Ibuprofen Max Aurovitas

Leaflet attached to the packaging: information for the user

Ibuprofen MAX Aurovitas, 400 mg, soft capsules

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 this patient leaflet or as directed by a doctor or pharmacist.

• This 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 this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days in adolescents or after 3 days in the case of fever or migraine and after 5 days in the case of pain in adults, there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

1. What is Ibuprofen MAX Aurovitas and what is it used for

Ibuprofen MAX Aurovitas contains the active substance ibuprofen. It belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs have analgesic and antipyretic effects.

Ibuprofen MAX Aurovitas is indicated for the short-term symptomatic treatment of mild to moderate pain, such as headache, flu-like symptoms, toothache, muscle pain, painful menstruation, and fever in adults and adolescents with a body weight of over 40 kg (from 12 years of age).

Ibuprofen MAX Aurovitas is also indicated for the treatment of mild to moderate pain in migraine with or without aura in adults.

If after 3 days in adolescents or after 3 days in the case of fever or migraine and after 5 days in the case of pain in adults, there is no improvement or the patient feels worse, they should contact a doctor.

2. Important information before taking Ibuprofen MAX Aurovitas

When not to take Ibuprofen MAX Aurovitas

• If the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• If the patient has had an allergic reaction, such as asthma, difficulty breathing, swelling of the face, tongue, or throat, hives, itching of the nose and sinusitis, after taking aspirin or another NSAID;
• If the patient has had stomach or duodenal ulcers (or has had two or more episodes in the past);
• If the patient has had bleeding or perforation of the gastrointestinal tract while taking NSAIDs;
• If the patient has had bleeding from the brain or other active bleeding;
• If the patient has unexplained blood disorders;
• If the patient has severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake);
• If the patient has severe liver, kidney, or heart failure;
• If the patient is in the last 3 months of pregnancy.

Warnings and precautions

Before starting treatment with Ibuprofen MAX Aurovitas, the patient should discuss it with their doctor or pharmacist.

• If the patient has recently had major surgery;
• If the patient has or has had asthma or an allergic disease, as they may experience shortness of breath;
• If the patient has hay fever, nasal polyps, or chronic obstructive pulmonary disease, as there is an increased risk of allergic reactions. Allergic reactions can occur in the form of asthma attacks (so-called analgesic asthma), Quincke's edema, or hives;
• If the patient has had stomach or intestinal ulcers (see also "When not to take Ibuprofen MAX Aurovitas");
• If the patient has had gastrointestinal disease (such as ulcerative colitis, Crohn's disease);
• If the patient has systemic lupus erythematosus or mixed connective tissue disease (a skin, joint, and kidney disease);
• If the patient has a hereditary blood disorder (acute intermittent porphyria);
• If the patient has a blood clotting disorder;
• If the patient is taking other NSAIDs. It is recommended to avoid concurrent use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, due to the increased risk of adverse effects (see "Ibuprofen MAX Aurovitas and other medicines" below);
• In the case of chickenpox (varicella), it is recommended to avoid taking this medicinal product;
• If the patient is elderly;
• If the patient has kidney or liver disease;
• If the patient has an infection - see "Infections" below;
• When taking ibuprofen, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, swelling around the face and neck (angioedema), chest pain. If any of these symptoms are noticed, the medicinal product should be discontinued immediately and medical help should be sought;
• Severe skin reactions have been reported with ibuprofen, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should discontinue Ibuprofen MAX Aurovitas and seek medical attention immediately.

Infections

• Ibuprofen MAX Aurovitas may mask the symptoms of infection, such as fever and pain. As a result, Ibuprofen MAX Aurovitas may delay the application of appropriate infection treatment, which can lead 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.

Treatment should be started with the lowest available dose, especially if the patient has had stomach or intestinal ulcers, is elderly, or needs to take low doses of acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal problems (see "Ibuprofen MAX Aurovitas and other medicines"). The doctor may also recommend taking medicines that protect the stomach lining (e.g., misoprostol or proton pump inhibitors). The patient should inform their doctor if they experience any unusual stomach symptoms, especially signs of bleeding, such as vomiting blood or black stools resembling coal (see also section 4 "Possible side effects").

Taking anti-inflammatory and analgesic medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. The recommended dose should not be exceeded, nor should the duration of treatment (see section 3). Before taking Ibuprofen MAX Aurovitas, the patient should discuss their treatment with their doctor or pharmacist if:

• The patient has heart disease, including heart failure, angina (chest pain), has had a heart attack, has had a bypass operation, has peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries), or has had any stroke (including "mini-stroke" or transient ischemic attack "TIA").
• The patient has high blood pressure, diabetes, high cholesterol, has a family history of heart disease or stroke, or smokes. Very rarely, during ibuprofen treatment, severe skin reactions have been reported, potentially life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis). Patients are more likely to experience such reactions in the first month of therapy. If a skin rash, mucosal lesions, or any other signs of an allergic reaction are noticed, the medicinal product should be discontinued and a doctor or pharmacist should be consulted (see section 4).

Side effects can be minimized by using the smallest effective dose for the shortest duration necessary to relieve symptoms. Elderly patients are more likely to experience side effects.

Skin reactions

Severe skin reactions have been reported with Ibuprofen MAX Aurovitas. If a skin rash, mucosal lesions, blisters, or other signs of allergy occur, the patient should discontinue Ibuprofen MAX Aurovitas and seek medical attention immediately, as these may be the first signs of a very severe skin reaction (see section 4).

Generally, frequent use (of several types) of painkillers can lead to permanent and serious kidney damage. This risk may be increased during physical exertion, associated with salt and dehydration loss. Therefore, this should be avoided. Long-term use of any painkillers for headache treatment can cause their worsening. If such a situation occurs or is suspected, the patient should stop taking the medicine and consult a doctor. In patients who experience frequent or daily headaches, despite (or due to) regular use of headache medicines, it should be suspected that this is a headache caused by overuse of medicines.

In the case of long-term use of Ibuprofen MAX Aurovitas, regular monitoring of liver and kidney function tests and blood morphology is required. The doctor may recommend blood tests during treatment.

Children and adolescents

There is a risk of kidney function disorders in dehydrated children and adolescents.

Ibuprofen MAX Aurovitas is not recommended for use in adolescents with a body weight below 40 kg or in children under 12 years of age.

Ibuprofen MAX Aurovitas and other medicines

This medicinal product may affect the action of other medicines or other medicines may affect its action. For example:

• medicines with anticoagulant action (i.e., blood thinners or medicines that prevent blood clots, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).

Also, some other medicines may be affected or have an effect on the action of Ibuprofen MAX Aurovitas. Therefore, before taking this medicinal product with other medicines, the patient should always consult a doctor or pharmacist.

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, and about any medicines they plan to take. In particular, they should inform their doctor or pharmacist if they are taking:

• Acetylsalicylic acid or other NSAIDs (anti-inflammatory and analgesic medicines): as this may increase the risk of stomach or intestinal ulcers and bleeding.
• Digoxin (used in heart failure): as the action of digoxin may be enhanced.
• Corticosteroids (medicines containing cortisone or substances similar to cortisone): as this may increase the risk of stomach or intestinal ulcers and bleeding.
• Phenytoin (used in the treatment of epilepsy): as the action of phenytoin may be enhanced.
• Selective serotonin reuptake inhibitors (medicines used in depression): as they may increase the risk of gastrointestinal bleeding.
• Lithium (a medicine used in the treatment of manic-depressive illness and depression): as the action of lithium may be enhanced.
• Probenecid and sulfinpyrazone (medicines used in the treatment of gout): as the excretion of ibuprofen may be delayed.
• Moclobemide (used in the treatment of depression).
• Potassium-sparing diuretics: as this may lead to hyperkalemia (high potassium levels in the blood).
• Methotrexate (a medicine used in the treatment of cancer or rheumatism): as the action of methotrexate may be enhanced.
• Tacrolimus and cyclosporin (immunosuppressive medicines): as kidney damage may occur.
• Zidovudine (a medicine used in the treatment of HIV/AIDS): as ibuprofen may increase the risk of bleeding into the joint or bleeding that leads to swelling in patients with hemophilia and HIV.
• Zidovudine or ritonavir (used in the treatment of HIV patients).
• Sulfonylurea (an antidiabetic medicine): as interactions may occur.
• Quinolone antibiotics: as the risk of seizures may be increased.
• Mifepristone (a medicine prescribed to terminate pregnancy medically): as ibuprofen may weaken the action of this medicine.
• Bisphosphonates (medicines prescribed for the treatment of osteoporosis): as they may increase the risk of stomach or intestinal ulcers and bleeding.
• Oxpentifylline (pentoxifylline) (a medicine recommended to increase blood flow to the hands and feet): as this may increase the risk of gastrointestinal bleeding.
• Baclofen, a muscle relaxant: as the toxicity of baclofen may be increased.
• A herbal medicine containing Ginkgo biloba: as there is a possibility of increased risk of bleeding when taken with ibuprofen.
• Voriconazole and fluconazole (CYP2C9 inhibitors) (used in fungal infections), as the action of ibuprofen may be enhanced. It is recommended to consider reducing the dose of ibuprofen, especially when high doses of ibuprofen are used with voriconazole or fluconazole.
• Cholestyramine (used in the treatment of high cholesterol levels).

Ibuprofen MAX Aurovitas and alcohol

While taking this medicinal product, the patient should avoid consuming alcohol, as this may enhance possible side effects.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Ibuprofen MAX Aurovitas should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. Ibuprofen MAX Aurovitas 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 or delay labor. During the first 6 months of pregnancy, Ibuprofen MAX Aurovitas should not be used unless the 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, Ibuprofen MAX Aurovitas may cause kidney function disorders in the unborn child if taken for more than a few days. This may lead to a low level of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the baby's heart. If treatment is required for a longer period than a few days, the doctor may recommend additional monitoring.

Breastfeeding

Small amounts of ibuprofen may pass into breast milk. However, as no harmful effects have been reported in breastfed infants to date, it is usually not necessary to stop breastfeeding during short-term use of ibuprofen for fever and pain.

Fertility

Ibuprofen MAX Aurovitas belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible after discontinuation of the medicine. The patient should inform their doctor before taking the medicine if they plan to become pregnant or are having trouble conceiving.

Driving and using machines

In the case of short-term use and usual dosing, this medicine does not affect or has negligible effects on the ability to drive and use machines. If side effects such as fatigue, dizziness, drowsiness, and vision disturbances occur, the patient should not drive vehicles or operate machines. Consuming alcohol increases the risk of these side effects.

Ibuprofen MAX Aurovitas contains sorbitol

This medicine contains 79.20 mg of sorbitol in each capsule.

Sorbitol is a source of fructose. If the patient (or their child) has been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, they should discuss this with their doctor before taking or administering this medicine to the patient (or their child).

3. How to take Ibuprofen MAX Aurovitas

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. If the patient is unsure, they should consult their doctor or pharmacist.

The patient should take the smallest effective dose for the shortest duration necessary to relieve symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, the patient should consult a doctor immediately (see section 2).

Dosage

Mild to moderate pain and/or fever

Adults and adolescents with a body weight of over 40 kg (from 12 years of age)

The recommended single dose is 1 capsule of 400 mg, which can be taken up to 3 times a day, every 6 to 8 hours. The patient should not take more than 3 capsules (1200 mg of ibuprofen) in 24 hours.

In elderly patients with an increased risk of side effects, the smallest possible dose should be used for the shortest possible time.

The patient should not exceed the recommended doses or duration of treatment (3 days in adolescents and 3 days in the case of fever and 5 days in the case of pain in adults).

Ibuprofen MAX Aurovitas is not intended for use in adolescents with a body weight below 40 kg and in children under 12 years of age.

In the case of a migraine attack

Adults

The patient should take one 400 mg capsule as soon as possible from the start of the attack.

If there is no relief after the first dose, the patient should not take a second dose during the same attack. However, the attack can be treated with another therapy that does not contain an NSAID or acetylsalicylic acid.

If the pain returns, the patient can take a second dose, provided that there is an interval of 8 hours between the two doses. The patient should not take more than 3 capsules (1200 mg of ibuprofen) in 24 hours.

If after 3 days the patient does not feel better or feels worse, they should contact a doctor.

Method of administration

Ibuprofen MAX Aurovitas capsules should be swallowed whole with a large amount of water. The capsules should not be chewed.

Taking a higher than recommended dose of Ibuprofen MAX Aurovitas

In the case of taking a higher than recommended dose of Ibuprofen MAX Aurovitas or accidental ingestion by children, the patient should always consult a doctor or the nearest hospital for advice on the risk and actions to be taken.

Symptoms of overdose may include nausea, abdominal pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, confusion, tremors, and blood in the stool. There may also be disorientation or coma. After taking high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, agitation, blue discoloration of the skin and mucous membranes (cyanosis), and feeling cold and breathing problems have been reported. Additionally, in the case of severe poisoning, the bleeding time may be prolonged, probably due to the disruption of the action of circulating clotting factors. Acute kidney failure and liver damage may occur. In asthmatics, asthma may worsen. Additionally, low blood pressure and slow breathing (respiratory depression) may occur.

In the case of overdose, the patient should seek medical attention immediately, even if they feel well.

Missing a dose of Ibuprofen MAX Aurovitas

The patient should read the instructions on how to take the medicine and not take more than recommended. The patient should not take a double dose to make up for a missed dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibuprofen MAX Aurovitas can cause side effects, although not everybody gets them.

Side effects can be minimized by using the smallest effective dose for the shortest duration necessary to relieve symptoms. Elderly patients taking this medicine are more likely to experience side effects.

Medicines such as Ibuprofen MAX Aurovitas may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (see section 2 "Warnings and precautions").

If the patient experiences any of the following side effects or symptoms, they should stop taking this medicine and seek medical attention immediately:

• stomach or intestinal ulcers, which may be accompanied by bleeding and perforation, vomiting blood or black stools (frequent: may occur in up to 1 in 10 people);
• kidney disease, manifested by blood in the urine. This may be associated with kidney failure (uncommon: may occur in up to 1 in 100 people);
• severe allergic reactions (very rare: may occur in up to 1 in 10,000 people), with symptoms such as:
• difficulty breathing or unexplained wheezing,
• dizziness or faster heart rate,
• low blood pressure leading to shock,
• swelling of the face, lips, or throat;
• a potentially life-threatening skin rash, characterized by extensive peeling and bleeding of the skin, and possibly accompanied by fever, flu-like symptoms, and changes in blood test results (very rare: may occur in up to 1 in 10,000 people);

exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare: may occur in up to 1 in 10,000 people);

• a red, scaly, widespread rash with thickening of the skin, and blisters, mainly on the folds of the skin, torso, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis). See also section 2 (frequency not known: frequency cannot be estimated from the available data);
• a severe skin reaction, which may occur around the mouth or other parts of the body, with symptoms such as: red, often itchy, pustules, similar to a measles rash, which may appear on the limbs and sometimes on the face and other parts of the body. The pustules may change into blisters or may develop into large, red spots with a pale center. The skin reaction may be accompanied by fever, sore throat, headache, and/or diarrhea (very rare: may occur in up to 1 in 10,000 people);
• severe peeling or "shedding" of the skin (very rare: may occur in up to 1 in 10,000 people);
• pancreatitis with severe abdominal pain, often with nausea and vomiting (very rare: may occur in up to 1 in 10,000 people);
• nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and whites of the eyes, pale stools, dark urine, which may be symptoms of liver inflammation or liver failure (very rare: may occur in up to 1 in 10,000 people);
• heart disease with shortness of breath and swelling of the feet or legs due to fluid accumulation (heart failure) (very rare: may occur in up to 1 in 10,000 people);
• aseptic meningitis (inflammation of the membranes surrounding the brain or spinal cord, with symptoms such as fever, nausea, vomiting, headache, stiff neck, and changes in consciousness, resulting in a lack of full contact with the environment) (very rare: may occur in up to 1 in 10,000 people);
• heart attack (myocardial infarction, very rare: may occur in up to 1 in 10,000 people) or stroke (frequency not known: frequency cannot be estimated from the available data);
• acute kidney failure (renal necrosis) especially after long-term use of the medicine (rare: may occur in up to 1 in 1,000 people);
• worsening of inflammatory conditions caused by infection (e.g., necrotizing fasciitis) especially when used concurrently with other NSAIDs (very rare: may occur in up to 1 in 10,000 people);
• disorders of blood cell production - the first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding (very rare: may occur in up to 1 in 10,000 people);
• may occur a severe skin reaction called 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).

Other side effects:

Very common (may occur in more than 1 in 10 people):

• nausea, heartburn, gas, diarrhea, constipation, vomiting, abdominal pain.

Common (may occur in up to 1 in 10 people):

• headache, drowsiness, dizziness, feeling of spinning, fatigue, agitation, insomnia, irritability;
• hidden blood loss, which may lead to a condition characterized by a reduced number of red blood cells (symptoms include fatigue, headaches, difficulty breathing during exercise, dizziness, and pale skin), mouth ulcers, and aphthous ulcers, inflammation of the colon (symptoms include diarrhea, usually with blood and mucus, abdominal pain, fever), worsening of inflammatory bowel disease, inflammation of the stomach lining.

Uncommon (may occur in up to 1 in 100 people):

• hives, itching, purpura, or bruising, skin rash, asthma attacks (sometimes with low blood pressure);
• runny nose or stuffy nose, sneezing, facial pressure or pain, difficulty breathing;
• gastritis (symptoms include pain, nausea, vomiting, vomiting blood, black stools);
• fluid accumulation in the body's tissues, especially in patients with high blood pressure or kidney function disorders;
• vision disturbances.

Rare (may occur in up to 1 in 1,000 people):

• diseases of the skin, joints, and kidneys (systemic lupus erythematosus);
• depression, confusion, hallucinations, mental disorders with strange or disturbing thoughts or moods;
• ringing, buzzing, whistling, or other persistent noises in the ears;
• increased urea levels in the blood, increased activity of aminotransferases and alkaline phosphatase in serum, decreased hemoglobin and hematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decreased calcium levels in serum, increased uric acid levels in serum, visible in blood tests;
• vision loss.

Very rare (may occur in up to 1 in 10,000 people):

• rapid or irregular heartbeat (palpitations);
• fluid accumulation in the body's tissues;
• high blood pressure;
• esophageal inflammation, intestinal narrowing;
• unusual hair loss or hair thinning;
• in the case of chickenpox, severe skin infections with soft tissue complications may occur;
• menstrual disorders.

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

• the skin becomes sensitive to light;
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 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, it is possible to gather more information on the safety of this medicine.

5. How to store Ibuprofen MAX Aurovitas

The medicine should be stored out of sight and reach of children.

This medicine should not be used after the expiry date stated on the packaging and blister after EXP.

The expiry date refers to the last day of the month stated.

The medicine should not be stored above 30°C.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ibuprofen MAX Aurovitas contains

• The active substance of the medicine is ibuprofen. Each capsule contains 400 mg of ibuprofen.
• The other ingredients are: Core of the capsule:macrogol 600, potassium hydroxide Coating of the capsule:gelatin, liquid sorbitol Printing ink:Printing ink ingredients (black): Iron oxide black (E 172) Propylene glycol (E 1520) Hypromellose 2910 (6 cP)

What Ibuprofen MAX Aurovitas looks like and contents of the pack

Transparent, colorless, oval, size "12", soft gelatin capsules with the imprint "I400" in black, edible ink, containing a transparent, colorless to light yellow, viscous liquid.

This medicinal product is available in PVC/PVDC/Aluminum blisters of 10, 12, 14, 20, 30, 36, and 50 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lokal 27

01-909 Warsaw

e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium:

Ibuprofen AB 400 mg soft capsules/capsules molles/Weichkapseln

France:

IBUPROFENE ARROW CONSEIL 400 mg, capsule molle

Italy:

Ibuprofene Aurobindo Pharma

Netherlands:

Ibuprofen Liquid Caps Auro 400 mg, zachte capsules

Poland:

Ibuprofen MAX Aurovitas

Portugal:

Ibuprofeno Generis

Date of last revision of the leaflet: 05/2025