Ibuprofen aurovitas

Package leaflet: Information for the user

Ibuprofen Aurovitas, 200 mg, film-coated tablets
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always take this medicine exactly as described in this patient leaflet or as your doctor,
pharmacist, or nurse has told you.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 days in adults or after 3 days in children, or if you feel worse, you should consult your doctor.

Table of contents

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

Ibuprofen Aurovitas is used to treat mild to moderate pain such as headache, including migraine headache, toothache, muscle pain, bruising and injury-related pain, as well as pain associated with flu-like conditions. It is also indicated for menstrual pain (primary dysmenorrhoea) and for the treatment of fever lasting less than 3 days.
If after 5 days in adults or after 3 days in children you do not feel better or feel worse, you should consult your doctor.

2. Important information before using Ibuprofen Aurovitas

When not to use Ibuprofen 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, rhinitis, itchy rash or swelling of the lips, face, tongue or throat after taking medicines containing acetylsalicylic acid (such as aspirin) or other pain-relieving and anti-inflammatory medicines (NSAIDs).

• if the patient has experienced gastrointestinal bleeding or perforation related to previous use of pain-relieving and anti-inflammatory medicines (NSAIDs).

• if the patient currently has a stomach or duodenal ulcer or gastrointestinal bleeding, or has had two or more such episodes in the past.

• if the patient has severe liver, kidney or heart failure.

• if the patient is in the last 3 months of pregnancy.

• if the patient is severely dehydrated (caused by vomiting, diarrhoea or
  insufficient fluid intake).

• if the patient has active bleeding (including in the brain).

• if the patient has an undiagnosed condition causing abnormal blood cell formation.

Ibuprofen Aurovitas is contraindicated in children under 12 years of age.
Warnings and precautions
Before using Ibuprofen Aurovitas, consult your doctor, pharmacist or
nurse

• if the patient has systemic lupus erythematosus (SLE) or mixed connective tissue disease
• if the patient has a hereditary blood pigment disorder – haemoglobin (porphyria)
• if the patient has chronic inflammatory bowel diseases such as ulcerative colitis, gastrointestinal inflammation (Crohn’s disease) or other stomach and intestinal disorders
• if the patient has blood cell formation disorders
• if the patient has problems with normal blood clotting mechanisms
• if the patient has allergies, hay fever, asthma, chronic nasal or sinus mucosal swelling, tonsillar swelling or chronic obstructive pulmonary disease, as the risk of airway narrowing with breathing difficulties (bronchospasm) 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 section “Infections” below.
• During treatment with ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, facial and neck swelling (angioedema), chest pain. If any of these symptoms occur, discontinue Ibuprofen Aurovitas immediately and contact a doctor or emergency medical services without delay.
• Serious 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 with ibuprofen use. If the patient develops any symptoms related to these serious skin reactions described in section 4, Ibuprofen Aurovitas must be discontinued immediately and medical help sought.

Infections
Ibuprofen Aurovitas may mask symptoms of infection such as fever and pain. Therefore,
Ibuprofen 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,
immediate medical advice should be sought.
Elderly patients
Elderly patients are more susceptible to adverse effects, especially gastrointestinal bleeding and
perforation, which may be fatal.
Ulcers, perforations and gastrointestinal bleeding
If the patient has previously been diagnosed with a stomach or intestinal ulcer, particularly if complicated
by perforation or bleeding, be alert for unusual abdominal symptoms and inform the doctor immediately, especially if such symptoms occur at the beginning
of treatment. The risk of gastrointestinal bleeding or ulceration is higher in such cases, particularly in elderly patients. If gastrointestinal bleeding
or ulceration occurs, treatment must be discontinued.
Bleeding, ulceration or perforation of the stomach or intestine may occur without warning signs, even in patients who have never previously experienced such problems. These may also lead to death.
The risk of gastric or intestinal ulcers, perforation or bleeding usually increases with higher doses of ibuprofen. The risk also increases if certain other medicines are taken concomitantly with ibuprofen (see section “Ibuprofen Aurovitas and other medicines” below).
Adverse effects can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Skin reactions
Serious skin reactions have been reported with Ibuprofen Aurovitas treatment. If a skin rash, mucosal lesions, blisters or other allergic symptoms occur, discontinue Ibuprofen Aurovitas and seek immediate medical advice, as these may be early signs of a very serious skin reaction (see section 4).
Avoid using this medicine during chickenpox.
Effects on heart and brain
Anti-inflammatory and/or 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 (7 days for adults or 3 days for children and adolescents).
Before using ibuprofen, discuss with your doctor or pharmacist if:

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

Effects on kidneys
Ibuprofen may cause kidney function problems even in patients
who previously had no kidney issues. This may result in leg swelling and may even lead to heart failure or increased blood pressure in predisposed individuals.
Ibuprofen may cause kidney damage, especially in patients who previously had kidney, heart or liver problems, those taking diuretics or ACE inhibitors, and in elderly patients. Discontinuation of ibuprofen usually leads to symptom resolution.
Aseptic meningitis (meningitis without bacterial infection)
Isolated cases of meningitis (manifesting as neck stiffness, headache, nausea, vomiting, fever or
disorientation) have been observed during ibuprofen treatment. Although it probably occurs more frequently in patients with pre-existing autoimmune diseases such as systemic lupus erythematosus or mixed connective tissue disease, cases have been reported in patients without chronic illness.
Other precautions
Severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been very rarely observed.
If early symptoms of hypersensitivity occur after taking Ibuprofen Aurovitas, treatment must be stopped immediately and a doctor informed without delay.
Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with bleeding disorders should be carefully monitored.
Prolonged use of any painkiller for headache may worsen it.
If this occurs or is suspected, ibuprofen should be discontinued and medical advice sought. Medication-overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of painkillers.
Chronic use of painkillers may cause permanent kidney damage and risk of kidney failure.
Ibuprofen may mask symptoms or signs of infection (fever, pain, swelling) and temporarily prolong bleeding time.
Ibuprofen may reduce the chances of becoming pregnant. Inform your doctor if the patient plans to become pregnant or has difficulty conceiving.
Children and adolescents
Do not use in children under 12 years of age.
Ibuprofen Aurovitas may cause kidney function disorders in dehydrated children and adolescents.
Ibuprofen Aurovitas and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Ibuprofen Aurovitas may affect the action of certain 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 (blood thinners), such as warfarin or heparin, as anticoagulant effects may be enhanced
• antiplatelet agents (anti-clotting), such as ticlopidine and clopidogrel
• methotrexate (used in cancer and autoimmune disease treatment)
• digoxin (used in various heart conditions), as digoxin effects may be enhanced
• phenytoin (used to prevent epileptic seizures), as phenytoin effects may be enhanced
• lithium (used in depression and mania treatment), as lithium effects may be enhanced
• diuretics (water tablets), as diuretic effects may be reduced
• potassium-sparing diuretics, as this may lead to hyperkalaemia
• antihypertensive 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 against certain bacteria), as NSAIDs may reduce aminoglycoside excretion
• SSRIs (antidepressants), such as paroxetine, sertraline, citalopram, as they may increase the risk of gastrointestinal bleeding
• cyclosporine, tacrolimus (used in organ transplant immunosuppression), as kidney damage may occur
• zidovudine or ritonavir (used in HIV treatment)
• mifepristone, as NSAIDs may reduce mifepristone's effect
• probenecid or sulfinpyrazone (used in gout treatment), as ibuprofen excretion may be delayed
• quinolone antibiotics, as the risk of seizures may be increased
• sulfonylurea derivatives (used in type 2 diabetes treatment), as they may affect blood glucose levels
• glucocorticoids (used in inflammatory conditions), as they may increase the risk of gastrointestinal ulcers or bleeding
• bisphosphonates (used in osteoporosis, Paget’s disease and to reduce high blood calcium levels)
• pentoxifylline (used in circulatory disorders of leg or arm arteries)
• baclofen (a muscle relaxant) due to increased baclofen toxicity
• herbal medicine Ginkgo biloba (there is a risk of increased bleeding if taken with ibuprofen)
• voriconazole and fluconazole (CYP2C9 inhibitors) (used in fungal infections), as ibuprofen effects may be enhanced. Consider reducing the ibuprofen dose, especially when high-dose ibuprofen is used with voriconazole or fluconazole.

Some other medicines may also affect treatment with Ibuprofen Aurovitas or other medicines may
affect Ibuprofen Aurovitas. Therefore, always consult a doctor or pharmacist before using Ibuprofen Aurovitas with other medicines.
Ibuprofen Aurovitas and alcohol
Avoid alcohol while taking Ibuprofen Aurovitas, as it may worsen possible adverse effects, especially those affecting the stomach, intestines or central nervous system.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Do not take Ibuprofen 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 Aurovitas may cause kidney and heart problems in the unborn child.
It may increase bleeding tendency in both mother and child and may delay or prolong labour.
Ibuprofen Aurovitas should not be used during the first 6 months of pregnancy unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ibuprofen Aurovitas may cause kidney function disturbances in the unborn child if used 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 longer than a few days is required, the doctor may recommend additional monitoring.
Ibuprofen belongs to a group of medicines (NSAIDs) that may adversely affect female fertility.
This effect is reversible after discontinuation of the medicine.
Ibuprofen passes into breast milk in very small amounts and, usually, short-term use does not require discontinuation of breastfeeding. However, if prolonged treatment is anticipated, consider stopping breastfeeding earlier.
Driving and operating machinery
Ibuprofen generally does not have undesirable effects on the ability to drive or operate machinery. However, adverse effects associated with high doses of the medicine, such as fatigue, drowsiness, dizziness (commonly reported) and visual disturbances (reported less frequently), may in individual cases impair the ability to drive or operate machinery. This effect may be intensified if alcohol is consumed concurrently.
Ibuprofen Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Ibuprofen Aurovitas

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

If this medicine is needed by adolescents for longer than 3 days or if symptoms worsen, a doctor should be consulted.
Children
Ibuprofen Aurovitas should not be given to children under 12 years of age without medical advice.
Other medicines more suitable for children should be considered.
Elderly people
In elderly patients, dose adjustment is not usually necessary unless renal or hepatic impairment is present; in such cases, the dose must be individualized. Caution should be exercised when adjusting the dose in this patient group.
Renal function impairment
Dose reduction is not required in patients with mild to moderate renal function impairment.
Hepatic function impairment
Dose reduction is not required in patients with mild to moderate hepatic function impairment.
Method of administration
For oral use.
Tablets should be swallowed whole with plenty of water or other liquid. They should not be chewed, broken, crushed, or sucked to avoid discomfort or throat irritation.
Overdose of Ibuprofen Aurovitas
In case of ingestion of more ibuprofen than recommended or accidental ingestion by children, always contact a doctor or nearest hospital for assessment of risk and advice on necessary actions.
Symptoms may include nausea, abdominal pain, vomiting (which may be bloody), headache, tinnitus, confusion, and nystagmus. After large doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, dizziness, blood in urine, feeling cold, and breathing difficulties have been reported. In cases of overdose, gastric lavage should be preceded by supportive measures, which will be considered appropriate in each individual case. There is no specific antidote for ibuprofen.
Missed dose of Ibuprofen Aurovitas
Do not take a double dose to make up for a missed dose.
If one or more doses are missed, take the next dose as usual.
If you have any further doubts concerning the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects should be considered as being largely dose-dependent and varying between patients.
The most commonly observed adverse effects are gastrointestinal in nature. Gastric or intestinal ulcers, perforations or gastrointestinal bleeding may occur, sometimes leading to death, particularly in elderly people. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after administration. Less frequently, inflammation of the gastric mucosa (gastritis) has been observed.
The use of medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction (heart attack) or stroke. Fluid retention (oedema), high blood pressure and heart failure have been reported in association with the use of NSAIDs.
The list of adverse effects below includes all adverse effects known during treatment with ibuprofen, including those occurring in patients with rheumatism undergoing long-term therapy with high doses of the drug. The frequencies provided, which go beyond very rare reports, refer to short-term use of daily doses up to a maximum of 1200 mg of ibuprofen for oral dosage forms and up to a maximum of 1800 mg for suppositories.
Adverse effects are listed according to frequency of occurrence. The following terminology has been used to estimate the frequency of adverse effects:
Very common: occurs in more than 1 in 10 people
Common: occurs in no more than 1 in 10 people
Uncommon: occurs in no more than 1 in 100 people
Rare: occurs in no more than 1 in 1,000 people
Very rare: occurs in no more than 1 in 10,000 people
Frequency not known: frequency cannot be estimated from the available data

The following adverse effects are serious and require immediate action if they occur in a patient. You must stop taking Ibuprofen Aurovitas and consult a doctor immediately if any of the following symptoms occur:

Uncommon:

• black, tarry stools or vomiting blood (gastrointestinal ulcer with bleeding)

Very rare:

• swelling of the face, tongue or throat (larynx), which may cause severe breathing difficulties (angioedema), rapid heartbeat, significant drop in blood pressure or life-threatening shock
• sudden allergic reaction with breathlessness, wheezing and drop in blood pressure
• severe skin rash with blisters on the skin, especially on the legs, arms, hands and feet, which may also affect the face and mouth, ulceration in the mouth, throat, nose, genital organs and eyes. 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 rupture and detachment of the epidermis (Lyell's syndrome/toxic epidermal necrolysis). Severe skin infection with destruction (necrosis) of the skin, subcutaneous tissue and muscles (necrotizing fasciitis) may also occur.

You must stop taking the medicine and contact your doctor as soon as possible if any of the following adverse effects occur:

Common:

• heartburn, abdominal pain, dyspepsia

Uncommon:

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

Rare:

• loss of vision

Very rare:

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

Other possible adverse effects associated with the use of Ibuprofen Aurovitas include:

Common:

• gastrointestinal disorders such as diarrhoea, nausea, vomiting, flatulence, constipation

Uncommon:

• inflammation of the gastric mucosa (gastritis)
• catarrh
• gastrointestinal ulcer with or without perforation
• inflammation of the intestine and exacerbation of inflammatory bowel disease (colitis) and gastrointestinal tract (Crohn's disease) and complications related to colonic diverticula (perforation or fistula)
• microscopic gastrointestinal bleeding, which may lead to anaemia
• oral ulceration and inflammatory conditions (ulcerative stomatitis)
• breathing difficulties (bronchospasm)
• headache, drowsiness, dizziness, fatigue, restlessness, insomnia and irritability

Rare:

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

Very rare:

• unpleasant sensation of heart palpitations, heart failure or heart attack
• blood cell formation disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia). Initial symptoms may include fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding.
• ringing and noise in the ears
• oesophagitis or pancreatitis
• intestinal stricture
• acute hepatitis, yellowing of the skin or whites of the eyes, liver function abnormalities
• liver damage, especially with long-term use, or liver failure
• kidney problems, including oedema, nephritis and kidney failure
• hair loss
• meningitis without bacterial infection (aseptic meningitis)

Frequency not known:

• tingling in hands and feet
• anxiety
• hearing loss
• general malaise
• optic neuritis, which may cause vision problems
• a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include skin rash, fever, swollen lymph nodes and increased eosinophil count (a type of white blood cell). If such symptoms occur, treatment with Ibuprofen Aurovitas must be stopped immediately and medical help sought without delay.
• red, scaly, widespread rash with subcutaneous nodules and blisters located mainly in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If these symptoms occur, treatment with Ibuprofen Aurovitas must be discontinued and immediate medical assistance sought. See also section 2.
• skin becomes sensitive to light
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome

Ibuprofen Aurovitas may cause a decrease in white blood cell count, and resistance to infection may be reduced. If a patient develops an infection with symptoms such as fever accompanied by a significant deterioration in general condition, or fever with local signs of infection such as sore throat/oral cavity/mouth or problems with urination, immediate contact with a doctor is required. A blood test will be performed to check for possible reduction in white blood cell count (agranulocytosis). It is important to inform the doctor about the medicine being used.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects 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
By reporting adverse effects, additional information on the safety of the medicine can be collected.
Adverse effects can also be reported to the marketing authorisation holder.

5. How to store Ibuprofen 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 specified month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ibuprofen Aurovitas contains

• The active substance is ibuprofen. Each coated tablet contains 200 mg of ibuprofen.
• Other ingredients are:
  Tablet core: maize starch, pregelatinized maize starch, colloidal anhydrous silica, sodium croscarmellose, talc, stearic acid.
  Tablet 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 division line on one side and smooth on the other side. The tablet may be divided into equal doses.
Ibuprofen Aurovitas coated tablets are available in blister packs contained in a cardboard box.
Pack sizes:
Blister packs: 10 and 50 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Ibuprofen Aurovitas
Portugal: Ibuprofeno Limeg