RELIFEX 500 MG/ 5 ML ORAL SUSPENSION

Active substance: NABUMETONE

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Patient Information Leaflet

Relifex 500 mg/5 ml Oral Suspension
Nabumetone
Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This 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.
• In this leaflet, Relifex 500mg/5ml Oral Suspension will
be called Relifex suspension.
In this leaflet:
1. hat Relifex suspension is for
W
2. efore you take Relifex suspension
B
3. ow to take Relifex suspension
H
4. ossible side effects
P
5. ow to store Relifex suspension
H
6. urther information
F
1. What Relifex suspension is for
Relifex suspension 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 suspension is used to treat the pain, stiffness and
swelling of joints which are affected by osteoarthritis or
rheumatoid arthritis.
2. efore you take Relifex suspension
B
Do not take Relifex suspension if:
• You are allergic to nabumetone
• You are allergic to any of the other ingredients of
Relifex suspension (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,
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
digestive 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
suspension 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
(hypertension)
• 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
erythematosus (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 an infection. NSAID medicines such as
Relifex suspension may hide the symptoms of
infections such as fever and inflammation.
Do not give Relifex suspension to children.
Warnings
Medicines such as Relifex suspension 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.
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 angioten-
sin 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 suspension
• 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)
• Protein bound drugs such as sulphonamides,
sulphonylureas 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 suspension 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 suspension 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.
Warnings about the ingredients in Relifex
suspension
This medicine contains sorbitol. If you have been told by
your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicine.
3. How to take Relifex suspension
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.
Some patients may need to take another medicine at the
same time as taking Relifex suspension. Your doctor will
prescribe this if you need it.
Adults
• The usual dose is 10ml solution (1 g) taken once a day
at bedtime.

Darley Job No.:
27583

Customer:
Pharmasol

Product:
Relifex UK

Customer Ref. No.:
MP00833

Product Licence No.:
N/A

Finished Size:
300mm x 155mm

Colours:
Black & Red 032

Originated by:
Graham

Date Originated:
18/03/2013

Updated By:
N/A

Date Updated:
N/A

Spell Checked By:
N/A

Operator Check:
Graham

2nd Check By:
Philip

Proof No.:
1

Date Proofed:
18/02/2013

• 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 5ml (500 mg) taken once a
day at bedtime.
• If you need to take more, your doctor will explain how
much to take and when to take it.
• Never take more than 10ml (1 g) each 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
swelling 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
during 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 suspension than you
should
Do not take more Relifex suspension 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 suspension may make you feel
or be sick, be dizzy or faint, develop a headache or have
fits (convulsions).
If you forget to take Relifex suspension
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 suspension 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,tanxiety

• 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 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
• 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 of existing stomach conditions such as
Crohn’s disease or ulcerative colitis.
Important: Medicines such as Relifex suspension 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 suspension
Keep out of the reach and sight of children.
Do not use Relifex suspension after the expiry date on
the bottle or carton. The expiry date refers to the last day
of that month.
Keep the solution in the original bottle. Protect from light.
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 suspension contains
• The active substance in Relifex suspension is
nabumetone.
• Each 5ml of solution contains 500mg nabumetone.
• The other ingredients are methylcellulose (E461),
xanthan gum (E415), sorbitol (E420), sodium benzoate
(E211), liquid vanilla flavour, liquid buttermint flavour,
monoammonium glycyrrhizinate, glycerin, dilute
hydrochloric acid (E507) and purified water.
What Relifex suspension looks like
Relifex 500mg/5ml Oral Suspension is a white to offwhite suspension. The suspension comes in plastic
bottles, each containing 300ml of solution.
Marketing Authorisation Holder:
Meda Pharmaceuticals Ltd, Skyway House, Parsonage
Road, Takeley, Bishop’s Stortford, CM22 6PU, UK.
Manufacturer:
Pharmasol Ltd., North Way, Walworth Industrial Estate,
Andover, Hampshire, SP10 5AZ, UK
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 Ltd,
Skyway House, Parsonage Road,
Takeley, Bishop’s Stortford
CM22 6PU, UK
MP00833

MH 2010-07-15

Darley Job No.:
27583

Customer:
Pharmasol

Product:
Relifex UK

Customer Ref. No.:
MP00833

Product Licence No.:
N/A

Finished Size:
300mm x 155mm

Colours:
Black & Red 032

Originated by:
Graham

Date Originated:
18/03/2013

Updated By:
N/A

Date Updated:
N/A

Spell Checked By:
N/A

Operator Check:
Graham

2nd Check By:
Philip

Proof No.:
1

Date Proofed:
18/02/2013

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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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