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IBUPROFENE DOC BB FL 150ML FR
043197019
10 Items
€5.94
€9.00
-€3.06
€5.94
PAVIK CHILDREN 100MG/5ML ORAL SUMMARY
active ingredients
PAVIK Children 100mg/5ml oral suspension taste orange without sugar Each ml of oral suspension contains: Active ingredient: ibuprofene 20 mg. Excipients with known effects: maltitol, sodium, benzoate sodium, citral and linalol. PAVIK Children 100mg/5ml oral suspension Strawberry taste without sugar Each ml of oral suspension contains: Active ingredient: ibuprofene 20 mg. Excipients with known effects: maltitol, sodium, benzoate sodium. For the full list of excipients, see paragraph 6.1.Excellent
PAVIK Children 100mg/5ml oral suspension Strawberry taste without sugar Monohydrate citric acid, citrate sodium, potassium acesulphame, xantana gum, benzoate sodium, strawberry aroma, maltitol syrup, glycerin, purified water PAVIK Children 100mg/5ml oral suspension taste orange without sugar Monohydrate citric acid, citrate sodium, potassium acesulphame, xantana gum, benzoate sodium, orange aroma, maltitol syrup, glycerin, purified waterTherapeutic indications
Symptomatic treatment of mild or moderate fever and pain.Contraindications
• Hypersensitivity to ibuprofen or any of the excipients listed in the paragraph 6.1. • Children under 3 months or less than 5.6 kg. • The drug is contraindicated in patients who show or have previously shown hypersensitivity (e.g. asthma, rhinitis, angioedema or urticaria) to acetylsalicylic acid or other analgesic, antipyretic, non-steroidal anti-inflammatory drugs (NSAID), especially when hypersensitivity is associated with nasal and asthma polypoxes. • Active peptic ulcer. • Severe kidney or liver failure (see paragraph 4.4). • Severe heart failure (see paragraph 4.4). • History of gastrointestinal hemorrhage or perforation related to previous NSAID therapies or history of hemorrhage/recurring peptic ulcer (two or more distinct episodes of proven ulceration or bleeding). • Concurrent use of NSAIDs, including specific COX-2 inhibitors. • Patients with cerebrovascular bleeding history or other active bleeding. • Patients with unclear disorders of blood formation. • Patients with severe dehydration (caused by vomiting, diarrhea or insufficient liquid intake). • During the last quarter of pregnancy (see paragraph 4.6).Population
The lowest effective dose should be used for the shortest period necessary to relieve symptoms (see paragraph 4.4). Population The daily dose is structured according to the weight and age of the patient. Undesirable effects can be minimized with the use of the minimum effective dose for the shortest possible treatment duration needed to control symptoms (see paragraph 4.4). In children aged 3 to 6 months limit administration to those weighing more than 5.6 kg. Method of administration Oral administration to infants and children aged between 3 months and 12 years should take place by means of a dose syringe provided with the product. Patients suffering from stomach problems can take the medicine during meals. The daily dose of 20-30 mg/kg body weight, divided 3 times a day at intervals of 6-8 hours, can be given on the basis of the following diagram (do not exceed the recommended doses). The graduated scale on the syringe body highlights the heels for different dosages; in particular the 2.5 ml notch corresponding to 50 mg of ibuprofene and the 5 ml notch corresponding to 100 mg of ibuprofene.PEOPLE | Age | Single dose in ml | no. max. of SOMMINISTRAZONI/day |
From 5,6 Kg | 3 - 6 months | 2.5 ml | 3 in 24 hours |
From 7 Kg | 6 - 12 months | 2.5 ml | |
From 10 Kg | 1 - 3 years | 5 ml | |
From 15 Kg | 4 - 6 years | 7.5 ml (5 ml + 2.5 ml) | |
From 20 Kg | 7 - 9 years | 10 ml | |
From 28 to 43 Kg | 10 - 12 years | 15 ml |
Conservation
This medicine does not require any special condition of conservation.Warnings
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). Other NSAIDs: the use of PAVIK must be avoided in conjunction with FANS, including selective COX-2 inhibitors. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause hypersensitivity reactions, potentially serious (anaphylactoid reactions), even in individuals not previously exposed to this type of medication. The risk of hypersensitivity reactions after taking ibuprofen is greater in individuals who have presented such reactions after the use of other analgesic, antipyretic, nonsteroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), hay fever, nasal polypoxes, chronic obstructive respiratory disorders or previous angioedema episodes (see paragraph 4.2 and paragraph 48). Gastrointestinal effects (GI): gastrointestinal hemorrhage, 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. Seniors: elderly 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). In the elderly and in patients with history of ulcer, especially if complicated by hemorrhage or perforation (see paragraph 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 considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see 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 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 or anti-aggregating agents such as acetilsalicylic acid (aspirin) (see paragraph 4.5). When bleeding or gastrointestinal ulceration occurs in patients taking PAVIK, treatment must be suspended. I FANS should be administered with caution to patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions can be exacerbated (see paragraph 4.8). Dermatory effects Strict skin reactions: Serious skin reactions have been reported, some of which fatal, including exfoliatory dermatitis, Stevens-Johnson's syndrome and toxic epidermal necrolysis in conjunction with the use of NSAIDs (see paragraph 4.8). Patients seem to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Generalized acute urstolosis (PEAG) was reported in relation to medicines containing ibuprofen. Ibuprofen should be interrupted by the first appearance of severe skin signs and symptoms such as rash, mucosa lesions or any other sign of hypersensitivity. Masking the symptoms of underlying infections: PAVIK may mask the symptoms of infection, which may delay the start of proper treatment and therefore worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When PAVIK is administered for relief from fever or pain related to infection, it is recommended to monitor the infection. In non-hospital contexts, the patient should contact the doctor if symptoms persist or worsen. 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 PAVIK in case of chickenpox. Cardiovascular and cerebrovascular effects Cautisus is required (discussed with your physician or pharmacist) before starting treatment in patients with positive anamnesis for hypertension and/or heart failure because in association with the treatment with the NSAIDs, fluid retention, hypertension and edema were found. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg/die) and for long-term treatments, 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 an increase in the risk of myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, established ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration. Analogue considerations must be made before starting a long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). Renal diseases In general, the usual use of analgesics, especially the combination of different analgesic substances, can cause permanent kidney injury, with risk of kidney failure (nephropathy from analgesics). In dehydrated children and adolescents there is a risk of alteration of kidney function (see paragraph 4.3 and 4.8). Other considerations 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 drug abuse headache (medication overuse headache - MOH) must be suspected in patients who experience frequent or daily headaches despite or due to the regular use of medicines for headaches. Promoted female fertility: see paragraph 4.6. The use of ibuprofen, acetylsalicylic acid or other analgesic, antipyretic, non-steroidal anti-inflammatory, requires special caution: • in case of asthma or allergic diseases in place or in advance: possible deterioration of bronchoconstriction; • in the presence of clotting defects as ibuprofen, the active ingredient of PAVIK, can temporarily inhibit the functionality of platelets (thrombocytic aggregation). Therefore it is recommended to carefully monitor patients with clotting disorders; • in the presence of kidney, heart or hypertension diseases: possible critical reduction of kidney function (especially in subjects with impaired kidney or liver function, heart failure or in treatment with diuretics), nephrotoxicity or fluid retention; • in the presence of liver diseases: possible hepatotoxicity; • rehydrate the subject before the start and during the treatment in case of dehydration (e.g. for fever, vomiting or diarrhea); • immediately after major surgery; • congenital disorders of porphyrin metabolism (e.g. intermittent acute porphyria). The following precautions are relevant during prolonged treatment: • monitor the signs or symptoms of gastrointestinal ulceration or bleeding; • monitor signs or symptoms of hepatotoxicity; • monitor signs or symptoms of nephrotoxicity; • if visual disturbances arise (unused or reduced view, rhytoms, alteration of color perception): stop treatment and consult the ophthalmologist; • if signs or symptoms of meningitis arise: assess the rare possibility that it is due to the use of ibuprofene (aseptic mingitis; most frequent in subjects suffering from systemic erythematose lupus and mixed disease of connective tissue or other collagenopathies) (see paragraph 4.8). Important information about some excipients This medicinal product contains liquid maltitol: patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicine does not contain sugar and is therefore indicated for those patients who need to control the intake of sugar and calories. This medicine contains 4.51 mg of sodium for each 2.5 ml dose equivalent to 0.23% of the maximum daily intake recommended by the WHO that corresponds to 2 g sodium for an adult. This medicine contains 2.5 mg of sodium benzoate per dose (2.5 ml suspension) equivalent to 15 mg per dose of 15 ml. PAVIK Children 100mg/5ml oral suspension orange taste without sugar also contains orange aroma, in turn containing linal and cyster which can cause allergic reactions.Interactions
Ibuprofen should be avoided in association with: • Acetylsalicylic acid: the concomitant administration of ibuprofen and acetylylylethyl acid is not generally recommended due to the potential increase in unwanted effects. Experimental data indicates that ibuprofen can inhibit the effects of acetylsalicylic acid at low doses on platelet aggregation when drugs are administered in conjunction. However, data evacuity and uncertainty regarding the application of ex-live data to the clinical situation do not allow to draw definitive conclusions on the regular use of ibuprofen; seems to be unlikely clinically relevant effects arising from the occasional use of ibuprofen (see paragraph 5.1) • Other NSAIDs included selective cycloxygenase-2 inhibitors: avoid the contemporary use of two or more analgesic, antipyretic, non-steroidal anti-inflammatory drugs: increased risk of side effects (see paragraph 4.4). Ibuprofen should be used with caution in association with: • corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4);• quinolone antibiotics: data from animal studies indicate that NSAIDs may increase the risk of convulsions associated with quinolone antibiotics.Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions;• anticoagulants, such as warfarin: NSAIDs may increase the effects of anticoagulants (see section 4.4);• antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4);• phenytoin: Concomitant use of PAVIK with phenytoin may increase the serum levels of these medicinal products.Correct use of the drugs (administered for a maximum period of 3 days) does not normally require monitoring of serum phenytoin levels;• antidiabetics: an increase in the hypoglycaemic effect of sulfonylureas is possible.In case of simultaneous treatment, monitoring of blood glucose levels is recommended;• antivirals, such as ritonavir: possible increase in the concentration of NSAIDs;• ciclosporin: increased risk of nephrotoxicity; • mifepristone: NSAIDs must not be administered in the 8-12 days following mifepristone intake as they may reduce its efficacy;• cytotoxics, such as methotrexate: reduced excretion (increased risk of toxicity);• lithium: reduced excretion (increased risk of toxicity);• tacrolimus: increased risk of nephrotoxicity;• uricosurics, such as probenecid and sulfinpyrazone: slow down the excretion of NSAIDs (increase in plasma concentrations);• methotrexate: potential increase in the plasma concentration of methotrexate;• zidovudine: increased risk of haematological toxicity when NSAIDs are used in combination with zidovudine.There is evidence of an increased risk of haemarthrosis and haematomas in HIV (+) haemophiliacs when treated concomitantly with zidovudine and ibuprofen;• diuretics and antihypertensives (ACE inhibitors and angiotensin II antagonists): NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible.These interactions should be considered in patients taking PAVIK concomitantly with ACE inhibitors or angiotensin II antagonists.Therefore, the combination should be administered with caution, especially in elderly patients;• Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy and periodically thereafter;• potassium-sparing diuretics: concomitant administration of PAVIK and potassium-sparing diuretics may lead to hyperkalaemia;• CYP2C9 inhibitors: concomitant administration of ibuprofen and CYP2C9 inhibitors may increase the exposure to ibuprofen (CYP2C9 substrate).In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased exposure to S(+)-ibuprofen by approximately 80% to 100% was demonstrated.Consideration should be given to reducing the dose of ibuprofen when strong CYP2C9 inhibitors are administered concomitantly, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole • cardiac glycosides (Digoxin): NSAIDs may worsen heart failure, reduce GFR (glomerular filtration rate) and increase plasma glycoside levels.Effects
The list of the following side effects includes all those that were recognized during treatment with ibuprofen for short periods of treatment and for daily doses up to a maximum of 1200 mg. In case of therapies for chronic or prolonged high dose pathologies, other side effects may occur. Adverse reactions associated with the administration of ibuprofen are listed to follow according to the classification for systems and organs and according to the frequency. The frequencies are defined as: Very common (1/10); City (1/100,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. The half-life of the drug in case of overdose is 1.5-3 hours. Synonyms Most patients who accidentally ingest clinically relevant amounts of ibuprofen will manifest symptoms within 4-6 hours. The most commonly reported 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, state of excitement, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose are possible kidney failure and liver damage. In cases of severe poisoning, it is possible that metabolic acidosis occurs. In the most serious cases, protrombine time (INR) may be prolonged, probably caused by interference with the action of the coagulation factors present in the circle. In asthmatic subjects there may be an exacerbation of the symptoms of the disease. Treatment There is no specific antidote for overdosing ibuprofen. In case of overdose, a symptomatic and support treatment is indicated and must include the maintenance of airway pervity and the monitoring of heart function and vital signs until the patient's stabilization. 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, the administration of activated carbon must be taken into account. 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 drug. Any occurrence of frequent or prolonged seizures must be treated with diazepam or lorazepam intravenously. If ibuprofen has already been absorbed, alkaline substances must be administered to promote excretion in the urine of acid ibuprofen. Administer bronchodilators in case of asthma. Other support measures may be required in relation to the patient's clinical conditions. For more information, contact the local anti-veleni center.It is unlikely that subjects under 12 years of age will go to pregnancy, or breast breastfeeding. The following considerations must also be taken into account in such circumstances.
Pregnancy
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered 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 disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. From 20a week of pregnancy onwards, the use of NSAID could cause oligoidramnios resulting from fetal kidney dysfunction. This condition may be found shortly after the start of treatment and is usually reversible with the termination of treatment. Moreover, cases of constriction of the arterial duct were reported following treatment in the second quarter, most of which resolved after the suspension of treatment. Therefore, during the first and second trimester of pregnancy, PAVIK should not be administered unless strictly necessary. If PAVIK is used by a woman who is planning a pregnancy, or during the first and second trimester of pregnancy, the lowest possible dose should be used for the shortest time possible. Following the exposure to PAVIK for several days from 20a week of gestation onwards, it should be considered an antenatal monitoring of oligoidramnios and the constriction of arterial duct. In case of oligoidramnios or of constriction of the arterial duct, treatment with PAVIK must be stopped. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: • cardiopulmonary toxicity (premature constriction/closing of arterial duct and pulmonary hypertension); • kidney dysfunction (see above); 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 that involve delay or extension of labor. Therefore, PAVIK is contraindicated during the third trimester of pregnancy (see paragraphs 4.3 and 5.3).Food
There are limited data that demonstrates that ibuprofen can go into low concentrations in breast milk and is unlikely to have side effects for infants.Fertility
There is evidence that medicines that inhibit cycloxygenase/prostaglandine synthesis can cause a female fertility impairment due to ovulation. This effect is reversible after termination of treatment. The administration of PAVIK should be suspended in women who have fertility problems or who are subject to fertility surveys.Source: Farmadati
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043197019
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