AIRTAL 100 mg Coated Tablet

Содержание инструкции

1. AIRTAL 100 mg coated tablets, 100 mg oral suspension powder
   1. What AIRTAL is and what it is used for
   2. What you need to know before taking AIRTAL
2. AIRTAL 100 mg powder for oral suspension. This medicine contains less than 1 mmol of
   1. How to take AIRTAL
   2. Possible side effects
   3. How to store AIRTAL
   4. Contents of the pack and other information
3. AIRTAL 1.5 g/100 g cream
   1. WHAT AIRTAL IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING AIRTAL
   3. HOW TO USE AIRTAL
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE AIRTAL
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

AIRTAL 100 mg coated tablets, 100 mg oral suspension powder

Aceclofenac

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What AIRTAL is and what it is used for
• 2. What you need to know before you take 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 the active ingredient aceclofenac which belongs to the category of non-steroidal anti-inflammatory drugs (NSAIDs) and antirheumatic drugs (drugs used for diseases affecting the bones, cartilage and muscles).
This medicine is indicated in adults for the treatment of:

• Rheumatic inflammatory diseases such as osteoarthritis (disease affecting the joints), rheumatoid arthritis (a progressive and chronic autoimmune disease affecting the joints), ankylosing spondylitis (a severe disabling rheumatic disease that can cause fusion of the joints).
• Extra-articular rheumatism such as periarthritis (inflammatory disease involving fibrous tissues surrounding a joint), bursitis (inflammation of the fluid-filled sacs that act as a cushion between bones and tendons and/or muscles surrounding a joint), tendinitis (inflammation of the tendons), enthesitis (inflammation of the insertion of a muscle onto a bone).
• Acute painful conditions of different causes such as sciatica (sensation of intense pain in the leg caused by irritation of the sciatic nerve), lumbago (back pain), myalgia (muscle pain), primary dysmenorrhea (painful menstrual cycle), pain following trauma of various kinds, odontalgia (toothache).

2. What you need to know before taking AIRTAL

Do not take AIRTAL

• If you are allergic to the active ingredient, to other NSAIDs (including acetylsalicylic acid) or to any of the other ingredients of this medicine (listed in section 6).
• If you have experienced in the past, after taking acetylsalicylic acid or other NSAIDs, asthma attacks or other allergic reactions such as urticaria (skin reaction), rhinitis (inflammation of the nasal mucosa), edema (fluid accumulation), rash (sudden redness of the skin)

or bronchospasm (narrowing of the bronchi). This applies to all non-steroidal anti-inflammatory drugs.

• If you have a heart and/or cerebrovascular disease (at the level of the brain vessels), for example if you have had a heart attack, a stroke (brain damage that occurs when the blood flow to the brain is suddenly interrupted), a mini-stroke (TIA), blockages of the blood vessels of the heart or brain or if you have undergone surgery to remove these blockages or a coronary bypass (surgery that creates an artificial bridge that allows bypassing an obstacle to blood circulation).
• If you have or have had problems with blood circulation (peripheral arterial disease).
• If you have an active gastroduodenal ulcer (erosion of the inner lining of the stomach or intestine) or bleeding (hemorrhage) in the gastrointestinal tract.
• If you have active bleeding and bleeding disorders (blood loss).
• If you have had gastrointestinal bleeding or perforation caused by previous treatments with non-steroidal anti-inflammatory drugs or if you have had a recurrent gastric/peptic ulcer (two or more distinct episodes of demonstrated ulceration or bleeding).
• If you suffer from decreased liver function (severe hepatic impairment).
• If you suffer from decreased kidney function (renal impairment).
• If you are pregnant, especially in the third trimester and during breastfeeding, unless there are valid reasons to take it. In this case, the minimum effective dose should be used (see “Pregnancy, breastfeeding and fertility”).

AIRTAL should not be administered to children (see “Children and adolescents”).

Warnings and precautions
Talk to your doctor or pharmacist before taking AIRTAL.
Do not take AIRTAL in combination with other NSAIDs, including COX-2 selective inhibitors.
Take AIRTAL with caution:

• If you smoke.
• If you have diabetes (increased blood sugar concentration).
• If you suffer from angina (chest pain caused by insufficient oxygen supply to the heart).
• If you have blood clots.
• If you suffer from hypertension (high blood pressure).
• If you have a high level of cholesterol or triglycerides (fats) in the blood.
• In case of hepatic dysfunction (malfunctioning liver).
• In case of heart or kidney failure.
• If you have undergone major surgery.
• If you are elderly.

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration necessary to control symptoms (see section 3 “How to take AIRTAL”).
If you are elderly, be aware that the frequency of adverse effects, especially gastrointestinal bleeding and perforation, which can be fatal, is higher (see section 3 “How to take AIRTAL”).
Gastrointestinal tract (stomach and intestines)
During treatment with all NSAIDs, at any time, with or without warning symptoms or after serious gastrointestinal events (diseases at the level of the stomach or intestines), bleeding in the stomach and intestines, ulceration or perforation have been reported, which can be fatal.

Stop taking AIRTAL immediatelyand consult your doctor if you experience gastrointestinal bleeding or ulceration while taking the medicine.
As with all NSAIDs, you must take AIRTAL with particular caution and under close medical supervision if you have symptoms indicative of disorders relating to the upper or lower gastrointestinal tract, if you have had gastric or intestinal ulcers in the past, bleeding, perforation, ulcerative colitis or Crohn's disease (inflammatory bowel diseases), hematological alterations (at the level of the blood) as these conditions may be worsened (see section 4 “Possible side effects”).
If you are elderly or if you have had an ulcer in the past, especially if complicated by bleeding or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is greater, especially with increased doses of NSAIDs. In these cases, start treatment with the lowest effective dose in order to reduce the risk of gastrointestinal toxicity.
If you are taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (such as other NSAIDs or corticosteroids - see “Other medicines and AIRTAL”), you may consider using gastric protective agents in combination (e.g. misoprostol or proton pump inhibitors).
If you have suffered from gastrointestinal toxicity (i.e. problems with the stomach and intestines), especially if you are elderly, you should report any abdominal symptoms (especially gastrointestinal bleeding) to your doctor, particularly in the early stages of treatment.
Be careful when taking AIRTAL if you are being treated concomitantly with medicines that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, antiplatelet agents or selective serotonin reuptake inhibitors (see “Other medicines and AIRTAL”).
Cardiovascular (at the level of the heart vessels) and cerebrovascular (at the level of the brain vessels) system
Undergo adequate monitoring and take AIRTAL with caution:

• If you have had hypertension and/or congestive heart failure (inability of the heart to supply blood in adequate quantities to the needs of the body) from mild to moderate, as fluid retention and edema have been found in association with treatment with NSAIDs.
• If you have significant risk factors for cardiovascular events (high blood pressure, high levels of fats in the blood, diabetes) or if you smoke.
• If you have had cerebrovascular bleeding in the past.

The use of AIRTAL may be associated with an increased risk of myocardial infarction (heart attack) (see section 4 “Possible side effects”).
Since the cardiovascular risks of AIRTAL may increase with dose and duration of treatment, use the lowest effective daily dose for the shortest period necessary. The response to therapy and the need for symptom improvement should be reassessed periodically.
Hypersensitivity (allergy) and skin (skin) reactions
Avoid the use of AIRTAL in case of varicella; in some cases, varicella can cause serious infectious complications of the skin and soft tissues and the role of NSAIDs in worsening these infections cannot be excluded (see section 4 “Possible side effects”).
As with other NSAIDs, hypersensitivity reactions, including anaphylactic/anaphylactoid reactions (rapidly occurring allergic reactions), even without previous exposure to aceclofenac, may occur in rare cases (see section 4 “Possible side effects”).
Serious skin reactions (at the level of the skin), some of which are fatal, including exfoliative dermatitis (skin irritation with scaling), Stevens-Johnson syndrome (lesions at the level of the skin and mucous membranes) and toxic epidermal necrolysis (severe skin disease in which the epidermis detaches in sheets), have been very rarely reported in association with the use of NSAIDs (see section 4 “Possible side effects”). The risk appears to be higher in the early stages of therapy as the onset of the reaction occurs in most cases within the first month of treatment.
Stop taking AIRTAL at the first appearance of skin rash, mucous membrane lesions or any other sign of hypersensitivity (allergy).
Renal function
Take AIRTAL with caution:

• In case of mild to moderate renal impairment as the use of NSAIDs may determine a deterioration of renal function. In these cases, take the minimum effective dose and undergo regular checks of renal function.
• If you are being treated concomitantly with diuretics (drugs that increase urine production).

The effects on renal function are generally reversible with the discontinuation of aceclofenac.
Hepatic function (liver)
Stop treatment with AIRTAL if liver function parameters are persistently altered or worsened, if clinical or symptomatic signs of hepatopathy (liver disease) develop or if other manifestations such as eosinophilia (elevated concentration of white blood cells in the blood) or rash (sudden redness of the skin) occur. Hepatitis (inflammation of the liver) may occur with AIRTAL without warning symptoms.
Use AIRTAL with caution if you have hepatic porphyria (rare disease in which there is a deficiency of liver enzymes), as it may trigger an attack.
Undergo regular medical checks in case of mild-moderate impairment of liver function.
Hematological problems (at the level of the blood)
Aceclofenac may temporarily block platelet aggregation (see “Other medicines and AIRTAL”).
Respiratory disorders
Pay particular attention when taking AIRTAL if you suffer from or have suffered in the past from bronchial asthma (disease caused by obstruction of the bronchi) as NSAIDs may worsen bronchospasm.
Long-term treatments
As a preventive measure, if you are undergoing long-term treatment with NSAIDs, you should be checked for blood cell count and renal and hepatic function parameters.

Children and adolescents
There are currently no clinical data on the use of the drug in children, therefore its administration is not recommended (see “Do not take AIRTAL”).

Other medicines and AIRTAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Take care when taking AIRTAL with:

• Diuretics (medicines used to increase urine production); aceclofenac, like other NSAIDs, can inhibit the activity of diuretics. In the case of concomitant administration with potassium-sparing diuretics, it is necessary to monitor blood potassium levels.
• Antihypertensives (medicines used to reduce blood pressure); NSAIDs can reduce the effect of antihypertensive medicines. If your kidney function is impaired (for example if you have lost a lot of fluids or if you are elderly) the co-administration of antihypertensive medicines such as ACE inhibitors or angiotensin II receptor antagonists and NSAIDs can increase the risk of acute renal failure, generally reversible. In these cases you should be adequately hydrated and monitoring of kidney function should be considered after starting concomitant therapy and periodically thereafter.
• Corticosteroids (medicines with anti-inflammatory action); an increased risk of ulceration or bleeding in the stomach and intestines (gastrointestinal bleeding) may occur (see “Warnings and precautions”).
• Anticoagulants; like other NSAIDs, aceclofenac can increase the activity of anticoagulant medicines such as warfarin (see “Warnings and precautions”) and therefore in case of combined therapy it must be strictly controlled.
• Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs); concomitant use with NSAIDs may increase the risk of gastrointestinal bleeding (see “Warnings and precautions”).
• Antidiabetics. Isolated cases of hypoglycemic (low blood sugar) and hyperglycemic (high blood sugar) effects have been reported; it is therefore advisable to consider the possibility of adjusting the dosage of hypoglycemic agents (medicines that reduce blood sugar levels) in conjunction with aceclofenac.
• Methotrexate (antineoplastic and antirheumatic drug, used for the treatment of some diseases such as leukemia, lymphoma, rheumatoid arthritis, lupus and psoriasis); the possible interaction between NSAIDs and methotrexate should be kept in mind even when low doses of methotrexate are administered, especially if you have reduced kidney function. When combined therapy is to be administered, kidney function should be monitored. Use particular caution in case of concomitant administration within 24 hours of NSAIDs and methotrexate, as an increase in the concentration of the antitumor agent in the blood with a consequent increase in its toxicity may occur.
• Lithium (mood stabilizer, used in the treatment of depression and bipolar disorder) and digoxin (medicine that stimulates heart function); several NSAIDs inhibit the elimination of lithium and digoxin, determining an increase in their concentration in the blood. The combination should therefore be avoided unless frequent monitoring of lithium and digoxin levels is possible.
• Other NSAIDs; concomitant use of acetylsalicylic acid and other NSAIDs may increase the frequency of adverse effects.
• Cyclosporine and tacrolimus (immunosuppressant drugs); it is believed that the administration of NSAIDs in conjunction with cyclosporine or tacrolimus may increase the risk of nephrotoxicity (toxicity to the kidneys). During combination therapy it is therefore important to carefully monitor kidney function.
• Zidovudine (antiviral drug); when NSAIDs are administered with zidovudine, the risk of hematological toxicity (of the blood) increases; there is evidence of increased risk of hemarthrosis (bleeding into a joint) and hematoma in HIV-positive hemophiliacs

positive undergoing concomitant treatment with zidovudine and ibuprofen (a drug belonging
to the category of NSAIDs).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take AIRTAL in the last 3 months of pregnancy, as it may harm the fetus or
cause problems during childbirth. It can cause problems with the heart, lungs or kidneys of the fetus.
It may affect your and your baby's tendency to bleed and delay or prolong
labor more than expected. You should not take AIRTAL in the first 6 months of pregnancy unless
absolutely necessary and under medical advice. If treatment is needed during this
period or during attempts to conceive, the minimum dose should be used for the
shortest possible time. From the 20th week of pregnancy, AIRTAL can cause kidney problems in the
fetus if taken for more than a few days, reducing the levels of amniotic fluid surrounding the
baby (oligohydramnios) or narrowing a blood vessel (ductus arteriosus) in the baby's heart.
If treatment is needed for more than a few days, your doctor may
recommend additional monitoring.
The inhibition of prostaglandin synthesis caused by NSAIDs can negatively affect
pregnancy and/or the development of the embryo and fetus. Results of epidemiological studies suggest
an increased risk of abortion and cardiac malformation and gastroschisis (defect of the abdominal wall in which the intestine and sometimes other organs develop outside the abdomen
of the fetus) after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy.
The absolute risk of cardiac malformations increased from less than 1%, to about 1.5%. It
is believed that the risk increases with dose and duration of therapy.
Breastfeeding
Do not take AIRTAL if you are breastfeeding, to avoid unwanted effects in the infant unless the
potential benefit to the mother outweighs the possible risk to the fetus (see “Do not take
AIRTAL”).
Fertility
NSAIDs may impair fertility and use is not recommended in women planning to become
pregnant. The administration of aceclofenac should be discontinued in women who have
fertility problems or are undergoing fertility investigations.
If you take AIRTAL in these cases, the dose should be kept as low as possible and the duration
of treatment should be as short as possible.

Driving and operating machinery
The administration of aceclofenac, as with other NSAIDs and in particularly predisposed patients, may give rise to dizziness, vertigo or other central nervous system disorders.
You should be informed of these possible effects before driving a vehicle or operating
machinery requiring integrity of the degree of vigilance.

AIRTAL 100 mg powder for oral suspension contains sorbitol.
This medicine contains 2639 mg of sorbitol in each sachet. Sorbitol is a source of
fructose. If your doctor has told you that you are intolerant to some sugars, or if you have a diagnosis of
hereditary fructose intolerance, a rare genetic disease in which patients cannot
metabolize fructose, talk to your doctor before you take this medicine.

AIRTAL 100 mg powder for oral suspension contains aspartame.
This medicine contains 10 mg of aspartame in each sachet. Aspartame is a source of
phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disease that
causes the accumulation of phenylalanine because the body is unable to dispose of it properly.

AIRTAL 100 mg powder for oral suspension. This medicine contains less than 1 mmol of

sodium (23 mg) per sachet, which is essentially "sodium-free".

AIRTAL 100 mg coated tablets.This medicine contains less than 1 mmol of sodium (23 mg)
per tablet, which is essentially "sodium-free".

3. How to take AIRTAL

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
AIRTAL 100 mg coated tablets

Adults
The recommended dose is 2 tablets per day (200 mg per day), 1 tablet every 12 hours.
Swallow the tablets with a sufficient amount of water.
Take the medicine preferably during meals.
AIRTAL 100 mg powder for oral suspension
The recommended dose is 2 sachets per day (200 mg per day), 1 sachet every 12 hours.
Dissolve the contents of one sachet in a glass of water (40-60 ml) and swallow
immediately.
Take the medicine preferably during meals.

Elderly
It is not considered necessary to modify the dosage.

Patients with hepatic impairment
In patients with liver problems (hepatic impairment) it is advisable to reduce the initial dose to
100 mg per day
However, as with other NSAIDs, use AIRTAL with caution if you are elderly and have impaired
renal or hepatic function, cardiovascular dysfunction or if you are undergoing other
pharmacological treatments simultaneously.
Adverse effects can be minimized by administering the lowest effective dose for the
shortest duration necessary to control the symptoms (see “Warnings and precautions”).

If you take more AIRTAL than you should
In case of accidental ingestion/intake of an excessive dose of AIRTAL, immediately
notify your doctor or go to the nearest hospital.
Currently, insufficient information is available regarding the clinical picture resulting from
overdose with AIRTAL.
The therapeutic measures to be adopted in case of acute poisoning with oral aceclofenac are
those commonly used in case of acute NSAID poisoning:

• Absorption should be prevented as soon as possible by means of gastric lavage (stomach emptying and washing) and treatment with activated charcoal.
• Supportive and symptomatic treatments should be adopted in case of complications such as hypotension (low blood pressure), renal failure, convulsions, gastrointestinal irritation and respiratory depression.
• Specific therapies, such as forced diuresis (method used to increase the elimination of substances already absorbed), dialysis (therapy that replaces kidney function) or hemoperfusion (passing blood through a resin column to remove a substance) do not allow the elimination of non-steroidal anti-inflammatory drugs, due to the high percentage of binding to blood proteins and their considerable metabolism.

If you forget to take AIRTAL
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop treatment with AIRTALand contact your doctor immediately if you experience any of the following side effects:

• Bleeding in the stomach and intestines (gastrointestinal).
• Lesions in the stomach (peptic ulcers).
• Persistent or worsening liver function parameters, clinical signs or symptoms consistent with liver disease, other manifestations such as eosinophilia.
• Skin rash (sudden redness of the skin), mucous membrane lesions or any other sign of allergy.

Possible side effects that may occur following the intake of AIRTAL are:

Common side effects (may affect up to 1 in 10 people)

• Dizziness.
• Increased levels of certain liver enzymes.
• Nausea, diarrhea, abdominal pain, dyspepsia (digestive pain).

Uncommon side effects (may affect up to 1 in 100 people)

• Gastritis (inflammation of the stomach), mouth ulcers (aphthae), flatulence (presence of gas in the intestine), constipation, vomiting.
• Urticaria (skin condition), rash (sudden redness of the skin), itching, dermatitis (skin inflammation).
• Increased levels of urea and creatinine in the blood.
• Constipation.

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

• Anemia (reduction in hemoglobin concentration in the blood).
• Angioedema (sudden swelling of the skin or mucous membranes).
• Vision disorders.
• Hypertension (high blood pressure).
• Anaphylactic reaction (rapid-onset allergic reaction) including shock, allergy.
• Heart failure (inability of the heart to provide an adequate amount of blood for the needs of the entire body).
• Dyspnea (difficulty breathing).
• Melena (emission of blood with the stool), gastrointestinal ulcer and bleeding (peptic ulcers, perforation or gastrointestinal bleeding may occur, sometimes fatal, especially in the elderly - see “Warnings and precautions”).

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

• Thrombocytopenia (decrease in the number of platelets in the blood), hemolytic anemia (decrease in hemoglobin concentration in the blood caused by the destruction of red blood cells), granulocytopenia (severe decrease in the number of granulocytes in the blood), bone marrow depression (decrease in the functionality of the bone marrow that produces blood cells).
• Depression, insomnia, abnormal dreams.
• Paresthesia (altered sensitivity), dysgeusia (altered taste), headache, drowsiness.
• Tinnitus (ringing in the ears), vertigo.
• Palpitations.
• Flushing.
• Vasculitis (inflammation of the veins), hot flashes.
• Bronchospasm (narrowing of the bronchi).
• Worsening of ulcerative colitis or Crohn's disease (inflammatory bowel diseases), stomatitis (inflammation of the oral mucosa), pancreatitis (inflammation of the pancreas), intestinal perforation, hematemesis (emission of blood with vomiting).
• Stevens-Johnson syndrome (acute allergic reaction involving the skin and mucous membranes), toxic epidermal necrolysis (or “Lyell's syndrome”, a serious skin disease induced by an allergy to certain drugs, characterized by the destruction of the epithelium and mucous membranes), purpura (lesion similar to a bruise, resulting from the rupture of capillaries under the surface of the skin), exanthema (skin rash).
• Renal failure, nephrotic syndrome (a set of symptoms and clinical signs caused by an alteration of the renal glomeruli that leads to protein loss in the urine).
• Liver lesions (including hepatitis - liver inflammation), increased alkaline phosphatase in the blood.
• Edema (fluid retention), fatigue.
• Weight gain.

Clinical trials and epidemiological data indicate that there may be an increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke) associated with the use of aceclofenac, especially at high doses and in long-term treatments (see “Warnings and precautions”).
Exceptionally, during chickenpox, serious skin and soft tissue infections have been reported in conjunction with treatment with NSAIDs. To date, the role of NSAIDs in worsening these infections cannot be ruled out (see “Warnings and precautions”).
If you experience one or more of the side effects described above, it is recommended to stop treatment with aceclofenac and contact your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store AIRTAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month and the product in intact packaging,
correctly stored.
AIRTAL 100 mg coated tablets
Store at a temperature not exceeding 30°C.
AIRTAL 100 mg oral suspension powder
No special storage precautions are required.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AIRTAL contains
AIRTAL 100 mg coated tablets
One coated tablet contains:

Active ingredient:aceclofenac 100 mg.

Other ingredients: microcrystalline cellulose, sodium croscarmellose, glyceryl palmitostearate,
povidone, hypromellose, polyethylene(40) stearate, titanium dioxide.
AIRTAL 100 mg powder for oral suspension
One sachet contains:

Active ingredient: aceclofenac 100 mg.

Other ingredients: sorbitol, sodium saccharin, caramel flavour, cream flavour, milk flavour, colloidal
anhydrous silica, aspartame, hypromellose, titanium dioxide.

Description of the appearance of AIRTAL and contents of the pack
AIRTAL 100 mg coated tablets
Circular white coated tablets.

• Blisters of 10 coated tablets in a cardboard box.
• Blisters of 40 coated tablets in a cardboard box.

AIRTAL 100 mg powder for oral suspension
White or off-white powder for oral suspension.
Pack of 30 sachets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
ALMIRALL S.A.
Ronda General Mitre 151
08022 Barcelona, Spain

Manufacturer
Industrias Farmacéuticas Almirall S.A. (Planta de Sant Andreu de la Barca) Ctra. de Martorell, 41-
61, 08740 Sant Andreu de la Barca –Barcelona (SPAIN).

AIRTAL 1.5 g/100 g cream

Aceclofenac

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet:

• 1. What AIRTAL is and what it is used for
• 2. What you need to know before using AIRTAL
• 3. How to use 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 the active substance aceclofenac, which belongs to the category of non-steroidal anti-inflammatory drugs (NSAIDs) and rheumatic drugs (drugs used for diseases affecting bones, cartilage and muscles).
This medicine is indicated in the local treatment of painful and inflammatory (inflammatory) conditions of rheumatic or traumatic origin of the joints, muscles, tendons and ligaments, such as tendinitis (inflammation of the tendons), tenosynovitis (inflammation of the membrane covering the tendon), sprains, bruises, periarthritis (inflammatory diseases involving fibrous tissues surrounding a joint), dislocations (joint dislocations), lumbago (back pain), stiff neck, bursitis (inflammation of fluid-filled sacs that act as cushions between bones and tendons and/or muscles surrounding a joint), strains and post-traumatic sequelae.

2. WHAT YOU NEED TO KNOW BEFORE USING AIRTAL

Do not use AIRTAL

• If you are allergic to the active ingredient, to other NSAIDs (including acetylsalicylic acid) or to any of the other components of this medicine (listed in section 6).
• If you have experienced in the past, after taking acetylsalicylic acid or other NSAIDs, a worsening of asthma attacks, acute rhinitis (inflammation of the nasal mucosa) or urticaria (skin redness with intense itching).
• If you have or have experienced in the past hypersensitivity (allergy) reactions to diclofenac, even if allergenicity cross-reactivity with this medicine has not been demonstrated.
• If you are in the last 3 months of pregnancy and during breastfeeding (see “Pregnancy, breastfeeding and fertility”).

AIRTAL is contraindicated in paediatric age (see “Children and adolescents”).

Warnings and precautions
Consult your doctor or pharmacist before using AIRTAL.
Use AIRTAL cream only for external use.
During treatment with AIRTAL you must avoid:

• Inappropriate exposure of the treated area to sunlight without adequate protection to prevent photosensitivity reactions (immune system reaction to sunlight).
• Applying the cream to wounds or open sores.
• Contact with the eyes, mucous membranes or any other site of application with ongoing skin lesions.

Stop treatment with AIRTAL and undergo appropriate therapeutic treatment if
you experience symptoms of local irritation.
Prolonged use of dermatological products can lead to sensitization phenomena
(allergy).
As with other NSAIDs, allergic reactions, including anaphylactic/ anaphylactoid reactions (rapid onset allergic reactions), may also occur, even without previous
exposure to aceclofenac (see section 4 “Possible side effects”).
Severe skin reactions (at the skin level), some of which are fatal, including exfoliative dermatitis
(skin irritation with scaling), Stevens-Johnson syndrome (lesions at the
skin and mucous membranes) and epidermal necrolysis (severe skin disease in which the epidermis detaches in
layers), have been very rarely reported in association with the use of NSAIDs (see section
4 “Possible side effects”). The risk appears to be higher in the early stages of therapy in
as the onset of the reaction occurs in most cases within the first month of
treatment.
Stop taking AIRTAL at the first sign of skin rash, mucosal lesions or
any other sign of hypersensitivity (allergy).
Avoid using AIRTAL in case of chickenpox; in some cases, chickenpox can cause serious infectious complications of the skin and soft tissues and it is not possible to exclude the role of NSAIDs
in exacerbating these infections (see section 4 “Possible side effects”).

Children and adolescents
Currently, there are no data available regarding the safety and efficacy of aceclofenac in
children up to 14 years of age, therefore its administration is not recommended (see “Do not use AIRTAL”).

Other medicines and AIRTAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Use caution when using AIRTAL with:

• Lithium (mood stabilizer, used in the treatment of depression and bipolar disorder).
• Digoxin (a medicine that stimulates heart function).
• Oral anticoagulants (medicines that increase blood fluidity).
• Diuretics (medicines used to increase urine production).
• Pain relievers (medicines used against pain).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Oral forms (e.g., tablets) of aceclofenac can cause adverse effects in the newborn.
It is not known whether the same risk applies to AIRTAL.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine. Do not
use AIRTAL if you are in the last 3 months of pregnancy.
You should not use AIRTAL during the first 6 months of pregnancy unless it is strictly
necessary and recommended by your doctor. If you need treatment during this period,
you must use the lowest dose for the shortest possible time.
Breastfeeding
Do not use AIRTAL if you are breastfeeding.
Fertility
The use of AIRTAL, like any drug that inhibits the synthesis of prostaglandins and
cyclooxygenase (anti-inflammatory drugs), is not recommended in women who intend to become
pregnant.
The administration of AIRTAL should be discontinued in women with fertility problems or who are undergoing fertility investigations.

Driving and operating machinery
AIRTAL does not impair the ability to drive vehicles or operate machinery.

AIRTAL 15 mg/g cream contains propylparaben and methylparaben.
They can cause allergic reactions (including delayed reactions).

3. HOW TO USE AIRTAL

Use this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1.5 g - 2 g of AIRTAL cream, equivalent to 4-5 cm, to be applied three times a day
to the affected area or as prescribed by your doctor.

If you use more AIRTAL than you should
Cases of overdose are unknown. In case of improper use or if an excessive dose of the medicine is taken,
it is appropriate to resort to general therapeutic measures normally
adopted in case of poisoning with non-steroidal anti-inflammatory drugs.

If you forget to use AIRTAL
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects that may occur following the use of AIRTAL are:
Mild to moderate skin irritation accompanied by redness and mild itching that
disappears with discontinuation of treatment.

Uncommon side effects (may affect up to 1 in 100 people)

• Photosensitivity in case treated skin areas have been exposed to strong sunlight without adequate protection (see “Warnings and precautions”).
• Erythema (skin irritation).
• Pruritus (itching).

Very rare side effects (may affect up to 1 in 10,000 people)
Bullous eruption (including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis).
Exceptionally, serious infectious skin and soft tissue complications have been reported during chickenpox in association with treatment with NSAIDs (see “Warnings and
precautions”).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. HOW TO STORE AIRTAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month and the product in intact packaging,
correctly stored.
Store at a temperature not exceeding 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What AIRTAL contains
100 g of cream contains:

Active substance: aceclofenac 1.5 g.

Other components: emulsifying wax, liquid paraffin, propylparahydroxybenzoate,
methylparahydroxybenzoate, purified water.

Description of the appearance of AIRTAL and contents of the pack
White cream.
Tube containing 50 g of cream.

Marketing Authorisation Holder
ALMIRALL S.A.
Ronda General Mitre 151
08022 Barcelona, Spain
Representative for Italy:
ALMIRALL S.p.A.
Via Messina, 38 – Torre C
20154 Milan

Manufacturer
Industrias Farmacéuticas Almirall , S.A. (Planta de Sant Andreu de la Barca), Ctra. de Martorell, 41-61 -
08740 Sant Andreu de la Barca - Barcelona (Spain) (exclusively for batch control and release).
Almirall Hermal GmbH, Scholtzstrasse 3, 21465 Reinbek (Germany).