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ITAMIFAST 25 MG FILM-COATED TABLETS 10 TABLETS IN PA/PVC/AL BLISTER
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Name
ITAMIFAST 25 mg film-coated tablets
Diclofenac potassium
What it is and what it is used for
Itamifast relieves pain and reduces inflammation. Itamifast belongs to a group of medicines called NSAIDs (nonsteroidal anti-inflammatory drugs/antirheumatic drugs).
Itamifast is used to treat mild to moderate pain, such as headache, toothache, muscle and joint pain, back pain, and menstrual cramps.
In adolescents Itamifast is used for the short-term treatment of pain related to infections with inflammation of the ear, nose or throat, acute postoperative pain after minor surgery.
Contact your doctor if you do not feel better or if you feel worse after 3 days of treatment.
What you need to know before taking the medicine
Do not take Itamifast
- if you are allergic (hypersensitive) to diclofenac or any of the other ingredients of this medicine (listed in section 6)
- if you have previously had an allergic reaction such as asthma, chest pain, sneezing or skin rash when taking painkillers containing acetylsalicylic acid or other medicines for pain/inflammation that belong to the group of NSAIDs
- if you have severe liver disease
- if you have an increased tendency to bleed
- if you have porphyria (metabolic disease)
- if you have or have had a stomach or duodenal ulcer in connection with treatment with diclofenac or similar preparations
- if you have severe kidney disease
- during the last 3 months of pregnancy
- if you suffer from established heart disease and/or cerebrovascular disease, e.g. you have had a heart attack, stroke, mini-stroke (TIA) or blockage of the blood vessels to the heart or brain or an operation to remove or avoid such blockages
- if you suffer or have suffered from blood circulation problems (peripheral arterial disease)
Itamifast should not be administered to children under 14 years of age.
Before taking diclofenac make sure your doctor knows:
• If you smoke
• If you suffer from diabetes
• If you suffer from angina, blood clots, high blood pressure, increased cholesterol or increased triglycerides
Undesirable effects can be minimised by using the lowest effective dose for the shortest duration necessary.
Warnings and precautions
Talk to your doctor or pharmacist before taking Itamifast.
The aim should always be to take the lowest possible dose over the shortest possible treatment period to reduce the risk of side effects. Doses higher than recommended may carry serious risks.
Ask your doctor for advice before treatment if you have or have had any of the following diseases:
• gastrointestinal or duodenal ulcer
• inflammation of the intestine (ulcerative colitis and Crohn's disease)
• liver disease
• heart or kidney disease
• inflammation of the nasal mucosa, asthma, chronic obstructive pulmonary disease, chronic airway infection or other allergic reactions such as hives or angioedema (local swelling that appears periodically)
• systemic lupus erythematosus (connective tissue disease)
• blood disorders or diseases that cause increased bleeding tendency
• high blood pressure.
It is advisable to avoid using this medicine during chickenpox.
Elderly people should be informed of the increased risk of age-related adverse effects.
In adolescents with pain associated with infection with inflammation of the ears, nose or throat, the underlying disease should be treated with an antibiotic, as needed. Fever without inflammation is not an indication.
NSAIDs, including Itamifast, may in rare cases cause gastric ulcers which may occur at any time during treatment with or without warning. If you experience pain in your stomach or intestines, particularly if you are elderly, contact your doctor.
Like other anti-inflammatories, Itamifast may mask the signs or symptoms of infection.
Itamifast may, in rare cases, affect your blood cells in a way that weakens your immune system. If you get an infection with symptoms such as fever and severe weakness, or fever with local infection such as sore throat/mouth or urinary tract problems, you should contact your doctor immediately for blood tests to rule out a lack of white blood cells (agranulocytosis). It is important that you tell your doctor what medicine you are taking.
Stop taking Itamifast and contact your doctor immediately if you develop swelling of the face, tongue and/or throat, and/or difficulty breathing or hives together with difficulty breathing.
Very rarely, serious skin reactions have been reported in association with the use of NSAIDs. If you experience any skin rash or mucosal damage, stop using Itamifast and contact a doctor.
Taking Itamifast (as with all medicines that inhibit cyclooxygenase and prostaglandin synthesis) may make it more difficult to conceive. Ask your doctor for advice if you are planning to become pregnant or if you are having problems getting pregnant. The effect is temporary and stops when you stop taking this type of medicine.
Medicines such as Itamifast may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, have had a stroke before or think you may be at risk of these conditions (e.g. if you have high blood pressure, diabetes or high cholesterol, or are a smoker) you should discuss your treatment with your doctor or pharmacist.
Tell your doctor if you have recently had or are about to have surgery on your stomach or intestinal tract before receiving/taking/using Itamifast, as Itamifast can sometimes worsen wound healing in the intestine following surgery.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You may experience gastrointestinal problems at the beginning of treatment. These side effects usually disappear within a few days.
Common side effects (occur in more than 1 in 100 patients):
abdominal pain, nausea, vomiting, diarrhea, digestive problems, decreased appetite, flatulence, headache, dizziness, skin rash, and increased liver values.
Uncommon side effects (occur in less than 1 in 100 patients):
convulsions in the trachea.
Rare side effects (occur in less than 1 in 1,000 patients):
tiredness, swelling of the body due to fluid retention, hypersensitivity reactions (hives, allergic reaction with fall in blood pressure), stomach ulcer, stomach bleeding (vomiting mixed with blood, blood in the stool, bloody diarrhoea), problems with the large intestine (constipation, inflammation of the intestine), worsening of Crohn's disease and ulcerative colitis, inflammation of the tongue, mouth or oesophagus, inflammation of the pancreas, impotence (in this case the association is uncertain), asthma (including difficulty breathing), disturbances in liver function (inflammation of the liver, jaundice).
Very rare side effects (occur in less than 1 in 10,000 patients): effects on vision (blurred vision, double vision) and hearing (reduced hearing, tinnitus), difficulty sleeping, nightmares, irritability, anxiety, depression, memory problems, confusion, disturbed sense of reality, changes in sense of taste, effects on the heart and blood vessels (such as chest pain, fast heartbeat, high blood pressure, heart failure, heart attack, inflammation of blood vessels), effects on the composition of the blood (reduced number of platelets which can lead to small haemorrhages in the skin and mucous membranes, reduced number of white blood cells (agranulocytosis), which can weaken the immune response, breakdown of red blood cells (anaemia)), eczema, itching, redness of the skin, severe allergic reactions including Stevens-Johnson syndrome (inflammation of the mucous membranes and skin with pustules and fever) and Lyell syndrome (similar to Stevens-Johnson syndrome but with the addition of sudden peeling), hair loss, hypersensitivity to light, effects on the kidneys (e.g. reduced or stopped urine production or blood in the urine), inflammation of the membranes of the brain or lungs without bacterial cause, stroke, angioedema (e.g. swelling of the face, skin rash, difficulty breathing).
Exceptionally, severe skin infections in case of chickenpox.
Medicines like Itamifast may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
Some side effects can be serious.
Stop treatment with Itamifast and tell your doctor immediately if you experience:
• Mild cramps and abdominal tension shortly after starting treatment with Itamifast, followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from the available data).
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
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.
ITAMIFAST 25 mg film-coated tablets
Diclofenac potassium
What it is and what it is used for
Itamifast relieves pain and reduces inflammation. Itamifast belongs to a group of medicines called NSAIDs (nonsteroidal anti-inflammatory drugs/antirheumatic drugs).
Itamifast is used to treat mild to moderate pain, such as headache, toothache, muscle and joint pain, back pain, and menstrual cramps.
In adolescents Itamifast is used for the short-term treatment of pain related to infections with inflammation of the ear, nose or throat, acute postoperative pain after minor surgery.
Contact your doctor if you do not feel better or if you feel worse after 3 days of treatment.
What you need to know before taking the medicine
Do not take Itamifast
- if you are allergic (hypersensitive) to diclofenac or any of the other ingredients of this medicine (listed in section 6)
- if you have previously had an allergic reaction such as asthma, chest pain, sneezing or skin rash when taking painkillers containing acetylsalicylic acid or other medicines for pain/inflammation that belong to the group of NSAIDs
- if you have severe liver disease
- if you have an increased tendency to bleed
- if you have porphyria (metabolic disease)
- if you have or have had a stomach or duodenal ulcer in connection with treatment with diclofenac or similar preparations
- if you have severe kidney disease
- during the last 3 months of pregnancy
- if you suffer from established heart disease and/or cerebrovascular disease, e.g. you have had a heart attack, stroke, mini-stroke (TIA) or blockage of the blood vessels to the heart or brain or an operation to remove or avoid such blockages
- if you suffer or have suffered from blood circulation problems (peripheral arterial disease)
Itamifast should not be administered to children under 14 years of age.
Before taking diclofenac make sure your doctor knows:
• If you smoke
• If you suffer from diabetes
• If you suffer from angina, blood clots, high blood pressure, increased cholesterol or increased triglycerides
Undesirable effects can be minimised by using the lowest effective dose for the shortest duration necessary.
Warnings and precautions
Talk to your doctor or pharmacist before taking Itamifast.
The aim should always be to take the lowest possible dose over the shortest possible treatment period to reduce the risk of side effects. Doses higher than recommended may carry serious risks.
Ask your doctor for advice before treatment if you have or have had any of the following diseases:
• gastrointestinal or duodenal ulcer
• inflammation of the intestine (ulcerative colitis and Crohn's disease)
• liver disease
• heart or kidney disease
• inflammation of the nasal mucosa, asthma, chronic obstructive pulmonary disease, chronic airway infection or other allergic reactions such as hives or angioedema (local swelling that appears periodically)
• systemic lupus erythematosus (connective tissue disease)
• blood disorders or diseases that cause increased bleeding tendency
• high blood pressure.
It is advisable to avoid using this medicine during chickenpox.
Elderly people should be informed of the increased risk of age-related adverse effects.
In adolescents with pain associated with infection with inflammation of the ears, nose or throat, the underlying disease should be treated with an antibiotic, as needed. Fever without inflammation is not an indication.
NSAIDs, including Itamifast, may in rare cases cause gastric ulcers which may occur at any time during treatment with or without warning. If you experience pain in your stomach or intestines, particularly if you are elderly, contact your doctor.
Like other anti-inflammatories, Itamifast may mask the signs or symptoms of infection.
Itamifast may, in rare cases, affect your blood cells in a way that weakens your immune system. If you get an infection with symptoms such as fever and severe weakness, or fever with local infection such as sore throat/mouth or urinary tract problems, you should contact your doctor immediately for blood tests to rule out a lack of white blood cells (agranulocytosis). It is important that you tell your doctor what medicine you are taking.
Stop taking Itamifast and contact your doctor immediately if you develop swelling of the face, tongue and/or throat, and/or difficulty breathing or hives together with difficulty breathing.
Very rarely, serious skin reactions have been reported in association with the use of NSAIDs. If you experience any skin rash or mucosal damage, stop using Itamifast and contact a doctor.
Taking Itamifast (as with all medicines that inhibit cyclooxygenase and prostaglandin synthesis) may make it more difficult to conceive. Ask your doctor for advice if you are planning to become pregnant or if you are having problems getting pregnant. The effect is temporary and stops when you stop taking this type of medicine.
Medicines such as Itamifast may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, have had a stroke before or think you may be at risk of these conditions (e.g. if you have high blood pressure, diabetes or high cholesterol, or are a smoker) you should discuss your treatment with your doctor or pharmacist.
Tell your doctor if you have recently had or are about to have surgery on your stomach or intestinal tract before receiving/taking/using Itamifast, as Itamifast can sometimes worsen wound healing in the intestine following surgery.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You may experience gastrointestinal problems at the beginning of treatment. These side effects usually disappear within a few days.
Common side effects (occur in more than 1 in 100 patients):
abdominal pain, nausea, vomiting, diarrhea, digestive problems, decreased appetite, flatulence, headache, dizziness, skin rash, and increased liver values.
Uncommon side effects (occur in less than 1 in 100 patients):
convulsions in the trachea.
Rare side effects (occur in less than 1 in 1,000 patients):
tiredness, swelling of the body due to fluid retention, hypersensitivity reactions (hives, allergic reaction with fall in blood pressure), stomach ulcer, stomach bleeding (vomiting mixed with blood, blood in the stool, bloody diarrhoea), problems with the large intestine (constipation, inflammation of the intestine), worsening of Crohn's disease and ulcerative colitis, inflammation of the tongue, mouth or oesophagus, inflammation of the pancreas, impotence (in this case the association is uncertain), asthma (including difficulty breathing), disturbances in liver function (inflammation of the liver, jaundice).
Very rare side effects (occur in less than 1 in 10,000 patients): effects on vision (blurred vision, double vision) and hearing (reduced hearing, tinnitus), difficulty sleeping, nightmares, irritability, anxiety, depression, memory problems, confusion, disturbed sense of reality, changes in sense of taste, effects on the heart and blood vessels (such as chest pain, fast heartbeat, high blood pressure, heart failure, heart attack, inflammation of blood vessels), effects on the composition of the blood (reduced number of platelets which can lead to small haemorrhages in the skin and mucous membranes, reduced number of white blood cells (agranulocytosis), which can weaken the immune response, breakdown of red blood cells (anaemia)), eczema, itching, redness of the skin, severe allergic reactions including Stevens-Johnson syndrome (inflammation of the mucous membranes and skin with pustules and fever) and Lyell syndrome (similar to Stevens-Johnson syndrome but with the addition of sudden peeling), hair loss, hypersensitivity to light, effects on the kidneys (e.g. reduced or stopped urine production or blood in the urine), inflammation of the membranes of the brain or lungs without bacterial cause, stroke, angioedema (e.g. swelling of the face, skin rash, difficulty breathing).
Exceptionally, severe skin infections in case of chickenpox.
Medicines like Itamifast may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
Some side effects can be serious.
Stop treatment with Itamifast and tell your doctor immediately if you experience:
• Mild cramps and abdominal tension shortly after starting treatment with Itamifast, followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from the available data).
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
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.