Pharmamentis Ibuprofen 200mg 24 Film-Coated Tablets

Therapeutic indications

Short-term symptomatic treatment of: - mild to moderate pain

Dosage

Posology The lowest effective dose should be used for the minimum time necessary to relieve symptoms. The dose of ibuprofen is based on the patient's body weight and age. The intervals between administrations depend on the symptoms and the maximum total daily dose. A minimum interval of at least 6 hours must be applied. The recommended dose should not be exceeded. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4). IBUPROFENE PHARMENTIS 200 mg film-coated tablets

Age	Single dose	Maximum daily dose
12–15 years	1 tablet (equivalent to 200 mg of ibuprofen)	3 tablets (equivalent to 600 mg of ibuprofen)
over 15 years	1–2 tablets (equivalent to 200–400 mg ibuprofen)	6 tablets (equivalent to 1200 mg ibuprofen)

For short-term use If the use of the medicinal product is necessary for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted. If use of the medicinal product is required for more than 4 days in adults, or if symptoms worsen, a doctor should be consulted. Special patient groups Elderly : No specific dose adjustment is required. Due to the possible undesirable effect profile (see section 4.4), elderly patients should be monitored with particular care. Renal impairment : No dose reduction is expected in patients with mild to moderate renal impairment (for patients with severe renal impairment, see section 4.3). Hepatic impairment (see section 5.2) : No dose reduction is expected in patients with mild to moderate hepatic impairment (for patients with severe hepatic dysfunction, see section 4.3). Children and adolescents : For use in children and adolescents, see also section 4.3. Method of administration For oral use. The film-coated tablets should be swallowed whole with water. In patients with gastric sensitivity it is recommended to take ibuprofen with meals.

Overdose

Symptoms Central nervous system disorders such as headache, dizziness, lightheadedness and unconsciousness (including myoclonic seizures in children) as well as abdominal pain, nausea and vomiting may occur following overdose. Gastrointestinal bleeding and impaired liver and kidney function are also possible. Hypotension, respiratory depression, cyanosis, and metabolic acidosis may also appear. Treatment There is no specific antidote. Treatment must be symptomatic.

Contraindications

IBUPROFENE PHARMENTIS 200 mg film-coated tablets are contraindicated in the following cases: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - known reactions of bronchospasm, asthma, rhinitis, angioedema or urticaria following previous intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) - unspecified disorders of blood formation - peptic ulcer / active bleeding or history of peptic ulcer / recurrent haemorrhage (two or more distinct episodes of proven ulceration or bleeding) - history of gastrointestinal haemorrhage or perforation related to previous NSAID treatment - cerebrovascular or other types of active haemorrhage - severely impaired liver or kidney function - severe heart failure (IV NYHA class; see also section 4.4) - severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake) - last trimester of pregnancy (see section 4.6). IBUPROFENE PHARMENTIS 200 mg film-coated tablets The drug is contraindicated in children under 12 years of age, as this dosage is not suitable due to the high amount of active ingredient.

Side effects

The list of undesirable effects below includes all known undesirable effects associated with ibuprofen treatment, including those reported by patients with rheumatism on prolonged treatment at high doses. Frequency data, except very rare reports, are based on short-term drug administration with maximum daily doses of 1200 mg ibuprofen for oral formulations, and maximum doses of 1800 mg for suppositories. The following frequencies have been used in the evaluation of undesirable effects: Very common (≥1 / 10) Common (≥1 / 100 to <1/10) Uncommon (≥1 / 1000 to <1/100) Rare (≥1 / 10000, <1/1000) Very rare (<1/10000) Not known (cannot be estimated from the available data) It should be considered that the following adverse reactions are predominantly dose-dependent and patient-patient variable. The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, especially in the elderly (see section 4.4). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of ibuprofen (see section 4.4). Gastritis was observed less frequently. In particular, the risk of gastrointestinal bleeding is dose-dependent and duration of treatment. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg / day) may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Infections and infestations Exacerbation of infection-associated inflammation (eg development of necrotizing fasciitis) has been reported very rarely in conjunction with the use of non-steroidal anti-inflammatory drugs. This is likely related to the mechanism of action of non-steroidal anti-inflammatory drugs. Therefore, if signs of an infection or worsening of an infection appear during treatment with IBUPROFENE PHARMENTIS 200 mg film-coated tablets , the patient is advised to seek medical attention without delay. It will therefore be necessary to assess whether there is a need for anti-infective / antibiotic therapy. Symptoms of aseptic meningitis, with neck stiffness, headache, nausea, vomiting, fever or clouding of consciousness have been observed very rarely during treatment with ibuprofen. Patients with autoimmune disorders (SLE, mixed connective tissue disease) appear to be predisposed. Blood and lymphatic system disorders Very rare: - haematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs may be the following: fever, sore throat, superficial oral lesions, flu-like symptoms, severe physical exhaustion, nosebleeds and skin. In these cases, the patient should be advised to stop taking the medicinal product immediately, to avoid self-medication with analgesics or antipyretics and to seek medical attention. Immune system disorders Uncommon: - hypersensitivity reactions, with rash and itching, or asthma attacks (possibly with drop in blood pressure). The patient should be advised to inform a doctor immediately and not to take IBUPROFENE PHARMENTIS 200 mg film-coated tablets in this case. Very rare: - severe general hypersensitivity reactions. This can present as face edema, swelling of the tongue, swelling of the internal larynx with consequent constriction of the airways, respiratory distress, rapid heartbeat, drop in blood pressure up to life-threatening shock. If any of these symptoms occur, which may also occur on the first use of the drug, immediate medical attention is required. Psychiatric disorders Very rare: - psychotic reactions, depression. Nervous system disorders Uncommon: - central nervous system disorders such as headache, dizziness, insomnia, excitement, irritability or fatigue. Eye disorders Uncommon: - visual disturbances. In this case, the patient should be advised to inform the doctor immediately and to stop taking ibuprofen. Ear and labyrinth disorders Rare: - tinnitus. Cardiac disorders Very rare: - palpitations, heart failure, myocardial infarction. Vascular disorders Very rare: - arterial hypertension, vasculitis. Gastrointestinal disorders Common: - gastrointestinal disorders such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation and slight gastrointestinal blood loss which can cause anemia in exceptional cases. Uncommon: - gastrointestinal ulcers, potentially with haemorrhage and perforation. Ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4), gastritis. Very rare: - esophagitis, pancreatitis, formation of diaphragmatic intestinal strictures. The patient should be advised to stop taking the medicinal product and to see a doctor immediately if relatively severe upper abdominal pain or melaena or haematemesis occurs. Hepatobiliary disorders Very rare: - hepatic dysfunction, liver damage, particularly in long-term therapy, hepatic failure, acute hepatitis. Skin and subcutaneous tissue disorders Uncommon: - various skin rashes Very rare: - bullous reactions including Stevens Johnson syndrome and Toxic Epidermal Necrolysis (Lyell's syndrome). - alopecia. - in isolated cases, severe skin infections with soft tissue complications may arise during a chickenpox infection (see also "Infections and infestations"). Renal and urinary disorders Rare: - renal tissue damage (papillary necrosis) - increased serum uric acid concentration Very rare: - edema formation, particularly in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis which may be accompanied by acute renal failure. - reduced urinary excretion and edema may be indicative of kidney disease, which can sometimes also include kidney failure. If such symptoms appear or worsen, the patient should be advised to stop taking ibuprofen and consult a physician immediately. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

Pregnancy Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development. Data from epidemiological studies show an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors induced an increase in pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the period of organogenesis. During the first and second trimester of pregnancy, ibuprofen should not be administered unless strictly necessary. If ibuprofen is used by a woman attempting to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose • the fetus to: - cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligohydramnios; • the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time and antiplatelet effect which can occur even at very low doses; - inhibition of uterine contractions with consequent delay or prolongation of labor. Consequently, the use of ibuprofen is contraindicated during the third trimester of pregnancy. Breastfeeding Only small amounts of ibuprofen and its metabolic products are excreted in breast milk. As there are no known undesirable effects in the infant, it is generally not necessary to discontinue breastfeeding during short-term use and at recommended doses for the treatment of mild to moderate pain. However, when prescribing the drug for prolonged treatment or in high doses, early weaning should be considered. Fertility There is evidence showing that drugs that inhibit cyclooxygenase / prostaglandin synthesis can cause impairment of female fertility as a result of an effect on ovulation. However, this event is reversible upon discontinuation of treatment.

Special warnings

Undesirable effects can be minimized by using the lowest effective dose for the minimum time necessary to achieve symptom control (see section 4.2 below on gastrointestinal and cardiovascular risks). Gastrointestinal safety Concomitant use of ibuprofen and other NSAIDs, including selective cyclooxygenase-2 inhibitors should be avoided. Elderly: Elderly patients are prone to an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal haemorrhage and perforation, which can be fatal (see section 4.2). Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported during treatment with all NSAIDs, at any time during therapy, with or without warning symptoms or a previous history of serious gastrointestinal events. . In patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly, the risk of gastrointestinal bleeding, ulceration or perforation is greater with increasing NSAID doses. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for both these patients and for patients taking concomitantly low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events ( see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any symptoms of an unusual gastrointestinal nature (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution is needed when treating patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking ibuprofen, the treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as these conditions may be exacerbated (see section 4.8). Cardiovascular and cerebrovascular effects Particular caution (discuss with doctor or pharmacist) is required before starting treatment in patients with a history of hypertension and / or heart failure, as fluid retention, hypertension and edema have been reported in association with NSAID therapy. . Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg / day) may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg / day) are associated with an increased risk of arterial thrombotic events. Patients suffering from uncontrolled hypertension, congestive heart failure (NYHA class II – III), established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses should be avoided ( 2400 mg / day). Careful consideration is also required before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking), especially if high doses of ibuprofen (2400 mg) are required. / day). Skin reactions Serious skin reactions, some of them fatal, such as exfoliative dermatitis, Stevens – Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). In the early stages of therapy, patients appear to be at a higher risk of these reactions: in fact, the onset of the reaction occurs in most cases within the first month of treatment. The use of ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Exceptionally, chickenpox can be the cause of severe skin and soft tissue infectious complications. So far, it has not been possible to exclude that NSAIDs contribute to the worsening of these infections. It is therefore recommended not to use IBUPROFENE PHARMENTIS 200 mg film-coated tablets in case of chickenpox. Particular caution is required in patients presenting with : - systemic lupus erythematosus (SLE) and mixed connective tissue disease (see section 4.8) - congenital disorders of porphyrin metabolism (e.g. acute intermittent porphyria) - gastrointestinal disorders or chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) - hypertension and / or heart failure - impaired renal function (as acute deterioration of renal function may occur in patients with pre-existing kidney disease) - dehydration - impaired liver function - hay fever, nasal polyps or chronic obstructive respiratory diseases as there is an increased risk of allergic reactions for them. These can manifest as asthma attacks (so-called analgesic asthma), Quincke's edema or urticaria - allergies to other substances, as there is an increased risk of hypersensitivity reactions even with the use of IBUPROFENE PHARMENTIS 200 mg film-coated tablets - directly after major surgery Additional information : Ibuprofen, the active substance in IBUPROFENE PHARMENTIS 200 mg film-coated tablets may temporarily inhibit the function of platelets (platelet aggregation). Patients with coagulation disorders should therefore be carefully monitored. If the physician considers prolonged therapy with ibuprofen necessary, regular checks of liver values, renal function and blood cell counts should be performed. Adequate water supply should be ensured during treatment to prevent dehydration and the possible increase in renal toxicity associated with the use of ibuprofen. Prolonged use of any pain reliever for headache can make it worse. If this occurs or is suspected, medical advice should be sought and treatment discontinued. The diagnosis of drug overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or due to) regular use of headache medications. In general, the habitual intake of analgesics, in particular a combination of several analgesic substances, can cause permanent renal damage with the risk of renal failure (analgesic nephropathy). Following concomitant alcohol consumption, undesirable effects related to the active substance, especially those affecting the gastrointestinal tract or the central nervous system, may increase during the use of NSAIDs. In rare cases, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Therapy should be discontinued at the first signs of a hypersensitivity reaction after taking / administering ibuprofen. Medical procedures appropriate to the symptoms must be performed by specialized personnel. NSAIDs can mask the symptoms of infections and fever. Pediatric population There is a risk of renal impairment in dehydrated adolescents.

Expiry and Retention

This medicinal product does not require any special storage conditions.

Active principles

IBUPROFENE PHARMENTIS 200 mg film-coated tablets Each film-coated tablet contains 200 mg ibuprofen For a full list of excipients, see section 6.1.

Excipients

Tablet core modified corn starch, croscarmellose sodium, hypromellose, stearic acid, anhydrous colloidal silica. Hypromellose coating , macrogol 8000, titanium dioxide.