Nurofen Rapid Mini 400 mg soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nurofen Rapid Mini 400 mg soft capsules

Ibuprofen

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the instructions for taking this medicine as described in this leaflet or as advised by your doctor or pharmacist.

• Keep this leaflet as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days in adolescents aged 12 years and older and in adults.

Leaflet contents:

1. What Nurofen Rapid Mini is and what it is used for
2. What you need to know before taking Nurofen Rapid Mini
3. How to take Nurofen Rapid Mini
4. Possible side effects
5. How to store Nurofen Rapid Mini

Pack contents and additional information

1. What Nurofen Rapid Mini 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.

This medicine is indicated for adults and adolescents weighing 40 kg or more (from 12 years of age).

This medicine is indicated for the symptomatic treatment of mild to moderate occasional pain, such as headache, dental pain, menstrual pain, and fever and pain associated with the common cold.

You should consult a doctor if your symptoms worsen or do not improve after 3 days in adolescents aged 12 years and older and in adults.

2. What you need to know before taking Nurofen Rapid Mini

Do not take Nurofen Rapid Mini:

• if you are allergic to ibuprofen, ponceau 4R (E124), peanut, or soya, or to any of the other ingredients of this medicine (listed in section 6)
• if you have ever experienced difficulty breathing, asthma, nasal discharge, swelling of the face and/or hands, or hives after taking ibuprofen, acetylsalicylic acid, or other similar painkillers (NSAIDs)
• if you have (or have had two or more separate episodes of) stomach or duodenal ulcer (peptic ulcer) or gastrointestinal bleeding
• if you have a history of gastrointestinal bleeding or perforation while previously taking NSAIDs (non-steroidal anti-inflammatory drugs)
• if you have severe liver, kidney, or heart failure
• if you have unexplained disorders of blood formation
• if you are in the last three months of pregnancy (see section 'Pregnancy, breastfeeding and fertility')
• if you have severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake)
• if you have cerebral haemorrhage (stroke) or any other active bleeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if:

• you have an infection; see the section "Infections" below.
• you have certain skin diseases (systemic lupus erythematosus (SLE)) or mixed connective tissue disease (immune system disorders causing joint pain, skin rashes, and fever).
• you have a certain inherited blood disorder (e.g., acute intermittent porphyria) or problems with blood clotting.
• you have or have ever had a bowel disease (ulcerative colitis or Crohn's disease).
• you have reduced kidney function.
• you have liver problems. With prolonged use of this medicine, regular monitoring of liver function, kidney function, and blood counts is required.
• you have recently undergone major surgery.
• you are trying to get pregnant.
• you have or have had asthma or an allergic condition, as you may experience difficulty breathing.
• you suffer from hay fever, nasal polyps, or chronic obstructive respiratory disorders, as there is an increased risk of allergic reactions. Allergic reactions may present as asthma attacks (analgesic-induced asthma), acute swellings (Quincke's oedema), or skin rash (urticaria).
• you are taking other medicines that could increase the risk of ulceration or bleeding, such as oral corticosteroids, blood-thinning medicines (e.g., warfarin), selective serotonin reuptake inhibitors (medicines for depression), or antiplatelet agents such as acetylsalicylic acid.
• you are taking other NSAIDs, including specific cyclooxygenase-2 (COX-2) inhibitors, as they may increase the risk of side effects and should be avoided (see section "Other medicines" below).
• you have chickenpox. Use of this medicine is not recommended.

Undesirable effects are minimised by using the lowest effective dose for the shortest possible duration.

Prolonged use of any type of painkiller for headaches may worsen them. If you experience or suspect this, you should stop taking this medicine and consult your doctor. Medication-overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) regular use of headache medications.

In general, regular use of (various types of) painkillers may lead to serious and long-lasting kidney problems, and should therefore be avoided. This risk may be further increased by physical exertion associated with salt loss and dehydration. Therefore, such use should be avoided.

There is a risk of kidney failure in dehydrated adolescents.

Anti-inflammatory/painkilling 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 consult your doctor or pharmacist before taking this medicine if you:

• have heart problems, including heart failure, angina (chest pain), or have had a myocardial infarction, 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 transient ischaemic attack "TIA").
• have hypertension, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker.

Signs of allergic reaction to this medicine, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Stop taking ibuprofen immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

Infections

This medicine may mask signs of infection, such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, 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 a doctor without delay.

Serious skin reactions

Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalised exanthematous pustulosis (AGEP), have been reported with ibuprofen treatment. Stop treatment with this medicine and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Elderly patients

Elderly patients have a higher risk of adverse effects.

Other medicines and Nurofen Rapid Mini

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform them if you are taking:

This medicine may affect or be affected by other medicines. For example:

• Medicines that are anticoagulants (i.e., thin the blood/prevent clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• Medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin-II receptor antagonists such as losartan).

Other medicines may also affect or be affected by treatment with this medicine. Therefore, you should always consult your doctor or pharmacist before using ibuprofen with other medicines.

Alcohol consumption with Nurofen Rapid Mini

You should not drink alcohol while taking this medicine. Some adverse effects, such as those affecting the gastrointestinal tract or the central nervous system, may be more likely when alcohol is consumed at the same time as this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you become pregnant while taking ibuprofen. Do not take this medicine during the last 3 months of pregnancy, as it may cause kidney and heart problems in the fetus. It may affect your tendency and that of your baby to bleed, and may delay or prolong labour beyond expected duration. Avoid taking this medicine during the first 6 months of pregnancy unless advised by your doctor. From week 20 of pregnancy, ibuprofen may cause kidney problems in the fetus if taken for more than a few days, which could lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Breastfeeding

Only small amounts of ibuprofen and its metabolites pass into breast milk. This medicine may be taken during breastfeeding if used at the recommended dose and for the shortest possible duration.

Fertility

This medicine belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible upon discontinuation of the medicine.

Driving and use of machines

For short-term use and at the recommended dose, the influence of this medicine on the ability to drive or operate machinery is none or negligible.

If you experience fatigue, dizziness, somnolence, vertigo, or visual disturbances while taking this medicine, you should not drive or operate dangerous machinery. These effects may worsen if ibuprofen is taken together with alcohol.

Nurofen Rapid Mini contains sorbitol, Ponceau 4R (E-124), and soybean lecithin

This medicine contains 27.77 mg of sorbitol per capsule.

This medicine may cause allergic reactions as it contains Ponceau 4R (E-124). It may cause asthma, particularly in patients allergic to acetylsalicylic acid.

This medicine contains soybean lecithin. Do not use this medicine if you are allergic to peanuts or soy.

3. How to take Nurofen Rapid Mini

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist. The recommended dose is:

Dosage

Adults and adolescents weighing 40 kg or more (from 12 years of age):

Initial dose: Take 1 capsule (400 mg of ibuprofen) with water. If necessary, take additional doses of 1 capsule (400 mg of ibuprofen), but do not exceed a total dose of 3 capsules (1,200 mg of ibuprofen) in any 24-hour period. The dosing interval should not be less than 6 hours.

This medicine is not intended for use in adolescents weighing less than 40 kg or in children under 12 years of age.

Method of administration:

This medicine is taken orally. Swallow the capsule whole with water. Do not chew.

Patients with a sensitive stomach are advised to take this medicine with food. If taken shortly after eating, the onset of action of this medicine may be delayed. If this occurs, do not take more ibuprofen than recommended in this section or until the correct dosing interval has passed.

Duration of treatment

This medicine is for occasional use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

If in adults or adolescents this medicine is required for more than 3 days or if symptoms worsen, you should consult a doctor.

If you take more ibuprofen than you should

If you have taken more medicine than you should, or if a child has accidentally ingested the medicine, contact a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on the measures to be taken. Symptoms of overdose may include: nausea (feeling unwell), stomach pain, vomiting (which may contain blood-stained material), blood in the stool (gastrointestinal bleeding), headache, tinnitus (ringing in the ears), diarrhoea, confusion, and involuntary eye movements. At high doses, the following have been reported: weakness and dizziness, vertigo, blurred vision, hypotension, excitement, disorientation, coma, hyperkalaemia (high blood potassium levels), prolonged prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, worsening of asthma in asthmatic patients, somnolence, disorientation, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), blood in urine, low blood potassium levels, chills, and breathing difficulties.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects can be minimized by taking the lowest effective dose for the shortest time necessary to relieve symptoms. You may experience some of the known adverse effects of NSAIDs (see below). If so, or if you have any concerns, stop taking this medicine and consult your doctor as soon as possible. Elderly individuals taking ibuprofen are at increased risk of developing problems associated with adverse effects.

STOP taking this medicine and seek immediate medical help if you experience:

• Signs of gastrointestinal bleeding, such as severe abdominal pain, black or tarry stools, vomiting blood or dark particles resembling ground coffee.
• Signs of a rare but severe allergic reaction, such as worsening of asthma, shortness of breath or wheezing of unknown origin, swelling of the face, tongue or throat, difficulty breathing, tachycardia, decreased blood pressure that may lead to shock. These may occur even with the first use of this medicine.
• Severe skin reactions such as rashes covering the entire body, skin peeling, blisters or exfoliation. Flat red spots, target-like or circular lesions on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) [Very rare – may affect up to 1 in 10,000 patients)].
• Generalized skin rash, elevated body temperature, swollen lymph nodes, elevated eosinophils (a type of white blood cell) (DRESS syndrome) [Frequency not known (cannot be estimated from available data)].
• Widespread, red, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) [Frequency not known (cannot be estimated from available data)].

Inform your doctor if you experience any of the following adverse effects, if they worsen, or if you notice any effect not listed here:

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

• Stomach problems such as heartburn, stomach pain, discomfort, nausea, indigestion, vomiting, flatulence (gas), diarrhea, constipation, and minor blood loss in the stomach and/or intestine, which may exceptionally lead to anemia.

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

• Gastrointestinal ulcers, sometimes with perforation and bleeding, inflammation of the mucous membrane of the mouth with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis), worsening of ulcerative colitis or Crohn's disease
• Disorders of the central nervous system, such as headache, dizziness, insomnia, restlessness, irritability, and fatigue
• Visual disturbances
• Allergic reactions, such as skin rashes, itching, and asthma attacks. You must stop taking this medicine and inform your doctor immediately.
• Various skin rashes

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

• Tinnitus (ringing in the ears)
• Increased blood urea concentration, pain in the sides and/or abdomen, blood in urine, and fever, which may be signs of kidney damage (papillary necrosis)
• Increased blood uric acid levels
• Hearing impairment
• Decreased hemoglobin levels

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

• Inflammation of the esophagus (esophagitis) or pancreas (pancreatitis), and formation of a membrane-like narrowing in the small and large intestine (diaphragm-type intestinal stenosis)
• Serious skin infections and complications of soft tissues during varicella infection
• High blood pressure, palpitations, heart failure, myocardial infarction, inflammation of blood vessels (vasculitis), and swelling (edema)
• Urinating less than 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 may lead to acute kidney failure. If any of the symptoms mentioned above occur, or if you feel generally unwell, stop taking this medicine and consult your doctor immediately, as these could be early signs of kidney damage or kidney failure
• Hepatic dysfunction, liver damage (early signs may include skin discoloration), especially during long-term 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 exhaustion, nose and skin bleeding, and unexplained bruising. In such cases, therapy must be stopped immediately and a doctor consulted. Do not treat these symptoms with analgesics or fever-reducing medicines (antipyretics)
• Psychotic reactions and depression
• Worsening of infections-related inflammation (e.g., necrotizing fasciitis) associated with the use of certain painkillers (NSAIDs). If signs of infection appear or worsen during use of this medicine, seek medical advice without delay to determine whether anti-infective/antibiotic therapy is needed
• Symptoms of aseptic meningitis such as neck stiffness, headache, malaise, nausea, vomiting, fever, or loss of consciousness have been reported with ibuprofen use. Patients with autoimmune disorders (SLE, mixed connective tissue disease) may be more likely to be affected. Contact a doctor immediately if this occurs
• Hair loss (alopecia)
• Severe generalized hypersensitivity reactions
• Worsening of asthma and bronchospasm

Frequency not known: (cannot be estimated from available data)

• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome
• Respiratory tract reactivity including asthma, bronchospasm, or dyspnea
• Skin becomes sensitive to light

This medicine contains Ponceau 4R (E124), which may cause allergic reactions.

Medicines like this one may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is an adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nurofen Rapid Mini

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 after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25 °C. Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nurofen Rapid Mini

The active substance is ibuprofen.

• Each soft capsule contains 400 mg of ibuprofen.

The other components (excipients) are:

• Core: macrogol (E1521), potassium hydroxide (minimum purity 85%) (E525), purified water.
• Soft capsule: partially dehydrated liquid sorbitol (E420), gelatin (E441), Ponceau 4R (E124).
• Printing ink: Opacode WB white NSP-78-180002 (contains titanium dioxide (E171), propylene glycol (E1520), alcohol SDA 35A (ethanol and ethyl acetate), isopropyl alcohol, poly(vinyl acetate) phthalate, purified water, macrogol 400 (E1521), and ammonium hydroxide 28% (E527)).
• Adjuvants: soya lecithin (E322).

Appearance of the product and contents of the container

Nurofen Rapid Mini 400 mg soft capsules are red, oval-shaped soft capsules with "NURO400" printed in white. Each capsule measures approximately 10 mm in width and 15.5 mm in length.

This medicine is available in blisters containing 10, 20, 24, 30 or 40 soft capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Reckitt Benckiser Healthcare, S.A.

C/ Mataró, 28

08403 Granollers (Barcelona)

Spain

Manufacturer:

RB NL Brands B.V., Schiphol Blvd 207,

1118 BH Schiphol,

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last review of this leaflet: September 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).