Nurofen

Leaflet accompanying the packaging: information for the user

Nurofen, 200 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.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those 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 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 packaging 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) that have the ability to alleviate symptoms such as pain, swelling, and fever.

Nurofen is intended for use in the following cases:

• pain of various origins of mild to moderate severity (headaches, including tension headaches and migraines, toothaches, neuralgia, muscle, joint, and bone pain, pain accompanying flu and colds);
• fever of various origins (including in the course of flu, colds, or other infectious diseases);
• painful menstruation.

The medicine is intended for short-term use.

2. Important information before taking Nurofen

When not to take Nurofen

Nurofen 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 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 peptic ulcer or gastrointestinal bleeding (two or more distinct episodes of confirmed ulceration or bleeding);
• with a history of gastrointestinal perforation or bleeding associated with previous NSAID treatment;
• with severe liver, kidney, or heart failure;
• during the last 3 months of pregnancy;
• with hemophilia.

Warnings and precautions – when to exercise special caution when taking Nurofen

Important information before taking Nurofen:

During treatment with ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling in the face and neck (angioedema), and chest pain.

If any of these symptoms are noticed, Nurofen should be discontinued immediately and medical help should be sought.

When taking Nurofen, special caution should be exercised:

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), as well as acute generalized exanthematous pustulosis (AGEP), have been reported with the use of NSAIDs.

If the patient experiences any symptoms associated with severe skin reactions described in section 4, Nurofen should be discontinued immediately and medical help should be sought.

Before starting treatment with Nurofen, the patient should discuss with their doctor if they have:

• systemic lupus erythematosus and mixed connective tissue disease;
• a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease);
• hypertension and/or heart failure;
• kidney function disorders;
• liver function disorders;
• blood coagulation disorders;
• active or history of bronchial asthma or allergic reactions in the past; taking the medicine may cause bronchospasm;
• diseases for which the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids);
• infection – see below, section titled "Infections".

In the case of chickenpox, it is recommended to avoid taking the medicine.

Nurofen should not be taken at the same time as acetylsalicylic acid, unless the doctor recommends taking low doses (no more than 75 mg per day), or with other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors.

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and may not be preceded by warning signs; they can also occur in patients who have had warning signs.

If gastrointestinal bleeding or ulceration occurs, the medicine should be discontinued immediately.

Patients with gastrointestinal diseases, especially the elderly, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, 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 and 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.

Do not exceed the recommended dose and duration of treatment.

Before taking Nurofen, the patient should discuss their treatment with a doctor or pharmacist if:

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

Infections

Nurofen may mask the symptoms of infection, such as fever and pain.

Therefore, Nurofen 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 associated with 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.

With the use of NSAIDs, rare but serious skin reactions have been reported, some of which are fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

The greatest risk of these serious skin reactions occurs at the beginning of treatment, in most cases within the first month of taking the medicine.

Medicines in this class (non-steroidal anti-inflammatory drugs) may adversely affect fertility in women.

This effect is transient and reverses after stopping treatment.

The patient should discuss this with their doctor, even if the above warnings refer to past situations.

Children and adolescents

Do not give the medicine to children with a body weight below 20 kg.

In dehydrated children and adolescents, there is a risk of kidney function disorders.

Use in the elderly

The elderly are more prone to side effects than younger people.

Nurofen and other medicines

Nurofen should not be taken at the same time as acetylsalicylic acid, unless the doctor recommends taking low doses (no more than 75 mg per day), or with other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors.

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.

Nurofen may affect the action of other medicines or other medicines may affect the action of Nurofen.

For example:

• anticoagulant medicines (i.e., blood thinners/preventing blood clots, such as aspirin (acetylsalicylic acid), warfarin, ticlopidine);
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
• antiplatelet and selective serotonin reuptake inhibitors (SSRIs);
• cardiac glycosides;
• lithium and methotrexate;
• cyclosporine;
• mifepristone;
• tacrolimus;
• zydovudine;
• quinolone antibiotics; corticosteroids.

Other medicines may also be affected or have an effect on treatment with Nurofen.

Therefore, before taking Nurofen 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 child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Nurofen should not be taken during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery.

Taking Nurofen 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 prolong or prolong labor.

Nurofen 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 for more 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.

In case of necessity for longer treatment, the doctor may recommend additional check-ups.

Breastfeeding

Ibuprofen may pass into breast milk in small amounts.

No cases of side effects have been reported in breastfed infants, so there is no need to stop breastfeeding during short-term use of the medicine in recommended doses.

Fertility

See section "Warnings and precautions".

Driving and using machines

No effect on the ability to drive and use machines is expected after taking the recommended dose and duration of treatment.

Nurofen 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

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered sodium-free.

3. How to take Nurofen

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.

For use in adults and children over 6 years old (with a body weight over 20 kg).

The smallest effective dose should be used for the shortest possible time to alleviate symptoms.

If the symptoms of the infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).

In case of doubt, the patient should consult their doctor again.

Usually, the following dosing is used:

Children:

The optimal dose is between 7-10 mg/kg of body weight, 3-4 times a day, which corresponds to a daily dose of 20-30 mg/kg of body weight.

It is recommended not to exceed a dose of 30 mg/kg of body weight per day for the treatment of pain and fever.

Children aged 6-9 years (with a body weight of 20-30 kg): 1 tablet of 200 mg.

If necessary, 1 tablet every 6 hours.

Do not exceed a dose of 3 tablets per day (600 mg).

Children aged 9-12 years (with a body weight of 30-40 kg): 1 tablet of 200 mg.

If necessary, 1 tablet every 4-6 hours.

Do not exceed a dose of 4 tablets per day (800 mg).

In the case of children, the patient should consult their doctor if the medicine needs to be given for more than 3 days or if the symptoms worsen.

Adults and adolescents over 12 years old (with a body weight over 40 kg):
The initial dose is 2 tablets, then if necessary, 1-2 tablets every 4-6 hours.

Tablets should be taken with water.

Do not take more than 6 tablets (1200 mg of ibuprofen) in 24 hours.

A 4-hour interval should be maintained between doses.

Elderly:no dose modification is necessary.

The medicine should not be taken by patients with a body weight below 20 kg.

In patients with gastrointestinal diseases, it is recommended to take the medicine during meals.

The medicine is intended for oral use only and for short-term use.

In the case of adolescents and adults, the patient should consult their doctor if the medicine needs to be given for more than 3 days or if the symptoms worsen.

Overdose of Nurofen

If the patient has taken a larger dose of Nurofen 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.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and nystagmus.

After taking large 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 may occur.

Abdominal pain or, less frequently, diarrhea, tinnitus, gastrointestinal bleeding, excitement, coma, prolonged bleeding time (prothrombin time/INR) probably due to impaired function of circulating clotting factors, acute kidney failure, or liver damage may also occur.

In patients with asthma, worsening of symptoms may occur.

Additionally, low blood pressure and slow breathing may occur.

Treatment of overdose: 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 vital signs, as long as they are stable.

The doctor will consider administering activated charcoal orally within 1 hour of overdose.

In the case of frequent or prolonged seizures, the doctor will administer diazepam or lorazepam intravenously.

In the case of patients with asthma, the doctor will administer bronchodilators.

Missed dose of Nurofen

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, Nurofen 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 ibuprofen is used for other indications and for a long time, 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 1,000 patients.

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

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

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

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

• peptic ulcers, perforation, or gastrointestinal bleeding, black stools, bloody vomiting, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease
• aseptic meningitis
• acute kidney failure, renal papillary necrosis, especially after prolonged 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 blood cells: red, white, and platelets, agranulocytosis - lack of a certain type of white blood cell - granulocytes).
• severe skin reactions, such as blistering reactions, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis
• severe hypersensitivity reactions.
• heart failure and edema
• hypertension
• decreased hemoglobin levels
• serious skin and soft tissue infections in the course of chickenpox.

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

• hypersensitivity reactions of the respiratory tract, 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 and seek medical help:

• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes.
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• red, peeling rash with nodules under the skin and blisters, usually located 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 serious allergic reaction called Kounis syndrome.

If the patient experiences any of the above symptoms, as well as any other symptoms not listed in this leaflet, they should stop taking the medicine and consult their doctor.

Reporting side effects

If side effects occur, including those 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

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel.: +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.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Nurofen

Do not store above 25°C.

Store in the original packaging.

Medicines should be kept out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after: EXP.

The expiry date refers to the last day of the month stated.

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 packaging and other information

What Nurofen contains

• The active substance of the medicine is ibuprofen - 1 coated tablet contains 200 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, 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 tablets with markings.

Tablets are available in packs of 2, 4, 6, 8, 10, 12, 24, 36, 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

tel: (22) 211 26 92

Date of last revision of the leaflet: