AISLAR 200 mg/30 mg Film-Coated Tablets

Зміст інструкції

1. Aislar 200 mg/30 mg film-coated tablets
   1. What Aislar is and what it is used for
   2. What you need to know before taking Aislar
   3. How to take Aislar
   4. Possible side effects
   5. How to store Aislar
   6. Contents of the pack and other information

Aislar 200 mg/30 mg film-coated tablets

ibuprofen and pseudoephedrine hydrochloride

Read this leaflet carefully before taking this medicine because it contains important
information for you.
Always take 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 (for adolescents) or 5 (for adults) days.

Contents of this leaflet

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

This medicine is called Aislar 200 mg/30 mg film-coated tablets, but in this leaflet it will be
referred to as Aislar.

1. What Aislar 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 alleviates 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 cold 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.
See your doctor if you do not feel better or if your symptoms worsen after 3 (for adolescents) or 5 (for adults) days.

2. What you need to know before taking Aislar

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 or itchy nose, swelling of the face or hives) while taking acetylsalicylic acid or other pain relievers, antipyretics or anti-inflammatory drugs;
• if you have or have had stomach ulcers;
• if you have previously experienced perforation or bleeding related to the use of NSAIDs;
• 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 serious heart or circulatory problems (cardiopathy, high blood pressure, angina, rapid heart rate), hyperthyroidism, diabetes or pheochromocytoma (a tumor of the adrenal gland);
• if you have previously had a heart attack (myocardial infarction);
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension;
• if you have had a stroke or are at risk of stroke;
• if you have previously suffered from convulsions;
• 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 (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 beforetaking Aislar:

• if you suffer from asthma (risk of asthma attack);
• if your doctor has told you that you suffer from a blood coagulation disorder;
• if you are taking medicines to thin the blood, e.g. warfarin, low-dose acetylsalicylic acid;
• if you are taking medicines that could increase the risk of ulcers or bleeding in the stomach, e.g. steroids, antidepressants belonging to the class of selective serotonin reuptake inhibitors (SSRIs) (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 problems with your kidneys or liver;
• 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 flow 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 if you notice any of these signs.
Use with caution in case of hyperexcitation. If hallucinations, restlessness or sleep disturbances occur during administration of the medicine, the use of the medicine should be discontinued.
Anti-inflammatory/pain relievers 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.
Abdominal pain or rectal bleeding may occur with Aislar, due to inflammation
of the colon (ischemic colitis). If you develop these gastrointestinal symptoms, stop treatment with Aislar
and contact your doctor or seek immediate medical attention. See section 4.
A reduction in blood flow 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 immediate medical
attention. See section 4.
Skin reactions
Severe skin reactions have been reported in association with treatment with Aislar. Stop the
treatment with Aislar and consult a doctor immediately if you develop rash, mucous membrane lesions, blisters or other signs of allergy, as they may be the first signs of a very
serious skin reaction. See section 4.
If you develop a generalized feverish erythema associated with pustules, stop taking this
medicine and contact your doctor or seek immediate medical attention. See section 4.
Infections
Aislar can mask signs of infection such as fever and pain. It is therefore possible that Aislar may delay the start of an
appropriate treatment of the infection, which may increase the risk of complications. This
has been observed with pneumonia caused by bacteria and with bacterial skin infections related to
chickenpox. If you are taking this medicine during an infection and the symptoms of the infection persist or
worsen, consult your doctor immediately.
Talk to your doctor or pharmacist 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 arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries) or have previously had a stroke of any kind (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 consuming alcohol 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 a therapeutic need constitutes doping and may still result in a positive
doping test.

Children and adolescents
Aislar must not be givento children under 15 years of age.

Other medicines and Aislar
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.

Aislar must not be used if you are taking:

• acetylsalicylic acid (more than 75 mg per day);
• other non-steroidal anti-inflammatory drugs (NSAIDs);
• other pain relievers or antipyretics;
• monoamine oxidase inhibitors (MAOIs; used in the treatment of Parkinson's disease or depression) or have taken MAOIs in the last 2 weeks;
• other vasoconstrictors used as nasal decongestants (e.g. phenylpropanolamine, phenylephrine and ephedrine administered orally or nasally).

Aislar can influence or be influenced by other medicines. For example:

• anticoagulants (i.e. medicines that thin the blood/prevent coagulation, for example acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-based medicines, angiotensin II receptor antagonists such as losartan);
• medicines that could increase the risk of ulcers or bleeding in the stomach, for example steroids, antidepressants belonging to the class of SSRIs (e.g. fluoxetine, paroxetine) or NSAIDs, including acetylsalicylic acid, and selective cyclooxygenase-2 (COX-2) inhibitors;
• medicines for irregular heartbeat, heart failure or fluid retention (e.g. cardiac glycosides), as Aislar may reduce their effects or increase the risk of cardiac arrhythmias, high blood pressure or impaired kidney function;
• cyclosporine (immunosuppressants) due to the possible increased risk of impaired kidney function;
• the medicines for depression (lithium, tricyclic antidepressants) may increase the risk of side effects;
• the concomitant use of phenytoin may increase the serum levels of these medicines. Proper use (for a maximum of 5 days) does not require monitoring of phenytoin levels;
• other decongestants or appetite suppressants, anti-migraine medicines, oxytocin, as they may increase the risk of side effects;
• probenecid or sulfinpyrazone may delay the excretion of ibuprofen;
• sulphonylureas (antidiabetics): although interactions with ibuprofen have not been described so far, it is recommended, as a precaution, to monitor blood glucose levels in case of concomitant use;
• medicines to increase urine production (diuretics);
• methotrexate at high doses (over 20 mg per week), as the effect of methotrexate may be increased;
• quinolone antibiotics due to the increased risk of developing convulsions;
• cyclosporine, tacrolimus and trimethoprim;
• zidovudine (for the treatment of HIV);
• injectable heparin and/or preparations containing Ginkgo bilobadue to the increased risk of bleeding;
• mifepristone: for 8-12 days after the administration of mifepristone, NSAIDs must not be administered as they may reduce its effect.

There are also other medicines that can influence or be influenced by treatment with Aislar.
Therefore, always ask your doctor or pharmacist for advice before using Aislar with other medicines,
including those available without a prescription.
Due to the administration of pseudoephedrine, an
acute hypertensive response may develop during the perioperative phase. Therefore, stop treatment with Aislar several days before surgery and
inform the anesthesiologist.

Aislar with food and drink
Swallow the tablets with water, preferably with a full stomach.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Aislar should not be taken during pregnancy. The active ingredients, ibuprofen and pseudoephedrine, can
cause serious problems for the fetus.
NSAIDs can cause problems with the kidneys and heart of the fetus. They may affect the mother's and
baby's tendency to bleed and delay or prolong labor more than expected. From the 20th week of
pregnancy, NSAIDs can cause kidney problems in the fetus, reducing the levels of amniotic fluid
surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in
the baby's heart.
Breastfeeding
Aislar should not be taken if you are breastfeeding. The active ingredients, ibuprofen and pseudoephedrine, have been shown to be present in breastfed infants of women who have taken them.
Fertility
Aislar contains ibuprofen, which belongs to a group of medicines (NSAIDs) that can
impair fertility in women. This effect is reversible by stopping treatment with the
medicine.

Driving and using machines
Aislar has no known effects on the ability to drive and operate machines. However, dizziness or hallucinations may occur in rare cases, a possibility that should be taken into consideration.

Aislar contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.

3. How to take Aislar

Take Aislar always as exactly described in this leaflet or as instructed by your doctor or
pharmacist. If you have any doubts, ask your doctor or pharmacist.
Aislar is only for oral use.
The minimum effective dose should be used for the shortest possible time needed to relieve symptoms. In case of
infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see
paragraph 2).

The recommended dose is:
Adults and adolescents aged 15 years and over: 1 tablet every 4-6 hours, as needed. For
more severe symptoms, 2 tablets every 6-8 hours, as needed.
Do not exceed the maximum daily dose of 6 tablets.
Swallow the tablets with water, preferably with a full stomach. Do not break or crush the tablets.

Use in children and adolescents
Do not give to children under the age of 15 years.

Duration of treatment
This medicine is intended for short-term use only. Use the minimum dose for the shortest time
necessary to relieve symptoms.
In adults, do not exceed 5 days of therapy.
In adolescents (15-18 years), do not exceed 3 days of therapy.
If symptoms persist or worsen, consult your doctor.

If you take more Aislar than you should
If you have taken more Aislar than you should, or if children have mistakenly taken this medicine,
always contact a doctor or the nearest hospital for advice on the risk and for advice on what
action to take.
Symptoms of overdose may include nausea, stomach pain, vomiting (sometimes with traces of blood),
diarrhoea, dry mouth, headache, ringing in the ears, confusion, blurred vision and eye tremor. At high doses, drowsiness, excitement and disorientation, chest pain,
palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, presence
of blood in the urine, low potassium levels in the blood, feeling cold to the body and breathing problems have been reported.
In addition, a prolongation of the prothrombin time (INR) may occur. Serious
damage to the kidneys and liver may occur. In asthmatic subjects, a worsening of asthma may occur.
In addition, insomnia, fever, sweating, anxiety, restlessness and tremor may occur.

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

4. Possible side effects

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

Stop taking Aislar immediately andseek urgent medical attention:

• if you experience any of the following effects, which may be signs of a severe allergicreaction:
• difficulty breathing or swallowing;
• swelling of the face, lips, tongue or throat;
• severe itching of the skin with hives;
• severe skin reactions with blisters under the skin;
• fast heartbeat with low blood pressure;
• if you experience signs of intestinal bleeding such as
• bright red stools (faeces), black tarry stools, vomiting blood or particles that look like coffee grounds;
• if you develop symptoms that may be signs of reversible posterior 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 fatigue;
• heart attack, seizures, aseptic meningitis;
• visual disturbances;
• dry mouth, thirst;
• abdominal discomfort, dyspepsia, nausea, vomiting, diarrhoea, decreased appetite;

Rare (may affect up to 1 in 1000 people):

• tinnitus (ringing in the ears);
• nervousness, tremor, anxiety, restlessness, hallucinations, insomnia;
• worsening of asthma;
• stomach pain, flatulence, constipation;
• swelling, high blood pressure, palpitations, fast heartbeat, heart attack, shortness of breath;
• irregular heartbeat, 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, meningitis symptoms (headache, fever, stiff neck);
• blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe fatigue, nosebleeds and unexplained bruising;
• severe allergic reactions;
• psychotic reactions, depression;
• kidney failure or other kidney problems;
• liver problems;
• ulcer in the stomach, sometimes with bleeding or perforation (blood in vomit or stools), gastritis, mouth ulcers, worsening of colitis and Crohn's disease, stenosis (narrowing) of the intestine;
• esophagitis (heartburn); pancreatitis;
• severe skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis;
• alopecia;
• severe skin infections, complications involving soft tissues during chickenpox infection;
• reduction of hemoglobin levels in the blood.

Frequency not known (frequency cannot be estimated from the available data):

• serious conditions affecting the blood vessels in the brain known as reversible posterior 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 cells);
• widespread red and scaly skin rash, accompanied by fever, at the beginning of treatment, with blisters under the skin and blisters mainly located in the skin folds, on the trunk and upper limbs (acute generalized exanthematous pustulosis, AGEP). Stop taking Aislar if you develop these symptoms and consult a doctor immediately. See also section 2; inflammation of the colon due to insufficient blood supply (ischemic colitis);
• the skin becomes sensitive to light;
• hallucinations, abnormal behavior;
• muscle weakness;
• difficulty urinating in men with prostate enlargement;
• reduction of blood supply to the optic nerve (ischemic optic neuropathy).
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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 Aislar

Keep this medicine out of the sight and reach of children.
This medicine does not require special storage conditions.
Do not use Aislar after the expiry date which is stated on the blister/on the package after “Scad.”. The expiry
date refers to the last day of that month.
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 Aislar contains

• The active ingredientsare ibuprofen (200 mg per tablet) and pseudoephedrine hydrochloride (30 mg per tablet, equivalent to a pseudoephedrine base of 24.6 mg).

The other ingredientsare microcrystalline cellulose, pregelatinized starch (corn), povidone K-30, colloidal anhydrous silica, stearic acid, sodium croscarmellose, sodium lauryl sulfate, polyvinyl alcohol (part.
hydrolyzed), talc (E553b), macrogol 3350, pearlescent pigment based on MICA (mixture of potassium and aluminum silicate [E555]-[mica] and titanium dioxide [E171]), polysorbate 80 (E433), hypromellose,
titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172). (See the end of paragraph 2 for more information about sodium).

Description of the appearance of Aislar and contents of the pack
Aislar tablets are film-coated tablets, oval in shape and yellow in colour (dimensions: approximately
15.6 mm x 7.7 mm).
The tablets are available in blisters of 12, 20 or 24 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
TEVA B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

Manufacturer
Teva Operations Poland Sp. z.o.o. ul. Mogilska 80. 31-546, Krakow, Poland
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany
Teva Czech Industries s.r.o., Ostravska 29, c.p. 305, 74770, Opava-Komarov, Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy: Aislar
Poland: Infex Zatoki
Romania: Tedolfen 200 mg/30 mg film-coated tablets