Nurofen

Package leaflet: Information for the user

Nurofen, 200 mg, coated tablets
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because 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 doctor 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 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.

Contents of the leaflet

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

1. What Nurofen is and what it is used for

Ibuprofen belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs), which have the ability to relieve pain, inflammation, and fever.
Nurofen is indicated for the following conditions:

• mild to moderate pain of various origins (headaches, including tension headache and migraine, toothache, neuralgia, muscular, joint and bone pain, pain associated with influenza and colds);
• fever of various causes (e.g. associated with influenza, colds or other infectious diseases);
• painful menstruation.

This medicine is intended for short-term use.

2. Important information before using Nurofen

When not to use Nurofen
Nurofen should 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);
• 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 ulcer or duodenal ulcer disease or gastrointestinal bleeding (two or more confirmed episodes of ulceration or bleeding);
• with a history of gastrointestinal perforation or bleeding associated with previous NSAID therapy;
• with severe hepatic insufficiency, severe renal insufficiency, or severe heart failure;
• during the last 3 months of pregnancy;
• with haemorrhagic diathesis.

Warnings and precautions – when to exercise special caution when using Nurofen
Important information before taking Nurofen:
Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported.
If any of these symptoms occur, Nurofen should be discontinued immediately and medical advice should be sought urgently from a doctor or emergency medical services.
Special caution is required when using Nurofen:

Serious skin reactions, including 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 should be discontinued immediately and medical help should be sought.

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

• systemic lupus erythematosus or mixed connective tissue disease;
• gastrointestinal disorders (e.g. ulcerative colitis, Crohn’s disease);
• hypertension and/or cardiac dysfunction;
• renal impairment;
• hepatic impairment;
• coagulation disorders;
• active or past asthma or allergic reactions; bronchospasm may occur after taking the medicine;
• diseases requiring concomitant medication (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids);
• infection – see below under the section titled "Infections".

Use of Nurofen is not recommended in chickenpox.
Concomitant use of Nurofen with other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, should be avoided.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and may occur without warning symptoms. These events may also occur in patients who have experienced warning signs. If gastrointestinal bleeding or ulceration occurs, Nurofen should be discontinued immediately. Patients with gastrointestinal disorders, especially elderly patients, should report any unusual gastrointestinal symptoms (particularly bleeding) to their doctor, especially during the initial treatment period.
Long-term, concomitant use of different analgesics may lead to kidney damage with risk of renal failure (analgesic nephropathy).
Use of anti-inflammatory and 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.
Before using Nurofen, patients should discuss treatment with a doctor or pharmacist if:

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

Infections
Nurofen may mask symptoms of infection such as fever and pain. Therefore, Nurofen 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 chickenpox. If a patient takes this medicine during an infection and symptoms persist or worsen, immediate medical advice should be sought.
Serious, sometimes fatal, skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been rarely reported with NSAIDs. The highest risk of these severe reactions occurs early in treatment, mostly within the first month of use.
NSAIDs may adversely affect fertility in women. This effect is reversible and resolves upon discontinuation of treatment.
Patients should consult a doctor even if the above warnings relate to conditions that occurred in the past.

Children and adolescents
Do not give Nurofen to children weighing less than 20 kg.
Dehydrated children and adolescents are at risk of renal impairment.

Use in elderly patients
Elderly patients are more susceptible to adverse effects than younger patients.

Nurofen and other medicines
Concomitant use of Nurofen with acetylsalicylic acid should be avoided unless a doctor has specifically recommended low-dose aspirin (not more than 75 mg daily), and with other NSAIDs, including selective COX-2 inhibitors. The simultaneous use of two or more NSAIDs should be avoided due to the potential for increased risk of adverse effects.
Inform your doctor about all medicines currently or recently taken, including those obtained without a prescription, and any medicines planned for future use.
Nurofen may affect the action of other medicines, or other medicines may affect the action of Nurofen. For example:

• anticoagulants (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, angiotensin II receptor antagonists such as losartan);
• antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs);
• cardiac glycosides;
• lithium and methotrexate;
• cyclosporine;
• mifepristone;
• tacrolimus;
• zidovudine;
• quinolone antibiotics; corticosteroids.

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

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not take Nurofen during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Use of Nurofen may cause renal and cardiac dysfunction in the unborn child. It may also affect bleeding tendency in both mother and child and may delay or prolong labour.
Nurofen should not be used during the first 6 months of pregnancy unless clearly necessary and recommended 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.
Use of Nurofen for longer than a few days beyond week 20 of pregnancy may cause impaired renal function 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.

Breastfeeding
Ibuprofen may pass into breast milk in small amounts. No adverse effects have been reported in breastfed infants; therefore, breastfeeding need not be discontinued during short-term use of Nurofen at recommended doses.

Effect on fertility
See section "Warnings and precautions".

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

Nurofen contains sucrose and sodium

Sucrose
If the patient has been previously diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered essentially "sodium-free".

3. How to take Nurofen

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
For use in adults and children over 6 years of age (with body weight above 20 kg).
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).
If in doubt, contact your doctor again. The usual dosage is as follows:
Children:
The optimal dosage is between 7–10 mg/kg body weight, given 3 to 4 times daily, corresponding to a total daily dose of 20–30 mg/kg body weight. It is recommended not to exceed a daily dose of 30 mg/kg body weight when treating pain and fever.
Children aged 6 to 9 years (body weight 20 to 30 kg): 1 tablet of 200 mg.
If needed, 1 tablet every 6 hours.
Do not exceed 3 tablets per day (600 mg).
Children aged 9 to 12 years (body weight 30 to 40 kg): 1 tablet of 200 mg.
If needed, 1 tablet every 4 to 6 hours.
Do not exceed 4 tablets per day (800 mg).
In children, consult a doctor if the medicine needs to be used for more than 3 days or if symptoms worsen.
Adults and adolescents over 12 years of age (body weight above 40 kg):
Initial dose – 2 tablets, then if needed, 1 to 2 tablets every 4 to 6 hours. Tablets should be taken with water. Do not take more than 6 tablets (1200 mg of ibuprofen) in 24 hours. Maintain at least a 4-hour interval between doses.
Elderly patients: dose adjustment is not necessary.
This medicine should not be used in patients with body weight below 20 kg.
In patients with gastrointestinal disorders, it is recommended to take the medicine during meals.
This medicine is intended for oral use only and for short-term treatment.
In adolescents and adults, consult a doctor if the medicine needs to be used for more than 3 days or if symptoms worsen.
Taking more than the recommended dose of Nurofen
If a patient takes more than the recommended dose of Nurofen or if a child accidentally ingests the medicine, always contact a doctor or go to the nearest hospital to assess possible health risks and receive advice on appropriate actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, confusion, and nystagmus. After large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties may occur. Upper abdominal pain or, less commonly, diarrhoea, tinnitus, gastrointestinal bleeding, agitation, coma, prolonged blood clotting time (so-called prothrombin time/INR), probably due to interference with circulating clotting factors, acute kidney failure, or liver damage may also occur. In patients with asthma, symptoms may worsen. Additionally, low blood pressure and slowed breathing may occur.
Treatment of overdose: 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 heart function and vital signs as long as they remain 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. In patients with asthma, the doctor will administer bronchodilators.
Missed dose of Nurofen
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The adverse effects listed below have been observed during short-term use of ibuprofen at over-the-counter doses.
When ibuprofen is used for other indications and for prolonged periods, additional adverse effects may occur.
Adverse effects are listed below according to their frequency of occurrence using the following terms:

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

• Dyspepsia, abdominal pain, nausea
• Headache
• Various types of skin rash
• Urticaria and itching

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

• Diarrhea, flatulence, constipation, vomiting, gastritis
• Dizziness
• Psychotic disorders, depression, insomnia, restlessness
• Tinnitus
• Irritability, fatigue

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

• Gastrointestinal ulcers, perforation or bleeding of the gastrointestinal tract, tarry stools, vomiting blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease
• Aseptic meningitis
• Acute renal failure, renal papillary necrosis, particularly after prolonged use, leading to increased serum urea levels and edema, hypernatremia (sodium retention), decreased urine output
• Liver function disorders
• Blood count abnormalities (anemia, leukopenia - reduced number of white blood cells, thrombocytopenia - reduced number of platelets, pancytopenia - hematological disorder characterized by deficiency of all normal blood cells: red, white and platelets, agranulocytosis - absence of granulocytes, a type of white blood cell). Initial symptoms include fever, sore throat, superficial ulceration of the oral mucosa, influenza-like symptoms, severe fatigue, unexplained bleeding and bruising (e.g. petechiae, purpura, epistaxis)
• 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 (rapid heartbeat), hypotension (anaphylaxis, angioedema or severe shock)
• Heart failure and edema
• Hypertension
• Decreased hemoglobin levels
• Serious skin and soft tissue infections during varicella (chickenpox). Exacerbation of inflammatory conditions associated with infection (e.g. necrotizing fasciitis) has been reported during treatment with certain analgesic drugs (NSAIDs).

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

• Respiratory hypersensitivity reactions, e.g. asthma, worsening of asthma, bronchospasm, dyspnea
• 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 skin lesions, often with blisters in the center, skin peeling, oral, throat, nasal, genital or ocular mucosal ulcers. These severe skin reactions may be preceded by fever and influenza-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 generalized exanthematous pustulosis).
• Chest pain, which may indicate a potentially serious allergic reaction known as Kounis syndrome.

Other adverse effects not listed above may occur in individual patients during treatment with this medicine. If any of the above effects, or any other effects not listed in this leaflet, are observed, the medicine should be discontinued and medical advice should be sought.

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Nurofen

Do not store above 25°C. Store in the original packaging.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Nurofen contains

• The active substance is ibuprofen – one coated tablet contains 200 mg of ibuprofen.
• The other components are:
  Tablet core: sodium croscarmellose, sodium lauryl sulfate, sodium citrate, stearic acid, anhydrous colloidal silicon dioxide;
  Sugar coating: sodium carmellose, talc, spray-dried gum arabic, sucrose, titanium dioxide (E 171), macrogol 6000;
  Printing ink: Opacode S-1-277001 (shellac, iron oxide black (E 172), propylene glycol).

What Nurofen looks like and contents of the pack
White, round, biconvex coated tablets with imprint. Tablets are available in packs containing
2, 4, 6, 8, 10, 12, 24, 36 or 48 coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer

Marketing Authorisation Holder
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Poland

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

For further information about this medicinal product, please contact the Marketing Authorisation Holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
tel: (22) 211 26 92