Axoprofen

Leaflet accompanying the packaging: information for the user

Axoprofen, 200 mg, coated tablets

Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If after 3 days, in the case of fever, or 4 days in the case of pain, there is no improvement or the patient feels worse, they should contact a doctor. If after 3 days, in the case of children or adolescents, there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

1. What is Axoprofen and what is it used for

Axoprofen contains the active substance ibuprofen.
Ibuprofen is a medicine that reduces fever and relieves pain (a non-steroidal anti-inflammatory drug - NSAID).
Axoprofen is used for the short-term symptomatic treatment of mild to moderate pain and/or fever in adults, adolescents, and children with a body weight of over 20 kg (from 7 years of age and above).

2. Important information before taking Axoprofen

When not to take Axoprofen:

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: swelling of the eyelids, lips, tongue, or throat;
• if the patient has ever had an allergic reaction after taking ibuprofen, acetylsalicylic acid, or other similar painkillers (NSAIDs), such as: bronchospasm (constriction of the muscles in the lungs causing shortness of breath), asthma, hay fever, itchy nose, and inflammation of the nose with sneezing, hives (itchy rash), or angioedema (swelling under the skin);
• if the patient has unexplained disturbances in the production of certain blood components;
• if the patient has or has had recurrent stomach ulcers and/or duodenal ulcers (peptic ulcers) or bleeding (at least two different episodes of confirmed ulcers or bleeding);
• if the patient has had bleeding or perforation of the gastrointestinal tract associated with previous use of non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has had bleeding in the brain (cerebral hemorrhage) or other active bleeding;
• if the patient has severe liver, kidney, or heart failure;
• if the patient is severely dehydrated (e.g., due to vomiting, diarrhea, or inadequate fluid intake);
• if the patient is in the third trimester of pregnancy.

Warnings and precautions

Taking the medicine in the smallest effective dose for the shortest possible time necessary to relieve symptoms reduces the risk of side effects.
Before starting treatment with Axoprofen, the patient should discuss it with their doctor or pharmacist if:

• the patient has systemic lupus erythematosus (SLE) and mixed connective tissue disease (autoimmune diseases of connective tissue);
• the patient has or has had gastrointestinal diseases (ulcerative colitis or Crohn's disease), as their condition may worsen;
• the patient has a certain congenital blood disorder (e.g., acute intermittent porphyria);
• the patient has kidney or liver function disorders;
• the patient has recently undergone extensive surgery;
• the patient has a tendency to allergies to other substances;
• the patient has hay fever, nasal polyps, or chronic obstructive respiratory diseases, as these patients are at increased risk of allergic reactions. These reactions can take the form of asthma attacks (so-called analgesic asthma), rapid swelling (Quincke's edema), or hives;
• the patient is dehydrated; the patient has an infection - see below, the section entitled "Infections". Effect on the gastrointestinal tract

Avoid concomitant use of Axoprofen with other non-steroidal anti-inflammatory drugs (NSAIDs), including so-called COX-2 inhibitors (selective cyclooxygenase-2 inhibitors).
Gastrointestinal bleeding, ulcers, and perforation:
There have been reports of gastrointestinal bleeding, gastric ulcers, and duodenal ulcers, as well as perforations resulting in death with the use of all NSAIDs. These events have occurred at various times during treatment, with and without warning symptoms, and with or without previously severe adverse reactions affecting the gastrointestinal tract.
The risk of gastrointestinal bleeding, gastric ulcers, and duodenal ulcers, as well as perforation, increases with increasing doses of NSAIDs and is higher in patients with a history of gastric ulcers and/or duodenal ulcers, especially if complicated by bleeding or perforation (see section 2 "When not to take Axoprofen") and in elderly patients. In such patients, treatment should be started with the lowest available dose.
Patients who have experienced adverse reactions affecting the gastrointestinal tract in the past, especially the elderly, should report all abnormal abdominal symptoms (especially gastrointestinal bleeding), especially at the start of treatment.
Caution is advised in patients taking concomitant medications that may increase the risk of developing gastric ulcers and/or duodenal ulcers or bleeding, such as: oral corticosteroids, oral anticoagulants, such as warfarin, selective serotonin reuptake inhibitors (used to treat mental illnesses, including depression), or antiplatelet agents, such as acetylsalicylic acid (see section 2 "Axoprofen and other medicines").
In the event of gastrointestinal bleeding or gastric ulcers and/or duodenal ulcers in a patient taking Axoprofen, treatment should be discontinued and a doctor consulted.
Effect on the cardiovascular system and blood vessels
Taking anti-inflammatory or pain-relieving medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose and duration of treatment.
Before taking Axoprofen, the patient should discuss treatment with their doctor or pharmacist if:

• the patient has heart disease, including heart failure and angina pectoris (chest pain), or has had a heart attack, coronary artery bypass grafting, or has peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has high blood pressure, diabetes, high cholesterol levels, or a family history of heart disease or stroke, or smokes.

Skin reactions
Severe skin reactions have been reported with the use of Axoprofen. If the following occur: any skin rash, changes in the mucous membranes, blisters, or other signs of hypersensitivity, the patient should stop taking Axoprofen and seek medical attention immediately, as these may be the first signs of a very severe skin reaction. See section 4.
It is recommended to avoid taking Axoprofen during chickenpox infection.
Infections
Axoprofen may mask the objective signs of infection, such as fever and pain. As a result, Axoprofen may delay the application of appropriate infection treatment, potentially leading to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should consult a doctor immediately.
Other warnings
Very rare, severe, acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed.
After the first symptoms of a hypersensitivity reaction occur after taking Axoprofen, treatment should be discontinued and the doctor informed immediately. Depending on the symptoms, medical personnel must take appropriate preventive measures.
Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Patients with bleeding disorders should be closely monitored.
With long-term use of Axoprofen, regular monitoring of liver parameters, kidney function, and blood morphology with a smear is necessary.
Long-term use of painkillers for headaches may lead to their worsening. If this occurs or is suspected, the patient should consult a doctor and discontinue the medicine.
Essentially, habitual use of painkillers, especially when taking several painkillers at the same time, can lead to permanent kidney damage. This risk may increase with physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.
The risk of kidney failure is higher in dehydrated patients, elderly patients, and those taking diuretics and ACE inhibitors.
If vision disturbances occur, the patient should consult a doctor.
Elderly patients:
Elderly patients should be aware of the increased risk of side effects, especially gastrointestinal bleeding and perforation, which can be fatal (also refer to the warnings regarding bleeding at the beginning of section 2).
Children and adolescents
Dehydrated children and adolescents are at risk of kidney function disorders.

Axoprofen and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Axoprofen may affect other medicines, and other medicines may affect the action of this medicine. For example:

• Digoxin, phenytoin, and lithium: Concomitant use of Axoprofen and digoxin (taken to strengthen the heart), phenytoin (taken to treat seizures/epilepsy), or lithium (taken to treat, for example, depression) may increase the levels of these medicines in the blood. Monitoring of lithium levels is necessary. Monitoring of digoxin and phenytoin levels is not generally required if they are used as recommended (for a maximum of 3 or 4 days)
• Anticoagulant medicines (i.e., blood thinners or anticoagulants, e.g., acetylsalicylic acid, warfarin, ticlopidine): NSAIDs may enhance the effect of anticoagulant medicines such as warfarin.
• Diuretic and blood pressure-lowering medicines: Axoprofen may reduce the effect of medicines used to increase urine production (diuretics) and lower blood pressure (antihypertensive medicines, i.e., ACE inhibitors, beta-blockers, and angiotensin II receptor antagonists). Concomitant use of Axoprofen and potassium-sparing diuretics (a type of diuretic) may lead to increased potassium levels in the blood.
• Blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, and angiotensin II receptor antagonists, such as losartan): Axoprofen may reduce the effect of ACE inhibitors (used to treat heart failure and high blood pressure). Additionally, concomitant use may increase the risk of kidney function disorders.
• Cholestyramine (a medicine used to reduce cholesterol levels) taken concomitantly with Axoprofen may reduce the absorption of Axoprofen in the gastrointestinal tract. However, the clinical significance is unknown.
• Other pain-relieving medicines: Concomitant use of Axoprofen with other non-steroidal anti-inflammatory drugs and pain-relieving medicines (NSAIDs), including COX-2 inhibitors (e.g., celecoxib), may increase the risk of ulcers and gastrointestinal bleeding.
• Platelet aggregation inhibitors and certain antidepressants (selective serotonin reuptake inhibitors, SSRIs) may increase the risk of gastrointestinal bleeding.

...

• Methotrexate: Taking Axoprofen within 24 hours before or after taking methotrexate (used to treat certain cancers and rheumatism) may increase methotrexate levels and enhance its side effects.
• Cyclosporine and tacrolimus: There is an increased risk of kidney damage.
• Probenecid and sulfinpyrazone: Medicines containing probenecid or sulfinpyrazone (used to treat gout) may delay the elimination of ibuprofen. This may lead to the accumulation of Axoprofen and enhancement of its side effects.
• Sulfonylurea derivatives: When Axoprofen is used concomitantly with sulfonylurea derivatives (medicines used to treat diabetes), blood glucose levels should be monitored.
• Zidovudine: There is evidence of an increased risk of bleeding into the joints and bruising in HIV-positive patients with hemophilia taking zidovudine (an antiviral medicine used to treat HIV infections) concomitantly with ibuprofen.
• Quinolone antibiotics: Concomitant use of quinolone antibiotics, such as ciprofloxacin, and ibuprofen may increase the risk of seizures.
• Aminoglycosides: Concomitant use of Axoprofen with aminoglycosides (a type of antibiotic) may inhibit the elimination of aminoglycosides.
• Voriconazole and fluconazole (CYP2C9 inhibitors) used to treat fungal infections, as they may increase exposure to ibuprofen. Consideration should be given to reducing the dose of ibuprofen, especially if ibuprofen is administered in high doses with voriconazole or fluconazole.
• Ginkgo biloba (a 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 effect of mifepristone.
• Ritonavir: Concomitant use with ritonavir (an antiviral medicine used to treat HIV infections) may increase the levels of NSAID medicines in the blood.
• Alcohol, bisphosphonates, and oxpentifylline (pentoxifylline): Concomitant use of ibuprofen with alcohol, bisphosphonates (used in osteoporosis), or pentoxifylline (used in peripheral circulatory disorders) may enhance the side effects on the gastrointestinal tract and increase the risk of bleeding and ulcers.
• Baclofen (a muscle relaxant), as it increases the toxicity of baclofen.
• Medicines used to treat inflammatory conditions (corticosteroids), as they increase the risk of ulcers and gastrointestinal bleeding. Also, some other medicines may be affected or may affect the treatment with Axoprofen. Therefore, before taking Axoprofen with other medicines, the patient should always consult their doctor or pharmacist.

Axoprofen and alcohol

Alcohol may enhance the side effects of Axoprofen, especially those affecting the central nervous system and gastrointestinal tract. The patient should not drink alcohol while taking Axoprofen.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Axoprofen should not be taken during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Axoprofen may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the mother and child and prolong labor.
In the first six months of pregnancy, the patient should not take this medicine unless their doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Axoprofen may cause kidney problems in the unborn child if taken for more than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts. There is no known negative effect on the infant, so breastfeeding does not usually need to be discontinued, especially if ibuprofen is used for a short period and in the recommended dose for fever and pain.
Fertility
Ibuprofen belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is temporary after stopping the medicine. The patient should inform their doctor if they plan to become pregnant or if they have problems conceiving.

Driving and using machines

Ibuprofen generally has no or negligible influence on the ability to drive and use machines. However, as high doses of the medicine may cause side effects such as drowsiness and dizziness, the ability to react and actively participate in traffic or operate machinery may be impaired in individual cases. This is especially important when consuming alcohol.

Axoprofen contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Axoprofen contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free".

3. How to take Axoprofen

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse.
The patient should use the smallest effective dose for the shortest possible time necessary to relieve symptoms.
In case of infection, the patient should consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
The recommended dose of Axoprofen is:
The dose should be in accordance with the information in the table below. In children and adolescents, the dose of Axoprofen is determined based on body weight and age, usually 7 to 10 mg/kg, given as a single dose up to 30 mg/kg, which is the maximum total daily dose.

Body weight Single dose Maximum daily dose

20 kg–29 kg
(Children aged 7 to 9 years)
(Age)
3 coated tablets
(600 mg ibuprofen)
30 kg-39 kg
(Children aged 10 to
11 years)
1 coated tablet
(200 mg ibuprofen)
1 coated tablet
4 coated tablets
(800 mg ibuprofen)
(200 mg ibuprofen)
>40 kg
(Adults and adolescents
1 to 2 coated tablets
(200-400 mg ibuprofen)
6 coated tablets
(1200 mg ibuprofen)
aged 12 and above)
The appropriate interval between doses should be determined based on symptoms and taking into account the maximum daily dose. This interval should not be less than 6 hours.
Axoprofen, 200 mg, coated tablets are not intended for use in children under 7 years of age and with a body weight below 20 kg.
Side effects can be minimized by using the smallest effective dose for the shortest possible time necessary to relieve symptoms.
If the patient has severe liver or kidney function disorders or is elderly, their doctor will inform them of the appropriate dose, which will be the smallest possible dose.

Method of administration

Axoprofen is intended for oral use.
Tablets should be swallowed whole with a glass of water.
To avoid irritating the stomach or throat, tablets should not be crushed, chewed, or sucked.
It is recommended that patients with sensitive stomachs take Axoprofen during meals.
The medicine is intended for short-term use only.

Adult patients

If an adult patient needs to take this medicine for more than 3 days to reduce fever or for more than 4 days to relieve pain, or if symptoms worsen, they should consult a doctor.

Children and adolescents

If children or adolescents need to take this medicine for more than 3 days or if symptoms worsen, they should consult a doctor.

Taking a higher dose of Axoprofen than recommended

If the patient has taken a higher dose of Axoprofen than recommended or if a child has accidentally taken this medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do.
Symptoms may include: nausea, stomach pain, vomiting (which may contain blood), or diarrhea. Additionally, there may be headaches, gastrointestinal bleeding, visual disturbances, ringing in the ears, disorientation, and nystagmus, as well as worsening of asthma in patients with asthma. After taking a large dose, drowsiness, excitement, disorientation, chest pain, palpitations, loss of consciousness, seizures (mainly in children), vertigo of labyrinthine origin, weakness, and dizziness may occur; there may also be blood in the urine, low blood pressure, increased potassium levels in the blood, prolonged prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, feeling of cold, and breathing difficulties.

Missing a dose of Axoprofen

The patient should not take a double dose to make up for a missed dose.
If the patient has any questions or doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Axoprofen can cause side effects, although not everybody gets them.
The most common side effects are related to the gastrointestinal tract. Gastric ulcers and/or duodenal ulcers, perforation, or bleeding may occur, sometimes leading to death, especially in elderly patients (see section 2: "Warnings and precautions").

Severe side effects

• The patient should stop taking Axoprofen and consult a doctor immediatelyif they experience symptoms of very rare but severe allergic reactions, such as:
• swelling of the face, tongue, or throat (throat edema with narrowing of the airways),
• difficulty breathing,
• rapid heartbeat,
• drop in blood pressure leading to life-threatening shock.
• The patient should consult a doctor immediately if they experience symptoms such as fever and severe deterioration of their condition or fever with local symptoms such as sore throat or mouth and urinary problems. Axoprofen may cause a decrease in the number of white blood cells (agranulocytosis, a very rare side effect that may affect up to 1 in 10,000 people) with reduced resistance to infections. It is essential to inform the doctor about taking this medicine.
• Severe skin and mucous membrane changes (blisters), such as Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), as well as a severe skin reaction called DRESS syndrome, have been reported. Symptoms of DRESS syndrome include skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell) [frequency not known (cannot be estimated from the available data)]. The patient should stop taking Axoprofen and consult a doctor if they experience a skin rash or mucous membrane changes. Severe skin reactions may include a skin rash with redness and blisters (e.g., Stevens-Johnson syndrome), erythema multiforme, hair loss (alopecia), or red or purple discoloration of the skin (purpura) or hypersensitivity reactions to light (photosensitivity). This can be even more severe if the blisters become larger and spread, and the skin starts to peel off partially (toxic epidermal necrolysis).
• The patient should stop taking Axoprofen and consult a doctor immediately if they experience severe abdominal pain, vomiting blood, bloody stools, and/or black stools.
• Fluid accumulation in the tissues (edema), especially in patients with high blood pressure (hypertension) or kidney function disorders, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute kidney failure (kidney failure) [very rare side effect (may affect up to 1 in 10,000 people)]. Reduced urine output, fluid accumulation in the body (edema), and general malaise may be symptoms of kidney disease, even kidney failure.

If any of these symptoms occur or worsen, the patient should stop taking Axoprofen and consult a doctor immediately.

Other side effects

Common (affecting up to 1 in 10 people):

• gastrointestinal symptoms, such as heartburn, stomach pain, nausea, vomiting, bloating, diarrhea, constipation, indigestion, and stomach upset, as well as minor gastrointestinal bleeding, which may occasionally lead to anemia.

Uncommon (affecting up to 1 in 100 people)

• central nervous system disorders, such as headache, dizziness, insomnia, overexcitement, irritability, or fatigue;
• visual disturbances. In this case, the patient should stop taking ibuprofen and consult a doctor.
• gastric ulcers and/or duodenal ulcers (peptic ulcers), sometimes with bleeding and perforation (holes in the wall of the gastrointestinal tract), sometimes fatal, especially in elderly patients, mouth ulcers (ulcerative stomatitis), exacerbation of ulcerative colitis and Crohn's disease (see section 2: "Warnings and precautions");
• gastritis (inflammation of the stomach);
• hypersensitivity reactions, such as skin rash and itching, as well as asthma attacks (with possible accompanying drop in blood pressure).

If such symptoms occur, the patient should consult a doctor immediately and discontinue Axoprofen.
Rare (affecting up to 1 in 1,000 people)

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

Very rare (affecting up to 1 in 10,000 people)

• blood disorders, such as reduced red blood cell count or hemoglobin level (anemia), reduced white blood cell count (leukopenia), or reduced platelet count (thrombocytopenia), and other blood disorders (pancytopenia, agranulocytosis, eosinophilia, coagulopathy, neutropenia, aplastic anemia, or hemolytic anemia). The first symptoms are: fever, sore throat, oral ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding.
• in connection with the use of non-steroidal anti-inflammatory drugs (including Axoprofen), cases of exacerbation of infections (e.g., development of necrotizing fasciitis) have been reported. If symptoms of infection (e.g., redness, swelling, feeling of heat, pain, fever) occur or worsen while taking Axoprofen, the patient should consult a doctor immediately. The doctor will determine whether there are indications for antibiotic therapy.
• aseptic meningitis (inflammation of the brain, which is not caused by infection) has been observed during ibuprofen treatment, with symptoms such as severe headache, nausea, vomiting, fever, stiff neck, or impaired consciousness. It appears that the risk is higher in patients with certain autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease).
• low blood sugar levels (hypoglycemia);
• low sodium levels in the blood (hyponatremia);
• palpitations, heart failure, heart attack;
• high blood pressure;
• vasculitis (inflammation of blood vessels);
• esophageal or pancreatic inflammation, formation of diaphragm-like constrictions in the intestine;
• psychotic reactions, hallucinations, confusion, depression, anxiety;
• asthma, breathing difficulties (dyspnea), bronchospasm;
• yellowing of the whites of the eyes and/or skin (jaundice), liver function disorders, liver damage, especially during long-term treatment, liver failure, acute liver inflammation;
• severe skin reactions, such as skin rash with redness and blisters (e.g., Stevens-Johnson syndrome), erythema multiforme, hair loss (alopecia), or red or purple discoloration of the skin (purpura) or hypersensitivity reactions to light (photosensitivity);
• in exceptional cases, during chickenpox, severe skin and soft tissue infections may occur.

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

• nasal inflammation (rhinitis);
• tingling and numbness (paresthesia) and optic neuritis;
• abnormal kidney function;
• a red, scaly rash with bumps and blisters, mainly in skin folds, on the trunk, and on the upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). If such symptoms develop, treatment should be discontinued and a doctor consulted immediately. See also section 2.

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

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Axoprofen

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
The medicine should not be stored above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Axoprofen contains

• The active substance of Axoprofen is ibuprofen. Each coated tablet contains 200 mg of ibuprofen.
• Other ingredients are:
• Core of the tablet: hypromellose, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, maize starch, silicon dioxide, anhydrous, and magnesium stearate Coating of the tablet:hypromellose, titanium dioxide (E 171), talc, propylene glycol.

What Axoprofen looks like and contents of the pack

White or almost white, round, coated tablets with a diameter of 10.25 mm and smooth on both sides.
The pack contains: 10 coated tablets.

Marketing authorization holder

Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warsaw

Manufacturer

Aristo Pharma GmbH
Wallenroder Str. 8-10
13435 Berlin
Germany
To obtain more detailed information on this medicine and its names in the Member States of the European Economic Area, the patient should contact the marketing authorization holder.
Date of last revision of the leaflet: December 2022