NUROFENBABY*10SUPP 60MG

Nurofenbaby 60 mg suppositories
Ibuprofen

What it is and what it is used for
Nurofenbaby 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.

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

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

Nurofenbaby is indicated for children weighing from 6 kg (3 months) to 12.5 kg (2 years).

Consult your doctor if you do not notice any improvement or if symptoms worsen after 24 hours in infants aged 3 to 5 months, or after 3 days of treatment in children aged 6 months or older.

What you need to know before taking the medicine
Do not use Nurofenbaby:
• 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 experienced wheezing, 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 bleeding
• if you have cerebrovascular hemorrhage or other types of active bleeding
• if you suffer from unexplained blood formation disorders
• if you suffer from severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake)
• if you suffer from severe kidney, liver, or heart failure
• if you are in the last 3 months of pregnancy
• in children weighing less than 6.0 kg (under 3 months of age).

Warnings and precautions
Talk to your doctor or pharmacist before using Nurofenbaby:
• if you have an infection - see section "Infections" below.
• in the presence of certain skin conditions (Systemic Lupus Erythematosus (SLE) or mixed connective tissue disease)
• if you suffer from a hereditary disorder of blood formation (e.g., acute intermittent porphyria)
• if you suffer from blood clotting disorders
• in the presence of or with a history of gastrointestinal diseases (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 might 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 edema, or urticaria.
• if gastrointestinal bleeding, ulceration, or perforation occur due to this medicine. These conditions are not necessarily preceded by warning symptoms, do not only affect patients with a previous history of serious gastrointestinal events, and can be fatal. When gastrointestinal bleeding or ulceration occurs in patients taking Nurofenbaby, treatment should be discontinued.
Caution should be exercised in patients taking other medicines that could increase the risk of ulceration or bleeding, such as oral corticosteroids (like prednisolone), anticoagulants (like warfarin), selective serotonin reuptake inhibitors (medicines for treating 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 Nurofenbaby
• in case of prolonged administration of Nurofenbaby, 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 duration of treatment 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 with physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.
• prolonged use of any type of analgesic for headache can worsen its 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) 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 Nurofenbaby") and should be avoided
• medicines such as Nurofenbaby may be associated with a modest increase in the 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, which is a maximum of 24 hours for infants aged 3 to 5 months and a maximum of 3 days for children aged 6 months or older.
• if you have heart problems or a 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
Nurofenbaby may mask the symptoms of infections such as fever and pain. Therefore, Nurofenbaby 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 related to chickenpox. If you take this medicine while you have an infection and the infection symptoms persist or worsen, consult your doctor immediately.

Skin reactions
Serious skin reactions have been reported in association with Nurofenbaby treatment. Stop taking Nurofenbaby and consult your doctor immediately if you experience 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, Nurofenbaby can cause side effects, although not everybody gets them.

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

You may experience any of the known side effects of NSAIDs (see below). If this happens, or if you have concerns about it, stop taking this medicine and inform your doctor as soon as possible.

Elderly patients taking this medicine are at higher 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, black stools, vomiting with blood or dark particles resembling 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 full-body skin rashes, peeling, blistering or flaking of the skin.

Consult your doctor if you experience any of the other possible side effects

Common (may affect up to 1 in 10 people):
• Stomach disorders, such as heartburn, stomach pain and nausea, indigestion, diarrhea, vomiting, flatulence and constipation, and minor blood loss in the stomach and/or intestines which in exceptional cases can cause anemia

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 with ulceration (ulcerative stomatitis), worsening of existing bowel disorders (colitis or Crohn's disease), gastritis, localized rectal irritation.
• Central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or fatigue.
• Vision disturbances.
• Various skin rashes

Rare (may affect up to 1 in 1,000 people): • Tinnitus (ringing in the ears).
• Increased urea concentrations in the blood, flank and/or abdominal pain, blood in the urine and fever which may be signs of kidney damage (papillary necrosis).
• Decreased hemoglobin levels

Very rare (may affect up to 1 in 10,000 people):
• Inflammation of the esophagus, pancreatitis, formation of diaphragm-like intestinal structures.
• Heart failure, heart attack and swelling of the face and hands (edema)
• Reduced urine output compared to normal 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 can lead to acute kidney failure. If any of the above symptoms occur or if you have a general feeling of being unwell, stop taking Nurofenbaby 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 discoloration), especially during long periods of treatment, liver failure, acute inflammation of the liver (hepatitis).
• Problems with blood cell production - the 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 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 a 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 dyspnea.
• A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell).
• A widespread, red, scaly rash with bumps under the skin and blisters located mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using Nurofenbaby if you develop these symptoms and contact your doctor immediately. See also section 2.
• skin becomes sensitive to light

Medicines like Nurofenbaby 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.