Package leaflet: Information for the patient

Axoprofen Max, 600 mg, coated tablets
Ibuprofenum
For use in adult patients and adolescents with body weight above 50 kg (aged 15 years
and older)
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is Axoprofen Max and what is it used for
Important information before taking Axoprofen Max
How to take Axoprofen Max
Possible side effects
How to store Axoprofen Max
Contents of the pack and other information

1. What is Axoprofen Max and what is it used for

Axoprofen Max contains the active substance ibuprofen.
Ibuprofen belongs to the group of NSAIDs (non-steroidal anti-inflammatory drugs).
Axoprofen Max relieves pain and has anti-inflammatory action.
In adult patients and adolescents aged 15 years and older (with body weight ≥50 kg), the medicine is used for symptomatic treatment of pain and inflammatory conditions in joint diseases (e.g. rheumatoid arthritis), degenerative joint diseases (e.g. osteoarthritis), as well as painful swelling and inflammation of soft tissues following injuries.

2. Important information before using Axoprofen Max

When not to use Axoprofen Max:

if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6). Symptoms of hypersensitivity reactions may include: eyelid, lip, tongue or throat swelling.
if the patient has ever experienced a hypersensitivity reaction after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs), such as: bronchospasm (constriction of muscles in the lungs, which may cause asthma and shortness of breath), asthma attacks, rhinitis, nasal polyps, skin reactions or sudden swelling;
if the patient has unexplained disorders in the production of certain blood components;
if the patient currently has or has had recurrent peptic ulceration of the stomach and/or duodenum (peptic ulcers) or bleeding (at least two separate episodes of confirmed ulcers or bleeding);
if the patient has experienced gastrointestinal bleeding or perforation related to previous use of non-steroidal anti-inflammatory drugs (NSAIDs);
if the patient currently has any bleeding (including bleeding in the brain);
if the patient has severe liver, kidney or heart failure;
if the patient is severely dehydrated (e.g. due to vomiting, diarrhoea or insufficient fluid intake);
if the patient is in the third trimester of pregnancy.

Warnings and precautions
Before starting treatment with Axoprofen Max, discuss this with your doctor or pharmacist.
Taking the medicine at the lowest effective dose for the shortest necessary duration
to relieve symptoms reduces the risk of adverse effects.
Before starting treatment with Axoprofen Max, discuss this with your doctor or pharmacist if:

the patient has systemic lupus erythematosus (SLE, sometimes known as lupus) or mixed connective tissue disease (autoimmune connective tissue disorders);
the patient has or has had gastrointestinal disorders (ulcerative colitis or Crohn's disease), as their condition may worsen;
the patient has certain inherited blood disorders (e.g. acute intermittent porphyria);
the patient has impaired kidney or liver function;
the patient has recently undergone major surgery;
the patient has a tendency towards allergies to other substances;
the patient has hay fever, nasal polyps or chronic obstructive respiratory diseases, as these patients have an increased risk of allergic reactions; These reactions may present as asthma attacks (so-called analgesic-induced asthma), rapidly developing swelling (Quincke's oedema) or urticaria;
the patient is dehydrated;
the patient has an infection – see below, section titled “Infections”.

Effect on the gastrointestinal tract
Avoid concomitant use of Axoprofen Max with other non-steroidal anti-inflammatory drugs (NSAIDs), including so-called COX-2 inhibitors (selective cyclooxygenase-2 inhibitors).
Gastrointestinal bleeding, ulceration and perforation:
Gastrointestinal bleeding, gastric and/or duodenal ulceration and perforation, some fatal, have been reported with all NSAIDs. These events may occur at any time during treatment, with or without warning symptoms, and with or without previous serious gastrointestinal adverse events.
The risk of gastrointestinal bleeding, gastric and/or duodenal ulceration and perforation increases with higher NSAID doses, is greater in patients with a history of peptic ulcer disease of the stomach and/or duodenum, especially if complicated by bleeding or perforation (see section 2 “When not to use Axoprofen Max”) and in elderly patients. In such patients, treatment should be initiated with the lowest available dose.
In such patients and in patients requiring concomitant administration of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal disorders, the doctor may consider concomitant use of gastroprotective agents (e.g. misoprostol or proton pump inhibitors).
Patients who have previously experienced gastrointestinal adverse effects, particularly elderly patients, should report any abnormal abdominal symptoms (especially gastrointestinal bleeding), particularly at the beginning of treatment.
Caution is advised in patients receiving concomitant medications that may increase the risk of gastric and/or duodenal ulceration or bleeding, such as: oral corticosteroids, oral anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (used in the treatment of psychiatric disorders including depression) or antiplatelet agents such as acetylsalicylic acid (see section 2 “Axoprofen Max and other medicines”).
If gastrointestinal bleeding or gastric and/or duodenal ulceration occurs in a patient taking Axoprofen Max, treatment should be discontinued and the patient should contact their doctor.

Effect on the circulatory system and cerebral vessels
Taking anti-inflammatory or pain-relieving medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before using Axoprofen Max, the patient should discuss treatment with their doctor or pharmacist if:

the patient has heart disease, including: heart failure, angina pectoris (chest pain) or a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries) or if the patient has had any stroke (including mini-stroke or transient ischaemic attack - TIA).
the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

During treatment with ibuprofen, allergic reactions have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. If the patient experiences any of these symptoms, they should immediately stop taking Axoprofen Max and contact their doctor or emergency services.

Skin reactions
Severe skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). Treatment with Axoprofen Max should be discontinued and immediate medical advice sought if any symptoms of severe skin reactions described in section 4 occur.

Avoid using Axoprofen Max during varicella virus infection.

Infections
Axoprofen Max may mask objective signs of infection such as fever and pain. Therefore, Axoprofen Max may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an existing infection and infection symptoms persist or worsen, medical advice should be sought immediately.

Other warnings
Very rarely, severe, acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. At the first signs of hypersensitivity after taking Axoprofen Max, treatment should be discontinued and the doctor informed immediately. Depending on symptoms, medical personnel must take appropriate preventive measures.

Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with coagulation disorders should be closely monitored.

Regular monitoring of liver function, kidney function and blood morphology with smear is necessary during long-term use of Axoprofen Max.

If Axoprofen Max is to be used before surgical procedures, this should be discussed with the doctor or dentist.

Long-term use of any type of pain-relieving medicine for headache may lead to worsening of headache. If this occurs or is suspected, medical advice should be sought and the medicine discontinued.

Regular use of pain-relieving medicines, especially when taking multiple pain-relieving medicines simultaneously, may lead to permanent kidney damage and risk of organ failure (analgesic nephropathy). This risk may increase with physical exertion associated with loss of salt and dehydration. Therefore, such use should be avoided.

The risk of kidney failure is higher in dehydrated patients, elderly patients and those taking diuretics and ACE inhibitors.

Patients who develop eye disorders during treatment with ibuprofen should discontinue treatment and undergo ophthalmological examination.

Elderly patients
Adverse effects may occur more frequently in elderly patients during use of non-steroidal anti-inflammatory drugs, especially gastrointestinal bleeding and perforation, which may in some cases be life-threatening. Therefore, particularly careful medical observation is necessary in elderly patients.

Children and adolescents
In dehydrated adolescents, there is a risk of impaired kidney function.

Axoprofen Max and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.

Axoprofen Max may affect other medicines, and other medicines may affect the action of this medicine. For example:

Digoxin, phenytoin and lithium: Concomitant use of Axoprofen Max with digoxin (used to strengthen the heart), phenytoin (used to treat seizures - epilepsy) or lithium (used to treat, for example, depression) may increase blood levels of these medicines. Monitoring of lithium levels is necessary. Monitoring of digoxin and phenytoin levels is recommended.
Anticoagulants (i.e. blood thinners or agents preventing clots, e.g. acetylsalicylic acid, warfarin, ticlopidine): NSAIDs may enhance the effect of anticoagulants such as warfarin.
Diuretics and blood pressure-lowering medicines: e.g. ACE inhibitors, beta-blockers and angiotensin II receptor antagonists. Concomitant use of Axoprofen Max and potassium-sparing diuretics (a certain type of diuretic) may lead to increased blood potassium levels. Therefore, monitoring of serum potassium levels is recommended.
Medicines lowering high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan): Axoprofen Max

may reduce the effect of ACE inhibitors (used in treating heart failure and high blood pressure). In addition, during concomitant use, there may be an increased risk of impaired kidney function.

Cholestyramine (a medicine used to reduce cholesterol levels) taken simultaneously with Axoprofen Max may reduce the absorption of Axoprofen Max in the gastrointestinal tract. However, the clinical significance is unknown.
Other pain-relieving medicines: concomitant use of Axoprofen Max with other non-steroidal anti-inflammatory and pain-relieving medicines (NSAIDs), including COX-2 inhibitors (e.g. celecoxib), may increase the risk of gastrointestinal ulcers and bleeding. Antiplatelet agents and certain antidepressants (selective serotonin reuptake inhibitors, SSRIs) may increase the risk of gastrointestinal bleeding.
Methotrexate: taking Axoprofen Max within 24 hours before or after methotrexate (used in treating certain cancers and rheumatism) may lead to increased methotrexate levels and intensified adverse effects.
Cyclosporine and tacrolimus may damage the kidneys.
Probenecid and sulfinpyrazone: medicines containing probenecid or sulfinpyrazone (used in treating gout) may delay the elimination of ibuprofen. This may lead to accumulation of Axoprofen Max and intensified adverse effects.
Sulfonylurea derivatives: when Axoprofen Max is used concomitantly with sulfonylureas (medicines used in treating diabetes), blood glucose levels should be monitored.
Zidovudine: evidence indicates an increased risk of haemarthrosis (accumulation of blood in joints) and petechiae in HIV-positive patients with haemophilia taking zidovudine (an antiviral medicine used in treating HIV infections) concomitantly with ibuprofen.
Quinolone antibiotics: concomitant use of antibiotics called quinolones, such as ciprofloxacin, and ibuprofen increases the risk of seizures.
Aminoglycosides: concomitant use of Axoprofen Max with aminoglycosides (a type of antibiotic) may inhibit the elimination of aminoglycosides.
Voriconazole and fluconazole (CYP2C9 inhibitors) used in treating fungal infections, as they may increase exposure to ibuprofen. Consideration should be given to reducing the dose of ibuprofen, especially if ibuprofen is administered at high doses with voriconazole or fluconazole.
Ginkgo biloba (herbal medicine) used with NSAIDs may increase the risk of bleeding.
Mifepristone: concomitant use of mifepristone with other anti-inflammatory and pain-relieving medicines (NSAIDs), e.g. ibuprofen, may reduce the effectiveness of mifepristone.
Ritonavir: concomitant use with ritonavir (an antiviral medicine used in treating HIV infections) may increase plasma concentrations of NSAID pain-relieving medicines.
Alcohol, bisphosphonates and oxpentifylline (pentoxifylline): concomitant use of ibuprofen with alcohol, bisphosphonates (used in osteoporosis) or pentoxifylline (used in peripheral circulatory disorders) may intensify adverse effects on the gastrointestinal tract and increase the risk of bleeding and ulcers.
Baclofen (a muscle relaxant), as it increases baclofen toxicity.
Medicines used in treating inflammatory conditions (corticosteroids), as they increase the risk of gastrointestinal ulcers and bleeding. Also, some other medicines may be affected by or may affect treatment with Axoprofen Max. Therefore, always consult a doctor or pharmacist before using Axoprofen Max with other medicines.

Axoprofen Max and alcohol
Alcohol may intensify adverse effects of Axoprofen Max, especially those affecting the central nervous system and gastrointestinal tract. Do not drink alcohol while taking Axoprofen Max.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant, suspects she may be pregnant or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Inform your doctor if pregnancy occurs during treatment with Axoprofen Max.

Do not use Axoprofen Max during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Axoprofen Max may cause kidney and heart disorders in the unborn child. It may increase the tendency to bleeding in both the mother and her child and may delay or prolong labour.

During the first six months of pregnancy, the patient should not use this medicine unless the doctor considers its use absolutely necessary. If treatment is required during this period or during attempts to conceive, the lowest possible dose should be used for the shortest possible duration. From week 20 of pregnancy, Axoprofen Max may cause kidney function disorders in the unborn child if taken for longer than a few days. This may lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk only in small amounts and usually it is not necessary to interrupt breastfeeding during short-term treatment of fever and pain at recommended doses.

During long-term treatment or treatment with higher doses, weaning the child from breastfeeding should be considered.

Fertility
Ibuprofen may impair fertility. Inform your doctor if the patient is planning pregnancy or has difficulty conceiving.

Driving and operating machinery
Ibuprofen generally has no effect or has a negligible effect on the ability to drive and operate machinery. However, adverse effects of central origin caused by high doses of the medicine, such as fatigue and dizziness, may impair the ability to react and actively participate in road traffic or operate machinery in individual cases. This is particularly important in case of concomitant alcohol consumption.

Axoprofen Max contains lactose
If the patient has been diagnosed with intolerance to certain sugars, consult your doctor before using this medicine.

Axoprofen Max contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Axoprofen Max

This medicine should always be used as directed by a physician.
If in doubt, consult a doctor or pharmacist.
Use the lowest effective dose for the shortest possible duration necessary
to relieve symptoms. In case of infection, contact a physician immediately
if symptoms (such as fever and pain) persist or worsen (see section 2).
Recommended dosage:
Rheumatic diseases and painful swelling and inflammation of soft tissues following injury
Adults
Single dose: 300–600 mg of ibuprofen.
Recommended daily dose: 1200–1800 mg of ibuprofen, given in divided doses.
The interval between doses should be at least 6 hours. In some patients, the maintenance dose
may be 600–1200 mg per day.
In acute and severe conditions, increasing the dose may be beneficial until the acute phase is controlled,
provided that the total daily dose does not exceed 2400 mg in divided doses.
Adolescents aged over 15 years (body weight ≥50 kg)
The recommended dose should be adjusted according to body weight: 20–40 mg/kg body weight per day
(maximum 2400 mg per day) in 3 or 4 divided doses.
Special patient groups
If the patient has severe hepatic or renal impairment or is elderly,
the physician will advise on the appropriate dose, which will be the lowest possible.
Children and adolescents
Axoprofen Max 600 mg, coated tablets are not indicated for use in adolescents
with body weight below 50 kg or in children and adolescents under 15 years of age.
Method of administration
Axoprofen Max is intended for oral use.
Tablets should be swallowed whole with a glass of water.
To avoid irritation of the stomach or throat, tablets must not be crushed, chewed, or sucked. However,
the tablet may be divided into equal doses.
Patients with a sensitive stomach are advised to take Axoprofen Max during meals.
Duration of treatment
The treating physician decides how long the treatment should last.
Long-term use of Axoprofen Max may be required in rheumatic diseases.
Overdose of Axoprofen Max
If a patient has taken more than the recommended dose of Axoprofen Max, or if a child
has accidentally ingested this medicine, always consult a doctor or go to the nearest hospital
to assess possible health risks and receive advice on necessary actions.
Symptoms of overdose may include: nausea, stomach pain, vomiting (possibly with blood), or, less commonly, diarrhoea. Additionally: headache, gastrointestinal bleeding, visual disturbances, tinnitus, disorientation, and nystagmus, as well as worsening of asthma in patients with asthma. After ingestion of a large dose, drowsiness, excitement, disorientation, chest pain, palpitations, loss of consciousness, coma, seizures (especially in children), vestibular dizziness, weakness, and dizziness, blood in urine, low blood potassium levels, low blood pressure, increased blood potassium levels, prolonged prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, feeling cold, and breathing difficulties may occur.
Missed dose of Axoprofen Max
Do not take a double dose to make up for a missed dose.
If you have any questions or doubts about using this medicine, contact your
doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
It should be noted that the occurrence of the adverse effects listed below primarily depends on the dose used and may vary between individuals.
The most commonly observed adverse effects involve the gastrointestinal tract. Gastric and (or) duodenal ulcers, perforation, or bleeding may occur, sometimes leading to death, especially in elderly patients (see section 2: "Warnings and precautions").
After administration of the medicine, nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, melaena, haematemesis, oral and pharyngeal ulcers (ulcerative stomatitis), exacerbation of colitis and Crohn’s disease have been reported (see section 2: "Warnings and precautions"). Gastritis has been observed rarely. The risk of gastrointestinal bleeding particularly depends on the dose and duration of treatment.

Fluid retention (oedema), increased blood pressure, and heart failure have been observed with the use of NSAIDs.

Most serious adverse effects

Stop taking Axoprofen Max and contact a doctor immediately if the patient experiences symptoms of very rare (may affect 1 in 10,000 people), but severe allergic reactions such as:
facial, tongue or throat swelling (laryngeal oedema with airway obstruction),
difficulty breathing,
rapid heartbeat,
drop in blood pressure leading to life-threatening shock,
chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome [Frequency unknown (frequency cannot be estimated from available data)].
Axoprofen Max may cause a decrease in white blood cell count (agranulocytosis, very rare adverse effect (may affect no more than 1 in 10,000 patients)), resulting in reduced resistance to infections. Contact a doctor immediately if the patient experiences symptoms such as: fever and severe worsening of general condition, or fever with local symptoms such as sore throat or laryngitis, oral ulcers, or difficulty urinating. It is important to inform the doctor about taking this medicine.
Stop taking ibuprofen and seek immediate medical help if any of the following symptoms occur:
red, non-blanching, target-like or round skin lesions on the trunk, often with blisters in the centre, skin peeling, oral, pharyngeal, nasal, genital or ocular mucosal ulcers. These severe skin reactions may be preceded by fever and influenza-like symptoms [toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome] [very rare adverse effect (affects no more than 1 in 10,000 patients)].
Additionally, a severe skin reaction called DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymphadenopathy, and increased eosinophil count (a type of white blood cell) [frequency unknown (frequency cannot be estimated from available data)].
rash or mucosal lesions. Severe skin reactions may include blisters on the skin, especially on the legs, arms, hands and feet, and may also affect the face and lips. This may become even more serious if blisters enlarge and spread, and the skin begins to peel off (toxic epidermal necrolysis). Severe infection with skin breakdown (necrosis), subcutaneous tissue and muscle may also occur [very rare adverse effect (affects no more than 1 in 10,000 patients)].
Red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, on the trunk and upper limbs, accompanied by fever at the beginning of treatment a (acute generalised exanthematous pustulosis) [frequency unknown (frequency cannot be estimated from available data)].
Stop taking Axoprofen Max and contact a doctor immediately if the patient experiences relatively severe upper abdominal pain, vomiting blood, bloody stools and (or) melaena.

Fluid accumulation in tissues (oedema), particularly in patients with high blood pressure (hypertension) or impaired kidney function, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute kidney failure (renal failure) [not common adverse effect (may affect no more than 1 in 100 people)]. Reduced urine output, fluid accumulation in the body (oedema), and malaise may be symptoms of kidney failure.

If any of the listed symptoms appear or worsen, stop using Axoprofen Max and contact a doctor immediately.

Other adverse effects
Very common (affects more than 1 in 10 patients):

gastrointestinal symptoms such as: heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation, indigestion, and minor gastrointestinal bleeding, which in isolated cases may lead to deficiency of red blood cells (anaemia).

Common (affects no more than 1 in 10 patients)

disorders of the central nervous system such as: headache, dizziness, insomnia, excessive excitation, irritability or fatigue;
peptic ulcer disease of the stomach and (or) duodenum (peptic ulcers), sometimes with bleeding and perforation (defects in the gastrointestinal wall), sometimes fatal, especially in elderly patients; ulcerative inflammation of the oral mucosa (cheilitis with ulceration), exacerbation of colitis and Crohn’s disease (inflammation of the large intestine);

Not common (affects no more than 1 in 100 patients)

visual disturbances. In such cases, discontinue ibuprofen and contact a doctor.
gastritis;
hypersensitivity reactions such as: skin rash and itching, and asthma attacks (possibly accompanied by sudden drop in blood pressure).

If such symptoms occur, inform a doctor immediately and discontinue Axoprofen Max.

Rare (affects no more than 1 in 1,000 patients)

tinnitus (ringing in the ears)
hearing loss
kidney tissue damage (papillary necrosis), elevated blood uric acid levels, elevated blood urea levels.

Very rare (affects no more than 1 in 10,000 patients)

blood cell formation disorders such as decreased red blood cell count or haemoglobin concentration (anaemia), white blood cell count (leukopenia) or platelet count (thrombocytopenia), and other blood disorders (pancytopenia, agranulocytosis, eosinophilia, coagulopathy, neutropenia, aplastic anaemia or haemolytic anaemia). Initial symptoms include: fever, sore throat, superficial oral ulcers, influenza-like symptoms, severe fatigue, nosebleeds and skin bleeding;
with the use of non-steroidal anti-inflammatory drugs (including Axoprofen Max), cases of worsening inflammatory conditions due to infections (e.g. necrotizing fasciitis) have been reported;
if symptoms of infection (e.g. redness, swelling, warmth, pain, fever) appear or worsen during treatment with Axoprofen Max, the patient should immediately consult a doctor. The doctor will determine whether antibiotic therapy is indicated;
during ibuprofen use, symptoms of aseptic meningitis (inflammation of the meninges not caused by infection) such as severe headache, nausea, vomiting, fever, neck stiffness or altered consciousness have been observed. The risk appears to be higher in patients with certain autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease).
low blood sugar levels (hypoglycaemia);
low blood sodium levels (hyponatraemia);
palpitations, heart failure, myocardial infarction;
hypertension;
vasculitis;
oesophagitis or pancreatitis, development of diaphragm-like strictures in the intestine;
psychotic reactions, hallucinations, confusion, depression, anxiety;
asthma, breathing difficulties (dyspnoea), bronchospasm;
yellowing of the sclera and (or) skin (jaundice), liver function abnormalities, liver damage, especially during long-term treatment, liver failure, acute hepatitis;
hair loss (alopecia), red or purple discoloured spots on the skin (purpura), or photosensitivity reactions (triggered by sunlight);
in exceptional cases, severe skin and soft tissue infections may occur during chickenpox;
alopecia, skin disease with purple spots (purpura), photosensitivity reactions.

Frequency unknown (frequency cannot be estimated from available data):

inflammation of the nasal mucosa (rhinitis);
tingling and pricking sensations (paraesthesiae) and optic neuritis;
abnormal kidney function.

Medicines such as Axoprofen Max may slightly increase the risk of heart attack (myocardial infarction) or stroke.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Axoprofen Max

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack after EXP. The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Axoprofen Max contains

The active substance is ibuprofen. Each coated tablet contains 600 mg of ibuprofen.
Other ingredients are:
- Core of the tablet: hypromellose, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, colloidal anhydrous silica, sodium lauryl sulfate, and magnesium stearate;
- Tablet coating: hypromellose, titanium dioxide (E 171), talc, propylene glycol.

What Axoprofen Max looks like and contents of the pack
White or almost white, elongated coated tablets, with a division line on both sides, measuring:
17.5 mm in length and 9 mm in width.
The tablet can be divided into equal doses.
Axoprofen Max 600 mg, coated tablets, is available in blister packs containing 10 coated tablets.

Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Ul. Baletowa 30
02-867 Warsaw
Poland

Manufacturer
Aristo Pharma GmbH
Wallenroder Str. 8-10
13435 Berlin
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Ibuprofen „Aristo“
Germany: IbuARISTO 600 mg
Italy: Ibuprofene Aristo Pharma
Poland: Axoprofen Max
Portugal: IBUPROFENO ARISTO
Spain: Diltix 600 mg comprimidos recubiertos con pelicula EFG
Sweden: Ibuprofen Aristo

Axoprofen max