Nurofen forte

Package leaflet: Information for the user

Warning! Keep the leaflet; the information on the immediate packaging is in a foreign language!
Nurofen Forte (Nureflex)
400 mg, enteric-coated tablets
Ibuprofen
Nurofen Forte and Nureflex are different brand names of the same medicine.
Please read carefully all the information in this leaflet before taking 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 a
physician or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 enteric-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. following tooth extraction, neuralgia, muscle and joint pain, painful menstruation;
• Fever associated with influenza and the common cold.

This medicine is intended for short-term use. Your doctor may prescribe this medicine for other conditions not mentioned 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 ingredients of this medicine (listed in section 6), or to other non-steroidal anti-inflammatory drugs (NSAIDs),
• in whom aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) have previously caused allergic-type reactions (e.g. urticaria, rhinitis, angioedema or bronchial asthma),
• with active or a history of peptic ulceration or bleeding of the stomach and/or duodenum, or with two or more documented episodes of peptic ulceration or bleeding,
• with a history of gastrointestinal perforation or bleeding associated with previous NSAID therapy (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-type reactions to ibuprofen, including difficulty in 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 urgently from a doctor or emergency medical services.

Particular caution is required when using Nurofen Forte:

Serious 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 serious 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 function disorders,
• hepatic function disorders,
• coagulation disorders (ibuprofen may prolong bleeding time),
• active or previous asthma or allergic-type symptoms; bronchospasm may occur after taking the medicine,
• conditions requiring concomitant use of other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids),
• infection – see below, section titled "Infections".

Concomitant use of Nurofen Forte with NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
In dehydrated adolescents, there is a risk of impaired renal function.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and may occur without warning symptoms or in patients with a history of such 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 a risk of renal failure (analgesic nephropathy).
The 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 should not be exceeded.
If symptoms persist, worsen, or do not resolve within 3 days, or if new symptoms occur, medical advice should be sought.
Before using Nurofen Forte, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina (chest pain), a history of heart attack, coronary artery bypass surgery, 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 hypertension, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

Infections
Nurofen Forte may mask signs 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 ongoing infection and symptoms of infection persist or worsen, immediate medical advice must be sought.

This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) which may adversely affect fertility in women. This effect is reversible and resolves upon discontinuation of treatment.

Nurofen Forte and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines planned for future use, 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);
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan).

Ibuprofen should be used cautiously 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 neoplastic diseases and rheumatoid arthritis),
• cyclosporine,
• mifepristone,
• tacrolimus,
• zidovudine (an antiviral medicine),
• quinolone antibiotics,
• corticosteroids.

Some 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
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
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 the 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 advised by a doctor. If treatment is necessary during this period or when trying to conceive, the lowest effective dose should be used for the shortest possible duration.
Prolonged use of Nurofen Forte beyond a few days after the 20th week of pregnancy may cause renal dysfunction in the unborn child, leading to reduced amniotic fluid levels (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If prolonged treatment is required, the doctor may recommend additional monitoring tests.

Breastfeeding
Ibuprofen may pass into breast milk in small amounts. No adverse effects in breastfed infants have been reported; therefore, breastfeeding need not be discontinued 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) per tablet. This corresponds to 1.37% of the maximum daily recommended dietary sodium intake 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 symptoms of infection (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 aged over 12 years: 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 intended for children under 12 years of age.
Elderly patients: dose adjustment is not necessary.
Do not exceed the recommended dose.
Consult a doctor if treatment with this medicine is required for more than 3 days or if symptoms worsen.
Overdose of Nurofen Forte
Overdose cases are rare, but 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 for assessment of potential health risks and advice on necessary actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, confusion and nystagmus. Other symptoms may include epigastric pain or, less commonly, diarrhoea, gastrointestinal bleeding. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness and dizziness, blood in urine, low blood potassium levels, feeling cold and breathing difficulties may occur. Metabolic acidosis (excess acid in the blood) may develop. The blood clotting time (so-called prothrombin time/INR) may be prolonged, probably due to impaired function of circulating coagulation factors. Acute renal failure or liver damage may also occur. In patients with asthma, worsening of asthma symptoms may occur. Additionally, low blood pressure and slowed breathing may occur. Very rarely, agitation, disorientation or coma, and convulsions may also 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, 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 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The side effects listed below have been observed during short-term use of ibuprofen at over-the-counter doses.
Other side effects may occur when ibuprofen is used for other indications or for prolonged periods.
Side effects are listed according to frequency using the following terms:

Not common: occur in less than 1 in 100 but more than 1 in 1000 patients.

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

Rare: occur in less than 1 in 1000 but more than 1 in 10,000 patients.

• diarrhoea, flatulence, constipation, vomiting, inflammation of the stomach lining
• dizziness
• psychotic disorders, depression, insomnia, restlessness
• tinnitus
• irritability, fatigue.

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

• gastrointestinal ulcers, perforation or bleeding from the gastrointestinal tract, tarry stools, vomiting blood (sometimes fatal, especially in elderly people), oral ulcerative mucosal inflammation, exacerbation of colitis and Crohn's disease
• aseptic meningitis
• acute renal failure, renal papillary necrosis, particularly 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 characterised by deficiency of all normal blood cells: red blood cells, white blood cells and platelets, agranulocytosis – absence of a certain type of white blood cells called granulocytes). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, unexplained bleeding and bruising (e.g. petechiae, purpura 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, tongue or laryngeal swelling, difficulty breathing, tachycardia, hypotension (anaphylaxis, angioedema or severe shock)
• heart failure and oedema
• hypertension
• decreased haemoglobin concentration.

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

• respiratory hyper-reactivity, 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 sought:

• red, flat, target-like or circular spots on the trunk, often with blisters in the centre, skin peeling, mouth, throat, nose, genital or eye ulcers. 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 swollen lymph nodes (DRESS syndrome);
• red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, trunk and upper limbs, accompanied by fever 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.

Other side effects may occur in some individuals 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 consulted.

Reporting of side effects
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Side effects can also 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 side effects helps provide more information on the safety of the medicine.

5. How to store Nurofen Forte
Do not store above 30°C.
Keep the medicine 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 should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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, anhydrous colloidal silicon dioxide (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 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, 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
The Netherlands
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in France, the country of export: 34009 301 861 4 5
Parallel import authorisation number: 202/25