DICLOFENAC SODIUM TABLETS 50MG

Active substance: DICLOFENAC SODIUM

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Diclofenac Sodium 25mg & 50mg
Gastro-resistant tablets
Read all of this leaflet carefully before you
start taking this medicine.
• 
Keep this leaflet. You may need to read it
again.
• f you have any further questions, ask your
I
doctor or pharmacist.
•  his medicine has been prescribed for you.
T
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
• f any of the side effects gets serious, or
I
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

In this leaflet
1 What Diclofenac Sodium 25 mg and
50 mg are and what they are used for
2 Before you take Diclofenac Sodium
25 mg or 50 mg
3 How to take Diclofenac Sodium
25 mg and 50 mg
4 Possible side effects
5 How to store Diclofenac Sodium
25 mg and 50 mg
6 Further information
1 What Diclofenac Sodium

25 mg and 50 mg are and what
they are used for

Diclofenac sodium, the active ingredient in
Diclofenac Sodium 25 mg and 50 mg tablets, is
one of a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). NSAIDs
reduce pain and inflammation.
Diclofenac Sodium tablets relieve pain, reduce
swelling and ease inflammation in a number of
conditions affecting the joints and muscles:
•  heumatoid arthritis, osteoarthritis, acute gout
R
(painful inflammation of the joints especially
in the feet and hands). ankylosing spondylitis
(form of spinal arthritis).
•  ackache, sprains and strains, soft tissue sports
B
injuries, frozen shoulder, dislocations and
fractures
•  onditions affecting the tendons for example,
C
tendonitis, tenosynovitis, bursitis.
They are also used to treat pain and
inflammation associated with dental and minor
surgery.
In children aged 1-12 years Diclofenac Sodium
25 mg tablets are used to treat juvenile chronic
arthritis.
In children aged 9 years and above Diclofenac
Sodium 25 mg tablets are used for short term
tratment of fever related to infections of the
ear, nose or throat, and for relief of acute postoperative pain.

2  EFORE YOU TAKE Diclofenac
B

Sodium 25 mg or 50 mg

Do not take Diclofenac Sodium
25 mg or 50 mg if

•  ou are allergic (hypersensitive) to diclofenac
y
sodium, aspirin, ibuprofen or any other
NSAID, or any of the other ingredients of
Diclofenac Sodium 25 mg and 50 mg tablets
(these are listed under section 6 “FURTHER
INFORMATION” of the leaflet).
•  ou have a history of allergy to aspirin,
y
ibuprofen or NSAIDs, which includes attacks of
asthma, swelling of the nose and throat, skin
rashes or a runny nose.
•  ou have an active or a history of recurrent
y
(more than two) peptic ulcers (ulcer in your
stomach or duodenum).
•  ou have a history of gastrointestinal bleeding
y
or perforation related to the use of NSAIDs (this
can include blood in vomit, bleeding when
emptying bowels, fresh blood in stools or black
tarry stools).
•  ou have had stomach or bowel problems
y
(bleeding or perforation) after you have taken
other NSAIDs
•  ou have severe heart, kidney or liver failure
y
•  ou are more than six months pregnant
y

Take special care with Diclofenac Sodium
25 mg or 50 mg

• f you suffer from any stomach or bowel
i
disorders including ulcerative colitis or Crohn’s
disease
• f you have kidney or liver problems, or you are
i
elderly
• if you have a condition called porphyria
• f you suffer from any blood or bleeding
i
disorder
• f you ever had asthma, seasonal allergic
i
rhinitis, swelling of the nasal mucosa (nasal
polyps), chronic pulmonary diseases or
infections of the respiratory tract.
• f you have heart problems, or you have had
i
a stroke, 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)
• f you have Systemic Lupus Erythematosus
i
(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 Diclofenac
Sodium 25 mg or 50 mg might not be the
right medicine for you.

Other special warnings

•  ou should take the lowest effective dose of
Y
Diclofenac Sodium 25 mg or 50 mg for the
shortest possible time to control symptoms,
particularly if you are underweight or elderly.
•  ou should be aware that medicines such as
Y
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.

Continued top of next column
AAAF3162

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.
•  hilst you are taking these medicines your
W
doctor may want to give you a check-up or
order a blood test from time to time.
• f you have a history of stomach problems
I
when you are taking NSAIDs, particularly if you
are elderly, you must tell your doctor straight
away if you notice any unusual symptoms.
•  ecause these are anti-inflammatory
B
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 Diclofenac Sodium 25 mg or 50 mg
tablets.
•  he 50 mg tablets are not suitable for children
T
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:
•  edicines to treat diabetes
M
•  ny other NSAID or COX-2 (cyclo-oxygenase-2)
A
inhibitor, for example aspirin or ibuprofen
•  edicines used to treat heart conditions or
M
high blood pressure, for example beta blockers
or ACE inhibitors
•  iuretics (water tablets)
D
•  ardiac glycosides (for example, digoxin), used
C
to treat heart problems
•  ithium (used to treat some mental problems)
L
•  ethotrexate (used for treatment of some
M
inflammatory diseases and some cancers)
•  iclosporin and tacrolimus (used to treat some
C
inflammatory diseases and after transplants)
• Trimethoprim (used to prevent or treat urinary
tract infections)
•  ifepristone (used to terminate pregnancy)
M
- now or up to 12 days from administration of
mifepristone
•  ral steroids (corticosteroids; antiO
inflammatory drugs or used as hormone
replacement therapy when the adrenal glands
or pituitary gland have been destroyed or
removed)
•  nti-coagulants (blood thinning tablets like
A
warfarin)
•  uinolone antibiotics (for infections)
Q
•  ulfinpyrazone (a medicine used to treat gout)
S
or voriconazole (a medicine used to treat
fungal infections)
•  edicines known as SSRIs (used to treat mental
M
disorders such as depression)
•  nti-platelet medicinal products (for example,
A
low dose aspirin) used to prevent blood clots
forming (a process called thrombosis)
•  henytoin (a medicine used to treat seizures)
P
•  olestipol and cholestyramine (used to reduce
C
high cholesterol)
•  idovudine (an anti-viral drug)
Z

Taking Diclofenac Sodium 25 mg or
50 mg with food and drink
Take this medicine with or after food.

Pregnancy and breast-feeding

•  lthough not common, abnormalities have
A
been reported in babies whose mothers have
taken NSAIDs during pregnancy. You should
not take Diclofenac Sodium tablets during the
last 3 months of pregnancy as it may affect the
baby’s circulation.
•  ou should advise your doctor or pharmacist if
Y
you think you might be pregnant or are up to 6
months pregnant.
•  aking Diclofenac Sodium 25 mg or 50 mg
T
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.
•  ou should avoid taking Diclofenac Sodium
Y
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 Diclofenac Sodium
25 mg and 50 mg tablets

Diclofenac Sodium 25 mg and Diclofenac
Sodium 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.
Diclofenac Sodium 25 mg and Diclofenac
Sodium 50 mg contain a colouring agent, sunset
yellow (E110), which may cause allergic reactions.

3  OW TO TAKE DICLOFENAC SODIUM
H

25 mg and 50 mg

The doctor will tell you how many Diclofenac
Sodium 25 mg or Diclofenac Sodium 50 mg
to take and when to take them. Always take
Diclofenac Sodium 25 mg and Diclofenac
Sodium 50 mg 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 (Diclofenac Sodium
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.

Continued over page

If you take more Diclofenac Sodium
25 mg or 50 mg than you should

If you, or anyone else, accidentally takes too
much Diclofenac Sodium, 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 Diclofenac Sodium
25 mg or 50 mg

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, Diclofenac Sodium 25 mg
or 50 mg 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
Diclofenac Sodium 25 mg or 50 mg and
seek immediate medical help:
•  ass blood in your faeces (stools/motions)
P
•  ass black tarry stools
P
•  omit any blood or dark particles that look like
V
coffee grounds
•  wollen face, lips, hands or fingers
S
•  ellowing of your skin or the whites of your
Y
eyes
•  ersistent sore throat or high temperature
P
•  llergic reactions which can include skin rash,
A
itching, bruising, painful red areas, peeling or
blistering, wheezing or shortness of breath
(bronchospasm)
•  n unexpected change in the amount of urine
A
produced and/or its appearance.
•  ases of Stevens Johnson Syndrome and Toxic
C
Epidermal Necrolysis (serious illnesses with
blistering of the skin, mouth, eyes and genitals).
• nflammation of the pancreas (causes
I
symptoms such as severe abdominal pain, back
pain, nausea, vomiting)
•  epatitis (raised levels of enzymes in the
H
blood and symptoms such as abdominal pain,
nausea, vomiting)

STOP TAKING DICLOFENAC SODIUM
25 mg or 50 mg and tell your doctor if
you notice:

• ndigestion or heartburn
I
•  bdominal pain (pains in your stomach) or
A
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 bowels, 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
or diarrhoea) and worsening of existing 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 (fastr 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, 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.

Continued top of next column
AAAF3162

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 (may affect up to 1 in

10,000 people):
Very rare side effects: 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, 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
Also you can help to make sure that
medicines remain as safe as possible by
reporting any unwanted side effects via the
internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808
100 3352 (available from 10 a.m. to 2 p.m.
Mondays to Fridays) or fill in a paper form
available from your local pharmacy.

5  OW TO STORE DICLOFENAC
H

SODIUM 25 mg and 50 mg

Keep out of the reach and sight of children.
Do not use Diclofenac Sodium 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  URTHER INFORMATION
F
What Diclofenac Sodium 25 mg and
50 mg contain

The name of your medicine is Diclofenac Sodium
25 mg or 50 mg.
Diclofenac Sodium 25 mg: Each gastroresistant 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.
Diclofenac Sodium 50 mg: Each gastroresistant 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 Diclofenac Sodium 25 mg and 50 mg
look like and contents of the pack
Diclofenac Sodium 25 mg gastro-resistant
tablets are marked D25 on one side and are
yellowish-brown in colour. Diclofenac Sodium 25
mg gastro-resistant tablets are packed in cartons
containing 84 tablets or 100 tablets in foil blister
strips.
Diclofenac Sodium 50 mg gastro-resistant
tablets are marked DICL50 on one side and are
reddish-brown in colour. Diclofenac Sodium 50
mg gastro-resistant 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 March 2013.

If you would like a
leaflet with larger
text, please contact
01271 311257.

Actavis, Barnstaple, EX32 8NS, UK

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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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