FEDOTASK 200 mg Proszek Doustny

Treść ulotki

1. FEDOTASK 200 mg oral powder in sachet
   1. What is FEDOTASK and what is it used for
   2. What you need to know before taking FEDOTASK
   3. How to take FEDOTASK
   4. Possible side effects
   5. How to store FEDOTASK
   6. Contents of the pack and other information
2. FEDOTASK 400 mg oral powder in sachet
   1. What is FEDOTASK and what is it used for
   2. What you need to know before taking FEDOTASK
   3. How to take FEDOTASK
   4. Possible side effects
   5. How to store FEDOTASK
   6. Contents of the pack and other information

FEDOTASK 200 mg oral powder in sachet

Ibuprofen

Read this leaflet carefully before taking this medicine as 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days if you have a fever or after 5 days if you have pain (3 days in children and adolescents).

Contents of this leaflet:

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

1. What is FEDOTASK and what is it used for

FEDOTASK contains ibuprofen as the active ingredient and belongs to a group of
medicines known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
This medicine is used in adults, adolescents and children weighing more than
20 kg (approximately 7 years of age) for the symptomatic relief of occasional mild to
moderate pain, such as headache, toothache, menstrual, muscular (spasms) or back
pain (lumbago), as well as in febrile states.

2. What you need to know before taking FEDOTASK

Do not take FEDOTASK

• if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6) or to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Allergic reactions may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, shortness of breath or asthma.
• if you have ever had a haemorrhage or perforation of the stomach or intestine related to a previous therapy with NSAIDs.
• if you have an ulcer (peptic ulcers) or recurrent bleeding in the stomach or duodenum or if you have had this problem repeatedly (two or more distinct episodes of ulceration or bleeding) in the past.
• if you vomit blood or if your stools are black or you have diarrhoea with blood.
• if you suffer from severe liver, kidney or heart failure.
• if you have bleeding disorders or blood coagulation disorders or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulants simultaneously, the doctor will perform blood coagulation tests.
• if you are severely dehydrated (due to vomiting, diarrhoea or insufficient fluid intake).
• if you are a woman in the third trimester of pregnancy (see “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking FEDOTASK:

• If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you are receiving treatment with this medicine, as it may mask fever, which is an important sign of infection, making diagnosis difficult.
• If you have kidney or liver disease, are over 60 years old or need to take the medicine for a long period (more than 1 or 2 weeks); the doctor may need to check you regularly. The doctor will tell you how often these checks will be.
• If you have had or develop an ulcer, bleeding or perforation of the stomach or duodenum, which may manifest with severe or persistent abdominal pain and/or black stools, or even without any prior warning symptoms. This risk is greater when using high doses and prolonged treatments, in patients with a history of peptic ulcer and in the elderly. In these cases, the doctor will assess the possibility of combining a medicine for stomach protection.
• If you suffer from acute intermittent porphyria (a metabolic disease that affects the blood and can cause symptoms such as reddish urine, blood in the urine or liver disease), the doctor will assess whether treatment with ibuprofen is appropriate or not.
• If you suffer from systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin and joints) as it may manifest as aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you suffer from or have suffered from bowel diseases (ulcerative colitis or Crohn's disease), as they may worsen (see section 4 “Possible side effects”).
• If you are being treated with diuretics (medicines to urinate) because the doctor must monitor kidney function.
• If you are taking other medicines that could increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), blood thinners (e.g. warfarin), selective serotonin reuptake inhibitors (medicines used for depression) and antiplatelet agents (e.g. acetylsalicylic acid).
• If you suffer from or have suffered from heart disease.
• If you have high blood pressure.
• If you suffer from headaches after prolonged treatment, you should not take higher doses of the medicine.
• If you suffer from allergies (e.g. skin reactions to other substances, asthma, hay fever), nasal polyps, chronic swelling of the nasal mucosa or chronic obstructive respiratory diseases, as in that case you are at greater risk of allergic reactions.
• If you have just undergone major surgery.
• If you have chickenpox.
• If you have an infection: see the "Infections" section below.

Skin reactions
Serious skin reactions have been reported in association with treatment with ibuprofen
including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic
epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute
generalized exanthematous pustulosis (AGEP). Stop using FEDOTASK and contact
your doctor immediately if you notice any of the symptoms related to these serious skin
reactions described in section 4.
Side effects can be limited by using the lowest effective dose for the shortest
time possible needed to control the symptoms.

Cardiovascular precautions
Anti-inflammatory/pain relievers such as ibuprofen may be associated with a slight
increased risk of heart attack or stroke, especially if used in high doses. Do not exceed the
recommended dose or duration of treatment.
You should discuss the treatment with your doctor or pharmacist before taking FEDOTASK:

• If you have heart problems including heart failure, angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral artery disease (problems with circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including a “mini-stroke” or a transient ischemic attack “TIA”)
• If you have high blood pressure, diabetes, high cholesterol
• If you have a family history of heart disease or stroke
• If you are a smoker.

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema) and chest pain have been reported with ibuprofen.
Stop FEDOTASK immediately and contact your doctor or emergency health service immediately if you notice any of these signs.

Infections
FEDOTASK can mask the signs of an infection, such as fever and pain. Consequently,
FEDOTASK can delay adequate treatment of the infection, increasing the risk of
complications. This has been observed in pneumonia caused by bacteria and skin infections
related to varicella. If you take this medicine while you have
an infection and the symptoms of the infection persist or worsen, consult your doctor immediately.

Precautions during pregnancy and breastfeeding
Since taking medicines such as FEDOTASK has been associated with an increased risk
of congenital abnormalities/miscarriage, its use is not recommended during the
first and second trimester of pregnancy unless deemed strictly
necessary. In these cases the dose and duration will be limited to the minimum possible.
In the third trimester, taking this medicine is contraindicated.
If you are a woman of childbearing potential, you should consider that medicines such as FEDOTASK have been
associated with a reduced ability to conceive.

Elderly
Elderly people taking NSAIDs are at greater risk of side effects, particularly
those related to the stomach and intestines. For more information, see section 4
“Possible side effects”.
If you have a history of gastrointestinal toxicity, especially if you are elderly, report any
unusual abdominal symptoms (especially bleeding in the stomach or intestines), in
particular in the early stages of treatment.
There is a risk of kidney impairment in dehydrated elderly patients.

Children and adolescents
There is a risk of kidney impairment in dehydrated children and adolescents.

Other medicines and FEDOTASK
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
FEDOTASK can affect or be affected by other medicines. For example:

• other non-steroidal anti-inflammatory drugs such as aspirin, as the risk of gastrointestinal ulcer and bleeding may be increased
• corticosteroids (such as cortisone and prednisolone)
• other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib) as these may increase the risk of bleeding and gastrointestinal ulcers
• anticoagulant medicines and antiplatelet agents (prevent blood clots from forming, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• selective serotonin reuptake inhibitors (medicines used for depression)
• lithium (a medicine used to treat depression). The doctor may adjust your dose of this medicine
• potassium-sparing diuretics
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-based medicines, angiotensin-II receptor antagonists such as losartan)
• diuretics (medicines used to increase urine production), as they may increase the risk of kidney toxicity
• methotrexate (a medicine used for cancer or rheumatism). The doctor may change the dose of this medicine
• tacrolimus (a medicine used to suppress the immune response)
• cyclosporine (a medicine used to suppress the immune response)
• zidovudine (a medicine for the treatment of AIDS)
• sulfonamides such as tolbutamide (antidiabetic drugs) as they may cause hypoglycemia
• probenecid (used in patients with gout or together with penicillin for infections)
• sulfinpyrazone (for gout)
• aminoglycoside antibiotics
• digoxin and cardiac glycosides (used for the treatment of heart disorders)
• hydantoins such as phenytoin (used for the treatment of seizures)
• quinolone antibiotics
• cholestyramine (a medicine used to treat high cholesterol)
• CYP2C9 inhibitors such as voriconazole and fluconazole (used for the treatment of fungal infections)
• mifepristone (abortion inducer)
• pentoxifylline (for intermittent claudication)
• thrombolytics (drugs that dissolve blood clots)
• sulfamides such as sulfamethoxazole and cotrimoxazole (used to treat some bacterial infections)
• herbal extracts: ginkgo biloba may increase the risk of bleeding

Other medicines can also affect or be affected by treatment with
FEDOTASK.
Therefore, always consult your doctor or
pharmacist before taking FEDOTASK with other medicines.
Taking ibuprofen can alter the following laboratory tests:

• Bleeding time (may last for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen levels and serum creatinine and potassium levels (mayincrease)
• Liver function tests: increased transaminase values

Tell your doctor if you are about to undergo a clinical test and are taking or have recently
taken ibuprofen.

FEDOTASK with food and alcohol
It is recommended to take the medicine during or after meals to reduce
the possibility of stomach discomfort.
Alcohol consumption should be avoided during treatment with ibuprofen as
it may increase adverse reactions at the gastrointestinal level.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Do not take FEDOTASK if you are in the last 3 months of pregnancy, as it may harm
the fetus or cause problems during childbirth. This medicine can cause problems with the kidneys and
heart of 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 FEDOTASK in the
first 6 months of pregnancy unless absolutely necessary and under the advice of a doctor.
If you need treatment during this period or during attempts to conceive,
the minimum dose should be used for the shortest possible time. From the 20th week
of pregnancy onwards, FEDOTASK can cause kidney problems in the fetus, if taken for more than
a few days, reducing the levels of amniotic fluid surrounding the baby
(oligohydramnios) or causing a narrowing of a blood vessel (ductus arteriosus) in the
baby's heart. If you need treatment for more than a few days, your doctor
may recommend additional monitoring.
Breastfeeding
Although only minimal amounts of the medicine are excreted in breast milk, it
is recommended not to take ibuprofen for prolonged periods during breastfeeding.

Driving and operating machinery
If you experience dizziness, vertigo, visual disturbances or other symptoms while taking this
medicine, you should not drive or operate dangerous machinery. If you take only one dose of
ibuprofen or take it for a short period, you do not need to take special precautions.
Ibuprofen can delay the reaction time. This should be taken into consideration
before undertaking activities that require greater attention, such as driving and
operating machinery.
This is especially true when combined with alcohol.

FEDOTASK contains isomalt
If you have been diagnosed with an intolerance to certain sugars, contact your
doctor before taking this medicine.

3. How to take FEDOTASK

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This medicine is only for occasional use and for limited periods.
The lowest effective dose should be used for the shortest time necessary to relieve symptoms. In case of infection, consult your doctor immediately if the symptoms (such as fever and pain) persist or worsen (see paragraph 2). Taking this medicine depends on the onset of pain or fever. When these symptoms disappear, the medicine should be stopped.
Method of administration
Put the oral powder on your tongue, let it dissolve and then swallow; water is not necessary. You can also take FEDOTASK on an empty stomach. If you suffer from stomach discomfort, it is recommended to take FEDOTASK during or after meals.
The recommended dose is:

Use in children
The use of this medicine in children weighing less than 20 kg (approximately 7 years) is not recommended.

• Children weighing more than 20 kg (approximately 7 years)

Adults and adolescents over 12 years of age (over 40 kg in weight)
The initial dose is between 200 mg and 400 mg of ibuprofen, depending on the intensity of the symptoms.

Elderly
The dosage must be established by the doctor as a reduction of the usual dose may be necessary.

Patients with kidney, liver or heart disease
If you have kidney, liver or heart problems, always consult your doctor before taking FEDOTASK because a reduction of the usual dose may be necessary.

Duration of treatment
Children and adolescents
Consult your doctor if symptoms worsen or if the use of this medicine is necessary for more than 3 days.
Adults
Consult your doctor if your symptoms worsen, or if taking this medicine is necessary for more than 5 days in case of pain or 3 days in case of fever.
If you think that the action of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more FEDOTASK than you should
If you have taken more FEDOTASK than you should or if your child has taken this medicine by mistake, contact your doctor or the nearest hospital immediately to get an opinion on the risk and ask for advice on the actions to be taken.
Symptoms
The symptoms of ibuprofen overdose appear within 4-6 hours.
These overdose symptoms may include nausea, stomach pain, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion and involuntary eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in the urine, low levels of potassium in the blood, chills and breathing problems have been reported. Rarely, an increase in plasma acidity (metabolic acidosis), hypothermia (lowering of body temperature), kidney effects, gastrointestinal bleeding, coma, apnea (cessation of breathing), depression of the central nervous system and respiratory system have also been reported. In cases of significant overdose, kidney failure and liver damage are possible. In these cases, the doctor will take the necessary measures.

If you forget to take FEDOTASK
Do not take a double dose to make up for a missed dose.
If you forget to take the corresponding dose, take it as soon as you remember. However, if the time of the next dose is too close, skip the missed dose and take the next dose at the usual time.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The incidence of side effects is lower with short treatments and if the daily dose is
lower than the maximum recommended dose.

Stop taking this medicine and contact your doctor immediately if you
experience:

• Allergic reactions such as skin rashes, facial swelling, wheezing or difficulty breathing
• Vomiting with blood or with an appearance similar to coffee grounds
• Blood in the stool or bloody diarrhea
• Severe stomach pain
• Blisters or severe skin peeling
• Severe or persistent headache
• Yellowing of the skin (jaundice)
• Signs of severe hypersensitivity
• Swelling of the extremities or fluid retention in the arms or legs
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome
• Flat, reddish, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis]
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome)
• Widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis)

Contact your doctor if you experience any of the following side effects, if they
worsen or if you notice any effect not listed.
The frequencies shown below refer to short-term use of maximum daily
doses of 1200 mg of oral ibuprofen:

Common(may affect up to 1 in 10 people):

• feeling of dizziness or lightheadedness, headache
• gastrointestinal bleeding, especially in the elderly, nausea, vomiting, diarrhea, flatulence, dyspepsia (disturbance of secretion or intestinal motility), constipation, abdominal pain, blood in the stool, vomiting with blood

Uncommon(may affect up to 1 in 100 people):

• sneezing, runny or stuffy nose or itchy nose (rhinitis)
• hypersensitivity reactions with skin rashes and itching, as well as asthma attacks (possibly with low blood pressure). In this case, your doctor should be informed immediately and you should stop taking ibuprofen.
• tingling or numbness, drowsiness
• difficulty sleeping, feeling anxious
• acne, hives, itching, small bruises on the skin or inside the mouth, nose or ears, skin sensitivity to light
• visual disturbances. In this case, your doctor should be informed immediately and you should stop taking ibuprofen.
• hearing problems
• difficulty breathing, wheezing or coughing, asthma or worsening of asthma
• inflammation of the stomach lining, gastrointestinal ulcers, in some cases with bleeding and perforation, ulcerative stomatitis
• hepatitis, yellowing of the skin or eyes, reduced liver function
• nephrotic syndrome (fluid accumulation inside the body (edema) and protein accumulation in the urine); renal inflammation (interstitial nephritis), which may be accompanied by acute renal dysfunction. Reduced urine output, fluid accumulation inside the body (edema) and generally a feeling of malaise may be signs of kidney disease and even kidney failure. If you experience any of the above symptoms, stop taking FEDOTASK and consult your doctor immediately.

Rare(may affect up to 1 in 1,000 people):

• feeling of depression or confusion
• during treatment with ibuprofen, symptoms of aseptic meningitis have been observed with stiff neck, headache, nausea, vomiting, fever or blurred consciousness. If such symptoms occur, contact a doctor immediately
• leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (the first symptoms are fever, sore throat, superficial ulcers of the mouth,

flu-like symptoms, severe fatigue, nosebleeds and skin bleeding,
unusual and unexplained bruising and ecchymoses of unknown cause). In these cases, it
is necessary to stop therapy immediately and consult a doctor

• damage to the optic nerve
• reversible toxic amblyopia (reduced vision)
• dizziness, tinnitus/ringing in the ears
• liver damage
• fluid retention (edema)
• anaphylactic reaction. In case of a generalized hypersensitivity reaction, facial swelling, tongue and larynx, dyspnea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock) may occur

Very rare(may affect up to 1 in 10,000 people)

• high blood pressure, heart failure, heart attack
• inflammation of the pancreas
• very severe blistering reactions including Stevens Johnson syndrome (widespread erosions affecting the skin and mucous membranes and purple lesions, preferably on the trunk)
• toxic epidermal necrolysis (mucosal lesions and painful lesions with necrosis and detachment of the skin)
• erythema multiforme (skin lesion)
• liver failure

Frequency not known(the frequency cannot be estimated on the basis of the available data):

• worsening of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine causing inflammation that usually causes bloody diarrhea)
• it is possible that a severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells)
• widespread, red and scaly rash, with bumps under the skin and blisters located mainly in the skin folds, on the trunk and upper limbs, which is accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking FEDOTASK if these symptoms occur and seek immediate medical attention.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
tell your doctor or pharmacist. You can also report side effects directly
through 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 FEDOTASK

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and on the
sachet after “EXP.”. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FEDOTASK contains
The active ingredient is ibuprofen.
Each sachet contains 200 mg of ibuprofen.
The other ingredients are: isomalt 720, anhydrous citric acid, acesulfame potassium (E 950),
glycerol distearate (Type I), lemon flavour

Description of the appearance of FEDOTASK and contents of the pack
FEDOTASK is an oral powder, white or almost white in colour, with a characteristic aroma of
lemon.
The pack contains 12 or 24 sachets in paper-PE/Al/PE
The pack contains 12 or 24 sachets in PET/Al/PE

Marketing Authorisation Holder
S.F. Group Srl – via Tiburtina, 1143 – 00156 Rome

Manufacturers
Edefarm S.L.
Polígono Industrial Enchilagar del Rullo, 117
46191 Villamarchante – Valencia, Spain
Farmalider S.A
C/Aragoneses, 2
28108 Alcobendas – Madrid, Spain

FEDOTASK 400 mg oral powder in sachet

Ibuprofen
Generic medicine

Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your
doctor or pharmacist have told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days in case of fever or after 5 days in case of pain (3 days in adolescents).

Contents of this leaflet:

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

1. What is FEDOTASK and what is it used for

FEDOTASK contains ibuprofen as the active ingredient and belongs to a group of
medicines known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
This medicine is used in adults and adolescents over 12 years of age weighing
more than 40 kg for the symptomatic relief of occasional mild to moderate pain,
such as headache, dental pain, menstrual pain, muscle pain (contractures) or back pain
(lumbago), as well as in febrile states.

2. What you need to know before taking FEDOTASK

Do not take FEDOTASK

• if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6) or to other medicines of the group of non-steroidal anti-inflammatory drugs (NSAIDs) or to aspirin. The reactions that indicate allergy may be: itchy rash, swelling of the face, lips or tongue, runny nose, shortness of breath or asthma.
• if you have ever had a hemorrhage or a perforation of the stomach or intestine related to a previous therapy with NSAIDs.
• if you have an ulcer (peptic ulcers) or active or recurrent bleeding in the stomach or duodenum or if you have had this problem repeatedly (two or more distinct episodes of ulceration or bleeding) in the past.
• if you vomit blood or if your stools are black or you have diarrhea with blood.
• if you suffer from severe liver, kidney or heart failure.
• if you have bleeding disorders or blood coagulation disorders or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulants simultaneously, the doctor will perform blood coagulation tests.
• if you are severely dehydrated (due to vomiting, diarrhea or insufficient fluid intake).
• if you are a woman in the third trimester of pregnancy (see “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before taking FEDOTASK:

• If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you are receiving treatment with this medicine, as it may mask the fever, which is an important sign of infection, making diagnosis difficult.
• If you have kidney or liver disease, are over 60 years of age or need to take the medicine for a long period (more than 1 or 2 weeks); the doctor may need to check you regularly. The doctor will tell you how often these checks will be.
• If you have had or develop an ulcer, bleeding or perforation of the stomach or duodenum, which may manifest with severe or persistent abdominal pain and/or black stools, or even without any prior warning symptoms. This risk is greater when using high doses and prolonged treatments, in patients with a history of peptic ulcer and in the elderly. In these cases, the doctor will assess the possibility of combining a medicine for the protection of the stomach.
• If you suffer from acute intermittent porphyria (a metabolic disease that affects the blood and can cause symptoms such as reddish urine, blood in the urine or liver disease), the doctor will assess whether treatment with ibuprofen is appropriate or not.
• If you suffer from systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin and joints) as aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria) may occur.
• If you suffer from or have suffered from bowel diseases (ulcerative colitis or Crohn's disease), as they may worsen (see section 4 “Possible side effects”).
• If you are being treated with diuretics (medicines for urination) because the doctor must monitor kidney function.
• If you are taking other medicines that could increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), medicines to thin the blood (e.g. warfarin), selective serotonin reuptake inhibitors (medicines used for depression) and antiplatelet agents (e.g. acetylsalicylic acid).
• If you suffer from or have suffered from heart disease.
• If you have high blood pressure.
• If you suffer from headaches after prolonged treatment, you should not take higher doses of the medicine.
• If you suffer from allergies (e.g. skin reactions to other substances, asthma, hay fever), nasal polyps, chronic swelling of the nasal mucosa or chronic obstructive respiratory diseases, as you are at greater risk of allergic reactions.
• If you have just undergone major surgery.
• If you have chickenpox.
• If you have an infection: see the "Infections" section below.

Skin reactions
Severe skin reactions have been reported in association with treatment with ibuprofen
including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic
epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute
generalized exanthematous pustulosis (AGEP). Stop using FEDOTASK and contact
your doctor immediately if you notice any of the symptoms related to these severe skin
reactions described in section 4.
Side effects can be limited by using the lowest effective dose for the shortest
time possible needed to control the symptoms.

Cardiovascular precautions
Anti-inflammatory/pain relievers such as ibuprofen may be associated with a slight
increased risk of heart attack or stroke, especially if used in high doses. Do not exceed the
recommended dose or duration of treatment.
You should discuss the treatment with your doctor or pharmacist before taking FEDOTASK:

• If you have heart problems including heart failure, angina (chest pain) or if you have had a heart attack, a bypass operation, peripheral artery disease (problems with circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including a “mini-stroke” or a transient ischemic attack “TIA”)
• If you have high blood pressure, diabetes, high cholesterol
• If you have a family history of heart disease or stroke
• If you are a smoker.

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema) and chest pain, have been reported with ibuprofen.
Stop FEDOTASK immediately and contact your doctor or emergency health service immediately if you notice any of these signs.

Infections
FEDOTASK can mask the signs of an infection, such as fever and pain. Consequently,
FEDOTASK can delay adequate treatment of the infection, increasing the risk of
complications. This has been observed in pneumonia caused by bacteria and skin infections
related to varicella. If you are taking this medicine while you have
an infection and the symptoms of the infection persist or worsen, consult your
doctor immediately.

Precautions during pregnancy and breastfeeding
Because the use of medicines such as FEDOTASK has been associated with an increased risk
of congenital malformations/spontaneous abortions, its use is not recommended during the
first and second trimester of pregnancy unless deemed strictly
necessary. In these cases the dose and duration will be limited to the minimum possible.
In the third trimester, taking this medicine is contraindicated.
If you are a woman of childbearing age, you should consider that medicines such as FEDOTASK have been
associated with a reduced ability to conceive.

Elderly
Elderly patients taking NSAIDs are at greater risk of side effects, particularly those
related to the stomach and intestines. For more information, see section 4
“Possible side effects”.
If you have a history of gastrointestinal toxicity, especially if you are elderly, report any
unusual abdominal symptoms (especially bleeding in the stomach or intestines), in
particular in the early stages of treatment.
There is a risk of kidney impairment in dehydrated elderly patients.

Children and adolescents
There is a risk of kidney impairment in dehydrated adolescents.
FEDOTASK 400 mg is not suitable for children under 12 years of age (with a body weight
less than 40 kg).

Other medicines and FEDOTASK
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
FEDOTASK can affect or be affected by other medicines. For example:

• other non-steroidal anti-inflammatory drugs such as aspirin, as the risk of gastrointestinal ulcer and bleeding may be increased
• corticosteroids (such as cortisone and prednisolone)
• other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib) as these may increase the risk of bleeding and gastrointestinal ulcers
• anticoagulant medicines and antiplatelet agents (prevent blood clots from forming, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• selective serotonin reuptake inhibitors (medicines used for depression)
• lithium (a medicine used to treat depression). The doctor may adjust your dose of this medicine
• potassium-sparing diuretics
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-based medicines, angiotensin-II receptor antagonists such as losartan)
• diuretics (medicines used to increase urine production), as they may increase the risk of kidney toxicity
• methotrexate (a medicine used for cancer or rheumatism). The doctor may modify the dose of this medicine
• tacrolimus (a medicine used to suppress the immune reaction)
• cyclosporine (a medicine used to suppress the immune reaction)
• zidovudine (a medicine for the treatment of AIDS)
• sulfonamides such as tolbutamide (antidiabetic drugs) as they may cause hypoglycemia
• probenecid (used in patients with gout or together with penicillin in infections)
• sulfinpyrazone (for gout)
• aminoglycoside antibiotics
• digoxin and cardiac glycosides (used for the treatment of heart disorders)
• hydantoins such as phenytoin (used for the treatment of seizures)
• quinolone antibiotics
• cholestyramine (a medicine used to treat high cholesterol)
• the CYP2C9 inhibitors such as voriconazole and fluconazole (used for the treatment of fungal infections)
• mifepristone (abortion inducer)
• pentoxifylline (for intermittent claudication)
• thrombolytics (drugs that dissolve blood clots)
• sulfamides such as sulfamethoxazole and cotrimoxazole (used to treat some bacterial infections)
• herbal extracts: ginkgo biloba may increase the risk of bleeding

Other medicines can also affect or be affected by treatment with
FEDOTASK.
Therefore, always consult your doctor or
pharmacist before taking FEDOTASK with other medicines.
Taking ibuprofen can alter the following laboratory tests:

• Bleeding time (may last for 1 day after stoppingtreatment)
• Glucose concentration in the blood (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen levels and serum creatinine and potassium levels (mayincrease)
• Liver function tests: increased transaminase values

Tell your doctor if you are about to undergo a clinical test and are taking or have recently
taken ibuprofen.

FEDOTASK with food and alcohol
It is recommended to take the medicine during or after meals to reduce
the possibility of stomach upset.
Alcohol consumption should be avoided during treatment with ibuprofen as
it may increase adverse reactions at the gastrointestinal level.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Do not take FEDOTASK if you are in the last 3 months of pregnancy, as it may harm the
fetus or cause problems during childbirth. This medicine can cause problems with the kidneys and
heart of 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 FEDOTASK in
the first 6 months of pregnancy, unless absolutely necessary and under the advice of a doctor.
If treatment is needed during this period or during attempts to conceive,
the minimum dose should be used for the shortest possible time. From the 20th week
of pregnancy onwards, FEDOTASK can cause kidney problems in the fetus, if taken for more than
a few days, reducing the levels of amniotic fluid surrounding the baby
(oligohydramnios) or causing a narrowing of a blood vessel (ductus arteriosus) in
the baby's heart. If treatment is needed for more than a few days, the doctor
may recommend additional monitoring.
Breastfeeding
Although only minimal amounts of the medicine are excreted in breast milk, it
is recommended not to take ibuprofen for prolonged periods during breastfeeding.

Driving and operating machinery
If you experience dizziness, vertigo, visual disturbances or other symptoms while taking this
medicine, you should not drive or operate dangerous machinery. If you take only one dose of
ibuprofen or if you take it for a short period, you do not need to take any special precautions.
Ibuprofen can delay the reaction time. This should be taken into consideration
before undertaking activities that require greater attention, such as driving and
operating machinery.
This is more true when combined with alcohol.

FEDOTASK contains isomalt
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before
taking this medicine.

3. How to take FEDOTASK

Take this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
This medicine is only for occasional use and for limited periods.
The lowest effective dose should be used for the shortest time necessary to relieve symptoms. In case of infection, consult your doctor immediately if symptoms (such as fever and pain) persist or worsen (see paragraph 2).
Method of administration
Put the oral powder on your tongue, let it dissolve and then swallow; water is not necessary. FEDOTASK can also be taken on an empty stomach. If you suffer from stomach discomfort, it is recommended to take FEDOTASK during or after meals.
The recommended dose is:

Adults and adolescents with a body weight of 40 kg or more (aged 12 years or older)
One sachet (400 mg of ibuprofen) every 6-8 hours.
Do not take more than 3 sachets (1200 mg of ibuprofen) in 24 hours.

Elderly
The dosage must be established by the doctor as a reduction of the usual dose may be necessary.

Patients with kidney, liver or heart diseases
If you have kidney, liver or heart problems, always consult your doctor before taking FEDOTASK as a reduction of the usual dose may be necessary.

Duration of treatment
If symptoms worsen, if fever persists for more than 3 days or pain persists for more than 5 days (3 days in adolescents), consult your doctor.
Taking this medicine is subject to the appearance of pain or fever. When these symptoms disappear, the medicine should be stopped.
If you think that the action of this medicine is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents
The use of this medicine in children (under 12 years of age) and adolescents weighing less than 40 kg is not recommended.

If you take more FEDOTASK than you should
If you have taken more FEDOTASK than you should or if your child has taken this medicine by mistake, contact your doctor or the nearest hospital immediately to get an opinion on the risk and ask for advice on what actions to take.
Symptoms
Symptoms of ibuprofen overdose appear within 4-6 hours.
These overdose symptoms may include nausea, stomach pain, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion and involuntary eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness and dizziness, blood in the urine, low potassium levels in the blood, chills and breathing problems have been reported. Rarely, increased acidity of the blood plasma (metabolic acidosis), hypothermia (lowering of body temperature), kidney effects, gastrointestinal bleeding, coma, apnea (cessation of breathing), depression of the CNS and respiratory system have also been reported. In cases of significant overdose, kidney failure and liver damage are possible. In these cases, the doctor will take the necessary measures.

If you forget to take FEDOTASK
Do not take a double dose to make up for a missed dose.
If you forget to take the corresponding dose, take it as soon as you remember. However, if the time of the next dose is too close, skip the missed dose and take the next dose at the usual time.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The incidence of side effects is lower in short treatments and if the daily dose is
lower than the maximum recommended dose.

Stop taking this medicine and contact your doctor immediately if you
experience:

• Allergic reactions such as skin rashes, swelling of the face, wheezing or difficulty breathing
• Vomiting with blood or with an appearance similar to coffee grounds
• Blood in the stools or bloody diarrhoea
• Severe stomach pain
• Blisters or severe skin peeling
• Severe or persistent headache
• Yellowing of the skin (jaundice)
• Signs of severe hypersensitivity
• Swelling of the extremities or fluid retention in the arms or legs
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome
• Flat, reddish, target-like or circular spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis]
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome)
• Widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis)

Contact your doctor if you experience any of the following side effects, if they
worsen or if you notice any effect not listed.
The frequencies shown below refer to short-term use of maximum daily
doses of 1200 mg of oral ibuprofen:

Common(may affect up to 1 in 10 people):

• feeling of dizziness or lightheadedness, headache
• gastrointestinal bleeding, especially in the elderly, nausea, vomiting, diarrhoea, flatulence, dyspepsia (disturbance of secretion or intestinal motility), constipation, abdominal pain, blood in the stools, vomiting with blood

Uncommon(may affect up to 1 in 100 people):

• sneezing, runny or blocked nose or itchy nose (rhinitis)
• hypersensitivity reactions with skin rashes and itching, as well as asthma attacks (possibly with low blood pressure). In this case, you should inform your doctor immediately and stop taking ibuprofen.
• tingling or numbness, drowsiness
• difficulty sleeping, feeling anxious
• acne, hives, itching, small bruises on the skin or inside the mouth, nose or ears, skin sensitivity to light
• visual disturbances. In this case, you should inform your doctor immediately and stop taking ibuprofen.
• hearing problems
• difficulty breathing, wheezing or coughing, asthma or worsening of asthma
• inflammation of the stomach lining, gastrointestinal ulcers, in some cases with bleeding and perforation, mouth ulcers
• hepatitis, yellowing of the skin or eyes, reduced liver function
• nephrotic syndrome (fluid accumulation inside the body (edema) and protein in the urine); kidney inflammation (interstitial nephritis), which may be accompanied by acute kidney dysfunction. Reduced urine output, fluid accumulation inside the body (edema) and generally a feeling of malaise may be signs of kidney disease and even kidney failure. If you experience any of the above symptoms, stop taking FEDOTASK and consult your doctor immediately.

Rare(may affect up to 1 in 1,000 people):

• feeling of depression or confusion
• during treatment with ibuprofen, symptoms of aseptic meningitis have been observed with stiff neck, headache, nausea, vomiting, fever or blurred consciousness. If such symptoms occur, contact a doctor immediately
• leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia (the first symptoms are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, unusual and unexplained bruising and ecchymosis of unknown cause). In these cases, therapy must be stopped immediately and a doctor consulted.
• optic nerve damage
• toxic reversible amblyopia (reduced vision)
• dizziness, tinnitus/ringing in the ears
• liver damage
• fluid retention (edema)
• anaphylactic reaction. In case of a widespread hypersensitivity reaction, swelling of the face, tongue and larynx, dyspnoea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock) may occur

Very rare(may affect up to 1 in 10,000)

• high blood pressure, heart failure, heart attack
• inflammation of the pancreas
• very severe blistering reactions including Stevens Johnson syndrome (widespread erosions affecting the skin and mucous membranes and violet lesions, preferably on the trunk)
• toxic epidermal necrolysis (lesions of the mucosa and painful lesions with necrosis and detachment of the skin)
• erythema multiforme (skin lesion)
• liver failure

Frequency not known(the frequency cannot be estimated on the basis of the available data):

• worsening of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine causing inflammation that usually causes bloody diarrhoea)
• it is possible that a severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells)
• widespread, red and scaly rash, with bumps under the skin and blisters located mainly in the skin folds, on the trunk and upper limbs, which is accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking FEDOTASK if these symptoms occur and seek immediate medical attention.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell your doctor or pharmacist. You can also report side effects directly
through 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 FEDOTASK

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and on the
sachet after “EXP.”. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FEDOTASK contains
The active ingredient is ibuprofen.
Each sachet contains 400 mg of ibuprofen.
The other ingredients are: isomalt 720, anhydrous citric acid, acesulfame potassium (E 950),
glycerol distearate (Type I), lemon flavour

Description of the appearance of FEDOTASK and contents of the pack
FEDOTASK is an oral powder, of white or almost white colour, with a characteristic aroma of
lemon.
The pack contains 12 or 24 sachets in paper-PE/Al/PE
The pack contains 12 or 24 sachets in PET/Al/PE

Marketing Authorisation Holder
S.F. Group Srl – via Tiburtina, 1143 – 00156 Roma

Manufacturers
Edefarm S.L.
Polígono Industrial Enchilagar del Rullo, 117
46191 Villamarchante – Valencia, Spain
Farmalider S.A
C/Aragoneses, 2
28108 Alcobendas – Madrid, Spain