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Active substance(s): DICLOFENAC SODIUM

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Gastro-resistant 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 TABLETS 50MG are and what
they are used for
2. 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. Further information

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
FENACTOL 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
• Conditions affecting the tendons for example,
tendonitis, tenosynovitis, bursitis.
They are also used to treat pain and inflammation
associated with dental and minor surgery.

Do not take FENACTOL TABLETS 50MG if
• you are allergic (hypersensitive) to diclofenac
sodium, aspirin, ibuprofen or any other NSAID,
or any of the other ingredients of FENACTOL
TABLETS 50MG (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 (ulcers 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
• 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
• if you suffer from any stomach or bowel
disorders including ulcerative colitis or Crohn's
• if you have kidney or liver problems, or you are
• 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
Tell your doctor or pharmacist if you have any
of these conditions because FENACTOL
TABLETS 50MG might not be the right medicine
for you.
Other special warnings
• You should take the lowest effective dose of
FENACTOL TABLETS 50MG 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 the recommended dose or duration of
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.

Type of Print (ie Litho) Litho


155 x 480 mm

• 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
• The 50 mg tablets are not suitable for 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:
• 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
• 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
• Quinolone antibiotics (for infections)
• Sulfinpyrazone (a medicine used to treat gout) or
voriconazole (a medicine used to treat fungal
• 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)
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 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
• 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.

Important information about some of the
ingredients of FENACTOL TABLETS 50MG
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.

The doctor will tell you how many FENACTOL
TABLETS 50MG to take and when to take them.
Always take FENACTOL TABLETS 50MG 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.
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.
Swallow the tablets whole with a glass of water,
with or after food. Do NOT crush or chew the
If you take more FENACTOL TABLETS 50MG
than you should
If you, or anyone else, accidentally takes 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

as stiff neck, headache together with a dislike of
bright lights, feeling sick, vomiting, fever or
disorientation, disturbances in sensation.

If you have any further questions on the use of
this product, ask your doctor or pharmacist.

Effects on hearing:
Common side effects (may affect up to 1 in 10
people): Vertigo (sensation of irregular or spinning
Very rare side effects (may affect up to 1 in 10,000
people): ringing in the ears, hearing loss or

If you forget to take
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.

Psychiatric disorders:
Very rare side effects (may affect up to 1 in 10,000
people): disorientation, mood changes, depression,
difficulty sleeping, nightmare, irritability, mental


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.

Like all medicines, FENACTOL TABLETS 50MG
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
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
• 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,
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.

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
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
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
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

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

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),
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
Very rare side effects (may affect up to 1 in 10,000
people): pneumonitis (inflammation of the lungs
which causes breathlessness, cough and raised
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

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: By reporting side
effects, you can help provide more information
on the safety of this medicine.

Keep out of the reach and sight 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

The name of your medicine is FENACTOL

gastro-resistant 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 September 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.