Nurofen Express

Leaflet accompanying the packaging: information for the user

Nurofen Express, 200 mg, coated tablets

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.
• If after 3 days there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

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

Nurofen Express contains 200 mg of ibuprofen in the form of ibuprofen sodium dihydrate. Ibuprofen belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs) with analgesic, antipyretic, and anti-inflammatory properties.
The medicine is intended for use in the following cases:

• Pain of various origins of mild to moderate severity:
• headaches, including tension headaches and migraines;
• toothaches;
• neuralgia;
• muscle, joint, and bone pain;
• pain accompanying the flu and colds.
• Fever of various origins (including flu, colds, or other infectious diseases)
• Painful menstruation

2. Important information before taking Nurofen Express

When not to take Nurofen Express

Nurofen Express should not be taken:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• in patients who have ever had hypersensitivity reactions (e.g., hives, runny nose, angioedema, or bronchial asthma) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• in patients with active or history of stomach and/or duodenal ulcers (two or more distinct episodes of confirmed ulceration or bleeding);
• in patients with perforation or gastrointestinal bleeding in the past, associated with previous NSAID treatment;
• in patients with severe liver, kidney, or heart failure;
• in pregnant women in the last 3 months of pregnancy;
• in patients with bleeding disorders.

Warnings and precautions

Important information before taking Nurofen Express:
During ibuprofen treatment, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling in the face and neck (angioedema), and chest pain.
If any of these symptoms are noticed, the patient should immediately stop taking Nurofen Express and seek medical attention immediately.
When taking Nurofen Express, special caution should be exercised:
Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred with ibuprofen use. If the patient experiences any symptoms associated with severe skin reactions as described in section 4, they should immediately stop taking Nurofen Express and seek medical attention.
Before starting Nurofen Express treatment, the patient should discuss with their doctor if they have:

• systemic lupus erythematosus and mixed connective tissue disease;
• allergic reactions after taking acetylsalicylic acid;
• gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• hypertension and/or heart failure;
• kidney function disorders;
• liver function disorders;
• blood coagulation disorders;
• active or history of bronchial asthma or allergic reactions in the past; taking the medicine may cause bronchospasm;
• diseases for which the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids);
• if the patient needs to limit sodium intake in their diet.
• infections - see below, section titled "Infections".

Nurofen Express should be avoided when taking other NSAIDs, including selective cyclooxygenase-2 inhibitors.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and may not be preceded by warning signs; they can also occur in patients who have had warning signs. If gastrointestinal bleeding or ulceration occurs, the medicine should be stopped immediately. Patients with gastrointestinal diseases, especially the elderly, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, especially during the initial treatment period.
Concomitant, long-term use of different painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).
Special caution should be exercised (the patient should consult a doctor or pharmacist) before using the medicinal product in patients with hypertension and/or heart failure with fluid retention, hypertension, and edema associated with NSAID use in the past.
Taking anti-inflammatory and pain-relieving medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. The recommended dose should not be exceeded, and the treatment duration should not be prolonged.
If symptoms persist or worsen despite taking the medicine, or if new symptoms appear, the patient should consult a doctor.
Before taking Nurofen Express, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, or has peripheral arterial disease (poor circulation in the legs due to narrowed or blocked arteries) or has had a stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has high blood pressure, diabetes, high cholesterol, has a family history of heart disease or stroke, or smokes.

Infections
Nurofen Express may mask the symptoms of an infection, such as fever and pain. Therefore, Nurofen Express may delay the use of appropriate infection treatment and lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to 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.
Skin reactions
Severe skin reactions, some of which are life-threatening, have been reported with the use of NSAIDs, including ibuprofen. The highest risk of these severe reactions occurs at the beginning of treatment, in most cases within the first month of taking the medicine.
The patient should stop taking the medicine at the first sign of a skin rash, mucosal lesions, or any other sign of hypersensitivity.
Medicines in this class (non-steroidal anti-inflammatory drugs) may adversely affect fertility in women. This effect is reversible upon cessation of treatment. If the patient is experiencing difficulty conceiving, they should consult a doctor before taking ibuprofen.

Use in the elderly

In the elderly, there is an increased risk of adverse reactions associated with ibuprofen use compared to younger patients. The frequency and severity of adverse reactions can be reduced by using the smallest effective dose for the shortest possible duration.
The patient should consult a doctor, even if the above warnings refer to situations that have occurred in the past.

Children and adolescents

The medicine is not indicated for children under 12 years of age.
In dehydrated adolescents aged 12-18 years, there is a risk of kidney function disorders.

Nurofen Express and other medicines

Nurofen Express should be avoided when taking other non-steroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors, such as celecoxib or etoricoxib), other painkillers, or acetylsalicylic acid (in analgesic doses).
The patient should inform their doctor about all medicines taken recently, including those available without a prescription.
Nurofen Express may affect the action of other medicines or other medicines may affect the action of Nurofen Express. For example:

• anticoagulant medicines (e.g., aspirin - acetylsalicylic acid, warfarin, ticlopidine);
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

In particular, before taking ibuprofen, the patient should inform their doctor about taking any of the following medicines:

• antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs);
• cardiac glycosides;
• lithium and methotrexate;
• cyclosporine;
• mifepristone;
• tacrolimus;
• zydovudine;
• quinolone antibiotics;
• diuretics;
• corticosteroids (e.g., prednisolone or dexamethasone).

Other medicines may also be affected by or have an effect on Nurofen Express treatment. Therefore, before taking Nurofen Express with other medicines, the patient should always consult a doctor or pharmacist.

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
Before taking any medicine, the patient should consult a doctor. Nurofen Express should not be taken during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Taking Nurofen Express may cause kidney and heart disorders in the unborn child. It may also affect the patient's and child's bleeding tendency and prolong or delay delivery. Nurofen Express should not be taken during the first 6 months of pregnancy unless it is clearly necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, the patient should use the smallest dose for the shortest possible time. Taking Nurofen Express 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 low amniotic fluid levels (oligohydramnios) or narrowing of the ductus arteriosus in the child's heart. If longer treatment is necessary, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts. There are no known cases of adverse reactions in breastfed infants, so there is no need to stop breastfeeding during short-term use of the medicine in small doses.
Before taking any medicine, the patient should consult a doctor.
Fertility
See "Warnings and precautions" section.

Driving and using machines

There is no data on the effect of Nurofen Express on the ability to drive vehicles, operate machinery, and mental performance during use of the medicine in recommended doses and for the recommended duration.

Nurofen Express contains sugar and sodium

Sugar

If the patient has been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

Sodium

The medicine contains 25.72 mg of sodium (the main component of table salt) per tablet. This corresponds to 1.29% of the maximum recommended daily sodium intake in the diet for adults. This should be taken into account in patients who need to significantly limit their sodium intake.

3. How to take Nurofen Express

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist.
The medicine is for short-term use only.
The medicine is intended for oral use only in adults, the elderly, and adolescents over 12 years of age.
The patient should use the smallest effective dose for the shortest possible duration. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult a doctor (see section 2).
Nurofen Express tablets should be taken as directed by the doctor. In case of doubt, the patient should consult a doctor again.
Usually, the following dosing is used:
Adults, the elderly, and adolescents over 12 years of age:initial dose - 1 to 2 tablets, then if necessary 1 to 2 tablets every 4 hours. The tablets should be taken with water.
Do not take more than 6 tablets in 24 hours. The patient should maintain at least a 4-hour interval between doses.
Elderly patients:in the elderly, there is a higher risk of adverse reactions. These can be minimized by using the smallest effective doses for the shortest possible duration.

Warning:

Do not exceed the recommended dose!
In case of overdose, the patient should consult a doctor.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult a doctor.
If the symptoms persist or worsen, or if new symptoms appear, the patient should consult a doctor.
The patient should use the smallest possible dose for the shortest possible duration. This reduces the risk of adverse reactions.
The patient should not take the medicine for more than 3 days without a doctor's recommendation.
The patient should consult a doctor if it is necessary to take the medicine for more than 3 days or if the symptoms worsen.

Taking a higher dose of Nurofen Express than recommended

Overdose cases are rare. However, if the patient has taken a higher dose of Nurofen Express 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 potential health risk and advice on what to do in such a case.
Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and nystagmus. After taking large doses, 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 may occur. The following may also occur: abdominal pain or diarrhea, gastrointestinal bleeding, very rarely excitement or coma, metabolic acidosis (excess of acids in the blood), prolonged prothrombin time/INR, probably due to impaired action of circulating clotting factors, acute kidney failure or liver damage, and in patients with asthma - worsening of asthma symptoms and bronchospasm.
There is no specific antidote. Treatment is symptomatic and supportive, aimed at maintaining vital functions until the medicine is eliminated from the body. The doctor will monitor heart function and control vital signs if they are stable. The doctor may consider administering activated charcoal orally within 1 hour of overdose. In case of frequent or prolonged seizures, the doctor will administer diazepam or lorazepam intravenously. In case of asthma, the doctor will administer bronchodilators.

Missing a dose of Nurofen Express

The patient should not take a double dose to make up for a missed dose.
In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Nurofen Express can cause side effects, although not everybody gets them.
During short-term use of ibuprofen in doses available without a prescription, the following side effects have been observed. When ibuprofen is used for other indications and long-term, other side effects may occur.
Side effects are listed by frequency of occurrence.

Uncommon (occurring in less than 1 in 100 but more than 1 in 1,000 patients):

• Indigestion, stomach pain, nausea, headaches, hives, and itching.

Rare (occurring in less than 1 in 1,000 but more than 1 in 10,000 patients):

• Diarrhea, bloating, constipation, vomiting, gastritis;
• Psychotic disorders, depression, tinnitus;
• Dizziness, insomnia, agitation, irritability, and fatigue, edema.

Very rare (occurring in less than 1 in 10,000 patients):

• Tarry stools, bloody vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease;
• Decreased urine output, kidney failure, renal papillary necrosis, increased sodium levels in the blood (sodium retention);
• Liver function disorders, especially during long-term use;
• Blood disorder symptoms (anemia, leukopenia - decreased white blood cell count, thrombocytopenia - decreased platelet count, pancytopenia - a blood disorder characterized by a deficiency of all normal blood cells: red, white, and platelets). The first symptoms are fever, sore throat, superficial mouth ulcers, flu-like symptoms, fatigue, bleeding (e.g., bruising, petechiae, purpura, nosebleeds);
• Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis;
• Facial edema, tongue and throat edema, dyspnea;
• Tachycardia - rapid heart rate, hypotension - sudden decrease in blood pressure, shock;
• Aseptic meningitis;
• Heart failure, hypertension, edema;
• Worsening of asthma and bronchospasm.

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

• Hyperreactivity of the airways, including asthma;
• Skin becomes sensitive to light.

If the patient experiences any of the following symptoms, they should immediately stop taking ibuprofen and seek medical attention:

• Red, non-raised, target-like or circular patches on the torso, often with blisters in the center, skin peeling, 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).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Red, scaly rash with bumps under the skin and blisters, mainly in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis).
• Chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

NSAID treatment, including high doses, has been associated with edema, hypertension, and heart failure. Taking medicines like Nurofen Express may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
If the patient experiences any of the above symptoms, as well as any other symptoms not listed in this leaflet, they should stop taking the medicine and consult a doctor.

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, 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
Aleje Jerozolimskie 181C
02-222 Warsaw
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 the medicine.

5. How to store Nurofen Express

There are no special recommendations for storage conditions.
The medicine should be stored out of sight and reach of children.
Nurofen Express should not be taken after the expiration date stated on the carton and blister pack after: EXP.
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 contains

• The active substance of the medicine is ibuprofen - 1 coated tablet contains 200 mg of ibuprofen in the form of 256 mg of ibuprofen sodium dihydrate
• The excipients are: sodium carmellose, xylitol, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, sodium carboxymethylcellulose, talc, spray-dried acacia, sucrose, titanium dioxide (E 171), macrogol 6000, Opacode S-1-277001 ink (shellac, iron oxide black (E 172), propylene glycol)

What Nurofen Express looks like and contents of the pack

White, round, biconvex tablets with markings. The tablets are available in packs of 2, 4, 6, 10, 12, 24, or 48 coated tablets. 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

Importer

RB NL Brands B.V.
WTC Schiphol Airport,
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
Phone: (22) 211 26 92

Date of last revision of the leaflet: