Relifex 500mg tablets

Main information

  • Trade name:
  • Relifex 500mg tablets
  • Dosage:
  • 500mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Relifex 500mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 10010100; GTIN: 7317510000011 5060035249190

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 15142/0106
  • Last update:
  • 11-07-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Patient Information Leaflet

Relifex 500 mg & 1 g Film-coated 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 further questions, ask your doctor or

pharmacist.

This

medicine

been

prescribed

you.

Do not pass it on to others. It may harm them, even if

their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist

or nurse. This includes any possible side effects not listed

in this leaflet. See section 4.

In this leaflet, Relifex 500 mg & 1 g Film-coated Tablets

will be called Relifex.

What is in this leaflet:

1. What Relifex is and what it is used for

2. What you need to know before you take Relifex

3. How to take Relifex

4. Possible side effects

5. How to store Relifex

6. Contents of the pack and other information

1. What Relifex is and what it is used for

Relifex belongs to a group of medicines called non-steroi-

dal anti-inflammatory drugs (known as NSAIDs).

It works by reducing the production of some natural

chemicals found in the body. These chemicals (prosta-

glandins) cause the symptoms of inflammation such as

pain and swelling.

Relifex is used to treat the pain, stiffness and swelling of

joints which are affected by osteoarthritis or rheumatoid

arthritis.

2. What you need to know before you take Relifex

Do not take Relifex if:

You are allergic to nabumetone

You are allergic to any of the other ingredients of Relifex

(see section 6)

You have ever had an allergic reaction like a rash, itchy,

runny or bleeding nose, or become short of breath when

you have taken aspirin or other NSAID medicines. Such

medicines

include

ibuprofen,

acetylsalicylic

acid,

diclofenac or naproxen. Some people who have had

previous allergic reactions to NSAID medicines have

very serious, sometimes fatal reactions if they take this

kind of medicine again.

You have, or have ever had a stomach (peptic) ulcer or

any perforation or bleeding (haemorrhage) in your diges

tive system or if you have or have ever had peptic disease

You have serious problems with your heart (severe

heart failure)

You are currently receiving treatment for a stroke or

other internal bleed

You have serious problems with your liver (liver cirrhosis)

You have serious problems with your kidneys (kidney

failure)

You are in the last three months of pregnancy.

You are breast-feeding

If any of the above applies to you, talk to your doctor or

pharmacist.

Check with your doctor before taking Relifex if:

You have, or have ever had asthma

You have, or have ever had stomach problems. This

includes Crohn’s disease or ulcerative colitis

You have kidney problems

You have liver problems

You have heart problems

You have or have ever had high blood pressure (hyper-

tension)

You have ever had a stroke

You have any signs of water building up in your body,

such as swollen ankles

You have a condition called systemic lupus erythema-

tosus (SLE or Lupus for short) or any other autoimmune

disease

You are in the first six months of pregnancy

You are trying to, or planning to become pregnant

You have diabetes

You have high cholesterol

You are a smoker

You are over 65 years of age

You

have

infection.

NSAID

medicines

such

Relifex may hide the symptoms of infections such as

fever and inflammation

Children

Do not give Relifex to children.

Warnings

Medicines such as Relifex may be associated with a small

increased risk of heart attack (myocardial infarction) or

stroke.

risk

more

likely

with

high

doses

prolonged treatment. Do not exceed the recommended

dose or duration of treatment.

Tell your doctor if you are taking any of the following

medicines:

Anticoagulants such as warfarin (to thin your blood)

Anticonvulsants such as phenytoin (to prevent fits)

Antidepressants such as selective serotoninreuptake

inhibitors (SSRI’s) (to treat depression)

Antidiabetics (taken by mouth to control blood sugar

levels)

Antihypertensives such as ACE inhibitors or angiotensin

receptor agonists (to control high blood pressure)

Cardiac glycosides such as digoxin (to manage certain

heart conditions)

Ciclosporin and tacrolimus (to prevent transplanted

organs being rejected)

Corticosteroids (to treat skin conditions)

Diuretics or ‘water tablets’ (to make you pass more water)

Lithium (to treat mental problems)

Methotrexate (to treat arthritis)

Mifepristone (used by doctors to terminate pregnancies).

If you have taken mifepristone within the last two weeks

you should not take Relifex

Non steroidal anti-inflammatory drugs (NSAIDs or COX-2).

These include ibuprofen acetylsalicylic acid, diclofenac,

naproxen, clopidogrel or aspirin

Quinolone antibiotics (to treat infections)

Zidovudine (to treat HIV)

Protein bound drugs such as sulphonamides, sulphony-

lureas, probenecid, sulfinpyrazone or hydantoin (used in

medicines to treat bacterial infections, diabetes, oedema,

hypertension and gout)

Bisphosphonates (used in medicines to treat conditions

that effect your bones)

Oxpentifylline (pentoxyfilline) (used in medicines to treat

the symptoms of intermittent claudication)

other

medicine,

including

medicines

obtained

without a prescription.

Taking Relifex with food

You must take this medicine with or after a meal.

Taking Relifex with alcohol

No alcohol should be consumed during treatment with

Relifex.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or breast-feeding.

Your doctor will decide if taking this medicine at this time

is right for you and/or your baby.

Remember: Taking this medicine may make it harder for

you to become pregnant. Ask your doctor for advice

Driving and using machines

Whilst taking Relifex you may feel dizzy, tired, drowsy,

confused or notice problems with your eye sight. If this

happens, do not drive or operate machinery. Your doctor

may arrange for you for have an eye examination if your

eyesight is affected whilst you are taking this medicine.

3. How to take Relifex

Important:

Only take the amount of this medicine your doctor

has prescribed

Only take this medicine for the treatment time

your doctor has prescribed.

This will stop you getting so many side-effects. This

will reduce any chance of you having a stroke or

heart attack.

Important:

Your doctor will choose the dose that is right for you.

Your dose will be shown clearly on the label that your

pharmacist puts on your medicine. If it does not, or

you are not sure, ask your doctor or pharmacist.

Remember: Always take this medicine with or after a meal.

Swallow the tablets whole with water. Do not chew the

tablets.

Some patients may need to take another medicine at the

same time as taking Relifex. Your doctor will prescribe this

if you need it.

Relifex tablets come in two strengths – 500 mg and 1 g.

The number of tablets you take will therefore depend on

which strength of tablet the doctor has prescribed for you.

Adults

The usual dose is 1 g taken once a day at bedtime (as

either two 500 mg tablets or one 1 g tablet).

The label your pharmacist puts on your medicine will

tell you exactly how many tablets to take.

If you need to take more, your doctor will explain how

much to take and when to take it.

Elderly (65 years and over)

The usual starting dose is 500 mg taken once a day at

bedtime (as either one 500 mg tablet or half a 1 g tablet).

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The label your pharmacist puts on your medicine will

tell you exactly how many tablets to take.

If you need to take more, your doctor will explain how

much to take and when to take it.

Never take more than 1 g of Relifex each day (either two

500 mg tablets or one 1 g tablet per day).

Medical check-ups

When you are taking this medicine, your doctor may

ask you to come for check-ups which may include:

Checking your kidneys to make sure they are working

properly. Your doctor may want to do some tests before

you start taking Relifex and then re-check your kidney

function once you have been taking the medicine for a

few weeks.

Checking your liver is working properly

Checking you are not getting any problems with swell-

ing of any part of your body. Your doctor may want to

give you some medicine to help with these symptoms.

If you are elderly you will need to go for check-ups dur-

ing the first four weeks of taking the medicine. This is to

make sure that the medicine is working properly and

that the dose you are taking is right for you.

If you take more Relifex than you should

Do not take more Relifex than you should. If you acciden-

tally take too much of your medicine, immediately tell your

doctor or go to the nearest hospital casualty department.

Taking too much Relifex may make you feel or be sick, be

dizzy or faint, develop a headache or have fits (convulsions).

If you forget to take Relifex

Do not take a double dose to make up for a forgotten dose.

Simply take the next dose as planned.

If you have any questions about the use of this medicine

ask your doctor or pharmacist.

4. Possible side effects

Like all medicines Relifex can cause side effects, although

not everybody gets them.

Stop taking this medicine and seek immediate medical

help if you have any of the following symptoms:

You have difficulty breathing

Your face or throat swells

You have a severe rash which may blister

You have chest pains or sudden numbness and

confusion

You have blood in your stools. They may look

black and tarry

You vomit blood or dark particles that look like

coffee granules.

Stop taking this medicine and tell your doctor if you

have any of the following symptoms:

This is especially important if you are elderly.

You have indigestion or heart burn

You have severe pains in your stomach

You have any other abnormal stomach

symptoms

The following side effects are common and may affect

up to one in 10 people taking Relifex:

Ringing in your ears or problems with the ears

Increase in blood pressure (you may feel dizzy and have

a headache)

Diarrhoea, constipation, feeling sick, inflammation of

the stomach lining, stomach ache, wind

Rash, itchy skin

Fluid retention which causes swelling e.g. swollen ankles

The following side effects are uncommon and may

affect up to one in 100 people:

Confusion, nervousness, problems sleeping

Tiredness, dizziness, headache, “pins and needles” or

tingling feelings, anxiety

Problems with your sight or with your eyes

Breathing difficulties, nose bleeds

Upset stomach, being sick,

Mouth ulcers, dry mouth

Increased skin sensitivity to sunlight or artificial light,

red, raised patches on the skin, sweating

Problems with your muscles

Problems with your urinary tract

Loss of strength or energy, fatigue

Abnormal liver enzymes

The following side effects are very rare and may affect

up to one in 10,000 people:

Low numbers of blood platelets

Inflammation of the lungs causing shortness of breath

and a dry cough

Yellowing of your skin and the whites of your eyes

(jaundice), liver failure

Severe skin eruptions where the skin reddens, peels

and swells and looks severely burnt, or a severe skin

rash with flushing, fever, blisters and ulcers or a wide-

spread skin rash with circular irregular red patches on

the hands and feet

Skin hives, loss of hair

A disorder called pseudoporphyria which causes skin

blisters, stomach pains and nervous system problems

Kidney problems such as blood in the urine, kidney failure

Heavy or unusually prolonged periods

The following side effects have also been reported by

people taking Relifex although it is not known how

many people have these side effects:

Depression, hallucinations

Aseptic

meningitis

(stiff

neck,

headache,

feeling

being sick, fever, disorientation) especially in patients

who already have an autoimmune disorder such as

systemic lupus erythematosus or mixed connective

tissue disorder

Vertigo, drowsiness

Inflammation of the optic nerve

Asthma or worsening of existing asthma

Red or purple skin patches

A problem with the kidneys known as interstitial nephritis.

The symptoms include fever, rash, enlarged kidneys,

lower back pain, problems when passing water

A general feeling of being unwell or “out of sorts”

Changes in the numbers and types of blood cells. You

may get ill more often with a sore throat, fever, chills,

anaemia or abnormal bruising

Worsening

existing

stomach

conditions

such

Crohn’s disease or ulcerative colitis

Important: Medicines such as Relifex may be associated

with a small increased risk of heart attack (myocardial

infarction) or stroke.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist

or nurse. This includes any possible side effects not listed

in this leaflet. You can also report any side effects directly

via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more

information on the safety of this medicine.

5. How to store Relifex

Keep out of the reach and sight of children.

Do not use Relifex after the expiry date on the label or

carton. The expiry date refers to the last day of that month.

Keep the tablets in their original bottle in order to protect

from light.

The blister strips do not require any special storage condi-

tions.

Medicines should not be disposed of via wastewater or in

household waste. Return any medicine you no longer

need to your pharmacist.

6. Contents of the pack and other Information

What Relifex contains

The active substance in Relifex is nabumetone.

Relifex 500 mg Film-coated Tablets

Each 500 mg tablet contains 500 mg nabumetone.

The other ingredients are sodium starch glycolate,

sodium lauryl sulfate, hypromellose, magnesium stea

rate, microcrystalline cellulose (E460), red carmine

(E120), yellow iron oxide (E172), titanium dioxide (E171),

talc, polyethylene glycol 400, saccharin sodium, liquid

caramel flavour, purified water and carnauba wax.

Relifex 1 g Film-coated Tablets

Each 1 g tablet contains 1 g nabumetone. The other

ingredients are hydroxyl-propyl-methylcellulose (E464),

macrogol 6000, sodium lauryl sulphate, sodium starch

glycollate, Type A, microcrystalline cellulose (E460) and

titanium dioxide (E171).

What Relifex looks like

Relifex 500 mg Film-coated Tablets are red, oblong and

marked ‘RELIFEX’ on one side and ‘500’ on the other. The

tablets come in plastic bottles containing 56 tablets or in

blister strips containing 60 tablets.

Relifex 1 g Film-coated Tablets are white, with a break-line

on one side. The tablets come in plastic bottles containing

100 or 200 tablets.

Marketing Authorisation Holder:

Meda Pharmaceuticals Ltd

Skyway House,

Parsonage Road, Takeley,

Bishop‘s Stortford, CM22 6PU, UK.

Manufacturer:

Haupt Pharma Wülfing GmbH,

Bethelner Landstraße 18,

31028 Gronau, Germany.

This leaflet was last updated February 2017.

If this leaflet is difficult to see or read or you would

like

different

format,

please

contact

Meda

Pharmaceuticals,

Skyway

House,

Parsonage

Road,

Takeley, Bishop’s Stortford, CM22 6PU, UK

225 8550 0

56UK1784132-05

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