Airtal 100 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Airtal 100 mg film-coated tablets

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; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects 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. How to store 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 painful inflammatory conditions such as low back pain (lumbago), toothache (odontalgia), and joint pain (shoulder periarthritis and extra-articular rheumatism). Airtal is also indicated for the chronic treatment of 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 another allergic reaction.
• If you have had a stomach or duodenal ulcer, or have experienced a perforation of the gastrointestinal tract.
• If you have bleeding disorders or coagulation problems (you bleed easily).
• If you have severe renal insufficiency.
• If you have severe hepatic insufficiency.
• 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 have undergone 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, gastrointestinal 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 higher when high doses are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor may consider adding a stomach-protective medication.

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

• If you have liver disease.
• If you have renal insufficiency.
• If you have heart problems or have suffered a stroke (cerebral infarction, 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.

Also, this type of 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 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 discuss the use of other medications 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 major surgery.
• If you have previously suffered or still suffer from 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 conditions occurred to you 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 3 months of pregnancy, as it may harm your unborn child or cause problems during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your tendency and your baby's tendency to bleed, and may result in delayed or prolonged labour. You should not take Airtal during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is required during this period or while trying to become pregnant, the lowest possible dose should be used for the shortest possible time. If taken for more than a few days beyond 20 weeks of pregnancy, 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 reversible reduction in fertility.

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 medication, do not drive or operate any tools or dangerous machinery.

Airtal contains sodium

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

3. How to take Airtal

Follow exactly the instructions given by your doctor for administering this medicine. If in doubt, consult your doctor or pharmacist again.

The tablets should be swallowed whole with a little water.

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

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

If you consider 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 take and should carry out periodic checks.

Use in patients with renal insufficiency or heart failure

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

Use in patients with hepatic insufficiency

The dose should be reduced to 1 tablet/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 Poison 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 can 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)

• Gastrointestinal 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 feces, 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 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, hot flushes, inflammation of blood vessels (vasculitis).
• Liver injury (including hepatitis), increased alkaline phosphatase.

Medicines like 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 part of the abdomen. If any of the following reactions occur—yellowing of the skin or eyes—discontinue treatment and inform your doctor IMMEDIATELY.

• Decreased white blood cells, decreased platelets, bone marrow depression, hemolytic anemia.
• Increased blood potassium levels.
• 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 Medicines: 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 sight and reach of children.

Store below 30°C.

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

6. Contents of the container and additional information

Composition of Airtal

The active substance is aceclofenac. Each tablet contains 100 mg of aceclofenac.

The other components (excipients) are: microcrystalline cellulose, sodium croscarmellose, glyceryl palmitostearate, povidone, hypromellose, polyoxyl 40 stearate, and titanium dioxide (E-171).

Appearance of Airtaly tablet and packaging contents

White, biconvex, circular tablets.

Supplied in packs of 20 or 40 tablets.

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 the most recent review of this leaflet: February 2023

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