

Lactation

Do not take this medication if you are breastfeeding.

Driving and operating machinery

If you experience dizziness, fainting, vertigo, or other central nervous system disturbances while taking this medication, do not drive or operate any hazardous tools or machinery.

Airtal containsaspartame,sorbitol, and sodium.

This medication contains 10 mg of aspartame in each sachet. Aspartame contains a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

This medication contains 2,639 mg of sorbitol in each sachet. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) in each sachet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The contents of the sachets must be dissolved in half a glass of water and taken immediately.

The recommended dose is 200 mg per day, that is, two sachets, one in the morning and one at night (1 sachet every 12 hours).

The duration of treatment will be established by your doctor. Do not discontinue treatment before the indicated time, even if you feel well.

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

Use in children

Not recommended.

Use in elderly patients

Your doctor will indicate the dose to take and you should undergo regular check-ups.

Use in patients with renal insufficiency or heart failure

Your doctor will indicate the dose to take and you should undergo regular check-ups.

Use in patients with liver insufficiency

The dose should be reduced to 1 sachet per day.

Long-term treatment

If you take this medication for a long period of time, your doctor should perform regular check-ups, for example, of the kidneys, liver, and blood tests.

If you take more Airtal than you should

Consult your doctor or pharmacist immediately, go to the nearest hospital, or contact the Toxicological Information Service. Phone 915 620 420. Bring this leaflet with you.

If you forget to take Airtal

Do not worry. Do not take a double dose to compensate for the missed doses. Take the next dose according to the usual schedule.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects that may occur with the use of this medicine are:

Frequent (may affect up to 1 in 10 people)

• Stomach discomfort, abdominal pain, nausea, and diarrhea.
• Dizziness.
• Increased liver enzymes.

Infrequent (may affect up to 1 in 100 people)

• Gas, stomach inflammation, constipation, vomiting, and mouth sores.
• Itching, skin rash, skin inflammation (dermatitis), and urticaria.
• Increased urea, increased creatinine.

Rare (may affect up to 1 in 1,000 people)

• Blood in stool, digestive bleeding, digestive ulcer.
• Face inflammation.
• Heart failure, high blood pressure.
• Anemia.
• Severe allergic reaction, allergies.
• Vision anomalies.
• Difficulty breathing.

Very rare (may affect up to 1 in 10,000 people)

• Mouth mucosa inflammation, pancreas inflammation, intestinal perforation, vomiting with blood.

Also, worsening of ulcerative colitis and Crohn's disease has been observed.

• Violaceous skin spots, severe skin reactions.

The medications like Airtal may be associated, in very rare cases, with very severe mucocutaneous reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

• Palpitations, redness, heat, inflammation of blood vessels (vasculitis).
• Liver damage (including hepatitis), increased alkaline phosphatase.

The medications like Airtal may be associated with liver disorders that cause yellow skin and eye discoloration, sometimes with high fever or swelling and abdominal tenderness. If any of the following reactions occur: yellow skin or eye discoloration, discontinue treatment and IMMEDIATELY report to the doctor.

• Decreased white blood cells, decreased platelets, bone marrow depression, hemolytic anemia.
• Increased potassium in blood.
• Depression, sleep alterations, difficulty falling asleep.
• Tickling, drowsiness, headache, taste alterations, tremors.
• Dizziness, tinnitus.
• Raucous breathing, bronchospasm.
• Leg cramps.
• Renal function alteration (nephrotic syndrome), renal failure.
• Fatigue, fluid retention (edema).
• Weight gain.

Exceptionally, severe skin infections have been observed during chickenpox.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Dispose of the packaging and medications you no longer need at the SIGRE collection pointofthe pharmacy. Incase of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Composition of Airtal

The active ingredient is aceclofenac. Each packet contains 100 mg of aceclofenac.

The other components (excipients) are: sorbitol (E-420), sodium saccharin, aspartame (E-951), anhydrous colloidal silica, hypromellose, titanium dioxide (E-171), milk flavor, caramel flavor, and cream flavor.

Appearance of Airtaland content of the packaging

White or off-white powder conditioned in packets.

It is presented in packaging of 20 or 40 packets.

Holder of the marketing authorization

Almirall, S.A.

General Mitre, 151

08022 – Barcelona (Spain)

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra.de Martorell, 41-61,

08740 Sant Andreu de la Barca‑Barcelona (Spain)

Date of the last review of this leaflet: February 2023

The detailed information of this medicine is available on the website ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)