NUROFENCAPS 10CPS MOLLI 400MG

NUROFENCAPS 400 MG CAPSULE MOLLI

active ingredients

Each capsule contains Ibuprofen 400 mg. Excipients with known effects: Sorbitol (E420) 16,27 mg/capsula Ponceau 4R (E124) 0,79 mg/capsula For the full list of excipients see section 6.1.

Excellent

Filling: Macrogol 600, Potassium hydroxide, Water purified. Jelly wrapper: Gelatina, Liquid Sorbitol (E420), Ponceau 4R (E124). Ink: Titanium dioxide (E171), propylene glycol, Ipromellose (E464). Process aids: Triglycerides (average chain), Lecithin (E322).

Therapeutic indications

This medicine is indicated in adults, children and adolescents weighing more than 40 kg (from 12 years of age) for the symptomatic treatment of short duration of mild to moderate pain, such as headaches, menstrual pain, toothache and pain associated with the common cold.

Contraindications

• Hypersensitivity to the active ingredient, ponceau 4R (E124) or any of the excipients listed in paragraph 6.1 • Patients who have manifested hypersensitivity reactions (such as bronchospasm, asthma, rhinitis, angioedema or urticaria) associated with the use of acetylsalicylic acid (ASAANS) or other non-steroidal anti-inflammatory products (F). • History of gastrointestinal hemorrhage or perforation related to previous treatments with NSAID • Patients with peptic ulcer/hemorrhage in place or history of ulcer/curring peptic hemorrhage (two or more distinct episodes of proven ulceration or bleeding). • Patients with severe liver, kidney or heart failure (IV NYHA class). See also section 4.4 • Patients with cerebrovascular bleeding or other bleeding in active phase. • Patients with unclear emopoiesi disorders. • Patients with severe dehydration (caused by vomiting, diarrhea or insufficient liquid intake) • During the last trimester of pregnancy (see section 4.6). • Teenagers weighing less than 40 kg or children under 12 years of age.

Dosage

For oral use and only for a short period of treatment. Capsules should not be chewed. 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 section 4.4). Adults, children and adolescents weighing more than 40 kg (from 12 years of age). The initial dose is a capsule to be taken with water. Later, if necessary, one capsule every 6 hours. Do not exceed the dose of 3 capsules (1200 mg) in 24 hours. 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. If in adults it is necessary to administer the product for more than 3 days in case of fever and 4 days for the treatment of pain, or if symptomatology worsens, consult your doctor. It is recommended that patients with gastric sensitivity problems take Nurofencaps on a full stomach. The onset of the effect of Nurofencaps can be delayed if the medicine is taken shortly after eating. If this occurs, do not take a dose of Nurofencaps higher than the one recommended in Section 4.2 (posology) or wait for the time needed between one administration and the other. Special popularity. . Seniors: No special dose adjustment is required. Due to the possible profile of side effects (see section 4.4) the elderly must be monitored with particular attention. Renal insufficiency: No dose reduction is required in patients with mild to moderate kidney function (for patients with severe kidney failure see section 4.3). Hepatic insufficiency (see section 5.2): No dose reduction is required in patients with impairment of mild to moderate liver function (for patients with severe liver failure see section 4.3). Children and teenagers: For use in children and adolescents see section 4.3.

Conservation

Store in the original packaging to protect the medicine from moisture.

Warnings

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 beyond gastrointestinal and cardiovascular risks). Caution is required in patients with the following conditions, which may worsen: • systemic erythematous lupus and mixed connective disease - for increased risk of aseptic meningitis (see section 4.8); • congenital disorders of porphyrin metabolism (e.g. intermittent acute porphyria); • gastrointestinal disorders and chronic intestinal inflammatory disease ( ulcerative colitis, Crohn's disease (see section 4.8); • hypertension and/or heart failure (see sections 4.3 and 4.8); • kidney failure, as kidney function can be compromised (see sections 4.3 and 4.8); • liver dysfunction (see sections 4.3 and 4.8); • immediately after major surgery; • In patients who experience allergic reactions to other substances, as they are at higher risk of developing hypersensitivity reactions even when using Nurofencaps; • In patients suffering from hay fever, nasal polyps, chronic obstructive respiratory disorders, or having a history of allergic pathologies, as there is an increased risk of developing allergic reactions for these patients. These can be manifested in the form of asthma attacks (called “analgesic asthma”), edema of Quincke or hives. Gastrointestinal safety (GI): Concurrent use of other NSAIDs, including selective cycloxygenase-2 inhibitors, increases the risk of adverse reactions (see section 4.5) and must be avoided. Seniors: Senior patients have an increase in the frequency of adverse reactions to NSAIDs, especially hemorrhages and gastrointestinal perforations, which can be fatal (see Section 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. When gastrointestinal hemorrhage occurs or ulceration as a result of ibuprofene administration the treatment must be stopped. In the elderly and in patients with history of ulcer, especially if complicated by hemorrhage or perforation (see section 4.3), the risk of gastrointestinal hemorrhage, ulceration or perforation is higher with increased doses of NSAID. These patients must begin treatment with the lowest dose available. Concurrent use of protective agents (e.g. misoprostol or protonic pump inhibitors) must be taken into account for these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (see section 4.5). Patients with history of gastrointestinal toxicity, especially elderly people, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage), especially in the early stages of treatment. Caution should be recommended to patients taking concomitant medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs) or anti-aggregating agents such as acetilsalicylic acid (see section 4.5). NSAIDs should be given with caution to patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions can be exacerbated (see section 4.8). Skin reactions: Severe skin reactions, some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and epidermal toxic necrolysis ( Lyell syndrome), have been reported very rarely in association with the use of NSAIDs (see Section 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. Nurofencaps must be stopped at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. The chickenpox can exceptionally be the origin of serious infectious complications to the skin and soft tissues. To date, the contribution of NSAIDs cannot be excluded in the worsening of such infections, therefore it is recommended to avoid the use of Nurofencaps in case of chickenpox. Cardiovascular and cerebrovascolar effectsi: Before starting treatment in patients with positive anamnesi for hypertension and/or heart failure is required caution (consulting your physician or pharmacist) since in association with the treatment with the NSAIDs fluid retention, hypertension and edema were reported. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg per day), 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. â?¤1200 mg per day) are associated with an increase in the 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. Other considerations: Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are rarely observed. To the first signs of reaction of hypersensitivity after administration/take of Nurofencaps the therapy must be interrupted. Medical relief measures required according to symptoms must be undertaken by specialized personnel. Ibuprofen, the active ingredient of Nurofencaps, can temporarily inhibit the functionality of platelets (thrombocytic aggregation), so it is recommended to carefully monitor patients with clotting disorders. In case of prolonged administration of Nurofencaps, regular control of hepatic values, kidney function and blood count is required. Prolonged use of any type of analgesic for headaches can make your symptoms worse. If this situation occurs or is suspected, the doctor must be consulted and the treatment must be suspended. Diagnosis of headaches from drug abuse (medication overuse headache -MOH) must be suspected in patients who experience frequent or daily headaches despite or due to the regular use of headache medications. The usual use of analgesics, especially of the associations of different active ingredients of analgesics, can lead to permanent kidney injuries with risk of kidney failure (nephropathy from analgesics). This risk can be increased by the loss of salts and dehydration. Undesirable effects related to the active ingredient, especially those related to the gastrointestinal tract or the central nervous system, can be increased by taking NSAIDs in association with alcohol. There are some evidence that medicinal products that inhibit the synthesis of cycloxygenase/prostaglandin may cause a weakening of female fertility due to ovulation. This effect is reversible after termination of treatment. (see section 4.6). In dehydrated children and adolescents there is a risk of alteration of kidney function. This medicinal product contains sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicinal product contains Ponceau 4R (E124). It can cause allergic reactions. NSAIDs can mask symptoms of infection and fever.

Interactions

Acetylsalicylic acid (low dosage): Concurrent administration of ibuprofen and acetylsalicylic acid is not generally recommended due to the potential increase in unwanted effects. Experimental data suggests that ibuprofen can competitively inhibit the effects 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 section 5.1). Other NSAIDs included selective cycloxygenase-2 inhibitors: Concurrent administration of several NSAIDs can increase the risk of gastrointestinal ulcers and hemorrhages due to the synergistic effect. Concurrent use of ibuprofen with other NSAIDs must therefore be avoided (see section 4.4) Digoxin, Fenitoine, Litio: The contemporary use of Nurofencaps with digoxin, phenytoin or lithium. can increase the serum levels of these medicines. With proper use (maximum for 4 days) it is not necessary to control lithium, dioxin, phenytoin in the serum. Courtesy.Corticosteroids can increase the risk of adverse reactions, especially gastrointestinal tract (ulceration or gastrointestinal hemorrhage) (see section 4.3) Selective serotonin reuptake inhibitors and anti-aggregating agents (SSRIs): Increased risk of gastrointestinal hemorrhage (see section 4.4). Antiagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin (see section 4.4) Probenecid and the Finpirazone: Medicines containing probenecid or sulfinpirazone may delay the excretion of ibuprofene Diuretics, ACE inhibitors and Angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) co-administration of an inhibitor ACE, beta-blocker or an antagonist of angiotensin II and agents inhibiting the cyclo-oxidase system may lead to further deterioration of kidney function, including a possible acute reversible failure, generally reversible. Therefore, the combination should be given with caution, especially in elderly patients. Patients should be properly hydrated and monitoring of renal function should be taken into consideration after the start of concomitant therapy, and periodically from there forward Diuretic potassium savers: Co-administration of Nurofencaps and potassium-saving diuretics can cause hyperkaliemia. Methodology: The administration of Nurofencaps in the previous 24 hours and after the administration of metotrexate can lead to an increase in plasma levels of metotrexate and an increase in its toxic effects. Ciclosporin: Co-administration with some non-steroidal anti-inflammatory drugs increases the risk of liver damage from cyclosporin. This effect cannot also be excluded for the association of cyclosporin with ibuprofen. Tacrolimus: the risk of nephrotoxicity increases if the two medicines are administered simultaneously. Zidovudina: There are evidence of increased risk of hematoma and hematoma in HIV seropositive hemophilic patients if treated simultaneously with zidovudine and ibuprofen. There is a risk of increased hematological toxicity when NSAIDs are administered with zidovudine. On the phone: Clinical investigations have highlighted interactions between non-steroidal and anti-diabetic anti-inflammatory drugs (Sulfoniluree). Although interactions between antidiabetics and ibuprofen have not yet been described, it is recommended to monitor plasma glucose levels as precaution in case of co-administration. Chinolonic Antibiotics: Experimental animal data indicates that NSAIDs can increase the risk of convulsions associated with chinolonic antibiotics. Patients taking NSAIDs and kinolonics may have an increased risk of having seizures. Mifepristone: NSAIDs should not be used for 8-12 days after administration of Mifepristone as NSAIDs can reduce the effect of Mifepristone. CYP2C9 inhibitors: Concurrent administration of ibuprofen and CYP2C9 inhibitors can enhance 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 powerful CYP2C9 inhibitors are administered simultaneously, particularly when high dose is administered with voriconazole and fluconazole.

Effects

The list of the following side effects includes all the side effects that have been recognized during treatment with ibuprofen, even those observed during prolonged high-dose therapy in patients with rheumatism. The frequencies reported, which extend beyond the indications of very rare unwanted effects, refer to short periods of treatment for daily doses up to a maximum of 1200 mg of ibuprofen for oral pharmaceutical forms and up to a maximum of 1800 mg for the supposed. You should consider that the following adverse reactions are predominantly dose-dependent and vary from individual to individual. The most commonly observed adverse reactions are gastrointestinal. Peptic ulcers, perforation or gastrointestinal bleeding may occur, sometimes fatal, especially in the elderly (see section 4.4). As a result of the administration of ibuprofen, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, ematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4). Less frequently gastritis was observed. In particular, the risk that gastrointestinal hemorrhage manifests depends on the dosage and duration of treatment. Edema, hypertension and heart failure have been reported in association with treatment with NSAIDs. 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). Hypersensitivity reactions have been reported that may occur as: (a) non-specific allergic reactions and anaphylaxis; (b) reactivity of the respiratory tract, such as asthma, aggravated asthma, bronchospasm, dispnea; (c) various skin reactions, such as itching, hives, angioedema and more rarely bollose and exfoliative dermatosis (including epidermal necrolysis and multiform erythema). The patient must be informed to immediately inform the doctor and suspend the taking of Nurofencaps, in case any of the adverse reactions mentioned above arise. It is noted that for each frequency group, the unwanted effects are presented in descending order of gravity:

Very common (>=1/10)

Common (>=1/100,

Not common (>=1/1.000,

Raro (>=1/10.000,

Very rare (

Notable (frequency cannot be defined on the basis of available data)

Infections and infestations. Very rare: with the use of non-steroidal anti-inflammatory drugs the exacerbation of inflammations related to infections (e.g. development of necrotizing fascites). This is potentially associated with the mechanism of action of non-steroidal anti-inflammatory drugs. If, during the use of Nurofencaps, signs of infection are manifested or worsened, the patient should immediately contact the doctor. Any indication for anti-infective/antibiotic therapy must be assessed. Symptoms of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever or disorientation were observed during treatment with ibuprofen. Patients with autoimmune disorders (systemic erythematosis, mixed connective disease) seem to be predisposed. Diseases of the emolinfopoietic system. Very rare: hematopoietic disorders (anemia, leucopenia, thrombocytopenia, pancitopenia, agranulocytosis). The first manifestations can be: fever, throat, superficial ulcers of the oral cavity, simil symptoms - flu, severe fatigue, nasal bleeding and cutaneous. In these cases the patient must be informed to immediately suspend the therapy, to avoid taking any analgesic or antipyretic automedication medicine and consult the doctor. For prolonged therapy the blood count must be checked regularly. Disorders of the immune system (hypersensitivity). Not common: hypersensitivity reactions with hives and itching, as well as as asthma attacks (possibly with blood pressure drop); Very rare: severe reactions of generalized hypersensitivity. The symptoms may be: swelling of the face, tongue and larynx, dispnea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Asthma and bronchospasm exacerbation. Psychiatric disorders. Very rare: psychotic reactions, depression. Nervous system pathologies. Not common: central nervous system disorders such as headaches, dizziness, drowsiness, agitation, irritability or fatigue. Eye pathologies. Not common: visual disorders. Ear and labyrinth pathologies. Rare: tinnitus, compromise of hearing. Heart disease. Very rare: palpitations, heart failure, myocardial infarction. Vascular diseases Very rare: artesious hypertension, vasculitis. Gastrointestinal disease. Common: gastrointestinal disorders such as dyspepsia, pirosis, abdominal pain, nausea, vomiting, diarrhea flatulence, constipation and slight gastrointestinal blood losses that in exceptional cases may cause anemia; Not common: gastrointestinal ulcers, potentially with gastrointestinal perforation and bleeding. Ulcerative symptoms, exacerbation of colitis and Crohn's disease (see section 4.4), gastritis; Very rare: esophagitis, pancreatitis, formation of symil-diaphragmtic bowel shrinkage. The patient must be informed of suspending the medicinal product and immediately contact the doctor if severe pain occurs to the upper abdomen, melena or ematemesis. Hepatobiliary pathologies. Very rare: liver dysfunction, liver damage, especially following long-term treatments, liver failure, acute hepatitis. Pathologies of skin and subcutaneous tissue. Not common: various rashes; Very rare: Bollose reactions including Stevens-Johnson syndrome and epidermal toxic necrolysis ( Lyell syndrome), alopecia. In exceptional cases, severe skin infections and soft tissue complications may arise during a chickenpox infection (see also “Infections and infestations”). Notable: reaction to the drug with eosinophilia and systemic symptoms ( DRESS syndrome). Kidney and urinary pathologies. Rare: rare damage to kidney tissues (paillar necrosis) and high concentrations of uric acid in the blood, high concentrations of urea in the blood; Very rare: formation of hedemas, especially in patients with arterial hypertension or kidney failure, nephrosic syndrome, interstitial nephritis that can be accompanied by acute kidney failure. The kidney function must therefore be checked regularly. 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.aifa.gov.it/content/segnalazioni-reazioni-avverse. . Diagnostic exams. Rare: decrease in hemoglobin levels.

Overdosing

In adults and adolescents there is no obvious dose-response effect The half-life in case of overdose is 1.5-3 hours. Synonyms Most patients who have ingested clinically relevant amounts of NSAIDs have exclusively nausea, vomiting, epigastric pain, or more rarely diarrhea. It is also possible to manifest tinnitus, headache, and gastrointestinal bleeding. In cases of more severe poisoning, toxicity is observed at the expense of the central nervous system that is manifested with dizziness, drowsiness, occasionally excitement and disorientation or coma. Occasionally patients develop seizures. In severe cases of poisoning, metabolic acidosis and protrombine/INR time may occur, probably caused by interference with the action of the coagulation factors present in the circle. Acute kidney failure and liver damage can also be presented. Asthmatic subjects can be exacerbated. Treatment The treatment must be symptomatic and supportive and must include the maintenance of airway pervity and the monitoring of heart function and vital signs until the patient's stabilization. Oral administration of activated carbon should be taken into account if the patient is present within 1 hour of ingestion of a potentially toxic quantity. Convulsions must be treated with diazepam or lorazepam intravenously if they are frequent or prolonged. Administer bronchodilators in case of asthma. A specific antidote is not available.

Pregnancy

: The inhibition of prostaglandin synthesis can 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 a prostaglandin synthesis inhibitor during the early stages 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, there was an increase in the incidence of various malformations, including cardiovascular disease, in animals that had been administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second quarter of pregnancy, ibuprofen should not be administered if not in strictly necessary cases. If used by women in the process of conceiving 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 expose the fetus to: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction that can progress to kidney failure with oligohydroamniosis; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect that can also occur at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.

Food

: Hybuprofen and its metabolites can pass in low concentrations in breast milk. No dangerous effect for infants is now known, so for short treatments with the recommended dose for pain and fever, breastfeeding is not generally necessary.

Fertility

: There are some evidence that drugs that inhibit cyclooxygenase/synthesis of prostaglandins can cause a compromise of female fertility with an effect on ovulation. This is reversible when the treatment is suspended (see paragraph 4.4).

Source: Farmadati