NABUTON VP

Package leaflet: information for the user

Nabuton VP
500 mg, tablets
Nabumetone
Please read this leaflet carefully before using the medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual and should not be passed on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

Nabuton VP contains nabumetone as the active substance. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) – it has anti-inflammatory, analgesic and antipyretic properties.
Nabumetone becomes active only after undergoing metabolic transformation in the body (in the case of nabumetone, the substance formed by this transformation and primarily responsible for the drug's biological action is 6-methoxy-2-naphthylacetic acid). As a result, its irritating effect on the gastrointestinal mucosa is significantly lower than that of many other non-steroidal anti-inflammatory drugs, which are administered in their fully active form.
Nabuton VP is used in the treatment of osteoarthritis and rheumatoid arthritis.

2. Information before using Nabuton VP

When not to use 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 previously experienced an asthma attack, urticaria, or other allergic reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has severe liver failure;
• if the patient currently has or has ever had gastrointestinal damage or bleeding;
• if the patient has or has ever had gastric or duodenal ulcer disease;
• if the patient has severe heart failure;
• if the patient has active cerebral haemorrhage or other bleeding disorders;
• if the patient is in the third trimester of pregnancy or is breastfeeding.

Warnings and precautions
Before starting treatment with Nabuton VP, discuss this with your doctor or pharmacist.

• if the patient is over 65 years of age (see also below and section 3);
• if the patient is concurrently taking oral corticosteroids, anticoagulants such as warfarin, other NSAIDs, antidepressants known as selective serotonin reuptake inhibitors (SSRIs), or antiplatelet agents such as acetylsalicylic acid or clopidogrel (see below "Nabuton VP and other medicines");
• if the patient has gastrointestinal disorders such as ulcerative colitis or Crohn's disease (risk of exacerbation of symptoms);
• if the patient has hypertension (high blood pressure);
• if the patient has symptoms of fluid retention (oedema);
• if the patient has heart diseases, such as mild to moderate heart failure or ischaemic heart disease;
• if the patient has peripheral arterial or cerebrovascular disease;
• if the patient has hyperlipidaemia (elevated cholesterol and triglyceride levels in the blood);
• if the patient has diabetes;
• if the patient smokes;
• if the patient has impaired kidney function (see section 3, subsection "Dosage in patients with renal impairment");
• if the patient has impaired liver function (see section 3, subsection "Dosage in patients with hepatic impairment").

Additional warnings:
If, during treatment with Nabuton VP, the patient experiences any signs of hypersensitivity,
such as skin rash, erythema, blisters, erosions, pain, particularly accompanied by general
symptoms such as fever, sore throat, cough, chills, or muscle and joint pain, the medicine should
be discontinued immediately and the patient should contact their doctor without delay. These may
be symptoms of a severe, sometimes life-threatening skin reaction.
If visual disturbances occur during treatment with Nabuton VP, such as blurred vision, the patient
should inform their doctor, who may recommend ophthalmological examination.
During treatment, gastrointestinal symptoms such as abdominal pain, indigestion, diarrhoea,
nausea, vomiting, blood in stools, tarry stools, or coffee-ground vomit may occur, which may
indicate gastrointestinal damage caused by Nabuton VP.
Gastrointestinal injury due to Nabuton VP, as with other NSAIDs, may occur at any time during
treatment, with or without preceding symptoms, regardless of whether the patient previously had
gastrointestinal problems. The risk is higher in elderly patients.
Use of medicines such as Nabuton VP may be associated with a small increased risk of myocardial
infarction (heart attack) or stroke. This risk increases with long-term use of high doses.
Doses higher than recommended or prolonged treatment duration should be avoided.
Nabuton VP may mask symptoms of existing infection.
Nabuton VP contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".
Children and adolescents
The use of Nabuton VP in children and adolescents is not recommended due to lack of data on safety and efficacy.
Nabuton VP and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Nabuton VP may affect the action of certain medicines, and some medicines may affect the action of Nabuton VP.
Inform your doctor or pharmacist if the patient is taking any of the following medicines:

• corticosteroids (medicines with strong anti-inflammatory and anti-allergic effects, used e.g. in skin diseases);
• anticoagulants such as warfarin;
• antiplatelet agents such as acetylsalicylic acid or clopidogrel;
• antidepressants known as selective serotonin reuptake inhibitors (used in the treatment of depression);
• paracetamol (analgesic and antipyretic medicine);
• acetylsalicylic acid (analgesic and anti-inflammatory medicine, also used prophylactically in diseases with risk of thrombosis and embolism);
• cimetidine (medicine used e.g. in the treatment of heartburn and peptic ulcer disease);
• aluminium-containing antacids (medicines used e.g. in the treatment of heartburn);
• cardiac glycosides (medicines used in certain heart diseases);
• methotrexate (medicine used e.g. in the treatment of cancer and rheumatic diseases);
• lithium (medicine used in the treatment of psychiatric disorders);
• diuretics;
• certain antihypertensive medicines: angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers;
• other NSAIDs, including selective COX-2 inhibitors;
• certain antibacterial sulphonamides and certain antidiabetic medicines.

Concomitant use of more than one NSAID is not recommended.
Taking Nabuton VP with food and drink
Nabuton VP should be taken during or after a meal.
Food accelerates the absorption of Nabuton VP.
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 her doctor or pharmacist before using this medicine.
Pregnancy
Nabuton VP should not be taken during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in both the mother and the child and may delay or prolong labour. The medicine should not be used during the first six months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration. From week 20 of pregnancy, Nabuton VP may cause kidney dysfunction in the unborn child if used for more than a few days. This may lead to reduced amniotic fluid volume (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment longer than a few days is required, the doctor may recommend additional monitoring.
Breastfeeding
Nabuton VP must not be used in women who are breastfeeding.
If the patient is breastfeeding, she should consult her doctor, who may decide to discontinue breastfeeding or stop treatment with Nabuton VP.
Effect on fertility
Use of Nabuton VP may adversely affect fertility in women and is not recommended in women who are planning to become pregnant. If the patient is planning to become pregnant, has difficulty conceiving, or is undergoing fertility investigations, she should inform her doctor. The doctor may consider discontinuing treatment with Nabuton VP.
Driving and using machines
Nabuton VP has a minor or moderate effect on the ability to drive and operate machinery.
After taking Nabuton VP, adverse effects such as dizziness or disorientation may occur, which could impair the ability to drive and operate machinery (see section 4). If such symptoms occur, driving and operating machinery should be avoided until symptoms have completely resolved.

3. How to use Nabuton VP

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Recommended dose
Adults:
Orally, 1 g (2 tablets) once daily.
Your doctor may decide that a higher dose is necessary.
The maximum dose is 2 g (2 times 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 lack of data
on safety and efficacy.
Use in elderly patients:
It is recommended to start treatment with a dose of 500 mg once daily.
Your doctor may decide that a higher dose is necessary.
Doses exceeding 1 g per day should not be used.
Dosing in patients with hepatic impairment:
Nabuton VP should not be used in patients with severe liver impairment.
Dosing in patients with renal impairment:
In patients with impaired renal function, the doctor may decide that a dose reduction is necessary.
Using the lowest effective dose for the shortest duration needed to relieve symptoms reduces the risk of adverse effects.
Use of a higher than recommended dose of Nabuton VP
If a higher than recommended dose is used, contact your doctor or pharmacist immediately.
After taking a higher than recommended dose of Nabuton VP, the following symptoms may occur:
nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhea,
disorientation, agitation, coma, drowsiness, dizziness, and in isolated cases
seizures. In cases of significant overdose, acute renal failure and
liver damage may occur.
Missed dose of Nabuton VP
If the next dose of medicine is missed at the scheduled time, take it as
soon as possible. However, if it is almost time for the next dose, skip the missed
dose. Do not take a double dose to make up for a missed dose.
Discontinuation of Nabuton VP
If treatment with Nabuton VP is discontinued, symptoms of the disease for which it was prescribed may worsen.
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 they do not occur in everyone.
The following adverse reactions may occur with the use of Nabuton VP:

Common (may occur in up to 1 in 10 people)

• Tinnitus, hearing disturbances;
• Increased blood pressure;
• Diarrhoea, constipation, dyspepsia, gastritis, nausea, abdominal pain, flatulence;
• Rash, pruritus (itching);
• Oedema.

Uncommon (may occur in up to 1 in 100 people)

• Disorientation, nervousness, insomnia;
• Drowsiness, dizziness, headache, paraesthesia (numbness, tingling);
• Visual disturbances, eye disorders;
• Dyspnoea, respiratory disorders, epistaxis;
• Gastric and/or duodenal ulcers, gastrointestinal bleeding, gastrointestinal disorders, melaena, vomiting, stomatitis, dry mouth;
• Photosensitivity, urticaria, sweating;
• Myopathy (muscle pain, muscle weakness);
• Urinary disorders;
• Asthenia (weakness, exhaustion), fatigue;
• Abnormal liver function test results.

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

• Thrombocytopenia (decreased platelet count);
• Anaphylaxis (severe, sometimes life-threatening generalized or systemic allergic reaction) and pseudoallergic reactions with symptoms similar to those observed in anaphylaxis;
• Interstitial lung disease;
• Liver failure, jaundice;
• Severe skin reactions such as toxic epidermal necrolysis and Stevens-Johnson syndrome (serious conditions in which general symptoms such as fever, sore throat, cough, chills, and joint-muscle pain are accompanied by skin and mucosal lesions such as erythema, blisters, erosions), erythema multiforme (erythematous-edematous lesions, typically ring-shaped, usually located on distal parts of limbs, but may also affect skin in other areas and mucous membranes);
• Angioedema (severe allergic reaction with swelling localized in the face, lips, oral cavity, tongue, and/or throat, which may lead to breathing difficulties), pseudoporphyria (manifesting as blisters, bullae on the skin);
• Alopecia;
• Renal failure, nephrotic syndrome;
• Excessive menstrual bleeding.

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

• Haematemesis (vomiting blood);
• Ulcerative stomatitis;
• Exacerbation of ulcerative colitis and Crohn's disease.

Use of medicines such as Nabuton VP may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Treatment with medicines such as Nabuton VP has been associated with reports of oedema, hypertension, and heart failure.
Widespread rash, high body temperature, elevated liver enzyme activity, blood disorders (eosinophilia), lymphadenopathy, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) have been reported. If such symptoms occur, treatment with Nabuton VP should be discontinued immediately and medical advice should be sought from your physician or urgent medical assistance obtained. See also section 2.
Reporting of 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 181 C, 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 Nabuton VP

Store below 25°C.
Keep in a place invisible and inaccessible to children.
Do not use Nabuton VP after the expiry date stated on the packaging after
"Expiry date". 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 packaging and other information

What the medicine Nabuton VP contains
The active substance is nabumetone.
Other components of the medicine are: microcrystalline cellulose (E 460), povidone (E 1201), sodium lauryl sulfate, magnesium stearate (E 572), sodium croscarmellose.
What the medicine Nabuton VP looks like and contents of the pack
Nabuton VP is in the form of tablets. It is packed in blisters of 10 tablets made of PVC/Al foil.
A cardboard carton contains 2 or 6 blisters together with the package leaflet.
Marketing Authorisation 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 the latest revision of the leaflet: May 2025