Axoprofen Max

Leaflet accompanying the packaging: patient information

Axoprofen Max, 600 mg, coated tablets

Ibuprofen
For use in adult patients and adolescents with a body weight of over 50 kg (from 15 years of age and above)

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Axoprofen Max and what is it used for
• 2. Important information before taking Axoprofen Max
• 3. How to take Axoprofen Max
• 4. Possible side effects
• 5. How to store Axoprofen Max
• 6. 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 a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Axoprofen Max relieves pain and has an anti-inflammatory effect.
In adult patients and adolescents over 15 years of age (with a body weight of 50 kg or more), the medicine is used for the symptomatic treatment of pain and inflammation in joint diseases (e.g. rheumatoid arthritis), degenerative joint diseases (e.g. osteoarthritis), as well as painful swelling and soft tissue inflammation after injuries.

2. Important information before taking Axoprofen Max

When not to take Axoprofen Max:

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6). Symptoms of a hypersensitivity reaction may include: swelling of the eyelids, lips, tongue or throat.
• if the patient has ever had a hypersensitivity reaction after taking acetylsalicylic acid or other similar painkillers (NSAIDs), such as: bronchospasm (constriction of the muscles in the lungs, which can cause asthma and shortness of breath), asthma attacks, rhinitis, nasal congestion, skin reactions or sudden swelling;
• if the patient has unexplained disorders of blood cell production;
• if the patient has or has had recurrent stomach 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 currently has any bleeding (including cerebral hemorrhage);
• if the patient has severe liver, kidney, or heart failure;
• if the patient is severely dehydrated (e.g. due to vomiting, diarrhea, or insufficient fluid intake);
• if the patient is in the third trimester of pregnancy.

Warnings and precautions

Before starting treatment with Axoprofen Max, the patient should discuss it with their doctor or pharmacist.
Taking the medicine in the smallest effective dose for the shortest necessary period to relieve symptoms reduces the risk of side effects.
Before starting treatment with Axoprofen Max, 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 manifest as asthma attacks (so-called analgesic asthma), rapid swelling (Quincke's edema), or hives;
• the patient is dehydrated;
• the patient has an infection - see below, section entitled "Infections".

Gastrointestinal effects
Concomitant use of Axoprofen Max with other non-steroidal anti-inflammatory drugs (NSAIDs), including so-called COX-2 inhibitors (selective cyclooxygenase-2 inhibitors), should be avoided.
Gastrointestinal bleeding, ulcers, and perforation:
There have been reports of gastrointestinal bleeding, stomach ulcers, and duodenal ulcers, as well as perforations resulting in death in patients taking 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, as well as perforation, increases with increasing doses of NSAIDs and is higher in patients with a history of stomach ulcers and duodenal ulcers, especially if complicated by bleeding or perforation (see section 2 "When not to take Axoprofen Max") and in elderly patients. In such patients, treatment should be started with the lowest available dose.
In these 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 any abnormal abdominal symptoms (especially gastrointestinal bleeding), especially at the start of treatment.
Care should be taken in patients receiving concomitant medications 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 Max and other medicines").
In the event of gastrointestinal bleeding or stomach ulcers and duodenal ulcers in a patient taking Axoprofen Max, treatment should be discontinued and a doctor consulted.
Effects on the cardiovascular system and blood vessels
Taking anti-inflammatory or pain-relieving medications, such as ibuprofen, may be associated with a slight increase in the risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose and duration of treatment.
Before taking Axoprofen Max, the patient should discuss their 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, bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries), or has had a stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or smokes.

During treatment with ibuprofen, allergic reactions to this medicine have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. If the patient notices any of these symptoms, they should stop taking Axoprofen Max immediately and consult a doctor or emergency services.
Skin reactions
Severe skin reactions have been reported in association with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Axoprofen Max should be discontinued and medical attention sought immediately if any of the symptoms of severe skin reactions described in section 4 occur.
Avoid taking Axoprofen Max during chickenpox infection.
Infections
Axoprofen Max may mask the objective symptoms of infection, such as fever and pain. Therefore, Axoprofen Max may delay the use 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 to Axoprofen Max appear, treatment should be discontinued and a doctor informed immediately. Depending on the symptoms, medical staff must take appropriate preventive measures.
Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Patients with bleeding disorders should be closely monitored.
During long-term use of Axoprofen Max, regular monitoring of liver parameters, kidney function, and blood morphology with a smear is necessary.
If Axoprofen Max is taken before surgical procedures, the patient should consult their doctor or dentist.
Long-term use of any type of pain reliever for headaches can lead to worsening of the headache. If this occurs or is suspected, the patient should consult a doctor and discontinue the medicine.
Essentially, habitual use of pain relievers, especially when taking several pain relievers at the same time, can lead to permanent kidney damage and increased risk of kidney failure (analgesic nephropathy). 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.
Patients who experience eye disorders during ibuprofen treatment should discontinue treatment and undergo vision tests.
Elderly patients
Adverse effects may occur more frequently in elderly patients taking non-steroidal anti-inflammatory drugs, especially gastrointestinal bleeding and perforation, which can be life-threatening in some cases. Therefore, close medical monitoring is necessary in elderly patients.
Children and adolescents
There is a risk of kidney function disorders in dehydrated adolescents.

Axoprofen Max 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 Max may interact with other medicines, and other medicines may affect the action of Axoprofen Max. For example:

• Digoxin, phenytoin, and lithium: Concomitant use of Axoprofen Max and digoxin (taken to strengthen the heart), phenytoin (taken to treat epilepsy), or lithium (taken to treat, for example, depression) may increase the levels of these medicines in the blood. Lithium levels should be monitored. Monitoring of digoxin and phenytoin levels is recommended.
• Anticoagulant medicines (i.e. blood thinners or anticoagulants, e.g. acetylsalicylic acid, warfarin, ticlopidine): NSAIDs may enhance the effects of anticoagulant medicines 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 type of diuretic) may lead to increased potassium levels in the blood. Therefore, monitoring of serum potassium levels is recommended.
• Blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, and angiotensin II receptor antagonists, such as losartan): Axoprofen Max 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 disorders.

Axoprofen Max may also interact with other medicines, so the patient should always consult their doctor or pharmacist before taking Axoprofen Max with other medicines.

Axoprofen Max and alcohol

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor if they become pregnant while taking Axoprofen Max.
Axoprofen Max should not be taken 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 also increase the risk of bleeding in the patient and their child and cause delayed or prolonged 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 patient should take the smallest possible dose for the shortest possible time. From the 20th week of pregnancy, Axoprofen Max may cause kidney function disorders in the unborn child if taken for more than a few days. This may lead to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the child's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen is excreted in small amounts into the breast milk of nursing mothers and is not usually a reason to discontinue breastfeeding during short-term treatment with recommended doses.
In the case of long-term treatment or treatment with higher doses of the medicine, the patient should consider weaning their child.
Fertility
Ibuprofen may make it more difficult to conceive. The patient should inform their doctor if they plan to conceive or if they have difficulty conceiving.

Driving and operating machinery

Ibuprofen generally has no or negligible influence 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 traffic or operate machinery. This is especially important when consuming alcohol.

Axoprofen Max contains lactose

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

Axoprofen Max 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 Max

This medicine should always be taken as directed by the doctor.
In case of doubts, the patient should consult their doctor or pharmacist.
The patient should take the smallest effective dose for the shortest possible period necessary to relieve symptoms. In case of infection, the patient should consult their doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
The recommended dose of Axoprofen Max is:
Rheumatic diseases and painful swelling and soft tissue inflammation after injuries
Adults
A single dose is 300-600 mg of ibuprofen.
The recommended daily dose is 1200-1800 mg of ibuprofen 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, it may be beneficial to increase the dose until the acute phase is brought under control, provided that the total daily dose does not exceed 2400 mg per day in divided doses.
Adolescents over 15 years of age (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 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 Max is intended for oral use.
The tablets should be swallowed whole with a glass of water.
To avoid irritating the stomach or throat, the tablets should not be crushed, chewed, or sucked. However, the tablet can be divided into equal doses.
Patient with sensitive stomachs should take Axoprofen Max during meals.

Duration of treatment

The treating doctor decides how long to take the medicine.
In rheumatic diseases, long-term use of Axoprofen Max may be necessary.

Overdose of Axoprofen Max

If the patient has taken a larger dose of Axoprofen Max than recommended or if a child has accidentally taken this medicine, they should always consult a doctor or go to the nearest hospital to assess potential health risks and receive advice on what to do.
Symptoms of overdose may include: nausea, stomach pain, vomiting (which may contain blood), or diarrhea. Additionally: headaches, gastrointestinal bleeding, visual disturbances, tinnitus, 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, coma, seizures (mainly in children), vertigo of labyrinthine origin, weakness, and dizziness may occur. Low blood sugar, low blood potassium levels, low blood pressure, elevated blood potassium levels, prolonged prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, feeling of cold, and breathing difficulties may also occur.

Missed dose of Axoprofen Max

The patient should not take a double dose to make up for a missed dose.
In case of questions or doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Axoprofen Max can cause side effects, although not everybody gets them.
It should be noted that the occurrence of the side effects listed below depends mainly on the dose used and varies from person to person.
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 taking the medicine, the following have been reported: nausea, vomiting, diarrhea, bloating, constipation, indigestion, stomach pain, black stools, bloody vomiting, mouth and throat ulcers (stomatitis), exacerbation of colitis and Crohn's disease (see section 2: "Warnings and precautions"). Rarely, gastritis has been observed. The risk of gastrointestinal bleeding depends mainly on the dose and duration of treatment.

Severe side effects

• The patient should stop taking Axoprofen Max and consult their doctor immediatelyif they experience symptoms of very rare but severe allergic reactions, such as:
• swelling of the face, tongue, or throat (laryngeal edema with respiratory tract narrowing),
• difficulty breathing,
• rapid heartbeat,
• drop in blood pressure leading to life-threatening shock
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome [Frequency not known (frequency cannot be estimated from available data)].
• Axoprofen Max may cause a decrease in the number of white blood cells (agranulocytosis, a very rare side effect [affects no more than 1 in 10,000 patients]) with reduced resistance to infections. The patient should consult their doctor immediatelyif they experience symptoms such as: fever and severe deterioration of their condition or fever with local symptoms such as: sore throat or laryngitis, or oral or genital ulcers. It is essential to inform the doctor that the patient is taking this medicine.
• The patient should stop taking ibuprofen and seek medical attention immediatelyif they experience any of the following symptoms:
• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling skin, mouth and throat ulcers, genital and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome] [very rare side effect (affects no more than 1 in 10,000 patients)].
• In addition, a severe skin reaction called DRESS syndrome may occur. The 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 (frequency cannot be estimated from available data)].
• skin rash or mucosal lesions. Severe skin reactions may include blisters on the skin, especially on the legs, arms, hands, and feet, as well as on 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). Severe infections with skin and soft tissue necrosis (necrotizing fasciitis) may also occur [very rare side effect (affects no more than 1 in 10,000 patients)].
• Red, scaly rash with thickening of the skin and blisters, mainly in skin folds, on the torso, and on the upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) [frequency not known (frequency cannot be estimated from available data].
• The patient should stop taking Axoprofen Maxand consult their doctor immediately if they experience relative severe abdominal pain, vomiting blood, bloody stools, and (or) black stools.
• Fluid accumulation 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) [uncommon side effect (affects no more than 1 in 100 people)]. Reduced urine output, fluid accumulation in the body (edema), and poor general condition may be symptoms of kidney failure.

If any of the above symptoms occur or worsen, the patient should stop taking Axoprofen Max and consult their doctor immediately.

Other side effects

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

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

Common (affects no more than 1 in 10 patients)

• disorders of the central nervous system, such as: headache, dizziness, insomnia, overexcitement, irritability, or fatigue;
• stomach ulcers and duodenal ulcers (peptic ulcers), sometimes with bleeding and perforation (gastrointestinal tract wall damage), sometimes fatal, especially in elderly patients, mouth and throat ulcers (stomatitis), exacerbation of colitis and Crohn's disease (see section 2: "Warnings and precautions");

Uncommon (affects no more than 1 in 100 patients)

• vision disorders. In this case, the patient should stop taking ibuprofen and consult their doctor.
• gastritis;
• allergic 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 immediately inform their doctor and discontinue Axoprofen Max.
Rare (affects no more than 1 in 1,000 patients)

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

• blood cell production 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 association with the use of non-steroidal anti-inflammatory drugs (including Axoprofen Max), cases of exacerbation of infections have been reported (e.g. development of necrotizing fasciitis);
• if symptoms of infection occur or worsen while taking Axoprofen Max (e.g. redness, swelling, feeling of heat, pain, fever), the patient should immediately consult their doctor. The doctor will determine whether there are indications for antibiotic therapy;
• during ibuprofen treatment, 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 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 blood sodium levels (hyponatremia);
• palpitations, heart failure, heart attack;
• high blood pressure;
• vasculitis;
• esophagitis or pancreatitis, formation of constricting 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 hepatitis;
• 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;
• hair loss (alopecia), skin disease with purple spots (purpura), allergic reactions to light.

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

• nasal congestion (rhinitis);
• tingling and numbness (paresthesia) and optic neuritis;
• abnormal kidney function.

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

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or 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, more information can be collected on the safety of this medicine.

5. How to store Axoprofen Max

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. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Axoprofen Max contains

• The active substance of Axoprofen Max is ibuprofen. Each coated tablet contains 600 mg of ibuprofen.
• Other ingredients are:
• Tablet core: hypromellose, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, corn starch, silicon dioxide, 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, oblong, coated tablets with a dividing line on both sides, 17.5 mm long and 9 mm wide.
The tablet can be divided into equal doses.
Axoprofen Max, 600 mg, coated tablets are available in blisters, in packs of 10 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

This medicine is authorized in the Member States of the European Economic Area 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 coated tablets EFG
Sweden:
Ibuprofen Aristo
Date of last revision of the leaflet: October 2024