DIFLUNISAL 500MG FILM-COATED TABLETS

Active substance: DIFLUNISAL

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In addition, Diflunisal is not recommended for use in
children.
PLEASE READ ALL OF THIS LEAFLET
CAREFULLY BEFORE YOU START TO TAKE
YOUR TABLETS.
Keep this leaflet. You may want to read it again.

Diflunisal

Diflunisal

Film-coated Tablets

Film-coated Tablets

250 mg

500 mg

WHAT IS IN YOUR TABLETS?
Active ingredient
The active ingredient in your Diflunisal Tablets is
diflunisal. Two strengths of Diflunisal Tablets are
available: peach-coloured, capsule-shaped,
film-coated tablets, marked 'MSD 675' containing
250 mg diflunisal; and orange-coloured,
capsule-shaped, film-coated tablets, marked 'MSD
697' containing 500 mg diflunisal.
Other ingredients
Diflunisal 250 mg and 500 mg Tablets contain the
following inactive ingredients: microcrystalline
cellulose E460, hydroxypropylcellulose E463,
pregelatinised maize starch, magnesium stearate
E572, sunset yellow aluminum lake E110, talc,
titanium dioxide E171, methylhydroxypropylcellulose
E464. In addition, the peach-coloured 250 mg tablets
contain carnauba wax E903.
Diflunisal tablets are supplied in blister packs of 60
tablets.

HOW DO YOUR TABLETS WORK?
The active ingredient in your tablets is diflunisal.
Diflunisal is one of a group of medicines known as
non-steroidal anti-inflammatory drugs or 'NSAIDs'.
NSAIDs work as painkillers and also reduce
inflammation in joints, muscles, and ligaments. These
medicines may do this by decreasing the production
of naturally occurring chemicals in your body, called
prostaglandins, which can cause inflammation.

WHO MAKES YOUR TABLETS?
Your tablets are made by Merck Manufacturing
Division, Merck Sharp & Dohme Limited, Shotton
Lane, Cramlington, Northumberland NE23 3JU, UK.
The Marketing Authorisation is held by Chemidex
Pharma Ltd, trading as Essential Generics, 7 Egham
Business Village, Crabtree Road, Egham, Surrey
TW20 8RB.

WHY DO YOU NEED TO TAKE THESE
TABLETS?
Your doctor has probably prescribed Diflunisal for you
for one of the following reasons which he will have
explained to you:
i to relieve pain
i to relieve pain and inflammation of joints or
tendons caused by a condition called rheumatoid
arthritis or osteoarthritis
i to relieve period pains.

ARE THERE PATIENTS WHO SHOULD NOT
TAKE THESE TABLETS?
Do not take the tablets if:
i you are in the last three months of pregnancy
i you are breast-feeding
i you have had a bad or allergic reaction to this or
similar medicines, or to any of the ingredients in
the past
i you have had difficulty breathing, including
asthma, itchy rashes, localized swelling or
hay fever, after taking aspirin, ibuprofen or other
NSAIDs
i you have, or have ever had an ulcer in your
stomach or intestine
i you have, or have ever had active bleeding in
your digestive system - symptoms of this would
be abdominal pain, vomiting blood, or if your
faeces are black or contain blood.
i you have severe liver, kidney or heart disease.

If you think any of these apply to you, do not take the
tablets, go and talk to your doctor first and follow his
advice.

WHAT ELSE SHOULD YOU KNOW BEFORE
TAKING YOUR TABLETS?
You should check with your doctor before taking
Diflunisal if:
i you have a problem with your blood clotting
i in the past you have had ulcers in your stomach or
intestine or had any bleeding from your digestive
system, or Crohn's disease.
i you suffer from heart, asthma, liver or kidney
problems, particularly if you are elderly.
i you suffer from high blood pressure, fluid
retention, or diabetes
i you are dehydrated
i you have a viral or bacterial infection.
Medicines such as Diflunisal 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.
If you have heart problems, previous stroke or think
that you might be at risk of these conditions (for
example if you have high blood pressure, diabetes or
high cholesterol or are a smoker) you should discuss
your treatment with your doctor or pharmacist.
Diflunisal may make it more difficult to become
pregnant. You should inform your doctor if you are
planning to become pregnant or if you have problems
becoming pregnant.
In addition, if you have problems with your eyes, you
should inform your doctor.

WHAT ABOUT DRIVING AND OPERATING
MACHINERY?

Diflunisal can cause dizziness, drowsiness, fatigue
and visual disturbances in some people. If this
happens to you, avoid activities which require you to
be alert, for example, driving a car or operating
machinery.

CAN YOU TAKE DIFLUNISAL TABLETS
WITH OTHER MEDICINES?
There are a few other medicines which may not mix
with Diflunisal. Your doctor knows about these and will
alter your treatment as needed. It is important that you
tell your doctor about all the medicines you are taking,
including any drugs you are taking without a doctor's
prescription.
If you are taking any of the following medicines, you
should talk to your doctor about them before taking
Diflunisal:
i antiplatelet agents such as aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) such
as indomethacin, sulindac, naproxen, or
cyclooxygenase-2 inhibitors
i the following painkillers: paracetamol and codeine
i diuretics, sometimes known as water tablets,
called frusemide or hydrochlorothiazide
i aluminum hydroxide antacid suspension, or other
antacids
i anti-clotting or blood thinning medicines - for
example, warfarin or nicoumalone
i ciclosporin, used in patients with transplants
i methotrexate, used in severe skin diseases,
severe rheumatoid arthritis and as anti-cancer
therapy
i gold salts, used in the treatment of arthritis
i cardiac glycosides such as digoxin, a medicine
used to treat heart failure and alterations of heart
rhythm
i antihypertensive medicines for the treatment of
high blood pressure.
i lithium for treatment of mental disorders

i corticosteroid drugs, including anti-inflammatory
and replacement therapies
i mifepristone, a treatment used in emergency for
termination of pregnancy
i antibiotics from the quinolone group of antibiotics.
i tacrolimus, used in treatment of
immunosupression
i selective serotonin-reuptake inhibitors (SSRIs),
used to treat depression

Eye disorders, including blurred vision and other
temporary disturbances in vision. If you develop eye
problems during treatment with Diflunisal, contact
your doctor immediately.

HOW SHOULD YOU TAKE DIFLUNISAL?

Medicines such as Diflunisal may be associated with
a small increased risk of heart attack ("myocardial
infarction") or stroke.

Diflunisal tablets must be swallowed whole and must
not be crushed or chewed. You should preferably take
your tablets with or after food, exactly as advised by
your doctor or pharmacist. The number of tablets you
take each day will depend on your condition. The
usual doses are:
For relief of pain: an initial dose of 1000 mg followed
by 500 mg every 12 hours is recommended for most
patients. Following the first dose your doctor may tell
you to take 500 mg every 8 hours, if the pain is more
severe. After the first day the daily dose should not
exceed 1500 mg per day.
For osteoarthritis and rheumatoid arthritis: the
recommended dose is 500 mg to 1000 mg a day,
taken once or twice a day.
For period pain: the recommended dose is 1000 mg
at the start of cramps or bleeding, then 500 mg every
12 hours for as long as symptoms last. After the first
day the daily dose should not exceed 1500 mg per
day. The tablets should not usually be taken for more
than five days.

WHAT IF YOU FORGET TO TAKE A TABLET
OR TAKE TOO MANY?
If you miss a dose just carry on with the next one as
normal. Do not take an extra one to make up.
If you take too many tablets by mistake, contact
your doctor immediately.

WHAT UNWANTED EFFECTS COULD YOUR
TABLETS HAVE?
Like all medicines, Diflunisal may occasionally cause
side effects in some patients. The most frequently
reported side effects are stomach or abdominal pain,
indigestion, nausea, diarrhoea, rash, headache.
Less frequent side effects that have occurred are
vomiting, constipation, wind, dizziness, sleepiness,
sleeplessness, ringing in the ears, tiredness.
The following rare side effects have also occurred:
Effects on the digestive system such as stomach or
intestinal ulcer, a hole in the lining of the intestines or
bleeding from the stomach or intestine, loss of
appetite, inflammation of the stomach.
Effects on the liver, the symptoms of which may be
pale faeces and dark urine, flu-like symptoms, and
yellowing of the skin and/or eyes.
Effects on the skin, such as a reaction to light,
itchiness, hives, sweating, dry and sore mouth, more
severe skin disorders, symptoms of which may include
redness, blisters, peeling skin, ulcerated mouth, eyes
and genitals.
Kidney problems including kidney damage, kidney
inflammation, changes in urine output, pain when
passing urine and blood stained urine.
Nervous system effects, including vertigo, lightheadedness, pins and needles, nervousness,
depression, confusion and hallucinations.
Blood disorders, the symptoms of which could include
a combination of pallor, tiredness, fever, sore throat
and mouth, bruising and prolonged bleeding after
injury.

In addition, weakness and fluid retention have
occurred. Breathlessness, palpitation, fainting, chest
pain and muscle cramps have also been reported
rarely.

If you notice any of the above effects, or you have any
other unusual symptoms or feelings, seek medical
assistance.
Serious allergic reactions to Diflunisal have been
reported and include fever, chills, difficulty in
breathing and swallowing, collapse, swollen lips, face,
tongue and throat, rash, and swollen glands. This may
also include problems with liver, kidneys, or blood
cells (see above for symptoms of each). If you notice
any of these effects, stop taking the tablets and
contact your doctor immediately.

HOW SHOULD YOUR TABLETS BE KEPT?
Do not take the tablets after the expiry date, which is
clearly marked on the pack.
Keep your tablets out of the reach and sight of
children.
Do not store above 25°C. Store in the original
package.
Do not put the tablets into another container as they
might get mixed up. If you have any tablets left over
when your doctor tells you to stop taking them, return
them to the pharmacist.
REMEMBER this medicine is for you. Do not share it
with anyone else. It may not suit them.
Date of revision: March 2009

HOW CAN YOU OBTAIN MORE
INFORMATION ABOUT DIFLUNISAL
TABLETS?
This leaflet gives you some important patient
information about Diflunisal. If you have any questions
after you have read it, ask your doctor or pharmacist,
who will give you further information.
ARTHRITIS CARE
(Arthritis Care is an organisation which helps arthritis
patients and their relatives, and is not associated with
Chemidex Pharma Ltd.)
Patients requiring further independent information or
advice should contact Arthritis Care, the UK's largest
voluntary organisation working with people with
arthritis. Arthritis Care works with and for all people
with arthritis to promote their health, well-being and
independence, through services, support, self-help,
influence, and information.
Address: 18 Stephenson Way, London NW1 2HD.
Telephone: 0207-380-6500.
Freephone Helpline: 0808 800 4050, 12 noon to
4 p.m., Monday to Friday.

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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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