Ibuprofen Aurovitas

Leaflet accompanying the packaging: information for the user

Ibuprofen Aurovitas, 600 mg, coated tablets

Ibuprofen

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

• Keep this leaflet, so you can read it again if you need to.
• 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 another person, even if their symptoms are the same.
• 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 Ibuprofen Aurovitas and what is it used for
• 2. Important information before taking Ibuprofen Aurovitas
• 3. How to take Ibuprofen Aurovitas
• 4. Possible side effects
• 5. How to store Ibuprofen Aurovitas
• 6. Contents of the packaging and other information

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

Ibuprofen Aurovitas belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs), which work by reducing pain and inflammation. Ibuprofen Aurovitas is used for the symptomatic treatment of pain and inflammation in joint diseases (e.g., rheumatoid arthritis), degenerative joint diseases (e.g., osteoarthritis), and painful swelling and inflammation after soft tissue injuries. Ibuprofen Aurovitas is used as a pain reliever for painful menstruation, pain after episiotomy, postpartum pain, toothache, pain after tooth extraction, postoperative pain, and injuries (sprains, bruises, dislocations, fractures), and pain associated with any inflammatory process. Ibuprofen Aurovitas is used as an antipyretic in fever of various etiologies.

2. Important information before taking Ibuprofen Aurovitas

When not to take Ibuprofen Aurovitas:

• if the patient is hypersensitive 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, hay fever, itchy skin rash, or swelling of the face, lips, tongue, or throat, after taking medicines containing acetylsalicylic acid (such as aspirin) or other pain and anti-inflammatory medicines (NSAIDs).
• if the patient has had gastrointestinal bleeding or perforation related to previous use of pain and anti-inflammatory medicines (NSAIDs).
• if the patient has a stomach or duodenal ulcer or has had two or more episodes of this condition in the past.
• if the patient has severe liver, kidney, or heart problems.
• if the patient is in the last three months of pregnancy.
• if the patient has severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
• if the patient has active bleeding (including in the brain).
• if the patient has a condition of unknown origin that causes abnormal blood cell formation.

Do not give Ibuprofen Aurovitas, 600 mg, coated tablets to children and adolescents under 15 years of age.

Warnings and precautions

Before taking Ibuprofen Aurovitas, consult a doctor or pharmacist

• if the patient has systemic lupus erythematosus (SLE) or mixed connective tissue disease
• if the patient has hereditary disorders of red blood cell pigment - hemoglobin (porphyria)
• if the patient has chronic inflammatory bowel diseases, such as ulcerative colitis, Crohn's disease, or other stomach and intestinal diseases
• if the patient has blood cell formation disorders
• if the patient has a problem with normal blood clotting
• if the patient has allergies, hay fever, asthma, chronic swelling of the nasal mucosa, sinuses, tonsils, or chronic obstructive pulmonary disease, as the risk of developing bronchospasm (constriction of the airways) is higher
• if the patient has liver, kidney, or heart problems
• if the patient has recently undergone major surgery
• if the patient is in the first six months of pregnancy
• if the patient is breastfeeding
• 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), and chest pain. If any of these symptoms are noticed, the patient should stop taking Ibuprofen Aurovitas and contact a doctor or emergency medical services immediately.
• Severe skin reactions have occurred with ibuprofen, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), as well as acute generalized exanthematous pustulosis (AGEP). If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should stop taking Ibuprofen Aurovitas and seek medical help.

Infections
Ibuprofen Aurovitas may mask the symptoms of infection, such as fever and pain. Therefore, it is possible that Ibuprofen Aurovitas may delay the use of appropriate infection treatment, which may lead to increased risk of complications. This has been observed in the course of bacterial pneumonia and bacterial skin infections related to 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.
Elderly
Elderly patients are more prone to side effects, especially gastrointestinal bleeding and perforation, which can be fatal. The doctor will advise the patient on the appropriate course of action.
Ulcers, perforations, and gastrointestinal bleeding
If the patient has previously been diagnosed with a stomach or intestinal ulcer, especially if complicated by perforation or bleeding, they should be aware of unusual abdominal symptoms and inform their doctor immediately, especially if these symptoms occur at the start of treatment. The risk of gastrointestinal bleeding or ulceration is higher in this case, especially in elderly patients. If gastrointestinal bleeding or ulceration occurs, treatment must be discontinued.
Gastrointestinal bleeding, ulceration, or perforation can occur without warning signs, even in patients who have never had such problems before. They can also lead to death.
The risk of ulcers, perforations, or gastrointestinal bleeding usually increases with the dose of ibuprofen. The risk also increases if certain other medicines are taken at the same time as ibuprofen (see "Ibuprofen Aurovitas and other medicines" below).
Side effects can be minimized by using the smallest effective dose for the shortest duration necessary to control symptoms.
Skin reactions
Severe skin reactions have been reported with Ibuprofen Aurovitas. If a skin rash, mucosal lesions, blisters, or other signs of allergy occur, the patient should stop taking Ibuprofen Aurovitas and consult a doctor immediately, as these may be the first signs of a severe skin reaction (see section 4).
During chickenpox, it is recommended to avoid taking this medicine.
Impact on the heart and brain
Anti-inflammatory and/or pain relieving medicines like 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.
Before taking Ibuprofen Aurovitas, discuss it with a doctor or pharmacist if:

• the patient has heart problems, including heart failure, angina (chest pain), or has had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any stroke (including "mini-stroke" or transient ischemic attack).
• the patient has high blood pressure, diabetes, high cholesterol, or has a family history of heart disease or stroke, or is a smoker.

Impact on the kidneys
Ibuprofen may cause kidney problems, even in patients who have not had problems before. This can lead to swelling of the feet, and in some cases, may cause heart failure or high blood pressure in susceptible individuals. Ibuprofen may cause kidney damage, especially in patients who have already had kidney, heart, or liver problems, or are taking diuretics or ACE inhibitors, as well as in the elderly. Stopping ibuprofen usually leads to the disappearance of symptoms.
Aseptic meningitis (meningitis without bacterial infection)
During ibuprofen treatment, single cases of meningitis (symptoms include stiffness of the neck, headache, nausea, vomiting, fever, or disorientation) have been observed. Although it is more likely to occur in patients with existing autoimmune diseases, such as systemic lupus erythematosus or mixed connective tissue disease, cases have been reported in patients without chronic disease.
Other precautions
Very rarely, severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed. If the patient experiences the first symptoms of a hypersensitivity reaction after taking Ibuprofen Aurovitas, they should stop the treatment and immediately inform their doctor. Ibuprofen may temporarily inhibit platelet aggregation. Therefore, patients with bleeding disorders should be closely monitored.
During long-term use of pain relievers in high doses, a headache may occur, which should not be treated with high doses of this medicine. Habitual use of pain relievers may cause permanent kidney damage and increase the risk of kidney failure. Ibuprofen may mask the symptoms or signs of infection (fever, pain, and swelling) and temporarily prolong bleeding time. Ibuprofen Aurovitas may reduce the chances of getting pregnant. The patient should inform their doctor if they are planning to get pregnant or are having trouble getting pregnant.

Young people

Ibuprofen Aurovitas is contraindicated in children and adolescents under 15 years of age (see section 3). Ibuprofen may cause kidney function disorders in dehydrated adolescents.

Ibuprofen Aurovitas and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take. Ibuprofen's side effects may be increased if certain medicines are taken at the same time. On the other hand, ibuprofen may increase or decrease the effect of other medicines or increase their side effects when taken at the same time. Ibuprofen Aurovitas may affect the action of some other medicines or other medicines may affect its action. For example:

• other NSAIDs, including COX-2 inhibitors, as they may increase the risk of gastrointestinal ulcers and bleeding
• anticoagulants (to prevent blood clotting), such as warfarin or heparin, as the effect of the anticoagulant may be increased
• platelet aggregation inhibitors (to prevent blood clotting), such as clopidogrel and ticlopidine
• methotrexate (used to treat cancer and autoimmune diseases)
• digoxin (used to treat various heart conditions), as the effect of digoxin may be increased
• phenytoin (used to prevent seizures), as the effect of phenytoin may be increased
• lithium (used to treat depression and mania), as the effect of lithium may be increased
• diuretics (water pills), as the effect of diuretics may be reduced
• potassium-sparing diuretics, as this may lead to hyperkalemia
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan)
• cholestyramine (used to treat high cholesterol)
• aminoglycosides (antibiotics), as NSAIDs may reduce the excretion of aminoglycosides
• SSRIs (antidepressants), such as paroxetine, sertraline, citalopram, as they may increase the risk of gastrointestinal bleeding
• cyclosporine, tacrolimus (used in immunosuppression after organ transplantation), as kidney damage may occur
• zidovudine or ritonavir (used to treat HIV)
• mifepristone, as NSAIDs may reduce the effect of mifepristone
• probenecid or sulfinpyrazone (used to treat gout), as the excretion of ibuprofen may be delayed
• quinolone antibiotics, as the risk of seizures may be increased
• sulfonylurea derivatives (used to treat type 2 diabetes), as this may affect blood sugar levels
• corticosteroids (used to treat inflammatory conditions), as they may increase the risk of ulcers or gastrointestinal bleeding
• bisphosphonates (used to treat osteoporosis, Paget's disease, and to lower high calcium levels in the blood)
• pentoxifylline (used to treat circulatory disorders in the legs or arms)
• baclofen (a muscle relaxant) due to increased toxicity of baclofen
• Ginkgo biloba herbal medicine, as there is a risk of easier bleeding if taken with ibuprofen
• voriconazole and fluconazole (CYP2C9 inhibitors) (used to treat fungal infections), as the effect of ibuprofen may be increased. It is recommended to consider reducing the dose of ibuprofen, especially when using high doses of ibuprofen with voriconazole or fluconazole.

Other medicines may also affect treatment with Ibuprofen Aurovitas or other medicines may be affected by Ibuprofen Aurovitas. Therefore, before taking Ibuprofen Aurovitas with other medicines, the patient should always consult a doctor or pharmacist.

Ibuprofen Aurovitas and alcohol

While taking Ibuprofen Aurovitas, the patient should avoid consuming alcohol, as this may increase the possible side effects, especially those affecting the stomach, intestines, or central nervous system.

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 a doctor or pharmacist before taking this medicine. Do not take Ibuprofen Aurovitas if the patient is in the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. Ibuprofen Aurovitas may cause kidney and heart problems in the unborn baby. It may increase the patient's and the baby's tendency to bleed and cause delayed or prolonged labor. During the first six months of pregnancy, Ibuprofen 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 smallest dose should be used for the shortest possible time. From the 20th week of pregnancy, Ibuprofen Aurovitas may cause kidney function disorders in the unborn baby if taken for more than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring. Ibuprofen passes into breast milk in very small amounts, and breastfeeding can usually be continued during short-term use. However, if long-term treatment is planned, the patient should consider stopping breastfeeding.

Driving and using machines

Ibuprofen generally does not affect the ability to drive or use machines. However, side effects that occur with high doses of the medicine, such as fatigue, drowsiness, dizziness (reported frequently), and vision disturbances (reported infrequently), may, in individual cases, impair the ability to drive or use machines. This effect may be increased if alcohol is consumed.

Ibuprofen Aurovitas contains sodium

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

3. How to take Ibuprofen Aurovitas

Always take the medicine as directed by the doctor. If in doubt, consult a doctor or pharmacist. Take the smallest effective dose for the shortest duration necessary to relieve symptoms. In case of infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2). Adults and children over 12 years old (≥ 40 kg): The recommended dose is 1200 mg to 1800 mg of ibuprofen (2 to 3 tablets per day with an 8-hour interval). The maintenance dose in some patients may be 600 mg to 1200 mg per day (1 to 2 tablets per day). In severe and acute cases, it may be beneficial to increase the dose until the acute phase is over. Generally, it is not recommended to exceed the maximum daily dose of ibuprofen 2400 mg. The recommended dose of ibuprofen for children is 20 mg/kg body weight per day in divided doses. In the treatment of juvenile rheumatoid arthritis, doses up to 40 mg/kg body weight per day of ibuprofen in divided doses may be necessary. Other strengths of ibuprofen may be more suitable for use in this age group based on body weight. Ibuprofen Aurovitas 600 mg is not recommended for children under 12 years of age. In rheumatic diseases, the use of Ibuprofen Aurovitas may be required for a longer period. The tablet should be swallowed with a glass of water, preferably after a meal. Patients with sensitive stomachs are advised to take ibuprofen with a meal. To facilitate swallowing or to adjust the dose, the tablet can be divided into equal doses.
Elderly
Elderly patients are more prone to side effects, especially gastrointestinal bleeding, ulcers, and perforation, which can be fatal. The doctor will advise the patient on the appropriate course of action.
Kidney and liver function disorders
No dose reduction is necessary in patients with mild or moderate kidney and/or liver function disorders.

Taking a higher dose of Ibuprofen Aurovitas than recommended

In case of overdose or accidental ingestion of the medicine by children, the patient should always consult a doctor or the nearest hospital to assess the risk and get advice on what to do. Symptoms may include nausea, abdominal pain, vomiting (which may be bloody), diarrhea, headache, gastrointestinal bleeding, ringing in the ears, confusion, and trembling of the eyeballs, as well as worsening of asthma in asthmatics. After high doses, drowsiness, excitement, disorientation, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported, as well as blood in the urine, low blood pressure, prolonged prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, feeling cold, and breathing difficulties. In case of overdose, after gastric lavage, supportive measures should be taken. There is no specific antidote for ibuprofen.

Missing a dose of Ibuprofen Aurovitas

If the patient misses one or more doses, they should continue taking the next dose as usual. Do not take a double dose to make up for a missed dose. If the patient has further questions about taking this medicine, they should consult a doctor or pharmacist.

Method and route of administration

Oral administration. The tablets should be taken whole, with a large amount of water or other liquid, and should not be chewed, broken, crushed, or sucked to avoid discomfort or throat irritation. The average duration of treatment varies depending on the patient and their clinical condition.

4. Possible side effects

Like all medicines, Ibuprofen Aurovitas can cause side effects, although not everybody gets them. The following side effects are largely dose-dependent and vary from person to person. The most common side effects are gastrointestinal. Gastrointestinal ulcers, perforations, or bleeding may occur, sometimes leading to death, especially in elderly patients. Nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black tarry stools, or vomiting blood have been reported. Less frequently, gastric ulceration has been observed. The use of medicines like ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Fluid retention (edema), high blood pressure, and heart failure have been reported in association with NSAID use. Side effects are listed according to their frequency of occurrence. The following terminology has been used to estimate the frequency of side effects: Very common: occurs in more than 1 in 10 people Common: occurs in less than 1 in 10 people Uncommon: occurs in less than 1 in 100 people Rare: occurs in less than 1 in 1,000 people Very rare: occurs in less than 1 in 10,000 people Frequency not known: frequency cannot be estimated from the available data

The following side effects are important and require immediate action if they occur in the patient. The patient should stop taking Ibuprofen Aurovitas and consult a doctor immediately if they experience the following symptoms:
Common:

• -black tarry stools or bloody vomiting (gastrointestinal bleeding)

Very rare:

• -swelling of the face, tongue, or throat, which may cause severe breathing difficulties (angioedema), rapid heartbeat, significant drop in blood pressure, or life-threatening shock
• -sudden allergic reaction with difficulty breathing, wheezing, and a drop in blood pressure
• -severe skin rash with blisters, especially on the hands, feet, mouth, and eyes, which may be accompanied by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome). It may also occur in a more severe form, with larger blisters that may rupture, and the top layer of the skin may peel off (Lyell's syndrome/toxic epidermal necrolysis). It can also occur as a severe skin infection with destruction (necrosis) of the skin, subcutaneous tissue, and muscles (necrotizing fasciitis).

The patient should stop taking the medicine and consult a doctor as soon as possible if they experience the following side effects:
Very common:

• -heartburn, abdominal pain, indigestion

Uncommon:

• -blurred vision
• -hypersensitivity reactions, such as hives, itching, rash, urticaria, and asthma attacks (sometimes with low blood pressure)

Rare:

• -loss of vision

Very rare:

• -sudden fluid buildup in the lungs, causing breathing difficulties, high blood pressure, fluid retention, and weight gain

Other possible side effects of Ibuprofen Aurovitas include:
Very common:

• -gastrointestinal disorders, such as diarrhea, nausea, vomiting, gas, constipation

Common:

• -gastrointestinal ulcer with perforation or without
• inflammation of the colon and worsening of ulcerative colitis and Crohn's disease, and complications related to diverticulitis (perforation or fistula)
• microscopic gastrointestinal bleeding, which may lead to anemia
• mouth ulcers and inflammatory conditions (stomatitis)
• headache, drowsiness, dizziness, fatigue, excitement, insomnia, and irritability

Uncommon:

• -gastritis
• kidney problems, including the development of edema, kidney inflammation, and kidney failure
• runny nose
• breathing difficulties (bronchospasm)

Rare:

• -depression, disorientation, hallucinations
• systemic lupus erythematosus
• increased blood urea nitrogen, serum transaminases, and alkaline phosphatase
• decreased hemoglobin and hematocrit, inhibited platelet aggregation, and prolonged bleeding time, decreased serum calcium, and increased blood uric acid
• kidney tissue damage

Very rare:

• -unpleasant sensation of palpitations, heart failure, or myocardial infarction
• blood cell formation disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia). The first symptoms may include fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding
• ringing or buzzing in the ears
• esophagitis or pancreatitis
• acute liver failure, jaundice, or liver function disorders
• liver damage, especially with long-term use or liver failure
• hair loss
• aseptic meningitis (meningitis without bacterial infection)

Frequency not known:

• tingling of hands and feet
• restlessness
• hearing loss
• general malaise
• optic neuritis, which may cause vision problems
• a severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell). If such symptoms occur, the patient should stop taking Ibuprofen Aurovitas and consult a doctor immediately.
• a red, scaly, widespread rash with bumps under the skin and blisters, mainly on the folds of the skin, torso, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). If these symptoms occur, the patient should stop taking Ibuprofen Aurovitas and seek medical help. See also section 2.
• skin sensitivity to light
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome

Ibuprofen Aurovitas may cause a decrease in white blood cell count, and the patient's resistance to infection may be reduced. If the patient experiences an infection with symptoms such as fever with a severe deterioration in general condition or fever with local signs of infection such as sore throat/pharyngitis, the patient should consult a doctor immediately. A blood test will be performed to check for a possible decrease in white blood cell count (agranulocytosis). It is essential to inform the doctor about the medicine being taken.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl By reporting side effects, more information can be collected on the safety of the medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Ibuprofen Aurovitas

Keep the medicine out of the 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. There are no special storage instructions for the medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ibuprofen Aurovitas contains

• The active substance is ibuprofen. Each coated tablet contains 600 mg of ibuprofen.
• The other ingredients are: Core:corn starch, pregelatinized corn starch, colloidal anhydrous silica, sodium croscarmellose, talc, stearic acid. Coating:talc (E 553b), polyvinyl alcohol, macrogol 3350 (E 1521), titanium dioxide (E 171).

What Ibuprofen Aurovitas looks like and contents of the pack

Coated tablet.
Ibuprofen Aurovitas, 600 mg, coated tablets:[size: 18.3 mm x 9.2 mm]
White or almost white, oval, coated tablets with a dividing line on one side and smooth on the other. The tablet can be divided into equal doses.
Ibuprofen Aurovitas, coated tablets are available in blisters in a cardboard box.
Pack size: 10 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João De Deus 19, Venda Nova
2700-487 Amadora
Portugal

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

Poland:

Ibuprofen Aurovitas

Portugal:

Ibuprofeno Limeg

Date of last revision of the leaflet: 03/2024