NurofenCaps

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nurofencaps 400 mg soft capsules

Indicated for adults and adolescents weighing more than 40 kg (from 12 years of age).
Ibuprofen
Please 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 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, 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 in case of fever and 4 days for pain treatment in adults.

Contents of this leaflet:

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

1. WHAT NUROFENCAPS IS AND WHAT IT IS USED FOR

Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines provide relief by altering the body's response to pain and fever.
Nurofencaps is used in adults and adolescents weighing over 40 kg (from 12 years of age) for the short-term symptomatic treatment of:

• mild to moderate pain such as headache, menstrual pain and toothache
• fever and pain associated with the common cold.

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING NUROFENCAPS

Do not take Nurofencaps if:

• you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• you have ever experienced breathing difficulties, asthma, runny nose, swelling, or hives after taking acetylsalicylic acid or other similar painkillers (NSAIDs)
• you have (or have had two or more separate episodes of) gastric/duodenal ulcer (peptic ulcer) or gastrointestinal bleeding
• you have had gastrointestinal bleeding or perforation following previous treatment with NSAIDs (non-steroidal anti-inflammatory drugs)
• you suffer from unexplained blood disorders
• you have severe liver, kidney, or heart failure
• you are in the last 3 months of pregnancy (see section “Pregnancy and breastfeeding”)
• you suffer from severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake)
• you have bleeding in the brain (cerebrovascular haemorrhage) or any other active bleeding.

Do not administer to adolescents weighing less than 40 kg or to children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Nurofencaps if:

• you have an infection – see section “Infections” below.
• you suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease (immune system conditions causing joint pain, skin rashes, and fever).
• you suffer from a certain inherited blood disorder (e.g. acute intermittent porphyria) or have blood clotting problems.
• you have or have had intestinal diseases (ulcerative colitis or Crohn's disease).
• you have reduced kidney function.
• you have liver problems.
• you have recently undergone major surgery.
• you suffer from or have suffered from asthma or allergies, as you may experience shortness of breath.
• you suffer from hay fever, nasal polyps, or chronic obstructive respiratory disorders, as there is an increased risk of developing allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma), acute swelling (Quincke's oedema), or skin rash.
• you are taking other medicines that could increase the risk of ulceration or bleeding, such as oral corticosteroids, blood-thinning medicines (such as warfarin), selective serotonin reuptake inhibitors (medicines for depression), or antiplatelet agents such as acetylsalicylic acid.

Other warnings

• Prolonged use of painkillers for headache may worsen the symptoms. If this occurs or is suspected, you must stop taking Nurofencaps and consult your doctor.
• You should avoid taking Nurofencaps if you have chickenpox.
• If you take Nurofencaps for long periods, regular blood tests and periodic monitoring of liver and kidney function are necessary.
• Taking Nurofencaps together with other NSAIDs, including selective cyclooxygenase-2 inhibitors, may increase the risk of adverse effects and should be avoided (see section “Other medicines and Nurofencaps”).
• Habitual use of (different types of) painkillers may generally lead to serious, long-term kidney problems and should be avoided. The risk is further increased by loss of salts and dehydration.
• In dehydrated adolescents, there is a risk of impaired kidney function.

Infections
Nurofencaps may mask symptoms of infections such as fever and pain. Therefore, Nurofencaps may delay appropriate treatment of the infection, which could increase 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, contact your doctor immediately.
Skin reactions
Serious skin reactions have been reported with the use of Nurofencaps. Stop taking Nurofencaps and contact your doctor immediately if you develop a rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a serious skin reaction. See section 4.
Anti-inflammatory/pain-relieving 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 Nurofencaps if you have:

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

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration. Elderly patients are at higher risk of experiencing adverse effects.
Consult your doctor before taking Nurofencaps if any of the above conditions concern you.
Other medicines and Nurofencaps
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.
Nurofencaps may affect or be affected by other medicines. For example:

• medicines with anticoagulant effects (i.e. substances that thin the blood and prevent clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine)
• medicines that lower 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 Nurofencaps. Always seek advice from your doctor or pharmacist before using Nurofencaps together with other medicines. In particular, inform them if you are using:

Nurofencaps and alcohol
You should not consume alcohol during treatment with Nurofencaps. Some adverse effects, such as those affecting the gastrointestinal tract or the nervous system, may be more likely if alcohol is consumed together with Nurofencaps.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you become pregnant while taking Nurofencaps.
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. This medicine may be used during breastfeeding, provided it is taken at the recommended doses and for the shortest possible duration.
Fertility
Nurofencaps belongs to a group of medicines (NSAIDs) that may have negative effects on female fertility. These effects are reversible after stopping treatment.
Driving and using machines
For short-term treatment and at normal dosage, this medicine has little or no influence on the ability to drive or operate machinery.
Patients who experience drowsiness, dizziness, vertigo or visual disturbances during treatment with Nurofencaps should avoid driving vehicles or operating machinery. These effects may worsen if Nurofencaps is taken together with alcohol.
Nurofencaps contains 36.6 mg of sorbitol per capsule. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
Nurofencaps contains the colour Ponceau 4R (E124), which may cause allergic reactions.

3. HOW TO TAKE NUROFENCAPS

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
If not otherwise prescribed by your doctor, the standard dose is:
Dosage
Adults and adolescents weighing more than 40 kg (from 12 years of age).
Initial dose: take 1 capsule (400 mg of ibuprofen) with water. Afterwards, if necessary, 1 capsule (400 mg of ibuprofen) every 6 hours. Do not exceed a dose of 3 capsules (1200 mg of ibuprofen) within 24 hours.
Do not administer Nurofencaps to adolescents weighing less than 40 kg or to children under 12 years of age.
Method of administration
For oral use. Do not chew.
Patients with known gastric sensitivity are advised to take Nurofencaps with food.
If taken immediately after eating, the onset of action of Nurofencaps may be delayed. If this occurs, do not take more Nurofencaps than recommended in this section or until the appropriate dosing interval has passed.
Duration of treatment
This medicine is intended only for short-term treatment. 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 (e.g. fever and pain) persist or worsen (see section 2).
In adolescents
If use of Nurofencaps is required for more than 3 days in adolescents, or if symptoms worsen, consult a doctor.
In adults
If it is necessary to take Nurofencaps for more than 3 days for fever or more than 4 days for pain, or if symptoms worsen, consult a doctor.
Inform your doctor or pharmacist if you feel that the effect of this medicine is stronger or weaker than expected.
If you take more Nurofencaps than you should
If you have taken more Nurofencaps 400 mg soft capsules than you should, or if your child has accidentally taken this medicine, always contact your doctor or the nearest hospital for advice on the risk and guidance on actions to take. Symptoms may include: nausea (feeling unwell), vomiting (feeling of sickness – possibly with traces of blood), blood in the stool (gastrointestinal bleeding), ringing in the ears, headache, stomach pain, diarrhoea, and uncontrolled eye movements. At high doses, weakness and dizziness, drowsiness, confusion, disorientation, loss of consciousness, feeling cold, chest pain, palpitations, seizures (especially in children), blood in the urine, and breathing difficulties have been reported.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, Nurofencaps can cause adverse effects, although not everyone experiences them.
Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration needed to relieve symptoms.
You may experience one of the known adverse effects of NSAIDs (see below). If this happens, or if you have any concerns, 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 adverse effects.

STOP TAKING THIS MEDICINE AND CONTACT YOUR DOCTOR IMMEDIATELY IF YOU EXPERIENCE:

• 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 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.

Contact your doctor if you experience any of the following adverse reactions, if they become severe, or if you notice any adverse reaction not listed in this leaflet.

Common (may affect up to 1 in 10 people)

• Gastrointestinal disorders such as heartburn, abdominal pain, nausea, indigestion, vomiting, flatulence, diarrhoea, constipation, and minor gastrointestinal bleeding which, in rare cases, may lead to anaemia.

Uncommon (may affect up to 1 in 100 people)

• Gastric or intestinal ulcers, sometimes with bleeding and perforation, inflammation of the oral mucosa with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis), worsening of colitis and Crohn's disease.
• Central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or fatigue.
• Visual disturbances.
• Allergic reactions, such as skin rashes, itching, and asthma attacks. You must stop taking Nurofencaps and contact your doctor immediately.
• Various skin rashes.

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

• Tinnitus (ringing in the ears)
• Kidney damage (papillary necrosis) and elevated blood uric acid levels
• Hearing impairment
• Increased blood urea concentration
• Reduction in haemoglobin levels

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

• Swelling (oedema), high blood pressure (hypertension), and heart failure have been reported in association with NSAID treatment.

• Inflammation of the oesophagus or pancreas, formation of membrane-like constrictions in the small and large intestine (diaphragm-like intestinal strictures).

• Severe skin infections and soft tissue complications have been observed during chickenpox infection.

• Reduced urine output and swelling (especially in patients with high blood pressure or impaired 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 you feel generally unwell, stop taking Nurofencaps and contact your doctor immediately, as these may be early signs of kidney damage or kidney failure.

• Disorders affecting blood cell production. Early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding. In such cases, you must immediately stop treatment and consult your doctor. Do not treat these symptoms with painkillers or fever-reducing medicines (antipyretics).

• Psychotic reactions and depression.

• Worsening of infections-related inflammation (e.g., necrotizing fasciitis) has been reported with the use of certain painkillers (NSAIDs). If signs of infection appear or worsen during treatment with Nurofencaps, contact your doctor immediately to determine whether anti-infective/antibiotic therapy is needed.

• High blood pressure, palpitations, heart failure, myocardial infarction.

• Liver dysfunction, liver damage—especially with long-term treatment—liver failure, acute inflammation of the liver (hepatitis).

• Symptoms of aseptic meningitis, including neck stiffness, headache, malaise, nausea, fever, or confusion, have been observed during ibuprofen use. Patients with autoimmune disorders (e.g., 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, toxic epidermal necrolysis/Lyell’s syndrome), hair loss (alopecia).

• Severe generalized hypersensitivity reactions.

• Worsening of asthma and bronchospasm.

• Inflammation of blood vessels (vasculitis).

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

• 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 affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using Nurofencaps if you develop these symptoms and contact your doctor immediately. See also section 2.
• Skin becomes sensitive to light

Nurofencaps contains Ponceau 4R (E124), which may cause allergic reactions.
Medicines such as Nurofencaps may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke.

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

5. HOW TO STORE NUROFENCAPS

Keep this medicine out of the sight and reach of children.
Do not use this medicine 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. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of this 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 Nurofencaps contains
Each capsule contains 400 mg of ibuprofen. The other components are:

• Capsule contents: Macrogol 600, Potassium hydroxide, Purified water
• Gelatin shell: Gelatin, Sorbitol liquid (E420), Ponceau 4R (E124)
• Ink: Titanium dioxide (E171), Propylene glycol, Hypromellose (E464)
• Processing aids: Triglycerides (medium chain), Lecithin (E322)

Description of the appearance of Nurofencaps and pack sizes
The capsules are red, transparent, oval-shaped, with the logo "Nurofencaps" printed in white.
The capsules are available in packs of 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 40 or 50 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Reckitt Benckiser Healthcare (Italia) S.p.A. – Via G. Spadolini 7 – 20141 Milano, Italy
Manufacturer
Reckitt Benckiser Healthcare International Ltd – Nottingham Site, Thane Road, Nottingham NG90 2DB (UK)
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, The Netherlands

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Austria: Nurofen Rapid 400 mg Weichkapseln
Bulgaria: Nurofen Express Forte
Cyprus: Nurofen Express 400mg Capsule, soft
France: NurofenCaps 400mg, capsule molles
Germany: Nurofen Immedia 400 mg Weichkapseln
Hungary: Nurofen Rapid Forte 400 mg lágy kapszula
Italy: Nurofencaps 400 mg capsule molli
The Netherlands: Nurofen Fastine Liquid Caps 400 mg, capsule, zacht
Poland: Nurofen Express Forte
Portugal: Nurofen Zavance 400 mg cápsulas moles
Romania: Nurofen Express Forte 400 mg capsules moi
United Kingdom: Nurofen 400mg Capsules, soft