Niebolix

Leaflet attached to the packaging: information for the user

Niebolix, 600 mg, coated tablets

Niebolix, 800 mg, coated tablets

Ibuprofen

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Niebolix and what is it 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 packaging and other information

1. What is Niebolix and what is it used for

The active substance of Niebolix is ibuprofen, a non-steroidal anti-inflammatory drug (NSAID). It prevents the transmission of pain sensations to the central nervous system by reducing the production of neurotransmitters that cause inflammation and pain. The medicine also lowers fever by reducing the production of neurotransmitters that cause fever.

Indications for use

Niebolix in the form of 600 mg and 800 mg tablets is used for conditions such as:

• rheumatoid arthritis, juvenile rheumatoid arthritis, other forms of rheumatoid arthritis, osteoarthritis (degenerative joint disease), gout, and other connective tissue diseases that require NSAID treatment.

In addition, Niebolix in the form of 600 mg tablets is used for conditions such as:

• sudden muscle and skeletal pain and post-traumatic conditions
• post-operative pain
• menstrual cramps and treatment of heavy menstrual bleeding in women using an intrauterine device
• migraine treatment and prevention
• temporary pain and feverish conditions accompanying viral colds and flu, muscle and joint pain, headache, and toothache. This medicine should not be used to treat chickenpox.

The doctor may also prescribe Niebolix for the treatment of other diseases not listed above.

2. Important information before taking Niebolix

When not to take Niebolix:

• if the patient currently has stomach or duodenal ulcers
• if the patient has had stomach or duodenal ulcers in the past and has experienced one or more relapses of the disease
• if the patient has had a perforation of the gastrointestinal tract or gastrointestinal bleeding (with symptoms such as black stools or blood in the stool, bloody vomiting, anemia) associated with the use of NSAIDs
• if the patient has been informed by their doctor that they are prone to gastrointestinal bleeding
• if the patient has hemophilia or a low platelet count, or if the patient is taking medications (such as warfarin) that prevent blood clotting or the formation of blood clots
• if the patient has severe heart failure
• if the patient has severe kidney or liver disease
• if the patient is in the third trimester of pregnancy
• if the patient has experienced allergic reactions (such as difficulty breathing, runny nose, facial swelling, lip or tongue swelling, hives) 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
In connection with the use of ibuprofen, severe skin reactions have been reported. You should stop taking Niebolix and seek medical attention immediately if you experience a rash, mucosal lesions, blisters, or other symptoms of an allergic reaction, as these may be the first symptoms of a very severe skin reaction. See section 4.
Taking anti-inflammatory or pain-relieving medications, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, particularly when taken in high doses. Do not exceed the recommended dose and duration of treatment.
During the use of ibuprofen, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, facial and neck swelling (angioedema), chest pain.
If you notice any of these symptoms, you should stop taking Niebolix immediately and contact your doctor or emergency medical services immediately.
Before starting to take Niebolix, you should discuss it with your doctor or pharmacist:

• if you have heart disease, such as heart failure, chest pain (angina pectoris), if you have had a heart attack, if you have peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries), if you have had a stroke (including a mini-stroke or transient ischemic attack, TIA) or have had coronary artery bypass grafting
• if you have high blood pressure, diabetes, high cholesterol, if there is a history of heart disease or stroke in your family, or if you smoke
• if you have coronary artery disease
• if you have kidney or liver failure
• if you have a gastrointestinal disease, such as ulcerative colitis or Crohn's disease
• if you have had stomach problems, nosebleeds, or an increased tendency to bruise in connection with the use of NSAIDs (including those available without a prescription)
• if you have asthma
• if you have an infection - see below under "Infections".

You should tell your doctor about any other diseases or allergies you have.
In children, adolescents, and the elderly with dehydration, there is a risk of kidney failure.
If you take Niebolix or other pain-relieving medications for a long time, it may lead to the occurrence of headaches that should not be treated with a higher dose of pain-relieving medications. If you suspect that this is the case, you should consult a doctor.
Infections
Niebolix may mask the symptoms of an infection, such as fever and pain. Therefore, Niebolix may delay the use of appropriate infection treatment, which can lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while you have an infection, and the symptoms of the infection persist or worsen, you should consult your doctor immediately.

Niebolix and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take. This includes prescription medicines, over-the-counter medicines, herbal products, and natural products. Niebolix may affect the action of other medicines, or other medicines may change its action. In such cases, your doctor may change the dose of the medicine or the way it is taken. These medicines include, for example:

• blood-thinning medicines (such as aspirin, warfarin, ticlopidine, and clopidogrel)
• medicines that lower high blood pressure (such as ACE inhibitors, beta blockers, and angiotensin II receptor antagonists)
• you should not take other NSAIDs, including COX-2 inhibitors, at the same time as Niebolix, as they can only increase the frequency of side effects, but not the effectiveness of treatment
• certain antidepressants (such as citalopram, fluoxetine, paroxetine, and sertraline), which are selective serotonin reuptake inhibitors (SSRIs), increase the risk of bleeding
• certain cholesterol-lowering medicines (such as cholestyramine and colestipol) should be taken at least 4 hours after taking Niebolix to avoid disturbances in the absorption of Niebolix
• medicines used to treat epilepsy, such as phenytoin and phenobarbital, and rifampicin used to treat tuberculosis, may reduce the effectiveness of Niebolix
• fluconazole taken orally to treat fungal infections may increase the side effects of Niebolix
• lithium, as concomitant use may lead to an excessive increase in lithium levels in the blood
• digitalis glycosides (digoxin), as concomitant use may lead to an excessive increase in digoxin levels in the blood in patients with kidney failure
• oral corticosteroids may increase the risk of gastrointestinal disorders or bleeding during concomitant use
• the side effects of methotrexate used to treat rheumatoid diseases may be exacerbated when used with Niebolix. You should not take Niebolix on the days when you take methotrexate
• Niebolix may reduce the effect of certain blood pressure medicines or diuretics (water pills). You should tell your doctor if your blood pressure is being monitored or if you are taking blood pressure medicines
• quinolone antibiotics
• aminoglycoside antibiotics
• Ginkgo biloba may increase the risk of bleeding associated with NSAIDs
• zydovudine (an antiviral medicine)
• mifepristone (a medicine used to terminate pregnancy)
• cyclosporine, tacrolimus, sirolimus (medicines used to suppress the immune system).

Other medicines may also affect the action of Niebolix or their action may be changed by this medicine. Therefore, before taking Niebolix with other medicines, you should always consult your doctor or pharmacist. You should remember to tell your doctor about taking Niebolix during subsequent visits.

Niebolix with food and drink

Niebolix tablets can be taken with or without food. Taking the medicine with food may slightly delay the onset of its action, but the tolerance of the tablets is usually better.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
You should not take Niebolix in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. This medicine may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in you and your child and cause delayed or prolonged labor. You should not take Niebolix during the first 6 months of pregnancy, unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, you should use the smallest possible dose for the shortest possible time. From the 20th week of pregnancy, Niebolix may cause kidney problems in the unborn child, and if taken for more than a few days, it may lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment is required for a longer period, your doctor may recommend additional monitoring.
Taking ibuprofen may lead to difficulties in becoming pregnant. You should inform your doctor if you plan to become pregnant or have difficulty becoming pregnant.
Only a small amount of ibuprofen passes into breast milk, so you can take this medicine while breastfeeding.

Driving and using machines

Niebolix usually does not affect the ability to drive and use machines.
You should avoid driving and using machines if you experience drowsiness while taking the medicine.

Niebolix contains sucrose and lactose

The tablets contain sucrose. Niebolix contains lactose. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Niebolix contains 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 Niebolix

This medicine should always be taken according to the doctor's instructions. If you have any doubts, you should consult your doctor or pharmacist. You should not change the dose of the medicine yourself.
The recommended dose for adultsis usually 400 mg to 600 mg, 3 to 4 times a day.
In the treatment of severe pain, you should not exceed the total daily dose of 3200 mg, and the single dose should not exceed 1600 mg.

Children and adolescents under 12 years of age

In 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.
You should use the smallest effective dose for the shortest period necessary to alleviate the symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, you should consult your doctor immediately (see section 2).
The tablets should be taken with a sufficient amount of liquid (e.g., a glass of water).
Food does not affect the effectiveness of the medicine. Taking the tablets with food may reduce stomach upset caused by taking ibuprofen.

Taking a higher dose of Niebolix than recommended

Symptoms may include nausea, stomach pain, vomiting (which may be bloody), headache, ringing in the ears, disorientation, and nystagmus. After taking 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 the urine, feeling cold, and difficulty breathing.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In elderly patients, patients in poor general condition, or with many concomitant diseases taking this medicine, there is an increased risk of side effects. The risk of serious side effects increases with long-term use of high doses and is several times higher when other NSAIDs are used concomitantly.
The following side effects have been commonly reported (may occur in up to 1 in 10 people):

• increased tendency to bruise or nosebleeds (related to platelet dysfunction)
• depressive mood or drowsiness
• dizziness or headache
• ringing in the ears
• worsening of heart failure (exacerbated edema or dyspnea)
• peripheral edema
• heartburn, stomach pain, nausea, or diarrhea
• hives, itching, or worsening of skin or mucous membrane swelling.

The following side effects have been reported less frequently (may occur in up to 1 in 100 people):

• nervousness, disorientation, nightmares, cognitive impairment, hallucinations, paranoia, insomnia
• tingling or prickling sensation on the skin without any apparent cause (paresthesia)
• stomatitis, ulcers, and gastrointestinal bleeding or blood in the stool.

The following side effects have been reported rarely (may occur in up to 1 in 1,000 people):

• decreased platelet count (symptoms may include increased tendency to bruise or nosebleeds)
• decreased white blood cell count (symptoms may include unexplained fever, flu-like symptoms, or sore throat)
• increased potassium levels in the blood
• blurred vision or changes in the cornea
• confusional state (in patients taking tacrine)
• meningitis (in patients with a certain type of connective tissue disease)
• hearing impairment
• worsening of coronary artery disease (exacerbated chest pain) or cardiac arrhythmias
• shortness of breath or worsening of asthma
• perforation of the gastrointestinal tract, worsening of ulcerative colitis, parotitis, or pancreatitis
• increased liver enzyme activity, jaundice, or hepatitis (symptom may be stomach pain)
• severe skin reactions or mucous membrane reactions, including exfoliation or blistering; photosensitivity, worsening of acne or psoriasis, hair loss, systemic lupus erythematosus (SLE)
• kidney dysfunction
• symptoms of severe allergic reaction (anaphylaxis).

The following side effects have been reported very rarely (may occur in up to 1 in 10,000 people):

• intestinal narrowing.

Frequency not known (frequency cannot be estimated from the available data):
A red, scaly, widespread rash with bumps under the skin and blisters, located mainly on the skin folds, torso, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If you experience such symptoms, you should stop taking Niebolix and seek medical attention immediately. See also section 2.
A severe skin reaction known as DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) may occur. The symptoms of DRESS include skin rash, fever, lymph node swelling, and an increased number of eosinophils (a type of white blood cell) in the blood.
Taking NSAIDs, such as Niebolix, may be associated with a slightly increased risk of heart attack or stroke.
You should stop taking the medicine and immediatelycontact your doctor or the emergency department of the nearest hospital if you experience any of the following symptoms:

• difficulty breathing or shortness of breath
• severe redness, itching, and swelling of the skin
• swelling of the tongue or throat
• sudden, severe stomach pain or bloody vomiting
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

You should contact your doctor as soon as possibleif you experience any of the following symptoms:

• heartburn and mild stomach discomfort
• black stools
• increased tendency to bruise or nosebleeds
• peripheral edema
• other skin symptoms that occur with a delay.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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, you can help provide more information on the safety of this medicine.

5. How to store Niebolix

Store in a temperature below 25°C.
The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, label, and blister after: Expiry date (EXP). The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Niebolix contains

• The active substance of Niebolix is ibuprofen. Each 600 mg Niebolix coated tablet contains 600 mg of ibuprofen. Each 800 mg Niebolix coated tablet contains 800 mg of ibuprofen
• The other ingredients are: sodium croscarmellose, lactose monohydrate, 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 the shape of a capsule, 9 mm in width and 20 mm in length, with a dividing line on one side.
Niebolix, 800 mg is a white or almost white coated tablet in the shape of a capsule, 10 mm in width and 20 mm in length, with a dividing line on one side.
The tablet can be divided into equal doses.
Pack sizes: 10, 30, or 100 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

Date of last revision of the leaflet: