Ibuprofen Aurovitas

Leaflet accompanying the packaging: information for the user

Ibuprofen Aurovitas, 200 mg, coated tablets

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 your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 5 days in adults or 3 days in children there is no improvement or you feel worse, you should contact your doctor.

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 pack and other information

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

Ibuprofen Aurovitas is used to treat mild to moderate pain, such as headache, including migraine headache, toothache, muscle pain, bruises, and post-traumatic pain, as well as pain associated with flu-like conditions. It is also indicated for menstrual pain (primary dysmenorrhea) and for the treatment of fever lasting less than 3 days. If after 5 days in the case of adults the patient does not feel better or feels worse, or after 3 days in the case of children, you should consult a doctor.

2. Important information before taking Ibuprofen Aurovitas

When not to take Ibuprofen Aurovitas:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• if you have had an allergic reaction, such as asthma, runny nose, itchy skin rash, or swelling of the face, lips, tongue, or throat after taking medicines containing acetylsalicylic acid (such as aspirin) or other pain-relieving and anti-inflammatory medicines (NSAIDs).
• if you have had bleeding or perforation of the gastrointestinal tract associated with previous use of pain-relieving and anti-inflammatory medicines (NSAIDs).
• if you have an active peptic ulcer or bleeding in the stomach or duodenum (small intestine) or if you have had two or more such episodes in the past.
• if you have severe liver, kidney, or heart failure.
• if you are in the last 3 months of pregnancy.
• if you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).

Ibuprofen Aurovitas is contraindicated in children under 12 years of age.

Warnings and precautions

Before taking Ibuprofen Aurovitas, you should discuss it with your doctor, pharmacist, or nurse

• if you have systemic lupus erythematosus (SLE) or mixed connective tissue disease
• if you have a hereditary disorder of red blood cell pigment - porphyria
• if you have chronic inflammatory bowel diseases, such as ulcerative colitis or Crohn's disease, or other stomach and intestinal diseases
• if you have blood clotting disorders
• if you have a problem with normal blood clotting
• if you have allergies, hay fever, asthma, chronic swelling of the nasal mucosa, sinuses, tonsils, or chronic obstructive pulmonary disease, as the risk of developing bronchospasm is higher
• if you have liver, kidney, or heart problems
• if you have recently undergone major surgery
• if you are in the first six months of pregnancy
• if you are breastfeeding
• if you have an infection - see "Infections" below.
• During ibuprofen treatment, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, swelling around the face and neck (angioedema), and chest pain. If you notice any of these symptoms, you should stop taking Ibuprofen Aurovitas and contact your doctor or emergency medical services immediately.
• Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred with ibuprofen use. If you experience any symptoms associated with these severe skin reactions described in section 4, you should stop taking Ibuprofen Aurovitas and seek medical attention.

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 pneumonia caused by bacteria and bacterial skin infections associated with chickenpox. If you are taking this medicine during an infection and the symptoms of the infection persist or worsen, you should consult your doctor immediately.
Elderly
Elderly people are more prone to side effects, especially bleeding and perforation of the gastrointestinal tract, which can be fatal.
Ulcers, perforations, and bleeding from the stomach or intestines
If you have previously had a stomach or intestinal ulcer, especially if it was complicated by perforation or bleeding, you should be aware of unusual symptoms in the abdominal cavity and inform your doctor immediately, especially if these symptoms occur at the beginning 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.
Bleeding, ulceration, or perforation of the stomach or intestines can occur without any warning signs, even in patients who have never had such problems before. They can also lead to death.
The risk of ulcers, perforations, or bleeding from the stomach or intestines usually increases with the increase in 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 the symptoms.
Skin reactions
Severe skin reactions have been reported with Ibuprofen Aurovitas treatment. In case of skin rash, mucosal lesions, blisters, or other signs of allergy, you should stop taking Ibuprofen Aurovitas and consult your doctor immediately, as these may be the first signs of a very severe skin reaction (see section 4).
During chickenpox, it is recommended to avoid taking this medicine.
Effect on the heart and brain
Pain-relieving and anti-inflammatory medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. You should not exceed the recommended dose or duration of treatment (7 days in adults or 3 days in children and adolescents).
Before taking ibuprofen, you should discuss it with your doctor or pharmacist if:

• you have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass grafting, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any stroke (including "mini-stroke" or transient ischemic attack).
• you have high blood pressure, diabetes, high cholesterol, or if there is a history of heart disease or stroke in your family, or if you are a smoker.

Effect on the kidneys
Ibuprofen may cause kidney problems even in patients who have not had problems with them before. This can lead to swelling of the feet, and may even lead to heart failure or increased 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 you experience the first symptoms of a hypersensitivity reaction after taking Ibuprofen Aurovitas, you should stop treatment and immediately inform your doctor. Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with bleeding disorders should be closely monitored.
Long-term use of any pain reliever for headaches can make them worse. If this happens or is suspected, you should stop taking ibuprofen and consult your doctor. Medication overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of pain relievers. Habitual use of pain relievers can 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 may reduce fertility in women. You should inform your doctor if you are planning to become pregnant or if you are having trouble becoming pregnant.

Children and adolescents

Do not give to children under 12 years of age.
Ibuprofen Aurovitas may cause kidney function disorders in dehydrated children and adolescents.

Ibuprofen Aurovitas and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
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 action of the anticoagulant may be enhanced
• platelet aggregation inhibitors (to prevent blood clotting), such as ticlopidine and clopidogrel
• methotrexate (used to treat cancer and autoimmune diseases)
• digoxin (used to treat various heart conditions), as the action of digoxin may be enhanced
• phenytoin (used to prevent seizures), as the action of phenytoin may be enhanced
• lithium (used to treat depression and mania), as the action of lithium may be enhanced
• diuretics (diuretics), as the action of diuretics may be weakened
• 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 levels)
• 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-infected patients)
• 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 in inflammatory conditions), as they may increase the risk of ulcers or gastrointestinal bleeding
• bisphosphonates (used to treat osteoporosis, Paget's disease, and to reduce 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 action of ibuprofen may be enhanced. It is recommended to consider reducing the dose of ibuprofen, especially when taking high doses of ibuprofen with voriconazole or fluconazole.

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

Ibuprofen Aurovitas with alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, you should ask your doctor or pharmacist for advice before taking this medicine.
You should not take Ibuprofen Aurovitas if you are in the last 3 months of pregnancy, as it may harm your unborn baby or cause problems during delivery.
Ibuprofen Aurovitas may cause kidney and heart problems in the unborn baby.
It may also increase the risk of bleeding in the mother and child and cause delayed or prolonged labor. During the first 6 months of pregnancy, you should not take Ibuprofen Aurovitas unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, you should use the smallest dose 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 arterial duct (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, your doctor may recommend additional monitoring.
Ibuprofen belongs to a group of medicines (NSAIDs) that may adversely affect female fertility. This effect is reversible upon cessation of the medicine.
Ibuprofen passes into breast milk in very small amounts, and during short-term use, breastfeeding usually does not need to be discontinued. However, if long-term treatment is planned, you 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 (which have been reported frequently), and vision disturbances (which have been reported less frequently), may, in individual cases, impair the ability to drive or use machines. This effect may be enhanced if you consume alcohol.

Ibuprofen Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., the medicine is considered "sodium-free".

3. How to take Ibuprofen Aurovitas

The medicine should always be taken as directed by your doctor. In case of doubt, consult your doctor, pharmacist, or nurse.
You should use the smallest effective dose for the shortest duration necessary to relieve the symptoms. In case of infection, you should contact your doctor immediately if the symptoms (such as fever and pain) persist or worsen (see section 2).
For short-term use only.
The dose of ibuprofen depends on the age and weight of the patient. The recommended dose is:
Adults and adolescents with a body weight of ≥ 40 kg (from 12 years of age and older):
For oral use only and short-term use.
The dose of ibuprofen depends on the age and weight of the patient. In adults and adolescents, you should not exceed the maximum single dose of 400 mg of ibuprofen per dose.
More than 400 mg at a time does not provide better pain relief. You should leave at least 4 hours between doses.
The total dose should not exceed 1200 mg of ibuprofen in 24 hours.
You should consult your doctor if the symptoms persist or worsen after 5 days in the case of pain and after 3 days in the case of fever.
The initial dose is 200 mg or 400 mg of ibuprofen. If necessary, you can take additional doses of 1 or 2 equivalent tablets (from 200 mg to 400 mg of ibuprofen), up to 3 times a day, at 4- to 6-hour intervals.

If this medicine is needed for adolescents for more than 3 days or if the symptoms worsen, you should consult your doctor.
Children
Ibuprofen Aurovitas should not be given to children under 12 years of age without a doctor's recommendation.
You should look for other medicines more suitable for children.
Elderly
In the elderly, there is no need to change the dose, unless there is kidney or liver failure, in which case the dose must be individualized. In this group of patients, caution should be exercised when adjusting the dose.
Kidney function disorders
It is not necessary to reduce the dose in patients with mild or moderate kidney function disorders.
Liver function disorders
It is not necessary to reduce the dose in patients with mild to moderate liver function disorders.
Method of administration
Oral administration.
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 irritation of the throat.

Taking a higher dose of Ibuprofen Aurovitas than recommended

In case of overdose or accidental ingestion of this medicine by children, you should always contact your doctor or the nearest hospital to get an opinion on the risk and advice on what actions to take.
Symptoms may include nausea, abdominal pain, vomiting (which may be bloody), headache, ringing in the ears, confusion, and tremors. After taking high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. In case of overdose, gastric lavage should be preceded by supportive measures, which will be deemed appropriate in each case. There is no specific antidote for ibuprofen.

Missing a dose of Ibuprofen Aurovitas

You should not take a double dose to make up for a missed dose.
If you miss one or more doses, you should take the next dose as usual.
In case of any further doubts about the use of this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Ibuprofen Aurovitas can cause side effects, although not everybody gets them.
Regarding the following side effects, it should be considered that they are largely dose-dependent and vary from patient to patient.
The most commonly observed side effects are gastrointestinal in nature. Gastrointestinal ulcers, perforations, or bleeding may occur, sometimes leading to death, especially in the elderly. After administration, nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black tarry stools, bloody vomiting, oral ulceration, and exacerbation of ulcerative colitis and Crohn's disease have been reported. Less frequently, gastritis (inflammation of the stomach lining) has been observed. Stomach and intestinal ulcers, perforations, or bleeding can occur without warning signs, even in patients who have never had such problems before. They can also lead to death.
The use of medicines such as 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.
The list of side effects below includes all side effects known to occur with ibuprofen treatment, including those that occurred in patients with rheumatism who received long-term treatment with high doses of the medicine. The frequencies given, which exceed very rare reports, refer to short-term use of daily doses of up to 1200 mg of ibuprofen in the case of oral dosage forms and up to 1800 mg in the case of suppositories.
Side effects are listed by frequency of occurrence. To estimate the frequency of occurrence of side effects, the following terminology has been used:
Very common: occurs in more than 1 in 10 people
Common: occurs in less than 1 in 10 people but more than 1 in 100 people
Uncommon: occurs in less than 1 in 100 people but more than 1 in 1,000 people
Rare: occurs in less than 1 in 1,000 people but more than 1 in 10,000 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. You should stop taking Ibuprofen Aurovitas and consult your doctor immediately if you experience the following symptoms:
Uncommon:

• black tarry stools or bloody vomiting (gastrointestinal bleeding)

Very rare:

• swelling of the face, lips, tongue, or throat (angioedema), which may cause severe breathing difficulties, rapid heartbeat, significant decrease in blood pressure, or life-threatening shock
• severe allergic reaction with difficulty breathing, wheezing, and a drop in blood pressure
• severe skin rash with blisters, especially on the legs, arms, hands, and feet, which may also affect the face and mouth, oral ulcers, genital ulcers, and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome). It may occur in a more severe form, with larger blisters that may burst and peel off the skin (Lyell's syndrome/toxic epidermal necrolysis). It may also occur as a severe skin infection with destruction (necrosis) of the skin, subcutaneous tissue, and muscle (necrotizing fasciitis).

You should stop taking the medicine and contact your doctor as soon as possible if you experience the following side effects:
Common:

• heartburn, abdominal pain, indigestion

Uncommon:

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

Rare:

• loss of vision

Very rare:

• sudden filling of the lungs with fluid, causing breathing difficulties, high blood pressure, fluid retention, and weight gain

Other possible side effects of Ibuprofen Aurovitas include:
Common:

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

Uncommon:

• gastritis (inflammation of the stomach lining)
• rhinitis
• gastrointestinal ulcer with perforation or without
• inflammation of the intestines and worsening of ulcerative colitis and Crohn's disease, and complications associated with diverticulitis (perforation or fistula)
• microscopic gastrointestinal bleeding, which may lead to anemia
• oral ulcers and inflammatory conditions (stomatitis)
• breathing difficulties (bronchospasm)
• headache, drowsiness, dizziness, fatigue, excitement, insomnia, and irritability

Rare:

• depression, disorientation, hallucinations
• systemic lupus erythematosus
• increased blood urea nitrogen, serum transaminases, and alkaline phosphatase
• decreased hemoglobin and hematocrit values in the blood, inhibition of platelet aggregation, and prolonged bleeding time, decreased serum calcium levels, and increased uric acid levels in the blood
• kidney tissue damage

Very rare:

• unpleasant feeling of heartbeat, heart failure, or heart attack
• blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia). The first symptoms may include fever, sore throat, oral ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding.
• ringing or buzzing in the ears
• esophagitis or pancreatitis
• intestinal stricture
• acute liver failure, yellowing of the skin or whites of the eyes, liver function disorders
• liver damage, especially with long-term use or liver failure
• kidney problems, including swelling, kidney inflammation, and kidney 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, swelling of the lymph nodes, and an increase in the number of eosinophils (a type of white blood cell). If you experience such symptoms, you should stop taking Ibuprofen Aurovitas and contact your 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, which is accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If you experience these symptoms, you should stop taking Ibuprofen Aurovitas and seek medical attention immediately. See also section 2.
• skin becomes sensitive 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 the number of white blood cells, and the ability to fight infections may be reduced. If you experience 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/pharynx/oral ulcers, you should contact your doctor immediately. A blood test will be performed to check for a possible decrease in the number of white blood cells (agranulocytosis). It is important to inform your doctor that you are taking this medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your 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 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Ibuprofen Aurovitas

The medicine should be stored 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 stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ibuprofen Aurovitas contains

• The active substance of the medicine is ibuprofen. Each coated tablet contains 200 mg of ibuprofen.
• The other ingredients are: Core:maize starch, pregelatinized maize 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, 200 mg, coated tablets:[size: 9.8 mm]
White or almost white, round, 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.
Package sizes:
Blisters: 10 and 50 coated tablets.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 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
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