Nurofen muscles and joints forte

Package leaflet: Information for the user

Nurofen Mięśnie i Stawy Forte, 400 mg, coated tablets
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
This medicine should always be taken 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 consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 3 days, you should consult your doctor.

Contents of the leaflet

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

1. What Nurofen Mięśnie i Stawy Forte is and what it is used for

Nurofen Mięśnie i Stawy Forte contains 400 mg of ibuprofen in the form of sodium salt dihydrate.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic and anti-inflammatory properties.
This medicine is intended for use in the following conditions:
Mild to moderate pain of various origins:

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

2. Important information before using Nurofen Mięśnie i Stawy Forte

When not to use Nurofen Mięśnie i Stawy Forte

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6), or to other non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has ever experienced hypersensitivity reactions (e.g. urticaria, rhinitis, angioedema or bronchial asthma) after taking acetylsalicylic acid or other NSAIDs;
• in patients with active or a history of recurrent peptic ulcer or gastrointestinal bleeding (two or more episodes of confirmed ulceration or bleeding);
• in patients with a history of gastrointestinal perforation or bleeding associated with previous NSAID treatment;
• if the patient has severe liver failure, severe kidney failure or severe heart failure;
• if the patient is currently 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 a bleeding tendency.

Warnings and precautions – when to exercise special caution when using Nurofen Mięśnie i Stawy Forte
Important information before taking Nurofen Mięśnie i Stawy 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, discontinue Nurofen Mięśnie i Stawy Forte immediately and contact a doctor or emergency medical services without delay.
Exercise special caution when using Nurofen Mięśnie i Stawy Forte:
Severe 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 the patient develops any symptoms related to severe skin reactions described in section 4, discontinue Nurofen Mięśnie i Stawy Forte immediately and seek medical help.
Before starting treatment with Nurofen Mięśnie i Stawy Forte, consult a doctor or pharmacist if the patient has previously been diagnosed with:

• systemic lupus erythematosus or mixed connective tissue disease;
• allergic reactions after taking acetylsalicylic acid;
• gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• hypertension and/or heart dysfunction;
• kidney function disorders;
• liver function disorders;
• blood clotting disorders;
• active or past history of bronchial asthma or allergic reactions; bronchospasm may occur after taking the medicine;
• diseases requiring concomitant use of other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids);
• if the patient needs to restrict dietary sodium intake;
• infections – see below, section titled "Infections".

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and may occur without warning symptoms; they may also occur in patients who have experienced warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately. Patients with gastrointestinal disorders, especially elderly individuals, should report any unusual gastrointestinal symptoms (particularly bleeding), especially during the initial treatment period.
Concurrent, long-term use of various painkillers may lead to kidney damage with risk of kidney failure (analgesic nephropathy).
Dehydrated adolescents aged 12–18 years are at risk of kidney function impairment.
Exercise special caution (the patient should consult a doctor or pharmacist) before using the medicine in patients with hypertension and/or heart failure with fluid retention, or a history of hypertension and edema associated with NSAID use.
Taking anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
If symptoms persist or worsen despite treatment, or new symptoms appear after 3 days, consult a doctor.
Before using Nurofen Mięśnie i Stawy Forte, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart diseases such as heart failure, angina (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 history of stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has hypertension, diabetes, high cholesterol levels, family history of heart disease or stroke, or if the patient smokes.

Infections
Nurofen Mięśnie i Stawy Forte may mask symptoms of infection such as fever and pain. Therefore, Nurofen Mięśnie i Stawy 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 chickenpox.
If the patient takes this medicine during an existing infection and symptoms of infection persist or worsen, consult a doctor immediately.
Serious, rarely occurring skin reactions, some of which are fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported with NSAIDs. The highest risk of these severe reactions occurs at the beginning of treatment, mostly within the first month of use.
NSAIDs may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment. In case of difficulty conceiving, consult a doctor before taking ibuprofen.
Elderly patients have an increased risk of adverse effects from ibuprofen compared to younger patients. The frequency and severity of adverse effects can be reduced by using the lowest effective dose for the shortest possible duration.
Consult a doctor even if the above warnings refer to conditions experienced in the past.

Children
This medicine is not indicated for children under 12 years of age.

Nurofen Mięśnie i Stawy Forte and other medicines
Do not take Nurofen Mięśnie i Stawy Forte if taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), other painkillers, or acetylsalicylic acid (in analgesic doses).
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.
In particular, before taking ibuprofen, inform the doctor if the patient is taking any of the following medicines:

• anticoagulants (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);
• 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 affect treatment with Nurofen Mięśnie i Stawy Forte. Therefore, always consult a doctor or pharmacist before combining Nurofen Mięśnie i Stawy Forte with other medicines.

Pregnancy, breastfeeding and effect 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 Mięśnie i Stawy Forte during the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. Use of Nurofen Mięśnie i Stawy Forte may cause kidney and heart function disorders in the unborn child. It may also affect bleeding tendency in both the mother and the child and may delay or prolong labour. Do not take Nurofen Mięśnie i Stawy Forte 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, use the lowest effective dose for the shortest possible duration. Taking Nurofen Mięśnie i Stawy Forte for longer than a few days beyond week 20 of pregnancy may cause kidney function disorders 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 have been reported in breastfed infants; therefore, breastfeeding need not be interrupted during short-term use of low doses. Consult a doctor before taking any medicine.

Effect on fertility
See section "Warnings and precautions".

Driving and operating machinery
There is no data on the effect of Nurofen Mięśnie i Stawy Forte on the ability to drive or operate machinery and psycho-physical performance when used at the recommended doses and duration.

Nurofen Mięśnie i Stawy Forte contains sucrose and sodium

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

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

3. How to use Nurofen Mięśnie i Stawy Forte
Always take this medicine exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for short-term use only.
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 intended for oral use only in adults, elderly patients, and adolescents aged at least 12 years.

Recommended dosage:
Adults, elderly patients, and adolescents aged over 12 years: 1 tablet every four hours. Swallow tablets with water. Do not take more than 3 tablets per day.

Note:
Do not exceed the recommended dose!
In case of overdose, contact a doctor.
If the effect of the medicine seems too strong or too weak, contact a doctor.
This medicine is intended for short-term use. If symptoms persist or worsen, or if new symptoms occur, contact a doctor.
Use the lowest possible dose for the shortest possible time to reduce the risk of adverse effects.
Do not take the medicine for more than 3 days unless otherwise advised by a doctor.
For adolescents aged 12–18 years, consult a doctor if treatment beyond 3 days is necessary or if symptoms worsen.

Taking a higher than recommended dose of Nurofen Mięśnie i Stawy Forte
If the patient has taken a higher than recommended dose of Nurofen Mięśnie i Stawy 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. After large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low blood potassium levels, cold sensation, and breathing difficulties may occur. Other possible symptoms include epigastric pain or, less commonly, diarrhea, gastrointestinal bleeding, very rarely agitation or coma, very rarely seizures, metabolic acidosis (excess acid in blood), prolonged blood clotting time (prothrombin time/INR), probably due to impaired clotting factor function, acute kidney failure or liver damage, and worsening of asthma symptoms in asthmatic patients. 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 drug is eliminated from the body. The doctor will monitor heart function and vital signs if stable. Activated charcoal may be administered orally within 1 hour of overdose. In case of frequent or prolonged seizures, the doctor will administer intravenous diazepam or lorazepam. In asthmatic patients, the doctor will administer bronchodilators.

Missed dose of Nurofen Mięśnie i Stawy 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 over-the-counter doses. Other adverse effects may occur when ibuprofen is used for other indications or for prolonged periods.
Adverse effects are listed below by frequency of occurrence using the following categories:

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

• Urticaria and itching;
• Headache;
• Abdominal pain, nausea, dyspepsia;
• Various skin rashes.

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

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

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

• 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 cellular components of blood: red blood cells, white blood cells and platelets, agranulocytosis – absence of granulocytes, a type of white blood cells). Initial symptoms include: fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, severe fatigue, unexplained bleeding and bruising;
• Severe hypersensitivity reactions. Symptoms may include: facial, tongue or laryngeal swelling, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe shock);
• Aseptic meningitis;
• Heart failure and edema;
• Hypertension;
• Gastrointestinal ulcers, perforation or gastrointestinal bleeding, tarry stools, vomiting blood (sometimes fatal, especially in elderly patients), ulcerative stomatitis, exacerbation of colitis, Crohn's disease;
• Severe skin reactions, such as blistering reactions, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis;
• Liver function disorders;
• Acute renal failure, renal papillary necrosis, particularly with prolonged use, leading to increased serum urea concentration and edema, hypernatremia;
• Decreased hemoglobin concentration, reduced urine output.

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

• Hyperreactivity of the airways, including asthma;
• 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 center, skin peeling, and ulcers in the mouth, throat, nose, genital organs 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 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 known as Kounis syndrome.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a 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 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Nurofen Miesnie i Stawy Forte

No special storage requirements.
The medicine should be stored out of sight and reach of children.
Do not use Nurofen Miesnie i Stawy Forte after the expiry date stated on the
carton and blister pack after: EXP. 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 in use. This will help protect
the environment.

6. Contents of the Package and Other Information

What Nurofen Mięśnie i Stawy Forte Contains

• The active substance is ibuprofen – one coated tablet contains 400 mg of ibuprofen in the form of ibuprofen sodium dihydrate 512 mg
• Excipients: sodium croscarmellose, xylitol, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, coating composition: sodium carmellose, talc, spray-dried arabic gum, 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 Mięśnie i Stawy Forte Looks Like and Contents of the Pack
White, round, biconvex coated tablets with an imprint. Tablets are available in packs of
12, 24 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
Importer
RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
The Netherlands

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