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DICLOFLEX RETARD 100MG

Active substance(s): DICLOFENAC SODIUM

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FENACTOL® 75MG SR and
FENACTOL® RETARD 100MG
Prolonged-release tablets
(diclofenac sodium)

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 FENACTOL 75MG SR and FENACTOL
RETARD 100MG are and what they are used for
2. Before you take FENACTOL 75MG SR or
FENACTOL RETARD 100MG
3. How to take FENACTOL 75MG SR or FENACTOL
RETARD 100MG
4. Possible side effects
5. How to store FENACTOL 75MG SR and
FENACTOL RETARD 100MG
6. Further information
1. WHAT FENACTOL 75MG SR and
FENACTOL RETARD 100MG ARE AND
WHAT THEY ARE USED FOR
Diclofenac sodium, the active ingredient in FENACTOL
75MG SR and FENACTOL RETARD 100MG tablets, is
one of a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). NSAIDs reduce
pain and inflammation. FENACTOL 75MG SR and
FENACTOL RETARD 100MG tablets are especially
formulated to release the diclofenac sodium slowly.
FENACTOL 75MG SR and FENACTOL RETARD
100MG tablets relieve pain, reduce swelling and ease
inflammation in a number of conditions affecting the
joints and muscles:
• 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.
FENACTOL 75MG SR and FENACTOL RETARD
100MG tablets are not suitable for children.
2. BEFORE YOU TAKE FENACTOL 75MG SR OR
FENACTOL RETARD 100MG
Do not take FENACTOL 75MG SR or FENACTOL
RETARD 100MG if
• you are allergic (hypersensitive) to diclofenac
sodium, aspirin, ibuprofen or any other NSAID, or
any of the other ingredients of FENACTOL 75MG
SR and FENACTOL RETARD 100MG 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 with FENACTOL 75MG SR or
FENACTOL RETARD 100MG
• 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 FENACTOL 75MG SR
or FENACTOL RETARD 100MG might not be the
right medicine for you.
Other special warnings
• You should take the lowest effective dose of
FENACTOL 75MG SR or FENACTOL RETARD
100MG 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

Type of Print (ie Litho) Litho

Format

155 x 480 mm

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 FENACTOL 75MG
SR or FENACTOL RETARD 100MG tablets.
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)
• Zidovudine (an anti-viral drug)
Taking FENACTOL 75MG SR or FENACTOL
RETARD 100MG 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
FENACTOL 75MG SR or FENACTOL RETARD
100MG 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 FENACTOL 75MG SR or FENACTOL
RETARD 100MG 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 FENACTOL 75MG SR or
FENACTOL RETARD 100MG 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 FENACTOL 75MG SR and
FENACTOL RETARD 100MG
FENACTOL 75MG SR and FENACTOL RETARD
100MG contain sucrose. If you have been told by your
doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal
product.
3. HOW TO TAKE FENACTOL 75MG SR or
FENACTOL RETARD 100MG
The doctor will tell you how many FENACTOL 75MG
SR or FENACTOL RETARD 100MG to take and when
to take them. Always take FENACTOL 75MG SR or
FENACTOL RETARD 100MG 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:
One tablet daily. Your doctor may wish to
increase your daily dose if required to
150mg.
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: These tablets are not suitable for
children.
Swallow the tablets whole with a glass of water, with or
after food. Do NOT crush or chew the tablets as this
will affect the special "slow release" system.
If you take more FENACTOL 75MG SR or
FENACTOL RETARD 100MG than you should
If you, or anyone else, accidentally takes too much
FENACTOL 75MG SR or FENACTOL RETARD
100MG, 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 FENACTOL 75MG SR or
FENACTOL RETARD 100MG
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, FENACTOL 75MG SR or
FENACTOL RETARD 100MG 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 FENACTOL
75MG SR or FENACTOL RETARD 100MG 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 Johnson 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 FENACTOL 75MG SR or FENACTOL
RETARD 100MG 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.
The frequency of possible side effects listed below is
defined using the following convention:
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, 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 FENACTOL 75MG SR and
FENACTOL RETARD 100MG
Keep out of the reach and sight of children.
Do not use FENACTOL 75MG SR or FENACTOL
RETARD 100MG 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 FENACTOL 75MG SR and
FENACTOL RETARD 100MG contain
The name of your medicine is FENACTOL 75MG SR
or FENACTOL RETARD 100MG.
FENACTOL 75MG SR: Each prolonged-release tablet
contains 75mg of the active ingredient diclofenac
sodium, and also contains the following inactive
ingredients: tablet core: cetostearyl alcohol, colloidal
anhydrous silica, compressible sugar, talc, povidone
and magnesium stearate. Subcoat: copovidone and
sucrose. Tablet film coat:
hydroxypropylmethylcellulose, polyethylene glycol, iron
oxide red (E172), titanium dioxide (E171) and gum
acasia. Polish: carnauba wax.
FENACTOL RETARD 100MG: Each prolongedrelease tablet contains 100mg of the active ingredient
diclofenac sodium, and also contains the following
inactive ingredients: tablet core: cetostearyl alcohol,
colloidal anhydrous silica, compressible sugar, talc,
povidone, magnesium stearate. Subcoat: copovidone
and sucrose.
Tablet film coat: hydroxypropylmethylcellulose,
polyethylene glycol, iron oxide red (E172), titanium
dioxide (E171) and gum acasia. Polish: carnauba wax.
What FENACTOL 75MG SR and FENACTOL
RETARD 100MG look like and contents of the pack
FENACTOL 75MG SR are marked DICL75 on one side
and are pink in colour, and are packed in cartons
containing 28 tablets or 56 tablets in foil blister strips.
FENACTOL RETARD 100MG are marked DICL100 on
one side and are pink in colour, and are packed in
cartons containing 28 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.
Manufactured for: Discovery Pharmaceuticals, The
Old Vicarage, Market Place, Castle Donington,
Derbyshire DE74 2JB, England
This leaflet was last revised in September 2014

Discovery

DSC-FNL-PIL75,100-081_02
10-09-2014

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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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