RELIFEX 1G FILM-COATED TABLETS

Active substance: NABUMETONE

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Patient Information Leaflet

Relifex 500 mg & 1 g Film-coated Tablets
Nabumetone
Read all of this leaflet carefully before you start taking
this medicine.
K
•  eep this leaflet. You may need to read it again.
I
• f you have any further questions, ask your doctor or
pharmacist.
T
•  his medicine has been prescribed for you.
Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
I
• n this leaflet, Relifex 500 mg & 1 g Film-coated Tablets
will be called Relifex.
In this leaflet:
1. hat Relifex is for
W
2. efore you take Relifex
B
3. ow to take Relifex
H
4. ossible side effects
P
5. ow to store Relifex
H
6. urther information
F
1. What Relifex is for
Relifex belongs to a group of medicines called non-steroidal anti-inflammatory drugs (known as NSAIDs).
It works by reducing the production of some natural
chemicals found in the body. These chemicals (prostaglandins) 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. Before you take Relifex
Do not take Relifex if:
Y
•  ou are allergic to nabumetone
Y
•  ou are allergic to any of the other ingredients of Relifex
(see section 6)
Y
•  ou 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, 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.
•  ou have, or have ever had a stomach (peptic) ulcer or
Y
any perforation or bleeding (haemorrhage) in your digestive system or if you have or have ever had peptic disease
•  ou have serious problems with your heart (severe
Y
heart failure)
Y
•  ou are currently receiving treatment for a stroke or
other internal bleed
Y
•  ou have serious problems with your liver (liver cirrhosis)
•  ou have serious problems with your kidneys (kidney
Y
failure)
Y
•  ou are in the last three months of pregnancy.
•  ou are breast-feeding
Y
If any of the above applies to you, talk to your doctor or
pharmacist.
Check with your doctor before taking Relifex if:
•  ou have, or have ever had asthma
Y
•  ou have, or have ever had stomach problems. This
Y
includes Crohn’s disease or ulcerative colitis
•  ou have kidney problems
Y
•  ou have liver problems
Y
•  ou have heart problems
Y
•  ou have or have ever had high blood pressure (hyperY
tension)
•  ou have ever had a stroke
Y
•  ou have any signs of water building up in your body,
Y
such as swollen ankles
•  ou have a condition called systemic lupus erythemaY
tosus (SLE or Lupus for short) or any other autoimmune
disease
•  ou are in the first six months of pregnancy
Y
•  ou are trying to, or planning to become pregnant
Y
•  ou have diabetes
Y
•  ou have high cholesterol
Y
•  ou are a smoker
Y
•  ou are over 65 years of age
Y
•  ou have an infection. NSAID medicines such as
Y
Relifex may hide the symptoms of infections such as
fever and inflammation
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. Any risk is more likely with high doses and
prolonged treatment. Do not exceed the recommended
dose or duration of treatment.

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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, diclofenac, naproxen, clopidogrel or aspirin
• 
Quinolone antibiotics (to treat infections)
• 
Zidovudine (to treat HIV)
•  rotein bound drugs such as sulphonamides, sulphoP
nylureas or hydantoin (used in medicines to treat
bacterial infections, diabetes, oedema, hypertension
and gout)
• 
Any other medicine, including medicines obtained
without a prescription.
Taking Relifex with food
You must take this medicine with or after a meal.
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:
•  nly take the amount of this medicine your doctor
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has prescribed
•  nly take this medicine for the treatment time
O
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
•  he usual dose is 1 g taken once a day at bedtime (as
T
either two 500 mg tablets or one 1 g tablet).
•  he label your pharmacist puts on your medicine will
T
tell you exactly how many tablets to take.
• f you need to take more, your doctor will explain how
I
much to take and when to take it.
Elderly (65 years and over)
T
•  he usual starting dose is 500 mg taken once a day at
bedtime (as either one 500 mg tablet or half a 1 g tablet).
•  he label your pharmacist puts on your medicine will
T
tell you exactly how many tablets to take.
• f you need to take more, your doctor will explain how
I
much to take and when to take it.
•  ever take more than 1 g of Relifex each day (either two
N
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:
C
•  hecking 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.

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•  hecking your liver is working properly
C
•  hecking you are not getting any problems with swellC
ing of any part of your body. Your doctor may want to
give you some medicine to help with these symptoms.
• f you are elderly you will need to go for check-ups durI
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 accidentally 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:
•  ou have difficulty breathing
Y
•  our face or throat swells
Y
•  ou have a severe rash which may blister
Y
•  ou have chest pains or sudden numbness and
Y
confusion
•  ou have blood in your stools. They may look
Y
black and tarry
•  ou vomit blood or dark particles that look like
Y
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.
•  ou have indigestion or heart burn
Y
•  ou have severe pains in your stomach
Y
•  ou have any other abnormal stomach
Y
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 widespread skin rash with circular irregular red patches on
the hands and feet
• 
Skin hives, loss of hair
•  disorder called pseudoporphyria which causes skin
A
blisters, stomach pains and nervous system problems
K
•  idney 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 or
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

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• 
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
•  general feeling of being unwell or “out of sorts”
A
• 
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 of existing stomach conditions such as
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.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
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 conditions.
Medicines should not be disposed of via wastewater or in
household waste. Return any medicine you no longer
need to your pharmacist.
6. Further 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 glycollate,
sodium lauryl sulphate, hydroxyl-propyl-methylcellulose
(E464), magnesium stearate, 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.
•  elifex 1 g Film-coated Tablets
R

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.
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 or in blister strips containing 20 or 100
tablets.
Marketing Authorisation Holder:
Meda Pharmaceuticals Ltd trading as
Meda Pharmaceuticals, 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 2013.
If this leaflet is difficult to see or read or you would
like it in a different format, please contact Meda
Pharmaceuticals, Skyway House, Parsonage Road,
Takeley, Bishop’s Stortford, CM22 6PU, UK

XXXXX
56UK11022013-00

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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