Nurofen Express Caps

Leaflet accompanying the packaging: information for the user

Nurofen Express Caps, 200 mg, soft capsules

Ibuprofen
Medicine for use in adults, adolescents, and children with a body weight of 20 kg or more (approximately 6 years of age)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including any not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• 4.
• Consult a doctor if there is no improvement or if the patient feels worse:
• after 3 days in the case of children and adolescents;
• after 3 days in the case of fever treatment or 4 days in the case of pain treatment in adults.

Table of contents of the leaflet:

• 1. What is Nurofen Express Caps and what is it used for
• 2. Important information before taking Nurofen Express Caps
• 3. How to take Nurofen Express Caps
• 4. Possible side effects
• 5. How to store Nurofen Express Caps
• 6. Contents of the pack and other information

1. What is Nurofen Express Caps and what is it used for

Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). These medicines are used to change the body's response to pain, swelling, and high temperature. Nurofen Express Caps dissolves easily in the body, and the active substance released from the capsule is easily absorbed and quickly reaches the site of pain.
Nurofen Express Caps is used for short-term symptomatic treatment of:

• mild or moderate pain, such as headache, toothache, painful menstruation,
• pain and fever associated with colds.

Medicine for use in adults, adolescents, and children with a body weight of 20 kg or more (approximately 6 years of age).
If after 3 days in children and adolescents, 3 days in the case of fever and 4 days in the case of pain in adults, there is no improvement or the patient feels worse, consult a doctor.

2. Important information before taking Nurofen Express Caps

When not to take Nurofen Express Caps:

• if the patient is allergic to ibuprofen, cochineal red (E 124), or any of the other ingredients of this medicine (listed in section 6)
• if the patient has ever had breathing difficulties, asthma, nasal congestion, facial swelling, and/or hives after taking ibuprofen, acetylsalicylic acid, or other similar painkillers (NSAIDs)
• if the patient has stomach ulcers or bleeding from the stomach (or has had two or more episodes)
• if the patient has had bleeding or perforation of the gastrointestinal tract in the past, associated with previous NSAID treatment
• if the patient has severe liver, kidney, coronary, or heart failure disease
• do not give to children with a body weight of less than 20 kg
• if the patient has had bleeding from blood vessels or other active bleeding
• if the patient has blood clotting disorders
• if the patient has severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake)
• in the last three months of pregnancy (see below)

Warnings and precautions

• Before taking Nurofen Express Caps, discuss it with your doctor, pharmacist, or nurse. If the patient has an infection - see below "Infections"
• If the patient has certain skin diseases (systemic lupus erythematosus) or mixed connective tissue disease). If there are hereditary blood disorders (e.g., acute intermittent porphyria).
• If the patient has a history of gastrointestinal disease (ulcerative colitis or Crohn's disease)
• If the patient has kidney function disorders
• If the patient has liver function disorders
• If the patient is trying to conceive
• Medical supervision is particularly required immediately after major surgical procedures
• If the patient has asthma or allergic disease, as breathing difficulties may occur
• If the patient has hay fever, nasal polyps, or chronic obstructive pulmonary disease, as there is an increased risk of allergic reactions. Allergic reactions can occur in the form of asthma attacks (so-called analgesic asthma), Quincke's edema, or urticaria
• In the case of chickenpox, it is recommended to avoid taking Nurofen Express Caps
• If the patient has blood clotting disorders
• In the case of long-term use of Nurofen Express Caps, regular monitoring of liver and kidney function parameters and blood morphology is required
• Avoid concomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, due to the increased risk of adverse reactions (see "Nurofen Express Caps and other medicines" below)
• Taking the medicine in the smallest effective dose for the shortest necessary period to alleviate symptoms reduces the risk of adverse reactions
• Elderly people are more likely to experience adverse reactions
• Chronic use of (various) painkillers can lead to kidney damage with a risk of kidney failure. This risk may increase with physical exertion associated with salt loss and dehydration. Therefore, this should be avoided.
• As a result of long-term use of any type of painkillers, headaches may occur, which should not be treated with increased doses of this medicine. In such a case, the medicine should be discontinued and medical advice should be sought. The diagnosis of headache caused by drug abuse should be suspected in patients who have frequent or daily headaches despite (or due to) regular use of pain-relieving medications
• There is a risk of kidney function disorders in dehydrated children and adolescents.

Taking anti-inflammatory/pain-relieving medications, such as ibuprofen, may be associated with a small increase in the risk of heart attack or stroke, particularly when taken in high doses. Do not exceed the recommended dose and duration of treatment.
Before taking Nurofen Express Caps, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina pectoris (chest pain), the patient has had a heart attack, bypass surgery, has coronary artery disease (poor blood circulation in the legs due to narrowing or blockage of arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has high blood pressure, diabetes, high cholesterol levels, there is a history of heart disease or stroke in the patient's family, or the patient smokes.

During ibuprofen treatment, symptoms of an allergic reaction to this medicine have been reported, including breathing difficulties, facial swelling, and chest pain. If the patient notices any of these symptoms, they should stop taking Nurofen Express Caps and consult a doctor or emergency services immediately.
Infections
Nurofen Express Caps may mask the symptoms of infection, such as fever and pain. As a result, Nurofen Express Caps may delay the use of appropriate infection treatment and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should consult a doctor immediately.
Skin reactions
Severe skin reactions have been reported with ibuprofen use, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should stop taking Nurofen Express Caps and seek medical attention immediately.
Before taking Nurofen Express Caps, consult a doctor, even if the above warnings refer to past situations.

Nurofen Express Caps and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
In particular, inform them if you are taking:

Nurofen Express Caps may affect the action of other medicines or other medicines may affect the action of Nurofen Express Caps. For example:

• medicines with anti-clotting action (i.e., blood thinners/anti-coagulants, such as aspirin, warfarin, ticlopidine);
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);

Also, some other medicines may be affected or have an effect on treatment with Nurofen Express Caps. Therefore, before taking Nurofen Express Caps with other medicines, always consult a doctor or pharmacist

Nurofen Express Caps with food and alcohol

Capsules should be swallowed with water. In people with gastrointestinal disorders, it is recommended to take the medicine during meals. If taken soon after a meal, the onset of action of Nurofen Express Caps may be delayed. In such a case, do not take more Nurofen Express Caps than recommended in the "How to take Nurofen Express Caps" section or before the recommended interval between doses.
The occurrence of certain side effects, such as those related to the gastrointestinal system, is more likely when consuming alcohol at the same time as taking Nurofen Express Caps.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine in the last 3 months of pregnancy. Taking it may cause kidney and heart problems in the unborn child. It may also affect the mother's and child's ability to clot and prolong labor. This medicine should be avoided during the first 6 months of pregnancy, unless the doctor recommends otherwise. Taking Nurofen Express Caps for more than a few days after the start of the 20th week of pregnancy may cause kidney problems in the unborn child and lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the ductus arteriosus in the child's heart. If longer-term treatment is necessary, the doctor may recommend additional monitoring.
Breastfeeding
The medicine passes into breast milk, but it can be taken during breastfeeding if given in recommended doses and for the shortest possible duration.
Fertility
The medicine belongs to a group of NSAIDs that may have a negative effect on female fertility. This effect is temporary and disappears after the end of treatment.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines if taken for a short period and as recommended. If side effects such as fatigue and dizziness occur, do not drive or operate machinery. Alcohol consumption increases the risk of these side effects.
Nurofen Express Caps contains 22.26 mg of sorbitol in each capsule. If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.
Nurofen Express Caps contains cochineal red 4R (E124). The medicine may cause allergic reactions.

3. How to take Nurofen Express Caps

Always take this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Take the smallest effective dose for the shortest necessary period to alleviate symptoms.
If the symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
The recommended dose is:
Adults and adolescents with a body weight of approximately 40 kg:
Initial dose: take 1 or 2 capsules (200 mg or 400 mg of ibuprofen) with water. Then, if necessary, an additional 1 or 2 capsules (200 mg to 400 mg of ibuprofen), but do not exceed a total dose of 6 capsules in 24 hours. After taking a dose of 200 mg, the next dose should be taken no earlier than 4 hours later, after taking a dose of 400 mg, the next dose should be taken no earlier than 6 hours later.
Children with a body weight of 20 kg to 39 kg:
Nurofen Express Caps should only be used in children with a body weight of at least 20 kg. The maximum daily dose of ibuprofen is 20-30 mg per kilogram of body weight, divided into 3 to 4 single doses. The interval between consecutive doses should not be less than 6 hours. Do not exceed the maximum recommended daily dose. In 24 hours, do not exceed a total dose of 30 mg of ibuprofen per kilogram of body weight. When using Nurofen Express Caps in children, the following dosing is usually used:

Body weight Dose How often?

Children 20 kg – 29 kg

1 capsule

(200 mg of ibuprofen)
Take another capsule if necessary after at least 8 hours.
Do not take more than 3 capsules (up to 600 mg of ibuprofen) in 24 hours.
Children 30 kg – 39 kg

1 capsule

(200 mg of ibuprofen)
Take another capsule if necessary after at least 6 to 8 hours.
Do not take more than 4 capsules (up to 800 mg of ibuprofen) in 24 hours

Method of administration

For short-term, oral use. Do not chew.

Children and adolescents

In the case of children and adolescents, consult a doctor if the medicine needs to be given for more than 3 days or if the symptoms worsen. Another form of this medicine may be more suitable for children, so consult a doctor or pharmacist.

Adults

If the symptoms worsen or do not improve after 3 days in the case of fever treatment or 4 days in the case of pain treatment, consult a doctor.

Taking a higher dose of Nurofen Express Caps than recommended

If the patient has taken a higher dose of Nurofen Express Caps than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to assess the potential risk to their health and seek advice on what to do in such a case.
Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood or dark particles resembling coffee grounds), gastrointestinal bleeding, headache, ringing in the ears, disorientation, and nystagmus or less frequently diarrhea. Additionally, after taking a large dose, balance disorders, vision disturbances, low blood pressure, excitement, disorientation, coma, hyperkalemia, metabolic acidosis, increased prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, and exacerbation of asthma in asthmatic patients, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties.

4. Possible side effects

Like all medicines, Nurofen Express Caps can cause side effects, although not everybody gets them.
Taking the medicine in the smallest effective dose for the shortest necessary period to alleviate symptoms reduces the risk of side effects. Although side effects are not common, it is possible to experience one of the known side effects of NSAIDs (see below). In such a case or in case of doubt, stop taking the medicine and consult a doctor as soon as possible. Elderly people taking this product are more likely to experience side effects.

STOP taking the medicine and consult a doctor immediately if you experience:

• symptoms of gastrointestinal bleeding, such as:severe abdominal pain, black stools, vomiting with blood or dark particles resembling coffee grounds;
• symptoms of a very rare but serious allergic reaction,such as worsening of asthma symptoms, unexplained wheezing or shortness of breath, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, low blood pressure leading to shock. Such a reaction can occur even after the first dose of the medicine;
• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) [Very rare - may occur in 1 in 10,000 people].
• widespread rash, high body temperature, enlarged lymph nodes, and an increased number of eosinophils (a type of white blood cell) (DRESS syndrome) [Frequency not known - cannot be estimated from available data]. red, peeling, widespread rash with nodules under the skin and blisters, mainly in skin folds, on the torso, and upper limbs, with accompanying fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) [Frequency not known - cannot be estimated from available data].

Tell your doctor if you experience any other possible side effects

Frequent: (may occur in 1 in 10 people)

• stomach problems, such as heartburn, stomach pain, nausea, indigestion, diarrhea, vomiting, bloating (gas), constipation, minor bleeding in the stomach and/or intestines, which in rare cases may cause anemia.

Uncommon: (may occur in 1 in 100 people)

• stomach ulcers, perforation, or bleeding, inflammation of the mucous membrane of the mouth with ulcers, worsening of existing intestinal disease (ulcerative colitis or Crohn's disease), inflammation of the stomach lining.
• central nervous system disorders, such as headache, dizziness, insomnia, excitement, irritability, or fatigue.
• vision disturbances.
• various skin rashes.
• allergic reactions with urticaria and itching.

Rare: (may occur in 1 in 1,000 people)

• ringing in the ears (tinnitus).
• increased urea levels in the blood, lower back pain and/or abdominal pain, and blood in the urine, as well as fever, may be symptoms of kidney damage (papillary necrosis).
• decreased hemoglobin levels.

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

• esophageal inflammation, pancreatitis, formation of constricting bands in the intestine.
• heart failure, heart attack, and facial or hand swelling.
• kidney failure, and swelling, as well as clouding of the urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis), which can lead to acute kidney failure. If any of the above symptoms occur or if the patient feels unwell, they should stop taking Nurofen Express Caps and consult a doctor immediately, as they may be the first signs of kidney damage or failure.
• psychotic reactions and depression.
• high blood pressure, vasculitis.
• palpitations.
• liver function disorders, liver damage (the first symptoms may be skin discoloration), particularly during long-term treatment, liver failure, acute liver inflammation.
• blood production disorders - the first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and unexplained bruising. In such cases, stop the treatment and consult a doctor. The patient should not self-medicate with painkillers or antipyretics.
• severe skin and soft tissue infections during chickenpox
• it has been reported that the condition of inflammatory infections may worsen (e.g., necrotizing fasciitis) due to the use of certain painkillers (NSAIDs). If symptoms of infection occur or worsen, the patient should immediately consult a doctor. The doctor will assess whether there are indications for the use of anti-infective treatment (antibiotic therapy).
• during ibuprofen treatment, symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, and changes in consciousness have been observed. In patients with autoimmune disorders (lupus, mixed connective tissue disease), there is a greater risk of such symptoms. If such symptoms occur, the patient should immediately consult a doctor.
• hair loss (alopecia).

Frequency not known: cannot be estimated from available data

• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome
• respiratory tract reactivity, including asthma, bronchospasm, shortness of breath.
• reactions to light.

Taking such medicines as Nurofen Express Caps may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke.

If any side effect worsens or any side effect not mentioned in this leaflet occurs

tell your doctor or pharmacist.

Reporting side effects

If side effects occur, including any not listed in the leaflet, tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Nurofen Express Caps

Keep the medicine out of the sight and reach of children.
Do not take this medicine after the expiry date stated on the packaging, on the carton, and on the blister. The expiry date (EXP) refers to the last day of the month. Do not store above 25°C. Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nurofen Express Caps contains

The active substance is ibuprofen.
Each capsule contains 200 mg of ibuprofen.
The other ingredients are:
Macrogol 600
Potassium hydroxide (at least 85% of the sum of bases, calculated as KOH)
Purified water
Capsule ingredients:
Liquid sorbitol, partially dehydrated
Gelatin
Cochineal red 4R (E124)
Ink:
Opacode WB white NS-78-18011 (containing titanium dioxide (E171), propylene glycol, hypromellose 3cP)

What Nurofen Express Caps looks like and contents of the pack

Red, oval, and transparent soft capsules with identification printing. Capsules are available in packs of 2, 4, 6, 8, 10, 12, 20, 24 soft capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder

Reckitt Benckiser (Poland) S.A.
Okunin 1
05-100 Nowy Dwór Mazowiecki

Importer

RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
Netherlands
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Reckitt Benckiser (Poland) S.A.
Okunin 1
05-100 Nowy Dwór Mazowiecki
Phone: (22) 211 26 92

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

Austria
Nurofen Rapid 200 mg Weichkapseln
Bulgaria
Nurofen Express 200mg Soft Capsules
Cyprus
Nurofen 200mg Liquid Capsules
Czech Republic
Nurofen Rapid 200mg capsules
France
NUROFLASH 200 mg capsule molle
Germany
Nurofen Immedia 200mg Weichkapseln
Greece
Nurofen 200mg Μαλακες κάψουλες
Hungary
Nurofen Rapid 200 mg lágy kapszula
Malta
Nurofen Express 200mg capsules
Netherlands
Nurofen Fastine Liquid Caps 200 mg, capsule, zacht
Poland
Nurofen Express Caps
Romania
NUROFEN EXPRESS 200 mg capsule moi
Slovakia
Nurofen Rapid 200 mg Capsules, mäkké kapsuly
Slovenia
Nurofen Immedia 200mg mehke kapsule

Date of last revision of the leaflet: 04/2025