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
T
you. 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 nonsteroidal 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
R
gout (painful inflammation of the joints
especially in the feet and hands). ankylosing
spondylitis (form of spinal arthritis).
•  ackache, sprains and strains, soft tissue
B
sports injuries, frozen shoulder, dislocations
and fractures
C
•  onditions 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 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
treatment 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

 not take Diclofenac Sodium
Do

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).
y
•  ou 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.
•  ou have or have had problems with your
y
blood circulation (peripheral arterial disease).
•  ou have a history of allergy to aspirin,
y
ibuprofen or NSAIDs, which includes attacks
of asthma, swelling of the nose and throat,
face and mouth, 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), 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).
•  ou have a history of stomach or bowel
y
problems (e.g. gastrointestinal bleeding or
perforation) related to the use of NSAIDs
•  ou have severe heart, kidney or liver failure
y
y
•  ou are more than six months pregnant
Make sure your doctor knows, before you
are given Diclofenac if
y
•  ou smoke
•  ou have diabetes
y
y
•  ou have angina, blood clots, high blood
pressure, raised cholesterol or raised
triglycerides
•  ou are breast-feeding (see section
y
Pregnancy and breast-feeding)
Side effects may be minimised by using the
lowest effective dose for the shortest duration
necessary.

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
i
are 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 think
i
you might be at risk of these conditions (for
example, if you have high blood pressure,
diabetes or high cholesterol or are a smoker)
i
• f 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 Diclofenac
Sodium25 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.

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•  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.
 you have heart problems, previous stroke
If
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
T
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:
•  edicines to treat diabetes
M
•  ny other NSAID or COX-2 (cycloA
oxygenase-2) inhibitor, for example aspirin or
ibuprofen
•  edicines used to treat heart conditions
M
or high blood pressure, for example beta
blockers or ACE inhibitors
•  iuretics (water tablets)
D
•  ardiac glycosides (for example, digoxin),
C
used to treat heart problems
•  ithium (used to treat some mental
L
problems)
•  ethotrexate (used for treatment of some
M
inflammatory diseases and some cancers)
•  iclosporin and tacrolimus (used to treat
C
some 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
S
gout) or voriconazole (a medicine used to
treat fungal infections)
•  edicines known as SSRIs (used to treat
M
mental disorders such as depression)
•  nti-platelet medicinal products (for
A
example, 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
C
reduce 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.
Y
•  ou should advise your doctor or pharmacist
if 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
H

SODIUM 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.
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dimensions: 155 x 560

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
V
like 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
A
urine produced and/or its appearance.
•  ases of Stevens Johnson Syndrome and
C
Toxic 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),
A
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 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 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 autoimmune 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

(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, 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 at: www.mhra.gov.uk/yellowcard. By
reporting side effects, you can help provide
more information on the safety of this
medicine.

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 FURTHER INFORMATION
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 September 2014

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

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Actavis, Barnstaple, EX32 8NS, UK

dimensions: 155 x 560

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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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