Package Insert: Information for the User

Relif 1000 mg Dispersible Tablets

nabumetona

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6.Contents of the Package and Additional Information

Relif belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs) with high anti-inflammatory activity and analgesic and antipyretic properties.

Relif is indicated in adults for the treatment of inflammatory processes, such as osteoarthritis and rheumatoid arthritis, and periarticular discomfort.

It is essential to use the smallest effective dose to alleviate/control pain and not to take this medication for longer than necessary to control your symptoms.

Do not take Relif:

• If you are allergic to nabumetone or any of the other components of this medication (listed in section 6).
• If you have experienced asthma, hives, or other allergic reactions after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• If you have a severe liver disease.
• If you have had or have a stomach or duodenal ulcer or have experienced gastrointestinal bleeding.
• If you are in the third trimester of pregnancy or breastfeeding.
• If you have severe heart failure, or a cerebrovascular problem (stroke or cerebral hemorrhage) or other hemorrhage.

Warnings and precautions

Consult your doctor or pharmacist before starting to take nabumetone:

• If you are taking other anti-inflammatory medications.
• If you are an elderly person, or have had ulcers, gastrointestinal bleeding, or perforation, as your doctor may prescribe a stomach protector.
• If you are taking medications that alter blood coagulation, such as oral anticoagulants, corticosteroids, antidepressants (selective serotonin reuptake inhibitors), and antiplatelet agents of the type acetylsalicylic acid and clopidogrel.
• If you have Crohn's disease or ulcerative colitis, as medications like Relif may worsen these conditions.
• If during treatment with nabumetone you experience bleeding or ulcers, discontinue the medication immediately.
• If you have or have had any heart disorder, cerebrovascular disorder, or high blood pressure.
• If you have edema (fluid retention).
• Severe skin reactions may occur with this medication (erythema, mucosal lesions, and other signs of hypersensitivity). In this case, discontinue nabumetone immediately.
• If you are a fertile woman or are trying to become pregnant.
• If acetylsalicylic acid or other anti-inflammatory medications cause you asthma, hives, or other allergic reactions. Your doctor will monitor your first dose of nabumetone.
• If you have systemic lupus erythematosus and mixed connective tissue disease (chronic diseases that affect the immune system), as meningitis may occur (inflammation of the meninges not caused by bacteria).
• If you have kidney or liver disease, your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks and if necessary, the interruption of treatment.

Nonsteroidal anti-inflammatory drugs, including nabumetone, may mask the symptoms or signs of an infection (fever, pain, and inflammation).

If you experience vision problems during treatment with nabumetone, consult your doctor, as an ophthalmological examination may be necessary.

The adverse effects can be minimized by taking the most effective dose and for the shortest time possible to control symptoms.

Children and adolescents

This medication is not recommended for children or adolescents.

Other medications and Relif

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The following medications may interact and should not be taken with nabumetone without consulting your doctor:

• Medications that alter blood coagulation, such as corticosteroids, oral anticoagulants of the type warfarin, or antiplatelet agents of the type acetylsalicylic acid.
• Medications that may increase the risk of bleeding, such as corticosteroids and antidepressants (selective serotonin reuptake inhibitors), bisphosphonates (to prevent osteoporosis), pentoxifylline (to treat intermittent claudication), sulfinpyrazone (to treat gout), and alcohol.

In general, nabumetone may also interact with other medications, such as:

• Methotrexate (to treat cancer and inflammatory diseases).
• Digoxin and other cardiac glycosides (to treat heart disorders).
• Lithium (antidepressant).

(Your doctor may adjust the doses of these medications).

• Diuretics (increase urine elimination).
• Antihypertensives (to treat high blood pressure).
• Sulfonamides (to treat certain bacterial infections).
• Sulfonylureas (to treat diabetes).
• Hydantoins (antiepileptic).
• Ciclosporin (to prevent organ transplant rejection).
• Mifepristone (to terminate pregnancy).
• Probenecid (to treat gout).
• Quinolone antibiotics.

It is not recommended to use nabumetone at the same time as another nonsteroidal anti-inflammatory drug.

However, other commonly used medications such as paracetamol, acetylsalicylic acid, cimetidine, and antacids of aluminum hydroxide do not interact with nabumetone.

Taking Relif with food, drinks, and alcohol

If you take alcohol while on treatment with this medication, you may be more prone to experiencing gastrointestinal side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are trying to become pregnant, consult your doctor or pharmacist before using this medication.

Due to the association of nabumetone administration with an increased risk of congenital anomalies/abortions, it is not recommended to administer the medication during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration should be limited to the minimum possible.

In the third trimester, the administration of nabumetone is contraindicated, as it may harm the fetus or cause problems during delivery. It may cause renal and cardiac problems in the fetus. It may affect your bleeding tendency and that of your baby, and may cause a delay or prolongation of delivery. Do not take nabumetone during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while trying to become pregnant, use the lowest dose for the shortest time possible. If taken for more than a few days after 20 weeks of pregnancy, nabumetone may cause renal problems in your unborn baby/fetus that may lead to low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

The excretion of nabumetone in breast milk is unknown, however, its active metabolite is excreted in milk in animals. Due to the possible risk of severe adverse reactions in the infant, it is necessary to decide whether to interrupt breastfeeding or interrupt treatment after considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Women of childbearing age should be aware that medications like nabumetone have been associated with a decrease in the ability to conceive, so it is not recommended to use them in women trying to become pregnant.

Driving and operating machinery

Patients who experience dizziness and confusion after taking nabumetone should not drive, operate hazardous machinery, and avoid situations that require special alertness.

Relif contains sodium and glucose

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free."

This medication contains glucose (from cornstarch maltodextrin). If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults:

1 tablet (1000 mg) per day, taken orally. Tablets can be taken with or without food. In cases where the doctor considers it necessary, the dose may be increased up to 1500 mg or 2000 mg, which can be taken in a single dose or divided into two doses.

Do not exceed a dose of 2000 mg (2 tablets) per day.

Use inchildren and adolescents:

This medication is not recommended for children or adolescents.

Older patients:

The total daily dose should not exceed 1000 mg. The initial dose should be 500 mg.

Renal problems:

Generally, no dose adjustment is necessary for patients with renal problems.

Administration form:

Oral route.

Relif tablets should be dissolved in a little water before administration.

Your doctor will indicate the duration of your treatment with Relif. Do not stop treatment prematurely.

Remember to take your medication.

If you take more Relif than you should

You may experience symptoms such as nausea, vomiting, stomach pain, gastrointestinal bleeding, rarely diarrhea, disorientation, excitement, coma, drowsiness, dizziness, and in some cases, seizures. In cases of severe poisoning, acute renal failure and liver damage may occur.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 5620420. However, if the amount is significant, go to your doctor as soon as possible or to the emergency service of the nearest hospital and bring this leaflet with you.

If you forgot to take Relif

Do not take a double dose to make up for the missed doses.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most common side effects that occur with medicines like nabumetona are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in older people. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stool, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, the appearance of gastritis has been observed.

If you experience any of these adverse reactions, inform your doctor and he will evaluate the convenience of suspending or continuing treatment.

The usual side effects in terms of frequency are as follows:

Frequent(affect up to 1 in 10 people):

Ringing or ear disturbances. Increased blood pressure. Diarrhea, constipation, stomach burning, stomach mucosa inflammation, nausea, abdominal pain, flatulence. Skin rash and itching. Edema.

Rare(affect up to 1 in 100 people):

Confusion, nervousness, insomnia. Drowsiness, dizziness, headache, paresthesia (tingling sensation in extremities). Abnormal vision, eye alterations. Difficulty breathing and respiratory alterations, nasal bleeding. Duodenal ulcer, gastrointestinal bleeding, gastric ulcer, gastrointestinal alterations, black stools, vomiting, stomatitis(inflammation of the mucous membrane ofthe mouth), dry mouth. Light sensitivity, itching, sweating. Myopathy (muscle disease). Urinary tract alterations. Feeling of fatigue, tiredness. Elevated liver function tests.

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

Platelet decrease. Allergic reactions. Interstitial pneumonitis (lung inflammation). Jaundice (yellow discoloration of the skin), liver failure. Bullous skin reactions including Stevens syndrome, toxic epidermal necrolysis, pseudoporphyria, erythema multiforme, angioedema (skin swelling), alopecia. Nephrotic syndrome (kidney inflammation), kidney failure. Menorrhagia (heavy menstrual bleeding).

Frequency unknown(cannot be estimated from available data):

Anemia (lack of blood due to insufficient production of red blood cells or premature destruction of the same). Hallucinations. Aseptic meningitis (with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or disorientation).

Edema, high blood pressure, and heart failure have been reported in association with treatment with NSAIDs. In addition, if NSAIDs are taken in high doses and for a prolonged period, it may increase the risk of atherothrombotic events (such as myocardial infarction or stroke).

Generalized rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and affection of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). Stop using Relif if you experience these symptoms and contact your doctor or seek medical attention immediately. See section 2.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Preserve the blister pack in the outer packaging to protect it from light and humidity. Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Relif

The active ingredient is nabumetone.

Each dispersible tablet contains 1000 mg of nabumetone.

The other components are: sodium saccharin, sodium croscarmellose, povidone, sodium lauryl sulfate, peppermint essence, vanilla essence (contains corn-derived maltodextrin), magnesium stearate, microcrystalline cellulose.

Appearance of the product and contents of the packaging

Relif is presented in the form of dispersible tablets. Each package contains a blister pack with 20 dispersible tablets.

Holder of the marketing authorization:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing:

Haupt Pharma Wülfing GmbH

Bethelner Landstraße 18

31028 Gronau/Leine, Niedersachsen

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the last review of this leaflet:February 2023

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/