Ibuprofen aurovitas

Package leaflet: Information for the user

Ibuprofen Aurovitas, 600 mg, coated tablets
Ibuprofenum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

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 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 symptomatic treatment of pain and inflammation in joint diseases (e.g. rheumatoid arthritis),
osteoarticular degenerative conditions (e.g. osteoarthritis), and painful swelling and inflammatory conditions following soft tissue injuries.
Ibuprofen Aurovitas is used as an analgesic in painful menstruation, episiotomy pain, postpartum pain, toothache, pain after tooth extraction, postoperative pain, injuries (sprains, contusions, 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 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 skin rash, or swelling of the lips, face, tongue or throat after taking medicines containing acetylsalicylic acid (such as aspirin) or other painkillers and anti-inflammatory drugs (NSAIDs).
• if the patient has experienced gastrointestinal bleeding or perforations related to previous use of painkillers and anti-inflammatory drugs (NSAIDs).
• if the patient currently has a stomach or small intestine (duodenum) ulcer or bleeding, or if the patient has had two or more such episodes in the past.
• if the patient has severe problems with the liver, kidneys or heart.
• if the patient is in the last three months of pregnancy.
• if the patient has severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
• if the patient has active bleeding (including in the brain).
• if the patient has a condition of unknown origin causing abnormal blood cell formation.

Ibuprofen Aurovitas 600 mg, coated tablets should not be given to children and adolescents under 15 years of age.
Warnings and precautions
Before using Ibuprofen Aurovitas, consult a doctor or pharmacist:

• if the patient has systemic lupus erythematosus (SLE) or mixed connective tissue disease
• if the patient has inherited disorders of the red blood pigment 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 disorders of blood cell formation
• if the patient has problems with normal blood clotting mechanisms
• 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 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
• Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported during treatment. If any of these symptoms occur, discontinue Ibuprofen Aurovitas 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 generalized exanthematous pustulosis (AGEP) have been reported with ibuprofen use. If the patient develops any symptoms associated with these severe skin reactions described in section 4, Ibuprofen Aurovitas must be stopped immediately and medical help should be sought.

Infections
Ibuprofen Aurovitas may mask symptoms of infection such as fever and pain. Therefore, the use of Ibuprofen Aurovitas may delay appropriate treatment of infection, 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 perforations, which may lead to death.
Ulcers, perforations and gastrointestinal bleeding
If the patient has previously been diagnosed with stomach or intestinal ulcers, particularly if complicated by perforation or bleeding, unusual abdominal symptoms should be noted and the doctor informed immediately, especially if these 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 had such problems before. These may also lead to death.
The risk of ulcers, perforations or gastrointestinal bleeding usually increases with higher doses of ibuprofen. The risk also increases if certain other medicines are taken simultaneously with ibuprofen (see section “Ibuprofen Aurovitas with other medicines” below).
Adverse effects can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Skin reactions
Severe skin reactions have been reported with Ibuprofen Aurovitas treatment. If a skin rash, mucosal lesions, blisters or other allergic symptoms occur, Ibuprofen Aurovitas should be discontinued immediately and a doctor consulted without delay, as these may be early signs of a very serious skin reaction (see section 4).
Use of this medicine should be avoided during chickenpox.
Effects on the 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 in high doses. Do not exceed the recommended dose or duration of treatment.
Discuss with a doctor or pharmacist before using Ibuprofen Aurovitas 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 levels, or a family history of heart disease or stroke, or if the patient is a smoker.

Effects on the kidneys
Ibuprofen may cause problems with normal kidney function 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. Stopping ibuprofen usually leads to symptom resolution.
Aseptic meningitis (inflammation of the meninges without bacterial infection)
Isolated cases of meningitis (characterised by neck stiffness, headache, nausea, vomiting, fever or confusion) have been observed during ibuprofen treatment. Although it probably occurs more frequently in patients with existing autoimmune diseases such as systemic lupus erythematosus or mixed connective tissue disorders, 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 the first signs 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 coagulation disorders should be carefully monitored.
Prolonged use of painkillers in high doses may lead to headache, which should not be treated with higher doses of this medicine.
Chronic use of painkillers may cause permanent kidney damage and risk of kidney failure.
Ibuprofen may mask symptoms or signs of infection (fever, pain and swelling) and temporarily prolong bleeding time.
Ibuprofen Aurovitas may reduce the chances of becoming pregnant. Inform the doctor if the patient is planning pregnancy or has difficulty conceiving.
Adolescents
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
Inform the doctor or pharmacist about all medicines currently or recently taken, and any medicines planned for use.
Adverse effects of ibuprofen may be intensified when taken together with certain medicines. Conversely, ibuprofen may enhance or weaken the effects of other medicines or increase their adverse effects when taken simultaneously.
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 (anti-clotting medicines), such as warfarin or heparin, as the anticoagulant effect may be enhanced
• platelet aggregation inhibitors (anti-clotting agents), such as clopidogrel and ticlopidine
• methotrexate (used in the treatment of cancers and autoimmune diseases)
• digoxin (used in the treatment of various heart conditions), as digoxin’s effect may be enhanced
• phenytoin (used to prevent epileptic seizures), as phenytoin’s effect may be enhanced
• lithium (used in the treatment of depression and mania), as lithium’s effect may be enhanced
• diuretics (water-removing medicines), as diuretic effects may be weakened
• potassium-sparing diuretics, as this may lead to hyperkalaemia
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists, e.g. losartan)
• cholestyramine (used in the treatment of high cholesterol levels)
• aminoglycosides (medicines against certain types of bacteria), as NSAIDs may reduce aminoglycoside excretion
• SSRIs (medicines used in depression treatment), 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 in the treatment of HIV patients)
• mifepristone, as NSAIDs may reduce mifepristone’s effect
• probenecid or sulfinpyrazone (used in the treatment of gout), as ibuprofen excretion may be delayed
• quinolone antibiotics, as the risk of seizures may be increased
• sulfonylurea derivatives (used in the treatment of type 2 diabetes), as they may affect blood sugar levels
• glucocorticoids (used in inflammatory conditions), as they may increase the risk of gastrointestinal ulcers or bleeding
• bisphosphonates (used in the treatment of osteoporosis, Paget’s disease, and to lower high blood calcium levels)
• pentoxifylline (used in the treatment of 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 easier bleeding if taken with ibuprofen)
• voriconazole and fluconazole (CYP2C9 inhibitors) (used in fungal infections), as ibuprofen’s effect may be enhanced. Dose reduction of ibuprofen should be considered, especially when high doses of ibuprofen are used with voriconazole or fluconazole.

Other medicines may also affect treatment with Ibuprofen Aurovitas or may be affected by it. Therefore, always consult a doctor or pharmacist before using Ibuprofen Aurovitas with other medicines.
Ibuprofen Aurovitas and alcohol
During treatment with Ibuprofen Aurovitas, alcohol consumption should be avoided, 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 three 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 the tendency to bleeding in both mother and child and may delay or prolong labour. Ibuprofen Aurovitas should not be used during the first six months of pregnancy unless a doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From week 20 of pregnancy, Ibuprofen Aurovitas may cause kidney function disturbances in the unborn child if used for longer 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.
Ibuprofen passes into breast milk in very small amounts and usually, during short-term use, breastfeeding does not need to be discontinued. However, if longer-term treatment is planned, earlier discontinuation of breastfeeding should be considered.
Driving and operating machinery
Ibuprofen generally does not have undesirable effects on the ability to drive or operate machinery. However, adverse effects such as fatigue, drowsiness, dizziness (frequently reported) and visual disturbances (reported less frequently), which may occur with high doses, could in individual cases impair the ability to drive or operate machinery. This effect may be intensified if alcohol is consumed simultaneously.
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 use Ibuprofen Aurovitas

The medicine should always be taken as directed by a doctor. In case of doubt, consult your doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. In case of infection, contact a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and children over 12 years of age (≥ 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 to 1200 mg per day (1 to 2 tablets per day). In severe and acute cases, increasing the dose may be beneficial until the acute phase has resolved. Generally, the maximum daily dose of ibuprofen should not exceed 2400 mg.

In children, the recommended dose of ibuprofen is 20 mg/kg body weight per day given 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 required.

Other strengths of ibuprofen are available which may be more suitable for use in indications required for this age group in terms of body weight.
Ibuprofen Aurovitas 600 mg is not recommended for children under 12 years of age.

In rheumatic diseases, long-term use of Ibuprofen Aurovitas may be required.

The tablet should be swallowed whole with a glass of water, preferably after a meal. Patients with a sensitive stomach are advised to take ibuprofen with food. To facilitate swallowing or for dose adjustment, the tablet may be divided into equal doses.

Elderly patients
Elderly patients are more susceptible to adverse effects, especially gastrointestinal bleeding, ulceration, and perforation, which may be fatal. The treating physician should advise the patient on appropriate management.

Renal and hepatic impairment
Dose reduction is not necessary in patients with mild to moderate renal and/or hepatic impairment.

Taking more Ibuprofen Aurovitas than recommended
If more ibuprofen than recommended is taken, or if the medicine is accidentally ingested by children, always contact a doctor or the nearest hospital for advice on the risk and actions to be taken.
Symptoms may include nausea, abdominal pain, vomiting (which may be bloody), diarrhoea, headache, gastrointestinal bleeding, tinnitus, confusion, and nystagmus, as well as worsening of asthma in asthmatic patients. After large doses, drowsiness, restlessness, disorientation, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, hypotension, prolonged prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, feeling of cold, and breathing difficulties have been reported.

In case of overdose, after gastric lavage, supportive measures should be applied. There is no specific antidote for ibuprofen.

If you forget to take a dose of Ibuprofen Aurovitas
If one or more doses are missed, continue taking the next dose as usual. Do not take a double dose to make up for a missed dose.

If you have further questions about the use of this medicine, consult your doctor or pharmacist.

Method and route of administration
Oral administration.
Tablets should be taken whole, swallowed with a large amount of water or other liquid, and must not be chewed, broken, crushed, or sucked, to avoid discomfort or irritation of the throat.

The average duration of treatment varies depending on the patient and their clinical condition.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following side effects should be considered as they are largely dose-dependent and may vary between patients.
The most commonly observed adverse effects are gastrointestinal in nature. Gastric or intestinal ulcers, perforations or gastrointestinal bleeding, sometimes leading to death, may occur, particularly in elderly patients. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, black tarry stools, vomiting blood, 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 heart attack (myocardial infarction) or stroke. Fluid retention (oedema), high blood pressure and heart failure have been reported in association with the use of NSAIDs.

Adverse effects are listed below according to their frequency of occurrence. The following terminology has been used to classify frequencies:
Very common: occurs in more than 1 in 10 people
Common: occurs in up to 1 in 10 people
Uncommon: occurs in up to 1 in 100 people
Rare: occurs in up to 1 in 1,000 people
Very rare: occurs in up to 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. You should stop taking Ibuprofen Aurovitas and consult your doctor immediately if you experience any of the following symptoms:
Common:

• 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, mouth ulcers, 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). The condition may present in a more severe form with larger blisters that may rupture and lead to detachment of the epidermis (Lyell's syndrome/toxic epidermal necrolysis). Severe skin infections with tissue destruction (necrosis) of the skin, subcutaneous tissue and muscles (necrotising fasciitis) may also occur.

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

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

Common:

• gastrointestinal ulcer with or without perforation
• intestinal inflammation and exacerbation of colitis (colitis) and gastrointestinal tract disease (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)
• headache, drowsiness, dizziness, fatigue, restlessness, insomnia and irritability

Uncommon:

• inflammation of the gastric mucosa
• kidney problems, including development of oedema, nephritis and renal failure
• catarrh
• breathing difficulties (bronchospasm)

Rare:

• depression, disorientation, hallucinations
• systemic lupus erythematosus
• increased blood urea nitrogen, serum transaminases and alkaline phosphatase levels
• decreased haemoglobin and haematocrit values in blood, 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 heartbeat, heart failure or heart attack
• blood cell formation disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia). Initial symptoms may include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding
• ringing and noise in the ears
• inflammation of the oesophagus or pancreas
• intestinal stricture
• acute hepatitis, yellowing of the skin or whites of the eyes, liver function disturbances
• liver damage, especially with long-term use, or liver 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, Ibuprofen Aurovitas should be discontinued immediately and medical advice sought without delay.
• red, scaly, widespread rash with subcutaneous nodules and blisters mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If these symptoms occur, Ibuprofen Aurovitas should be discontinued and immediate medical help sought. 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 white blood cell count, and resistance to infections may be reduced. If a patient develops an infection with symptoms such as fever with significant deterioration in general condition or fever with local signs of infection such as sore throat/mouth/oral cavity 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 taken.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
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 after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system 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 packaging and other information

What Ibuprofen Aurovitas contains

• The active substance is ibuprofen. Each coated tablet contains 600 mg of ibuprofen.
• Other ingredients are: Tablet core: corn starch, pregelatinized corn 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, 600 mg, coated tablets: [size: 18.3 mm x 9.2 mm]
White or almost white, oval coated tablets with a division line on one side and smooth on the other side. The tablet can be divided into equal doses.
Ibuprofen Aurovitas coated tablets are available in blister packs contained in a cardboard box.
Pack size: 10 coated tablets.
Marketing Authorisation Holder and Manufacturer
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
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 under the following names:
Poland: Ibuprofen Aurovitas
Portugal: Ibuprofeno Limeg