Nurofen Forte

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Nurofen Forte(Nureflex)

400 mg, effervescent tablets

Ibuprofen
Nurofen Forte and Nureflex are different trade names for the same medicine.

You should carefully read the contents of the leaflet 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.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should 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, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

One effervescent tablet of Nurofen Forte contains 400 mg of ibuprofen, which belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). The medicine relieves symptoms such as fever, pain, and swelling by acting at the site of their occurrence.
The medicine is intended for use in the following cases:

• pains of various origins of mild to moderate severity: headaches, e.g. migraines, back pain, toothaches, e.g. after tooth extraction, neuralgia, muscle and joint pain, painful menstruation;
• fever in the course of flu and colds.

The medicine is intended for short-term use. A doctor may prescribe the use of the medicine for other purposes than those listed above (also in some chronic diseases). In this case, the doctor's instructions regarding dosage and treatment duration should be followed.

2. Important information before taking Nurofen Forte

When not to take Nurofen Forte

Nurofen Forte should not be taken by patients:

• with an allergy to ibuprofen or any of the other ingredients of this medicine (listed in section 6) and to other nonsteroidal anti-inflammatory drugs (NSAIDs),
• who have ever had hypersensitivity reactions (e.g. hives, rhinitis, angioedema, or bronchial asthma) after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs),
• with active or history of stomach and/or duodenal ulcers or bleeding (two or more confirmed episodes of ulceration or bleeding),
• with a history of perforation or gastrointestinal bleeding associated with previous NSAID treatment (see "Warnings and precautions"),
• with severe liver, kidney, or heart failure (see "Warnings and precautions"),
• in the last three months of pregnancy (see "Pregnancy, breastfeeding, and fertility"),
• with a bleeding disorder.

Warnings and precautions – when to be particularly cautious when taking Nurofen Forte

Important information before taking Nurofen Forte:
During treatment with ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling in the face and neck (angioedema), chest pain.
In case of any of these symptoms, Nurofen Forte should be discontinued immediately and medical help should be sought immediately.
When taking Nurofen Forte, particular 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 been reported with ibuprofen. If the patient experiences any symptoms associated with severe skin reactions described in section 4, Nurofen Forte should be discontinued immediately and medical help should be sought.
Before starting treatment with Nurofen Forte, the patient should discuss with their doctor if they have:

• systemic lupus erythematosus and mixed connective tissue disease,
• 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 (ibuprofen may prolong bleeding time),
• active or history of bronchial asthma or allergic reactions; after taking the medicine, bronchospasm may occur,
• diseases for which the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids),
• infection - see below, "Infections" section.

Nurofen Forte should be avoided when taken with NSAIDs, including selective cyclooxygenase-2 inhibitors.
Dehydrated adolescents are at risk of kidney function disorders.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and does not necessarily have to be preceded by warning signs or may occur in patients who have had such warning signs. In case of gastrointestinal bleeding or ulceration, the medicine should be discontinued immediately. Patients with a history of gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period.
Prolonged use of different painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).
Taking anti-inflammatory/pain-relieving medicines, such as ibuprofen, may be associated with a slight increase in the 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, worsen, or new symptoms occur, the patient should consult their doctor.
Before taking Nurofen Forte, the patient should discuss their treatment with their doctor or pharmacist if:

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

Infections
Nurofen Forte may mask the symptoms of infection, such as fever and pain. Therefore, Nurofen Forte 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 during an infection and the infection symptoms persist or worsen, they should consult their doctor immediately.
This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is temporary and reverses after the end of treatment.

Nurofen Forte and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as medicines they plan to take, including those available without a prescription.
The patient should avoid taking ibuprofen with the following medicines:

• acetylsalicylic acid,
• other NSAIDs, including selective cyclooxygenase-2 inhibitors.

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

• anticoagulant medicines (i.e. blood thinners/anti-clotting agents, such as aspirin - 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).

Ibuprofen should be used with caution with the following medicines:

• diuretics,
• antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs),
• cardiac glycosides,
• lithium (a medicine used for manic and depressive states) and methotrexate (a medicine used for certain cancers and rheumatoid arthritis),
• cyclosporin,
• mifepristone,
• tacrolimus,
• zydovudine (an antiviral medicine),
• quinolone antibiotics,
• corticosteroids.

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Nurofen Forte 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 Forte may cause kidney and heart disorders in the unborn child. It may also affect the patient's and their child's bleeding tendency and prolong or prolong labor. Nurofen Forte 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 lowest dose should be used for the shortest possible time.
Taking Nurofen Forte 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 blood vessel (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. No cases of adverse effects in breastfed infants have been reported, so there is no need to stop breastfeeding during short-term use of the medicine at recommended doses. Before taking any medicine, the patient should consult their doctor.
Fertility
See "Warnings and precautions" section.

Driving and using machines

No effect of Nurofen Forte on the ability to drive and use machines is expected after taking the recommended dose and duration of treatment.

Nurofen Forte contains sugar and sodium

Sugar

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

Sodium

Nurofen Forte contains 27.42 mg of sodium (the main component of common salt) per tablet.
This corresponds to 1.37% of the maximum recommended daily intake of sodium in the diet for adults. This should be taken into account in patients who need to significantly restrict their sodium intake.

3. How to take Nurofen Forte

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 their doctor or pharmacist.
The patient should use the smallest effective dose for the shortest necessary period to relieve symptoms. If the symptoms of infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).
The medicine should be taken orally, for a short period.
Adults and adolescents over 12 years of age:1 tablet every 4 hours. The tablets should be taken with a liquid.
No more than 3 tablets (1200 mg of ibuprofen) should be taken in 24 hours.
In case of liver or kidney failure, the doctor will determine the individual dosage.
The medicine is not intended for children under 12 years of age.
Elderly patients:dose modification is not necessary.
A higher dose of the medicine than recommended should not be taken.
The patient should consult their doctor if the medicine needs to be taken for more than 3 days or if the symptoms worsen.

Taking a higher dose of Nurofen Forte than recommended

Overdose cases are rare, but if the patient has taken a higher dose of Nurofen Forte than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to get an opinion on the possible health risk and advice on what to do.
Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and nystagmus. They may also include: abdominal pain or, more rarely, diarrhea, gastrointestinal bleeding. After taking high 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, metabolic acidosis (excess of acids in the blood), and the coagulation time (prothrombin time/INR) is likely to be increased due to the disruption of circulating coagulation factors, acute kidney failure, or liver damage. In patients with asthma, worsening of asthma symptoms may occur. Additionally, low blood pressure and slow breathing may occur. Very rarely, excitement and disorientation or coma and convulsions may occur.
There is no specific antidote. Treatment is symptomatic and supportive, consisting of 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. They will 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. Patients with asthma will be given bronchodilators.

Missing a dose of Nurofen Forte

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, Nurofen Forte 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 using ibuprofen for other indications and long-term, other side effects may occur.
Side effects are ranked according to frequency of occurrence using the following terms:

Uncommon: occurs in less than 1 in 100 but more than 1 in 1,000 patients.

• stomach pain, nausea, and indigestion
• headache
• various skin rashes
• hives and itching.

Rare: occurs in less than 1 in 1,000 but more than 1 in 10,000 patients.

• diarrhea, bloating, constipation, vomiting, gastritis
• dizziness
• psychotic disorders, depression, insomnia, agitation
• tinnitus
• irritability, fatigue.

Very rare: occurs in less than 1 in 10,000 patients.

• peptic ulcers, perforation, or gastrointestinal bleeding, melena, hematemesis (sometimes fatal, especially in the elderly), oral mucosal ulceration, exacerbation of ulcerative colitis and Crohn's disease
• aseptic meningitis
• acute kidney failure, renal papillary necrosis, especially with prolonged use, leading to increased serum urea levels and edema, hypernatremia (sodium retention), decreased urine output
• liver function disorders
• blood count disorders (anemia, leukopenia - decreased white blood cell count, thrombocytopenia - decreased platelet count, pancytopenia - a blood disorder characterized by a deficiency of all normal blood cell elements: red blood cells, white blood cells, and platelets, agranulocytosis - absence of a certain type of white blood cell - granulocytes). The first symptoms include: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, unexplained bleeding, and bruising (e.g. purpura, petechiae, and nosebleeds)
• severe skin reactions, such as blistering reactions, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis
• severe hypersensitivity reactions. Symptoms may include: facial swelling, tongue or throat swelling, shortness of breath, tachycardia, low blood pressure (anaphylaxis, angioedema, or severe shock)
• heart failure and edema
• hypertension
• decreased hemoglobin levels.

Frequency not known: frequency cannot be estimated from the available data.

• respiratory tract hyperreactivity, e.g. asthma, worsening of asthma, bronchospasm, shortness of breath
• skin becomes sensitive to light.

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

• 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 fever, and enlarged lymph nodes (DRESS syndrome);
• red, scaly rash with nodules 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.

In some people, other side effects may occur during treatment. If the patient experiences any of the above symptoms or any other symptoms not listed in this leaflet, they should stop taking the medicine and consult their doctor.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Nurofen Forte

Do not store above 30°C.
The medicine should be stored out of sight and reach of children.
Nurofen Forte should not be taken after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Nurofen Forte contains

• The active substance of the medicine is ibuprofen - 1 effervescent tablet contains 400 mg of ibuprofen
• The excipients are: tablet core: sodium croscarmellose, sodium lauryl sulfate, sodium citrate, stearic acid, silicon dioxide (Aerosil 200); sugar coating: sodium carmellose, talc, gum arabic, sucrose, titanium dioxide, Macrogol 6000; ink for printing: shellac, iron oxide red (E 172), propylene glycol (E 1520), ammonium hydroxide (E 527), simethicone.

What Nurofen Forte looks like and contents of the packaging

White, round, biconvex tablets with markings. The tablets are available in packs of 12, 24, or 48 effervescent tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in France, the country of export:

Reckitt Benckiser Healthcare France
38 rue Victor Basch
CS 11018
91305 Massy Cedex
France

Manufacturer:

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

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in France, the country of export: 34009 301 861 4 5
Parallel import authorization number: 202/25

Date of leaflet approval: 13.06.2025

[Information about the trademark]