AIRTAL 100 mg POWDER FOR ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Airtal 100 mg powder for oral suspension

aceclofenac

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Airtal and what is it used for
2. What you need to know before you take Airtal
3. How to take Airtal
4. Possible side effects
5. Storage of Airtal
6. Contents of the pack and other information

1. What is Airtal and what is it used for

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

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

2. What you need to know before you take Airtal

It is important to use the smallest dose that relieves your pain and do not take this medicine for longer than necessary to control your symptoms.

Do not take Airtal

• If you are in the third trimester of pregnancy or if you are breastfeeding.
• If you are allergic to aceclofenac or any of the other ingredients of this medicine (listed in section 6).
• If acetylsalicylic acid or other non-steroidal anti-inflammatory drugs have caused you asthma, rhinitis, urticaria, or other allergic reactions.
• If you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• If you have bleeding or coagulation problems (you bleed easily).
• If you have severe kidney problems.
• If you have severe liver problems.
• If you have established heart disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, transient ischaemic attack (TIA), or blockages in the blood vessels of the heart or brain, or have had surgery to remove a blockage or perform a coronary bypass.
• If you have had problems with blood circulation (peripheral arterial disease).

Warnings and precautions

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

• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by severe and persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcers, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medication.

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

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

This medicine 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 time. Do not exceed the recommended dose or duration of treatment.

Also, this medicine 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 medications that alter blood coagulation, such as oral anticoagulants like warfarin, or antiplatelet agents like acetylsalicylic acid, tell your doctor. You should also discuss 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 medicine may worsen these conditions.
• If you are recovering from major surgery.
• If you have had or still have bronchial asthma.
• In case of chickenpox, you should avoid using this medicine because, in rare cases, severe skin infections can occur.
• Hypersensitivity reactions may occur, and very rarely, severe allergic reactions (see section 4. Possible side effects). The risk is higher during the first month of treatment. Stop treatment immediately if you experience any symptoms of skin rash, mucosal lesions, or other signs of hypersensitivity.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Other medicines and Airtal

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Certain medicines may interact with this medicine. In these cases, it may be necessary to change the dose or interrupt treatment with one of the medicines.

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

Taking Airtal with food and drinks

This medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy and women of childbearing age

Do not take Airtal if you are in the last 3 months of pregnancy, as it may harm your unborn baby or cause problems during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your tendency and that of your baby to bleed and make labor longer than expected. You should not take Airtal during the first 6 months of pregnancy unless it is absolutely necessary and your doctor advises you to do so. If you need treatment during this period or while trying to become pregnant, you should use the lowest dose for the shortest possible time. If you take this medicine for more than a few days from the 20th week of pregnancy, it may cause kidney problems in your unborn baby, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

For women of childbearing age, it should be noted that this medicine has been associated with a decrease in fertility.

Breastfeeding

This medicine should not be taken if you are breastfeeding.

Driving and using machines

If you experience dizziness, fainting, vertigo, or other central nervous system disorders while taking this medicine, do not drive or use any tools or machinery.

Airtal containsaspartame,sorbitol, and sodium.

This medicine contains 10 mg of aspartame in each sachet. Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medicine 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 you 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 medicine.

This medicine contains less than 23 mg of sodium (1 mmol) in each sachet; this is, essentially “sodium-free”.

3. How to take Airtal

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

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

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

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

Use in children

Not recommended.

Use in elderly patients

Your doctor will indicate the dose to take and will perform periodic checks.

Use in patients with kidney or heart failure

Your doctor will indicate the dose to take and will perform periodic checks.

Use in patients with liver failure

The dose should be reduced to 1 sachet/day.

Long-term treatment

If you take this medicine for a long time, your doctor should perform quarterly checks, 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 Toxicology Information Service. Telephone 915 620 420. Bring this leaflet with you.

If you forget to take Airtal

Do not worry. Do not take a double dose to make up for forgotten doses. Take the next dose according to your usual schedule.

4. Possible side effects

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

The side effects that may appear with the use of this medicine include:

Common (may affect up to 1 in 10 people)

• Gastrointestinal disorders, abdominal pain, nausea, and diarrhea.
• Dizziness.
• Increased liver enzymes.

Uncommon (may affect up to 1 in 100 people)

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

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

• Blood in stools, gastrointestinal bleeding, gastrointestinal ulcers.
• Facial inflammation.
• Heart failure, high blood pressure.
• Anemia.
• Severe allergic reactions, allergies.
• Vision disorders.
• Breathing difficulties.

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

• Inflammation of the mouth mucosa, pancreatitis, intestinal perforation, vomiting blood.

Worsening of ulcerative colitis and Crohn's disease has also been observed.

• Purple spots on the skin, severe skin reactions.

Medicines like Airtal may be associated with very rare but severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

• Palpitations, flushing, hot flushes, inflammation of blood vessels (vasculitis).
• Liver damage (including hepatitis), increased alkaline phosphatase.

Medicines like Airtal may be associated with liver disorders that cause yellowing of the skin and eyes, sometimes with high fever and swelling and sensitivity of the upper abdomen. If you experience any of the following reactions: yellowing of the skin or eyes, stop treatment and inform your doctor IMMEDIATELY.

• Decreased white blood cells, decreased platelets, bone marrow depression, hemolytic anemia.
• Increased potassium in the blood.
• Depression, sleep disorders, difficulty falling asleep.
• Numbness, drowsiness, headache, taste disorders, tremors.
• Vertigo, tinnitus.
• Noisy breathing, bronchospasm.
• Leg cramps.
• Kidney function disorders (nephrotic syndrome), kidney failure.
• Fatigue, fluid retention (edema).
• Weight gain.

Exceptionally, severe skin infections have been observed during chickenpox.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Airtal

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition of Airtal

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

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

Appearance of Airtal and contents of the pack

White or off-white powder in sachets.

Available in packs of 20 or 40 sachets.

Marketing authorization holder

Almirall, S.A.

General Mitre, 151

08022 – Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca – Barcelona (Spain)

Date of last revision of this leaflet: February 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)