Nurofen Express Forte

Leaflet accompanying the packaging: patient information

Nurofen Express Forte, 400 mg, soft capsules

Ibuprofen
For use in adults and adolescents with a body weight of over 40 kg (from 12 years of age and above)

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 a 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 this leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or feel worse, you should contact your doctor:
• after 3 days in the case of 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 Forte and what is it used for
• 2. Important information before taking Nurofen Express Forte
• 3. How to take Nurofen Express Forte
• 4. Possible side effects
• 5. How to store Nurofen Express Forte
• 6. Contents of the packaging and other information

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

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by changing the body's response to pain and high temperature.
Nurofen Express Forte is intended for use in adults and adolescents with a body weight of over 40 kg (from 12 years of age and above), for the short-term symptomatic treatment of:

• mild and moderate pain, such as headache, menstrual pain, toothache
• fever and pain associated with a cold

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, they should consult a doctor.

2. Important information before taking Nurofen Express Forte

When not to take Nurofen Express Forte:

• in case of hypersensitivity to ibuprofen, carmoisine (E124) or any of the other ingredients of the medicine (listed in section 6),
• if the patient has experienced shortness of breath, asthma, rhinitis, swelling, or hives when taking acetylsalicylic acid or other similar painkillers (NSAIDs),
• if the patient has (or has had two or more distinct episodes of) stomach or duodenal ulcers (peptic ulcers) or bleeding,
• if the patient has experienced bleeding or perforation in the gastrointestinal tract when taking NSAIDs (non-steroidal anti-inflammatory drugs),
• if the patient has unexplained blood disorders,
• if the patient has severe liver, kidney, or heart failure,
• if the patient is in the last 3 months of pregnancy (see section Pregnancy and breastfeeding),
• if the patient is seriously dehydrated (due to vomiting, diarrhea, or insufficient fluid intake),
• if the patient has a cerebral hemorrhage or other active bleeding.

The medicine should not be given to children under 12 years of age and adolescents with a body weight of less than 40 kg.

Warnings and precautions:

Before starting to take Nurofen Express Forte, the patient should discuss it with their doctor, pharmacist, or nurse.

• if the patient has an infection - see below "Infections"
• if the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system diseases causing joint pain, skin changes, and fever),
• if the patient experiences severe skin reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis. The use of Nurofen Express Forte should be stopped immediately if the patient experiences the first symptoms of a skin rash, changes in the mucous membranes, or any other symptoms of an allergic reaction,
• if the patient has certain congenital blood disorders (e.g., acute intermittent porphyria) or bleeding disorders,
• if the patient has (or has had) bowel disease (ulcerative colitis or Crohn's disease),
• in case of kidney function disorders,
• in case of liver function disorders,
• if the patient has recently undergone surgery,
• if the patient has asthma or an allergic disease, as they may experience shortness of breath,
• if the patient has hay fever, nasal polyps, or chronic obstructive respiratory disease, as there is an increased risk of an allergic reaction. The allergic reaction may manifest as an asthma attack (so-called analgesic asthma), acute angioedema, or skin rash,

An allergic reaction can manifest as an asthma attack (so-called analgesic asthma), acute angioedema, or skin rash.

• if the patient is taking medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors (antidepressants), or antiplatelet agents such as acetylsalicylic acid.

Other warnings

• Long-term use of painkillers for headache treatment may worsen symptoms. If this occurs or is suspected, the use of Nurofen Express Forte should be stopped and a doctor consulted.
• Nurofen Express Forte should be avoided during chickenpox.
• During long-term use of Nurofen Express Forte, regular monitoring of liver and kidney function, as well as blood morphology, should be performed.
• Taking Nurofen Express Forte at the same time as other NSAIDs, including specific cyclooxygenase-2 inhibitors, may increase the risk of side effects, so such combinations should be avoided (see section "Concomitant use with other medicines").
• Habitual use (more than one) of painkillers may lead to serious kidney function disorders and should be avoided. This risk is higher in case of salt loss and dehydration.
• Dehydrated adolescents are at risk of kidney function disorders.

Infections
Nurofen Express Forte may mask the symptoms of an infection, such as fever and pain. Therefore, Nurofen Express Forte 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 immediately consult a doctor.
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 of the symptoms associated with these severe skin reactions described in section 4, they should immediately stop taking Nurofen Express Forte and seek medical attention.

Taking anti-inflammatory/pain-relieving medications, such as ibuprofen, may be associated with a slight increase in the risk of heart attack or stroke, particularly when used in high doses. The recommended dose should not be exceeded, and the duration of treatment should be as short as possible.
Before taking Nurofen Express Forte, the patient should discuss the treatment with their doctor or pharmacist if:

• the patient has heart diseases, such as heart failure, angina pectoris (chest pain), has had a heart attack, has undergone coronary artery bypass grafting, or has peripheral 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, has a family history of heart disease or stroke, or smokes.

During ibuprofen use, symptoms of an allergic reaction to this medicine have been reported, including difficulty breathing, swelling around the face and neck (angioedema), chest pain. If any of these symptoms are observed, the patient should immediately stop taking Nurofen Express Forte and urgently contact their doctor or emergency services.

The risk of side effects can be minimized by using the smallest effective dose for the shortest possible time. In elderly patients, the risk of side effects is higher

If the patient experiences any of the above disorders or conditions, they should consult their doctor before starting to take Nurofen Express Forte.

Nurofen Express Forte and other medicines

Before taking Nurofen Express Forte with other medicines, the patient should always consult their doctor or pharmacist. Nurofen Express Forte may affect the action of other medicines or other medicines may affect the action of Nurofen Express Forte. For example:

• anticoagulant medicines (i.e., blood thinners/preventing blood clots, such as acetylsalicylic acid, warfarin, ticlopidine)
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan)

Some other medicines may also be affected or have an effect on the treatment with Nurofen Express Forte. Therefore, before taking Nurofen Express Forte with other medicines, the patient should always consult their doctor or pharmacist.
In particular, the patient should inform their doctor about taking the following medicines:

Nurofen Express Forte and alcohol

Alcohol should not be consumed during treatment with Nurofen Express Forte. Some side effects, such as those related to the gastrointestinal tract or central nervous system, may be more likely when consuming alcohol and taking Nurofen Express Forte.

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 their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor if they suspect they are pregnant during treatment with Nurofen Express Forte.
Nurofen Express Forte should not be used during the last 3 months of pregnancy. Its use may cause kidney and heart disorders in the unborn child. It may also affect the patient's and their child's ability to clot and prolong or delay labor. Nurofen Express Forte should be avoided during the first 6 months of pregnancy, unless the doctor recommends otherwise. Taking ibuprofen for more than a few days after the start of the 20th week of pregnancy may cause kidney disorders 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 necessary, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen and its metabolites may pass into breast milk in small amounts. The medicine can be used during breastfeeding if taken in the recommended dose and for the shortest possible time.
Fertility
Nurofen Express Forte belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible after stopping the medicine.

Driving and using machines

During short-term use of therapeutic doses, the medicine does not have a significant effect on the ability to drive vehicles and operate machines.
If the patient experiences dizziness, drowsiness, balance disorders, or vision disturbances while taking Nurofen Express Forte, they should avoid driving vehicles and operating machines. These effects may be enhanced when consuming alcohol.
Nurofen Express Forte contains 36.6 mg of sorbitol in each capsule. Patients with known intolerance to some sugars should consult their doctor before taking this medicine.
Nurofen Express Forte contains carmoisine (E124), which may cause allergic reactions.

3. How to take Nurofen Express Forte

The patient should always take this medicine exactly as described in this leaflet. If they are unsure, they should consult their doctor or pharmacist. Unless the doctor recommends otherwise, the usual dose is:

Dosage:

Adults and adolescents with a body weight of over 40 kg (from 12 years of age and above):
Initial dose: 1 capsule (400 mg ibuprofen), taken with water; if necessary, take 1 capsule (400 mg ibuprofen) every 6 hours. Do not take more than 3 capsules (1200 mg ibuprofen) in 24 hours.
The medicine should not be given to adolescents with a body weight of less than 40 kg under the age of 12.

Method of administration

Take orally. Do not chew the capsules.
Patient with sensitive stomachs should take Nurofen Express Forte during meals. If the medicine is taken immediately after eating, the onset of action may be delayed. In such cases, do not take a higher dose of Nurofen Express Forte or take it at shorter intervals than recommended.

Duration of treatment

The product is intended for short-term use only. The patient should take the smallest effective dose for the shortest time necessary to reduce symptoms. In case of infection, they should immediately consult a doctor if symptoms (such as fever and pain) persist or worsen (see section 2).

Adolescents

In adolescents, the doctor's advice should be sought if Nurofen Express Forte is necessary for more than 3 days or if symptoms worsen.

Adults

If after 3 days in the case of fever treatment or 4 days in the case of pain treatment, there is no improvement or the patient feels worse, they should contact their doctor.
If the patient feels that the effect of the medicine is stronger or weaker than expected, they should talk to their doctor or pharmacist.

Taking a higher dose of Nurofen Express Forte than recommended

If the patient has taken a higher dose of Nurofen Express Forte than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on the possible risk to their health and advice on what to do in such a case.
Symptoms of overdose may include nausea, vomiting (which may contain blood), black stools, headache, ringing in the ears, stomach pain, diarrhea, disorientation, and nystagmus. After taking a large dose, drowsiness, dizziness, confusion, disorientation, 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 may occur.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Nurofen Express Forte can cause side effects, although not everybody gets them.
Side effects can be minimized by using the smallest effective dose for the shortest time necessary to reduce symptoms. The patient may experience known side effects typical of NSAIDs. If they are unsure, they should stop taking the medicine and consult their doctor as soon as possible. In elderly patients taking this medicine, there is an increased risk of side effects.

The patient should STOP TAKING the medicine and immediately consult their doctor if they experience any of the following symptoms:

• symptoms of gastrointestinal bleeding, such as:severe stomach pain, black stools, vomiting with blood or dark particles that look like coffee grounds.
• symptoms of a very rare but serious allergic reactionsuch as worsening of asthma, 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 may 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 reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) [Very rare - frequency 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 bumps 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].

Other possible side effects

If the patient experiences or worsens any of the side effects or experiences any side effects not listed in this leaflet, they should tell their doctor

or pharmacist.

Frequent (may occur in 1 in 10 people)

• gastrointestinal disorders, such as heartburn, stomach pain, nausea, indigestion, vomiting, bloating, diarrhea, constipation, minor gastrointestinal bleeding that may rarely lead to anemia.

Uncommon (may occur in 1 in 100 people)

• stomach or intestinal ulcers, sometimes with accompanying bleeding and perforation, inflammation of the mouth with ulcers (stomatitis), inflammation of the stomach lining (gastritis), worsening of colitis or Crohn's disease
• central nervous system disorders, such as headache, dizziness, insomnia, restlessness, irritability, or fatigue
• vision disorders
• allergic reactions, such as rash, itching, or asthma attacks. In such cases, the patient should stop taking Nurofen Express Forte and immediately consult their doctor.

Rare (may occur in 1 in 1000 people)

• ringing in the ears (tinnitus)
• kidney damage (papillary necrosis) and increased uric acid levels in the blood

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

• edema, high blood pressure, and heart failure have been reported with NSAID use
• esophageal or pancreatic inflammation, formation of intestinal strictures
• during chickenpox, severe skin and soft tissue infections have been observed
• decreased urine output and swelling (especially in patients with high blood pressure or kidney function disorders); swelling and clouding of the urine (nephrotic syndrome); kidney inflammation (interstitial nephritis) that may lead to acute kidney failure. If any of these symptoms occur or the patient feels generally unwell, they should stop taking Nurofen Express Forte and immediately consult their doctor, as these may be the first symptoms of kidney damage or failure.
• blood disorders: first symptoms are fever, sore throat, mouth ulcers, flu-like symptoms, severe weakness, nosebleeds, and skin bleeding. In such cases, the patient should immediately stop the treatment and consult their doctor. They should not treat these symptoms with painkillers or antipyretics.
• psychotic reactions and depression
• severe infections, as the use of some painkillers (NSAIDs) may worsen the condition (e.g., necrotizing fasciitis). If the patient's symptoms of infection worsen or persist while taking Nurofen Express Forte, they should immediately consult their doctor to determine if antibiotic treatment is necessary.
• high blood pressure, palpitations, heart failure, heart attack
• liver function disorders, liver damage, especially during long-term treatment, liver failure, acute liver inflammation
• the patient taking ibuprofen has reported symptoms of aseptic meningitis with stiffness in the neck, headache, nausea, vomiting, and changes in consciousness. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are at higher risk of these disorders. If such symptoms occur, the patient should immediately consult their doctor.
• hair loss (alopecia)
• severe, generalized allergic reactions
• worsening of asthma or bronchospasm
• vasculitis

Frequency not known

• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome
• allergic reactions to light.

The medicine contains carmoisine (E124), which may cause allergic reactions.

If any of the side effects worsen or any side effects not listed in this leaflet occur, the patient should immediately stop taking the medicine and tell their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Nurofen Express Forte

The medicine should be stored out of sight and reach of children. Do not use Nurofen Express Forte after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month. Do not store above 25°C. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Nurofen Express Forte contains

Each capsule contains 400 mg of ibuprofen. The medicine also contains:
Macrogol 600
Potassium hydroxide
Purified water
Capsule ingredients:
Gelatin
Sorbitol liquid, partially dehydrated
Purified water
Carmoisine (E124)
Ink:
Opacode WB White NS-78-18011
Composition: Titanium dioxide (E171)
Propylene glycol
Hypromellose 3 cP
Excipients in processing:
Saturated fatty acid triglycerides with medium chain length
Lecithin

What Nurofen Express Forte looks like and contents of the pack

Red, oval, transparent capsules with a white Nurofen logo. Each capsule is approximately 10.3 mm wide and 16.9 mm long. Available in packs of 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 40, or 50 soft capsules.
PVC/PVDC/Aluminum blister in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder

Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Helpline number: (22) 211 26 92

Importer

RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
Netherlands

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria
Nurofen Rapid 400 mg soft capsules
Bulgaria
Nurofen Express Forte
Cyprus
Nurofen Express 400mg capsules, soft
France
NurofenCaps 400mg, soft capsules
Germany
Nurofen Intensive 400 mg soft capsules
Hungary
Nurofen Rapid Forte 400 mg soft capsules
Italy
Nurofencaps 400 mg soft capsules
Netherlands
Nurofen Fastine Liquid Capsules 400 mg, soft capsules
Poland
Nurofen Express Forte
Portugal
Nurofen Zavance 400 mg soft capsules
Romania
Nurofen Express Forte 400 mg soft capsules
United Kingdom
Nurofen 400mg capsules, soft

Date of last revision of the leaflet: 04/2025