Relif 1000 mg dispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Relif 1000 mg dispersible tablets

nabumetone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Relif is and what it is used for

2. What you need to know before taking Relif

3. How to take Relif

4. Possible side effects

5. How to store Relif

6. Contents of the pack and other information

1. What Relif is and what it is used for

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

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

2. What you need to know before taking Relif

It is important to use the lowest dose that relieves/controls your pain and not to take this medicine for longer than necessary to control your symptoms.

Do not take Relif:

• If you are allergic to nabumetone or to any of the other ingredients of this medicine (listed in section 6).
• If you have experienced asthma, itching, or other allergic reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If you have severe liver disease.
• If you have had or currently have a stomach or duodenal ulcer, gastrointestinal bleeding, or a perforation of the digestive tract.
• If you are in the third trimester of pregnancy or during breastfeeding.
• If you have severe heart failure, a cerebrovascular disorder (stroke or cerebral hemorrhage), or another type of hemorrhage.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take nabumetone:

• If you are taking other anti-inflammatory medicines.
• If you are elderly or have had ulcers, gastrointestinal bleeding, or perforation, as your doctor may prescribe a stomach-protecting agent.
• If you are taking medications that affect blood clotting, such as oral anticoagulants, corticosteroids, antidepressants (selective serotonin reuptake inhibitors), or antiplatelet agents such as acetylsalicylic acid and clopidogrel.
• If you have Crohn's disease or ulcerative colitis, as medicines like Relif may worsen these conditions.
• If you develop gastrointestinal bleeding or an ulcer while taking nabumetone, stop the medication immediately.
• If you have or have had heart problems, cerebrovascular disorders, or high blood pressure.
• If you experience edema (fluid retention).
• Serious skin reactions may occur with this medicine (skin erythema, mucosal lesions, and other signs of hypersensitivity). In such cases, stop nabumetone treatment immediately.
• If you are a woman of childbearing age or trying to become pregnant.
• If acetylsalicylic acid or other anti-inflammatory drugs cause you asthma, itching, or other allergic reactions. Your doctor will monitor you closely when starting nabumetone.
• If you have systemic lupus erythematosus or mixed connective tissue disease (chronic disorders affecting the immune system), as aseptic meningitis (inflammation of the meninges not caused by bacteria) may occur.
• If you have kidney or liver disease, your doctor may need to perform regular monitoring. Your doctor will advise you on how often these checks are needed and whether treatment should be interrupted.

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

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

Adverse effects can be minimized by using the lowest effective dose for the shortest duration needed to control symptoms.

Children and adolescents

This medicine is not recommended for children or adolescents.

Other medicines and Relif

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

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

• Medicines that affect blood clotting, such as: corticosteroids, oral anticoagulants like warfarin, or antiplatelet agents like acetylsalicylic acid.
• Medicines that may increase the risk of bleeding, such as: corticosteroids and selective serotonin reuptake inhibitor antidepressants, bisphosphonates (to prevent osteoporosis), pentoxifylline (to treat intermittent claudication), sulfinpyrazone (to treat gout), and alcohol.

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

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

(Your doctor may need to adjust the doses of these medicines.)

• Diuretics (increase urine elimination).
• Antihypertensives (for treating high blood pressure).
• Sulfonamides (for treating certain bacterial infections).
• Sulfonylureas (for treating diabetes).
• Hydantoins (antiepileptic drugs).
• Cyclosporine (to prevent organ transplant rejection).
• Mifepristone (for medical termination of pregnancy).
• Probenecid (for treating gout).
• Antibiotics of the quinolone group.

The use of nabumetone together with another non-steroidal anti-inflammatory drug is not recommended.

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

Taking Relif with food, drinks, and alcohol

If you consume alcohol while taking this medication, you may be more likely to experience gastrointestinal adverse effects.

Pregnancy, breastfeeding, and fertility

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

Since the administration of drugs of the type of nabumetone has been associated with an increased risk of congenital anomalies/miscarriage, administration during the first and second trimesters of pregnancy is not recommended unless considered strictly necessary. In such cases, the dose and duration of treatment should be limited to the minimum possible.

During the third trimester, the administration of nabumetone is contraindicated, as it may harm the fetus or cause complications during childbirth. It may cause renal and cardiac problems in the fetus. It may affect your tendency to bleed and that of your baby, and may delay or prolong labor. You should not take nabumetone during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is required during this period or while trying to become pregnant, the lowest possible dose should be used for the shortest possible time. If taken for more than a few days starting from 20 weeks of pregnancy, nabumetone may cause kidney problems in your unborn baby/fetus, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for more than a few days is needed, your doctor may recommend additional monitoring.

It is unknown whether nabumetone is excreted in human breast milk; however, its active metabolite is excreted in the milk of animals. Due to the potential risk of serious adverse reactions in the nursing infant, a decision must be made whether to discontinue breastfeeding or to discontinue treatment, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Female patients of childbearing potential should be aware that drugs of the type of nabumetone have been associated with a reduced fertility capacity; therefore, their use is not recommended in women attempting to become pregnant.

Driving and operating machinery

Patients who experience dizziness or confusion after taking nabumetone should not drive cars, operate heavy machinery, or engage in any activities requiring special alertness.

Relif contains sodium and glucose

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

This medicine contains glucose (derived from corn maltodextrin). If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Relif

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults:

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

The daily dose must not exceed 2000 mg (2 tablets).

Use in children and adolescents:

This medicine is not recommended for children or adolescents.

Elderly patients:

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

Kidney problems:

In general, dose adjustment is not necessary in patients with kidney problems.

Method of administration:

Oral use.

Relif tablets must be dissolved in a small amount of water before administration.

Your doctor will advise you on how long your treatment with Relif should last. Do not stop treatment prematurely.

Remember to take your medicine.

If you take more Relif than you should

Symptoms such as nausea, vomiting, stomach pain, gastrointestinal bleeding, rarely diarrhea, disorientation, excitement, coma, drowsiness, dizziness, and occasionally seizures may occur. In cases of severe poisoning, acute kidney failure and liver damage may occur.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 5620420. However, if the amount ingested is significant, seek immediate medical attention or go to the nearest hospital emergency department and take this leaflet with you.

If you forget to take Relif

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

4. Possible adverse effects

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

The most common adverse effects associated with medicines such as nabumetone are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhoea, flatulence, constipation, heartburn, abdominal pain, blood in stools, mouth ulcers, and worsening of ulcerative colitis and Crohn's disease have also been observed. Gastritis has been observed less frequently.

If you experience any of these adverse reactions, inform your doctor, who will assess whether treatment should be discontinued or continued.

The commonly occurring adverse effects, according to their frequency, are as follows:

Frequent (affects up to 1 in 10 people):

Tinnitus or ear disorders. Increased blood pressure. Diarrhoea, constipation, heartburn, inflammation of the stomach lining, nausea, abdominal pain, flatulence. Skin rash and itching. Oedema.

Uncommon (affects up to 1 in 100 people):

Confusion, nervousness, insomnia. Drowsiness, dizziness, headache, paraesthesia (tingling sensation in limbs). Visual disturbances, ocular disorders. Difficulty breathing and respiratory disorders, nosebleeds. Duodenal ulcer, gastrointestinal bleeding, gastric ulcer, gastrointestinal disorders, black stools, vomiting, stomatitis (inflammation of the mucosa of the mouth), dry mouth. Light sensitivity, itching, sweating. Myopathy (muscle disease). Urinary tract disorders. Feeling of tiredness, fatigue. Elevated liver function tests.

Rare (affects up to 1 in 10,000 people):

Decreased platelet count. Allergic reactions. Interstitial pneumonitis (lung inflammation). Jaundice (yellowing of the skin), liver failure. Blistering skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, pseudoporphyria, erythema multiforme, angioedema (skin swelling), alopecia. Nephrotic syndrome (kidney inflammation), kidney failure. Menorrhagia (heavy menstrual bleeding).

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

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

Oedema, arterial hypertension, and heart failure have been reported in association with NSAID treatment. In addition, when NSAIDs are taken at high doses and for prolonged periods, the risk of atherothrombotic events (such as myocardial infarction or stroke) may increase.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Relif

Keep the blister in the outer packaging to protect it from light and moisture. Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP or CAD. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Relif

The active substance is nabumetone.

Each dispersible tablet contains 1000 mg of nabumetone.

The other components are: sodium saccharin, croscarmellose sodium, povidone, sodium lauryl sulfate, peppermint flavor, vanilla flavor (contains maltodextrin from maize), magnesium stearate, microcrystalline cellulose.

Appearance of the product and contents of the pack

Relif is presented as dispersible tablets. Each pack contains a blister with 20 dispersible tablets.

Marketing Authorization Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Haupt Pharma Wülfing GmbH

Bethelner Landstraße 18

31028 Gronau/Leine, Niedersachsen

Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the most recent review of this leaflet: February 2023

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/