NUROFEN RAPID MINI 400 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Nurofen Rapid Mini 400 mg Soft Capsules

Ibuprofen

Read the package leaflet carefully before starting to take this medicine because it contains important information for you.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

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

Contents of the Package Leaflet:

1. What is Nurofen Rapid Mini and what is it 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. Storage of Nurofen Rapid Mini

Contents of the pack and further information

1. What is Nurofen Rapid Mini and what is it used for

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines provide relief by modifying the body's response to pain and fever.

This medicine is indicated in adults and adolescents from 40 kg body weight (from 12 years of age).

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

You should consult a doctor if it worsens or does not improve after 3 days in adolescents from 12 years 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 soy, or to any of the other components of this medicine (listed in section 6)
• if you have ever had difficulty breathing, asthma, nasal secretion, swelling of the face and/or hands, or urticaria after using ibuprofen, acetylsalicylic acid, or other similar analgesics (NSAIDs)
• if you have (or have had two or more distinct episodes of) stomach or duodenal ulcer (peptic ulcer) or bleeding
• if you have a history of gastrointestinal bleeding or perforation when previously taking NSAIDs (non-steroidal anti-inflammatory drugs)
• if you have severe liver, kidney, or heart failure
• if you have unexplained blood formation disorders
• if you are in the last three months of pregnancy (see section 'Pregnancy, breastfeeding, and fertility')
• if you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake)
• if you are suffering from a cerebral hemorrhage (cerebrovascular hemorrhage) or other active bleeding.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine if:

• you have an infection; consult the section "Infections" below.
• you have certain skin diseases (systemic lupus erythematosus (SLE)) or mixed connective tissue disease (conditions of the immune system that cause joint pain, skin rashes, and fever).
• you have a certain hereditary blood formation disorder (e.g., acute intermittent porphyria) or problems with blood coagulation.
• you have or have had an intestinal disease (ulcerative colitis or Crohn's disease).
• you have reduced kidney function.
• you have liver disorders. In the prolonged administration of this medicine, regular monitoring of liver values, kidney function, as well as the blood count, is required.
• you have recently undergone major surgery.
• you are trying to become pregnant.
• you have or have had asthma or an allergic disease, as you may experience difficulty breathing.
• you suffer from hay fever, nasal polyps, or chronic obstructive respiratory disorders, as there is a higher risk of allergic reactions. Allergic reactions can present as asthma attacks (anaphylactic asthma), acute swelling (angioedema), 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 (such as warfarin), selective serotonin reuptake inhibitors (medicines for depression), or antiplatelet agents like acetylsalicylic acid.
• you are taking other NSAID medicines, including specific cyclooxygenase-2 (COX-2) inhibitors, as they may increase the risk of side effects and should be avoided (see the section "Other medicines" below).
• you have chickenpox. It is advisable to avoid using this medicine.

Undesirable effects are minimized by using the minimum effective dose for the shortest possible time.

The prolonged use of any type of analgesic for headaches can worsen them. If you experience or suspect this situation, you should stop taking this medicine and consult your doctor. The diagnosis of medication-overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or due to) the regular use of headache medicines.

In general, the habitual use of (various types of) analgesics can cause serious and lasting kidney problems, so they should be avoided. This risk may be further increased by physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.

There is a risk of kidney failure in dehydrated adolescents.

Anti-inflammatory/analgesic medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should consult your doctor before taking this medicine if you:

• have heart problems, including heart failure, angina pectoris (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (poor circulation in the legs or feet due to narrow or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack "TIA").
• suffer from high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or are a smoker.

With ibuprofen, signs of an allergic reaction to this medicine have been reported, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain. Stop using ibuprofen immediately and contact your doctor or the emergency medical service immediately if you notice any of these signs.

Infections

This medicine may hide the signs of an infection, such as fever and pain. Consequently, this medicine may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and in bacterial skin infections related to chickenpox. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Severe skin reactions

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

Elderly

Elderly people have a higher risk of side effects.

Other medicines and Nurofen Rapid Mini

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. In particular, tell 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 like captopril, beta blockers like atenolol, angiotensin-II receptor antagonists like 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.

Taking Nurofen Rapid Mini with alcohol

Do not drink alcohol while taking this medicine. Some side effects, such as those affecting the gastrointestinal tract or the central nervous system, may be more likely when taking alcohol 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Tell your doctor if you become pregnant while taking ibuprofen. Do not take this medicine if you are in 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 labor more than expected. Avoid taking this medicine during the first 6 months of pregnancy unless your doctor advises you to do so. From the 20th week of pregnancy, ibuprofen may cause kidney problems in the fetus if taken for more than a few days, which may lead to low levels of the fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

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

Fertility

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

Driving and using machines

For short-term use and at the recommended dose, the influence of this medicine on the ability to drive or use machines is zero or insignificant.

If you notice fatigue, dizziness, drowsiness, vertigo, or vision disturbances while taking this medicine, do not drive or use hazardous machinery. These effects may worsen if ibuprofen is taken in combination with alcohol.

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

This medicine contains 72.59 mg of sorbitol in each capsule.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine.

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

This medicine contains soy lecithin. Do not use this medicine in case of peanut or soy allergy.

3. How to take Nurofen Rapid Mini

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist. The recommended dose is:

Dose

Adults and adolescents from 40 kg body weight (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 the total dose of 3 capsules (1200 mg of ibuprofen) in any 24-hour period. The dosing interval should not be less than 6 hours.

This medicine is not indicated for use in adolescents who weigh 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.

It is recommended that patients with sensitive stomachs 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 necessary time to relieve symptoms. If you have an infection, consult a doctor without delay if the symptoms (such as fever and pain) persist or worsen (see section 2).

If in adults or adolescents the use of 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, consult a doctor or go to the nearest hospital immediately to find out about the risk and ask for advice on the measures to be taken. Symptoms of overdose may include: nausea (discomfort), stomach pain, vomiting (which may contain blood), blood in the stool (gastrointestinal bleeding), headache, ringing in the ears, diarrhea, and confusion, involuntary eye movements. At high doses, weakness and dizziness, vertigo, blurred vision, hypotension, excitement, disorientation, coma, hyperkalemia (high potassium levels in the blood), increased prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, and exacerbation of asthma in asthmatics, drowsiness, disorientation, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), blood in urine, low potassium levels in the blood, chills, and breathing problems.

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can have adverse effects, although not all people suffer from them.

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

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

• Signs of intestinal bleeding,such as: severe abdominal pain, black or tarry stools, vomiting blood or dark particles that resemble coffee grounds.
• Signs of a very 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, rapid heartbeat, decreased blood pressure that can cause shock. These can occur even with the first use of this medicine.
• Severe skin reactionssuch as eruptions that cover the entire body, scaling, blisters or peeling of the skin. Red patches that are not raised, target-shaped or circular on the torso, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals and eyes. These severe skin reactions can 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].
• Widespread 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 and scaly rash, with bumps under the skin and blisters, mainly located in skin folds, torso and upper limbs, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis) [Frequency not known (cannot be estimated from available data)].

Tell your doctor if you experience the following adverse effects,if they worsen or if you notice any effect not mentioned in this list:

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

• stomach problems, such as heartburn, stomach pain, discomfort and nausea, indigestion, vomiting, flatulence (gas), diarrhea and constipation, and minor bleeding in the stomach and/or intestine that can cause anemia in exceptional cases.

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
• central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability and fatigue
• visual disturbances
• allergic reactions, such as skin rashes, itching and asthma attacks. You should 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 concentration of urea in the blood, pain in the sides and/or abdomen, blood in the urine and fever, may be signs of kidney damage (papillary necrosis)
• increased concentrations of uric acid in the blood
• hearing impairment
• decrease in 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 intestines (intestinal diaphragm-like stenosis)
• severe skin infections and soft tissue complications have occurred during chickenpox 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) that can cause acute kidney failure. If you experience any of the above symptoms or feel unwell, stop taking this medicine and consult your doctor immediately, as these could be the first signs of kidney damage or kidney failure
• liver dysfunction, liver damage (the first signs may be skin discoloration), especially during long-term treatment, liver failure, acute liver inflammation (hepatitis)
• problems with blood cell production: the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, intense fatigue, nosebleeds and skin bruising and unexplained bruising. In these cases, you should immediately suspend therapy and consult a doctor. Do not treat these symptoms with pain relievers or fever-reducing medications (antipyretics)
• psychotic reactions and depression
• worsening of inflammation-related infections (e.g., necrotizing fasciitis) associated with the use of certain pain relievers (NSAIDs). If signs of infection appear or worsen during the use of this medicine, you should see a doctor without delay to investigate whether anti-infective/antibiotic therapy is necessary
• asymptomatic meningitis symptoms with neck stiffness, headache, malaise, nausea, vomiting, fever or loss of consciousness have been observed when using ibuprofen. 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 general 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 severe 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 may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

Reporting of Adverse Effects

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

5. Storage of Nurofen Rapid Mini

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and blister pack after "EXP". The expiration date is the last day of the month indicated.

Do not store above 25 ºC. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Nurofen Rapid Mini

The active ingredient is ibuprofen.

• Each soft capsule contains 400 mg of ibuprofen.

The other ingredients (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), SDA 35A alcohol (ethanol and ethyl acetate), isopropyl alcohol, poly(vinyl acetate) phthalate, purified water, macrogol 400 (E1521), and ammonium hydroxide 28% (E527).
• Auxiliaries: soy lecithin (E322).

Appearance of the Product and Package Contents

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

This medicine is presented in blister packs 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 with the following names:

Date of the last revision of this leaflet:April 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/).