Nurofen Forte

Leaflet attached to the packaging: information for the user

Nurofen Forte, 400 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 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 pack 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 a group of non-steroidal 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, including migraines, back pain, toothaches, including 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:

• who are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6) and to other non-steroidal anti-inflammatory drugs (NSAIDs),
• who have ever had hypersensitivity reactions (e.g. hives, rhinitis, angioedema or bronchial asthma) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• with active or history of stomach and duodenal ulcers or bleeding (two or more confirmed episodes of ulceration or bleeding),
• with perforation or bleeding from the gastrointestinal tract in history, related to 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 hemorrhagic diathesis.

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

Important information before taking Nurofen Forte:
During the use of 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 noticing 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:
Due to the use of ibuprofen, severe skin reactions have occurred, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). 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 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 coagulation disorders (ibuprofen may prolong bleeding time),
• active or history of bronchial asthma or symptoms of allergic reactions in the past; 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".

Nurofen Forte should be avoided when taken simultaneously with NSAIDs, including selective cyclooxygenase-2 inhibitors.
In dehydrated adolescents, there is a 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 symptoms or may occur in patients who have had such warning symptoms. 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.
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. The recommended dose should not be exceeded and the duration of treatment should not be prolonged.
If symptoms persist, worsen or do not improve after 3 days, or if new symptoms occur, a doctor should be consulted.
Before taking Nurofen Forte, the patient should discuss 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 infection symptoms persist or worsen, they should consult their doctor immediately.
This medicine belongs to a group of medicines (non-steroidal 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

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as about medicines they plan to take, including those available without a prescription.
Nurofen Forte should be avoided when taken simultaneously 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-adrenergic blocking agents, 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 and depressive states) and methotrexate (a medicine used, among others, in some 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 Nurofen Forte treatment. 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. The use of Nurofen Forte may cause kidney and heart disorders in the unborn child. It may also affect the patient's and their child's tendency to bleed and may 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 during attempts to conceive, the smallest dose should be used 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 disorders in the unborn child and lead to a decreased level of amniotic fluid surrounding the child (oligohydramnios), or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If necessary, the doctor may recommend additional monitoring tests.
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, the patient should consult their 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 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 limit their total 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 smallest effective dose should be used for the shortest duration necessary to relieve symptoms. If the symptoms of an 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 administration of the medicine is necessary 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 a doctor or go to the nearest hospital to get an opinion on possible health risks 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. The following may also occur: abdominal pain or, less frequently, 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 blood coagulation period (so-called prothrombin time/INR) is likely to be increased due to the disruption of the action of circulating coagulation factors, or acute kidney failure or liver damage may occur. 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 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 by the doctor.

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, 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:

Uncommon: occurs in less than 1 in 100, but more than 1 in 1000 patients.

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

Rare: occurs in less than 1 in 1000, 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 long-term 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 hematological disorder characterized by a deficiency of all normal morphological elements of blood: red blood cells, white blood cells and platelets, agranulocytosis - lack of a certain type of white blood cells - granulocytes). 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

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 immediately and seek medical help:

• red, flat, 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 the use of the medicine, other side effects may occur. In case of observing the above symptoms, as well as others not listed in this leaflet, the medicine should be discontinued and a doctor should be consulted.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient 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
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 to gather more information on the safety of the medicine.

5. How to store Nurofen Forte

Do not store above 25°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 carton and on the blister after: EXP. The expiry date refers to the last day of the month.
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 pack 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; sugar coating: sodium carmellose, talc, spray-dried acacia gum, sucrose, titanium dioxide, Macrogol 6000; printing ink: Opacode S-1-15094 (shellac, iron oxide red (E 172), propylene glycol, simethicone).

What Nurofen Forte looks like and contents of the pack

White, round, biconvex tablets with engraving. The tablets are available in packs of 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: