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FENACTOL RETARD 100MG

Active substance(s): DICLOFENAC SODIUM

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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.
− This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
− If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
In this leaflet
1. What FENACTOL 75MG SR and FENACTOL
RETARD 100MG are and what they are used for
2. What you need to know 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. Contents of the pack and other 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 conditions affecting the joints,
muscles and tendons including:
• 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. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE FENACTOL 75MG SR OR FENACTOL
RETARD 100MG
Do not take FENACTOL 75MG SR or FENACTOL
RETARD 100MG if
• you are allergic to diclofenac sodium, aspirin,
ibuprofen or any other NSAID, or to any of the
other ingredients of FENACTOL 75MG SR and
FENACTOL RETARD 100MG tablets (these are
listed under section 6 "CONTENTS OF THE PACK
AND OTHER INFORMATION" of the leaflet). Signs
of a hypersensitivity reaction include swelling
of the face and mouth (angioedema), breathing
problems, runny nose, skin rash or any other
allergic type reaction.
• you have now, or have ever had, a stomach
(gastric) or duodenal (peptic) ulcer, or bleeding in
the digestive tract (this can include blood in vomit,
bleeding when emptying bowels, fresh blood in
faeces or black, tarry faeces)
• you have had stomach or bowel problems after
you have taken other NSAIDs
• you have severe heart, kidney or liver failure
• 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 are more than six months pregnant
Warnings and precautions
Talk to your doctor or pharmacist before taking
Diclofenac if:
• you suffer from any stomach or bowel disorders
including ulcerative colitis or Crohn’s disease
• you have kidney or liver problems, or you are
elderly
• you have a condition called porphyria
• you suffer from any blood or bleeding disorder. If
you do, your doctor may ask you to go for regular
check-ups while you are taking these tablets.
• you ever had asthma, seasonal allergic rhinitis,
swelling of the nasal mucosa (nasal polyps),
chronic pulmonary diseases or infections of the
respiratory tract.
• you are breast feeding
• you have angina, blood clots, high blood pressure,
raised cholesterol or raised triglycerides
• you have heart problems or if you had 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)
• you have diabetes
• you smoke
• 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
• you have an intolerance to some sugars such as
sucrose (these tablets contain sucrose)
Tell your doctor or pharmacist if you have any
of these conditions because FENACTOL 75MG
SRor FENACTOL RETARD 100MG might not be
the right medicine for you.
Children
FENACTOL 75MG SR and FENACTOL RETARD
100MG tablets are not suitable for children.

Other medicines and Fenactol 75mg SR and
Fenactol Retard 100mg
Some medicines can interfere with your treatment.
Please tell your doctor or pharmacist if you are
takingany of the following:
• Medicines to treat diabetes
• Anticoagulants (blood thinning tablets like warfarin)
• Diuretics (water tablets)
• Lithium (used to treat some mental problems)
• Methotrexate (for treatment of some inflammatory
diseases and some cancers)
• Ciclosporin and tacrolimus (used to treat some
inflammatory diseases and after transplants)
• Trimethoprim (a medicine used to prevent or treat
urinary tract infections)
• Quinolone antibiotics (for infections)
• Any other NSAID or COX-2 (cyclo-oxygenase-2)
inhibitor, for example aspirin or ibuprofen
• Mifepristone (a medicine used to terminate
pregnancy)
• Cardiac glycosides (for example digoxin), used to
treat heart problems
• Medicines known as SSRIs (used to treat
depression)
• Oral steroids (an anti-inflammatory drug)
• Medicines used to treat heart conditions or high
blood pressure, for example beta blockers or ACE
inhibitors
• Voriconazole (a medicine used to treat fungal
infections).
• Phenytoin (a medicine used to treat seizures)
• Colestipol/cholestyramine (used to lower
cholesterol)
Always tell your doctor or pharmacist about all the
medicines you are taking. This means medicines
you have bought yourself as well as medicines on
prescription from your doctor.
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.
Other special warnings
• You should take the lowest effective dose of
Diclofenac Sodium for the shortest possible time
particularly if you are underweight or elderly.
• There is a small increased risk of heart attack
or stroke when you are taking any medicine like
Diclofenac Sodium. The risk is higher if you are
taking high doses for a long time. Always follow the
doctor’s instructions on how much to take and how
long to take it for.
• Whilst you are taking these medicines your doctor
may want to give you a check-up 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 it is an anti-inflammatory medicine,
Diclofenac Sodium tablets 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 tablets.
FENACTOL 75MG SR and FENACTOL
RETARD 100MG contains
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 this medicine
exactly as described in this leaflet or as your doctor
or pharmacist has told you. You should check with
your doctor or pharmacist if you are not sure.
Take the tables with or after food.
Swallow the tablets whole with a glass of water. DO
NOT crush or chew the tablets as this will affect the
special “slow release” system.
The recommended dose is:
Adults: 100-150mg daily divided into two or three
doses. The number of tablets which you
take will depend on the strength the doctor has
given you.
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.
The doctor may also prescribe another drug to
protect the stomach to be taken at the same time,
particularly if you have had stomach problems
before, or if you are elderly, or taking certain other
drugs as well.
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
STOP TAKING FENACTOL 75MG SR or
FENACTOL RETARD 100MG and tell your doctor
straight away if you notice:
• Stomach pain, indigestion, heartburn, wind,
nausea (feeling sick) or vomiting (being sick)
• Any sign of bleeding in the stomach or intestine,
for example, when emptying your bowels, blood in
vomit or black, tarry faeces
• Allergic reactions which can include skin rash,
itching, bruising, painful red areas, peeling or
blistering
• Wheezing or shortness of breath (bronchospasm)
• Swollen face, lips, hands or fingers
• Yellowing of your skin or the whites of your eyes
• Persistent sore throat or high temperature
• An unexpected change in the amount of urine
produced and/or its appearance.
• Mild cramping and tenderness of the abdomen,
starting shortly after the start of the treatment with
FENACTOL 75MG SR or FENACTOL RETARD
100MG and followed by rectal bleeding or bloody
diarrhea usually within 24 hours of the onset of
abdominal pain
• Stevens-Johnson syndrome (serious illnesses with
blistering of the skin, mouth, eyes and genitals)
If you notice that you are bruising more easily than
usual or have frequent sore throats or infections, tell
your doctor.
The side effects listed below have also been
reported.
Common (may affect up to 1 in 10 people):
• Stomach pain, heartburn, nausea, vomiting,
diarrhea, indigestion, wind, loss of appetite
• Headache, dizziness, vertigo
• Skin rash or spots
• Raised levels of liver enzymes in the blood
Rare (may affect up to 1 in 1,000 people):
• Stomach ulcers or bleeding (there have been very
rare reported cases resulting in death, particularly
in the elderly)
• Gastritis (inflammation, irritation or swelling of the
stomach lining)
• Vomiting blood
• Diarrhoea with blood in it or bleeding from the back
passage
• Black, tarry faeces or stools
• Drowsiness, tiredness
• Hypotension (low blood pressure, symptoms of
which may include faintness, giddiness or light
headedness)
• Skin rash and itching
• Fluid retention, symptoms of which include swollen
ankles
• Liver function disorders, including hepatitis and
jaundice
Very rare (may affect up to 1 in 10,000 people):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, blurred
or double vision, hearing loss or impairment, tinnitus
(ringing in the ears), sleeplessness, nightmares,
mood changes, depression, anxiety, mental
disorders, disorientation and loss of memory, fits,
headaches together with a dislike of bright lights,
fever and a stiff neck, disturbances in sensation

(pneumonitis), heart disorders, including congestive
heart failure or heart attack, blood disorders
(including anaemia).
Effects on the liver or kidneys:
Kidney or severe liver disorders including liver
failure, presence of blood or protein in the urine
Effects on skin or hair:
Serious skin rashes including Stevens-Johnson
syndrome, Lyell’s syndrome and other skin rashes
which may be made worse by exposure to sunlight.
Hair loss
Other side effects that have also been reported
include:
Inflammation of the pancreas, impotence. Facial
swelling, inflammation of the lining of the brain
(meningitis), stroke, throat disorders, confusion,
hallucinations, malaise (general feeling of
discomfort), inflammation of the nerves in the eye.
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 sight and reach 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. CONTENTS OF THE PACK AND OTHER
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 prolonged-release tablets
are marked DICL75 on one side and are pink in
colour. FENACTOL 75MG SR prolonged-release
tablets are packed in cartons containing 28 tablets
or 56 tablets in foil blister strips.
FENACTOL RETARD 100MG prolonged-release
tablets are marked DICL100 on one side and
are pink in colour. FENACTOL RETARD 100MG
prolonged-release tablets 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 July 2017

Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth
ulcers, inflammation of the inside of the mouth or
lips, taste changes, lower gut disorders (including
of the colon or worsening of ulcerative colitis or
Crohn’s disease).
Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain,
hypertension (high blood pressure), inflammation of
blood vessels (vasculitis), inflammation of the lung

V-1363

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