IBUPROFENE SAN 24CPR RIV 200MG

IBUPROFECT SANDOZ 200 MG FILM

active ingredients

Each tablet coated with film contains 200 mg of ibuprofene For the full list of excipients, see paragraph 6.1.

Excellent

Anidra colloidal silica; talc; sodium carbossimetilamido; polyvinylpyrrolidone; microcrystalline cellulose; starch of corn; polyethyleneglycol 400; titanium dioxide; hydroxypropylmethylcellulose.

Therapeutic indications

Pain from various origins and nature (menstrual pains, headaches, toothaches, nerves, osteoarticocular and muscle pains).

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. • Subjects with hypersensitivity to acetylsalicylic acid or other analgesic, antipyretic, non-steroidal anti-inflammatory (NSAID), especially when hypersensitivity is associated with angioedema and/or asthma nasal polypoxes. • Severe liver failure. • Severe renal insufficiency (glomeral filtration less than 30 ml/min). • severe heart failure (IV class NYHA). • Severe or active peptic ulcer. • History of gastrointestinal hemorrhage or perforation related to previous active treatments or history of hemorrhage/recurring peptic ulcer (two or more separate episodes of proven ulceration or bleeding). • Ibuprofen should not be administered to patients with clinical conditions that may lead to an increase in the tendency to bleeding. • Ibuprofen is contraindicated during the third trimester of pregnancy (see paragraph 4.6). • Children under 12 years old.

Population

Population Adults and boys over 12 years: 1-2 tablets 2-3 times a day. Do not exceed the dose of 6 tablets per day. Do not exceed the recommended doses; in particular, elderly patients should comply with the above minimum dosages. Method of administration Take the medicine on a full stomach. After 3 days of treatment without appreciable results, consult your doctor. In case the use of the medicine is necessary for more than 3 days in adolescents, or in case of worsening of the symptomatology the doctor must be consulted. Undesirable effects can be minimized with the use of the minimum effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.4).

Conservation

This medicine does not require any special condition of conservation.

Warnings

The use of Ibuprofene Sandoz in conjunction with other NSAIDs, including selective cycloxygenase-2 inhibitors (COX-2), must be avoided due to an increase in the risk of ulceration or bleeding (see paragraph 4.5). Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see below paragraphs on gastrointestinal and cardiovascular risks). Like other NSAIDs, ibuprofen can mask signs of infection. Senior Patients Senior patients have an increase in the frequency of adverse reactions to NSAIDs, especially hemorrhages and gastrointestinal perforations, which can be fatal (see paragraph 4.2). Gastrointestinal bleeding, ulceration and drilling During treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration and perforation, which may be fatal. In the elderly and patients with ulcer history, especially if complicated by hemorrhage or perforation (see paragraph 4.3), the risk of gastrointestinal hemorrhage, ulceration or perforation is higher with high doses of NSAID. These patients must begin treatment with the lowest dose available. For these patients and also for patients taking low doses of acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal events, the concomitant use of protective agents (misoprostol or protonic pump inhibitors, see below and paragraph 4.5). Patients with history of gastrointestinal toxicity, particularly elderly, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Caute should be lent in patients taking medications at the same time that may increase the risk of ulceration or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRI) or anti-aggregating agents such as acetyl acid (see paragraph 4.5). When bleeding or gastrointestinal ulceration occurs in patients taking Ibuprofene Sandoz treatment must be suspended. NSAIDs should be given with caution to patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions may aggravate (see paragraph 4.8). Use carefully also in patients with clotting defects. Cardiovascular and cerebrovascular effects Adequate monitoring and appropriate instructions are necessary in patients with positive anamnesiums for hypertension and/or mild to moderate congestive heart failure, since in association with the treatment with NSAIDs, fluid and edema retention was found. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/die), may be associated with a modest increase in the 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/die) are associated with increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (II-III class NYHA), proven ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and should avoid high doses (2400 mg/die). Careful consideration should be exercised even before starting long-term treatment patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg/die) are required of ibuprofen. Dermatory effects Severe skin reactions some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and epidermal toxic necrolysis, have been observed very rarely in association with the use of NSAIDs (see paragraph 4.8). In the early stages of therapy patients seem to be at higher risk: the onset of reaction occurs in most cases within the first month of treatment. Treatment with Ibuprofene Sandoz must be stopped at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity, as well as if visual disturbances or persistent signs of liver dysfunction occur. Renal effects When treatment with ibuprofen begins, care should be given to patients with considerable dehydration. Long-term use of ibuprofen, as with other NSAIDs, has led to kidney papillar necrosis and other kidney pathological alterations. In general, the habitual use of analgesics, especially of the associations of different active analgesics, can lead to permanent kidney injuries with risk of kidney failure (nephropathy from analgesics). Renal toxicity has been found in patients where kidney prostaglandins have a compensatory role in maintaining renal perfusion. The administration of NSAIDs in these patients may result in a dose-dependent reduction in prostaglandin formation and, as a secondary effect, kidney blood flow. This can lead quickly to kidney failure. Patients most at risk of these reactions are those with reduced kidney function, heart failure, liver dysfunction, elderly and all those patients taking diuretics and ACE inhibitors. The suspension of treatment with NSAIDs is usually followed by the recovery of pretreatment. In case of prolonged use, watch the kidney function particularly in case of widespread erythematosum lupus. In dehydrated children and adolescents there is a risk of alteration of kidney function. Respiratory disorders Ibuprofene Sandoz must be prescribed with caution in patients with bronchial asthma or allergic diseases in place or pregresse because it may arise bronchospasm. The same for those who have manifested bronchospasm, after the use of aspirin or other NSAIDs. Reactions of hypersensitivity Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause hypersensitivity reactions, potentially serious (anaphylactoid reactions), even in subjects not previously exposed to this type of medicines. The risk of hypersensitivity reactions after hiring ibuprofen is greater in individuals who have presented such reactions after the use of other analgesic, antipyretic, non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), nasal polyposi or previous angioedema episodes (see paragraphs 4.3 and 4.8). Reduced heart, kidney and liver function Particular caution should be taken in the treatment of patients with severely reduced heart, liver or kidney function. In such patients, periodic monitoring of clinical and laboratory parameters should be used, especially in case of prolonged treatment. Ematologic effects Ibuprofen, like other NSAIDs, can inhibit piastrinic aggregation and has given evidence to prolong bleeding time in healthy subjects. Synthetic Meningitis On rare occasions in patients with ibuprofen has been observed aseptic meningitis. Although it is more likely to occur in patients with systemic erythematous lupus and related connective tissue pathologies, it was also observed in patients who did not manifest concomitant chronic pathologies (see paragraph 4.8). Since eye alterations have been observed during animal studies with non-steroidal anti-inflammatory drugs, it is recommended, in case of prolonged treatments, to carry out periodical ophthalmologic controls. The use of Ibuprofene Sandoz, as of any medicinal inhibitor of the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to begin a pregnancy. The administration of Ibuprofene Sandoz must be suspended in women who have fertility problems or who are subject to fertility surveys.

Interactions

Ibuprofen (like other NSAIDs) must be used with caution in association with: - corticosteroids : increased risk of gastrointestinal ulceration or hemorrhage (see paragraph 4.4). - anticoagulants : NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4).Patients treated with coumarins should be monitored;- other : these substances may increase the risk of adverse reactions to the gastrointestinal tract (see paragraph 4.4). - acetylsalicylic acid : the concomitant administration of ibuprofen and acetylylylethyl acid is not generally recommended due to the potential increase in unwanted effects. Experimental data suggests that ibuprofen can competitively inhibit the effect of acetylsalicylic acid at low doses on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, it cannot be ruled out the possibility that regular long-term use of ibuprofen can reduce the cardioprotective effect of acetylsalicylic acid at low doses. No significant clinical effect is considered likely due to occasional use of ibuprofen (see paragraph 5.1) - anti-aggregating agents and selective serotonin reuptake inhibitors (SSRIs) : increased risk of gastrointestinal hemorrhage (see paragraph 4.4). - diuretics, ACE inhibitors and antagonists of angiotensin II : NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. Diuretics can also increase the risk of nephrotoxicity associated with NSAIDs. In some patients with impaired kidney function (e.g. dehydrated or elderly patients) co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxidase system may lead to further deterioration of the kidney function, which includes a possible acute kidney failure, generally reversible. These interactions must be considered in patients taking Ibuprofene Sandoz in conjunction with ACE inhibitors or antagonists of angiotensin II. Therefore, this combination should be administered with caution, especially in elderly patients. Patients should be properly hydrated and monitoring of renal function must be taken into consideration after the start of concomitant therapy and, periodically, from then on; - lithium lithium lithium : the simultaneous administration of lithium and NSAID causes increased lithium levels in the blood for reduced elimination, with the possibility of reaching the toxic threshold. If this association is necessary, the lithemia must be monitored in order to adapt lithium posology during the contemporary treatment with ibuprofen; - metotrexa : NSAIDs can inhibit metotrexate tubular secretion and reduce its clearance by increasing the risk of toxicity; - aminoglycosides : NSAIDs may decrease the excretion of aminoglycosides; - heart glycosides : NSAIDs can aggravate heart failure, reduce glomerular filtration rate and increase plasma levels of cardiac glycosides; - colestamine : concurrent administration of ibuprofen and choleramine may reduceabsorption ibuprofen at the gastrointestinal tract level. However the clinical relevance of such interaction is not known; - cyclosporins : increase the risk of nephrotoxicity with NSAIDs; - cox-2 inhibitors and other NSAIDs : Concurrent use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, must be avoided due to the potential additive effect (see paragraph 4.4). - vegetable extracts : Ginkgo Biloba can increase the risk of bleeding in association with FANS; - mifepristone : Due to the antiprostaglandiniche properties of the NSAIDs, a decrease in the effectiveness of the medicinal product can be theoretically determined. The limited evidence suggests that the administration of NSAIDs on the day of administration of prostaglandins does not negatively affect the effects of mifepristone or prostaglandin on cervical maturation or uterine contractility and does not reduce the clinical effectiveness of the drug on the interruption of pregnancy; - chinolonic antibiotics : animal data indicate that NSAIDs can increase the risk of convulsions associated with chinolonic antibiotics. Patients taking NSAIDs and Knolones may have an increased risk of developing seizures; - solfaniluree : the NSAIDs can increase the effect of sulfaniluree. Rare cases of hypoglycemia were reported in patients treated with sulphanluree taking ibuprofen; - tacrolimus : possible increase in the risk of nephrotoxicity when NSAIDs are administered with tacrolimus; - zidovudine : increased risk of blood toxicity in case of co-administration with NSAIDs. There is evidence of an increase in the risk of hematoma and hematoma in hemophiliac patients with HIV in contemporary treatment with zidovudine and other NSAIDs; - ritonavir : an increase in the concentration of NSAIDs is possible; - provenecid : slows down the excretion of NSAIDs, with possible increase in their plasma concentrations; - cYP2C9 inhibitors : Concurrent administration of ibuprofen and inhibitors of CYP2C9 may increase exposure to ibuprofen (substrate of CYP2C9). In a study with voriconazole and fluconazole (CYP2C9) inhibitors, an increased exposure to S(+)-ibuprofen from approximately 80% to 100% was observed. You should consider reducing the dose of ibuprofen when concurrently administering strong inhibitors of CYP2C9, especially when high doses of ibuprofen are administered with voriconazole or fluconazole.

Effects

The undesirable effects observed with ibuprofen are generally common to other analgesic, antipyretic, non-steroidal anti-inflammatory drugs. Immune system disorders : after treatment with NSAIDs, hypersensitivity reactions were reported. These can include non-specific and anaphylaxis allergic reactions, reaction to the respiratory tract including asthma, also severe, bronchospasm or dispnea, or various skin ailments, including skin rashes of various types, erytheses, itching, urticaria, porpora, angioedema and, more seldom, esfoliative and bollosis dermatitis (included syndrome. Heart disease : In association with the treatment with NSAIDs were reported edema and fatigue, hypertension and heart failure. Vascular diseases : Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/die), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4). Gastrointestinal diseases : the most commonly observed adverse events are gastrointestinal. Peptic ulcers, perforation or gastrointestinal hemorrhage may occur, sometimes fatal, especially in the elderly (see paragraph 4.4) Gastrointestinal drilling with the use of ibuprofen has rarely been observed. After administration of Ibuprofene Sandoz were reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, epigastric pain, gastric pyrosis, abdominal pain, melena, ematemesis, ulcerative stomatitis, aggravation of colitis and Crohn's disease (see paragraph 4.4). Less frequently gastritis were observed. Pancreatitis were rarely observed. Other adverse events observed with less frequency and for which a causality has not necessarily been established include: Infections and infestations : aseptic rhinitis and meningitis (especially in patients with pre-existing autoimmune disorders, such as systemic erythematous lupus and mixed connectivity) with symptoms of nucan stiffness, headache, nausea, vomiting, fever or disorientation (see paragraph 4.4). Pathologies of the haemolymphopoietic system : leucopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and haemolytic anemia. Psychiatric disorders : insomnia, anxiety, depression, confusion, hallucinations. Diseases of the nervous system : headache, paresthesia, dizziness, drowsiness, optic neuritis. Pathologies of the eye : rare cases of ocular alteration with consequent visual disorders, toxic optic neuropathy. Ear and labyrinth pathologies : hearing compromise, tinnitus, vertigo. Respiratory, chest and mediastinic pathologies : bronchospasmo, dispnea, apnea. Hepatobiliary diseases : altered liver function, liver failure, hepatitis and jaundice. Pathologies of skin and subcutaneous tissue : Bollose reactions, including Stevens-Johnson syndrome and epidermal toxic necrolysis (very rare), and photosensitivity reactions. Kidney and urinary pathologies : harm of the kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and kidney failure. Systemic pathologies and conditions for administration : malaise, fatigue. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Toxicity Signs and symptoms of toxicity were generally not observed at doses less than 100 mg/kg in children or adults. However, in some cases you may need a support treatment. It has been observed that children manifest signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater. Synonyms Most patients who have ingested significant quantities of ibuprofen will manifest symptoms within 4-6 hours. The most commonly observed overdose symptoms include nausea, vomiting, abdominal pain, lethargy and drowsiness. The effects on the central nervous system (SNC) include headaches, tinnitus, dizziness, seizures and loss of consciousness. Rarely, nistagm, metabolic acidosis, hypothermia, kidney effects, gastrointestinal bleeding, coma, apnea, diarrhea and depression of the SNC and respiratory system were also reported. Disorientation, excitement, fainting and cardiovascular toxicity have also been reported, including hypotension, bradycardia and tachycardia. In cases of significant overdose, kidney failure and liver damage may occur. Treatment There is no specific antidote for overdosing ibuprofen. In case of overdose, a symptomatic and support treatment is therefore indicated. Particular attention is given to the control of blood pressure, acid-base balance and gastrointestinal bleeding. Within an hour of the ingestion of a potentially toxic quantity must be considered the administration of activated carbon. Alternatively, in the adult, within an hour of the ingestion of a potentially dangerous overdose for life must be taken into account the gastric lavender. An adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours after ingestion of a potentially toxic medicinal quantity. Any occurrence of frequent or prolonged seizures must be treated with intravenous diazepam. Other support measures may be required in relation to the patient's clinical conditions. For more information, contact the local anti-veleni center.

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Data obtained from epidemiological studies suggest an increase in the risk of abortion, heart malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis during the first period of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It is believed that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disease, was observed in animals that had been administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, Ibuprofene Sandoz should not be administered unless necessary. If used by a woman waiting for conception or during the first and second trimester of pregnancy, the dose and duration of treatment must be the lowest and the shortest possible respectively. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can exhibit: - fetus a: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligo-idroamnios; - the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the time of bleeding, and anti-aggregating effect that can also be necessary at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Ibuprofene Sandoz is contraindicated during the third quarter of pregnancy.

Food

In the few studies available today, NSAIDs can be excreted in breast milk in very low concentrations. NSAIDs, if possible, should be avoided during breastfeeding.

Fertility

The use of Ibuprofen can compromise female fertility and is not recommended in women waiting for conception. In women who have difficulty in conceiving or who are being investigated on infertility, it should be considered the interruption of treatment with ibuprofen.

Source: Farmadati