Axoprofen Forte

Leaflet attached to the packaging: information for the user

Axoprofen Forte, 400 mg, coated tablets

Ibuprofen

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should talk to your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your 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 you feel worse, you should contact your doctor. If after 3 days in the case of adolescents, there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

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

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

Axoprofen Forte contains the active substance ibuprofen.
Ibuprofen is a medicine that reduces fever and relieves pain (a non-steroidal anti-inflammatory drug - NSAID).
Axoprofen Forte is used for the short-term symptomatic treatment of mild to moderate pain and/or fever in adults and adolescents with a body weight of over 40 kg (from 12 years of age).

2. Important information before using Axoprofen Forte

When not to use Axoprofen Forte:

• if you are allergic 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 you have 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, sneezing, runny itchy nose, and inflammation of the nasal passages with sneezing, hives (itchy rash), or angioedema (swelling under the skin);
• if you have unexplained disturbances in the production of certain blood components;
• if you have a history of recurrent stomach ulcers and/or duodenal ulcers (peptic ulcers) or bleeding (at least two different episodes of confirmed ulcers or bleeding);
• if you have had bleeding or perforation of the gastrointestinal tract associated with previous use of non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have had bleeding in the brain (cerebral hemorrhage) or other active bleeding;
• if you have severe liver, kidney, or heart failure;
• if you are severely dehydrated (e.g., due to vomiting, diarrhea, or insufficient fluid intake);
• if you are 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 Forte, you should discuss it with your doctor or pharmacist if:

• you have systemic lupus erythematosus (SLE) and mixed connective tissue disease (autoimmune diseases of connective tissue);
• you have or have had gastrointestinal diseases (ulcerative colitis or Crohn's disease), as your condition may worsen;
• you have a certain congenital blood disorder (e.g., acute intermittent porphyria);
• you have kidney or liver function disorders;
• you have recently undergone major surgery;
• you have a tendency to allergies to other substances;
• you have 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;
• you are dehydrated;
• you have an infection - see below, the section titled "Infections".

Gastrointestinal effects
You should avoid taking Axoprofen Forte at the same time as 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, stomach ulcers, and duodenal ulcers, as well as perforations resulting in death with the use of all NSAIDs. These events occurred at various times during treatment, with and without warning symptoms, and with or without previously severe gastrointestinal adverse effects.
The risk of gastrointestinal bleeding, stomach ulcers, and duodenal ulcers, and perforation increases with increasing doses of NSAIDs and is higher in patients with a history of stomach ulcers and duodenal ulcers, especially if they were complicated by bleeding or perforation (see section 2 "When not to use Axoprofen Forte") and in elderly patients. In such patients, treatment should be started with the lowest available dose.
In such patients, as well as in patients requiring concomitant administration of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal disorders, the doctor will consider concomitant administration of drugs with a protective effect on the stomach lining (e.g., misoprostol or proton pump inhibitors).
Patients who have had gastrointestinal adverse effects 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 drugs that may increase the risk of developing stomach ulcers and 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 Forte and other medicines").
In the event of gastrointestinal bleeding or stomach ulcers and duodenal ulcers in a patient taking Axoprofen Forte, treatment should be discontinued and a doctor consulted.
Effects 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 using Axoprofen Forte, you should discuss treatment with your doctor or pharmacist if:

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

Skin reactions
Severe skin reactions have been reported with the use of Axoprofen Forte. If you experience: any skin rash, changes in mucous membranes, blisters, or other signs of allergy, you should stop taking Axoprofen Forte and seek medical help immediately, as these may be the first signs of a very severe skin reaction. See section 4.
It is recommended to avoid using Axoprofen Forte during chickenpox infection.
Infections
Axoprofen Forte may mask the signs of infection, such as fever and pain. As a result, Axoprofen Forte may delay the use of appropriate infection treatment and consequently lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If you are taking this medicine during an infection and the symptoms of the infection persist or worsen, you should consult a doctor immediately.
Other warnings
Very rarely, severe, acute allergic reactions (e.g., anaphylactic shock) have been observed.
After the first symptoms of an allergic reaction after taking Axoprofen Forte, treatment should be discontinued and a 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 Forte, 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, you 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.
In the event of vision disturbances, you should contact 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).
Adolescents
There is a risk of kidney function disorder in dehydrated adolescents.

Axoprofen Forte and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Axoprofen Forte may affect other medicines, and other medicines may affect the action of this medicine.
For example:

• Digoxin, phenytoin, and lithium: Concomitant use of Axoprofen Forte 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 anti-clotting agents, e.g., acetylsalicylic acid, warfarin, ticlopidine): NSAIDs may enhance the effects of anticoagulant medicines such as warfarin.
• Diuretics and blood pressure-lowering medicines: Axoprofen Forte may reduce the effects 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 Forte 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, angiotensin II receptor antagonists, such as losartan): Axoprofen Forte may reduce the effects of ACE inhibitors (used to treat heart failure and high blood pressure). Additionally, concomitant use may increase the risk of kidney function disorder.
• Cholestyramine (a medicine used to lower cholesterol levels) taken at the same time as Axoprofen Forte may reduce the absorption of Axoprofen Forte in the gastrointestinal tract. However, the clinical significance is unknown.
• Other pain-relieving medicines: concomitant use of Axoprofen Forte with other non-steroidal anti-inflammatory drugs and pain-relieving medicines (NSAIDs), including COX-2 inhibitors (e.g., celecoxib), may increase the risk of stomach ulcers and gastrointestinal bleeding.

Also, some other medicines may be affected or have an effect on treatment with Axoprofen Forte. Therefore, before using Axoprofen Forte with other medicines, you should always consult a doctor or pharmacist.

Axoprofen Forte with alcohol

Alcohol may increase the side effects of Axoprofen Forte, especially those related to the central nervous system and gastrointestinal tract. Do not drink alcohol while taking Axoprofen Forte.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not use Axoprofen Forte in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Axoprofen Forte may cause kidney and heart disorders in the unborn child. It may increase the risk of bleeding in the mother and her child and cause prolongation or prolongation of labor.
In the first 6 months of pregnancy, you should not use this medicine unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Axoprofen Forte may cause kidney disorders 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, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts, so it is not usually necessary to stop breastfeeding, 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 reversible after stopping the medicine. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Driving and using machines

Ibuprofen generally has no or negligible influence on the ability to drive and use machines. However, as side effects such as drowsiness and dizziness may occur after taking high doses of the medicine, 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 Forte contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before using this medicine.

Axoprofen Forte contains sodium

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

3. How to use Axoprofen Forte

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor, pharmacist, or nurse.
You should use the smallest effective dose for the shortest possible time necessary to relieve symptoms. In the case of infection, you should contact your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
The recommended dose of the medicine is:
Adults and adolescents with a body weight of over 40 kg (from 12 years of age)
half a tablet of 400 mg (i.e., 200 mg) or one whole tablet (400 mg) given as a single dose. If necessary, additional doses can be taken, i.e., half a tablet or one whole tablet.
The appropriate interval between doses is determined based on symptoms and with consideration of the maximum daily dose. This interval should not be less than 6 hours.
Do not take more than 3 tablets (1200 mg of ibuprofen) in 24 hours.
Axoprofen Forte, 400 mg is not intended for use in children under 12 years of age or adolescents with a body weight below 40 kg.
Side effects can be minimized by using the smallest effective dose for the shortest possible time necessary to relieve symptoms.
If you have severe liver or kidney function disorders or are elderly, your doctor will inform you about the appropriate dose of the medicine, which will be the smallest possible dose.

Method of administration

Axoprofen Forte 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. The tablet can be divided into equal doses.
It is recommended that patients with sensitive stomachs take Axoprofen Forte during meals.
The medicine is intended for short-term use only.

Adults

If you need to use this medicine for more than 3 days to reduce fever or for more than 4 days to relieve pain, or if your symptoms worsen, you should consult a doctor.

Adolescents

If you need to use this medicine for more than 3 days or if your symptoms worsen, you should consult a doctor.

Using a higher dose of Axoprofen Forte than recommended

If you have used a higher dose of Axoprofen Forte than recommended or if a child has accidentally taken this medicine, you 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, headaches, gastrointestinal bleeding, visual disturbances, ringing in the ears, disorientation, and nystagmus, as well as worsening of asthma in patients with asthma, may occur. 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, 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 cold, and breathing difficulties may occur.

Missing a dose of Axoprofen Forte

Do not take a double dose to make up for a missed dose.
If you have any questions or doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Axoprofen Forte can cause side effects, although not everybody gets them.
The most common side effects are related to the gastrointestinal tract. Stomach ulcers and duodenal ulcers, perforation, or bleeding may occur, sometimes leading to death, especially in elderly patients (see section 2: "Warnings and precautions").
After using the medicine, the following have been reported: nausea, vomiting, diarrhea, bloating, constipation, indigestion, stomach pain, flatulence, and minor gastrointestinal bleeding, which in individual cases may lead to anemia (a decrease in the number of red blood cells).
Rarely, gastritis has been observed.
The risk of gastrointestinal bleeding depends in particular on the dose and duration of treatment.
With the use of NSAIDs, fluid retention (edema), increased blood pressure, and heart failure have been observed.

Severe side effects

• You should stop using Axoprofen Forte and contact your doctor immediatelyif you experience symptoms of very rare (may affect up to 1 in 10,000 people) 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.
• You should contact your doctor immediately if you experience symptoms such as fever and severe worsening of your condition or fever with local symptoms such as sore throat or mouth problems, or urinary problems. Axoprofen Forte may cause a decrease in the number of white blood cells (agranulocytosis, a very rare side effect (may affect up to 1 in 10,000 people)) with reduced resistance to infections. It is essential to inform your doctor that you are taking this medicine.
• Reports have been made of severe skin and mucous membrane changes (blisters), such as Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), and (or) drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). The symptoms of DRESS syndrome include: skin rash, fever, swelling of the lymph nodes, and an increased number of eosinophils (a type of white blood cell) [frequency not known (frequency cannot be estimated from the available data)]. You should stop taking Axoprofen Forte and contact your doctor if you experience a rash or changes in the mucous membranes. Severe rashes may include blisters on the skin, especially on the legs, arms, hands, and feet, and may also affect the face and lips. This can be even more severe if the blisters become larger and spread, and the skin starts to peel off partially (toxic epidermal necrolysis).
• You should stop using Axoprofen Forte and contact your doctor immediately if you experience severe abdominal pain, vomiting blood, bloody stools, and (or) black stools.
• Fluid retention in 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 retention in the body (edema), and poor general condition may be symptoms of kidney disease, and even kidney failure.

If you experience or worsen any of the above symptoms, you should stop using Axoprofen Forte and contact your doctor immediately.

Other side effects

Frequent (may affect up to 1 in 10 people):

• gastrointestinal symptoms, such as: heartburn, stomach pain, nausea, vomiting, bloating, diarrhea, constipation, indigestion, and minor gastrointestinal bleeding, which in individual cases may lead to anemia.

Uncommon (may affect up to 1 in 100 people)

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

If you experience such symptoms, you should contact your doctor immediately and discontinue Axoprofen Forte.
Rare (may affect 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 (may affect 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, mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding.
• in connection with the use of non-steroidal anti-inflammatory drugs (including Axoprofen Forte), 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 Forte, you should contact your doctor immediately. The doctor will determine whether there are indications for antibiotic therapy.
• during ibuprofen use, symptoms of aseptic meningitis (meningitis not caused by infection) have been observed, such as: severe headache, nausea, vomiting, fever, stiff neck, or impaired consciousness. It seems 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;
• esophagitis or pancreatitis, formation of diaphragm-like strictures in the intestine.
• psychotic reactions, hallucinations, confusion, depression, anxiety;
• asthma, breathing difficulties (dyspnea), bronchospasm;
• jaundice (yellowing of the whites of the eyes and skin), 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), red or purple discoloration of the skin (purpura), or allergic reactions to light (photosensitivity);
• in rare cases, during chickenpox, severe skin and soft tissue infections may occur.

Frequency not known (frequency 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 located 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, you should stop treatment and contact your doctor immediately. See also section 2.

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

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 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.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Axoprofen Forte

The medicine should be stored out of sight and reach of children.
Do not use 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.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Axoprofen Forte contains

• The active substance of the medicine is ibuprofen. Each coated tablet contains 400 mg of ibuprofen.
• Other ingredients are:
• Tablet core:hypromellose, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, maize starch, colloidal anhydrous silica, sodium lauryl sulfate, and magnesium stearate Coating:hypromellose, titanium dioxide (E 171), talc, propylene glycol.

What Axoprofen Forte looks like and contents of the pack

White or almost white, round, coated tablets with a dividing line on one side, 12 mm in diameter.
The tablet can be divided into equal doses.
The pack contains 20 or 50 coated tablets.

Marketing authorization holder

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

Manufacturer

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