Nurofen Express Forte Mini

Leaflet accompanying the packaging: information for the user

Nurofen Express Forte Mini, 400 mg, soft capsules

Ibuprofen

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 this 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 additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist.

See section 4.

• Adolescents from 12 years of age and adults: If there is no improvement or the patient feels worse after 3 days, they should contact a doctor.

Table of contents of the leaflet

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

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

Ibuprofen belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs). These drugs work by changing the body's response to pain and fever.
Nurofen Express Forte Mini is intended for use in adults and adolescents with a body weight of 40 kg or more (from 12 years of age and older).
Nurofen Express Forte Mini is used for short-term symptomatic treatment of mild to moderate pain, such as headache, toothache, menstrual pain, fever, and pain associated with colds.
In adolescents from 12 years of age and adults: If there is no improvement or the patient feels worse after 3 days, they should contact a doctor.

2. Important information before taking Nurofen Express Forte Mini

Nurofen Express Forte Mini should not be taken with other Nurofen line medicines or those containing ibuprofen.

When not to take Nurofen Express Forte Mini

• if the patient is allergic to ibuprofen, cochineal red A (E 124), peanuts, or soy, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has ever had difficulty breathing, asthma, hay fever, swelling of the face and/or hands, or hives after taking ibuprofen, acetylsalicylic acid, or other similar painkillers (NSAIDs)
• if the patient has or has had stomach or duodenal ulcers (peptic ulcers) or bleeding
• if the patient has had bleeding or perforation of the gastrointestinal tract in the past while taking NSAIDs (non-steroidal anti-inflammatory drugs)
• if the patient has severe liver, kidney, or heart failure
• if the patient has unexplained blood disorders
• if the patient is in the last three months of pregnancy (see "Pregnancy, breastfeeding, and fertility" section)
• if the patient has severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake)
• if the patient has bleeding in the brain (cerebral hemorrhage) or other active bleeding.

Warnings and precautions:

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

• if the patient has an infection - see "Infections" section below
• if the patient has certain skin diseases (systemic lupus erythematosus, SLE) or mixed connective tissue disease (an immune system disorder causing joint pain, skin rashes, and fever)
• if the patient has certain inherited blood disorders (e.g., acute intermittent porphyria) or blood clotting problems
• if the patient has or has had bowel disease (ulcerative colitis or Crohn's disease)
• if the patient has kidney function disorders
• if the patient has liver function disorders. During long-term use of this medicine, regular monitoring of liver, kidney function, and blood morphology parameters is necessary
• if the patient has recently undergone major surgery
• if the patient is trying to conceive
• if the patient has or has had asthma or allergic diseases, as they may experience difficulty breathing
• If the patient has hay fever, nasal polyps, or chronic obstructive pulmonary disease, there is an increased risk of allergic reactions. Allergic reactions can occur in the form of asthma attacks (so-called analgesic asthma), sudden swelling (Quincke's edema), or skin rash (hives)
• if the patient is taking other medicines that may increase the risk of stomach ulcers or bleeding, such as oral corticosteroids, blood thinners (e.g., warfarin), selective serotonin reuptake inhibitors (antidepressants), or antiplatelet agents (e.g., acetylsalicylic acid)
• if the patient is taking other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, as they may increase the risk of side effects, so they should be avoided (see "Other medicines" section below)
• if the patient has chickenpox, it is recommended to avoid taking this medicine.

Side effects can be minimized by taking the smallest effective dose for the shortest necessary time.
Long-term use of any pain reliever to relieve headache can worsen it. If this situation occurs or is suspected, the patient should stop taking this medicine and talk to their doctor. Medication overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or due to) regular use of pain relievers.
In general, habitual use (of several types) of pain relievers can lead to permanent severe kidney damage, so it should be avoided. This risk may be further increased by salt loss and dehydration associated with physical exertion.
There is a risk of kidney damage in dehydrated adolescents.
Pain relievers and anti-inflammatory drugs, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. The recommended dose should not be exceeded, nor should the duration of treatment be prolonged.
Before taking this medicine, the patient should discuss treatment with their doctor or pharmacist:

• if the patient has diseases such as heart failure, angina pectoris (chest pain), or if they have had a heart attack, coronary artery bypass grafting, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack "TIA"),
• if the patient has high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if they smoke.

Infections
This medicine may mask the symptoms of an infection, such as fever and pain. As a result, this medicine may delay the use of appropriate infection treatment, potentially leading to 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 while an infection is present, and the infection symptoms persist or worsen, they should immediately consult a doctor.
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), and acute generalized exanthematous pustulosis (AGEP), have been reported with ibuprofen use. If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should immediately stop taking Nurofen Express Forte Mini and seek medical attention.
Allergic reaction symptoms to this medicine, including difficulty breathing, swelling around the face and neck (angioedema), chest pain, have been reported. If the patient notices any of these symptoms, they should immediately stop taking Nurofen Express Forte Mini and urgently contact their doctor or emergency medical services.

Elderly patients

Elderly patients are more likely to experience side effects.

Nurofen Express Forte Mini and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, if the patient is taking the following medicines:

This medicine may affect the action of other medicines or be affected by other medicines, such as:

• anticoagulant medicines that thin the blood and prevent clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine),
• medicines that lower high blood pressure (ACE inhibitors, e.g., captopril, beta-blockers, e.g., atenolol, angiotensin II receptor antagonists, e.g., losartan).

Other medicines may also affect this medicine or be affected by it. Therefore, before taking this medicine with other medicines, the patient should always consult their doctor or pharmacist.

Taking Nurofen Express Forte Mini with alcohol

The patient should not consume alcohol while taking this medicine. Some side effects, such as those related to the gastrointestinal tract or central nervous system, may be more likely when consuming alcohol and taking this medicine.

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 tell their doctor if they become pregnant while taking Nurofen Express Forte Mini. This medicine should not be taken during the last three months of pregnancy. Taking the medicine may cause kidney and heart problems in the unborn child. The medicine may also affect the patient's and their child's bleeding tendency and may prolong or delay labor. The patient should not take this medicine during the first six months of pregnancy unless their doctor advises otherwise. Taking this medicine for more than a few days after the beginning 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 baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart.
In case of need for longer treatment, the 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 it is taken in 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 temporary and reverses after stopping the medicine.

Driving and using machines

When taken for a short period in recommended doses, this medicine has no or negligible influence on the ability to drive and use machines.
If the patient experiences side effects such as fatigue, dizziness, drowsiness, or vision disturbances while taking this medicine, they should not drive or operate machinery. These effects may be enhanced when the medicine is taken with alcohol.

Nurofen Express Forte Mini contains sorbitol

This medicine contains 72.59 mg of sorbitol in each capsule.
Sorbitol is a source of fructose. If the patient (or child) has a confirmed intolerance to some sugars or has been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the body cannot break down fructose, they should talk to their doctor before taking this medicine.

Nurofen Express Forte Mini contains cochineal red (E 124)

The medicine may cause allergic reactions.

Nurofen Express Forte Mini contains soy lecithin.

If the patient is allergic to peanuts or soy, they should not take this medicine.

3. How to take Nurofen Express Forte Mini

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Dosage

Adults and adolescents with a body weight of 40 kg or more (from 12 years of age and older):
Initial dose: Take 1 capsule (400 mg ibuprofen), with water. If necessary, the patient can take an additional 1 capsule (400 mg ibuprofen), but the total dose should not exceed 3 capsules (1200 mg ibuprofen) in 24 hours. The interval between doses should not be less than 6 hours.
This medicine should not be given to adolescents with a body weight below 40 kg or children under 12 years of age.

Method of administration

For oral use. The capsules should be swallowed whole, with water. Do not chew.
It is recommended that patients with sensitive stomachs take this medicine with food. If taken soon after eating, the onset of action of the medicine may be delayed. In such cases, the patient should not take a higher dose than recommended or before the recommended interval between doses has passed.

Duration of treatment

This medicine is intended for short-term use only. The patient should take the smallest effective dose for the shortest time necessary to relieve symptoms. In case of infection, the patient should immediately contact their doctor if symptoms (such as fever and pain) persist or worsen (see section 2).
Adolescents: the patient should consult their doctor if the medicine needs to be taken for more than 3 days or if symptoms worsen.

Taking a higher dose of Nurofen Express Forte Mini than recommended

If the patient takes a higher dose than recommended or accidentally takes this medicine, they should always contact their doctor or the nearest hospital for advice on the risk and what to do. Symptoms of overdose may include: nausea, stomach pain, vomiting (which may contain blood), blood in the stool (gastrointestinal bleeding), headache, ringing in the ears, diarrhea, confusion, and trembling of the eyeballs. After high doses, reports have included weakness, dizziness, blurred vision, low blood pressure, agitation, disorientation, coma, hyperkalemia (elevated potassium levels in the blood), prolonged prothrombin time/INR, acute kidney failure, liver damage, depression, respiratory depression, cyanosis, and worsening of asthma in asthmatics, drowsiness, loss of consciousness, feeling cold, chest pain, palpitations, and seizures (mainly in children), blood in the urine, low potassium levels in the blood, and breathing problems.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimized by taking the smallest effective dose for the shortest time necessary to relieve symptoms. The patient may experience known side effects typical of NSAIDs (see below). If in doubt, the patient should stop taking the medicine and talk to their doctor as soon as possible. Elderly patients taking this medicine are at increased risk of side effects.

The patient should STOP taking this medicine and immediately contact their doctor if they experience:

• Symptoms of gastrointestinal bleeding, such as severe stomach pain, black stools, vomiting blood or dark particles that look like coffee grounds.
• Symptoms of a very rare but serious allergic reaction, such as worsening 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 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 - frequency may occur in 1 in 10,000 people].

• A widespread rash, high body temperature, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell) (DRESS syndrome) [frequency not known - cannot be estimated from available data].
• A 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].

The patient should tell their doctor if they experience any of the following side effects, if they worsen, or if they notice any other symptoms not listed in this leaflet.

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

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

Uncommon (may affect up to 1 in 100 people)

• stomach and/or intestinal ulcers, sometimes with bleeding and perforation, mouth ulcers with bleeding (ulcerative stomatitis), stomach inflammation (gastritis), worsening of colitis and Crohn's disease;
• central nervous system disorders, such as headache, dizziness, insomnia, excitement, irritability, or fatigue;
• vision disturbances;
• allergic reactions, such as skin rashes, itching, and asthma attacks. The patient should stop taking this medicine and immediately inform their doctor;
• various skin rashes.

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

• ringing in the ears (tinnitus);
• increased blood urea levels, side and back pain, and/or stomach pain, blood in the urine, and fever may be symptoms of kidney damage (renal papillary necrosis);
• increased blood uric acid levels;
• hearing impairment;
• decreased hemoglobin levels.

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

• esophageal or pancreatic inflammation and the formation of stricture-like narrowings in the small and large intestines;
• during chickenpox, severe skin infections and soft tissue complications have been reported;
• high blood pressure, palpitations, heart failure, vasculitis, and edema;
• kidney problems, including decreased urine output and swelling (especially in patients with high blood pressure or kidney function disorders), swelling and clouding of the urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis), which can lead to acute kidney failure. If any of these symptoms occur, or if the patient feels unwell, they should stop taking this medicine and immediately consult their doctor, as they may be the first signs of kidney damage or failure;
• liver function disorders, liver damage (the first symptoms may be skin discoloration), particularly during long-term treatment, liver failure, acute hepatitis;
• blood disorders. The first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and unexplained bruising. In such cases, the patient should immediately stop treatment and consult their doctor. They should not treat themselves with pain relievers or antipyretics;
• psychotic reactions and depression;
• exacerbation of infections (e.g., necrotizing fasciitis) has been reported with the use of some pain relievers (NSAIDs). If the patient experiences or worsens infection symptoms while taking this medicine, they should immediately consult their doctor to determine if there is a need for anti-infective treatment or antibiotic therapy;
• aseptic meningitis with stiff neck, headache, malaise, nausea, vomiting, and disturbances of consciousness. In patients with autoimmune disorders (lupus, mixed connective tissue disease), there is a higher risk of such symptoms. If the patient experiences any of these symptoms, they should immediately contact their doctor;
• hair loss (alopecia);
• severe hypersensitivity reactions;
• worsening of asthma and bronchospasm.

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

• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome
• respiratory hypersensitivity reactions, including asthma, bronchospasm, or shortness of breath;
• skin sensitivity to light.

This medicine contains cochineal red (E 124), which may cause allergic reactions.
Taking medicines like this one may be associated with a small increased risk of heart attack or stroke.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist.
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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Nurofen Express Forte Mini

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the carton and blister pack after "EXP". 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 need. This will help protect the environment.

6. Contents of the packaging and other information

What Nurofen Express Forte Mini contains

The active substance is ibuprofen.

• One soft capsule contains 400 mg of ibuprofen

Other ingredients are:
Capsule contents:

• Macrogol 600
• Potassium hydroxide (purity of at least 85%) (E 525)
• Purified water

Soft capsule shell:

• Partially dehydrated liquid sorbitol
• Gelatin (E 441)
• Cochineal red (E 124)

Ink:

• Opacode WB white NSP-78-180002, consisting of titanium dioxide (E 171), propylene glycol (E 1520), SDA 35A alcohol (ethanol and ethyl acetate), isopropyl alcohol, polyvinyl acetate phthalate, purified water, PEG 400 (E 1521), and 28% ammonium hydroxide (E 527)

Excipients in the manufacturing process:

• Soy lecithin (E 322)

What Nurofen Express Forte Mini looks like and contents of the pack

The soft capsules are red and oval, with white printing NURO400. Each capsule is approximately 10.0 mm wide and 15.5 mm long. The capsules are available in packs of 10, 20, 24, 30, or 40 capsules in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

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

Manufacturer/Importer:

RB NL Brands B.V.
Schiphol Boulevard 207
1118 BH Schiphol
Netherlands
To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
email: [email protected]

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

Date of last revision of the leaflet: 04/2025