Nurofen forte

Patient Information Leaflet

Warning! Keep this leaflet! Information on the outer packaging in a foreign language.
Nurofen Forte (Nureflex), 400 mg, coated tablets
Ibuprofenum
Nurofen Forte and Nureflex are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Table of Contents

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

One coated tablet of Nurofen Forte contains 400 mg of ibuprofen, which belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs). The medicine relieves symptoms such as fever, pain, and swelling by acting at the site where these symptoms originate.
This medicine is intended for use in the following conditions:

• Mild to moderate pain of various origins: headaches, e.g. migraine, lower back pain, toothache, e.g. after tooth extraction, neuralgia, muscle and joint pain, painful menstruation.
• Fever associated with influenza and colds.

This medicine is intended for short-term use. Your doctor may prescribe this medicine for other conditions not listed above (including certain chronic diseases). In such cases, follow your doctor's instructions regarding dosage and duration of treatment.

2. Important information before using Nurofen Forte

When not to use Nurofen Forte
Nurofen Forte must not be used in patients:

• who are hypersensitive to ibuprofen or any of the other components of this medicine (listed in section 6), or to other non-steroidal anti-inflammatory drugs (NSAIDs),
• who have previously experienced hypersensitivity reactions (e.g. urticaria, rhinitis, angioedema, or bronchial asthma) after taking acetylsalicylic acid or other NSAIDs,
• with active or a history of peptic ulceration or bleeding of the stomach and/or duodenum (two or more distinct episodes of confirmed ulceration or bleeding),
• with a history of gastrointestinal perforation or bleeding associated with previous NSAID treatment (see section "Warnings and precautions"),
• with severe hepatic insufficiency, severe renal insufficiency, or severe heart failure (see section "Warnings and precautions"),
• during the last three months of pregnancy (see section "Pregnancy, breastfeeding and fertility"),
• with bleeding disorders.

Warnings and precautions – when to exercise particular caution when using Nurofen Forte
Important information before taking Nurofen Forte:
Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported during treatment.
If any of these symptoms occur, Nurofen Forte must be discontinued immediately and medical advice must be sought without delay.
Particular caution is required when using Nurofen Forte:
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 any of the symptoms associated with severe skin reactions described in section 4 occur, Nurofen Forte must be discontinued immediately and medical help must be sought.

Before starting treatment with Nurofen Forte, consult a doctor if the patient has previously been diagnosed with:

• systemic lupus erythematosus or mixed connective tissue disease,
• gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• hypertension and/or cardiac dysfunction,
• renal impairment,
• hepatic impairment,
• coagulation disorders (ibuprofen may prolong bleeding time),
• active or past history of bronchial asthma or allergic reactions; bronchospasm may occur after taking the medicine,
• conditions requiring concomitant use of other medications (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids),
• infection – see below under the section titled "Infections".

Concomitant use of Nurofen Forte with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
In dehydrated patients, there is a risk of renal impairment.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and may occur without warning symptoms or in patients with prior warning symptoms. If gastrointestinal bleeding or ulceration occurs, the drug must be discontinued immediately. Patients with a history of gastrointestinal disorders, particularly the elderly, should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial phase of treatment.
Prolonged, concomitant use of various analgesics may lead to kidney damage with risk of renal failure (analgesic nephropathy).
Use of anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, particularly when used at high doses. The recommended dose and duration of treatment must not be exceeded.
If symptoms persist, worsen, or do not resolve within 3 days, or if new symptoms occur, medical advice must be sought.
Before using Nurofen Forte, the patient should discuss treatment with a doctor or pharmacist if:

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

Infections
Nurofen Forte may mask symptoms of infection such as fever and pain. Therefore, Nurofen Forte may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with varicella (chickenpox). If this medicine is taken during an existing infection and symptoms persist or worsen, immediate medical advice must be sought.
This medicine belongs to a group of drugs (non-steroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is reversible and resolves after discontinuation of treatment.

Nurofen Forte and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Concomitant use of ibuprofen with the following medicines should be avoided:

• 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/preventing clot formation, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine);
• antihypertensive medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, 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 certain cancers and rheumatoid arthritis),
• cyclosporine,
• mifepristone,
• tacrolimus,
• zidovudine (an antiviral medicine),
• quinolone antibiotics,
• corticosteroids.

Other medicines may also interact with or be affected by treatment with Nurofen Forte.
Therefore, always consult a doctor or pharmacist before using Nurofen Forte with other medicines.

Pregnancy, breastfeeding and fertility
Pregnancy
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Do not take Nurofen Forte during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Use of Nurofen Forte may cause renal and cardiac dysfunction in the unborn child. It may also affect bleeding tendency in both the mother and the child and may delay or prolong labour. Nurofen Forte should not be taken during the first 6 months of pregnancy unless clearly necessary and recommended by a doctor. If treatment is required during this period or when trying to conceive, the lowest effective dose should be used for the shortest possible duration.
Use of Nurofen Forte for longer than a few days beyond week 20 of pregnancy may cause renal dysfunction in the unborn child and lead to reduced amniotic fluid levels surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If prolonged treatment is required, the doctor may recommend additional monitoring tests.

Breastfeeding
Ibuprofen may pass into breast milk in small amounts. There are no known cases of adverse effects in breastfed infants; therefore, breastfeeding need not be interrupted during short-term use at recommended doses. However, medical advice should be sought before taking any medicine.

Fertility
See section "Warnings and precautions".

Driving and operating machinery
Nurofen Forte is not expected to affect the ability to drive or operate machinery when used at recommended doses and for the recommended duration of treatment.

Nurofen Forte contains sucrose and sodium
Sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.

Sodium
Nurofen Forte contains 27.42 mg of sodium (the main component of table salt) in each tablet. This corresponds to 1.37% of the maximum recommended daily dietary intake of sodium for adults. This should be taken into account in patients whose total sodium intake must be significantly restricted.

3. How to use Nurofen Forte

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If, during an infection, its symptoms (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
This medicine is for oral use and short-term treatment only.
Adults and adolescents over 12 years of age: 1 tablet every 4 hours. Tablets should be taken with liquid.
Do not exceed 3 tablets (1200 mg of ibuprofen) in 24 hours.
In cases of hepatic or renal impairment, the doctor will determine an individual dosage.
This medicine is not recommended for children under 12 years of age.
Elderly patients: dose adjustment is not required.
Do not exceed the recommended dose.
Consult a doctor if treatment is required for longer than 3 days or if symptoms worsen.
Overdose of Nurofen Forte
Overdose cases are rare; however, if a patient has taken more than the recommended dose of Nurofen Forte or if a child has accidentally ingested the medicine, always contact a doctor or go to the nearest hospital to assess potential health risks and receive advice on necessary actions. Symptoms may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, confusion, and nystagmus. Other possible symptoms include epigastric pain or, less frequently, diarrhoea, gastrointestinal bleeding, somnolence, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, cold sensation, and breathing difficulties. Metabolic acidosis (excess acid in the blood) may occur, and the blood coagulation time /INR may be prolonged. Acute renal failure or liver damage may also occur. In patients with asthma, worsening of asthma symptoms may occur. Very rarely, agitation, confusion, coma, or convulsions may occur.
There is no specific antidote. Treatment is symptomatic and supportive, aimed at maintaining vital functions until the drug is eliminated from the body. The doctor will monitor cardiac function and vital signs, provided they are stable. Administration of activated charcoal by mouth may be considered within 1 hour of overdose. In case of frequent or prolonged seizures, the doctor may administer intravenous diazepam or lorazepam. Patients with asthma will be given bronchodilators by the doctor.
Missed dose of Nurofen Forte
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The adverse effects listed below have been observed during short-term use of ibuprofen at doses available without a prescription. Other adverse effects may occur when ibuprofen is used for other indications or for prolonged periods.
Adverse effects are listed according to frequency using the following categories:
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 1,000 patients.
Rare: occur in less than 1 in 1,000, but more than 1 in 10,000 patients.
Very rare: occur in less than 1 in 10,000 patients and in single cases.
Not known: frequency cannot be estimated from the available data.

Uncommon:

• abdominal pain, nausea and indigestion
• headache
• various types of skin rashes
• urticaria and itching

Rare:

• diarrhoea, flatulence, constipation, vomiting, gastritis
• dizziness
• psychotic disorders, depression, insomnia, restlessness
• tinnitus
• irritability, fatigue

Very rare:

• gastrointestinal ulcers, perforation or bleeding from the gastrointestinal tract, tarry stools, vomiting blood (sometimes fatal, especially in elderly patients), ulcerative stomatitis, exacerbation of colitis and Crohn's disease
• aseptic meningitis
• acute renal failure, renal papillary necrosis (especially with long-term use), leading to increased blood urea levels and oedema, hypernatraemia (sodium retention), reduced urine output
• liver function disorders
• blood count abnormalities (anaemia, leukopenia - reduced number of white blood cells, thrombocytopenia - reduced number of platelets, pancytopenia - a haematological disorder involving deficiency of all normal blood cells: red blood cells, white blood cells and platelets, agranulocytosis - absence of certain white blood cells called granulocytes). Initial symptoms may include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, unexplained bleeding and bruising (e.g. petechiae, purpura, 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, tongue or laryngeal swelling, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe shock)
• heart failure and oedema
• hypertension
• decreased haemoglobin concentration

Frequency not known:

• hyper-reactivity of the airways, e.g. asthma, worsening of asthma, bronchospasm, dyspnoea
• skin becomes sensitive to light.

If any of the following symptoms occur in a patient, ibuprofen should be discontinued immediately and medical help should be sought:

• red, flat, target-like or circular spots on the trunk, often with blisters in the centre, skin peeling, ulcers in the mouth, throat, nose, genital organs and eyes. These severe skin reactions 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 subcutaneous nodules and blisters, mainly located in skin folds, on the trunk and upper limbs, accompanied by fever occurring at the beginning of treatment (acute generalised exanthematous pustulosis).
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

In some individuals, other adverse effects may occur during treatment. If any of the above symptoms or other symptoms not listed in this leaflet are observed, the medicine should be discontinued and a doctor should be consulted.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Nurofen Forte

Do not store above 30°C.
Keep the medicine in a place 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Nurofen Forte contains

• The active substance is ibuprofen – one coated tablet contains 400 mg of ibuprofen.
• Excipients:
  Tablet core: sodium croscarmellose, sodium lauryl sulfate, sodium citrate, stearic acid, colloidal anhydrous silica (Aérosil 200);
  Sugar coating: sodium carmellose, talc, gum arabic, sucrose, titanium dioxide, macrogol 6000;
  Printing ink: shellac, iron oxide red (E 172), propylene glycol (E 1520), ammonium hydroxide (E 527), simeticone.

What Nurofen Forte looks like and contents of the pack
White, round, biconvex coated tablets with imprint. Tablets are available in packs of
12, 24 or 48 coated tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in France, 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
The Netherlands
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged at:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in France, country of export: 34009 301 861 4 5
Parallel Import Licence Number: 375/24