Fedotask

Patient Information Leaflet

FEDOTASK 200 mg oral powder in sachet

Ibuprofen
Please read all of 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 instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, please ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days when treating fever or after 5 days when treating pain (after 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 taking 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 FEDOTASK is and what it is 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 mild to
moderate occasional pain, such as headache, dental pain, menstrual pain, muscle pain (strains), or back pain (lumbago), as well as in febrile conditions.

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. Signs of allergy may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, shortness of breath or asthma.
• if you have ever had gastrointestinal bleeding or perforation related to a previous treatment with NSAIDs.
• if you currently have or have had recurrent peptic ulcers or gastrointestinal bleeding, or if you have experienced this problem repeatedly in the past (two or more distinct episodes of ulceration or bleeding confirmed).
• if you are vomiting blood or have black stools or diarrhoea with blood.
• if you suffer from severe liver, kidney or heart failure.
• if you have bleeding disorders or blood coagulation problems, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulants concomitantly, your 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 oedema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you are being treated with this medicine, as it may mask fever, an important sign of infection, making diagnosis more 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); your doctor may need to monitor you regularly. Your doctor will advise you on how often these checks should be performed.
• If you have had or develop a stomach or duodenal ulcer, bleeding or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms. This risk is higher when high doses and prolonged treatments are used, in patients with a history of peptic ulcer, and in the elderly. In such cases, your doctor may consider adding a medicine to protect the stomach.
• If you suffer from acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in the urine or liver disease), your doctor will assess whether treatment with ibuprofen is appropriate.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may affect various vital organs, the nervous system, blood vessels, skin and joints), as aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria) may occur.
• If you have or have had intestinal diseases (ulcerative colitis or Crohn's disease), as they may worsen (see section 4 “Possible side effects”).
• If you are taking diuretics (medicines to increase urination), because your doctor needs to monitor your kidney function.
• If you are taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), blood-thinning medicines (e.g. warfarin), selective serotonin reuptake inhibitors (medicines used for depression) and antiplatelet agents (e.g. acetylsalicylic acid).
• If you have or have had heart problems.
• 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 have 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 may be at higher risk of allergic reactions.
• If you have recently undergone major surgery.
• If you have chickenpox.
• If you have an infection: see the section "Infections" below.

Skin reactions
Serious skin reactions have been reported with ibuprofen treatment,
including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic
epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and
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 may be minimized by using the lowest effective dose for the shortest possible
time needed to control symptoms.
Cardiovascular precautions
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a
slight increase in the risk of heart attack or stroke, especially when used at high doses. Do not
exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking FEDOTASK:

• If you have heart problems, including heart failure, angina (chest pain), or have had a heart attack, bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischaemic attack "TIA").
• If you have high blood pressure, diabetes, or 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 difficulties, swelling of the
face and neck (angioedema), and chest pain, have been reported with ibuprofen. Stop
FEDOTASK immediately and contact your doctor or emergency medical services immediately
if you notice any of these signs.
Infections
FEDOTASK may mask signs of infection, such as fever and pain. Consequently, FEDOTASK may
delay appropriate treatment of the infection, increasing the risk of complications. This has
been observed in bacterial pneumonia and skin infections associated with chickenpox. If you
take this medicine while having an infection and infection symptoms persist or worsen,
consult your doctor immediately.
Precautions during pregnancy and in women of childbearing age
Since the use of medicines such as FEDOTASK has been associated with an increased risk
of congenital abnormalities/spontaneous abortions, their use is not recommended during
the first and second trimesters of pregnancy unless strictly necessary. In such cases, the
dose and duration should be limited to the minimum possible.
In the third trimester, the use of this medicine is contraindicated.
If you are a woman of childbearing age, you should be aware that medicines such as
FEDOTASK have been associated with reduced fertility.
Elderly
Elderly patients taking NSAIDs are at increased risk of side effects, particularly those
affecting the stomach and intestines. For further 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 (particularly bleeding in the stomach or intestines), especially 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 may affect or be affected by other medicines. For example:

• other non-steroidal anti-inflammatory drugs such as aspirin, as the risk of gastrointestinal ulceration 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 gastrointestinal bleeding and ulcers
• anticoagulant medicines and antiplatelet agents (prevent blood clot formation in blood vessels, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• selective serotonin reuptake inhibitors (medicines used for depression)
• lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine
• potassium-sparing diuretics
• medicines that reduce 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). Your doctor may modify the dose of this medicine
• tacrolimus (a medicine used to suppress the immune response)
• ciclosporin (a medicine used to suppress the immune response)
• zidovudine (a medicine for the treatment of AIDS)
• sulfonylureas such as tolbutamide (antidiabetic drugs), as they may cause hypoglycaemia
• probenecid (used in patients with gout or together with penicillin in infections)
• sulfinpyrazone (for gout)
• aminoglycoside antibiotics
• digoxin and cardiac glycosides (used to treat heart disorders)
• hydantoins such as phenytoin (used to treat seizures)
• quinolone antibiotics
• cholestyramine (a medicine used to treat high cholesterol)
• CYP2C9 inhibitors such as voriconazole and fluconazole (used to treat fungal infections)
• mifepristone (abortion-inducing agent)
• pentoxifylline (for the treatment of intermittent claudication)
• thrombolytics (medicines that dissolve blood clots)
• sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections)
• herbal extracts: Ginkgo biloba may increase the risk of bleeding

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

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

Inform 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 intake should be avoided during treatment with ibuprofen, as it may increase
gastrointestinal adverse reactions.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not take FEDOTASK during the last 3 months of pregnancy, as it may harm the fetus or
cause problems during delivery. This medicine may cause kidney and heart problems in the
fetus. It may affect your and your baby's tendency to bleed and delay or prolong labour
longer than expected. You should not take FEDOTASK during the first 6 months of pregnancy
unless absolutely necessary and under medical advice.
If treatment is required 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 onwards,
FEDOTASK may 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
narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required 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, prolonged use of
ibuprofen during breastfeeding is not recommended.
Driving and using machines
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 a single dose
of ibuprofen or use it for a short period, you do not need to take special precautions.
Ibuprofen may delay reaction time. This should be taken into account before engaging in
activities requiring high attention, such as driving and operating machinery.
This is particularly relevant when combined with alcohol.
FEDOTASK contains isomalt
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before
taking this medicine.

3. How to take FEDOTASK

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This medicine is intended only for occasional use and for short-term periods.
The lowest effective dose should be used for the shortest time necessary to relieve symptoms. In case of infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2). This medicine should be taken only when pain or fever occurs. When these symptoms disappear, the medicine should be discontinued.
Method of administration
Place the oral powder on the tongue, allow it to dissolve, and then swallow; water is not required. FEDOTASK may also be taken on an empty stomach. If you suffer from stomach discomfort, it is recommended to take FEDOTASK during or after meals.
Recommended dose:
Use in children
The use of this medicine is not recommended in children weighing less than 20 kg (approximately 7 years of age).

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

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

Elderly
The dosage should be determined by a 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, as a reduction of the usual dose may be necessary.

Duration of treatment
Children and adolescents
Consult your doctor if symptoms worsen or if use of this medicine is needed for more than 3 days.

Adults
Consult your doctor if your symptoms worsen, or if taking this medicine is required for more than 5 days for pain or 3 days for fever.

If you think that the effect 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 a doctor or the nearest hospital immediately to obtain advice on the risk and guidance on actions to take.

Symptoms
Symptoms of ibuprofen overdose appear within 4–6 hours.
Such overdose symptoms may include nausea, stomach ache, 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 blood potassium levels, chills and breathing problems have been reported.
Rarely, increased blood plasma acidity (metabolic acidosis), hypothermia (lowered body temperature), kidney effects, gastrointestinal bleeding, coma, apnoea (lack of breathing), central nervous system (CNS) and respiratory depression have also been reported. In cases of significant overdose, kidney failure and liver damage are possible. In such cases, the doctor will take the necessary measures.

If you forget to take FEDOTASK
Do not take a double dose to make up for the forgotten dose.
If you forget to take your scheduled dose, take it as soon as you remember.
However, if the time for 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, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The incidence of side effects is lower with short-term treatment and when the daily dose is below the maximum recommended dose.
Stop taking this medicine and contact a doctor immediately if you experience:

• Allergic reactions such as skin rash, facial swelling, wheezing or difficulty breathing
• Vomiting blood or material resembling coffee grounds
• Blood in the stool or bloody diarrhoea
• Severe stomach pain
• Blisters or severe peeling of the skin
• Severe or persistent headache
• Yellowing of the skin (jaundice)
• Signs of severe hypersensitivity
• Swelling of the extremities or fluid accumulation in the arms or legs
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome
• Flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious 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 swollen lymph nodes (DRESS syndrome)
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (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 here.
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):

• dizziness or vertigo, headache
• gastrointestinal bleeding, especially in elderly people, nausea, vomiting, diarrhoea, flatulence, dyspepsia (digestive discomfort), constipation, abdominal pain, blood in stools, vomiting blood

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

• sneezing, stuffy or runny nose or nasal itching (rhinitis)
• hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly with low blood pressure). In such cases, a doctor must be informed immediately and ibuprofen must be discontinued.
• sensation of tingling or pins and needles, drowsiness
• difficulty sleeping, feeling anxious
• acne, urticaria, itching, small bruises on the skin or inside the mouth, nose or ears, skin sensitivity to light
• vision disturbances. In such cases, a doctor must be informed immediately and ibuprofen must be discontinued.
• hearing problems
• difficulty breathing, wheezing or coughing, asthma or worsening of asthma
• inflammation of the stomach lining, gastrointestinal ulcers, sometimes with bleeding and perforation, ulcerative stomatitis
• hepatitis, yellowing of the skin or eyes, reduced liver function
• nephrotic syndrome (fluid accumulation in 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 in the body (edema) and general malaise may be signs of kidney disease and even kidney failure. If any of the above symptoms occur, stop taking FEDOTASK and consult a doctor immediately.

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

• feeling depressed or confused
• during treatment with ibuprofen, symptoms of aseptic meningitis have been observed, including neck stiffness, headache, nausea, vomiting, fever or altered consciousness. If such symptoms occur, contact a doctor immediately
• leucopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia (early symptoms include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, unusual and unexplained bruising and ecchymosis of unknown cause). In such cases, treatment must be stopped immediately and a doctor consulted
• optic nerve damage
• reversible toxic amblyopia (reduced vision)
• dizziness, tinnitus (ringing or noises in the ear)
• liver damage
• fluid retention (edema)
• anaphylactic reaction. In case of generalized hypersensitivity reaction, facial, tongue and laryngeal swelling, dyspnoea (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, mainly on the trunk)
• toxic epidermal necrolysis (mucosal lesions and painful lesions with necrosis and skin detachment)
• erythema multiforme (skin lesion)
• liver failure

Frequency not known (frequency cannot be estimated from the available data):

• worsening of colitis and Crohn's disease (chronic conditions in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea)
• a serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell)
• widespread red, scaly rash with subcutaneous bumps and blisters, mainly located in skin folds, on the trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized exanthematous pustulosis). Stop taking FEDOTASK if these symptoms occur and contact a doctor immediately.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact 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.
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 stated on the carton and sachet after "EXP.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
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. Pack contents and other information

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

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

Marketing Authorization Holder
S.F. Group Srl – Via Tiburtina, 1143 – 00156 Rome, Italy

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

Patient information leaflet: information for the patient

FEDOTASK 400 mg oral powder in sachet

Ibuprofen
Generic medicine
Please 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 instructed you.

• 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 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 FEDOTASK is and what it is 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

1. What FEDOTASK is and what it is used for

FEDOTASK contains ibuprofen as the active substance 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 mild to moderate occasional pain, such as headache, dental pain, menstrual pain, muscular pain (cramps), or back pain (lumbago), as well as in febrile conditions.

2. What you should 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. Signs of allergy may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, shortness of breath or asthma.
• if you have ever had gastrointestinal bleeding or perforation related to a previous treatment with NSAIDs.
• if you have a current or recurrent peptic ulcer or gastrointestinal bleeding, or if you have had this problem repeatedly in the past (two or more distinct episodes of ulceration or bleeding confirmed).
• if you are vomiting blood or have black stools or 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 concomitantly, your 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 oedema (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 more 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); your doctor may need to monitor you regularly. Your doctor will tell you how often these checks should be performed.
• If you have had or develop a stomach or duodenal ulcer, bleeding or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms. This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a medicine to protect the stomach.
• If you suffer from acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in the urine or liver disorders), your doctor will assess whether treatment with ibuprofen is appropriate.
• If you suffer from systemic lupus erythematosus (a chronic disease affecting the immune system that may affect various vital organs, the nervous system, blood vessels, skin and joints), as aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria) may occur.
• If you have or have had intestinal diseases (ulcerative colitis or Crohn’s disease), as these may worsen (see section 4 “Possible side effects”).
• If you are taking diuretics (medicines to increase urination), because your doctor needs to monitor kidney function.
• If you are taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), blood-thinning medicines (e.g. warfarin), selective serotonin reuptake inhibitors (medicines used for depression) and antiplatelet agents (e.g. acetylsalicylic acid).
• If you have or have had heart problems.
• If you have high blood pressure.
• If you suffer from headaches after prolonged treatment, do 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 may be at higher risk of allergic reactions.
• If you have recently undergone major surgery.
• If you have chickenpox.
• If you have an infection: see the section "Infections" below.

Skin reactions
Serious skin reactions have been reported with ibuprofen treatment,
including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and 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 minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Cardiovascular precautions
Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss 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 arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischaemic 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 difficulties, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen. Stop FEDOTASK immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
Infections
FEDOTASK may mask signs of infection, such as fever and pain. As a result, FEDOTASK may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and symptoms of infection persist or worsen, consult your doctor immediately.
Precautions during pregnancy and in women of childbearing age
Since the use of medicines such as FEDOTASK has been associated with an increased risk of congenital malformations/spontaneous abortion, their use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration will be limited to the minimum possible.
During the third trimester, the use of this medicine is contraindicated.
If you are a woman of childbearing age, you should be aware that medicines such as FEDOTASK have been associated with reduced fertility.
Elderly
Elderly patients taking NSAIDs are at higher risk of side effects, particularly those affecting 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 (particularly bleeding in the stomach or intestines), especially during the initial 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 body weight below 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 may 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 gastrointestinal bleeding and ulcers
• anticoagulant medicines and antiplatelet agents (prevent blood clot formation in blood vessels, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• selective serotonin reuptake inhibitors (medicines used for depression)
• lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine for you
• 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). Your doctor may adjust the dose of this medicine
• tacrolimus (a medicine used to suppress the immune response)
• ciclosporin (a medicine used to suppress the immune response)
• zidovudine (a medicine for the treatment of AIDS)
• sulfonylureas such as tolbutamide (antidiabetic medicines), as they may cause hypoglycaemia
• probenecid (used in patients with gout or together with penicillin in infections)
• sulfinpyrazone (for gout)
• aminoglycoside antibiotics
• digoxin and cardiac glycosides (used to treat heart disorders)
• hydantoins such as phenytoin (used to treat seizures)
• quinolone antibiotics
• cholestyramine (a medicine used to treat high cholesterol)
• CYP2C9 inhibitors such as voriconazole and fluconazole (used to treat fungal infections)
• mifepristone (abortion-inducing agent)
• pentoxifylline (for the treatment of intermittent claudication)
• thrombolytics (medicines that dissolve blood clots)
• sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections)
• herbal extracts: ginkgo biloba may increase the risk of bleeding

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

• Bleeding time (may last up to 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Haematocrit or haemoglobin (may decrease)
• Blood urea nitrogen levels and serum creatinine and potassium levels (may increase)
• Liver function tests: increased transaminase values

Inform 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 disturbances.
Alcohol intake should be avoided during treatment with ibuprofen, as it may increase gastrointestinal adverse reactions.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take FEDOTASK during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. This medicine may cause kidney and heart problems in the fetus. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labour beyond the expected time. You should not take FEDOTASK during the first 6 months of pregnancy unless absolutely necessary and under medical advice.
If treatment is required 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 onwards, FEDOTASK 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 cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required 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, prolonged use of ibuprofen during breastfeeding is not recommended.
Driving and using machines
If you experience dizziness, vertigo, visual disturbances or other symptoms while taking this medicine, you must not drive or operate dangerous machinery. If you take only a single dose of ibuprofen or use it for a short period, you do not need to take special precautions.
Ibuprofen may delay reaction time. This should be taken into account before engaging in activities requiring high attention, such as driving and operating machinery.
This is particularly relevant when combined with alcohol.
FEDOTASK contains isomalt
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take FEDOTASK

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This medicine is intended for occasional use only and for short-term periods.
The lowest effective dose should be used for the shortest time necessary to relieve symptoms. In case of infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Method of administration
Place the oral powder on the tongue, allow it to dissolve, then swallow; water is not required. FEDOTASK may also be taken on an empty stomach. If you suffer from stomach discomfort, it is recommended to take FEDOTASK during or after meals.

Recommended dose
Adults and adolescents with body weight equal to or greater than 40 kg (aged 12 years and older)
One sachet (400 mg of ibuprofen) every 6–8 hours.
Do not exceed 3 sachets (1200 mg of ibuprofen) in 24 hours.

Elderly
Dosage must be determined by the doctor, as a reduction of the usual dose may be necessary.

Patients with renal, hepatic or cardiac disease
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 if pain persists for more than 5 days (3 days in adolescents), consult your doctor.
This medicine should only be taken when pain or fever is present. When these symptoms resolve, the medicine should be discontinued.
If you feel that the effect 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 accidentally taken this medicine, contact a doctor or the nearest hospital immediately for advice on the risk and guidance on necessary actions.

Symptoms
Symptoms of ibuprofen overdose usually appear within 4–6 hours.
Such overdose symptoms may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, tinnitus, confusion, and involuntary eye movements. At higher doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties may occur.
Rarely, increased blood plasma acidity (metabolic acidosis), hypothermia (lowered body temperature), renal effects, gastrointestinal bleeding, coma, apnea (absence of breathing), central nervous system (CNS) depression, and respiratory depression have also been reported. In cases of significant overdose, kidney failure and liver damage are possible. In such 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 forgotten dose.
If you forget to take your scheduled dose, take it as soon as you remember.
However, if it is almost time for your next dose, skip the missed dose and take the next dose at the usual time.

If you have any questions 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 with short-term treatment and when the daily dose is lower than the maximum recommended dose.
Stop taking this medicine and contact a doctor immediately if you experience:

• Allergic reactions such as skin rash, swelling of the face, wheezing or difficulty breathing
• Vomiting blood or vomiting material that looks like coffee grounds
• Blood in the stool or bloody diarrhoea
• Severe stomach pain
• Blisters or severe peeling of the skin
• Severe or persistent headache
• Yellowing of the skin (jaundice)
• Signs of severe hypersensitivity
• Swelling of the extremities or fluid accumulation in the arms or legs
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome
• Reddish, flat spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious 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 swollen lymph nodes (DRESS syndrome)
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (generalized pustular eruption, acute generalized exanthematous pustulosis)

Contact your doctor if you experience any of the following side effects, if they worsen, or if you notice any side effect not listed here.
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):

• Dizziness, vertigo, headache
• Gastrointestinal bleeding, especially in the elderly, nausea, vomiting, diarrhoea, flatulence, dyspepsia (intestinal secretion or motility disorder), constipation, abdominal pain, blood in stool, vomiting blood

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

• Sneezing, blocked or runny nose, or nasal itching (rhinitis)
• Hypersensitivity reactions with skin rash and itching, and asthma attacks (possibly with low blood pressure). In this case, a doctor must be informed immediately and ibuprofen must be discontinued.
• Tingling or numbness, drowsiness
• Difficulty sleeping, feeling anxious
• Acne, urticaria, itching, small bruises on the skin or inside the mouth, nose or ears, skin sensitivity to light
• Vision disturbances. In this case, a doctor must be informed immediately and ibuprofen must be discontinued.
• Hearing problems
• Difficulty breathing, wheezing or coughing, asthma or worsening of asthma
• Inflammation of the stomach lining, gastrointestinal ulcers, sometimes with bleeding and perforation, mouth ulcers
• Hepatitis, yellowing of the skin or eyes, reduced liver function
• Nephrotic syndrome (fluid accumulation in 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 in the body (edema), and general feeling of malaise may be signs of kidney disease and even kidney failure. If any of the above symptoms occur, stop taking FEDOTASK and consult a doctor immediately.

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

• Feeling depressed or confused
• During treatment with ibuprofen, symptoms of aseptic meningitis have been observed, including neck stiffness, headache, nausea, vomiting, fever or altered consciousness. If these symptoms occur, contact a doctor immediately
• Leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia (early symptoms include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nose and skin bleeding, unusual and unexplained bruising, and unexplained ecchymoses). In these cases, treatment must be stopped immediately and a doctor consulted.
• Optic nerve damage
• Reversible toxic amblyopia (reduced vision)
• Dizziness, tinnitus (ringing or noises in the ears)
• Liver damage
• Fluid retention (edema)
• Anaphylactic reaction. In case of generalized 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 people):

• High blood pressure, heart failure, heart attack
• Pancreatitis
• Very severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and mucous membranes and purple lesions, mainly on the trunk)
• Toxic epidermal necrolysis (mucosal lesions and painful lesions with necrosis and skin detachment)
• Erythema multiforme (skin lesion)
• Liver failure

Frequency not known (frequency cannot be estimated from the available data):

• Worsening of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine causing inflammation, usually resulting in bloody diarrhoea)
• A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell)
• Widespread red, scaly rash with subcutaneous bumps and blisters mainly located in skin folds, on the trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking FEDOTASK if these symptoms occur and contact a doctor immediately.

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 FEDOTASK

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

6. Package contents and other information

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

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

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

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