Nabuton Vp

Package Leaflet: Information for the User

Nabuton VP

500 mg, tablets

Nabumetone
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 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 and should not be given 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 Nabuton VP and what is it used for
• 2. Important information before taking Nabuton VP
• 3. How to take Nabuton VP
• 4. Possible side effects
• 5. How to store Nabuton VP
• 6. Contents of the pack and other information

1. What is Nabuton VP and what is it used for

Nabuton VP contains the active substance nabumetone. It belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs) - it has anti-inflammatory, analgesic, and antipyretic effects.
Nabumetone works only after it has undergone metabolic changes in the body (in the case of nabumetone, the substance that is formed as a result of these changes and which is mainly responsible for the biological effect of the medicine is 6-methoxy-2-naphthylacetic acid). This means that its irritating effect on the mucous membrane of the gastrointestinal tract is significantly smaller than that of many other nonsteroidal anti-inflammatory drugs, which are administered directly in their fully active form.
Nabuton VP is used to treat osteoarthritis and rheumatoid arthritis.

2. Important information before taking Nabuton VP

When not to take Nabuton VP

• if the patient is allergic to nabumetone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had an asthma attack, hives, or other allergic reactions after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;
• if the patient has severe liver failure;
• if the patient has or has ever had gastrointestinal bleeding or perforation;
• if the patient has or has ever had stomach or duodenal ulcers;
• if the patient has severe heart failure;
• if the patient has active bleeding from blood vessels in the brain or other bleeding;
• if the patient is in the third trimester of pregnancy or breastfeeding.

Warnings and precautions

Before starting treatment with Nabuton VP, you should discuss it with your doctor or pharmacist.

• if the patient is over 65 years old (see also below and section 3);
• if the patient is taking oral corticosteroids, anticoagulant medications such as warfarin, other nonsteroidal anti-inflammatory drugs, antidepressant medications from the group of selective serotonin reuptake inhibitors (SSRIs), or antiplatelet medications such as acetylsalicylic acid or clopidogrel (see below "Nabuton VP and other medicines");
• if the patient has gastrointestinal diseases, such as ulcerative colitis or Crohn's disease (possibility of exacerbating symptoms of these diseases);
• if the patient has high blood pressure;
• if the patient has symptoms of water retention in the body (edema);
• if the patient has heart disease, such as mild to moderate heart failure or coronary artery disease;
• if the patient has peripheral arterial disease or cerebral blood vessel disease;
• if the patient has hyperlipidemia (elevated cholesterol and triglyceride levels) in the blood;
• if the patient has diabetes;
• if the patient smokes;
• if the patient has kidney function disorders (see section 3, subsection "Dosage in patients with kidney function disorders");
• if the patient has liver function disorders (see section 3, subsection "Dosage in patients with liver function disorders").

Additional warnings:
If the patient experiences any symptoms of hypersensitivity, such as skin rash, redness, blisters, erosions, pain, especially with accompanying general symptoms such as fever, sore throat, cough, chills, muscle and joint pain, they should stop taking the medicine and contact their doctor immediately. These may be symptoms of a severe skin reaction, sometimes life-threatening.
If the patient experiences vision disturbances, such as blurred vision, they should inform their doctor, who may order ophthalmological examinations.
During treatment, gastrointestinal disturbances may occur, such as abdominal pain, nausea, diarrhea, nausea, vomiting, blood in the stool, or black tarry stools, which may indicate gastrointestinal damage caused by Nabuton VP.
Gastrointestinal damage caused by Nabuton VP, like other nonsteroidal anti-inflammatory drugs, can occur at any time during treatment, with or without preceding symptoms, regardless of whether the patient has previously had gastrointestinal problems or not. In elderly patients, this risk is higher.
Taking such medications as Nabuton VP may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. You should not take higher doses or for a longer period than recommended.
Nabuton VP may mask symptoms of an existing infection.

Nabuton VP contains sodium

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

Children and adolescents

Nabuton VP is not recommended for use in children and adolescents due to the lack of data on safety and efficacy.

Nabuton VP and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Nabuton VP may affect the action of some medicines, and some medicines may affect the action of Nabuton VP.
The patient should inform their doctor or pharmacist about taking any of the following medicines:

• corticosteroids (medicines with strong anti-inflammatory and anti-allergic effects, used in skin diseases);
• anticoagulant medications, such as warfarin;
• antiplatelet medications, such as acetylsalicylic acid or clopidogrel;
• antidepressant medications from the group of selective serotonin reuptake inhibitors (SSRIs);
• paracetamol (a pain reliever and antipyretic);
• acetylsalicylic acid (a pain reliever and anti-inflammatory, also used prophylactically in diseases that threaten the formation of blood clots and embolisms in blood vessels);
• cimetidine (a medicine used in the treatment of heartburn and stomach ulcers);
• antacids containing aluminum (medicines used in the treatment of heartburn);
• cardiac glycosides (medicines used in the treatment of certain heart diseases);
• methotrexate (a medicine used in the treatment of cancer and rheumatic diseases);
• lithium (a medicine used in the treatment of mental disorders);
• diuretics;
• certain medicines used to treat high blood pressure, such as angiotensin-converting enzyme inhibitors or angiotensin receptor antagonists;
• other nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors;
• certain medicines used to treat bacterial infections from the group of sulfonamides and certain antidiabetic medicines.

It is not recommended to take more than one nonsteroidal anti-inflammatory drug at the same time.

Taking Nabuton VP with food and drink

Nabuton VP should be taken during a meal or after a meal.
Food accelerates the absorption of Nabuton VP.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Nabuton VP should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. It may cause kidney and heart problems in the unborn baby.
It may increase the risk of bleeding in the patient and their baby and cause delayed or prolonged labor. During the first 6 months of pregnancy, the medicine should not be taken unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or during attempts to become pregnant, the smallest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Nabuton VP may cause kidney problems in the unborn baby if taken for more than a few days. This may lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
Nabuton VP should not be taken by breastfeeding women.
If the patient is breastfeeding, they should contact their doctor, who may decide to stop breastfeeding or discontinue Nabuton VP.
Fertility
Taking Nabuton VP may have a negative effect on fertility in women and is not recommended for women who plan to become pregnant. If the patient plans to become pregnant, has problems becoming pregnant, or is undergoing fertility tests, they should inform their doctor. The doctor may consider stopping Nabuton VP.

Driving and using machines

Nabuton VP has a minor or moderate effect on the ability to drive and use machines.
After taking Nabuton VP, the patient may experience side effects, including dizziness or disorientation, which may impair the ability to drive and use machines (see section 4). If such symptoms occur, the patient should not drive or use machines until they have completely resolved.

3. How to take Nabuton VP

This medicine should always be taken exactly as directed by the doctor. If you have any doubts, you should consult a doctor or pharmacist.
Recommended dose
Adults:
Orally, 1 g (2 tablets) once a day.
The doctor may decide to use a higher dose.
The maximum dose is 2 g (2 x 2 tablets) per day, taken in the morning and evening.
Children and adolescents:
Nabuton VP is not recommended for use in children and adolescents due to the lack of data on safety and efficacy.
Use in elderly patients:
Treatment should be started with a dose of 500 mg once a day.
The doctor may decide to use a higher dose.
Doses higher than 1 g per day should not be taken.
Dosage in patients with liver function disorders:
Nabuton VP should not be taken by patients with severe liver failure.
Dosage in patients with kidney function disorders:
In patients with kidney function disorders, the doctor may decide to reduce the dose of the medicine.
Taking the medicine in the smallest effective dose for the shortest possible time necessary to alleviate symptoms reduces the risk of side effects.

Taking a higher dose of Nabuton VP than recommended

In case of taking a higher dose of the medicine than recommended, you should immediately contact a doctor or pharmacist.
After taking a higher dose of Nabuton VP than recommended, the following symptoms may occur:
nausea, vomiting, abdominal pain, gastrointestinal bleeding, diarrhea, disorientation, agitation, coma, drowsiness, dizziness, and in single cases, convulsions. In case of significant overdose, acute kidney failure and liver damage may occur.

Missing a dose of Nabuton VP

In case of missing a dose of the medicine at the scheduled time, you should take it as soon as possible. However, if it is close to the time of taking the next dose, you should skip the missed dose. You should not take a double dose to make up for the missed dose.

Stopping treatment with Nabuton VP

In case of stopping treatment with Nabuton VP, the symptoms of the disease for which it was taken may worsen.
If you have any further doubts about taking the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Nabuton VP can cause side effects, although not everybody gets them.
The following side effects may occur in connection with taking Nabuton VP:

Common (may affect up to 1 in 10 people)

• tinnitus, hearing disturbances;
• increased blood pressure;
• diarrhea, constipation, nausea, gastritis, nausea, abdominal pain, bloating with gas;
• rash, itching (pruritus);
• edema.

Uncommon (may affect up to 1 in 100 people)

• disorientation, nervousness, insomnia;
• drowsiness, dizziness, headache, paresthesia (numbness, tingling);
• vision disturbances, eye diseases;
• shortness of breath, breathing difficulties, nosebleeds;
• stomach ulcers and (or) duodenal ulcers, gastrointestinal bleeding, gastrointestinal disorders, black tarry stools, vomiting, oral mucositis, dryness of the oral mucosa;
• photosensitivity, hives, sweating;
• myopathy (muscle pain, muscle weakness);
• urinary tract disorders;
• asthenia (weakness, fatigue), tiredness;
• abnormal liver function test results.

Rare (may affect up to 1 in 10,000 people)

• decreased platelet count;
• anaphylaxis (a severe, potentially life-threatening, generalized or systemic allergic reaction) and pseudoallergic reactions, whose symptoms are similar to those observed in anaphylaxis;
• interstitial lung disease;
• liver failure, jaundice;
• severe skin reactions, such as toxic epidermal necrolysis and Stevens-Johnson syndrome (severe syndromes in which general symptoms, such as fever, sore throat, cough, chills, muscle and joint pain, are accompanied by skin and mucous membrane changes, such as redness, blisters, erosions), erythema multiforme (a rash characterized by ring-shaped lesions, usually located on the extremities, although they can also affect other areas and mucous membranes);
• angioedema (a severe allergic reaction with swelling localized in the face, lips, mouth, tongue, and (or) throat, which can cause difficulty breathing), pseudo-porphyria (a condition characterized by blisters, bullae on the skin);
• alopecia;
• kidney failure, nephrotic syndrome;
• excessive menstrual bleeding.

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

• hematemesis;
• ulcerative stomatitis;
• exacerbation of ulcerative colitis and Crohn's disease.

Taking such medications as Nabuton VP may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
In connection with treatment with such medications as Nabuton VP, edema, hypertension, and heart failure have been reported.
Widespread rash, high body temperature, elevated liver enzyme activity, blood disorders (eosinophilia), lymphadenopathy, and involvement of other organs (a reaction to the medicine with eosinophilia and systemic symptoms, also known as DRESS or hypersensitivity syndrome). If such symptoms occur, you should stop taking Nabuton VP and consult your doctor or seek immediate medical attention. See also section 2.

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 Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181 C, 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Nabuton VP

Store in a temperature below 25°C.
Store in a place out of sight and reach of children.
Do not take Nabuton VP after the expiry date stated on the packaging after "Expiry date". The expiry date refers to the last day of the month stated.
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 pack and other information

What Nabuton VP contains

The active substance of the medicine is nabumetone.
The other ingredients of the medicine are: microcrystalline cellulose (E 460), povidone (E 1201), sodium lauryl sulfate, magnesium stearate (E 572), croscarmellose sodium.

What Nabuton VP looks like and contents of the pack

Nabuton VP is available in the form of tablets. It is packaged in blisters of 10 tablets made of PVC/Al foil.
The carton contains 2 or 6 blisters, along with the patient information leaflet.

Marketing authorization holder:

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel.: +48 17 865 51 00

Manufacturer:

ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-105 Rzeszów
Date of last revision of the leaflet:May 2025