Nurofenkid for fever and pain

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nurofenkid Fever and Pain 100 mg, chewable soft capsules

Indicated for children with a body weight between 20 kg (7 years) and 40 kg (12 years).
Ibuprofen
Please read carefully all of this leaflet before using this medicine as it contains important information for you.
Always use 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 your child experiences 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 any improvement or if symptoms worsen after 3 days.

Contents of this leaflet:

1. What Nurofenkid Fever and Pain is and what it is used for
2. What you need to know before giving Nurofenkid Fever and Pain
3. How to give Nurofenkid Fever and Pain
4. Possible side effects
5. How to store Nurofenkid Fever and Pain
6. Contents of the pack and other information

1. What Nurofenkid Fever and Pain is and what it is used for

The active ingredient (the component that makes this medicine effective) is ibuprofen, which is a non-steroidal anti-inflammatory drug (NSAID).
Nurofenkid Fever and Pain is indicated in children with a body weight between 20 kg (7 years) and 40 kg (12 years) for the short-term symptomatic treatment of mild to moderate pain, such as toothache, headache, and for fever and pain associated with the common cold.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

2. What you should know before administering Nurofenkid Fever and Pain

Do not use this medicine if your child:

• is allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
• has previously experienced hypersensitivity reactions (e.g. asthma, runny nose, urticaria, swelling of the face, tongue, lips or throat) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• is allergic to peanuts or soy, as this medicine contains soy lecithin;
• suffers (or has suffered) from recurrent gastric/duodenal ulcers (peptic ulcers) or gastrointestinal bleeding (at least two episodes of proven ulceration and bleeding);
• has experienced gastrointestinal bleeding or perforation related to previous NSAID treatments;
• suffers from severe heart failure;
• suffers from severe renal or hepatic impairment;
• is experiencing cerebral haemorrhage (cerebrovascular bleeding) or any other active bleeding;
• suffers from unexplained blood disorders;
• suffers from severe dehydration (e.g. caused by vomiting, diarrhoea or insufficient fluid intake).

Do not take Nurofenkid Fever and Pain during the last 3 months of pregnancy.
Warnings and precautions
Consult your doctor or pharmacist before using Nurofenkid Fever and Pain if your child:

• has an infection – see section “Infections” below;
• suffers from asthma or an allergic disease, as they may experience breathing difficulties;
• suffers from hay fever, nasal polyps, or chronic obstructive respiratory disorders; this increases the risk of allergic reactions. Allergic reactions may present as asthma attacks (so-called analgesic-induced asthma), Quincke's oedema (angioedema), or urticaria;
• has reduced kidney function;
• suffers from liver disorders. During prolonged administration of Nurofenkid Fever and Pain, regular monitoring of liver function tests, renal function, and blood counts is necessary;
• caution is required if the child is taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), antiplatelet agents (such as warfarin), selective serotonin reuptake inhibitors (an antidepressant medication), or antiplatelet agents (such as acetylsalicylic acid);
• is already taking another NSAID (including COX-2 inhibitors such as celecoxib or etoricoxib), as concomitant use should be avoided;
• suffers from SLE (Systemic Lupus Erythematosus, an autoimmune disease affecting connective tissue, causing joint pain, skin changes, and organ disorders) or mixed connective tissue disease;
• suffers from a hereditary blood disorder (e.g. acute intermittent porphyria);
• suffers from coagulation disorders;
• suffers from chronic inflammatory bowel diseases such as Crohn’s disease or ulcerative colitis;
• is dehydrated, as there is a risk of renal impairment in dehydrated children;
• has undergone major surgery;
• has chickenpox, as it is advisable to avoid using Nurofenkid Fever and Pain during the course of the infection.

Infections
Nurofenkid Fever and Pain may mask symptoms of infections such as fever and pain. Therefore, Nurofenkid Fever and Pain 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 infection symptoms persist or worsen, consult your doctor immediately.

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

Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
During treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal bleeding, ulceration, or perforation have been reported, which may be fatal. In case of gastrointestinal bleeding or ulceration, treatment must be stopped immediately. The risk of gastrointestinal bleeding, ulceration, or perforation is higher with increasing NSAID doses, in patients with a history of ulcers, especially if complicated by bleeding or perforation (see section 2 Do not use Nurofenkid Fever and Pain), and in the elderly. Such patients should start treatment with the lowest available dose. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and for patients requiring concomitant administration of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal damage.

In general, habitual use of (various types of) analgesics may lead to persistent serious kidney problems with risk of renal failure (analgesic nephropathy).
Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a modest 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.
Treatment should be evaluated with your doctor or pharmacist before taking Nurofenkid Fever and Pain in case of:

• heart problems, including heart failure, angina pectoris (chest pain), history of 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 "mini-stroke" or transient ischemic attack "TIA");
• high blood pressure (hypertension), diabetes, high cholesterol (hypercholesterolemia), family history of heart disease or stroke, or if you are a smoker.

During treatment with Nurofenkid Fever and Pain, the doctor or dentist must be consulted or informed before your child undergoes any surgical procedure.
Prolonged use of any type of analgesic 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 headache medications.
Patients reporting visual disturbances during treatment with ibuprofen should discontinue therapy and undergo ophthalmological examination.

Elderly patients
Elderly patients have a higher risk of adverse reactions to NSAIDs, particularly affecting the stomach and intestines.
Patients with a history of gastrointestinal toxicity, especially the elderly, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially during the initial stages of treatment.

Other medicines and Nurofenkid Fever and Pain
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
Nurofenkid Fever and Pain may affect or be affected by other medicines. For example:

• anticoagulant medicines (i.e. antiplatelet/anticoagulant drugs such as acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).

Other medicines may also influence or be influenced by treatment with Nurofenkid Fever and Pain. Always consult your doctor or pharmacist before using Nurofenkid Fever and Pain with other medicines.
In particular, inform your doctor or pharmacist if you are taking:

Nurofenkid Fever and Pain with alcohol
Do not consume alcoholic beverages when using Nurofenkid Fever and Pain. Some adverse effects, such as those affecting the gastrointestinal tract or the central nervous system, may become more likely when alcohol is consumed concomitantly with Nurofenkid Fever and Pain.

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

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 your doctor.

Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. Nurofenkid Fever and Pain may be used during breastfeeding, provided it is taken at the recommended doses and for the shortest possible duration.

Fertility
Nurofenkid Fever and Pain belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible after discontinuation of the drug.

Driving and use of machines
When used short-term and at the recommended doses, this medicine has no effect or negligible effects on the ability to drive vehicles or operate machinery. If undesirable effects such as fatigue or dizziness occur, do not drive or operate machinery. Alcohol consumption increases the risk of these adverse effects.

Nurofenkid Fever and Pain contains soybean lecithin. If you are allergic to peanuts or soy, do not use this medicine.

Nurofenkid Fever and Pain contains glucose and sucrose. If your child has been diagnosed by a doctor with an intolerance to certain sugars, consult your doctor before administering this medicine. It may be harmful to teeth.

Nurofenkid Fever and Pain contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".

3. How to administer Nurofenkid Fever and Pain

Use this medicine exactly as stated in this leaflet or as directed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not administer Nurofenkid Fever and Pain to children under 7 years of age or to children
weighing less than 20 kg.
The recommended dose is as follows:
In children, the dose of ibuprofen depends on body weight. Normally, 5–10 mg/kg of body weight as a single dose, up to a maximum of 20–30 mg/kg of body weight as the total daily dose.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If
you have an infection, contact your doctor immediately if symptoms (for example, fever and pain)
persist or worsen (see section 2).
This medicine is intended only for short-term treatment.
Nurofenkid Fever and Pain is for oral use.
The capsules should be chewed and then swallowed. Water is not required.
If you take more Nurofenkid Fever and Pain than you should
If you have taken more Nurofenkid Fever and Pain than you should, or if your child has taken this
medicine by mistake, contact your doctor or the nearest hospital for advice on the potential risk and the
necessary actions to take.
Symptoms may include: nausea, vomiting (possibly with traces of blood), stomach pain, gastrointestinal
bleeding, headache, ringing in the ears, confusion, and uncontrolled eye movements (nystagmus), or, more
rarely, diarrhoea. In addition, at high doses, blurred vision, dizziness, low blood pressure, agitation,
disorientation, coma, metabolic acidosis, increased blood potassium levels, prolonged prothrombin time/INR,
acute kidney failure, liver damage, respiratory depression, cyanosis, worsening of asthma in asthmatic
patients, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children),
weakness and dizziness, blood in the urine, feeling cold, and breathing difficulties have been reported.
If you forget to take Nurofenkid Fever and Pain
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects can be minimised by taking the lowest dose for the shortest time necessary to relieve symptoms. Your child may experience one of the known side effects of NSAIDs (see below). In this case, or if you have any doubts, stop giving the medicine to your child and contact your doctor as soon as possible. Elderly people using this medicine have a higher risk of developing problems related to side effects.
STOP giving this medicine and contact your doctor immediately if
your child has:

• signs of gastrointestinal bleeding such as severe stomach pain, dark stools, vomiting blood or dark particles resembling coffee grounds;
• signs of 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, low blood pressure leading to shock. These symptoms may occur even after the first use of this medicine. If any of these symptoms occur, contact a doctor immediately;
• serious skin reactions such as rashes all over the body, cracked skin, blisters or peeling of the skin.

Contact your doctor if your child experiences any of the
following side effects, if you notice a worsening of these effects or if you notice any unlisted effects.
Common (may affect up to 1 in 10 people)

• Gastrointestinal disorders such as heartburn, stomach ache and nausea, indigestion, diarrhoea, vomiting, flatulence (aerophagia) and 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)

• Gastrointestinal ulcer, perforation or bleeding, inflammation of the mouth mucosa with ulceration, worsening of existing intestinal disorders (colitis or Crohn's disease), gastritis
• Headache, dizziness, insomnia, agitation, irritability and fatigue
• Visual disturbances
• Skin rashes of various types
• Hypersensitivity reactions with urticaria and itching

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

• Tinnitus (ringing in the ears), hearing loss
• Increased blood urea levels, pain in the flanks and/or abdomen, blood in the urine and fever, which may be signs of kidney damage (papillary necrosis)
• Increased blood uric acid levels
• Decreased haemoglobin levels

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

• Inflammation of the oesophagus, pancreatitis and formation of diaphragm-like intestinal strictures
• Heart failure, heart attack
• 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 any of these symptoms occur or if general malaise develops, stop taking Nurofenkid Fever and Pain and consult your doctor immediately, as these may be the first 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), particularly with long-term treatment, liver failure, acute inflammation of the liver (hepatitis)
• Problems with blood cell production – early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, and unexplained bruising. In such cases, treatment must be stopped immediately and a doctor consulted. Any self-medication with painkillers or fever-reducing medicines (antipyretics) must be avoided.
• Severe skin infections and complications affecting soft tissues during chickenpox infection
• Worsening of infections-related inflammation (e.g. necrotising fasciitis) has been reported with the use of certain analgesics (NSAIDs). If signs of infection appear or worsen, seek immediate medical advice to determine whether anti-infective/antibiotic therapy is required.
• 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 a doctor immediately if these symptoms occur.
• Severe forms of skin reactions such as rash with redness and blisters (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 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).
• A widespread, red, scaly rash with pustules under the skin and blisters mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalised pustular eruption). Stop using Nurofenkid Fever and Pain if these symptoms develop and contact your doctor immediately. See also section 2.
• Skin becomes sensitive to light.

Medicines such as Nurofenkid Fever and Pain may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If your child experiences 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 Nurofenkid Fever and Pain

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. 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 Nurofenkid Fever and Pain contains
The active substance is ibuprofen. Each chewable capsule contains 100 mg of ibuprofen.
The other components are: gelatin, purified water, liquid glucose, sucrose, fumaric acid (E297), sucralose, citric acid (E330), acesulfame K (E950), edetate sodium, glycerol, orange flavour, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), propylene glycol and HPMC 2910/hypromellose 3cP.
Technological adjuvants: medium-chain triglycerides, soybean lecithin and stearic acid.

Description of the appearance of Nurofenkid Fever and Pain and package contents
Nurofenkid Fever and Pain is a soft, chewable gelatin capsule, orange in colour and square-shaped, with the logo “N100” printed in white ink.
Nurofenkid Fever and Pain is available in PVC/PE/PVdC/Al blisters.
Pack sizes of 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 capsules.
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 European Economic Area countries under the following names:
Austria Nureflex Junior Orange 100 mg Weichkapseln zum Zerbeißen
Spain Nurofen Junior 100 mg cápsulas blandas masticables
Portugal Nurofen 100 mg Cápsulas moles para mastigar
Germany Nurofen Junior Kaudragee Orange