Itamifast

PACKAGE LEAFLET: Information for the User

ITAMIFAST 25 mg film-coated tablets

diclofenac potassium
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. (See section 4)
• Contact your doctor if you do not notice any improvement or if you notice worsening of symptoms after 3 days.

Contents of this leaflet:

1. What Itamifast is and what it is used for
2. What you need to know before taking Itamifast
3. How to take Itamifast
4. Possible side effects
5. How to store Itamifast
6. Contents of the pack and other information

1. What Itamifast 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,
muscular and joint pain, backache and menstrual pain.
In adolescents, Itamifast is used for the short-term treatment of pain associated with infections causing
inflammation of the ear, nose or throat, and for acute postoperative pain following minor surgery.
Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you need to know before taking Itamifast

Do not take Itamifast

• if you are allergic (hypersensitive) to diclofenac or to any of the other ingredients of this medicine (listed in section 6)
• if you previously had an allergic reaction such as asthma, chest pain, sneezing, or skin rash when taking painkillers containing acetylsalicylic acid or other pain/inflammation medicines belonging to the group of NSAIDs
• if you have severe liver disease
• if you have a tendency to bleed easily
• if you have porphyria (a metabolic disorder)
• if you currently have or have previously had a stomach or duodenal ulcer related to treatment with diclofenac or similar preparations
• if you have severe kidney disease
• during the last 3 months of pregnancy
• if you have established heart disease and/or cerebrovascular disease, e.g., you have had a heart attack, stroke, mini-stroke (TIA), or blockage of blood vessels supplying the heart or brain, or undergone a procedure to remove or prevent such blockages
• if you currently have or have previously had circulation problems (peripheral arterial disease)

Itamifast must not be administered to children under 14 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Itamifast.
The aim should always be to take the lowest possible dose for the shortest possible duration of treatment
to minimize the risk of adverse effects. Doses higher than those recommended may
pose serious risks.
Consult your doctor before starting treatment if you have or have previously had any of the following conditions:

• gastrointestinal or duodenal ulcer
• intestinal inflammation (ulcerative colitis and Crohn’s disease)
• liver disease
• heart or kidney disease
• nasal mucosal inflammation, asthma, chronic obstructive pulmonary disease (COPD), chronic airway infection, or other allergic reactions such as urticaria or angioedema (periodic local swelling)
• systemic lupus erythematosus (a connective tissue disease)
• blood disorders or diseases causing increased tendency to bleed
• high blood pressure.

Before taking diclofenac, make sure your doctor is aware:

• if you smoke
• if you have diabetes
• if you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides
• if you have ever developed severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers after taking Itamifast or other analgesics

Adverse effects can be minimized by using the lowest effective dose for the shortest necessary duration.
It is advisable to avoid using this medicine during chickenpox.
Elderly people should be informed about the increased risk of age-related adverse effects.
In adolescents with pain associated with infection and inflammation of the ears, nose, or throat, the underlying condition should be treated with an antibiotic, as clinically indicated. Fever without inflammation is not an indication.
NSAIDs, including Itamifast, may rarely cause gastric ulcers, which can occur at any time during treatment, with or without warning symptoms. If you experience stomach or intestinal pain, especially if you are elderly, contact your doctor.
Like other anti-inflammatory drugs, Itamifast may mask signs or symptoms of infection.
Itamifast may, in rare cases, affect blood cells, thereby weakening your immune system. If you develop an infection with symptoms such as fever and severe weakness, or fever with localized infection such as sore throat/mouth or urinary tract problems, you must contact your doctor immediately for blood tests to rule out a deficiency in white blood cells (agranulocytosis). It is important that you inform your doctor about the medicines 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 accompanied by breathing difficulties.
Very rarely, serious skin reactions have been reported in association with the use of NSAIDs. If you develop 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. Consult your doctor if you are planning a pregnancy or are experiencing difficulties becoming pregnant. This effect is temporary and stops when you discontinue 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 higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, have previously had a stroke, or think you may be at risk of these conditions (e.g., if you have high blood pressure, diabetes, high cholesterol, or are a smoker), discuss your treatment with your doctor or pharmacist.
Inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving/using/taking Itamifast, as Itamifast may sometimes impair wound healing in the intestine following surgery.
Other medicines and Itamifast
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Itamifast may interact with or be affected by other medicines containing the following active ingredients:

• anticoagulants (e.g., warfarin, ticlopidine, acetylsalicylic acid, heparin)
• medicines for diabetes, except insulin
• lithium or SSRIs (used for various forms of depression)
• digoxin (used for heart problems)
• tacrolimus (used in transplant patients and for eczema)
• cyclosporine (used in transplant patients, for severe psoriasis, and rheumatic diseases)
• certain medicines for high blood pressure (beta-blockers, angiotensin II receptor antagonists, and ACE inhibitors)
• diuretics (agents that stimulate urine production and are used for high blood pressure)
• quinolone antibiotics (used to treat urinary tract infections)
• corticosteroids (used to treat inflammatory diseases)
• colestipol and cholestyramine (used to treat high blood fat levels)
• rifampicin (an antibiotic used for tuberculosis)
• carbamazepine (used for epilepsy)
• St. John’s wort (used for depression)
• phenytoin (used for epilepsy)
• methotrexate (used for psoriasis, rheumatic diseases, and some cancers).

Never take different types of painkillers simultaneously without a doctor’s prescription.
Itamifast with food and drinks
The tablets should be swallowed whole with liquid. To achieve the best effect, they should not be taken with a meal or immediately after a meal.
Pregnancy, breastfeeding, and fertility

• Do not take Itamifast during the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause kidney and heart problems in the fetus. It may affect your and your baby’s tendency to bleed and delay or prolong labor more than expected. You should not take Itamifast during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed during this period or when trying to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy, Itamifast may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or constricting a blood vessel (ductus arteriosus) in the fetal heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.

• The medicine passes into breast milk with potential effects on the infant. Therefore, Itamifast must not be used during breastfeeding. Consult your doctor before taking any medicine while breastfeeding.

Driving and using machines
In some people, Itamifast may cause adverse effects such as visual disturbances, dizziness, and drowsiness.
Itamifast contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.

3. How to take Itamifast

The dose has been personally prescribed for you by a doctor. The dose and duration of treatment will depend on the type of pain condition.
Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Acute pain conditions, such as headache, toothache, muscle and joint pain, or menstrual pain:
Usual dose in adults and adolescents over 14 years: 25 mg taken every 8 hours as needed. Do not take more than 75 mg within 24 hours, corresponding to 3 tablets of 25 mg, within 24 hours. Do not exceed the recommended dose.
The tablets must be swallowed whole with liquid. For optimal effect, they should not be taken with food.
If you have any doubts, consult your doctor or pharmacist. If you think that the effect of Itamifast is too strong or too weak, contact your doctor.
If you take more Itamifast than you should
If you have taken more Itamifast than you should, or if a child has accidentally taken Itamifast, contact your doctor or go to hospital for advice on possible risks and necessary measures.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Some side effects may be serious.
Stop treatment with Itamifast and contact your doctor immediately if you notice any of the following serious side effects. You may require urgent medical care:

• Mild cramps and abdominal discomfort shortly after starting treatment with Itamifast, followed by rectal bleeding or hemorrhagic diarrhea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated based on available data).
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.
• A severe skin allergic reaction that may include widespread red and/or dark patches, skin swelling, blisters, and itching (Generalized fixed drug eruption).

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, rash, and increased liver values.
Uncommon side effects (occur in less than 1 in 100 patients):
tracheal seizures.
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 low blood pressure), stomach ulcer, stomach bleeding (vomiting blood, blood in stools, hemorrhagic diarrhea), problems affecting the large intestine (constipation, intestinal inflammation), worsening of Crohn’s disease and ulcerative colitis, inflammation of the tongue, mouth or esophagus, pancreatitis, impotence (causal relationship uncertain in this case), asthma (including difficulty breathing), liver function disorders (liver inflammation, jaundice).
Very rare side effects (occur in less than 1 in 10,000 patients):
effects on vision (blurred vision, double vision) and hearing (hearing loss, tinnitus), difficulty sleeping, nightmares, irritability, anxiety, depression, memory disturbances, confusion, distorted sense of reality, disturbances in taste perception, 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 platelet count which may lead to minor skin and mucosal bleeding, reduced white blood cell count (agranulocytosis), which may impair immune response, red blood cell breakdown (hemolytic anemia)), 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 sudden skin peeling), hair loss, photosensitivity, effects on the kidneys (e.g. reduced or blocked urine production or blood in urine), inflammation of the membranes of the brain or lungs without bacterial cause, stroke, angioedema (e.g. facial swelling, skin rash, difficulty breathing).
Side effects with unknown frequency (cannot be estimated from available data):
A skin allergic reaction, which may include round or oval patches with redness and swelling of the skin, blistering rash, and itching (Fixed drug eruption). Darkening of the skin in the affected areas may also occur, which may persist after healing. A fixed drug eruption usually recurs at the same site (or sites) if the medicine is taken again.
Exceptionally, severe skin infections may occur in case of chickenpox.
Medicines such as Itamifast may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Itamifast

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of the month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Itamifast contains

• The active substance is potassium diclofenac. Each tablet contains 25 mg of potassium diclofenac.
• The other components are: potassium hydrogen carbonate, mannitol, sodium lauryl sulfate, macrogol, crospovidone, magnesium stearate, hypromellose.

Description of the appearance of Itamifast and pack contents
The tablets are white, round and biconvex.
Blister pack (25 mg) containing 10 or 20 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)
Italy

Responsible manufacturer for batch release
Laboratorio Farmacologico Milanese S.r.l.
Via Monterosso, 273
21042 Caronno Pertusella (VA)
Italy

Product manufactured by APR Applied Pharma Research SA under license to Fidia Farmaceutici S.p.A.

PATIENT INFORMATION LEAFLET: Information for the user

ITAMIFAST 50 mg film-coated tablets

potassium diclofenac
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist (see section 4).

Contents of this leaflet:

1. What Itamifast is and what it is used for
2. What you need to know before taking Itamifast
3. How to take Itamifast
4. Possible side effects
5. How to store Itamifast
6. Contents of the pack and other information

1. What Itamifast 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 to treat mild to moderate pain, such as headache, toothache, muscle and joint pain, back pain, and menstrual pain.
In children and adolescents, Itamifast is used for the short-term treatment of pain associated with infections causing inflammation of the ear, nose, or throat, and for acute postoperative pain following minor surgery.

2. What you should know before taking Itamifast

Do not take Itamifast

• if you are allergic (hypersensitive) to diclofenac or to 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 pain/inflammation medicines belonging to the group of NSAIDs
• if you have severe liver disease
• if you have an increased tendency to bleed
• if you have porphyria (a metabolic disorder)
• if you have or have had a stomach or duodenal ulcer related to treatment with diclofenac or similar preparations
• if you have severe kidney disease
• during the last 3 months of pregnancy
• if you have established heart disease and/or cerebrovascular disease, e.g., you have had a heart attack, stroke, mini-stroke (TIA), or blockage of blood vessels to the heart or brain, or undergone a procedure to remove or prevent such blockages
• if you have or have had circulatory problems (peripheral arterial disease)

Warnings and precautions
Talk to your doctor or pharmacist before taking Itamifast.
The aim should always be to take the lowest possible dose for the shortest possible duration
of treatment to reduce the risk of unwanted effects. Doses higher than those recommended may
involve serious risks.
Consult your doctor before treatment if you have or have had any of the following conditions:

• gastric or duodenal ulcer
• inflammation of the intestine (ulcerative colitis and Crohn's disease)
• liver disease
• heart or kidney disease
• inflammation of nasal mucosa, asthma, chronic obstructive pulmonary disease, chronic respiratory tract infection, or other allergic reactions such as urticaria or angioedema (localized swelling that occurs periodically)
• systemic lupus erythematosus (a connective tissue disease)
• blood disorders or diseases causing increased bleeding tendency
• high blood pressure

Before taking diclofenac, make sure your doctor is aware if:

• You smoke
• You have diabetes
• You have angina, blood clots, high blood pressure, high cholesterol or high triglycerides
• You have ever developed severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers after taking Itamifast or other analgesics.

Unwanted effects can be minimized by using the lowest effective dose for the shortest necessary duration.
It is advisable to avoid using this medicine during chickenpox.
Elderly people should be informed about the higher risk of age-related unwanted effects.
In children and adolescents with pain associated with infection and inflammation of the ears, nose or throat,
the underlying condition should be treated with an antibiotic, as clinically indicated. Fever without
inflammation is not an indication.
NSAIDs, including Itamifast, may rarely cause gastric ulceration, which may occur at any time
during treatment, with or without warning symptoms. If you experience stomach or intestinal pain, especially if you are elderly, contact your doctor.
Like other anti-inflammatory medicines, Itamifast may mask signs or symptoms of infection.
Itamifast may, in rare cases, affect blood cells in a way that weakens your immune system. If you develop an infection with symptoms such as fever and severe weakness, or fever with a localized infection such as sore throat/mouth or urinary tract problems, you must contact your doctor immediately for blood tests to rule out a deficiency 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, serious skin reactions have been reported in association with the use of NSAIDs. If you develop 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. Consult your doctor if you are planning a pregnancy or are experiencing difficulties becoming pregnant. This effect is temporary and stops when you discontinue 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 higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, have previously had a stroke, or think you may be at risk of these conditions (e.g., if you have high blood pressure, diabetes, high cholesterol or are a smoker), discuss your treatment with your doctor or pharmacist.
Inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving/taking/using Itamifast, as Itamifast may sometimes impair wound healing in the intestine following surgery.

Other medicines and Itamifast
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription.
Itamifast may affect or be affected by other medicines containing the following active substances:

• medicines for blood clotting (e.g., warfarin, ticlopidine, acetylsalicylic acid, heparin)
• medicines for the treatment of diabetes, except insulin
• lithium or SSRIs (used for various forms of depression)
• digoxin (used for heart problems)
• tacrolimus (used during transplants and for eczema)
• cyclosporine (used during transplants, for severe psoriasis and for rheumatism)
• certain medicines for high blood pressure (beta-blockers, angiotensin II receptor antagonists and ACE inhibitors)
• diuretics (agents that stimulate urine production and are used for high blood pressure)
• quinolone antibiotics (used to treat urinary tract infections)
• corticosteroids (used for the treatment of inflammatory diseases)
• colestipol and cholestyramine (used for treating high blood fat levels)
• rifampicin (an antibiotic used for tuberculosis)
• carbamazepine (used for epilepsy)
• St. John's wort (used for depression)
• phenytoin (used for epilepsy)
• methotrexate (used for psoriasis, rheumatism and some cancers)

Never take different types of painkillers simultaneously without a doctor's prescription.

Itamifast with food and drinks
The tablets should be swallowed whole with liquid. To achieve the best effect, they should not be taken with a meal or immediately after a meal.

Pregnancy, breastfeeding and fertility

• Do not take Itamifast during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your bleeding tendency and that of the baby, and delay or prolong labor more than expected. You should not take Itamifast during the first 6 months of pregnancy unless absolutely necessary and
  under medical advice. If treatment is needed during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy, Itamifast may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or constricting a blood vessel (ductus arteriosus) in the fetal heart. If treatment for more than a few days is needed, your doctor may recommend additional monitoring.

• The medicine passes into breast milk with a risk of effects on the baby. Therefore, Itamifast must not be used during breastfeeding. Consult your doctor before taking any medicine during breastfeeding.

Driving and using machines
In some people, Itamifast may cause unwanted effects such as visual disturbances, dizziness and drowsiness.
Itamifast contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to take Itamifast

The dose has been personally prescribed for you by a doctor. The dose and duration of treatment will depend on the type of pain condition.
Always take this medicine exactly as directed by your doctor or pharmacist.

Acute pain conditions, such as headache, toothache, muscle and joint pain, or menstrual pain:
Usual dose in adults and adolescents above 16 years: 50 mg taken every 4–6 hours as needed. Do not take more than 150 mg within 24 hours, corresponding to 3 tablets of 50 mg, within 24 hours. Do not exceed the recommended dose.

Children (above 9 years)
Acute painful conditions in children and adolescents with infections causing inflammation of the ear, nose, and throat, and after minor surgery.
Usual dose in children aged 9–11 years (over 35 kg): 1 tablet of 25 mg 3 times a day, evenly distributed over 24 hours. Do not exceed the recommended dose.
Usual dose in children aged 12–16 years: 1 tablet of 25 mg 3–4 times a day, evenly distributed over 24 hours. Do not exceed the recommended dose.

The tablets must be swallowed whole with liquid. For optimal effect, they should not be taken with food.

If you have any doubts, consult your doctor or pharmacist. If you think that the effect of Itamifast is too strong or too weak, contact your doctor.

If you take more Itamifast than you should
If you have taken more Itamifast than you should, or if a child has accidentally taken Itamifast, contact your doctor or go to hospital immediately to receive advice on potential risks and necessary measures.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects may be serious.
Stop treatment with Itamifast and contact your doctor immediately if you notice any of the following serious side effects. You may need emergency medical treatment:

• Mild cramps and abdominal discomfort shortly after starting treatment with Itamifast, followed by rectal bleeding or hemorrhagic diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from available data).
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.
• A severe skin allergic reaction that may include widespread red and/or dark patches, skin swelling, blisters, and itching sensation (Fixed drug eruption with generalized bullous rash).

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 disorders, decreased appetite, flatulence, headache, dizziness, skin rash, and increased liver values.

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

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 blood, blood in stools, hemorrhagic 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 (causal relationship uncertain), asthma (including difficulty breathing), liver function disorders (liver inflammation, 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 disturbances, confusion, distorted sense of reality, changes in taste sensation, 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 platelet count which may lead to minor bleeding of the skin and mucous membranes, reduced white blood cell count (agranulocytosis), which may weaken the immune response, breakdown of red blood cells (anaemia)), eczema, pruritus, 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 sudden skin peeling), hair loss, photosensitivity, effects on the kidneys (e.g. reduced or blocked urine production or blood in urine), inflammation of the membranes of the brain or lungs without bacterial cause, stroke, angioedema (e.g. facial swelling, skin rash, breathing difficulties).

Side effects not known (frequency cannot be estimated from available data):
A skin allergic reaction, which may include round or oval patches with redness and swelling of the skin, blistering rash, and itching sensation (Drug eruption, fixed type). Darkening of the skin in the affected areas may also occur, which could persist after healing. A fixed drug eruption usually recurs at the same site (or sites) if the medicine is taken again.
Exceptionally, severe skin infections may occur in case of chickenpox.
Medicines such as Itamifast may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

Reporting of side effects
If you experience any side effect, including those 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/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store itamifast

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of the month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Itamifast contains

• The active substance is potassium diclofenac. Each tablet contains 50 mg of potassium diclofenac.
• The other components are: potassium hydrogen carbonate, mannitol, sodium lauryl sulfate, macrogol, crospovidone, magnesium stearate, hypromellose.

Description of the appearance of Itamifast and pack contents
The tablets are white, round and biconvex.
Blister pack (50 mg) containing 20 and 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica 3/A
35031 Abano Terme – PD
Italy

Manufacturer responsible for batch release
Laboratorio Farmacologico Milanese S.r.l.
Via Monterosso, 273
21042 Caronno Pertusella (VA)
Italy

Product developed by APR Applied Pharma Research SA under license to Fidia Farmaceutici S.p.A.