Ibuprofen max aurovitas
Poland
Table of Contents
- Patient leaflet: information for the user
- 1. What Ibuprofen MAX Aurovitas is and what it is used for
- 2. Important information before using Ibuprofen MAX Aurovitas
- 3. How to use Ibuprofen MAX Aurovitas
- 4. Possible adverse reactions
- 5. How to store Ibuprofen MAX Aurovitas
- 6. Contents of the packaging and other information
Patient leaflet: information for the user
Ibuprofen MAX Aurovitas, 400 mg, soft capsules
Ibuprofenum
Please read this 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
the doctor or pharmacist.
- Keep this leaflet so that it can be read again if necessary.
- If advice or further information is needed, please consult a pharmacist.
- If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
- If there is no improvement after 3 days in adolescents or after 3 days for fever or migraine and after 5 days for pain in adults, or if the patient feels worse, medical advice should be sought.
Table of contents
- What Ibuprofen MAX Aurovitas is and what it is used for
- Important information before taking Ibuprofen MAX Aurovitas
- How to take Ibuprofen MAX Aurovitas
- Possible side effects
- How to store Ibuprofen MAX Aurovitas
- Contents of the pack and other information
1. What Ibuprofen MAX Aurovitas is and what it is used for
Ibuprofen MAX Aurovitas contains the active substance ibuprofen. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs have analgesic and antipyretic effects.
Ibuprofen MAX Aurovitas is indicated in adults and adolescents with body weight above 40 kg (aged 12 years and older) for short-term symptomatic treatment of mild to moderate pain such as headache, symptoms of influenza-like illness, toothache, muscle pain, dysmenorrhoea, and fever.
Ibuprofen MAX Aurovitas is also indicated for the treatment of mild to moderate migraine pain with or without aura in adults.
If there is no improvement after 3 days in adolescents or after 3 days for fever or migraine and after 5 days for pain in adults, or if the patient feels worse, medical advice should be sought.
2. Important information before using Ibuprofen MAX Aurovitas
When not to use 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 experienced an allergic reaction such as asthma, difficulty breathing, swelling of the face, tongue or throat, hives, runny nose or nasal congestion after taking aspirin or another NSAID (non-steroidal anti-inflammatory drug);
- If the patient has a stomach or duodenal ulcer or gastrointestinal bleeding (or if they have had two or more such episodes in the past);
- If the patient has previously experienced gastrointestinal bleeding or perforation while taking NSAIDs;
- If the patient has had bleeding from blood vessels in the brain or any other active bleeding;
- If the patient has unexplained disorders of the blood-forming system;
- If the patient has severe dehydration (caused by vomiting, diarrhoea 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, discuss this with your doctor or
pharmacist
- If the patient has recently undergone major surgery;
- If the patient has or has previously had asthma or an allergic condition, as they may experience shortness of breath;
- If the patient suffers from hay fever, nasal polyps or chronic obstructive pulmonary disease (COPD), as there is an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma), Quincke's oedema (angioedema) or urticaria;
- If the patient has ever had stomach or intestinal ulcers (see also section "When not to use Ibuprofen MAX Aurovitas");
- If the patient has a gastrointestinal disorder (such as ulcerative colitis or Crohn's disease);
- If the patient has systemic lupus erythematosus or mixed connective tissue disease (affecting skin, joints and kidneys);
- If hereditary blood-forming disorders (acute intermittent porphyria) have been diagnosed;
- If the patient has a blood clotting disorder;
- If the patient is taking other NSAIDs. Concomitant use with other NSAIDs, including selective COX-2 inhibitors, should be avoided due to increased risk of adverse effects (see section "Ibuprofen MAX Aurovitas with other medicines" below);
- In case of chickenpox (varicella), use of this medicinal product is not recommended;
- If the patient is elderly;
- If the patient has kidney or liver disease;
- If the patient has an infection – see section "Infections" below;
- If the patient has experienced symptoms of an allergic reaction to ibuprofen, including difficulty breathing, facial or neck swelling (angioedema), or chest pain. If any of these symptoms occur, discontinue this medicine immediately and contact a doctor or emergency medical services without delay;
- Severe skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported during ibuprofen treatment. If the patient develops any of the symptoms associated with these serious skin reactions described in section 4, Ibuprofen MAX Aurovitas should be discontinued immediately and medical help should be sought.
Infections
- Ibuprofen MAX Aurovitas may mask symptoms of infection such as fever and pain. Therefore, Ibuprofen MAX Aurovitas may delay appropriate treatment of infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an infection and symptoms persist or worsen, medical advice should be sought immediately.
Treatment should be initiated at the lowest available dose if the patient has ever had stomach or intestinal ulcers, is elderly, or requires concomitant low-dose acetylsalicylic acid or other drugs that may increase gastrointestinal risk (see "Ibuprofen MAX Aurovitas with other medicines"). The doctor may also prescribe gastroprotective agents (e.g. misoprostol or proton pump inhibitors). Inform the doctor immediately if any unusual gastrointestinal symptoms occur, especially signs of bleeding such as vomiting blood or black, tarry stools (see also section 4 "Possible side effects").
Taking anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment (see section 3).
Before using Ibuprofen MAX Aurovitas, discuss treatment with your doctor or
pharmacist if:
- The patient has heart disease, including heart failure, angina (chest pain), a history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or has had any stroke (including "mini-stroke" or transient ischaemic attack "TIA").
- The patient has high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if the patient smokes. Very rarely, life-threatening severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported during ibuprofen treatment. Patients are at higher risk of such reactions during the first month of therapy. If a skin rash, mucosal lesions or any other allergic symptoms occur, discontinue this medicine and contact a doctor or pharmacist (see section 4).
Side effects can be minimised by using the lowest effective dose for the shortest possible duration. Elderly patients are more susceptible to adverse effects.
Skin reactions
Serious skin reactions have been reported with Ibuprofen MAX Aurovitas treatment. If a skin rash, mucosal lesions, blisters or other allergy symptoms occur, discontinue Ibuprofen MAX Aurovitas immediately and consult a doctor, as these may be early signs of a very serious skin reaction (see section 4).
In general, frequent use (multiple types) of painkillers may lead to permanent, severe kidney dysfunction. This risk may be increased during physical exertion associated with salt loss and dehydration. Therefore, such use should be avoided.
Long-term use of any painkillers for headache treatment may worsen headaches. If this occurs or is suspected, discontinue the medicine and contact a doctor. In patients who experience frequent or daily headaches despite (or because of) regular use of headache medications, medication-overuse headache should be suspected.
Regular monitoring of liver and kidney function tests and blood counts is required during long-term use of Ibuprofen MAX Aurovitas. Your doctor may recommend periodic blood tests during treatment.
Children and adolescents
There is a risk of kidney dysfunction in dehydrated children and adolescents.
Ibuprofen MAX Aurovitas is not recommended for use in adolescents weighing less than 40 kg or in children under 12 years of age.
Ibuprofen MAX Aurovitas with other medicines
This medicinal product may affect the action of certain other medicines, or other medicines may affect its action. For example:
- Medicines with anticoagulant effects (i.e. blood thinners/preventing blood clots), such as aspirin (acetylsalicylic acid), warfarin, ticlopidine;
- Medicines for lowering high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).
Some other medicines may also interact with or affect the action of Ibuprofen MAX Aurovitas. Therefore, patients should always consult a doctor or pharmacist before using this medicinal product concomitantly with other medicines.
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take. In particular, inform them if the patient is taking:
- Acetylsalicylic acid or other NSAIDs (non-steroidal anti-inflammatory and pain-relieving medicines): as this may increase the risk of gastrointestinal ulcers or bleeding.
- Digoxin (used in heart failure): as digoxin's effects may be enhanced.
- Glucocorticoids (medicines containing cortisone or cortisone-like substances): as this may increase the risk of gastrointestinal ulcers or bleeding.
- Phenytoin (used in epilepsy treatment): as phenytoin's effects may be enhanced.
- Selective serotonin reuptake inhibitors (medicines used for depression): these may increase the risk of gastrointestinal bleeding.
- Lithium (used in bipolar disorder and depression): as lithium's effects may be enhanced.
- Probenecid and sulfinpyrazone (used in gout treatment): as ibuprofen excretion may be delayed.
- Moclobemide (used in depression treatment).
- Potassium-sparing diuretics: as this may lead to hyperkalaemia (high blood potassium levels).
- Methotrexate (used in cancer or rheumatism treatment): as methotrexate's effects may be enhanced.
- Tacrolimus and cyclosporine (immunosuppressive medicines): as kidney damage may occur.
- Zidovudine (used in HIV/AIDS treatment): as ibuprofen use may increase the risk of joint bleeding or bleeding leading to swelling in HIV patients with haemophilia.
- Zidovudine or ritonavir (used in HIV treatment).
- Sulfonylureas (antidiabetic medicines): interactions may occur.
- Quinolone antibiotics: as the risk of seizures may be increased.
- Mifepristone (prescribed for pharmacological termination of pregnancy): as ibuprofen may reduce its effectiveness.
- Bisphosphonates (prescribed for osteoporosis treatment): as they may increase the risk of gastrointestinal ulcers or bleeding.
- Pentoxifylline (recommended to improve blood flow to hands and feet): as this may increase the risk of gastrointestinal bleeding.
- Baclofen, a muscle relaxant: as baclofen toxicity may be increased.
- Herbal medicine containing Ginkgo biloba (there is a possible increased risk of bleeding when used concomitantly with ibuprofen).
- Voriconazole and fluconazole (CYP2C9 inhibitors) (used in fungal infections), as ibuprofen's effects may be enhanced. Consider reducing the ibuprofen dose, especially when high doses of ibuprofen are used with voriconazole or fluconazole.
- Cholestyramine (used in treatment of high cholesterol levels).
Ibuprofen MAX Aurovitas with alcohol
Avoid alcohol while taking this medicinal product, as it may worsen possible adverse effects.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Do not take Ibuprofen MAX Aurovitas 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 increase the tendency to bleeding in both mother and child and may delay or prolong labour. During the first 6 months of pregnancy, Ibuprofen MAX Aurovitas should not be used unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose for the shortest possible time should be used. From the 20th week of pregnancy, Ibuprofen MAX Aurovitas may cause kidney function disturbances 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 a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer 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 on infants have so far been reported, breastfeeding usually does not need to be interrupted during short-term use of ibuprofen at the recommended dose for fever and pain.
Fertility
Ibuprofen MAX Aurovitas belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of the medicine. Inform your doctor before taking this medicine if you are planning pregnancy or have difficulty conceiving.
Driving and operating machinery
When used short-term and at the usual recommended dose, this medicine has no or negligible effect on the ability to drive or operate machinery.
If side effects such as fatigue, dizziness, drowsiness or visual disturbances occur, do not drive or operate machinery. Alcohol consumption increases the risk of these side effects.
Ibuprofen MAX Aurovitas contains sorbitol
This medicine contains 79.20 mg of sorbitol per capsule.
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, consult a doctor before taking or administering this medicine to the patient (or their child).
3. How to use Ibuprofen MAX Aurovitas
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Dosage
Mild to moderate pain and (or) fever
Adults and adolescents with body weight above 40 kg (aged 12 years and older)
The recommended single dose is 1 capsule of 400 mg, which may be repeated if necessary up to 3 times daily, every 6 to 8 hours. Do not exceed 3 capsules (1200 mg of ibuprofen) within 24 hours.
In elderly patients at increased risk of adverse effects, use the lowest possible dose for the shortest duration necessary to relieve symptoms.
Do not exceed the recommended doses or duration of treatment (3 days for adolescents, and 3 days for fever and 5 days for pain in adults).
Ibuprofen MAX Aurovitas is not intended for use in adolescents with body weight below 40 kg or in children under 12 years of age.
In case of migraine attack
Adults
Take one 400 mg capsule as soon as possible at the onset of an attack.
If no relief occurs after the first dose, do not take a second dose during the same attack. However, the attack may be treated with another therapy that does not contain a non-steroidal anti-inflammatory drug or acetylsalicylic acid.
If pain recurs, a second dose may be taken provided that an interval of 8 hours is maintained between doses. Do not exceed 3 capsules (1200 mg of ibuprofen) within 24 hours.
If the patient does not feel better or feels worse after 3 days, consult a doctor.
Method of administration
Ibuprofen MAX Aurovitas capsules should be swallowed whole with a large amount of water. Do not chew the capsules.
Overdose of Ibuprofen MAX Aurovitas
If more than the recommended dose of Ibuprofen MAX Aurovitas is taken or if the medicine is accidentally ingested by children, always contact your doctor or the nearest hospital for advice regarding the risk and actions to be taken.
Symptoms of overdose may include nausea, abdominal pain, vomiting (possibly containing blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, nystagmus, and blood in the stool. Disorientation or coma may also occur. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness have been reported, as well as blood in the urine, low blood potassium levels, restlessness, cyanosis (bluish discoloration of the skin and mucous membranes), cold sensation, and breathing difficulties. In cases of severe poisoning, bleeding time may be prolonged, probably due to impaired function of circulating coagulation factors. Acute kidney failure and liver damage may also occur. In asthmatics, asthma may worsen. Additionally, low blood pressure and slowed breathing (respiratory depression) may occur.
In case of overdose, seek medical advice immediately, even if the patient feels well.
Missed dose of Ibuprofen MAX Aurovitas
Refer to the instructions on how to take the medicine and do not use more than recommended. Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions can be minimised by using the lowest effective dose for the shortest duration necessary to relieve symptoms. Elderly patients taking this medicine are at higher risk of experiencing adverse reactions.
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 you suspect any of the following adverse reactions or symptoms, stop taking this medicine immediately and contact your doctor:
-
Gastric or intestinal ulcers, which may sometimes be accompanied by bleeding and perforation, vomiting blood, or black, tarry stools (common: may occur in 1 in 10 people);
-
Kidney disease characterised 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 rapid heartbeat,
- Low blood pressure leading to shock,
- Swelling of the face, lips, or throat;
-
Potentially life-threatening skin rash characterised by extensive blistering and bleeding from the lips, eyes, mouth, throat, nose, or genital area, or a severe skin reaction starting with painful red spots, progressing to large blisters, and ending with peeling of skin sheets. This is accompanied by fever, chills, muscle pain, and general malaise (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
(very rare: may occur in up to 1 in 10,000 people); -
Red, scaly, widespread rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk, and upper limbs, with fever at the beginning of treatment (acute generalised exanthematous pustulosis). See also section 2 (frequency unknown: frequency cannot be determined from available data);
-
Severe skin reaction, which may appear around the mouth or other body parts, with symptoms such as: red, often itchy blisters resembling measles-like rash, appearing on limbs and sometimes on the face and other body parts. Blisters may evolve into larger blisters or develop into large red spots with pale centres. The skin reaction may be accompanied by fever, sore throat, headache, and/or diarrhoea (very rare: may occur in up to 1 in 10,000 people);
-
Severe peeling or "sloughing" of the skin (very rare: may occur in up to 1 in 10,000 people);
-
Pancreatitis with severe pain in the upper abdomen, often accompanied by 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-coloured urine, which may indicate liver inflammation or liver failure (very rare: may occur in up to 1 in 10,000 people);
-
Heart problems with breathlessness 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 meninges around the brain or spinal cord, accompanied by symptoms such as fever, nausea, vomiting, headache, neck stiffness, and altered consciousness leading to reduced environmental awareness) (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 unknown: frequency cannot be determined from available data);
-
Acute kidney failure (renal papillary necrosis), especially after prolonged use of the medicine (rare: may occur in up to 1 in 1,000 people);
-
Worsening of inflammatory conditions caused by infection (e.g. necrotising fasciitis), particularly when used concomitantly with other NSAIDs (very rare: may occur in up to 1 in 10,000 people);
-
Blood cell production disorders – initial symptoms include: 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);
-
A severe skin reaction called DRESS syndrome may occur. DRESS symptoms include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell) (frequency unknown: frequency cannot be determined from available data).
Other adverse reactions:
Very common (may affect more than 1 in 10 people):
- Nausea, heartburn, flatulence, diarrhoea, constipation, vomiting, abdominal pain.
Common (may affect up to 1 in 10 people):
- Headache, drowsiness, dizziness, vertigo, fatigue, restlessness, insomnia, irritability;
- Occult blood loss, which may lead to a condition characterised by reduced red blood cell count (symptoms include fatigue, headaches, shortness of breath during exercise, dizziness, and pale skin), mouth ulcers, cold sores, colitis (symptoms include diarrhoea, usually with blood and mucus, abdominal pain, fever), exacerbation of inflammatory bowel disease, mucositis.
Uncommon (may affect up to 1 in 100 people):
- Urticaria, itching, petechiae or bruising under the skin, skin rash, asthma attacks (sometimes with hypotension);
- Nasal congestion or stuffy nose, sneezing, facial pressure or pain, difficulty breathing;
- Gastritis (symptoms include pain, nausea, vomiting, vomiting blood, blood in stools);
- Fluid accumulation in body tissues, especially in patients with high blood pressure or impaired kidney function;
- Visual disturbances.
Rare (may affect up to 1 in 1,000 people):
- Skin, joint, and kidney diseases (systemic lupus erythematosus);
- Depression, confusion, hallucinations, psychiatric disorders with unusual or disturbing thoughts or mood;
- Tinnitus, ringing, buzzing, whistling, or other persistent noises in the ears;
- Increased blood urea nitrogen, increased serum aminotransferase and alkaline phosphatase activity, decreased haemoglobin and haematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium concentration, increased serum uric acid concentration, detectable in blood tests;
- Loss of vision.
Very rare (may affect up to 1 in 10,000 people):
- Rapid or irregular heartbeat (palpitations);
- Fluid accumulation in body tissues;
- High blood pressure;
- Oesophagitis, intestinal stricture;
- Unusual hair loss or hair thinning;
- In case of chickenpox, severe skin infections with complications involving soft tissues;
- Menstrual disorders.
Frequency not known (frequency cannot be determined from available data):
- Skin becomes sensitive to light;
- Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.
5. How to store Ibuprofen MAX Aurovitas
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30 °C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the packaging and other information
What Ibuprofen MAX Aurovitas contains
- The active substance is ibuprofen. Each capsule contains 400 mg of ibuprofen.
- The other ingredients are:
Capsule core: macrogol 600, potassium hydroxide
Capsule shell: gelatin, sorbitol liquid
Printing ink: Components of printing ink (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, colourless, oval soft gelatin capsules of size "12", printed with
"I400" in black, edible ink, containing a transparent, colourless to pale yellow, sticky liquid.
This medicinal product is available in PVC/PVDC/Aluminium blisters of 10, 12, 14, 20, 30, 36 and 50
capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
e-mail: [email protected]
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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Ibuprofen AB 400 mg zachte 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