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, coated 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 your 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 you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your 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 Nurofen Forte coated tablet 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. Your doctor may prescribe the use of the medicine for other purposes than those listed above (also in certain chronic diseases). You should then follow the doctor's instructions regarding dosage and treatment duration.

2. Important information before taking Nurofen Forte

When not to take Nurofen Forte

Nurofen Forte should not be taken by patients:

• with hypersensitivity 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 past peptic ulcer disease of the stomach and/or duodenum or bleeding (two or more clear episodes of confirmed ulceration or bleeding),
• with perforation or bleeding from the gastrointestinal tract in the past, associated with previous NSAID treatment (see "Warnings and precautions"),
• with severe liver failure, severe kidney failure or severe heart failure (see "Warnings and precautions"),
• in the last three months of pregnancy (see "Pregnancy, breastfeeding and fertility"),
• with hemorrhagic diathesis.

Warnings and precautions – when to be particularly careful 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.
If you notice any of these symptoms, you should stop taking Nurofen Forte immediately and contact your doctor or emergency medical services immediately.
When taking Nurofen Forte, you should be particularly careful:
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 you experience any symptoms associated with severe skin reactions described in section 4, you should stop taking Nurofen Forte immediately and seek medical attention.
Before starting treatment with Nurofen Forte, you should discuss with your doctor if you have previously been diagnosed with:

• 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 clotting disorders (ibuprofen may prolong bleeding time),
• active or past bronchial asthma or a history of 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, section entitled "Infections".

You should avoid taking Nurofen Forte at the same time as NSAIDs, including selective cyclooxygenase-2 inhibitors.
In patients who are dehydrated - there is a risk of kidney function disorder.
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. If gastrointestinal bleeding or ulceration occurs, you should stop taking the medicine 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.
Concomitant, long-term 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 small increased risk of heart attack or stroke, especially when used in high doses. You should not exceed the recommended dose and treatment duration.
If symptoms persist, worsen or do not improve after 3 days, or if new symptoms occur, you should contact your doctor.
Before taking Nurofen Forte, the patient should discuss the treatment with their 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, has peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked 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.

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 consequently 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 symptoms of the infection 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 fertility in women. This effect is temporary and reverses after the end of treatment.

Nurofen Forte and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as about medicines you plan to take, including those available without a prescription.
You should avoid taking ibuprofen at the same time as 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-adrenergic 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, among others, in the treatment of manic states and recurrent depression) and methotrexate (a medicine used, among others, in the treatment of certain cancers and rheumatoid arthritis),
• cyclosporin,
• mifepristone,
• tacrolimus,
• zydovudine (an antiviral medicine),
• quinolone antibiotics,
• corticosteroids.

Also, some other medicines may be affected or have an effect on treatment with Nurofen Forte.
Therefore, before taking Nurofen Forte with other medicines, you should always consult your doctor or pharmacist.

Pregnancy, breastfeeding and fertility

Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
You should not take Nurofen Forte in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Taking Nurofen Forte may cause kidney and heart problems in the unborn baby. It may also affect the mother's and baby's tendency to bleed and may prolong or prolong labor. You should not take Nurofen Forte during the first 6 months of pregnancy, unless it is clearly necessary and recommended by your doctor. If treatment is necessary during this period or when trying to conceive, you should use the smallest dose for the shortest possible time.
Taking Nurofen Forte for a period longer than a few days after the start of the 20th week of pregnancy may cause kidney problems in the unborn baby 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. If necessary, the doctor may recommend additional check-ups.
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 in recommended doses. Before taking any medicine, you should consult your doctor.
Fertility
See "Warnings and precautions".

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 sucrose and sodium

Sucrose

If you have been diagnosed with intolerance to some sugars, you should consult your 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 your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
You should use the smallest effective dose for the shortest duration necessary to relieve symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, you should consult your doctor immediately (see section 2).
The medicine should be taken orally, for a short period.
Adults and adolescents over 12 years old:1 tablet every 4 hours. Tablets should be taken with a liquid.
Do not take more than 3 tablets (1200 mg of ibuprofen) in 24 hours.
In case of liver or kidney failure, the doctor will determine the individual dosage.
The medicine is not indicated for children under 12 years old.
Elderly:dose modification is not necessary.
You should not take a higher dose of the medicine than recommended.
You should consult your 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 Forte than recommended

Overdose cases are rare, but if you have taken a higher dose of Nurofen Forte than recommended or if a child has accidentally taken the medicine, you should always consult your doctor or go to the nearest hospital to get an opinion on the possible risk to your health and advice on what to do in such a case. Symptoms may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation and nystagmus. The following may also occur: abdominal pain or, less frequently, diarrhea, gastrointestinal bleeding, or stomach or intestinal ulcers. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, feeling cold and breathing problems, metabolic acidosis (excess of acids in the blood), and the prothrombin time/INR may be increased, acute kidney failure or liver damage. In patients with asthma, worsening of asthma symptoms may occur. Very rarely, excitement and disorientation or coma and convulsions may also 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. The doctor 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

You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine 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:
Very common: occur in more than 1 in 10 treated patients.
Common: occur in less than 1 in 10 but more than 1 in 100 patients.
Uncommon: occur in less than 1 in 100 but more than 1 in 1000 patients.
Rare: occur in less than 1 in 1000 but more than 1 in 10,000 patients.
Very rare: occur in less than 1 in 10,000 patients and in individual cases.
Unknown: frequency cannot be estimated from the available data.

Uncommon:

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

Rare:

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

Very rare:

• 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 long-term use, leading to an increase in 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 hematological disorder characterized by a deficiency of all normal morphological elements of blood: red blood cells, white blood cells and platelets). The first symptoms include: fever, sore throat, superficial oral ulceration, flu-like symptoms, severe fatigue, unexplained bleeding and bruising (e.g. ecchymoses, 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, blood pressure drop (anaphylaxis, angioedema or severe shock)
• heart failure and edema
• hypertension
• decreased hemoglobin levels

Unknown:

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

If you experience any of the following symptoms, you should stop taking ibuprofen immediately 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 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, during treatment with the medicine, other side effects may occur. If you notice any of the above symptoms, as well as any other symptoms not listed in this leaflet, you should stop taking the medicine and consult your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information 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.
Do not use Nurofen Forte after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 coated tablet contains 400 mg of ibuprofen
• The excipients are: tablet core: sodium carmellose, sodium lauryl sulfate, sodium citrate, stearic acid, anhydrous colloidal silica (Aerosil 200); sugar coating: sodium carmellose, talc, arabic gum, sucrose, titanium dioxide, macrogol 6000; printing ink: shellac, iron oxide red (E 172), propylene glycol (E 1520), ammonium hydroxide (E 527), simethicone.

What Nurofen Forte looks like and what the packaging contains

White, round, biconvex tablets with markings. Tablets are available in packs of 12, 24 or 48 coated tablets.
For more detailed information, you should contact the marketing authorization holder or the 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in France, the country of export:34009 301 861 4 5

Parallel import authorization number: 375/24

Date of leaflet approval: 25.10.2024

[Information about the trademark]