Relifex 1g, Relifex 500mg Nabumetone Film Coated Tablets
What Relifex Is And What Relifex Used For?
Relifex belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory / anti-rheumatic medicines). Relifex works by inhibiting a group of substances in the body called prostaglandins, which are formed in increased amounts, including inflammation.
Relifex used for stiff and sore joints in case of joint wear and tear ( osteoarthritis ).
What You Need To Know Before Taking Relifex
Do Not Take Relifex
- If you are allergic to nabumetone or any of the other ingredients of this medicine (listed in section 6)
- If you have previously had allergic reactions such as asthma, rash, or other types of allergic reactions when you have taken painkillers containing acetylsalicylic acid or other pain/inflammation medicines within the NSAID group
- If you have an increased tendency to bleed
- If you have stomach ulcers or duodenal ulcers
- If you have had stomach ulcers or duodenal ulcers during treatment with nabumetone or similar preparations
- If you have had recurrent stomach ulcers, duodenal ulcers, or gastrointestinal disease
- If you have a severe hepatic impairment, severe heart failure, or severe kidney disease
- During the last 3 months of pregnancy
- During breastfeeding
- Ongoing cerebral hemorrhage or another bleeding
Warnings And Cautions
Never use several different painkillers at the same time without consulting a doctor or pharmacist.
The lowest possible dose and the shortest possible treatment time should always be sought to reduce the risk of side effects. For painkillers, it generally applies that higher doses than those recommended can lead to serious risks.
Talk to your doctor or pharmacist before using Relifex if you have or have had the following diseases:
- Connective tissue diseases ( SLE or MCTD)
- Impaired renal or hepatic function
- Heart failure
- High blood pressure
- Asthma
- Inflammatory bowel disease (such as ulcerative colitis or Crohn’s disease )
- Gastric ulcer or duodenal ulcer
- Diseases with an increased tendency to bleed
- Fluid retention in the body ( fluid retention )
Elderly people should be aware of the increased risk of side effects that exist in old age. Especially at the beginning of treatment, patients who have previously had problems with the gastrointestinal tract, especially elderly patients, should contact a doctor in case of symptoms from the abdomen.
Stop taking Relifex and contact a doctor immediately if swelling of the face, tongue, and throat or difficulty swallowing or hives with breathing difficulties occur ( angioedema ).
Severe skin reactions when using NSAIDs have been reported in very rare cases. Stop taking Relifex and consult a doctor if you get a rash or damage to the mucous membranes. For chickenpox, this medicine should not be used.
Like other NSAIDs, Relifex can mask signs or symptoms of infection.
Medicines such as Relifex may have a small increased risk of heart attack or stroke. Such an increase in risk is more likely with high doses and long-term treatment. Do not exceed the recommended dose or treatment time (two weeks).
Tell your doctor if you develop blurred or impaired vision during treatment with Relifex. Talk to your doctor or pharmacist about your treatment if you have heart problems, had a stroke before, or think you have an increased risk of these conditions (eg if you have high blood pressure, diabetes, high cholesterol, or if you smoke).
Other Medicines And Relifex
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and (traditional) herbal and herbal medicines. Treatment with Relifex may affect or be affected by certain drug substances against:
- Blood clots (eg warfarin, ticlopidine)
- Cancer and disorders of the immune system (methotrexate)
- Depression (so-called SSRIs )
- High blood pressure and heart disease (eg so-called beta-receptor blockers, diuretics, ACE inhibitors, angiotensin II inhibitors)
- Inflammation and hypersensitivity reactions ( corticosteroids )
- Manic depression (lithium)
- Pain (so-called NSAIDs )
- Organ rejection after transplantation (cyclosporine, tacrolimus)
- Epilepsy (eg phenytoin )
- Arrhythmias in the heart (cardiac glycosides)
- Infection is ( sulfonamides, quinolones are)
- Diabetes (sulphonylureas)
- Termination of pregnancy (mifepristone)
- Gout (probenecid)
Concomitant use of alcohol, bisphosphonates, oxpentifylline (pentoxifylline), and sulfinpyrazone may increase the risk of bleeding or ulceration of the gastric mucosa.
Using Relifex With Food And Drink
Relifex can be taken with or without food. For alcohol use, see section ‘Other medicines and Relifex’.
Pregnancy, Breastfeeding, And Fertility
Pregnant women should not use Relifex during the last three months of pregnancy. Relifex should be avoided by women who are planning to become pregnant or are pregnant.
Treatment during any part of the pregnancy should only be done after a doctor’s prescription. It is not known whether nabumetone passes into breast milk. You should not take Relifex if you are breastfeeding. Your doctor will decide if you should stop taking Relifex or breastfeed your baby. Always consult your doctor.
Relifex, like all medicines that inhibit cyclooxygenase/prostaglandin synthesis, may make it difficult for you to get pregnant. Talk to your doctor if you are planning a pregnancy or have problems getting pregnant.
Driving And Using Machines
During treatment with Relifex, dizziness, confusion, and fatigue may occur. If such or similar symptoms occur, this should be considered when sharper attention is required, for example, when driving a car.
You are responsible for assessing whether you can drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects.
Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Relifex Contains Sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How To Take Relifex?
- Always take this medicine as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- The usual dose for adults
- 2 tablets of 500 mg once daily.
- The analgesic effect occurs gradually. Higher doses do not increase the effect, so the recommended dose should not be exceeded.
Contact a doctor if the condition does not improve within two weeks.
If You Use More Relifex Than You Should
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Possible Relifex Side Effects
Relifex can cause side effects like all medicines, although not everybody gets them.
Common Relifex side effects (may affect up to 1 in 10 people):
- Diarrhoea
- Indigestion (including acid reflux)
- Abdominal pain
- Gastritis
- Nausea
- Flatulence
- Constipation
- Blood in the stool
- Edema (accumulation of fluid in tissues )
- Drowsiness
- Itching
- Rash
- Blurred vision
- Tinnitus
- High blood pressure
Uncommon (may affect up to 1 in 100 people):
- Shortness of breath
- Anxiety
- Depression
- Stomach ulcers
- Duodenal ulcers
- Photosensitivity
- Hives
- Sweating
- Confusion
- Nervousness
- Drowsiness
- Fatigue
- Weakness
- Dizziness
- Headache
- Crawling
- Insomnia
- Visual disturbances
- Eye effects
- Lung disease
- Nosebleeds
- Bleeding from the stomach and intestines
- Disorders of the gastrointestinal tract
- Black stools
- Vomiting
- Elevated liver function values
- Muscle disease
- Disorders of the urinary tract
- Inflammation of the mouth
- Dry mouth
- If dry mouth occurs, careful oral hygiene is important (toothbrushing with fluoride toothpaste twice daily).
Very rare (may affect up to 1 in 10,000 people):
- Decreased platelet count
- Hypersensitivity reactions
- Pneumonia
- Liver failure
- Jaundice
- Hypersensitivity reaction in the form of swelling of the face, lips, tongue, and throat ( angioedema see Warnings and caution)
- Hair loss
- Severe skin effects such as:
- Epidermis
- Multiple skin redness and skin reaction with inflammation
- High fever
- Skin changes with blistering (pseudoporphyria)
- Kidney failure
- Kidney effects
- Heavy menstruation
- Widespread rash
- Fever
- Elevated liver enzyme levels
- Blood abnormalities ( eosinophilia )
- Enlarged lymph nodes
- Involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also
- called DRESS, or drug hypersensitivity syndrome)
Stop using Relifex immediately if you develop these symptoms, and contact your doctor or seek medical attention immediately. See also section 2.
The following side effects have also been reported (occurring in an unknown number of users):
- High blood pressure
- Heart failure
- Oedema (fluid accumulation in tissues )
- Bloody vomiting
- Black stools
- Inflammation of the lining of the stomach
- Inflammation of the mouth, swelling of colitis
- Crohn’s disease
- Various forms of anemia
- Hallucinations
- Meningitis
In rare cases
- Severe skin infections are associated with chickenpox.
Medicines such as Relifex, especially in high doses and with long-term treatment, may have a small increased risk of heart attack or stroke.
How To Store Relifex?
- Keep out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton after EXP.
- Medicines should not be disposed of via wastewater or household waste. Ask at the pharmacy how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information
Content Declaration
- Active substance: Nabumetone 500 mg.
- The other ingredients are sodium starch glycolate, sodium lauryl sulfate, hypromellose, microcrystalline cellulose, saccharin sodium, macrogol, titanium dioxide (dye E 171), and caramel flavouring.
What The Medicine Looks Like And The Contents Of The Pack
- White, oblong tablet.
- Printed packaging: 30 tablets (non-prescription) and 20 and 100 tablets (prescription).
- Not all pack sizes may be marketed.