Airtal 100 mg powder for oral suspension

Patient Information Leaflet

Introduction

Patient Information Leaflet

Airtal 100 mg powder for oral suspension

aceclofenac

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Package leaflet:

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

1. What Airtal is and what it is used for

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

Your doctor has prescribed this medicine for the treatment of inflammatory and painful conditions such as low back pain (lumbago), toothache (odontalgia), and joint pain (shoulder periarthritis and extra-articular rheumatism). Airtal is also indicated for the long-term treatment of chronic pain and inflammation associated with chronic joint disorders: osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

2. What you need to know before starting to take Airtal

It is important that you use the smallest dose that relieves/controls the pain, and you should 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 your child.
• If you are allergic to aceclofenac or to any of the other components 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, gastrointestinal bleeding, or a perforation of the digestive tract.
• If you have bleeding disorders or coagulation problems (you bleed easily).
• If you have severe renal failure.
• If you have severe hepatic failure.
• If you have established heart disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA), or blockages in the blood vessels of the heart or brain, or surgery to remove an obstruction or coronary bypass.
• If you have or have had circulatory problems (peripheral arterial disease).

Warnings and precautions

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

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

This risk is greater when high doses and prolonged treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor will consider the possibility of adding a stomach-protective medication.

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

• If you have a liver disease.
• If you have kidney failure.
• If you have heart problems or have suffered 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 medicine may be associated with an increased risk of heart attacks ("myocardial infarction"). Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration. Do not exceed the recommended dose or treatment duration.

Furthermore, this medicine may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

• If you have blood disorders.
• If you are simultaneously taking medications that affect blood coagulation, such as oral anticoagulants like warfarin, or antiplatelet agents such as acetylsalicylic acid, inform your doctor. You should also inform your doctor about the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn's disease or ulcerative colitis, as this medicine may worsen these conditions.
• If you are recovering from a major surgical procedure.
• If you have previously suffered from or still have bronchial asthma.
• In case of chickenpox, the use of this medicine should be avoided, as severe skin infections related to its use may rarely occur.
• Hypersensitivity reactions may occur 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 at the first signs of skin rash, mucosal lesions, or other signs of hypersensitivity.

Consult your doctor, even if any of the above-mentioned circumstances occurred in the past.

Other medicines and Airtal

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

Certain medicines may interact with this medicine. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

This is especially important if you are taking lithium, digoxine, 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 beverages

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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy and women of childbearing potential

Do not take Airtal during the last three months of pregnancy, as it may harm your unborn child or cause complications during delivery. It may cause kidney and heart problems in your unborn baby. It may also affect your own and your baby's tendency to bleed and may result in delayed or prolonged labor. You should not take Airtal during the first six months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is required during this period or while trying to conceive, the lowest possible dose should be used for the shortest possible duration. If taken for more than a few days beyond 20 weeks of gestation, this medicine may cause kidney problems in your unborn baby, which could 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 treatment for more than a few days is needed, your doctor may recommend additional monitoring.

For women of childbearing potential, it should be noted that this medicine has been associated with a reduced ability to conceive.

Breastfeeding

This medicine should not be taken if you are breastfeeding.

Driving and operating machinery

If you experience dizziness, fainting, vertigo, or other central nervous system disturbances while taking this medicine, do not drive or operate any tools or machinery that could be dangerous.

Airtal contains aspartame, sorbitol, and sodium.

This medicine contains 10 mg of aspartame per sachet. Aspartame contains a source of phenylalanine which may be harmful if you have 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 per sachet. Sorbitol is a source of fructose. If your doctor has informed you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize fructose, consult your doctor before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per sachet, i.e., it is essentially "sodium-free".

3. How to take Airtal

Follow exactly the instructions for use of this medicine provided 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, i.e. two sachets, one in the morning and one at night (1 sachet every 12 hours).

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

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

Use in children

Not recommended.

Use in elderly patients

Your doctor will determine the dose to be taken and should carry out periodic checks.

Use in patients with renal impairment or heart failure

Your doctor will determine the dose to be taken and should carry out periodic checks.

Use in patients with hepatic impairment

The dose should be reduced to 1 sachet/day.

Long-term treatment

If you take this medicine for a long period of time, your doctor should carry out quarterly checks, for example of kidney and liver function, and blood tests.

If you take more Airtal than you should

Contact your doctor or pharmacist immediately, go to the nearest hospital, or contact the Toxicology Information Service at telephone number 915 620 420. Take this leaflet with you.

If you forget to take Airtal

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

4. Possible adverse effects

Like all medicines, this medicine may have adverse effects, although not everyone will experience them.

The adverse effects that may occur with the use of this medicine include:

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

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

• Blood in stool, gastrointestinal bleeding, gastrointestinal ulcer.
• Facial swelling.
• Heart failure, high blood pressure.
• Anemia.
• Severe allergic reaction, allergies.
• Vision abnormalities.
• Difficulty breathing.

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

• Inflammation of the mucous membrane of the mouth, inflammation of the pancreas, intestinal perforation, vomiting with blood.

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

• Purple spots on the skin, severe skin reactions.

Medicines such as Airtal may, in very rare cases, be associated with serious mucocutaneous reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

• Palpitations, flushing, feeling of warmth, inflammation of blood vessels (vasculitis).
• Liver injury (including hepatitis), increased alkaline phosphatase.

Medicines such as Airtal may be associated with liver disorders causing yellowing of the skin and eyes, sometimes accompanied by high fever or swelling and tenderness in the upper abdomen. If any of the following reactions occur—yellowing of the skin or eyes—discontinue treatment immediately and inform your doctor IMMEDIATELY.

• Decrease in white blood cells, decrease in platelets, bone marrow suppression, hemolytic anemia.
• Increased potassium in blood.
• Depression, sleep disturbances, difficulty falling asleep.
• Tingling, drowsiness, headache, taste disturbances, tremors.
• Dizziness, ringing in the ears (tinnitus).
• Noisy breathing, bronchospasm.
• Leg cramps.
• Impaired kidney function (nephrotic syndrome), renal failure.
• Fatigue, fluid retention (edema).
• Weight gain.

Exceptionally, severe skin infections have been observed during chickenpox.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Airtal

The active substance is aceclofenac. Each sachet 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 Airtaly, contents of the package

White or almost white powder contained in sachets.

Available in packs of 20 or 40 sachets.

Marketing Authorization Holder

Almirall, S.A.

General Mitre, 151

08022 – Barcelona (Spain)

Manufacturer

Industrias Farmacéut游戏副本Almirall, S.A.
Ctra. de Martorell, 41-61,
08740 Sant Andreu de la Barca - Barcelona (Spain)

Date of the most recent revision of this leaflet: February 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)