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DICLOFENAC SODIUM TABLETS 50MG

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 TABLETS 50MG are and
what they are used for
2. What you need to know before you take
FENACTOL TABLETS 50MG
3. How to take FENACTOL TABLETS 50MG
4. Possible side effects
5. How to store FENACTOL TABLETS 50MG
6. Contents of the pack and other information
1. WHAT FENACTOL TABLETS 50MG ARE AND
WHAT THEY ARE USED FOR
Diclofenac sodium, the active ingredient in
FENACTOL TABLETS 50MG, is one of a group of
medicines called non-steroidal anti-inflammatory
drugs (NSAIDs). NSAIDs reduce pain and
inflammation.
FENACTOL 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE FENACTOL TABLETS 50MG
Do not take FENACTOL TABLETS 50MG if:
• you are allergic to diclofenac sodium, aspirin,
ibuprofen or any other NSAID, or to any of the
other ingredients of FENACTOL TABLETS 50MG
(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
lactose (these tablets contain lactose)

• 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 TABLETS 50MG 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 TABLETS 50MG 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 TABLETS 50MG 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 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.
• These tablets are not suitable for children aged
under 12.
FENACTOL TABLETS 50MG contains
FENACTOL TABLETS 50MG 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.
FENACTOL TABLETS 50MG contain a colouring
agent, sunset yellow (E110), which may cause
allergic reactions.
3. HOW TO TAKE FENACTOL TABLETS 50MG
The doctor will tell you how many FENACTOL
TABLETS 50MG 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. Check with your doctor or pharmacist if you
are not sure.
Take the tablets with or after food.
Swallow the tablets whole with a glass of water.
DO NOT crush or chew the tablets.
The recommended dose is:

Tell your doctor or pharmacist if you have
any of these conditions because FENACTOL
TABLETS 50MG might not be the right
medicine for you.

Adults
75 to 150 mg daily divided into two or three doses.
The number of tablets which you take will depend
on the strength the doctor has given you.

Children
These tablets are not suitable for children aged
under 12.

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. Your doctor may
also want to check closely that the FENACTOL
TABLETS are not affecting your stomach.

Other medicines and FENACTOL TABLETS
50mg
Some medicines can interfere with your treatment.
Please tell your doctor or pharmacist if you are
taking any of the following:
• Medicines to treat diabetes

Children
These tablets are not suitable for children aged

under 12.
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 TABLETS 50MG
than you should
If you, or anyone else, accidentally take too much
FENACTOL, 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 TABLETS
50MG
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 TABLETS 50MG
can cause side effects, although not everybody
gets them.
Some side effects can be serious
STOP TAKING FENACTOL TABLETS 50MG 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 TABLETS 50MG 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 side (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

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 TABLETS 50MG
Keep out of the sight and reach of children.
Do not use FENACTOL 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 TABLETS 50MG contain
The name of your medicine is FENACTOL
TABLETS 50MG.
FENACTOL TABLETS 50MG: 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 FENACTOL TABLETS 50MG look like and
contents of the pack
FENACTOL TABLETS 50MG gastro-resistant
tablets are marked DICL50 on one side and are
reddish-brown in colour. FENACTOL TABLETS
50MG 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.
Manufactured for:
Discovery Pharmaceuticals, The Old Vicarage,
Market Place, Castle Donington, Derbyshire DE74
2JB, England
This leaflet was last revised in July 2017

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
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 (pneumonitis), heart
disorders, including congestive heart failure or
heart attack, blood disorders (including anaemia).
Effects on the liver or kidneys:

V-1363

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