NurofenBaby

Patient Information Leaflet

Nurofenbaby 60 mg Suppositories

Early Infancy
For children weighing between 6 kg (3 months) and 12.5 kg (2 years)
Ibuprofen
Please read this leaflet carefully before using 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, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if symptoms worsen:
• within 24 hours in infants aged 3 to 5 months, or
• after 3 days of treatment in children aged 6 months and older.

Contents of this leaflet:

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

1. What Nurofenbaby 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 between 6 kg (3 months) and 12.5 kg (2 years).
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after 24 hours in infants aged between 3 and 5 months, or after 3 days of treatment in children aged 6 months and older.

2. What you need to know before using Nurofenbaby

Do not use Nurofenbaby:

• if you are allergic (hypersensitive) to ibuprofen or to other similar painkillers (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6)
• if you have experienced shortness of breath, asthma, rhinorrhea (runny nose), facial and/or hand swelling, or hives after taking ibuprofen, acetylsalicylic acid, or other similar painkillers (NSAIDs)
• if you have a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs
• if you have had or have two or more episodes of gastric/duodenal ulcer (peptic ulcer) or bleeding
• if you have active cerebrovascular bleeding or other types of active bleeding
• if you suffer from unexplained blood disorders
• if you suffer from severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake)
• if you suffer from severe renal, hepatic, or cardiac insufficiency
• during 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.
• if you have certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease)
• if you suffer from a hereditary blood disorder (e.g. acute intermittent porphyria)
• if you suffer from blood coagulation disorders
• if you have or have had gastrointestinal disorders (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 problems
• if you have disorders of the rectum or anus
• if you have had 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 diseases, there is an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called “analgesic-induced asthma”), Quincke's edema, or urticaria
• if gastrointestinal bleeding, ulceration, or perforation occurs while taking this medicine. These conditions are not necessarily preceded by warning symptoms, do not affect only patients with a previous history of serious gastrointestinal events, and can be fatal. If gastrointestinal bleeding or ulceration occurs in patients taking Nurofenbaby, treatment must be discontinued. Caution should be exercised in patients taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (medicines used to treat depression), or antiplatelet agents (e.g. acetylsalicylic acid)
• if you are taking other NSAIDs (including selective COX-2 inhibitors such as celecoxib or etoricoxib)
• if you have chickenpox, it is advisable to avoid using Nurofenbaby
• if Nurofenbaby is administered for prolonged periods, regular monitoring of liver values, renal function, and blood counts is required
• adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms
• elderly patients have an increased risk of adverse effects
• in general, habitual use of painkillers may lead to serious and permanent kidney problems. This risk may increase with physical exertion associated with loss of salts and dehydration. Therefore, such use should be avoided
• prolonged use of any type of painkiller for headache may worsen headache symptoms. If this occurs or is suspected, consult your doctor and discontinue treatment. Medication-overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of analgesics
• concomitant use with other NSAIDs, including selective cyclooxygenase-2 (COX-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 small increased risk of heart attack (“myocardial infarction”) or stroke. The risk is higher with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment: maximum 24 hours for infants aged 3 to 5 months, and maximum 3 days for children aged 6 months and older.

• if you have heart problems or a history of stroke, or think you are at risk for these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or are a smoker), discuss your treatment with your doctor or pharmacist
• there is a risk of kidney damage in dehydrated children
• special medical monitoring is required immediately after major surgery

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

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

Other medicines and Nurofenbaby
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Nurofenbaby may affect or be affected by certain medicines. For example:

• medicines such as anticoagulants (to prevent blood clotting) (e.g. acetylsalicylic acid, warfarin, ticlopidine)
• medicines for high blood pressure (ACE inhibitors e.g. captopril, beta-blockers e.g. atenolol, angiotensin II antagonists e.g. losartan)

Other medicines may also affect or be affected by treatment with Nurofenbaby. Therefore, always ask your doctor or pharmacist for advice before using Nurofenbaby together with other medicines.
In particular, inform them if you are taking:

Nurofenbaby and alcohol
Do not drink alcoholic beverages while using Nurofenbaby. Some adverse effects, such as those affecting the gastrointestinal tract or the nervous system, may be more likely when alcohol is consumed concurrently with Nurofenbaby.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Contact your doctor if you become pregnant while using Nurofenbaby. 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 your doctor.

Breastfeeding
This medicine may be used during breastfeeding if taken at the recommended doses and for the shortest possible duration.

Fertility
This product belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible after discontinuation of treatment.

Driving and using machines
For short-term treatment, this medicine has little or no influence on the ability to drive or operate machinery.

3. How to use Nurofenbaby

The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If your child has an infection, consult your doctor immediately if symptoms (such as fever and
pain) persist or worsen (see section 2).
Use this medicine exactly as stated in this leaflet or according to your doctor’s or pharmacist’s
instructions. If in doubt, consult your doctor or pharmacist.
Nurofenbaby should be administered to children older than 3 months of age and weighing at least 6.0 kg (see also section 2). The maximum daily dose of ibuprofen is 20–30 mg/kg body weight, divided into 3 or 4 doses throughout the day. Nurofenbaby may be administered according to the following dosing schedule (note that in this schedule, the child’s body weight is more important than age):

The suppositories must be administered rectally, pointed end first. Before administration, it may be helpful to warm the suppository between the hands.
For short-term treatment only.
In infants aged between 3 and 5 months, consult a doctor if symptoms worsen or within 24 hours if symptoms persist.
If this medicine is required for more than 3 days in children aged 6 months and older, or if symptoms worsen, a doctor should be consulted.
If you use more Nurofenbaby than you should
If you have taken more Nurofenbaby than you should, or if your child has accidentally taken this medicine, always contact your doctor or the nearest hospital for advice on the potential risk and actions to take.
Symptoms may include nausea, vomiting (possibly with traces of blood), stomach pain, gastrointestinal bleeding, confusion, headache, tinnitus (ringing in the ears), uncontrolled eye movements (nystagmus), or more rarely, diarrhoea. In addition, with higher doses, dizziness, weakness, vertigo, drowsiness, blurred vision, low blood pressure, chest pain, palpitations, excitement, disorientation, coma, seizures (particularly in children), loss of consciousness, hyperkalaemia (increased blood potassium levels), prolonged prothrombin time/INR, acute kidney failure, liver damage, blood in the urine, feeling cold, respiratory depression, cyanosis, worsening of asthma in asthmatic patients, and breathing problems have been reported.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nurofenbaby can cause side effects, although not everyone experiences them.
Side effects can be minimised 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 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 using this medicine and contact your doctor immediately if you develop:

• Signs of intestinal 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 shortness of breath or difficulty breathing, 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 detachment.

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

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

• Gastrointestinal disturbances such as heartburn, stomach pain, nausea, indigestion, diarrhoea, vomiting, flatulence, constipation, and minor bleeding in the stomach and/or intestines, which in rare cases may lead to anaemia.

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

• Hypersensitivity reactions such as hives and itching.
• Gastrointestinal ulcers, perforation or bleeding, inflammation of the mouth mucosa with ulceration (ulcerative stomatitis), worsening of existing intestinal disorders (colitis or Crohn’s disease), gastritis, localised rectal irritation.
• Central nervous system disturbances such as headache, dizziness, insomnia, agitation, irritability, or fatigue.
• Visual disturbances.
• Various skin rashes.

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

• Tinnitus (ringing in the ears).
• Increased blood urea levels, pain in the flanks and/or abdomen, blood in the urine, and fever, which may indicate kidney damage (papillary necrosis).
• Decreased 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 may lead to acute kidney failure. If you experience any of these symptoms or feel generally unwell, stop taking Nurofenbaby and contact your doctor immediately, as these may be early signs of kidney damage or kidney failure.
• Psychotic reactions, depression.
• High blood pressure, vasculitis.
• Palpitations.
• Liver dysfunction, liver damage (early signs may include skin discolouration), especially during 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, nosebleeds, skin bleeding, and unexplained bruising. In such cases, you must stop treatment immediately and contact your doctor without delay. Avoid any self-medication with painkillers or fever-reducing medicines (antipyretics).
• Severe skin infections and soft tissue complications during chickenpox infection.
• Worsening of infections-related inflammation (e.g., necrotising fasciitis) has been reported with the use of certain painkillers (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 stiff neck, 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 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 reactions 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 increased eosinophils (a type of white blood cell).
  • A widespread, red, scaly rash with pustules under the skin and blisters, mainly appearing in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalised exanthematous pustulosis). Stop using Nurofenbaby if you develop these symptoms and contact your doctor immediately. See also section 2: the skin becomes sensitive to light. Medicines like Nurofenbaby may be associated with a modestly increased 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 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 Nurofenbaby

Keep this medicine out of the sight and reach of children.
Do not use Nurofenbaby after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Nurofenbaby contains
The active substance is ibuprofen. Each suppository contains 60 mg of ibuprofen.
The other ingredients are solid semisynthetic glycerides.

Description of the appearance of Nurofenbaby and package contents
White or almost white cylindrical suppositories.
The pack contains 1, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 suppositories.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Reckitt Benckiser Healthcare (Italia) S.p.A. – Via Spadolini 7 – 20141 Milan, Italy

Manufacturer:
Famar A.V.E., Avlon Plant, 49th km National Road, Athens - Lamia, 19011 Avlona Attiki, Greece

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Nurodon für Kinder 60 mg Zäpfchen
Netherlands: Nurofen voor Kinderen Zeptil-60
Italy: Nurofenbaby 60 mg supposte prima infanzia
Romania: Nurofen pentru copii 60 mg supozitoare
Slovenia: Nurofen za otroke 60 mg svečke