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DICLOFENAC SODIUM 50 MG GASTRO-RESISTANT TABLETS

Active substance(s): DICLOFENAC SODIUM

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DICLOFENAC SODIUM 25 mg AND
50 mg GASTRO-RESISTANT TABLETS
PACKAGE LEAFLET:
INFORMATION FOR THE USER

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 or nurse.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their symptoms are the
same as yours.
• If you get any side effects, talk to your
doctor or pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET:

1. What Diclofenac is and what it is used for
2. What you need to know before you take
Diclofenac
3. How to take Diclofenac
4. Possible side effects
5. How to store Diclofenac
6. Contents of the pack and other information

1

WHAT DICLOFENAC IS AND WHAT IT
IS USED FOR

Diclofenac is a non-steroidal anti-inflammatory
(NSAID) drug.
Diclofenac 25 mg and 50 mg Gastro-resistant
Tablets are used to relieve pain and
inflammation in conditions such as:
• rheumatoid arthritis
• osteoarthrosis
• ankylosing spondylitis (arthritis of the
spine)
• low back pain
• other conditions affecting the muscles,
joints, tendons and bones e.g. strains,
sprains, fractures or dislocations
• acute gout
• dental and other minor surgery.
Diclofenac 25 mg Gastro-resistant Tablets may
also be used to relieve juvenile chronic
arthritis.
Children aged 9 years and above
Diclofenac 25 mg Gastro-resistant Tablets may
be used as a short treatment for fever, caused
due to infections of the ear, nose or throat.
Diclofenac 25 mg Gastro-resistant Tablets may
be used alone or as an additional therapy with
other pain killers to relieve pain caused due to
surgery.

2

WHAT YOU NEED TO KNOW BEFORE
YOU TAKE DICLOFENAC

Pharma code

Do not take Diclofenac if you:
• are allergic (hypersensitive) to diclofenac
sodium or any of the other ingredients of
this medicine
• have experienced asthma, an itchy or runny
nose, skin rashes or breathing difficulties
after taking any other NSAID (Non-steroidal
anti-inflammatory drugs) e.g. aspirin or
ibuprofen
• have, or have ever had, peptic ulceration
(ulcer in your stomach or duodenum)
• have ever experienced stomach or intestinal
bleeding (black tarry stools or vomiting
blood) after taking any other NSAID
• have severe liver, kidney or heart problems
• are more than 6 months pregnant or you
are planning to become pregnant (see
‘Pregnancy and breast-feeding’)
• have established heart disease and/or
cerebrovascular disease e.g. if you have
had a heart attack, stroke, mini-stroke (TIA)
or blockages to blood vessels to the heart or
brain or an operation to clear or bypass
blockages
• have or have had problems with your blood
circulation (peripheral arterial disease).
Warnings and precautions
Talk to your doctor or pharmacist or nurse
before taking diclofenac gastro-resistant
tablets if you:
• suffer from any stomach or bowel disorders
such as ulcerative colitis or Crohn’s disease
• suffer from a disease called porphyria
(symptoms of porphyria are discolouration
of the urine, serious skin disorders,
anaemia, abdominal pains and severe
mental disorders)
• suffer from or have in the past suffered
from asthma
• suffer from serious illness with blistering of
the skin, mouth, eyes and genitals or
connective tissue disorders such as lupus
• notice skin rash or appearance of lesions
after starting this medicine, please seek
medical advice immediately
• suffer from runny nose, nasal polyps,
chronic lung disease or chronic lung
infection
• suffer from kidney, liver or heart problems
or if you are elderly or recovering from
major surgery
• smoke
• suffer from diabetes
• have angina, blood clots, high blood
pressure, raised cholesterol or raised
triglycerides.
Side effects may be minimised by using the
lowest effective dose for the shortest duration
necessary.
This medicine may mask the sign and
symptoms of infection.
Your doctor may decide to monitor your
kidney function, liver function, blood sugar
and blood cell counts whilst you are taking
diclofenac sodium.

Medicines such as diclofenac 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.
Other medicines and Diclofenac
Tell your doctor about any other medicines
you are taking or took recently (in the last
week) – even medicines you bought yourself
without a prescription. Medicines can
sometimes interfere with each other. Your
doctor may limit your use of a medicine or you
may need to take a different medicine. It is
especially important to mention any of the
following:
• any other non-steroidal anti-inflammatory
drug (NSAID) for pain relief such as
ibuprofen, aspirin or cyclooxygenase-2
selective inhibitors. Taking two or more
NSAID medicines at the same time is not
recommended, but your doctor may decide
that it is necessary for your treatment and
the benefits you will gain outweigh the
risks.
• aspirin in order to prevent blood clots
• medicines for high blood pressure
• medicines for high blood sugar
• diuretics (”water tablets”) e.g.
spironolactone
• cardiac glycosides e.g. digoxin
• lithium
• methotrexate
• mifepristone
• corticosteroids, which are drugs given to
treat a variety of conditions such as
allergies and hormone imbalances e.g.
prednisolone
• anti-coagulants e.g. warfarin
• immunosuppressive agents e.g. ciclosporin,
tacrolimus
• quinolone antibiotics e.g. ciprofloxacin,
ofloxacin
• drugs for depression called selective
serotonin reuptake inhibitors (SSRIs)
• zidovudine, used to treat HIV infection
• phenytoin (used to treat fits)
• colestipol, cholestyramine (used to reduce
the amount of cholesterol and certain fatty
substances in your blood)
• sulfinpyrazone (used to treat gout)
• voriconazole (used to treat fungal infection).
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Pregnancy, Breast-feeding and Fertility
• DO NOT take Diclofenac if you are more
than 6 months pregnant
• If you are less than 6 months pregnant, ask
your doctor for advice before taking this
medicine
• Diclofenac 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.
• Diclofenac should not be taken if you are
breast-feeding, therefore please talk to your
doctor before taking this medicine.
Driving and using machines
• Diclofenac may cause dizziness,
drowsiness, tiredness, and problems with
your vision. DO NOT drive or operate
machinery if you are affected.
Diclofenac tablets contains Lactose
• Patients who are intolerant to lactose
should note that Diclofenac tablets contain
a small amount of lactose. If your doctor
has told you that you have an intolerance to
some sugars, contact your doctor before
taking this medicine.

3

HOW TO TAKE DICLOFENAC

Always take Diclofenac exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
The tablets should be swallowed preferably
with a drink of water, with or after food. DO
NOT chew the tablets. The tablets have been
coated with a substance, which allows them to
pass through the stomach before dissolving. It
is important that the coating is not damaged
by chewing. The usual dose is:
Use in children and adolescents
• Adults
75 – 150 mg a day, in divided doses. The
maximum daily dose is 150 mg.
• Elderly
Elderly patients should take the lowest
effective dose for the shortest possible time
to reduce the risk of side effects.
• Children 1 year old and over
The dose depends on the child’s body
weight. Your doctor will calculate the
appropriate dose for your child.
• Children under 1 year old
Diclofenac is not recommended for use in
children under 1 year old.
For treatment of surgical pain and fever
caused due to infections of the ear and nose in
children aged 9 years (with minimum 35 kg
bodyweight) or over and adolescents
• The dose depends on the bodyweight and
severity of the disorder. Your doctor will
decide the appropriate dose.
Diclofenac 50 mg Gastro-resistant Tablets
should not be used in children under 12 years
of age.

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FRONT

If you take more Diclofenac than you should
If you (or someone else) swallow a lot of the
tablets all together, or if you think a child has
swallowed any of the tablets, contact your
nearest hospital casualty department or your
doctor immediately.
An overdose is likely to cause headache,
feeling sick, being sick, stomach pain,
intestinal bleeding, diarrhoea, breathing
problems, coma, drowsiness, dizziness, fits,
ringing in the ears and fainting.
Please take this leaflet, any remaining tablets,
and the container with you to the hospital or
doctor so that they know which tablets were
consumed.
If you forget to take Diclofenac
If you forget to take a tablet, take one as soon
as you remember, unless it is nearly time to
take the next one. DO NOT take a double dose
to make up for a forgotten dose.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
If you stop taking Diclofenac
Do not suddenly stop taking your tablets as
side effects may occur. If treatment is to be
stopped your doctor will gradually reduce your
dose.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Pharma code

Like all medicines, Diclofenac can cause side
effects, although not everybody gets them.
Stop taking the tablets and tell your doctor
immediately or go to the casualty department
at your nearest hospital if the following
happens at any time during your treatment:
• an allergic reaction (swelling of the lips,
face or neck leading to severe difficulty in
breathing; skin rash, very low blood
pressure or shock and hives)
• passing blood in your faeces (stools/
motions)
• passing black tarry stools
• vomiting any blood or dark particles that
look like coffee grounds.
These are very serious side effects. You may
need urgent medical attention or
hospitalisation.
Stop taking the tablets and tell your doctor
immediately if the following happens:
• a serious illness with blistering of the skin,
mouth, eyes and genitals (Stevens-Johnson
syndrome)
• a severe blistering rash in which the surface
layers of the skin may peel off (Lyell's
syndrome)
• indigestion or heartburn
• abdominal pain (pains in your stomach) or
other abnormal stomach symptoms
• symptoms which include stiff neck,
headache, feeling and being sick, fever or
disorientation, particularly in patients with
systemic lupus erythematosus (SLE) or
connective tissue disorders.
Medicines such as Diclofenac may be
associated with a small increased risk of heart
attack (“myocardial infarction”) or stroke.
Usually the frequency of side effects is
classified as follows:
Very common (more than 1 out of 10 persons)
Common (more than 1 out of 100 persons)
Uncommon (more than 1 out of 1,000 persons)
Rare (more than 1 out of 10,000 persons)
Very rare (less than 1 out of 10,000 persons)
Not known (cannot be estimated from the
available data)
Blood Disorders
Very rare: blood disorders such as anaemia,
reduction in the number of white blood cells,
which may be characterised by fever or chills,
sore throat, ulcers in your mouth or throat and
infection.
Psychological disorders
Very rare: disorientation, depression, difficulty
in sleeping, nightmares, irritability and
psychological problems.
Nervous system disorders
Common: headache, dizziness
Rare: drowsiness
Very rare: abnormal sensation of skin (e.g.
tingling, numbness), memory impairment, fits,
anxiety, shaking, serious inflammation of the
linings of the brain (Aseptic meningitis), taste
disorders, stroke
Not known: optic nerve inflammation,
sensation disorders.
Eye disorders
Very rare: visual disturbances, blurred vision
and double vision.
Ear disorders
Common: a feeling of dizziness or “spinning”
Very rare: ringing in the ears, hearing
impairment.
Heart Disorders
Very rare: palpitation, chest pain and heart
failure, stroke.
Blood circulation disorders
Very rare: high blood pressure and
inflammation of blood vessels, often with skin
rash.
Breathing disorders
Rare: asthma including shortness of breath
Very rare: inflammation of lungs, symptoms
you may feel are like fever, shortness of
breath, chills etc.
Stomach and bowel disorders
Common: feeling sick, being sick, loose stools,
abdominal pain, indigestion, wind, loss of
appetite
Rare: inflammation of the lining of the
stomach, vomiting blood, black tarry stools,
ulcers.

Very rare: inflammation of colon causes
abdominal pain or diarrhoea, aggravation of
existing digestive problems such as colitis and
Crohn’s disease, constipation, inflammation or
ulceration of the mouth e.g. mouth ulcers and
cold sores, inflammation of the tongue,
inflammation of the pancreas (pancreatitis),
which causes severe pain in the abdomen and
back
Not known: throat lesions, damage of colon,
narrowing in the intestine.
Liver disorders
Common: abnormal liver function tests
Rare: yellowing of the skin or whites of the
eyes caused by liver or blood problems,
inflammation of liver, liver disorders
Very rare: very serious liver disease, acute
liver failure.
Skin disorders
Common: rash
Rare: nettle rash
Very rare: skin reaction causing large blisters,
eczema, redness of the skin, serious illness
with blistering of the skin, mouth, eyes and
genitals, scaly skin, loss of hair, sensitivity to
light, bruise like rash, itching.
Kidney and urinary disorders
Very rare: kidney failure, blood in the urine,
increased amount of protein in the urine,
serious kidney disorders.
General disorders
Rare: fluid retention resulting in swelling of the
ankles or feet.
Other disorders
Not known: Difficulty in getting and
maintaining an erection.
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
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 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 DICLOFENAC

Keep this medicine out of the sight and reach
of children.
The tablets should be stored below 25°C, in a
dry place in the original package or container
supplied. Keep the container tightly closed. Do
not transfer them to another container.
Do not use Diclofenac after the expiry date that
is stated on the outer packaging. The expiry
date refers to the last day of that month.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help
protect the environment.

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Diclofenac Gastro-resistant Tablets
contain:
• The active ingredient is diclofenac sodium,
25 mg or 50 mg
• The other ingredients are lactose
monohydrate, maize starch, povidone
(E1201), sodium starch glycolate (Type A),
colloidal anhydrous silica and magnesium
stearate (E572). The gastro-resistant coating
contains hydroxypropyl methylcellulose
(E464), citric acid monohydrate (E330),
methacrylic acid copolymer, purified talc
(E553b), polyethylene glycol (E1520) and the
colours are titanium dioxide (E171), sunset
yellow (E110) and iron oxide yellow (E172).
The 50 mg tablets also contain iron oxide
red (E172). The 25 mg tablets also contain
quinoline yellow (E104).
The black printing ink contains shellac, iron
oxide black (E172) and propylene glycol
(E1520).
What Diclofenac Gastro-resistant Tablets look
like and contents of the pack:
• The 25 mg tablets are yellow, round,
biconvex, bevel-edged, gastro-resistant
tablets. They are printed ‘25’ over ‘0518’ and
plain on the reverse.
• The 50 mg tablets are tan, round, biconvex,
bevel-edged, gastro-resistant tablets. They
are printed ‘50’ over ‘0519’ and plain on the
reverse.
• The product is available in pack sizes of 10,
20, 28, 30, 50, 56, 60, 84, 100, 250, 500, and
1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation holder and company
responsible for manufacture:
TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: 02/2014
PL 00289/0738 and 0739

84233-E

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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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