Niebolix

Package leaflet: Information for the user

Niebolix, 600 mg, coated tablets
Niebolix, 800 mg, coated tablets
Ibuprofenum
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Niebolix is and what it is used for

The active substance in Niebolix is ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It works by reducing the production of certain neurotransmitters in the body that cause pain, inflammation, and fever, thereby preventing pain signals from reaching the central nervous system. Niebolix also reduces fever by decreasing the production of neurotransmitters responsible for elevated body temperature.

Indications
Niebolix tablets 600 mg and 800 mg are indicated for the treatment of the following conditions:

• Rheumatoid arthritis, juvenile rheumatoid arthritis, other forms of rheumatoid arthritis, osteoarthritis (degenerative joint disease), gouty arthritis, and other connective tissue diseases requiring treatment with NSAIDs.

Additionally, Niebolix 600 mg tablets are indicated for:

• Acute musculoskeletal pain and post-traumatic conditions
• Pain following surgical procedures
• Dysmenorrhea and treatment of heavy menstrual bleeding in women using intrauterine devices
• Treatment and prophylaxis of migraine
• Transient pain and fever associated with viral colds and influenza, muscle and joint pain, headache, and toothache. This medicine must not be used in the treatment of chickenpox.

Your doctor may also prescribe Niebolix for conditions other than those listed above.

2. Important information before using Niebolix

When not to use Niebolix:

• if the patient currently has a stomach or duodenal ulcer
• if the patient has previously had a stomach or duodenal ulcer and experienced one or more recurrences of the disease
• if the patient has previously experienced gastrointestinal perforation or gastrointestinal bleeding (with symptoms such as black stools or blood in stool, bloody vomiting, anaemia) related to the use of NSAIDs
• if the patient has been informed by a doctor of being predisposed to gastrointestinal bleeding
• if the patient has a bleeding disorder (haemophilia) or low platelet count (thrombocytopenia), or if the patient is taking medications (such as warfarin) that prevent blood clotting or thrombus formation
• if the patient has severe heart failure
• if the patient has severe kidney or severe liver disease
• if the patient is in the third trimester of pregnancy
• if the patient has experienced allergic reactions (e.g. difficulty breathing, runny nose, swelling of the face, lips, tongue or throat, rash) to acetylsalicylic acid or other NSAIDs
• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Skin reactions
Severe skin reactions have been reported with the use of ibuprofen, including exfoliative
dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and
systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Treatment with
Niebolix should be discontinued and immediate medical attention sought if any of the symptoms of
severe skin reactions described in section 4 occur.
Allergic reactions to ibuprofen, including difficulty breathing, swelling of the face and neck (angioedema),
and chest pain, have occurred during treatment. If any of these symptoms are observed, treatment with
Niebolix should be stopped immediately and medical help or emergency services contacted without delay.
The use of anti-inflammatory or pain-relieving medicines such as ibuprofen may be associated with a
slight increase in the risk of heart attack or stroke, particularly when used at high doses. The recommended
dose and duration of treatment should not be exceeded.
Before starting treatment with Niebolix, discuss with your doctor or pharmacist:

• if the patient has heart diseases such as heart failure, chest pain (angina), previous heart attack, peripheral arterial disease (poor blood circulation in legs or feet due to narrowed or blocked arteries), history of stroke (including mini-stroke or transient ischaemic attack, TIA), or coronary artery bypass surgery
• the patient has high blood pressure, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes
• if the patient has coronary artery disease
• if the patient has kidney or liver failure
• if the patient has gastrointestinal disorders such as ulcerative colitis or Crohn's disease
• if the patient has previously experienced abdominal discomfort, nosebleeds, or increased tendency to bruising related to NSAID use (including those available without prescription)
• if the patient has asthma
• if the patient has an infection – see section below “Infections”.

Inform the doctor about any other medical conditions and allergies the patient may have.
In dehydrated children, adolescents, and elderly patients, there is a risk of kidney failure.
If the patient uses Niebolix or other painkillers for a long time, this may lead to headaches that should not be treated with higher doses of painkillers. If the patient suspects this is occurring, medical advice should be sought.
Infections
Niebolix may mask symptoms of infection such as fever and pain. Therefore, Niebolix 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 persist or worsen, immediate consultation with a doctor is required.
Niebolix and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes prescription medicines, over-the-counter medicines, herbal products, and natural supplements. Niebolix may affect the action of other medicines or other medicines may alter its effect. In such cases, the doctor may adjust the dose or method of administration. Examples include:

• anticoagulant medicines (i.e. blood thinners or those preventing clot formation), such as aspirin (acetylsalicylic acid), warfarin, ticlopidine, and clopidogrel
• medicines for high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)
• do not use other NSAIDs, including medicines known as cyclooxygenase-2 (COX-2) inhibitors, together with Niebolix, as they may only increase the frequency of adverse effects without enhancing treatment efficacy
• certain antidepressants (such as citalopram, fluoxetine, paroxetine, sertraline), which are selective serotonin reuptake inhibitors (SSRIs), may increase the risk of bleeding
• certain cholesterol-lowering medicines (cholestyramine and colestipol) should be taken at least 4 hours after taking Niebolix to avoid interference with absorption
• antiepileptic medicines such as phenytoin and phenobarbital, and rifampicin used in tuberculosis treatment, may reduce the effectiveness of Niebolix
• oral fluconazole used to treat fungal infections may worsen adverse effects of Niebolix
• lithium, because concomitant use may lead to excessive increase in blood lithium levels
• cardiac glycosides (digoxin), because concomitant use may lead to excessive increase in blood digoxin levels in patients with kidney failure
• oral corticosteroids, which may increase the risk of gastrointestinal disorders or gastrointestinal bleeding when used concurrently
• adverse effects of methotrexate used in rheumatoid diseases may be intensified when used concomitantly with Niebolix. Niebolix should not be taken on days when methotrexate is administered
• Niebolix may reduce the effectiveness of certain antihypertensive or diuretic medicines (water tablets). Inform the doctor if blood pressure is being monitored or if the patient is taking blood pressure-lowering medicines
• quinolone antibiotics
• aminoglycoside antibiotics
• Ginkgo biloba, which may increase the risk of bleeding associated with NSAID use
• zidovudine (antiviral medicine)
• mifepristone (medicine used to terminate pregnancy)
• cyclosporine, tacrolimus, sirolimus (medicines used to suppress immune system function).

Other medicines may also affect the action of Niebolix or their effects may be altered by this medicine. Therefore, always consult a doctor or pharmacist before using Niebolix with other medicines. Remember to inform your doctor about using Niebolix during future medical visits.
Niebolix with food and drink
Niebolix tablets may be taken with or without food. Taking the medicine with food may slightly delay the onset of action, but gastrointestinal tolerance is generally better.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Niebolix must not be taken during the last 3 months of pregnancy, as it may harm the unborn child or cause delivery complications. This medicine may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. Niebolix should not be used during the first 6 months of pregnancy unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose for the shortest possible time should be used. From the 20th week of pregnancy, Niebolix may cause kidney problems in the unborn child if taken for more than a few days, potentially leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Ibuprofen use may lead to difficulties in becoming pregnant. Inform the doctor if the patient is planning pregnancy or has difficulty conceiving.
Only a small amount of ibuprofen passes into breast milk; therefore, this medicine may be used during breastfeeding.
Driving and operating machinery
Niebolix generally does not affect the ability to drive or operate machinery. However, driving and operating machinery should be avoided if drowsiness occurs during treatment.
Niebolix contains sucrose and lactose
The tablets contain sucrose. Niebolix contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Niebolix contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Niebolix

This medicine should always be used according to the doctor's instructions. If in doubt, consult
your doctor or pharmacist. Do not change the dose of the medicine on your own.
The recommended dose for adults is usually 400 mg to 600 mg, taken 3 to 4 times daily.
In the treatment of severe pain, the total daily dose should not exceed 3200 mg, and the single
dose should not exceed 1600 mg.
Children and adolescents under 12 years of age
For children and adolescents under 12 years of age, the dose is 20 to 40 mg/kg body weight per day,
divided into 3 to 4 doses. The single dose should not exceed 10 mg/kg body weight.
The lowest effective dose should be used 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).
Tablets should be taken with sufficient fluid (e.g. a glass of water).
Food does not affect the effectiveness of the medicine. Taking tablets with food may reduce
gastric irritation caused by ibuprofen.
Accidental overdose of Niebolix
Symptoms may include nausea, abdominal pain, vomiting (vomiting blood may occur), headache,
tinnitus, disorientation, and nystagmus. After ingestion of a large dose, the following symptoms have been reported:
drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness,
blood in urine, feeling cold, and breathing difficulties.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
In elderly individuals, patients in poor general condition or with multiple concomitant diseases,
the risk of adverse reactions is increased. The risk of serious adverse reactions increases with
prolonged use of high doses and is several times higher when other NSAIDs are used concomitantly.
You should stop taking Niebolix and seek immediate medical attention if any of the following
symptoms occur:

• Reddish, flat, target-shaped or circular spots on the trunk, often with blisters in the center, skin peeling, mucosal 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, swollen lymph nodes (DRESS syndrome)
• Red, scaly widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually occur early in treatment (acute generalized exanthematous pustulosis)

Other adverse reactions:
Common ( may affect up to 1 in 10 people ):

• Increased tendency to bruise or nosebleeds (related to platelet dysfunction)
• Depressed mood or drowsiness
• Dizziness or headache
• Tinnitus (ringing in the ears)
• Worsening of heart failure (increased swelling or shortness of breath)
• Peripheral swelling of body parts such as hands and feet
• Heartburn, upper abdominal pain, nausea, or diarrhea
• Urticaria, skin itching, or increased swelling of the skin or mucous membranes.

Uncommon ( may affect up to 1 in 100 people ):

• Nervousness, disorientation, nightmares, cognitive disturbances, hallucinations, paranoia, insomnia
• Tingling or prickling sensation of the skin without apparent cause (paresthesia)
• Oral inflammation, gastrointestinal ulceration and bleeding, or presence of blood in stool.

Rare ( may affect up to 1 in 1000 people ):

• Decreased platelet count (symptoms may include increased tendency to bruising or nosebleeds)
• Decreased number or absence of white blood cells (symptoms may include unexplained fever, flu-like symptoms, or sore throat)
• Increased blood potassium levels
• Blurred vision or corneal changes
• Confusion (in patients taking tacrine)
• Meningitis (in patients with a certain type of connective tissue disease)
• Hearing impairment
• Worsening of coronary artery disease symptoms (increased chest pain) or cardiac arrhythmias
• Shortness of breath or worsening asthma
• Gastrointestinal perforation, exacerbation of ulcerative colitis, sialadenitis, or pancreatitis
• Increased liver enzyme activity, jaundice, or hepatitis (symptoms may include upper abdominal pain)
• Severe skin or mucosal reactions involving skin peeling or blistering; photosensitivity, worsening of acne or psoriasis, hair loss, systemic lupus erythematosus (SLE)
• Impaired kidney function
• Symptoms of severe allergic reaction (anaphylaxis).

Very rare ( may affect up to 1 in 10,000 people ):

• Intestinal stricture.

The use of NSAIDs such as Niebolix may be associated with a slightly increased risk of heart attack
or stroke.
You should stop taking the medicine and immediately contact your doctor or the emergency department
of the nearest hospital if any of the following symptoms occur:

• Difficulty breathing or shortness of breath
• Severe redness, itching, and swelling of the skin
• Swelling of the tongue or throat
• Sudden, severe abdominal pain or vomiting blood
• Chest pain, which may indicate a potentially serious allergic reaction known as Kounis syndrome.

You should contact your doctor as soon as possible if any of the following symptoms occur:

• Heartburn and mild abdominal discomfort
• Black stools
• Increased tendency to bruise or nosebleeds
• Swelling of the limbs
• Other skin symptoms occurring with delay.

Reporting adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Niebolix

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle label, and blister
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 pack and other information

What Niebolix contains

• The active substance is ibuprofen. Each 600 mg coated tablet of Niebolix contains 600 mg of ibuprofen. Each 800 mg coated tablet of Niebolix contains 800 mg of ibuprofen.
• The other ingredients are: sodium croscarmellose, monohydrate lactose, gelatin, macrogol 6000, colloidal anhydrous silica, microcrystalline cellulose, sucrose, hypromellose, polysorbate 80, titanium dioxide (E 171), glycerol (E 422) (85%), magnesium stearate.

What Niebolix looks like and contents of the pack
Niebolix 600 mg is a white or almost white coated tablet in capsule shape, 9 mm wide and 20 mm long, with a score line on one side.
Niebolix 800 mg is a white or almost white coated tablet in capsule shape, 10 mm wide and 20 mm long, with a score line on one side.
The tablet can be divided into equal doses.
Pack sizes: 10, 30 or 100 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]