ITAMIFAST*10FC TAB 25MG

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 (non-steroidal anti-inflammatory drugs/anti-rheumatic medicines).

Itamifast is used for the treatment of mild to moderate pain, such as headache, toothache, muscle and joint pain, back pain and menstrual pain.

In adolescents, Itamifast is used for the short-term treatment of pain related to infections with inflammation of the ear, nose or throat, acute post-operative pain after minor surgery.

Consult 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 rash when you have taken painkillers containing acetylsalicylic acid or other pain/inflammation medicines belonging to the NSAID group
- if you have severe liver disease
- if you have an increased tendency to bleed
- if you have porphyria (a 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, a stroke, a mini-stroke (TIA) or an obstruction of the blood vessels leading to the heart or brain or an operation to eliminate or avoid such obstructions
- if you suffer or have suffered from circulatory problems (peripheral arterial disease)

Itamifast should not be given to children under 14 years of age.

Before taking diclofenac, make sure your doctor is aware:
• If you smoke
• If you have diabetes
• If you suffer from angina, blood clots, high blood pressure, increased cholesterol or increased triglycerides

Side effects can be minimised by using the lowest effective dose for the shortest necessary duration.

Warnings and precautions
Consult your doctor or pharmacist before taking Itamifast.
The aim should always be to take the lowest possible dose for the shortest possible treatment period to reduce the risk of side effects. Doses higher than those recommended can lead to 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 mucous membranes, asthma, chronic obstructive pulmonary disease, chronic airway infection or other allergic reactions such as urticaria or angioedema (local swelling that appears periodically)
• systemic lupus erythematosus (connective tissue disease)
• blood disorders or diseases that cause an increased tendency to bleed
• high blood pressure.

It is advisable to avoid the use of this medicine during chickenpox.

Elderly people should be informed of the increased risk of age-related side effects.

In adolescents with pain associated with infection with inflammation of the ears, nose or throat, the underlying condition should be treated with an antibiotic, according to therapeutic needs. Fever without inflammation is not an indication.

NSAIDs, including Itamifast, can in rare cases cause gastric ulcer, which can occur at any time during treatment with or without warning. If you experience stomach or intestinal pain, especially if you are elderly, contact your doctor.

Like other anti-inflammatory drugs, Itamifast can mask the signs or symptoms of infection.

Itamifast can, in rare cases, affect blood cells in such a way as to weaken your immune system. If you get an infection with symptoms such as fever and severe debility, or fever with local infection such as sore throat/mouth or urinary tract problems, you should immediately contact your doctor for blood tests to rule out a lack of white blood cells (agranulocytosis). It is important that you inform your doctor about the medicine you are taking.

Stop treatment with Itamifast and contact your doctor immediately if you develop swelling of the face, tongue and/or throat, and/or difficulty breathing or urticaria together with difficulty breathing.

Very rarely, severe skin reactions have been reported in association with the use of NSAIDs. If you experience any rash or damage to the mucous membrane, 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 a pregnancy or if you are having problems getting pregnant. The effect is temporary and ceases when you stop taking this type of medicine.

Medicines such as Itamifast may be associated with a small increased risk of heart attacks (“myocardial infarction”) or stroke. Any risk is more likely with high doses and with prolonged treatment. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, have had a stroke previously 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.

Inform your doctor if you have recently undergone or are about to undergo surgery to the stomach or intestinal tract before receiving/taking/using Itamifast, as Itamifast may sometimes worsen wound healing in the intestine after 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, diarrhoea, digestive problems, decreased appetite, flatulence, headache, dizziness, rash and increased liver values.

Uncommon side effects (occur in less than 1 in 100 patients):
bronchospasm.

Rare side effects (occur in less than 1 in 1,000 patients):
fatigue, body swelling due to fluid retention, hypersensitivity reactions (urticaria, allergic reaction with drop in blood pressure), stomach ulcer, stomach bleeding (vomiting mixed with blood, blood in faeces, 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), impaired 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 disorders, confusion, disturbed sense of reality, altered sense of taste, effects on the heart and blood vessels (such as chest pain, tachycardia, high blood pressure, heart failure, heart attack, inflammation of blood vessels), effects on blood composition (reduced number of platelets which can lead to small skin and mucous membrane haemorrhages, reduced number of white blood cells (agranulocytosis), which can weaken the immune response, red blood cell breakdown (anaemia)), eczema, itching, skin redness, severe allergic reactions including Stevens-Johnson syndrome (inflammation of mucous membranes and skin with pustules and fever) and Lyell's syndrome (similar to Stevens-Johnson syndrome but with the addition of sudden peeling), hair loss, light hypersensitivity, effects on the kidneys (e.g. reduced or blocked urine production or blood in the urine), inflammation of the brain or lung membranes without bacterial cause, stroke, angioedema (e.g. swelling of the face, rash, difficulty breathing).

Exceptionally, severe skin infections in case of chickenpox.

Medicines such as 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 tenderness 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, including any not listed in this leaflet, talk to your doctor or pharmacist. 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.