AISLAR*24FC TAB 200MG+30MG

Aislar 200 mg/30 mg film-coated tablets
Ibuprofen and pseudoephedrine hydrochloride

What it is and what it is used for
Aislar contains the active ingredients ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), and pseudoephedrine, a nasal decongestant.
• Ibuprofen relieves pain, swelling and high temperature.
• Pseudoephedrine acts on the blood vessels inside the nose to relieve nasal congestion.

Aislar is indicated for the relief of symptoms of nasal congestion with headache, fever and/or pain associated with colds and flu.
Aislar is indicated in adults and adolescents over 15 years of age.

Use this combination product only if you have a blocked nose with pain or fever. Do not use this product if you experience only one of these symptoms.

Consult your doctor if symptoms do not improve or worsen after 3 (for adolescents) or 5 (for adults) days.

What you need to know before taking the medicine
DO NOT take Aislar:
- if you are allergic to ibuprofen, pseudoephedrine or any of the other ingredients of this medicine (listed in section 6);
- if you are under 15 years of age;
- if you are pregnant or breastfeeding;
- if you have previously developed an allergic reaction (such as wheezing, worsening of asthma, runny and itchy nose, facial swelling or hives) while taking acetylsalicylic acid or other painkillers, antipyretics or anti-inflammatory drugs;
- if you have or have had stomach ulcers;
- if you have previously experienced perforation or bleeding related to NSAID use;
- if you suffer from severe liver failure;
- if you suffer from severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
- if you suffer from severe heart failure;
- if you suffer from severe heart or circulatory problems (heart disease, high blood pressure, angina, rapid heart rate), overactive thyroid, diabetes or phaeochromocytoma (an adrenal tumour);
- if you have previously had a heart attack (myocardial infarction);
- if you have very high blood pressure (severe hypertension) or hypertension not controlled by medication;
- if you have had a stroke or are at risk of stroke;
- if you have previously suffered from seizures;
- if you suffer from blood disorders of unknown origin;
- if you suffer from glaucoma (increased intraocular pressure);
- if you have difficulty urinating due to prostate problems;
- if you suffer from systemic lupus erythematosus (SLE), a disease that affects the immune system and causes e.g. joint pain and skin changes;
- if you are taking:
- acetylsalicylic acid (more than 75 mg per day) or other non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics;
- other nasal decongestants such as phenylpropanolamine, phenylephrine, ephedrine or methylphenidate;
- non-selective monoamine oxidase inhibitors (known as MAOIs) (used in the treatment of Parkinson's disease or depression) or have taken MAOIs in the last 2 weeks.

Warnings and precautions
Talk to your doctor or pharmacist before taking Aislar:
- if you suffer from asthma (risk of asthma attack);
- if your doctor has told you that you suffer from a blood clotting disorder;
- if you are taking medicines to thin the blood, e.g. warfarin, low-dose acetylsalicylic acid;
- if you are taking medicines that may increase the risk of stomach ulcers or bleeding, e.g. steroids, antidepressants belonging to the selective serotonin reuptake inhibitors (SSRIs) class (e.g. fluoxetine, paroxetine) or NSAIDs, including acetylsalicylic acid;
- if you suffer from psychosis or diabetes;
- if you have previously suffered from a gastrointestinal disease (such as ulcerative colitis or Crohn's disease);
- if you have kidney or liver problems;
- if you are taking anti-migraine medications;
- if you have an infection; see the section entitled Infections below.

Cases of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS) have been reported following the use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that can lead to reduced blood supply to the brain. Stop using Aislar immediately and seek immediate medical attention if you develop symptoms that could be signs of PRES or RCVS (see section 4 Possible side effects for symptoms).

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema), chest pain, have been reported with ibuprofen. Stop Aislar immediately and contact your doctor or emergency room immediately if you notice any of these signs.

Anti-inflammatory/painkillers such as Aislar may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke, especially when used at high doses. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

Sudden abdominal pain or rectal bleeding, due to colon inflammation (ischemic colitis), may occur with Aislar. If you develop these gastrointestinal symptoms, stop treatment with Aislar and contact your doctor or seek medical attention immediately. See section 4.

A reduction in blood supply to the optic nerve may occur with Aislar. In case of sudden loss of vision, stop treatment with Aislar and contact your doctor or seek medical attention immediately. See section 4.

Skin reactions
Severe skin reactions have been reported in association with Aislar treatment. Stop Aislar treatment and consult a doctor immediately if you develop a rash, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

If you develop a widespread feverish rash associated with pustules, stop taking this medicine and contact your doctor or seek medical attention immediately. See section 4.

Infections
Aislar may mask signs of infection such as fever and pain. It is therefore possible that Aislar may delay the initiation of appropriate treatment for the infection, which may lead to an increased risk of complications. This has been observed with pneumonia caused by bacteria and with bacterial skin infections related to chickenpox. If you take this medicine during an infection and the symptoms of the infection persist or worsen, consult a doctor immediately.

Talk to your doctor or pharmacist about treatment before taking Aislar:
- if you suffer from heart problems, including heart failure and angina (chest pain), have had a heart attack, have undergone bypass surgery, have suffered from peripheral artery disease (poor circulation in the legs or feet due to narrowed or blocked arteries) or have previously had any type of stroke (including mini-stroke or transient ischemic attack [TIA]);
- if you suffer from high blood pressure, diabetes or high cholesterol, have a family history of heart disease or stroke, or are a smoker.

Avoid alcohol consumption during treatment.

In dehydrated adolescents, there is a risk of kidney problems.

Contact a doctor if symptoms persist or worsen.

For athletes
The use of the drug without therapeutic necessity constitutes doping and may in any case lead to positive results in anti-doping tests.

Children and adolescents
Aislar should not be given to children under 15 years of age.

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

Stop treatment with Aislar immediately and contact your doctor urgently:
- if you experience any of the following effects, which may be signs of a severe allergic reaction:
• difficulty breathing or swallowing;
• swelling of the face, lips, tongue or throat;
• severe skin itching with hives;
• severe skin reactions with blisters under the skin;
• rapid heart beat with low blood pressure;
- if you experience signs of intestinal bleeding such as:
• bright red stools (bowel movements), black tarry stools, vomiting blood or dark particles similar to coffee grounds;
- if you develop symptoms that could be signs of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS). These include:
• severe headache with sudden onset;
• nausea;
• vomiting;
• confusion;
• seizures;
• changes in vision.

Other side effects may include:

Uncommon (may affect up to 1 in 100 people):
- headache, dizziness, difficulty sleeping, agitation, irritability or tiredness;
- heart attack, seizures, aseptic meningitis;
- visual disturbances;
- dry mouth, thirst;
- abdominal discomfort, dyspepsia, nausea, vomiting, diarrhoea, reduced appetite.

Rare (may affect up to 1 in 1,000 people):
- tinnitus (ringing in the ears);
- nervousness, tremor, anxiety, restlessness, hallucinations, insomnia;
- worsening of asthma;
- stomach pain, flatulence, constipation;
- swelling, high blood pressure, palpitations, rapid heart beat, heart attack, shortness of breath;
- heart rhythm disorder, chest pain;
- kidney tissue damage, high uric acid concentration in the blood;
- skin rashes, hives, itching, redness, excessive sweating.

Very rare (may affect up to 1 in 10,000 people):
- infectious inflammations, symptoms of meningitis (headache, fever, neck stiffness);
- blood disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe exhaustion, nosebleeds and bruising of unknown origin;
- severe allergic reactions;
- psychotic reactions, depression;
- kidney failure or other kidney diseases;
- liver diseases;
- stomach ulcer, sometimes with bleeding or perforation (blood in vomit or stools), gastritis, mouth ulcers, worsening of colitis and Crohn's disease, intestinal stenosis (narrowing);
- oesophagitis (heartburn); pancreatitis;
- severe skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis;
- alopecia;
- severe skin infections, soft tissue complications during chickenpox infection.

Frequency not known (frequency cannot be estimated from the available data):
- serious conditions affecting the cerebral blood vessels known as Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS);
- drug reaction with eosinophilia and systemic symptoms: a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include rash, fever, swollen lymph nodes and increased levels of eosinophils (a type of white blood cell);
- widespread red and scaly rash, accompanied by fever, at the beginning of treatment, with bumps under the skin and blisters mainly located on skin folds, trunk and upper limbs (acute generalised exanthematous pustulosis, AGEP). Stop treatment with Aislar if you develop these symptoms and consult a doctor immediately. See also section 2; colon inflammation due to insufficient blood supply (ischemic colitis);
- skin becomes sensitive to light;
- hallucinations, abnormal behaviour;
- difficulty urinating in men with prostate enlargement;
- reduced blood supply to the optic nerve (ischemic optic neuropathy);
- chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

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