Nurofenteen

Package leaflet: Information for the user

NUROFENTEEN 200 mg orodispersible tablets lemon

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.

• 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, tell your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen:
  • After 3 days in adolescents;
  • After 3 days if you have fever or after 4 days if you have pain in adults.

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

NUROFENTEEN contains 200 mg of ibuprofen. Ibuprofen belongs to a group of
medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines
work by altering the body's response to pain, swelling, and high temperature.
NUROFENTEEN is used for:

• relieving symptoms of mild to moderate pain such as headache, toothache, and menstrual pain
• reducing fever

Consult your doctor if you do not feel better or if you feel worse after 3 days in
adolescents, or after 3 days in case of fever or after 4 days for pain treatment
in adults.

Do not take NUROFENTEEN if:

• you are allergic (hypersensitive) to ibuprofen or to any of the other ingredients of NUROFENTEEN (listed in section 6)
• you have experienced breathing difficulties, asthma, rhinitis, swelling of the face and/or hands, or urticaria after taking ibuprofen, acetylsalicylic acid, or other similar painkillers (NSAIDs)
• you suffer from severe liver failure, severe kidney failure, or severe heart failure
• you have (or have had) two or more episodes of stomach ulcer or gastrointestinal bleeding
• you have had gastrointestinal bleeding or perforation following previous treatment with NSAIDs
• you have cerebrovascular haemorrhage or other types of active bleeding
• you suffer from unexplained blood disorders
• you suffer from severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake)
• you are in the last 3 months of pregnancy (see below).

Warnings and precautions
Talk to your doctor or pharmacist before taking NUROFENTEEN

• if you have an infection – see section “Infections” below
• if you suffer from certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease)
• if you suffer from a hereditary blood disorder (acute intermittent porphyria)
• if you have problems with blood clotting
• if you suffer from or have suffered from gastrointestinal disorders (ulcerative colitis or Crohn's disease)
• if you have impaired kidney function
• if you suffer from liver disorders
• if you are planning a pregnancy
• if you suffer from or have suffered from asthma or allergic diseases, as you may experience shortness of breath
• if you suffer from hay fever, nasal polyps, or chronic obstructive respiratory diseases, as there is an increased risk of developing allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma), skin swelling (Quincke's oedema), or urticaria
• it is advisable to avoid taking NUROFENTEEN if you have chickenpox
• if you take NUROFENTEEN for long periods, regular tests to assess liver and kidney function, as well as blood cell counts, are necessary
• side effects can be minimized by using the lowest effective dose for the shortest possible duration
• elderly patients have a higher risk of developing adverse reactions
• in general, the habitual use of (various types of) painkillers may lead to serious permanent kidney problems. This risk may increase with physical exertion associated with loss of salts and dehydration. Therefore, it should be avoided.
• prolonged use of any type of painkiller for headache may worsen symptoms. If this occurs or is suspected, you should stop taking NUROFENTEEN and consult your doctor. Medication-overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of analgesic medicines
• concomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, may increase the risk of adverse effects and should be avoided (see section “Use with other medicines”)
• in dehydrated adolescents, there is a risk of kidney impairment
• particular caution is required if you have recently undergone major surgery
• anti-inflammatory/pain 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 NUROFENTEEN if you have:

• heart problems including heart attack, angina (chest pain), or history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowing or blockage of arteries), or any type of stroke (including 'mini-stroke' or "TIA", transient ischaemic attack);
• high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

Infections
NUROFENTEEN may mask symptoms of infections such as fever and pain. Therefore,
NUROFENTEEN may delay appropriate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.
Skin reactions
Serious skin reactions have been reported in association with treatment with
NUROFENTEEN. Stop taking NUROFENTEEN and consult your doctor immediately if you develop rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a very serious skin reaction. See section 4.
Other medicines and NUROFENTEEN
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
NUROFENTEEN may affect or be affected by other medicines. For example:

• medicines that have an anticoagulant effect (i.e., substances that thin the blood and prevent clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)

Some other medicines may also affect or be affected by treatment with NUROFENTEEN.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription. In particular, inform your doctor or pharmacist if you are taking:

NUROFENTEEN with food
It is recommended to take NUROFENTEEN with food in individuals with gastric hypersensitivity.

Pregnancy, breastfeeding and fertility

Pregnancy
Do not take this medicine during the last 3 months of pregnancy. Avoid using this medicine during the first 6 months of pregnancy unless prescribed by your doctor.

Breastfeeding
This medicine passes into breast milk, but may be used during breastfeeding if taken at the recommended doses and for short periods of time.
Ask your doctor or pharmacist for advice before taking any medicine.

Fertility
Avoid taking this medicine if you are planning a pregnancy.

Driving and using machines
For short-term treatment, this medicine does not affect or affects negligibly the ability to drive and use machines.

NUROFENTEEN contains 15 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

NUROFENTEEN contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

NUROFENTEEN should not be taken by children under 12 years of age.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, seek immediate medical advice should your symptoms (e.g. fever and pain) persist or worsen (see section 2).

In adolescents:
If treatment with this medicine is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.

In adults:
Consult a doctor if symptoms worsen or do not improve after 3 days of treatment for fever or after 4 days for pain.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has directed. If in doubt, consult your doctor or pharmacist. The recommended dose is:

Let the orodispersible tablets dissolve on the tongue and swallow the dissolved mass of the tablets. It is not necessary to take liquids with them.
If you take more NUROFENTEEN than you should
If you have taken more NUROFENTEEN than you should, or if your child has taken this medicine by mistake, always contact your doctor or the nearest hospital for advice on the risk and guidance on actions to be taken. Symptoms may include nausea, stomach ache, vomiting (possibly with traces of blood), gastrointestinal bleeding, headache, ringing in the ears, confusion and uncontrolled eye movements (nystagmus), or more rarely, diarrhoea. In addition, at high doses, dizziness, blurred vision, low blood pressure, excitement, disorientation, coma, hyperkalemia (increased blood potassium levels), prolonged prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, and worsening of asthma in asthmatic patients have been reported, as well as drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in the urine, feeling cold, and breathing problems.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

As with all medicines, NUROFENTEEN may cause side effects, although not everyone experiences them.
Side effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
You may experience one of the known side effects of NSAIDs (see below). If this occurs, or if you have any concerns, stop taking this medicine and contact your doctor as soon as possible. Elderly patients taking this medicine are at higher risk of developing problems related to side effects.

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

• signs of gastrointestinal bleeding, such as severe abdominal pain, dark stools, vomiting blood or dark particles resembling coffee grounds;
• signs of very rare but serious allergic reactions, such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, drop in blood pressure leading to shock. These symptoms may occur even with the first use of this medicine;
• severe skin reactions, such as rashes affecting the entire body, skin peeling, blistering or skin detachment.

Consult your doctor if you experience any of the following adverse reactions

Common (may affect up to 1 in 10 users)

• gastrointestinal problems such as heartburn, abdominal pain, nausea, indigestion, diarrhea, vomiting, flatulence (gas), constipation, and minor bleeding in the stomach and/or intestines, which in rare cases may lead to anemia.

Uncommon (may affect up to 1 in 100 users)

• gastrointestinal ulcers, bleeding and perforation, inflammation of the oral mucosa with ulceration, worsening of existing intestinal disorders (ulcerative colitis or Crohn's disease), gastritis
• central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or fatigue
• visual disturbances
• various skin rashes
• hypersensitivity reactions with urticaria and itching

Rare (may affect up to 1 in 1,000 users)

• tinnitus (ringing in the ears)
• increased blood uric acid levels, pain in the hips and/or abdomen, blood in the urine and fever may be signs of kidney damage (papillary necrosis)
• decreased hemoglobin levels

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

• esophagitis, pancreatitis, formation of membrane-like constrictions in the intestine (diaphragm-like intestinal strictures)
• heart failure, myocardial infarction, and swelling of the face and hands (edema)
• reduced urine output and swelling (especially in patients with high blood pressure or impaired kidney function); swelling (edema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) which may lead to acute kidney failure. If any of these symptoms occur, or if you feel generally unwell, stop taking NUROFENTEEN and consult your doctor immediately, as these could be early signs of kidney damage or kidney failure.
• psychotic reactions and depression
• high blood pressure and vasculitis
• palpitations
• liver dysfunction, liver damage (first sign may be change in skin color), especially after prolonged treatment, liver failure, acute inflammation of the liver (hepatitis)
• problems in blood cell production – early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nose and skin bleeding, and unexplained bruising. In such cases, you must stop taking NUROFENTEEN and consult your doctor immediately. Self-treatment with analgesics and antipyretic medicines should not be attempted.
• severe skin infections and soft tissue complications have been observed during chickenpox infection
• worsening of infection-related inflammation (e.g., necrotizing fasciitis) has been associated with the use of certain analgesics (NSAIDs). If signs of infection appear or worsen, seek immediate medical advice to determine whether anti-infective/antibiotic treatment is needed.
• symptoms of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever or confusion have been observed during ibuprofen use. Patients with autoimmune diseases (SLE, mixed connective tissue disease) may be more susceptible. Contact your doctor immediately if these symptoms occur.
• severe forms of skin reactions such as skin rashes with redness and blistering (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia)

Not known (frequency cannot be estimated from available data):

• respiratory tract reactivity including asthma, bronchospasm and dyspnea
• 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 cells).
• a widespread, red, scaly rash with pustules under the skin and blisters mainly in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using NUROFENTEEN if you develop these symptoms and contact your doctor immediately. See also section 2: the skin becomes sensitive to light.

Medicines such as NUROFENTEEN may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. Do not use
NUROFENTEEN after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the month indicated. Do not store above 25°C.
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.

What NUROFENTEEN contains
The active substance is ibuprofen. Each orodispersible tablet contains 200 mg of
ibuprofen. The other ingredients are: ethylcellulose, precipitated silica, hypromellose,
mannitol, aspartame (E951), sodium croscarmellose, magnesium stearate, flavour (lemon –
containing sorbitol).

What NUROFENTEEN looks like and contents of the pack
The orodispersible tablets are white to off-white, round, and have a characteristic lemon odour.
Orodispersible tablets are available in packs containing 4, 6, 10, 12, 18, 20, 24,
30, 36, 40 and 48 orodispersible tablets. Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Reckitt Benckiser Healthcare (Italia) S.p.A. – via G. Spadolini 7 – 20141 Milano
Manufacturer:
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, Netherlands

This medicinal product is authorised in the Member States of the European Economic Community under the following names:
Austria: Nurofen 200 mg Schmelztabletten Lemon
Belgium: Nurofen Smelttabletten, orodispergeerbare tabletten
France: Nurofen 200mg, Comprimé orodispersible
Greece: Nurofen Lemon Orodispersible Tablet 200mg
Italy: NUROFENTEEN 200mg Compresse Orodispersibili Limone
Luxembourg: Nurofen Comprimés Fondants, comprimés orodispersible
Netherlands: Nurofen 200 Lemon Smelttablet

Package leaflet: information for the user

NUROFENTEEN 200 mg mint-flavored orodispersible tablets

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

• 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen:
  – After 3 days in adolescents
  – After 3 days if you have fever, or after 4 days if you have pain in adults.

1 What NUROFENTEEN is and what it is used for
2 What you need to know before taking NUROFENTEEN
3 How to take NUROFENTEEN
4 Possible side effects
5 How to store NUROFENTEEN
6 Package contents and other information

NUROFENTEEN contains 200 mg of ibuprofen. Ibuprofen belongs to a group of
medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines
work by altering the body's response to pain, swelling, and high temperature.
NUROFENTEEN is used for

• relieving symptoms of mild to moderate pain such as headache, toothache, and menstrual pain
• reducing fever

Consult your doctor if you do not feel better or if you feel worse after 3 days in
adolescents, or after 3 days in case of fever or after 4 days for pain treatment
in adults.

Do not take NUROFENTEEN if:

• you are allergic (hypersensitive) to ibuprofen or to any of the other ingredients of NUROFENTEEN (listed in section 6)
• you have experienced breathing difficulties, asthma, rhinitis, swelling of the face and/or hands, or hives after taking ibuprofen, acetylsalicylic acid, or other similar painkillers (NSAIDs)
• you suffer from severe liver failure, severe kidney failure, or severe heart failure
• you have (or have had) two or more episodes of stomach ulcer or gastrointestinal bleeding
• you have had gastrointestinal bleeding or perforation following previous treatment with NSAIDs
• you have cerebrovascular haemorrhage or other types of active bleeding
• you suffer from unexplained blood disorders
• you suffer from severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake)
• you are in the last 3 months of pregnancy (see below)

Warnings and precautions
Talk to your doctor or pharmacist before taking NUROFENTEEN

• if you have an infection – see section "Infections" below
• if you suffer from certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease)
• if you suffer from a hereditary blood disorder (acute intermittent porphyria)
• if you have blood clotting problems
• if you suffer or have suffered from gastrointestinal disorders (ulcerative colitis or Crohn's disease)
• if you suffer from reduced kidney function
• if you suffer from liver disorders
• if you are planning a pregnancy
• if you suffer or have suffered from asthma or allergic diseases, as you may experience shortness of breath
• if you suffer from hay fever, nasal polyps, or chronic obstructive respiratory diseases, as there is an increased risk of developing allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma), skin swelling (angioedema), or hives.
• it is recommended to avoid taking NUROFENTEEN if you have chickenpox.
• if you take NUROFENTEEN for long periods of time, regular tests to assess liver and kidney function and blood cell counts should be performed.
• side effects can be minimized by using the lowest effective dose for the shortest possible duration
• elderly patients have a higher risk of developing adverse reactions
• in general, habitual use of (various types of) painkillers may lead to serious, permanent kidney problems. This risk may increase with physical exertion associated with loss of salts and dehydration. Therefore, it should be avoided.
• prolonged use of any type of painkiller for headache may worsen symptoms. If this occurs or is suspected, you should stop taking NUROFENTEEN and consult your doctor. Medication-overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) regular use of analgesic medicines.
• concomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, may increase the risk of adverse effects and should be avoided (see section "Taking with other medicines")
• in dehydrated adolescents, there is a risk of kidney impairment
• particular caution is required if you have recently undergone major surgery
• anti-inflammatory/painkillers 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 NUROFENTEEN if you have:

• heart problems including heart attack, angina (chest pain), or history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowing or blockage of arteries), or any type of stroke (including 'mini-stroke' or TIA, transient ischaemic attack);
• high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

Infections
NUROFENTEEN may mask symptoms of infections such as fever and pain. Therefore, NUROFENTEEN may delay appropriate treatment of infection, potentially 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 infection symptoms persist or worsen, consult your doctor immediately.

Skin reactions
Serious skin reactions have been reported in association with treatment with
NUROFENTEEN. Stop taking NUROFENTEEN and consult your doctor immediately if you develop a skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a serious skin reaction. See section 4.

Other medicines and NUROFENTEEN
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
NUROFENTEEN may affect or be affected by other medicines. For example:

• medicines with an anticoagulant effect (i.e. substances that thin the blood and prevent clot formation, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan). Other medicines may also affect or be affected by treatment with NUROFENTEEN.

Inform your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those without a prescription. In particular, inform your
doctor or pharmacist if you are taking:

NUROFENTEEN with food
It is recommended to take NUROFENTEEN with food in individuals with gastric hypersensitivity.

Pregnancy, breastfeeding and fertility
Pregnancy
Do not take this medicine during the last three months of pregnancy. Avoid using this medicine during the first six months of pregnancy unless prescribed by a doctor.

Breastfeeding
This medicine passes into breast milk, but it may be used during breastfeeding if taken at the recommended doses and for short periods of time.
Ask your doctor or pharmacist for advice before taking any medicine.

Fertility
Avoid taking this medicine if you are planning a pregnancy.

Driving and use of machines
For short-term treatment, this medicine does not affect or affects only slightly the ability to drive and operate machinery.

NUROFENTEEN contains 0.072 mg of sorbitol per tablet. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

NUROFENTEEN contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

NUROFENTEEN contains 25 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot properly eliminate it.

NUROFENTEEN should not be taken by children under 12 years of age.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, consult your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

In adolescents:
If use of the medicine is required for more than 3 days in adolescents, or if symptoms worsen, a doctor should be consulted.

In adults:
You should consult a doctor if symptoms worsen or do not improve after 3 days of treatment for fever or after 4 days for pain.

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. The recommended dose is:

Let the orodispersible tablets dissolve on the tongue and swallow the dissolved mass.
It is not necessary to take liquids with this medication.
If you take more NUROFENTEEN than you should
If you have taken more NUROFENTEEN than prescribed, or if your child has accidentally taken this medicine, contact your doctor or the nearest hospital immediately for advice regarding the risk and the necessary actions to take. Symptoms may include: nausea, stomach pain, vomiting (possibly with traces of blood), gastrointestinal bleeding, headache, tinnitus (ringing in the ears), confusion, and uncontrolled eye movements (nystagmus), or more rarely, diarrhea. Additionally, at high doses, dizziness, weakness, dizziness upon standing, drowsiness, blurred vision, low blood pressure, chest pain, palpitations, excitement, disorientation, coma, seizures (especially in children), loss of consciousness, hyperkalemia (increased potassium levels in the blood), prolonged prothrombin time/INR, acute renal failure, liver damage, blood in the urine, feeling cold, respiratory depression, cyanosis, worsening of asthma in asthmatic patients, and breathing difficulties have been reported.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

As with all medicines, NUROFENTEEN can cause side effects, although not everyone experiences them.
Side effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
You may experience one of the known side effects of NSAIDs (see below). If this occurs, or if you have any concerns, stop taking this medicine and contact your doctor as soon as possible. Elderly patients taking this medicine are at higher risk of developing problems associated with side effects.

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

• signs of gastrointestinal bleeding, such as severe abdominal pain, dark stools, vomiting blood or dark particles resembling coffee grounds;
• signs of very rare but serious allergic reactions, such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, or a drop in blood pressure leading to shock. These symptoms may occur even with the first use of this medicine.
• severe skin reactions, such as rashes affecting the entire body, skin peeling, blistering or skin sloughing.

Contact your doctor if you experience any of the following adverse reactions

Common (may affect up to 1 in 10 users)

• gastrointestinal problems such as heartburn, abdominal pain, nausea, indigestion, diarrhea, vomiting, flatulence (gas), constipation, and minor bleeding in the stomach and/or intestines, which in rare cases may lead to anemia.

Uncommon (may affect up to 1 in 100 users)

• gastrointestinal ulcers, bleeding and perforation, inflammation of the oral mucosa with ulceration, worsening of existing intestinal disorders (ulcerative colitis or Crohn's disease), gastritis
• central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or fatigue
• visual disturbances
• various skin rashes
• hypersensitivity reactions with hives and itching

Rare (may affect up to 1 in 1,000 users)

• tinnitus (ringing in the ears)
• increased blood uric acid levels, pain in the flanks and/or abdomen, blood in the urine and fever may be signs of kidney damage (papillary necrosis)
• decreased hemoglobin levels

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

• esophagitis, pancreatitis, formation of membranous strictures in the intestine (membranous intestinal strictures)
• heart failure, heart attack and swelling of the face and hands (edema)
• reduced urine output and swelling (especially in patients with high blood pressure or reduced kidney function); swelling (edema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) which may lead to acute kidney failure. If any of these symptoms occur, or if you feel generally unwell, stop taking NUROFENTEEN and contact your doctor immediately, as these may be early signs of kidney damage or kidney failure.
• psychotic reactions and depression
• high blood pressure and vasculitis
• palpitations
• liver dysfunction, liver damage (first sign may be change in skin color), particularly with long-term treatment, liver failure, acute inflammation of the liver (hepatitis)
• problems in blood cell production – early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nose and skin bleeding, and unexplained bruising. In such cases, you must stop taking NUROFENTEEN and contact your doctor immediately. Self-medication with analgesics and antipyretic medicines must not be attempted.
• severe skin infections and soft tissue complications have been reported during chickenpox infection
• worsening of infection-related inflammation (e.g., necrotizing fasciitis) has been associated with the use of some analgesics (NSAIDs). If signs of infection appear or worsen, contact your doctor immediately to determine whether anti-infective/antibiotic therapy is needed.
• symptoms of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever or confusion have been observed during ibuprofen use. Patients with autoimmune disorders (SLE, mixed connective tissue disease) may be more susceptible. Contact your doctor immediately if these symptoms occur.
• severe forms of skin reactions such as skin rashes with redness and blistering (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia).

Not known (frequency cannot be estimated from available data)

• respiratory tract reactivity including asthma, bronchospasm and dyspnea.
• 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 pustules under the skin and blisters mainly in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using NUROFENTEEN if you develop these symptoms and contact your doctor immediately. See also section 2: skin becomes sensitive to light.

Medicines such as NUROFENTEEN may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. Do not use
NUROFENTEEN after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the month indicated. Do not store above 25°C.
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.

What NUROFENTEEN contains
The active substance is ibuprofen. Each orodispersible tablet contains 200 mg of
ibuprofen. The other ingredients are: ethylcellulose, precipitated silica, hypromellose,
mannitol, aspartame (E951), sodium croscarmellose, magnesium stearate, flavour (mint –
containing sorbitol).
What NUROFENTEEN looks like and contents of the pack
The orodispersible tablets are white to off-white, round, and have a characteristic mint odour. The orodispersible tablets are available in packs containing 4, 6, 10, 12, 18, 20, 24,
30, 36, 40 and 48 orodispersible tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Reckitt Benckiser Healthcare (Italia) S.p.A. – via G. Spadolini 7 – 20141 Milan, Italy
Manufacturer:
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, The Netherlands
This medicinal product is authorised in the Member States of the European Economic
Community under the following names:
Austria: Nurofen Meltlets Mint 200 mg - Schmelztabletten
France: Nurofentabs 200mg, Comprimé orodispersible
Greece: Nurofen Mint Orodispersible Tablet 200mg
Italy: NUROFENTEEN 200mg orodispersible tablets, mint flavour