Niebolix

Package Leaflet: Information for the User

Niebolix, 600 mg, Coated Tablets

Niebolix, 800 mg, Coated Tablets

Ibuprofen

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• This leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform 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 pack 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 medication also reduces 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
• pain after surgical procedures
• 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 medication 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 recurrences 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 medication (listed in section 6).

Warnings and Precautions

Skin Reactions
Severe skin reactions have been reported with the use of ibuprofen. The patient should stop taking Niebolix and seek medical attention immediately if they experience a rash, mucosal lesions, blisters, or other symptoms of an allergic reaction, as these may be the first signs of a severe skin reaction. See section 4.
Taking anti-inflammatory or pain medications, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. The patient should not exceed the recommended dose and duration of treatment.
Ibuprofen has been associated with symptoms of an allergic reaction to this medication, including difficulty breathing, facial swelling, and chest pain.
If the patient experiences any of these symptoms, they should stop taking Niebolix immediately and contact their doctor or emergency medical services.
Before starting treatment with Niebolix, the patient should discuss the following with their doctor or pharmacist:

• if the patient has heart disease, such as heart failure, chest pain (angina), or has had a heart attack, or if the patient has peripheral artery disease (poor blood circulation in the legs or feet due to narrowed or blocked arteries), or if the patient has had a stroke (including a mini-stroke or transient ischemic attack, TIA) or has had coronary artery bypass grafting
• if the patient has high blood pressure, diabetes, high cholesterol, or if there is a history of heart disease or stroke in the patient's family, or if the patient smokes
• if the patient has coronary artery disease
• if the patient has kidney or liver failure
• if the patient has a gastrointestinal disease, such as ulcerative colitis or Crohn's disease
• if the patient has had stomach problems, nosebleeds, or an increased tendency to bruise in the past when taking NSAIDs (including those available over-the-counter)
• if the patient has asthma
• if the patient has an infection - see below under "Infections".

The patient should inform their doctor about any other diseases or allergies they have.
In children, adolescents, and the elderly with dehydration, there is a risk of kidney failure.
If the patient takes Niebolix or other pain medications for a long time, it may lead to headaches that should not be treated with higher doses of pain medications. If the patient suspects this is the case, they should consult their doctor.
Infections
Niebolix may mask the symptoms of an infection, such as fever and pain. As a result, 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 the patient takes this medication while they have an infection, and the symptoms of the infection persist or worsen, they should consult their doctor immediately.

Niebolix and Other Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking, have recently taken, or plan to take. This includes prescription medications, over-the-counter medications, herbal products, and natural products. Niebolix may affect the action of other medications or other medications may change its action. In such cases, the doctor may change the dose of the medication or the way it is taken. These medications include:

• blood-thinning medications (such as aspirin, warfarin, ticlopidine, and clopidogrel)
• medications that lower high blood pressure (such as ACE inhibitors, beta blockers, and angiotensin II receptor antagonists)
• other NSAIDs, including COX-2 inhibitors, should not be taken at the same time as Niebolix, as they may only increase the frequency of side effects without increasing the effectiveness of treatment
• certain antidepressants (such as citalopram, fluoxetine, paroxetine, and sertraline), which are selective serotonin reuptake inhibitors (SSRIs), may increase the risk of bleeding
• certain cholesterol-lowering medications (such as cholestyramine and colestipol) should be taken at least 4 hours after taking Niebolix to avoid absorption problems
• medications 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 when taken with Niebolix
• the side effects of methotrexate used to treat rheumatoid diseases may be increased when taken with Niebolix. Niebolix should not be taken on the days when methotrexate is taken
• Niebolix may reduce the effectiveness of certain blood pressure medications or diuretics. The patient should inform their doctor if their blood pressure is being monitored or if they are taking blood pressure medications
• quinolone antibiotics
• aminoglycoside antibiotics
• Ginkgo biloba may increase the risk of bleeding associated with NSAIDs
• zydovudine (an antiviral medication)
• mifepristone (a medication used to terminate pregnancy)
• cyclosporine, tacrolimus, and sirolimus (medications used to suppress the immune system).

Other medications may also affect the action of Niebolix or their action may be changed by this medication. Therefore, before taking Niebolix with other medications, the patient should always consult their doctor or pharmacist. The patient should remember to inform their doctor about taking Niebolix during follow-up visits.

Niebolix with Food and Drink

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

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 medication.
Niebolix should not be taken during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. The medication may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the mother and child and cause a delay or prolongation of labor. Niebolix should not be taken during the first 6 months of pregnancy, unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Niebolix may cause kidney problems in the unborn child if taken for more than a few days, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Taking ibuprofen may lead to difficulties in conceiving. The patient should inform their doctor if they plan to conceive or are having difficulty conceiving.
Only a small amount of ibuprofen passes into breast milk, so it can be taken during breastfeeding.

Driving and Operating Machines

Niebolix usually does not affect the ability to drive or operate machines.
The patient should avoid driving or operating machines if they experience drowsiness while taking the medication.

Niebolix Contains Sucrose and Lactose

The tablets contain sucrose. Niebolix contains lactose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.

Niebolix Contains Sodium

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

3. How to Take Niebolix

This medication should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The patient should not change the dose of the medication on their own.
The recommended dose for adultsis usually 400 mg to 600 mg, 3 to 4 times a day.
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

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.
The patient should use the smallest effective dose for the shortest period necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their 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 medication. Taking the tablets with food may reduce stomach upset caused by ibuprofen.

Taking a Higher Than Recommended Dose of Niebolix

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.
In case of any further doubts about the use of this medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Niebolix can cause side effects, although not everyone will experience them.
In elderly patients, patients in poor general condition, or with multiple concomitant diseases taking this medication, 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 taken 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 rash.

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 1000 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 include stomach pain)
• severe skin reactions or mucosal reactions involving exfoliation or blistering; photosensitivity, worsening of acne or psoriasis, hair loss, systemic lupus erythematosus (SLE)
• kidney dysfunction
• symptoms of a severe allergic reaction (anaphylaxis).

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

• intestinal stricture.

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 the patient experiences such symptoms, they 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.
The patient should stop taking the medication and immediatelycontact their doctor or the emergency department of the nearest hospital if they 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 vomiting blood
• chest pain, which may be a sign of a potentially severe allergic reaction known as Kounis syndrome.

The patient should contact their doctor as soon as possibleif they 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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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.
Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Niebolix

Store in a temperature below 25°C.
The medication should be stored in a place that is out of sight and reach of children.
The medication should not be used after the expiration date stated on the carton, label, and blister pack after: Expiration Date (EXP). The expiration date refers to the last day of the specified month.
Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Niebolix Contains

• The active substance of Niebolix is ibuprofen. Each 600 mg tablet of Niebolix contains 600 mg of ibuprofen. Each 800 mg tablet of Niebolix contains 800 mg of ibuprofen
• The other ingredients are: sodium croscarmellose, lactose monohydrate, gelatin, macrogol 6000, colloidal silicon dioxide, 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, capsule-shaped, coated tablet, 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, capsule-shaped, coated tablet, 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 medication, the patient 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: