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Oki pain and fever 25 mg effervescent tablets 25 mg effervescent tablets 12 tablets in sachet eyedrops

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048414104

Brand

OKI

€6.60

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Details

25 MG EFFERVESCENT TABLETS 12 TABLETS IN SACHET PAP/PE/AL/PE

Package Leaflet -
- Directions - What itis and what it is used for
  The active substance in this medicine is ketoprofen lysine salt which belongs to a group of medicines called "Non-steroidal anti-inflammatory drugs" (NSAIDs). These medicines provide short-term relief by changing the body's response to pain, swelling and high temperature. Ketoprofen lysine salt is a ketoprofen salt that is rapidly and completely absorbed by the body. It is used to relieve mild to moderate pain, such as muscle and joint pain, headache, pain associated with sore throat, toothache and menstrual pain, and fever in adults 18 years of age and older.
  
  Talk to your doctor if you do not feel better or feel worse after 3 days in case of fever and 5 days in case of pain.
- Contraindications - What you need to know before taking the medicine
  Do not take OKi pain and fever -
  - if you are allergic (hypersensitive) to ketoprofen or any of the other ingredients of this medicine (listed in section 6)
  - if you have asthma or have had allergic reactions (hypersensitivity) to NSAIDs (e.g. acetylsalicylic acid, ibuprofen) in the past
  - in the third trimester of pregnancy (from the 29th week onwards). See section 2 "Pregnancy and lactation"
  - if you are suffering from a serious heart disease causing a malfunction of the heart
  - if you are affected or have had intestinal problems in the past such as -
     - active or recurrent peptic ulcer
     - ulcers in the stomach or intestine
     - intestinal bleeding
     - perforation in the stomach or esophagus (gastrointestinal perforation)
     - any of the above conditions caused by treatment with an NSAID
     - pain or discomfort during digestion, which may include nausea, vomiting, heartburn, bloating and stomach discomfort (chronic dyspepsia)
     - inflammation of the stomach lining (gastritis)
  - if you have a low number of blood cells (leukocytopenia or thrombocytopenia), an ongoing bleeding or a tendency to bleed during treatment with medicines for the prevention of clots (anticoagulants)
  - if you have severe kidney or liver problems
- Special warnings and precautions for use - Warnings and precautions
  If you notice any signs of rash, red and sore skin around the body orifices (mucous membranes) or allergic reactions after taking OKi pain and fever, stop taking this medicine and tell your doctor immediately.
  
  If you notice signs of bleeding in your stomach or intestine (for example, bright red stools, black tarry stools, vomit containing blood or dark particles similar to coffee grounds), stop taking this medicine and tell your doctor immediately.
  
  If you notice signs of ulceration or perforation (symptoms of which may include severe stomach pain, chills, nausea, vomiting, heartburn) after taking OKi pain and fever, stop taking this medicine and tell your doctor immediately.
  
  Older people may experience greater side effects with NSAIDs, particularly in the stomach and intestines, which can be fatal. Elderly patients should use this medicine with caution.
  
  Side effects can be minimised by taking the lowest dose for as short a time as possible to relieve symptoms.
  
  Anti-inflammatory/pain medicines such as ketoprofen may be associated with a slightly increased risk of heart attack or stroke, particularly when taken in high doses and for long periods of time. Do not exceed the duration of treatment or the recommended dose.
  
  Tell your doctor or pharmacist before taking this medicine if you have high blood pressure, weakening of the heart, arterial disease, and/or problems with the blood vessels that supply the brain, or if you are at an increased risk of these diseases (for example, if you have diabetes, high blood cholesterol, or are a smoker).
  
  Tell your doctor if you experience palpitations, i.e. sensations of acceleration, discomfort and irregular heartbeat.
  
  Use of OKi pain and fever with other medicines containing NSAIDs (e.g. ibuprofen, acetylsalicylic acid, celecoxib) should be avoided.
  
  Stop taking this medicine if you have vision problems, such as blurred vision.
  
  Being intended to treat symptoms such as fever, OKi pain and fever could mask more serious underlying conditions. If symptoms persist, tell your doctor.
  
  Long-term use of painkillers to relieve headaches can make headaches worse.
  
  Talk to your doctor or pharmacist before taking OKi pain and fever -
  - if you are pregnant, conceiving or breastfeeding (see section 2 “Pregnancy and breastfeeding”)
  - if there is fluid retention and swelling
  - if you have a blood disease (e.g. anaemia)
  - if you have liver disease
  - if you have kidney disease
  - if you have allergies (e.g. hay fever)
  - if you have hepatic porphyria (a rare disease of the blood characterised by alteration of the activity of one of the liver enzymes) because the medicine may cause an attack.
  - if you have an infection - see Infections section below.
  
  Infections
  OKPain and fever can hide the symptoms of infections such as fever and pain. It is therefore possible that OKi pain and fever may delay appropriate treatment of the infection, which could increase the risk of complications. This has been observed in bacterial pneumonia and varicella-related bacterial skin infections. If you take this medicine while you have an infection and the symptoms of the infection persist or get worse, talk to your doctor immediately.
  
  Children and adolescents
  Do not give ketoprofen lysine salt to children under 18 years of age.
- Interactions -
- Side Effects - Possible Side Effects
  Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects can be minimised by taking the lowest dose for as short a time as possible to relieve symptoms.
  
  Stop taking OKi pain and fever and consult a doctor immediately if, at any time during treatment with OKi pain and fever, you develop -
  • signs of intestinal bleeding such as bright red stool (excrement), black tarry stool, vomit containing blood or dark particles similar to coffee grounds
  • signs of rashes, severe skin reactions and blistering of the skin, mouth and eyes
  • signs of a severe allergic reaction, such as -
  - breathing difficulties or unexplained wheezing
  - dizziness or acceleration of the heartbeat
  - swelling of the lips, face, throat or tongue
  • worsening of Crohn's disease and colitis (a chronic inflammatory bowel disease characterized by symptoms such as abdominal pain, diarrhea, fever, and weight loss)
  
  Tell your doctor if you experience -
  • fever, sore throat, oral ulcers, headache, vomiting, unexplained bleeding and bruising, severe fatigue
  • indigestion, stomach or abdominal pain, constipation, diarrhoea, flatulence or malaise, chest pain or rapid and irregular heartbeat
  • liver and kidney problems associated with swelling of the arms and legs.
  
  Side effects associated with OKi pain and fever may include - Common (may affect up to 1 in 10 people)
  • digestive difficulties (dyspepsia), nausea, abdominal pain, vomiting
  
  Uncommon (may affect up to 1 in 100 people)
  • headache, dizziness, drowsiness
  • constipation, diarrhoea, flatulence, inflammation of the stomach lining
  • swelling due to fluid accumulation
  • itching and rashes irritations
  • fatigue
  
  Rare (may affect up to 1 in 1,000 people)
  • iron deficiency (anemia) caused by bleeding
  • numbness, tingling
  • blurred vision
  • noise in the ear (tinnitus)
  • asthma
  • inflammation of the lining of the mouth
  • stomach ulcers
  • liver inflammation (hepatitis), increased liver enzymes, yellowing of the skin or whites of the eyes (jaundice)
  • weight gain
  
  Not known (frequency cannot be defined based on available data)
  • alteration of blood cell and platelet counts
  • allergic reactions (anaphylaxis)
  • impairment of the glands located above the kidneys (adrenal glands)
  • high blood pressure, redness (vasodilation)
  • heart failure
  • kidney failure, inflammation in the kidneys, abnormal kidney function test results
  • colitis
  • worsening of gastrointestinal conditions
  • dark or black faeces
  • presence of blood in vomit
  • stuffy, runny nose (rhinitis)
  • swelling of the throat
  • swelling of the deep layers of the skin, caused by excess fluids (e.g. on the face or hands)
  • breathing difficulties (dyspnoea)
  • headache
  • breathing difficulty caused by narrowing of the airway
  • uncontrolled muscle contractions (convulsions)
  • sensitivity to sunlight or UV lamps
  • taste alterations
  • behavioural alterations
  • hair loss
  • itchy rash
  • bleeding from the stomach and/or intestine, symptoms of which may include severe stomach pain, chills, nausea, vomiting, vomiting containing blood or dark particles similar to coffee grounds, heartburn, bright red or black tarry stools
  
  Reporting of undesirable effects
  If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at - https - //www.aifa.gov.it/content/segalazionireazioni-avverse.
  By reporting side effects you can help provide more information about the safety of this medicine.
Recommendations on how to store - Store the medicine in the original package, to protect from moisture and light.
Active substances - Each tablet contains the active substance ketoprofen 25 mg (as ketoprofen lysine salt 40 mg). Excipients with known effects - This medicinal product contains 147 mg sorbitol per effervescent tablet. This medicinal product contains 321.9 mg sodium per effervescent tablet, equivalent to approximately 16% of the who recommended maximum daily intake of 2 g sodium for an adult. For the full list of excipients, see section 6.1.
Excepents - Mannitol (E421), Sodium hydrogen carbonate (E500), Citric acid (E330), Orange flavour, Sorbitol (E420), Sodium carbonate (E500), Leucine, Sodium saccharin (E954), Polysorbate 20 (E432), Simethicone, Colloidal anhydrous silica (E551).
Therapeutic Indications - OKPain and fever are recommended in the short-term symptomatic treatment of acute pain of mild to moderate intensity and/or fever. OKPain and fever is indicated in adults 18 years of age and older.
Contraindications - The medicine should not be used in the following cases - • In patients with a history of hypersensitivity reactions such as bronchospasm, asthma attack, acute rhinitis, urticaria, 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 these 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 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 haemorrhage or haemorrhagic diathesis while being treated with anticoagulants • In patients with severe renal or hepatic impairment, e.g. liver cirrhosis or severe hepatitis.

Dosage - Dosage

Indication	Age group	Dose	Duration
Symptomatic relief from pain and fever	Adults 18 years of age and older	1 tablet in single dose repeated 2-3 times a day, as needed. *	The minimum effective dose capable of alleviating symptoms should be used for the shortest possible time (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 healthcare professional should be consulted. Elderly - Pain and fever should be used with caution in the elderly. For elderly patients, a dose of 1 tablet per day is recommended. Paediatric patients - Oki pain and fever should not be used in children under 18 years of age. Method of administration - For oral use only. Dissolve the tablet in a glass of water before administration.

Warnings - Very rare cases of severe reactions, some of which are fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with NSAID use (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. Ketoprofen lysine salt should be discontinued at the first signs of rash, mucosal lesions or any other signs of hypersensitivity. Concomitant use of OKi pain and fever with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided. Side effects can be minimized by using the lowest effective dose for the shortest time needed to control symptoms. Excessive use of NSAIDs may cause medication-induced headaches, patients are advised to discontinue treatment. Patients should be advised of possible withdrawal symptoms, which may include a worsening of headache that may last for several days. Elderly - in the elderly the frequency of adverse reactions to NSAIDs increases, especially haemorrhage and gastrointestinal perforation that could be fatal (see section 4.2). Gastrointestinal haemorrhage, ulceration and perforation - Gastrointestinal haemorrhage, ulceration or perforation, with even fatal outcome, have been reported for all FANS at any time during treatment, with or without prodromal symptoms or even in the absence of previous cases of serious events affecting the gastrointestinal tract. Some epidemiological evidence suggests that ketoprofen may be associated with a high risk of severe gastrointestinal toxicity, compared to other NSAIDs, especially at high doses (see also sections 4.2 and 4.3). The risk of bleeding, ulceration or perforation of the gastrointestinal tract is increased with increasing dosage of NSAIDs, in patients who have experienced cases of ulceration, particularly if complicated by bleeding or perforation (see section 4.3), and in elderly patients. These patients should start treatment with the lowest available dose. Concomitant use of gastroprotectants (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and for patients concurrently taking low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). Patients who have experienced cases of gastrointestinal toxicity, especially the elderly, should be advised to report any unusual abdominal symptoms (especially gastrointestinal haemorrhage), particularly in the early stages of treatment. Caution is needed when treating patients taking concomitant medicinal products that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelets such as acetylsalicylic acid (see section 4.5). Discontinue treatment if patients treated with ketoprofen lysine salt experience gastrointestinal bleeding or ulceration. NSAIDs should be administered with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as these conditions may worsen (see section 4.8). Patients should be closely monitored, particularly for the onset of gastrointestinal bleeding. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatments) may be associated with an increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). There are insufficient data to exclude a similar risk associated with ketoprofen. As with other NSAIDs, patients with uncontrolled hypertension, confirmed ischemic cardiomyopathy, peripheral arterial disease and/or cerebrovascular disease can only be treated with ketoprofen lysine salt after careful evaluation. Similar considerations should be made before starting long-term treatment in patients with risk factors for cardiovascular events (e.g. arterial hypertension, hyperlipidaemia, diabetes mellitus, smoking). At the start of treatment, renal function should be closely monitored in patients with heart failure, cirrhosis, nephrotic syndrome or probable hypovolaemia, due to the increased risk of nephrotoxicity. This applies to patients treated with diuretics (see section 4.5) and to patients with renal impairment, particularly the elderly. In such patients, the use of ketoprofen could cause a reduction in blood flow to the kidneys caused by prostaglandin inhibition and lead to renal failure. Ketoprofen should be administered with caution in patients with impaired renal function, bearing in mind that the compound is excreted through the kidneys. Like all NSAIDs, ketoprofen can increase values for blood nitrogen and serum creatinine. Like other prostaglandin synthesis inhibitors, ketoprofen may be associated with adverse kidney events that can cause glomerulonephritis, renal papillary necrosis, nephrotic syndrome, and acute renal failure. In patients with abnormal liver function values or a history of liver disease, transaminase values should be assessed periodically, particularly during long-term treatment. Rare cases of jaundice and hepatitis have been reported in association with the use of ketoprofen. Caution is required when administering the product to patients with hepatic porphyria, as it may trigger an attack. As with other NSAIDs, in the presence of an infection, it should be remembered that the anti-inflammatory, analgesic and antipyretic properties of ketoprofen could conceal symptoms commonly associated with the progression of an infection, such as fever. In case of pregnancy, fertility or lactation, see section 4.6. Administer with caution to patients with previous manifestations of allergy. Patients with asthma associated with chronic or allergic rhinitis, chronic sinusitis and/or nasal polyposis are more prone to allergies to acetylsalicylic acid and/or NSAIDs than the rest of the population. Administration of ketoprofen lysine salt could cause asthma attack or bronchospasm, shock and other allergic reactions in subjects allergic to acetylsalicylic acid or NSAIDs (see section 4.3). Discontinue treatment in case of vision problems, such as blurred vision. Masking the symptoms of underlying infections - OKThe pain and fever 25 mg can mask the symptoms of infection, which could delay the initiation of appropriate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and in bacterial complications of chickenpox. When OKi pain and fever 25 mg is administered for relief of fever or pain related to infection, infection monitoring is recommended. In non-hospital settings, the patient should seek medical advice if symptoms persist or worsen. Warnings regarding excipients - OKi pain and fever 25 mg effervescent tablets contain sorbitol; patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this medicine. This medicinal product contains 321.9 mg sodium per effervescent tablet, equivalent to 16% of the who recommended maximum daily intake of 2 g sodium for an adult. If symptoms persist or worsen or a new symptom occurs, the patient should consult a doctor.
Interactions - Combinations to avoid Alcohol - Alcohol consumed alone can cause irritation of the gastrointestinal tract, therefore, taking NSAIDs in conjunction with alcohol leads to an increased risk of bleeding and gastrointestinal ulceration. Patients should be advised to avoid this combination. Anticoagulants (such as heparin and warfarin) - NSAIDs may potentiate the effects of anticoagulants (see section 4.4). In the event that concomitant administration is necessary, patients should be closely monitored because of the increased risk of bleeding. Cyclosporine - co-administration of NSAIDs and cyclosporine results in an increased risk of nephrotoxicity. Dabigatran - concomitant administration of NSAIDs and dabigatran leads to a possible increased risk of bleeding.Erlotinib - concomitant administration of NSAIDs and erlotinib leads to an increased risk of bleeding. Lithium - risk of increased plasma concentrations of lithium, which can reach toxic levels, due to a reduction in the renal excretion of lithium. Where relevant, plasma lithium levels should be closely monitored and the relevant dose adjusted during and after treatment with FANS. Methotrexate, at doses above 15 mg/week - increased risk of haematological toxicity associated with methotrexate, particularly when administered at high doses (>15 mg/week), likely related to displacement of methotrexate-binding proteins and reduced 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 - co-administration of NSAIDs and quinolones leads to a possible increased risk of seizures.Venlafaxine - Concomitant administration of NSAIDs and venlafaxine results in an increased risk of bleeding. Associations that require caution. Anti-aggregants 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), concomitant administration of an ACE inhibitor or angiotensin II receptor antagonist and cyclooxygenase inhibitors may cause further deterioration of renal function, including potential acute renal failure. Therefore, these combinations should be administered with caution, particularly in the elderly. Patients should be adequately hydrated and monitoring of renal function should be considered once concomitant therapy is initiated. NSAIDs may antagonize the blood pressure lowering effects of antihypertensive therapy. Baclofen - NSAIDs may reduce the excretion of baclofen (increased risk of toxicity). Cardiac glycosides - NSAIDs can increase the plasma concentration of cardiac glycosides, possibly exacerbating heart failure and reducing kidney function. Corticosteroids - increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4). Coumarins - NSAIDs may intensify the anticoagulant effect of coumarins. Phenytoin and sulfonamides - since ketoprofen has a strong protein binding, it may be necessary to reduce the dose of phenytoin or sulfonamides administered during treatment. Diuretics - patients taking diuretics and among these, those who are severely dehydrated, are more at risk of developing renal failure secondary to reduced renal blood flow caused by prostaglandin inhibition. These patients should be rehydrated prior to initiation of concomitant administration and renal function should be closely monitored (see section 4.4) after initiation of treatment. NSAIDs may reduce the effect of diuretics. Gemeprost - reduction of the effectiveness of gemeprost. Hypoglycemic agents (sulphonylureas) - NSAIDs can intensify the effects of sulphonylureas, by displacing the binding to plasma proteins. Methotrexate at doses below 15 mg/week - increased haematological toxicity of methotrexate due to reduction of its renal clearance with FANS in general. Complete weekly blood count monitoring is required in the first weeks of concomitant use. Monitoring should be performed more frequently in the presence of impaired renal function and in the elderly. Mifepristone - theoretically there may be a reduction in the effectiveness 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 maturation or uterine contractility and does not reduce the clinical efficacy of pharmacological termination of pregnancy. Pentoxifylline - increased risk of bleeding. The frequency of clinical check-ups and monitoring of bleeding time should be increased. Penicillamine - co-administration of NSAIDs and penicillamine leads to a possible increased risk of nephrotoxicity. Pemetrexed - NSAIDs may reduce renal excretion of pemetrexed. Prasugrel - co-administration of NSAIDs and prasugrel leads to a possible increased risk of bleeding. Platelet antiplatelets (ticlopidine and clopidogrel) - increased risk of bleeding 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 - co-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 glucuronoconjugation and requires adjustment of the ketoprofen dose. Tacrolimus - concomitant administration of NSAIDs and tacrolimus leads to an increased risk of nephrotoxicity. Zidovudine - concomitant administration of NSAIDs and zidovudine leads to an increased risk of haematological toxicity due to the effects of reticulocytes, resulting in severe anaemia occurring one week after initiation of NSAID treatment. The blood count and reticulocyte count should be monitored for one to two weeks from the start of NSAID treatment. Ritonavir - plasma concentrations of NSAIDs may be increased by ritonavir.

Side Effects - Gastrointestinal - the most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, even fatal, may occur, particularly in the elderly (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after administration (see section 4.4). Gastritis was detected less frequently. In very rare cases, hypersensitivity may occur in the form of severe systemic reactions (laryngeal oedema, glottis oedema, dyspnoea, palpitations, Stevens-Johnson syndrome) up to anaphylactic shock. In such cases, immediate medical assistance is required.

MedDRA System Organ Class	Very common (≥1/10)	Common (≥1/100, <1/10)	Uncommon (≥1/1,000, <1/100)	Rare (≥1/10,000, <1/1,000)	Very rare (<1/10,000)	Frequency not known
Blood and lymphatic system disorders	Haemorrhagic anaemia					Thrombocytopenia, agranulocytosis, bone marrow failure and hypoplasia
Immune system disorders						Anaphylactic reaction (including shock), hypersensitivity
Psychiatric disorders	Altered mood
Nervous system disorders			Headache, vertigo, drowsiness	Paraesthesia		Seizures, dysgeusia
Eye disorders				Blurred vision
Ear and labyrinth disorders				Tinnitus
Cardiac disorders						Heart failure
Vascular disorders						Hypertension, vasodilation
Respiratory, thoracic and mediastinal disorders				Asthma		Bronchospasm (particularly in patients with proven hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis
Gastrointestinal disorders		Dyspepsia, nausea, abdominal pain, vomiting	Constipation, diarrhoea, flatulence and gastritis	Stomatitis, peptic ulcer		Exacerbation of colitis and Crohn's disease, gastrointestinal bleeding and perforation, mouth ulceration, melena, hematemesis, duodenal perforation and ulceration
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 exanthema
Renal and urinary disorders						Acute renal failure, tubulo-interstitial nephritis, nephritic syndrome
General disorders and conditions related to the site of administration			Tiredness, edema
Diagnostic tests	Increased weight, increased transaminases and elevated serum bilirubin concentrations due to liver disorders				Renal function test abnormal

Reporting of suspected adverse reactions. The reporting of suspected adverse reactions occurring after the authorisation of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national reporting system at https - //www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdose - Symptoms Cases of overdose have been reported with doses up to 2.5 g ketoprofen. In most cases, the symptoms observed were limited to lethargy, drowsiness, abdominal pain, nausea, vomiting, generally reversible with supportive therapies. 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 events. Treatment measures There are no specific antidotes for ketoprofen overdose lysine salt. In case of suspected overdose, the recommended treatment consists of 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 renal failure, hemodialysis may be useful to eliminate the drug in the circulation.
Pregnancy - Pregnancy - Inhibition of prostaglandin synthesis can adversely affect pregnancy and/or embryo-foetal 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 the early stages of pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to about 1.5%. The risk is believed to increase proportionally to the dose and duration of therapy. Administration of a prostaglandin synthesis inhibitor has been shown to increase pre- and post-implantation losses and embryo-foetal 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 trimesters of pregnancy, ketoprofen lysine salt should not be administered, except in strictly necessary cases. If ketoprofen lysine salt is used by a woman during conception or during the first and second trimesters 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 may expose • the foetus to - • cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); • renal dysfunction, which may progress to renal failure with oligo-hydroamnios; • the mother and the newborn, at the end of pregnancy, to - • possible prolongation of bleeding time, an antiplatelet effect that can occur even at very low doses; • inhibition of uterine contractions resulting in delayed or prolonged labour. The use of ketoprofen during labour can adversely affect the pulmonary haemodynamics of the foetus with serious consequences on breathing. Consequently ketoprofen lysine salt is contraindicated in the third trimester of pregnancy. Lactation - Insufficient data are available on the excretion of ketoprofen in breast 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, reversible with discontinuation of treatment. The use of ketoprofen, like any cyclooxygenase/prostaglandin synthesis inhibitor drug, may impair fertility and is not recommended in women seeking pregnancy. Discontinuation of ketoprofen treatment should be considered in women who have difficulty conceiving or who are undergoing infertility screening.

More Information

More Information
Marca	OKI
MISAN	048414104
Casa farmaceutica	DOMPE' FARMACEUTICI SpA
Tipo	FARMACO DA BANCO
Sintomi	Febbre
is used for	KETOPROFENE
Linea	OKI DOLORE E FEBBRE

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We offer the possibility to make payments through Apple Pay using the renowned online payment platform, Stripe. Apple Pay allows you to make payments with a simple touch or glance, offering a fast and hassle-free payment experience. With Stripe, you can enjoy a secure and fast payment experience when you choose Apple Pay as your payment method.

Google Pay

Fast and Secure Payments with Google Pay: We are pleased to accept payments through Google Pay using the renowned online payment platform, Stripe. Google Pay offers you a simple and secure way to make online and in-store payments. With Stripe, you can enjoy a secure and fast payment experience when you choose Google Pay as your payment option.

Klarna

We offer the possibility to make payments through Klarna using the renowned online payment platform, Stripe. Klarna offers you flexible and convenient payment options, allowing you to split the amount of your purchase into installments or pay at a later time. With Stripe, you can enjoy a secure and personalized payment experience when you choose Klarna as your payment option.