Nurofen Miemshnie i Stavi Forte

Leaflet attached to the packaging: information for the user

Nurofen Muscles and Joints 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 advised by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• 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 Nurofen Muscles and Joints Forte is and what it is used for
• 2. Important information before taking Nurofen Muscles and Joints Forte
• 3. How to take Nurofen Muscles and Joints Forte
• 4. Possible side effects
• 5. How to store Nurofen Muscles and Joints Forte
• 6. Contents of the pack and other information

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

Nurofen Muscles and Joints Forte contains 400 mg of ibuprofen in the form of ibuprofen sodium dihydrate. Ibuprofen belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs) with analgesic, antipyretic, and anti-inflammatory properties. The medicine is intended for use in the following cases: Pain of various origins of mild and moderate intensity: back pain, neuralgia, muscle and joint pain.

• back pain,
• neuralgia,
• muscle and joint pain.

2. Important information before taking Nurofen Muscles and Joints Forte

When not to take Nurofen Muscles and Joints Forte

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6) and to other non-steroidal anti-inflammatory drugs;
• if the patient has ever had hypersensitivity reactions (e.g., hives, nasal congestion, angioedema, or bronchial asthma) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• in patients with active or recurrent peptic ulcer or bleeding (two or more confirmed episodes of ulceration or bleeding);
• in patients with a history of perforation or bleeding in the gastrointestinal tract associated with previous NSAID treatment;
• in patients with severe liver failure, severe kidney failure, or severe heart failure;
• if the patient is taking other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (increased risk of adverse effects);
• if the patient is in the last three months of pregnancy;
• if the patient has hemophilia.

Warnings and precautions – when to exercise special caution when taking Nurofen Muscles and Joints Forte

Important information before taking Nurofen Muscles and Joints Forte: During treatment with ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling in the face and neck area (angioedema), and chest pain. If any of these symptoms are noticed, the patient should immediately stop taking Nurofen Muscles and Joints Forte and contact a doctor or emergency medical services immediately. When taking Nurofen Muscles and Joints Forte, 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 ibuprofen use. If the patient experiences any symptoms associated with severe skin reactions described in section 4, they should immediately stop taking Nurofen Muscles and Joints Forte and seek medical attention. Before starting treatment with Nurofen Muscles and Joints Forte, the patient should discuss with their doctor or pharmacist if they have previously been diagnosed with: systemic lupus erythematosus and mixed connective tissue disease; symptoms of allergic reactions after taking acetylsalicylic acid; 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; active or past asthma or a history of allergic reactions; after taking the medicine, bronchospasm may occur; diseases for which the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids); if the patient needs to limit sodium intake in their diet. Infection – see below, section titled "Infections".

• systemic lupus erythematosus and mixed connective tissue disease;
• symptoms of allergic reactions after taking acetylsalicylic acid;
• 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;
• active or past asthma or a history of allergic reactions; after taking the medicine, bronchospasm may occur;
• diseases for which the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids);
• if the patient needs to limit sodium intake in their diet.
• infection – see below, section titled "Infections".

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and may not be preceded by warning signs; these complications can also occur in patients who have experienced warning signs. If gastrointestinal bleeding or ulceration occurs, the medicine should be stopped 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). In dehydrated adolescents aged 12-18, there is a risk of kidney function disorders. Special caution should be exercised (the patient should consult a doctor or pharmacist) before using the medicinal product in patients with hypertension and/or heart failure with fluid retention, hypertension, and edema associated with NSAID use in their medical history. Taking anti-inflammatory and analgesic 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 be as short as possible. If, despite taking the medicine, symptoms persist or worsen, or new symptoms appear, the patient should consult a doctor. Before taking Nurofen Muscles and Joints Forte, the patient should discuss their treatment with a doctor or pharmacist if they have: heart diseases, such as heart failure, angina pectoris (chest pain), if they have had a heart attack, coronary artery bypass grafting, or if they have peripheral artery disease (poor blood circulation in the legs due to narrowed or blocked arteries) or if they have had any stroke (including mini-stroke or transient ischemic attack - TIA).

Infections Nurofen Muscles and Joints Forte may mask the symptoms of infection, such as fever and pain. As a result, Nurofen Muscles and Joints Forte may delay the use of appropriate infection treatment and 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 while an infection is present, and the infection symptoms persist or worsen, they should immediately consult a doctor. 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 reactions occurs at the beginning of treatment, in most cases within the first month of using the medicine. Medicines in this group (non-steroidal anti-inflammatory drugs) may adversely affect female fertility. This effect is temporary and reverses after treatment is stopped. If the patient is having difficulty conceiving, they should consult a doctor before taking ibuprofen. In elderly patients, there is an increased risk of adverse reactions associated with ibuprofen use compared to younger patients. The frequency and severity of adverse reactions can be reduced by using the smallest effective dose for the shortest possible duration. The patient should consult a doctor, even if the above warnings refer to situations that have occurred in the past.

Children

The medicine is not intended for children under 12 years of age.

Nurofen Muscles and Joints Forte and other medicines

Nurofen Muscles and Joints Forte should not be taken if the patient is using other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors, such as celecoxib or etoricoxib), other painkillers, or acetylsalicylic acid (in analgesic doses). 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. In particular, before taking ibuprofen, the patient should inform their doctor if they are taking any of the following medicines: 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 agents and selective serotonin reuptake inhibitors (SSRIs); cardiac glycosides; lithium and methotrexate; cyclosporine; mifepristone; tacrolimus; zidovudine; quinolone antibiotics; corticosteroids.

• 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 agents and selective serotonin reuptake inhibitors (SSRIs);
• cardiac glycosides;
• lithium and methotrexate;
• cyclosporine;
• mifepristone;
• tacrolimus;
• zidovudine;
• quinolone antibiotics;
• corticosteroids.

Some other medicines may also interact with or influence treatment with Nurofen Muscles and Joints Forte. Therefore, before taking Nurofen Muscles and Joints Forte with other medicines, the patient should always consult a 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 a doctor or pharmacist before taking this medicine. Pregnancy Do not take Nurofen Muscles and Joints Forte during the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Taking Nurofen Muscles and Joints Forte may cause kidney and heart disorders in the unborn baby. It may also affect the mother's and baby's bleeding tendency and prolong or delay delivery. Nurofen Muscles and Joints Forte should not be taken during the first 6 months of pregnancy unless it is clearly necessary and advised by a doctor. If treatment is necessary during this period or when trying to conceive, the smallest dose should be used for the shortest possible time. Taking Nurofen Muscles and Joints Forte for more than a few days after the start of the 20th week of pregnancy may cause kidney disorders in the unborn baby and lead to a decreased level of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the ductus arteriosus in the baby's heart. If longer treatment is necessary, the doctor may recommend additional check-ups. Breastfeeding Ibuprofen may pass into breast milk in small amounts. There are no known cases of adverse effects in breastfed infants, so there is no need to stop breastfeeding during short-term use of the medicine in small doses. However, before taking any medicine, the patient should consult a doctor. Fertility See "Warnings and precautions".

Driving and using machines

There are no data on the effects of Nurofen Muscles and Joints Forte on the ability to drive and use machines. However, when taking the recommended doses and for the recommended duration, Nurofen Muscles and Joints Forte is unlikely to affect these abilities.

Nurofen Muscles and Joints Forte contains sugar and sodium

Sugar

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

Sodium

The medicine contains 51.45 mg of sodium (the main component of common salt) per tablet. This corresponds to 2.57% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Nurofen Muscles and Joints Forte

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. If in doubt, the patient should consult a doctor or pharmacist. The medicine is for short-term use only. The smallest effective dose should be used for the shortest possible time. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult a doctor (see section 2). The medicine is intended for oral use only in adults, the elderly, and adolescents aged 12 and over. Recommended dosage: Adults, the elderly, and adolescents over 12 years: 1 tablet every 4 hours. Tablets should be taken with water. Do not take more than 3 tablets in 24 hours.

Note:

Do not exceed the recommended dose! If the patient has taken more than the recommended dose of the medicine, they should consult a doctor. If the patient feels that the effect of the medicine is too strong or too weak, they should consult a doctor. The medicine is intended for short-term use. If symptoms persist or worsen, or if new symptoms appear, the patient should consult a doctor. The smallest possible dose should be used for the shortest possible time to minimize the risk of adverse effects. The patient should not take the medicine for more than 3 days unless advised by a doctor. In adolescents aged 12-18, the patient should consult a doctor if the medicine needs to be taken for more than 3 days or if symptoms worsen.

Taking a higher dose of Nurofen Muscles and Joints Forte than recommended

If the patient has taken a higher dose of Nurofen Muscles and Joints 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. 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. Other symptoms may include stomach pain or, more rarely, diarrhea, gastrointestinal bleeding, very rarely excitement or coma, very rarely seizures, metabolic acidosis (excess acid in the blood), prolonged prothrombin time/INR, probably due to interference with circulating coagulation factors, acute kidney failure, or liver damage, and in patients with asthma, worsening of symptoms. Additionally, low blood pressure and slow breathing may occur. Treatment of overdose: there is no specific antidote. Treatment is symptomatic and supportive, aimed at maintaining vital functions until the medicine is eliminated from the body. The doctor will monitor the patient's heart function and control vital signs if they are stable. The doctor may consider administering activated charcoal orally within 1 hour of overdose. In cases of frequent or prolonged seizures, the doctor will administer diazepam or lorazepam intravenously. In patients with asthma, the doctor will administer bronchodilators.

Missing a dose of Nurofen Muscles and Joints Forte

The patient should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Nurofen Muscles and Joints Forte 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 longer period, 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.

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

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

• dizziness, insomnia, agitation;
• psychotic disorders, depression;
• tinnitus;
• diarrhea, bloating, constipation, vomiting, gastritis;
• edema;
• irritability, fatigue.

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

• blood disorders (anemia, leukopenia - decreased white blood cell count, thrombocytopenia - decreased platelet count, pancytopenia - a blood disorder characterized by a deficiency of all normal blood cell elements: red blood cells, white blood cells, and platelets, agranulocytosis - absence of a certain type of white blood cell - granulocytes). The first symptoms include: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, unexplained bleeding, and bruising;
• severe hypersensitivity reactions. Symptoms may include: facial swelling, tongue or laryngeal edema, shortness of breath, tachycardia, decreased blood pressure (anaphylaxis, angioedema, or severe shock);
• aseptic meningitis;
• heart failure and edema;
• hypertension;
• peptic ulcers, perforation, or gastrointestinal bleeding, melena, hematemesis (sometimes fatal, especially in the elderly), oral ulceration, exacerbation of ulcerative colitis and Crohn's disease;
• severe skin reactions, such as blistering reactions, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis;
• liver function disorders;
• acute kidney failure, renal papillary necrosis, especially with long-term use, leading to increased urea levels in the blood and edema, hypernatremia;
• decreased hemoglobin levels, decreased urine output.

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

• hypersensitivity reactions of the respiratory tract, including asthma;
• skin becomes sensitive to light.

If the patient experiences any of the following symptoms, they should immediately stop taking ibuprofen and seek medical attention: red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling skin, 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 bumps 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 severe allergic reaction called Kounis syndrome.

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 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 Muscles and Joints Forte

There are no special precautions for storage. The medicine should be stored out of sight and reach of children. Do not use Nurofen Muscles and Joints Forte after the expiry date stated on the packaging 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 pack and other information

What Nurofen Muscles and Joints Forte contains

• The active substance of the medicine is ibuprofen - 1 coated tablet contains 400 mg of ibuprofen in the form of ibuprofen sodium dihydrate 512 mg
• Excipients are: croscarmellose sodium, xylitol, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, coating: sodium carmellose, talc, spray-dried acacia, sucrose, titanium dioxide, macrogol 6000, Opacode S-1-15094 ink (shellac, iron oxide red (E 172), propylene glycol, ammonium hydroxide (E 527), simethicone)

What Nurofen Muscles and Joints Forte looks like and contents of the pack

White, round, biconvex tablets with markings. The tablets are available in packs of 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 For more detailed information on 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: