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Oki pain and fever 12 effervescent tablets ketoprofen 25mg

  • DOMPE' FARMACEUTICI SpA
  • 048414104

Oki pain and fever is a new drug based on Ketoprofen

Indicated in case of headache, fever, sore throat.

Practical effervescent tablets.

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OKI PAIN AND FEVER * 12CPR EFF

Therapeutic indications

OKi pain and fever is recommended for the short-term symptomatic treatment of acute mild to moderate pain and / or fever. OKi pain and fever is indicated in adults aged 18 years and over.

Dosage and method of use

Dosage

Indication Age range Dose Duration
Symptomatic relief from pain and fever Adults aged 18 and over 1 tablet in a single dose repeated 2-3 times a day, as needed. * The lowest effective dose to relieve symptoms should be used for the shortest time possible (see section 4.4).

* Wait at least 4 hours between doses. Do not exceed the recommended daily dose of 75 mg. If symptoms persist for more than three days in case of fever or five days in case of pain, or if symptoms worsen, a health care professional should be consulted.Elderly people: OKi Pain and Fever should be used with caution in the elderly. For elderly patients, a dose of 1 tablet per day is recommended.Pediatric patients: Oki Pain and Fever should not be used in children under the age of 18.Method of administration: For oral use only. Dissolve the tablet in a glass of water before administration.

Contraindications

The medicine must not be used in the following cases: • In patients with a history of hypersensitivity reactions such as bronchospasm, asthma attack, acute rhinitis, hives, skin rashes or other allergic reactions to ketoprofen or substances with a similar mechanism of action (such as acetylsalicylic acid or other NSAIDs). Serious and, on rare occasions, fatal reactions have been observed in such patients (see section 4.8). • In patients with hypersensitivity to any of the excipients listed in section 6.1. • During the third trimester of pregnancy (see section 4.6). • In case of severe heart failure. • In patients with active or recurrent peptic ulcer or a history of gastrointestinal bleeding, ulceration or perforation • History of gastrointestinal bleeding or perforation following previous NSAID therapy. • In patients with gastric or duodenal ulcer, chronic dyspepsia and gastritis • In patients with leukocytopenia or thrombocytopenia, ongoing bleeding or bleeding diathesis during treatment with anticoagulants • In patients with severe renal or hepatic insufficiency, for example liver cirrhosis or severe hepatitis .

Side effects

Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or haemorrhage, possibly fatal, may occur, particularly 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 (see section 4.4). Gastritis was reported less frequently. In very rare cases, hypersensitivity may occur in the form of severe systemic reactions (laryngeal edema, glottal edema, dyspnoea, palpitations, Stevens-Johnson syndrome) up to anaphylactic shock. In such cases, immediate medical attention is required.

MedDRA System Organ Class Very common (≥1 / 10) Common (≥1 / 100, Uncommon (≥1 / 1,000 to Rare (≥1 / 10,000, Very rare ( Frequency not known
Disorders of the blood and lymphatic system       Hemorrhagic anemia   Thrombocytopenia, agranulocytosis, bone marrow failure and hypoplasia
Disorders of the immune system           Anaphylactic reaction (including shock), hypersensitivity
Psychiatric disorders           Disturbed mood
Nervous system disorders     Headache, dizziness, sleepiness Paresthesia   Seizures, dysgeusia
Eye disorders       Blurred vision    
Ear and labyrinth disorders       Tinnitus    
Cardiac pathologies           Heart failure
Vascular pathologies           Hypertension, vasodilation
Respiratory, thoracic and mediastinal disorders       Asthma   Bronchospasm (particularly in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis
Gastrointestinal disorders   Dyspepsia, nausea, abdominal pain, vomiting Constipation, diarrhea, flatulence and gastritis Stomatitis, peptic ulcer   Exacerbation of colitis and Crohn's disease, gastrointestinal haemorrhage and perforation, mouth ulceration, melaena, haematemesis, duodenal perforation and ulcer
Hepatobiliary disorders       Hepatitis    
Skin and subcutaneous tissue disorders     rash, itching     Photosensitivity reaction, alopecia, urticaria, angioedema, bullous skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, edema and rash
Renal and urinary disorders           Acute renal failure, tubulointerstitial nephritis, nephritic syndrome
General disorders and administration site conditions     Fatigue, edema      
Diagnostic tests       Increased weight, increased transaminases and elevated serum bilirubin concentrations due to liver disorders   Abnormal kidney function test
Reporting of suspected adverse reactions

. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Very rare cases of serious reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk for these reactions in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. The intake of ketoprofen lysine salt should be discontinued at the first signs of rash, mucosal lesions or any other signs of hypersensitivity. The concomitant use of OKi pain and fever with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided. Undesirable effects can be minimized by using the lowest effective dose for the shortest time needed to control symptoms. Excessive use of NSAIDs can cause drug-induced headaches, patients are advised to discontinue treatment. Patients should be warned of possible withdrawal symptoms, which may include worsening of the headache which can last for several days.Elderly people:the frequency of adverse reactions to NSAIDs increases in the elderly, especially gastrointestinal haemorrhage and perforation which could be fatal (see section 4.2).Gastrointestinal bleeding, ulceration and perforation: emorragia, ulcerazione o perforazione gastrointestinale, con esito anche fatale, sono state segnalate per tutti i FANS in qualsiasi momento del trattamento, con o senza sintomi prodromici o anche in assenza di precedenti casi di eventi gravi a carico del tratto gastrointestinale. Alcune evidenze epidemiologiche suggeriscono che ketoprofene potrebbe essere associato a un alto rischio di grave tossicità gastrointestinale, rispetto ad altri FANS, specialmente a dosi elevate (vedere anche i paragrafi 4.2 e 4.3). Il rischio di sanguinamento, ulcerazione o perforazione del tratto gastrointestinale è maggiore con l’aumentare del dosaggio dei FANS, nei pazienti che hanno manifestato casi di ulcera, in particolare se complicata da emorragia o perforazione (vedere paragrafo 4.3), e nei pazienti anziani. Questi pazienti dovrebbero iniziare il trattamento con la dose minima disponibile. L’uso concomitante di gastroprotettori (ad esempio misoprostolo o inibitori di pompa protonica) dovrebbe essere considerato per questi pazienti e per i pazienti che assumono contemporaneamente acido acetilsalicilico a basso dosaggio o altri farmaci che possono aumentare il rischio di eventi gastrointestinali (vedere di seguito e paragrafo 4.5). I pazienti che hanno manifestato casi di tossicità gastrointestinale, soprattutto se anziani, devono essere invitati a segnalare qualsiasi sintomo inusuale a livello addominale (specialmente emorragia gastrointestinale), in particolare nelle fasi iniziali del trattamento. È necessaria cautela nel trattamento di pazienti che assumono medicinali concomitanti che potrebbero aumentare il rischio di ulcerazione o emorragia, come corticosteroidi orali, anticoagulanti come il warfarin, inibitori selettivi del reuptake della serotonina o antiaggreganti come l’acido acetilsalicilico (vedere paragrafo 4.5). Interrompere il trattamento nel caso in cui i pazienti trattati con ketoprofene sale di lisina manifestino sanguinamento o ulcerazione gastrointestinale. I FANS devono essere somministrati con cautela nei pazienti con un’anamnesi di malattia gastrointestinale (colite ulcerosa, morbo di Crohn), poiché tali condizioni potrebbero aggravarsi (vedere paragrafo 4.8). I pazienti dovrebbero essere monitorati attentamente, in particolare per l’insorgenza di emorragia gastrointestinale. Studi clinici e dati epidemiologici suggeriscono che l’uso di alcuni FANS (specialmente ad alti dosaggi e per trattamenti a lungo termine) può essere associato a un aumento del rischio di eventi trombotici arteriosi (ad esempio infarto miocardico o ictus). Non sono disponibili dati sufficienti per escludere un rischio analogo associato a ketoprofene. Come con altri FANS, i pazienti con ipertensione non controllata, cardiomiopatia ischemica confermata, arteriopatia periferica e/o malattia cerebrovascolare possono essere trattati con ketoprofene sale di lisina soltanto dopo attenta valutazione. Analoghe considerazioni devono essere effettuate prima di iniziare un trattamento di lunga durata in pazienti con fattori di rischio per eventi cardiovascolari (ad esempio ipertensione arteriosa, iperlipidemia, diabete mellito, fumo). All’inizio del trattamento, la funzionalità renale deve essere attentamente monitorata nei pazienti con insufficienza cardiaca, cirrosi, sindrome nefrosica o probabile ipovolemia, per via del maggiore rischio di nefrotossicità. Questo vale per i pazienti trattati con diuretici (vedere paragrafo 4.5) e per i pazienti con compromissione renale, in particolare se anziani. In tali pazienti, l’uso di ketoprofene potrebbe causare una riduzione dell’afflusso di sangue ai reni provocata dall'inibizione delle prostaglandine e portare a insufficienza renale. Ketoprofene deve essere somministrato con cautela in pazienti con compromissione della funzionalità renale, tenendo presente che il composto viene escreto attraverso i reni. Come tutti i FANS, ketoprofene può aumentare i valori relativi ad azotemia e creatinina sierica. Come gli altri inibitori della sintesi delle prostaglandine, ketoprofene può essere associato a eventi avversi a carico dei reni in grado di causare glomerulonefrite, necrosi papillare renale, sindrome nefrosica e insufficienza renale acuta. Nei pazienti con valori anormali di funzionalità epatica o con anamnesi di patologie epatiche, è necessario valutare periodicamente i valori delle transaminasi, in particolare durante il trattamento a lungo termine. Rari casi di itterizia ed epatite sono stati riferiti in associazione all’uso di ketoprofene. Viene richiesta attenzione quando il prodotto viene somministrato a pazienti con porfiria epatica, in quanto potrebbe scatenare un attacco. Come per altri FANS, in presenza di un’infezione, occorre ricordare che le proprietà antinfiammatorie, analgesiche e antipiretiche di ketoprofene potrebbero occultare i sintomi comunemente associati alla progressione di un’infezione, come la febbre. In caso di gravidanza, fertilità o allattamento, vedere paragrafo 4.6. Somministrare con cautela ai pazienti con pregresse manifestazioni di allergia. I pazienti affetti da asma associata a rinite cronica o allergica, sinusite cronica e/o poliposi nasale sono maggiormente soggetti ad allergie all’acido acetilsalicilico e/o ai FANS rispetto al resto della popolazione. La somministrazione di ketoprofene sale di lisina potrebbe causare attacco d’asma o broncospasmo, shock e altre reazioni allergiche in soggetti allergici all’acido acetilsalicilico o ai FANS (vedere paragrafo 4.3). Interrompere il trattamento in caso di problemi alla vista, come visione offuscata. Mascheramento dei sintomi di infezioni sottostanti: OKi dolore e febbre 25 mg può mascherare i sintomi di infezione, cosa che potrebbe ritardare l’avvio di un trattamento adeguato e peggiorare pertanto l’esito dell’infezione. Ciò è stato osservato nella polmonite batterica acquisita in comunità e nelle complicanze batteriche della varicella. Quando OKi dolore e febbre 25 mg è somministrato per il sollievo dalla febbre o dal dolore correlati a infezione, è consigliato il monitoraggio dell’infezione. In contesti non ospedalieri, il paziente deve rivolgersi al medico se i sintomi persistono o peggiorano. Avvertenze relative agli eccipienti: OKi dolore e febbre 25 mg compresse effervescenti contiene sorbitolo; i pazienti affetti da rari problemi ereditari d’intolleranza al fruttosio, da malassorbimento di glucosio-galattosio o da deficit di sucrasi-isomaltasi non devono assumere questo medicinale. Questo medicinale contiene 321,9 mg di sodio per compressa effervescente, equivalenti al 16% dell’assunzione massima giornaliera raccomandata dall’OMS che corrisponde a 2 g di sodio per un adulto. Se i sintomi persistono o peggiorano oppure si manifesta un nuovo sintomo, il paziente deve consultare un medico.

Pregnancy and breastfeeding

Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo-fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. Administration of a prostaglandin synthesis inhibitor has been shown to cause an increase in pre- and post-implantation losses and embryo-fetal lethality in animals. In addition, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals administered a prostaglandin synthesis inhibitor during the organogenetic period. In the first and second trimester of pregnancy, ketoprofen lysine salt should not be administered unless strictly necessary. If ketoprofen lysine salt is used by a woman conceiving or during the first and second trimester of pregnancy, the dose should be kept as low as possible for the shortest possible duration of treatment. 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 oligo-hydroamnios; • the mother and the newborn, at the end of pregnancy, to: • possible prolongation of the bleeding time, an antiplatelet effect which can occur even at very low doses; • inhibition of uterine contractions resulting in delayed or prolonged labor. The use of ketoprofen during labor can adversely affect the pulmonary haemodynamics of the fetus with serious consequences on breathing. Consequently, ketoprofen lysine salt is contraindicated in the third trimester of pregnancy.Feeding time: There are insufficient data on the excretion of ketoprofen in human milk. Ketoprofen lysine salt is not recommended in breastfeeding women.Fertility: Long-term use of some NSAIDs is associated with a reduction in female fertility, which is reversible upon discontinuation of treatment. The use of ketoprofen, like any cyclooxygenase / prostaglandin inhibitor drug, may impair fertility and is not recommended in women trying to become pregnant. Discontinuation of ketoprofen treatment in women who have difficulty conceiving or who are undergoing infertility testing should be considered.

Expiration and retention

Store the medicine in the original package in order to protect it from moisture and light.

Interactions with other drugs

Associations to be avoided Alcohol:alcohol consumed alone can cause irritation of the gastrointestinal tract, therefore, taking NSAIDs concomitantly with alcohol carries an increased risk of gastrointestinal bleeding and ulceration. Patients should be advised to avoid this association.Anticoagulants(such as heparin and warfarin): NSAIDs may potentiate the effects of anticoagulants (see section 4.4). If concomitant administration is necessary, patients should be carefully monitored for the increased risk of haemorrhage.Cyclosporine: Concomitant administration of NSAIDs and cyclosporine involves an increased risk of nephrotoxicity.Dabigatran: Concomitant administration of NSAIDs and dabigatran carries a possible increased risk of haemorrhage.Erlotinib: Concomitant administration of NSAIDs and erlotinib involves an increased risk of haemorrhage.Lithium:risk of increased plasma lithium concentrations, which may reach toxic levels, due to a reduction in renal lithium excretion. Where relevant, plasma lithium levels should be closely monitored and the corresponding dose adjusted during and after treatment with NSAIDs.Methotrexate, at doses above 15 mg / week: increased risk of haematological toxicity associated with methotrexate, particularly when administered at high doses (> 15 mg / week), possibly related to displacement of methotrexate-binding proteins and decreased renal clearance . Therefore, patients being treated with such medicines should consult a doctor before taking the product.Other NSAIDs(including selective cyclooxygenase-2 inhibitors) and high doses of salicylates (> 3 g per day): increased risk of gastrointestinal ulceration and bleeding.Quinolones:concomitant administration of NSAIDs and quinolones carries a possible increased risk of convulsions.Venlafaxine:concomitant administration of NSAIDs and venlafaxine carries an increased risk of haemorrhage.Associations requiring caution. Antiplatelet and selective serotonin re-uptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).Antihypertensives, ACE inhibitors and angiotensin II receptor antagonists: In patients with impaired renal function (e.g. dehydrated and elderly patients), the concomitant administration of an ACE inhibitor or angiotensin II receptor antagonist and cyclooxygenase inhibitors may cause further deterioration of renal function, including an potential acute renal failure. Therefore, these combinations should be administered with caution, particularly in the elderly. Patients should be adequately hydrated and renal function monitoring should be considered once concomitant therapy is initiated. NSAIDs may antagonize the blood pressure lowering effects of antihypertensive therapy.Baclofen: NSAIDs may reduce baclofen excretion (increased risk of toxicity).Cardiac glycosides: NSAIDs may increase the plasma concentration of cardiac glycosides, with the possible exacerbation of heart failure and reduction of renal function.Corticosteroids:increased risk of gastrointestinal ulceration or bleeding (see section 4.4).Coumarinics: NSAIDs can intensify the anticoagulant effect of coumarins.Phenytoin and sulfonamides:Since ketoprofen is highly protein bound, it may be necessary to reduce the dose of phenytoin or sulphonamides administered during treatment.Diuretics: Patients taking diuretics and among them, those severely dehydrated, are at increased risk of developing renal failure secondary to reduced renal blood flow caused by prostaglandin inhibition. These patients should be rehydrated prior to initiating concomitant administration and renal function should be closely monitored (see section 4.4) after initiation of treatment. NSAIDs can reduce the effect of diuretics.Gemeprost:reduction in the effectiveness of gemeprost.Hypoglycaemics(sulfonylureas): NSAIDs can intensify the effects of sulfonylureas by displacing plasma protein binding.Methotrexate at doses below 15 mg / week: increased haematological toxicity of methotrexate due to the reduction of its renal clearance with NSAIDs in general. In the first few weeks of concomitant use, weekly complete blood count is required. Monitoring should be performed more frequently in the presence of impaired renal function and in elderly subjects.Mifepristone:theoretically there may be a reduction in the efficacy of this contraceptive medicine due to the antiprostaglandin properties of NSAIDs, including aspirin (acetylsalicylic acid). Limited evidence suggests that concomitant use of NSAIDs on the day of prostaglandin administration does not adversely affect the effects of mifepristone or prostaglandins on cervical ripening or uterine contractility and does not reduce the clinical efficacy of drug termination of pregnancy.Pentoxifylline:increased risk of bleeding. The frequency of clinical checks and monitoring of bleeding time should be increased.Penicillamine: Concomitant administration of NSAIDs and penicillamine involves a possible increased risk of nephrotoxicity.Pemetrexed: NSAIDs may reduce the renal excretion of pemetrexed.Prasugrel: Concomitant administration of NSAIDs and prasugrel leads to a possible increased risk of haemorrhage.Antiplatelet agents (ticlopidine and clopidogrel): increased risk of haemorrhage due to inhibition of platelet function and damage to the gastrointestinal mucosa (see section 4.4). If concomitant administration cannot be avoided, the patient should be closely monitored.Probenecid:concomitant administration of probenecid may significantly reduce the plasma clearance of ketoprofen and consequently the plasma concentrations of ketoprofen may be increased. The interaction may be due to inhibition of renal tubular secretion and glucuronide conjugation and requires adjustment of the ketoprofen dose.Tacrolimus: Concomitant administration of NSAIDs and tacrolimus involves an increased risk of nephrotoxicity.Zidovudine: Concomitant administration of NSAIDs and zidovudine carries an increased risk of haematological toxicity due to the effects of reticulocytes, resulting in severe anemia occurring one week after starting treatment with the NSAID. Complete blood count and reticulocyte counts should be monitored for one to two weeks after initiation of NSAID treatment.Ritonavir: Plasma concentrations of NSAIDs may be increased by ritonavir.

Overdose

SymptomsCases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most cases, symptoms observed were limited to lethargy, somnolence, abdominal pain, nausea, vomiting, usually reversible with supportive care. Respiratory depression, coma or seizures have also occurred following severe overdoses of ketoprofen. In addition, gastrointestinal bleeding, hypotension, hypertension or acute renal failure may occur, but these are rare.Treatment measuresThere is no specific antidote for ketoprofen lysine salt overdose. In the event of a suspected overdose, recommended treatment is gastric lavage associated with the administration of symptomatic and supportive treatment to compensate for dehydration, monitoring of urinary excretion and correction of acidosis, if present. In case of kidney failure, hemodialysis can be helpful in clearing the medicine into the circulation.

Active principles

Each tablet contains the active ingredient ketoprofen 25 mg (as ketoprofen lysine salt 40 mg). Excipients with known effect: This medicinal product contains 147 mg of sorbitol per effervescent tablet. This medicinal product contains 321.9 mg of sodium per effervescent tablet, equivalent to approximately 16% of the WHO recommended maximum daily intake of 2 g of sodium for an adult. For the full list of excipients, see section 6.1.

Excipients

Mannitol (E421), Sodium hydrogen carbonate (E500), Citric acid (E330), Orange flavor, Sorbitol (E420), Sodium carbonate (E500), Leucine, Sodium saccharin (E954), Polysorbate 20 (E432), Simethicone, Anhydrous colloidal silica (E551).

048414104
14 Items

Data sheet

Packaging
25 mg 12 effervescent tablets
Product Type
HUMAN DRUG
ATC code
M01AE03
ATC description
Ketoprofen
Therapeutic Group
NSAID analgesics
Active principle
ketoprofen lysine salt
Class
C.
Pharmaceutical form
effervescent tablet
Type of Administration
oral
Container
paper / aluminum / polyethylene sachets
Quantity
12 effervescent tablet
Quantity of the Active Ingredient
25MG
Recipe required
OTC - self-medication medicine