NUROFENJUNIOR*10SUPP 125MG

Nurofenjunior 125 mg suppositories
Ibuprofen

What it is and what it is used for
Nurofenjunior contains ibuprofen and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by controlling the body's response to pain and fever.

Nurofenjunior is indicated for the short-term symptomatic treatment of:
• fever
• mild to moderate pain

Nurofenjunior is particularly suitable when oral administration is not recommended, e.g., in case of vomiting.

Nurofenjunior is indicated for children weighing from 12.5 kg (2 years) to 20.5 kg (6 years).

Consult your doctor if you do not notice any improvement or if the child's symptoms worsen after three days of treatment.

What you need to know before taking the medicine
Do not use Nurofenjunior:
• if you are allergic (hypersensitive) to ibuprofen or other similar analgesics (NSAIDs) or any of the other ingredients of this medicine (listed in section 6)
• if you have suffered from shortness of breath, asthma, rhinorrhea (runny nose), swelling of the face and/or hands, or urticaria after using ibuprofen, acetylsalicylic acid or other similar analgesics (NSAIDs)
• if you have a history of gastrointestinal bleeding or perforation associated with previous NSAID treatments
• if you have (or have had two or more episodes of) gastric/duodenal ulcer (peptic ulcer) or stomach bleeding
• if you have cerebrovascular haemorrhage or other types of active bleeding
• if you suffer from unexplained blood formation disorders
• if you suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)
• if you suffer from severe kidney, liver or heart failure
• if you are in the last three months of pregnancy
• in children weighing less than 12.5 kg (under 2 years of age)

Warnings and precautions
Talk to your doctor or pharmacist before using Nurofenjunior:
• if you have an infection - see the Infections section below
• if you have certain skin conditions (Systemic Lupus Erythematosus (SLE) or mixed connective tissue disease).
• if you suffer from a hereditary blood formation disorder (e.g., acute intermittent porphyria).
• if you suffer from blood clotting disorders.
• if you have or have had gastrointestinal conditions (ulcerative colitis or Crohn's disease).
• if you have ever suffered from high blood pressure and/or heart failure.
• if you have reduced kidney function.
• if you suffer from liver disorders.
• in the presence of rectal or anal disorders
• in case of previous episodes of high blood pressure and/or heart failure
• 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 disorders, there is an increased risk of allergic reactions. Allergic reactions can manifest as asthma attacks (so-called analgesic asthma), Quincke's oedema or urticaria.
• If gastrointestinal bleeding, ulcer or perforation occurs due to this medicine. These conditions are not necessarily preceded by warning symptoms, do not only affect patients with a previous history of severe gastrointestinal events and can be fatal. When gastrointestinal bleeding or ulceration occurs in patients taking Nurofenjunior, treatment should be discontinued. Caution should be exercised in patients taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (like prednisolone), anticoagulants (like warfarin), selective serotonin reuptake inhibitors (medicines for the treatment of depression) or antiplatelet agents (like acetylsalicylic acid).
• if you are taking other NSAIDs (including selective COX-2 inhibitors such as celecoxib or etoricoxib).
• in the presence of chickenpox, it is advisable to avoid the use of Nurofenjunior.
• In case of prolonged administration of Nurofenjunior, regular monitoring of liver values, kidney function and blood count is required.
• undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration necessary to control symptoms.
• elderly patients have an increased risk of undesirable effects.
• in general, habitual use of analgesics can lead to serious and permanent kidney problems. This risk may increase in case of physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.
• prolonged use of any type of analgesic for headaches can worsen symptoms. If this occurs or is suspected, you should consult your doctor and discontinue treatment. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of analgesic medications.
• concomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, may increase the risk of adverse reactions (see section Other medicines and Nurofenjunior) and should be avoided.
• medicines such as Nurofenjunior may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment (maximum 3 days).
• if you have heart problems or a previous history of stroke or think you may be at risk for these conditions (for example, if you have high blood pressure, diabetes or high cholesterol or if you are a smoker) you should discuss your therapy with your doctor or pharmacist.
• there is a risk of kidney damage in dehydrated children.
• particular medical supervision is required immediately after major surgery

Infections
Nurofenjunior can mask the symptoms of infections such as fever and pain. Therefore, it is possible that Nurofenjunior may delay adequate 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 related to chickenpox. If you take this medicine while you have an infection and the infection symptoms persist or worsen, contact your doctor immediately.

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

Possible side effects
Like all medicines, Nurofenjunior can cause side effects, although not everyone gets them.

Side effects can be minimized by using the lowest effective dose for the shortest time necessary to relieve symptoms.

You may experience one of the known side effects of NSAIDs (see below). If this happens, or if you have concerns, stop taking this medicine and inform your doctor as soon as possible. Elderly people taking this medicine are at greater risk of developing problems associated with side effects.

Stop using this medicine and consult your doctor immediately if you develop:
• signs of intestinal bleeding such as: severe abdominal pain, dark stools, vomiting with blood or dark particles similar to coffee grounds;
• signs of very rare but severe 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 also occur with the first use of this medicine;
• severe skin reactions such as rashes over the entire body, peeling, blistering or flaking of the skin.

Consult your doctor if you experience any of the possible other side effects
Common (may affect up to 1 in 10 people):
• Gastric disorders, such as heartburn, stomach pain and nausea, indigestion, diarrhoea, vomiting, flatulence and constipation, and slight blood loss in the stomach and/or intestine, which in exceptional cases may cause anaemia.

Uncommon (may affect up to 1 in 100 people):
• Hypersensitivity reactions with urticaria and itching.
• Gastrointestinal ulcers, perforation or bleeding, inflammation of the oral mucosa (ulcerative stomatitis), worsening of existing intestinal disorders (colitis or Crohn's disease), gastritis, localized rectal irritation.
• Central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or fatigue.
• Vision disorders.
• Various skin rashes.

Rare (may affect up to 1 in 1,000 people):
• Tinnitus (ringing in the ears).
• Increased urea concentrations in the blood, pain in the sides and/or abdomen, blood in the urine and fever, which may be a sign of kidney damage (papillary necrosis).
• Decrease in haemoglobin levels.

Very rare (may affect up to 1 in 10,000 people):
• Inflammation of the oesophagus, pancreatitis, formation of diaphragm-like intestinal structures.
• Heart failure, heart attack and swelling of the face and hands (oedema).
• Reduced urine output compared to normal and swelling (especially in patients with high blood pressure or reduced kidney function); swelling (oedema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) which can lead to acute kidney failure. If any of the above symptoms occur or if you have a general feeling of ill health, stop taking Nurofenjunior and consult your doctor immediately as these could be the first signs of kidney damage or kidney failure.
• Psychotic reactions, depression.
• High blood pressure, vasculitis.
• Palpitations.
• Liver dysfunction, liver damage (the first signs may be skin discolouration), especially during long periods of treatment, liver failure, acute inflammation of the liver (hepatitis).
• Problems in the production of blood cells - first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, bleeding from the nose and skin and unexplained bruising. In these cases, you must immediately stop therapy and consult your doctor immediately. Any self-medication treatment with analgesics or fever-reducing medicines (antipyretic medicines) should be avoided.
• Severe skin infections and soft tissue complications during chickenpox infection.
• Worsening of infection-related inflammations (e.g., necrotizing fasciitis) associated with the use of certain analgesics (NSAIDs) has been described. If signs of an infection appear or worsen, you should immediately contact your doctor to assess whether anti-infective/antibiotic therapy is necessary.
• Symptoms of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever or disorientation have been observed during the use of ibuprofen. 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 rashes with redness and blistering (e.g., Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia).

Not known (frequency cannot be estimated from the available data):
• Respiratory tract reactivity including asthma, bronchospasm or dyspnoea.
• A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell).
• A widespread, red, scaly rash with subcutaneous pustules and vesicles localized mainly on skin folds, trunk and upper limbs accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using Nurofenjunior if you develop these symptoms and contact your doctor immediately. See also section 2.
• the skin becomes sensitive to light

Medicines such as Nurofenjunior may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke.

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