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KETESSE 25 MG COATED TABLETS 20 TABLETS
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Descrizione
Pagamenti
Spedizioni
Name
Ketesse 25 mg film-coated tablets
Dexketoprofen
What it is and what it is used for
Ketesse is a painkiller that belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
It is used to treat mild to moderate pain, such as muscle pain, painful periods (dysmenorrhea), toothache.
Contact your doctor if you do not feel better or if you feel worse after 3-4 days.
What you need to know before taking the medicine
Do not take Ketesse:
• If you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;
• If you have asthma or have had asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (polypoid masses in the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing) or wheezing in the chest, after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• If you have suffered from photoallergic or phototoxic reactions (a particular form of redness and/or blistering of the skin following exposure to sunlight) during treatment with ketoprofen (a non-steroidal anti-inflammatory drug) or with fibrates (drugs used to reduce fat levels in the blood);
• If you suffer from a peptic ulcer/bleeding of the stomach or intestines or if you have suffered from stomach or intestinal bleeding, ulceration or perforation in the past;
• If you suffer from chronic digestive problems (e.g. indigestion, heartburn);
• If you have suffered in the past from bleeding or perforation in the stomach or intestine due to previous use of non-steroidal anti-inflammatory drugs (NSAIDs) used for pain;
• If you suffer from intestinal diseases with chronic inflammation (Crohn's disease or ulcerative colitis);
• If you suffer from severe heart failure, or have moderate to severe kidney problems or serious liver problems;
• If you have bleeding problems or clotting disorders;
• If you are severely dehydrated (have lost a large amount of body fluids) due to vomiting, diarrhoea or insufficient fluid intake;
• If you are in your third trimester of pregnancy or are breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before using Ketesse:
• If you suffer from allergies, or have had problems due to allergies in the past;
• If you have kidney problems, liver or heart problems (hypertension and/or heart failure) or fluid retention, or have previously suffered from one of these disorders;
• If you are taking diuretics or have problems with very poor hydration or have a reduced blood volume due to excessive fluid loss (for example due to excessive urination, diarrhoea, vomiting);
• If you have heart problems, have had a stroke or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes or high cholesterol, or are a smoker) you should discuss your treatment with your doctor or pharmacist; medicines like Ketesse may be associated with a small increased risk of heart attack ('myocardial infarction') or stroke. These risks are more likely with high doses of the medicine and with long-term treatment. Do not exceed the recommended dose or duration of treatment;
• If you are elderly: you are more likely to experience side effects (see section 4).
If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (this medicine may reduce your fertility, so you should not take the medicine if you are planning to become pregnant or if you are undergoing fertility tests);
• If you suffer from a disorder of blood and blood cell formation;
• If you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If you have suffered in the past from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have or have suffered in the past from other stomach or intestinal problems;
• If you have an infection – see section “Infections” below;
• If you are taking other medicines that increase the risk of peptic ulcer or bleeding, for example oral steroids, some antidepressants (SSRIs, i.e. Selective Serotonin Reuptake Inhibitors), medicines that prevent blood clots such as aspirin or anticoagulants such as warfarin. In these cases, talk to your doctor before taking this medicine: he or she may prescribe an additional medicine to protect your stomach (for example misoprostol or other medicines that block the production of stomach acids);
• If you suffer from asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyposis as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population. Administration of this medicine may cause asthma attacks or bronchospasm, particularly in subjects allergic to acetylsalicylic acid or NSAIDs.
Infections
Dexketoprofen may hide the symptoms of infection such as fever and pain. It is therefore possible that this medicine may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or get worse, contact your doctor immediately.
The use of this medicine is not recommended during chickenpox virus infection.
Children and adolescents
This medicinal product has not been studied in children and adolescents. Therefore, safety and efficacy have not been established and the product should not be used in children and adolescents.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects are listed below, in order of how likely they are to occur.
Common side effects: may affect up to 1 in 10 patients
Nausea and/or vomiting, abdominal pain mainly in the upper quadrants, diarrhoea, digestive problems (dyspepsia).
Uncommon side effects: may affect up to 1 in 100 patients
Dizziness, vertigo, drowsiness, sleep disturbances, nervousness, headache, palpitations, hot flushes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, skin rash, tiredness, pain, feeling of fever and chills, feeling generally unwell.
Rare side effects: may affect up to 1 in 1,000 patients
Peptic ulcer, peptic ulcer haemorrhagic or perforated (which may be manifested by traces of blood in the vomit or stool), fainting, high blood pressure, slow breathing, fluid retention and peripheral oedema (e.g. swollen ankles), oedema of the larynx, loss of appetite (anorexia), changes in sensation (paraesthesia), itchy rash, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute kidney failure.
Very rare side effects: may affect up to 1 in 10,000 patients
Anaphylactic reaction (hypersensitivity reaction which may also lead to collapse), ulceration of the skin, mouth, eyes and genital area (Stevens Johnson and Lyell syndromes), swelling of the face or lips and throat (angioedema), difficulty breathing due to contraction of the muscles surrounding the airways (bronchospasm), shortness of breath, fast heart beat, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), skin reactions, sensitivity to light, itching, kidney problems. Decrease in white blood cells (neutropenia), decrease in blood platelets (thrombocytopenia).
Tell your doctor immediately if you notice any side effects in your stomach or intestines at the beginning of treatment (for example, stomach pain, acidity or bleeding), if you have previously suffered from some of these side effects due to the long-term use of anti-inflammatory drugs, and especially if you are elderly.
Stop using this medicine as soon as you notice the appearance of a skin rash, or any lesions on the inside of the mouth or genitals, or any sign of allergy.
Fluid retention and swelling (particularly in the ankles and legs), increased blood pressure and heart failure have been reported during treatment with nonsteroidal anti-inflammatory drugs.
Medicines like this may be associated with a small increased risk of heart attack ('myocardial infarction') or cerebrovascular accident (stroke).
In patients with immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may rarely cause fever, headache and stiff neck.
The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal especially in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, worsening of colitis and Crohn's disease have been reported following administration. Less frequently, inflammation of the gastric wall (gastritis) has been observed.
As with other NSAIDs, haematological reactions (purpura, aplastic and haemolytic anaemia and rarely agranulocytosis and bone marrow hypoplasia) may occur.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.
Ketesse 25 mg film-coated tablets
Dexketoprofen
What it is and what it is used for
Ketesse is a painkiller that belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
It is used to treat mild to moderate pain, such as muscle pain, painful periods (dysmenorrhea), toothache.
Contact your doctor if you do not feel better or if you feel worse after 3-4 days.
What you need to know before taking the medicine
Do not take Ketesse:
• If you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;
• If you have asthma or have had asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (polypoid masses in the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing) or wheezing in the chest, after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• If you have suffered from photoallergic or phototoxic reactions (a particular form of redness and/or blistering of the skin following exposure to sunlight) during treatment with ketoprofen (a non-steroidal anti-inflammatory drug) or with fibrates (drugs used to reduce fat levels in the blood);
• If you suffer from a peptic ulcer/bleeding of the stomach or intestines or if you have suffered from stomach or intestinal bleeding, ulceration or perforation in the past;
• If you suffer from chronic digestive problems (e.g. indigestion, heartburn);
• If you have suffered in the past from bleeding or perforation in the stomach or intestine due to previous use of non-steroidal anti-inflammatory drugs (NSAIDs) used for pain;
• If you suffer from intestinal diseases with chronic inflammation (Crohn's disease or ulcerative colitis);
• If you suffer from severe heart failure, or have moderate to severe kidney problems or serious liver problems;
• If you have bleeding problems or clotting disorders;
• If you are severely dehydrated (have lost a large amount of body fluids) due to vomiting, diarrhoea or insufficient fluid intake;
• If you are in your third trimester of pregnancy or are breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before using Ketesse:
• If you suffer from allergies, or have had problems due to allergies in the past;
• If you have kidney problems, liver or heart problems (hypertension and/or heart failure) or fluid retention, or have previously suffered from one of these disorders;
• If you are taking diuretics or have problems with very poor hydration or have a reduced blood volume due to excessive fluid loss (for example due to excessive urination, diarrhoea, vomiting);
• If you have heart problems, have had a stroke or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes or high cholesterol, or are a smoker) you should discuss your treatment with your doctor or pharmacist; medicines like Ketesse may be associated with a small increased risk of heart attack ('myocardial infarction') or stroke. These risks are more likely with high doses of the medicine and with long-term treatment. Do not exceed the recommended dose or duration of treatment;
• If you are elderly: you are more likely to experience side effects (see section 4).
If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (this medicine may reduce your fertility, so you should not take the medicine if you are planning to become pregnant or if you are undergoing fertility tests);
• If you suffer from a disorder of blood and blood cell formation;
• If you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If you have suffered in the past from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have or have suffered in the past from other stomach or intestinal problems;
• If you have an infection – see section “Infections” below;
• If you are taking other medicines that increase the risk of peptic ulcer or bleeding, for example oral steroids, some antidepressants (SSRIs, i.e. Selective Serotonin Reuptake Inhibitors), medicines that prevent blood clots such as aspirin or anticoagulants such as warfarin. In these cases, talk to your doctor before taking this medicine: he or she may prescribe an additional medicine to protect your stomach (for example misoprostol or other medicines that block the production of stomach acids);
• If you suffer from asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyposis as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population. Administration of this medicine may cause asthma attacks or bronchospasm, particularly in subjects allergic to acetylsalicylic acid or NSAIDs.
Infections
Dexketoprofen may hide the symptoms of infection such as fever and pain. It is therefore possible that this medicine may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or get worse, contact your doctor immediately.
The use of this medicine is not recommended during chickenpox virus infection.
Children and adolescents
This medicinal product has not been studied in children and adolescents. Therefore, safety and efficacy have not been established and the product should not be used in children and adolescents.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects are listed below, in order of how likely they are to occur.
Common side effects: may affect up to 1 in 10 patients
Nausea and/or vomiting, abdominal pain mainly in the upper quadrants, diarrhoea, digestive problems (dyspepsia).
Uncommon side effects: may affect up to 1 in 100 patients
Dizziness, vertigo, drowsiness, sleep disturbances, nervousness, headache, palpitations, hot flushes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, skin rash, tiredness, pain, feeling of fever and chills, feeling generally unwell.
Rare side effects: may affect up to 1 in 1,000 patients
Peptic ulcer, peptic ulcer haemorrhagic or perforated (which may be manifested by traces of blood in the vomit or stool), fainting, high blood pressure, slow breathing, fluid retention and peripheral oedema (e.g. swollen ankles), oedema of the larynx, loss of appetite (anorexia), changes in sensation (paraesthesia), itchy rash, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute kidney failure.
Very rare side effects: may affect up to 1 in 10,000 patients
Anaphylactic reaction (hypersensitivity reaction which may also lead to collapse), ulceration of the skin, mouth, eyes and genital area (Stevens Johnson and Lyell syndromes), swelling of the face or lips and throat (angioedema), difficulty breathing due to contraction of the muscles surrounding the airways (bronchospasm), shortness of breath, fast heart beat, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), skin reactions, sensitivity to light, itching, kidney problems. Decrease in white blood cells (neutropenia), decrease in blood platelets (thrombocytopenia).
Tell your doctor immediately if you notice any side effects in your stomach or intestines at the beginning of treatment (for example, stomach pain, acidity or bleeding), if you have previously suffered from some of these side effects due to the long-term use of anti-inflammatory drugs, and especially if you are elderly.
Stop using this medicine as soon as you notice the appearance of a skin rash, or any lesions on the inside of the mouth or genitals, or any sign of allergy.
Fluid retention and swelling (particularly in the ankles and legs), increased blood pressure and heart failure have been reported during treatment with nonsteroidal anti-inflammatory drugs.
Medicines like this may be associated with a small increased risk of heart attack ('myocardial infarction') or cerebrovascular accident (stroke).
In patients with immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may rarely cause fever, headache and stiff neck.
The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal especially in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, worsening of colitis and Crohn's disease have been reported following administration. Less frequently, inflammation of the gastric wall (gastritis) has been observed.
As with other NSAIDs, haematological reactions (purpura, aplastic and haemolytic anaemia and rarely agranulocytosis and bone marrow hypoplasia) may occur.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.
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NOTA BENE: le informazioni presenti nelle schede prodotto che potrete consultare in questo sito non devono essere interpretate come consulenza medica e non intendono, né possono sostituire le prescrizioni mediche. Le immagini, se presenti, sono fornite al solo scopo illustrativo e non costituiscono elemento identificativo.