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DICLOFLEX 25MG

Active substance(s): DICLOFENAC SODIUM

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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.
- 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.
In this leaflet
1. What DICLOFLEX is and what it is used for
2. Before you take DICLOFLEX
3. How to take DICLOFLEX
4. Possible side effects
5. How to store DICLOFLEX
6. Further information
1. WHAT DICLOFLEX IS AND WHAT IT IS
USED FOR
Diclofenac sodium, the active ingredient in
DICLOFLEX, is one of a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
NSAIDs reduce pain and inflammation.
DICLOFLEX tablets relieve pain, reduce swelling
and ease inflammation in a number of conditions
affecting the joints and muscles:

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• Rheumatoid arthritis, osteoarthritis, acute gout
(painful inflammation of the joints especially in
the feet and hands), ankylosing spondylitis (form
of spinal arthritis).
• Backache, sprains and strains, soft tissue
sports injuries, frozen shoulder, dislocations and
fractures
• Conditions affecting the tendons for example,
tendonitis, tenosynovitis, bursitis.
They are also used to treat pain and inflammation
associated with dental and minor surgery.
In children aged 1-12 years DICLOFLEX 25 mg
tablets are used to treat juvenile chronic arthritis.
In children aged 9 years and above DICLOFLEX
25 mg tablets are used for short term treatment of
fever related to infections of the ear, nose or throat,
and for relief of acute post-operative pain.
2. BEFORE YOU TAKE DICLOFLEX
Do not take if
• you are allergic (hypersensitive) to diclofenac
sodium, aspirin, ibuprofen or any other NSAID,
or any of the other ingredients of DICLOFLEX
tablets (these are listed under section 6
"FURTHER INFORMATION" of the leaflet).
• you 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.
• you have or have had problems with your blood
circulation (peripheral arterial disease).
• you have a history of allergy to aspirin, ibuprofen
or NSAIDs, which includes attacks of asthma,
swelling of the nose and throat, face and mouth,
skin rashes or a runny nose.
• you have an active or a history of recurrent (more
than two) peptic ulcers (ulcer in your stomach
or duodenum), bleeding or perforation in the
digestive tract (this can include blood in vomit,
bleeding when emptying bowels, fresh blood in
faeces or black, tarry faeces).
• you have a history of stomach or bowel problems
(e.g. gastrointestinal bleeding or perforation)
related to the use of NSAIDs.
• you have severe heart, kidney or liver failure
• you are more than six months pregnant
Make sure your doctor knows, before you are
given Diclofenac if
• you smoke
• you have diabetes
• you have angina, blood clots, high blood pressure,
raised cholesterol or raised triglycerides
• you are breast-feeding (see section Pregnancy
and breast-feeding)
Side effects may be minimised by using the lowest
effective dose for the shortest duration necessary.
Take special care
• if you suffer from any stomach or bowel disorders
including ulcerative colitis or Crohn's disease
• if you have kidney or liver problems, or you are
elderly
• if you have a condition called porphyria
• if you suffer from any blood or bleeding disorder
• if you ever had asthma, seasonal allergic rhinitis,
swelling of the nasal mucosa (nasal polyps),
chronic pulmonary diseases or infections of the
respiratory tract.
• if you have heart problems or you think you might
be at risk of these conditions (for example, if
you have high blood pressure, diabetes or high
cholesterol or are a smoker)
• if you have Systemic Lupus Erythematosus
SLE (inflammatory, auto-immune disorder
which causes symptoms such as joint pain, joint
inflammation, skin rashes, fever) or any similar
condition
Tell your doctor or pharmacist if you have any
of these conditions because DICLOFLEX might
not be the right medicine for you.
Other special warnings
• You should take the lowest effective dose of
DICLOFLEX for the shortest possible time
to control symptoms, particularly if you are
underweight or elderly.
• You should be aware that 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.
• Whilst you are taking these medicines your
doctor may want to give you a check-up or order

a blood test from time to time.
• If you have a history of stomach problems when
you are taking NSAIDs, particularly if you are
elderly, you must tell your doctor straight away if
you notice any unusual symptoms.
• Because these are anti-inflammatory medicines,
they may reduce the symptoms of infection, for
example, headache, and high temperature. If you
feel unwell and need to see a doctor, remember
to tell him or her that you are taking DICLOFLEX
tablets.
• The 50 mg tablets are not suitable for children
aged under 12.
Taking other medicines
Some medicines can interfere with your treatment.
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without a
prescription, especially any of the following:
• Medicines to treat diabetes
• Any other NSAID or COX-2 (cyclo-oxygenase-2)
inhibitor, for example aspirin or ibuprofen
• Medicines used to treat heart conditions or high
blood pressure, for example beta blockers or
ACE inhibitors
• Diuretics (water tablets)
• Cardiac glycosides (for example digoxin), used
to treat heart problems
• Lithium (used to treat some mental problems)
• Methotrexate (used for treatment of some
inflammatory diseases and some cancers)
• Ciclosporin and tacrolimus (used to treat some
inflammatory diseases and after transplants)
• Trimethoprim (used to prevent or treat urinary
tract infections)
• Mifepristone (used to terminate pregnancy) now or up to 12 days from administration of
mifepristone
• Oral steroids (corticosteroids; anti-inflammatory
drugs or used as hormone replacement therapy
when the adrenal glands or pituitary gland have
been destroyed or removed)
• Anti-coagulants (blood thinning tablets like
warfarin)
• Quinolone antibiotics (for infections)
• Sulfinpyrazone (a medicine used to treat gout)
or voriconazole (a medicine used to treat fungal
infections)
• Medicines known as SSRIs (used to treat mental
disorders such as depression)
• Anti-platelet medicinal products (for example,
low dose aspirin) used to prevent blood clots
forming (a process called thrombosis)
• Phenytoin (a medicine used to treat seizures)
• Colestipol and cholestyramine (used to reduce
high cholesterol)
• idovudine (an anti-viral drug)
Taking DICLOFLEX with food and drink
Take this medicine with or after food.
Pregnancy and breast-feeding
• Although not common, abnormalities have been
reported in babies whose mothers have taken
NSAIDs during pregnancy. You should not take
DICLOFLEX tablets during the last 3 months of
pregnancy as it may affect the baby's circulation.
• You should advise your doctor or pharmacist if
you think you might be pregnant or are up to 6
months pregnant.
• Taking DICLOFLEX tablets may make it more
difficult to become pregnant. You should talk
to your doctor if you are planning to become
pregnant, or if you have problems getting
pregnant.
• You should avoid taking DICLOFLEX whilst
breast feeding.
Driving and using machines
Very occasionally people have reported that
diclofenac sodium tablets have made them feel
dizzy, tired or sleepy. Problems with eyesight have
also been reported. If you are affected in this way,
you should not drive or operate machinery.
Important information about some of the
ingredients of DICLOFLEX tablets
DICLOFLEX 25 mg and DICLOFLEX 50 mg contain
lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
DICLOFLEX 25 mg and DICLOFLEX 50 mg
contain a colouring agent, sunset yellow (E110),
which may cause allergic reactions.
3. HOW TO TAKE DICLOFLEX
The doctor will tell you how many DICLOFLEX
tablets to take and when to take them. Always take
DICLOFLEX exactly as your doctor has told you.
You should check with your doctor or pharmacist
if you are not sure. Keep taking your tablets for as
long as you have been told, unless you have any
problems. In that case, check with your doctor. The
usual dose is:
Adults and children over 12 years old: 75 to 150
mg daily in two or three divided doses.
The recommended maximum daily dose of
diclofenac sodium is 150 mg.
Elderly: The lowest effective dose should be used.
Your doctor may advise you to take a dose that is
lower than the usual adult dose if you are elderly.
Close surveillance is advisable.
Children aged 1 to 12 years (DICLOFLEX 25 mg
tablets only): Doses vary with the age and weight
of the child. 25 mg tablets may be given to children
but not to infants, where applicable, within the daily
dose range of 1-3 mg per kilogram of body weight
in two or three divided doses.
Swallow the tablets whole with a glass of water,
with or after food. Do NOT crush or chew the
tablets.
If you take more DICLOFLEX than you should
If you, or anyone else, accidentally takes too much
DICLOFLEX, tell your doctor or go to your nearest
hospital casualty department immediately. Take
your medicine pack with you so that people can
see what you have taken.
Symptoms of an overdose can include: headache,
nausea (feeling sick), vomiting, abdominal pain,
stomach or intestinal bleeding, rarely diarrhoea,
disorientation, excitation, coma, drowsiness,
dizziness, ringing in the ears, fainting, or

occasionally convulsions (seizures, uncontrolled
fits).
If you forget to take DICLOFLEX
It is important that you do not miss a dose. If you
forget to take a dose, take one as soon as you
remember. If it is nearly time for your next dose,
just take the next dose and forget about the one
you missed. Do NOT take a double dose to make
up for a forgotten tablet. Do not take more than 150
mg in 24 hours. If you have trouble remembering
to take the tablets, tell your doctor or pharmacist.
If you have any further questions on the use
of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, DICLOFLEX can cause side
effects, although not everybody gets them.
Some side effects can be serious
If you suffer from any of the following at any
time during your treatment STOP TAKING
DICLOFLEX and seek immediate medical help:
• Pass blood in your faeces (stools/motions). Pass
black tarry stools
• Vomit any blood or dark particles that look like
coffee grounds
• Swollen face, lips, hands or fingers
• Yellowing of your skin or the whites of your eyes
• Persistent sore throat or high temperature
• Allergic reactions which can include skin rash,
itching, bruising, painful red areas, peeling or
blistering, wheezing or shortness of breath
(bronchospasm)
• An unexpected change in the amount of urine
produced and/or its appearance.
• Cases of Stevens Johnsons Syndrome and Toxic
Epidermal Necrolysis (serious illnesses with
blistering of the skin, mouth, eyes and genitals).
• Inflammation of the pancreas (causes symptoms
such as severe abdominal pain, back pain,
nausea, vomiting).
• Hepatitis (raised levels of enzymes in the blood
and symptoms such as abdominal pain, nausea,
vomiting).
STOP TAKING DICLOFLEX and tell your doctor
if you notice:
• Indigestion or heartburn
• Abdominal pain (pains in your stomach), wind,
nausea (feeling sick) or vomiting (being sick) or
other abnormal stomach symptoms.
If you notice that you are bruising more easily than
usual or have frequent sore throats or infections,
tell your doctor.
Effects on the stomach and intestine:
Common side effects (may affect up to 1 in 10
people): nausea (feeling sick), vomiting, diarrhoea,
wind, indigestion, heartburn, loss of appetite,
abdominal (stomach) pain.
Rare side effects (may affect up to 1 in 1,000
people): gastritis (inflammation of the stomach),
any sign of bleeding, for example when emptying
your bowls, black tarry stools, blood in your vomit,
stomach and/or intestine ulcers or bleeding (there
have been very rare reported cases resulting in
death, particularly in the elderly).
Very rare side effects (may affect up to 1 in
10,000 people): colitis (inflammation of the lower
gut which causes symptoms such as abdominal
pain, diarrhoea) and worsening of existing
ulcerative colitis or Crohn’s disease, constipation,
inflammation of the mouth (including mouth
ulcers), inflammation of the tongue, oesophageal
disorders (causes symptoms such as difficulty
swallowing and chest or back pains
Immune system disorders:
Rare side effects (may affect up to 1 in 1,000
people): allergic reactions (see in section 4 "Some
side effects can be serious"), anaphylactic and
anaphylactoid reactions (serious allergic reaction
which causes symptoms such as fast throbbing
heart beat, flushing, dizziness, fainting, difficulty
breathing).
Very rare side effects (may affect up to 1 in 10,000
people): angioedema (serious allergic reaction
which causes swelling mainly of the face, lips,
tongue, throat).
Effects on the heart or chest:
Very rare side effects (may affect up to 1 in 10,000
people): heart attack (‘myocardial infarction’),
chest pain, palpitations (fast or irregular heart
beat), heart failure.
Effects on the vascular system:
Rare side effects (may affect up to 1 in 1,000
people): low blood pressure which may include
faintness, giddiness or light headedness.
Very rare side effects (may affect up to 1 in 10,000
people): high blood pressure, inflammation of
blood vessels.
Effects on the kidneys:
Very rare side effects (may affect up to 1 in 10,000
people): abnormal kidney function or failure
causing swelling, particularly of the ankles (fluid
retention), high or low blood pressure, presence
of blood or protein in the urine, an unexpected
change in the amount of urine produced and/or its
appearance.
Effects on the liver:
Common side effects (may affect up to 1 in 10
people): elevated liver enzymes in the blood
(shows up in blood tests).
Rare side effects (may affect up to 1 in 1,000
people): abnormal liver function, including hepatitis
and jaundice (yellowing of the skin and the whites
of the eyes).
Very rare side effects (may affect up to 1 in 10,000
people): rapidly progressive hepatitis, liver failure.
Effects on the nervous system:
Common side effects (may affect up to 1 in 10
people): headaches, dizziness.
Rare side effects (may affect up to 1 in 1,000
people): drowsiness, tiredness.
Very rare side effects (may affect up to 1 in 10,000
people): tingling or numbness in the hands and/
or feet, loss of memory, fits, anxiety, shaking,
change in sense of taste, sleeplessness, stroke,
non-infectious meningitis (particularly if you suffer
from auto-immune disorders such as Systemic
Lupus Erythematosus (SLE)) with symptoms such
as stiff neck, headache together with a dislike
of bright lights, feeling sick, vomiting, fever or
disorientation, disturbances in sensation.
Psychiatric disorders:
Very rare side effects (may affect up to 1 in
10,000 people): disorientation, mood changes,
depression, difficulty sleeping, nightmare,
irritability, mental disorders.
Effects on hearing:
Common side effects (may affect up to 1 in 10

people): Vertigo (sensation of irregular or spinning
motion).
Very rare side effects (may affect up to 1 in
10,000 people): ringing in the ears, hearing loss
or impairment.
Effects on vision:
Very rare side effects (may affect up to 1 in
10,000 people): blurred or double vision, partial or
complete loss of eyesight.
Effects on the blood:
Very rare side effects (may affect up to 1 in 10,000
people): blood disorders (including anaemia)
resulting in unexplained or unusual bruising or
bleeding, pinpoint red spots, fever, sore throat,
mouth ulcers, extreme pallor or weakness.
Effects on the skin:
Common side effects (may affect up to 1 in 10
people): rash or spots.
Rare side effects (may affect up to 1 in 1,000
people): hives (redness and swelling of the skin),
itching.
Very rare side effects (may affect up to 1 in 10,000
people): purplish spots or patches and flaking or
blistering of the skin, itching, eczema (inflammatory
skin disease), redness of the skin , photosensitivity
(increased sensitivity to sunlight), loss of hair.
Effects on the respiratory system:
Rare side effects (may affect up to 1 in 1,000
people): asthma, difficulty and/or shortness of
breath.
Very rare side effects (may affect up to 1 in 10,000
people): pneumonitis (inflammation of the lungs
which causes breathlessness, cough and raised
temperature).
General disorders:
Rare side effects (may affect up to 1 in 1,000
people): oedema (water retention leading to
swelling of the hands, ankles or feet).
Other side effects that have also been reported
include (frequency cannot be estimated from
the available data):
Impotence, throat disorders, hallucinations,
confusion, general feeling of discomfort,
inflammation of the nerves of the eyes.
Do not be alarmed by this list - most people
take Diclofenac Sodium Tablets without any
problems.
If any of the side effects becomes serious, or if
you notice side effects not listed in this leaflet,
please tell your doctor. He/she may want to
give you a different medicine.
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 DICLOFLEX
Keep out of the reach and sight of children.
Do not use DICLOFLEX tablets after the expiry
date which is printed after ‘Exp’ on the carton.
Do not store above 25°C. Keep the tablets in their
original pack.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.
6. FURTHER INFORMATION
What DICLOFLEX tablets contain
The name of your medicine is DICLOFLEX 25 mg
or 50 mg.
DICLOFLEX 25 mg: Each gastro-resistant
tablet contains 25 mg of the active ingredient
diclofenac sodium, and also contains the following
inactive ingredients: tablet core: copolyvidone,
microcrystalline cellulose, colloidal anhydrous
silica, lactose, maize starch, magnesium
stearate, crospovidone. Tablet enteric coat:
triethyl citrate, methacrylic acid-ethylacrylate
copolymer (1:1) dispersion 30%, talc. Tablet film
coat: hydroxypropylmethylcellulose, polyethylene
glycol, iron oxide yellow (E172), sunset yellow
(E110), titanium dioxide (E171). Polish: carnauba
wax.
DICLOFLEX 50 mg: Each gastro-resistant
tablet contains 50 mg of the active ingredient
diclofenac sodium, and also contains the following
inactive ingredients: tablet core: copolyvidone,
microcrystalline cellulose, colloidal anhydrous
silica, lactose, maize starch, magnesium
stearate, crospovidone. Tablet enteric coat:
triethyl citrate, methacrylic acid-ethylacrylate
copolymer (1:1) dispersion 30%, talc. Tablet film
coat: hydroxypropylmethylcellulose, polyethylene
glycol, iron oxide yellow (E172), iron oxide red
(E172), sunset yellow (E110), titanium dioxide
(E171). Polish: carnauba wax.
What DICLOFLEX look like and contents of the
pack
DICLOFLEX 25 mg gastro-resistant tablets are
marked D25 on one side and are yellowish-brown
in colour. DICLOFLEX 25 mg gastro-resistant
tablets are packed in cartons containing 84 tablets
or 100 tablets in foil blister strips.
DICLOFLEX 50 mg gastro-resistant tablets are
marked DICL50 on one side and are reddishbrown in colour. DICLOFLEX 50 mg gastroresistant tablets are packed in cartons containing
28, 84 or 100 tablets in foil blister strips.
Not all pack sizes may be marketed.
Marketing Authorisation Holder/Manufacturer:
Dexcel®-Pharma Ltd., 7 Sopwith Way, Drayton
Fields, Daventry, Northamptonshire NN11 8PB,
UK.
This leaflet was last revised in April 2015

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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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