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VOLTAROL 75MG SR TABLETS

Active substance(s): DICLOFENAC SODIUM / DICLOFENAC SODIUM / DICLOFENAC SODIUM

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Assessed against UK PIL dated August 2016
Voltarol® 75 mg SR Tablets
(diclofenac sodium)
Patient Information Leaflet
®

The name of your medicine is Voltarol 75 mg SR
Tablets, but it will be referred to as Voltarol
Tablets in this leaflet. This product is also
available as the 100 mg strength.
What you need to know about Voltarol Tablets
Your doctor has decided that you need this
medicine to help treat your condition.
Please read this leaflet carefully before you
start to take your medicine. It contains
important information. Keep the leaflet in a safe
place because you may want to read it again.
If you have any other questions, or if there is
something you don’t understand, please ask your
doctor or pharmacist.
This medicine has been prescribed for you.
Never give it to someone else. It may not be the
right medicine for them even if their symptoms
seem to be 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 Voltarol Tablets are, and what they are
used for
2. Things to consider before you start to take
Voltarol Tablets
3. How to take Voltarol Tablets
4. Possible side effects
5. How to store Voltarol Tablets
6. Further information

1. What Voltarol Tablets are, and what
they are used for
Diclofenac sodium, the active ingredient in
Voltarol Tablets, is one of a group of medicines
called non-steroidal anti-inflammatory drugs
(NSAIDs). NSAIDs reduce pain and inflammation.
Voltarol SR tablets are specially formulated to
release the diclofenac sodium slowly.
• Voltarol Tablets relieve pain, reduce swelling
and ease inflammation in conditions affecting
the joints, muscles and tendons including:
– Rheumatoid arthritis, osteoarthritis, acute
gout, ankylosing spondylitis
– Backache, sprains and strains, soft tissue
sports injuries, frozen shoulder,
dislocations and fractures
– Tendonitis, tenosynovitis, bursitis.


They are also used to treat pain and
inflammation associated with dental and
minor surgery.

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Some people MUST NOT take Voltarol
Tablets. Talk to your doctor if:
• you think you may be allergic to diclofenac
sodium, aspirin, ibuprofen or any other
NSAID, or to any of the other ingredients of
Voltarol Tablets. (These are listed at the end
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
• if 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
• if you have or have had problems with your
blood circulation (peripheral arterial disease)
you are more than six months pregnant.
You should also ask yourself these questions
before taking Voltarol Tablets:
• Do you suffer from any stomach or bowel
disorders including ulcerative colitis or
Crohn's disease?
• Do you have kidney or liver problems, or are
you elderly?
• Do you have a condition called porphyria?
• Do 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.
• Have you ever had asthma?
• Are you breast-feeding?
• Do you have angina, blood clots, high blood
pressure, raised cholesterol or raised
triglycerides
• Do you have heart problems, or have you
had a stroke, or do 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)?
• Do you have diabetes
• Do you smoke

such as sucrose? (These tablets contain
sucrose.)
If the answer to any of these questions is
YES, tell your doctor or pharmacist because
Voltarol Tablets might not be the right
medicine for you.
Are you taking other medicines?
Some medicines can interfere with your
treatment. Tell your doctor or pharmacist if you
are taking any 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 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-oxgenase2) 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.

Pregnancy
• Are you pregnant or planning to become
pregnant? Although not common,
abnormalities have been reported in babies
whose mothers have taken NSAIDs during
pregnancy. You should not take Voltarol
Tablets during the last 3 months of
pregnancy as it may affect the baby’s
circulation.
• Are you trying for a baby? Taking Voltarol
Tablets may make it more difficult to
conceive. You should talk to your doctor if
you are planning to become pregnant, or if
you have problems getting pregnant.
Will there be any problems with driving or
using machinery?
Very occasionally people have reported that
Voltarol 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 dose of Voltarol
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 Voltarol. 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,
Voltarol 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 Voltarol Tablets.

3. How to take Voltarol Tablets

4. Possible side effects

The doctor will tell you how many Voltarol Tablets
to take and when to take them. Always follow
his/her instructions carefully. The dose will be on
the pharmacist’s label.
Check the label carefully. If you are not sure, ask
your doctor or pharmacist. Keep taking your
tablets for as long as you have been told, unless
you have any problems. In that case, check with
your doctor.
Take the tablets with or after food.
Swallow the tablets whole with a glass of water.
Do not crush or chew them as this will affect the
special ‘slow release’ system.

Voltarol Tablets are suitable for most people, but,
like all medicines, they can sometimes cause
side effects.
Side effects may be minimised by using the
lowest effective dose for the shortest duration
necessary.
Some side effects can be serious
Stop taking Voltarol Tablets 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 Voltarol tablets and followed
by rectal bleeding or bloody diarrhoea usually
within 24 hours of the onset of abdominal
pain.

The usual doses are:
Adults
100-150 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.
Elderly
Your doctor may advise you to take a dose that is
lower than the usual adult dose if you are elderly.
Your doctor may also want to check closely that
the Voltarol Tablets are not affecting your
stomach.
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.
What if you forget to take 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, though, just take the next dose and forget
about the one you missed. Do not double up on
the next dose to make up for the one missed. Do
not take more than 150 mg in 24 hours.
What if you take too many tablets?
If you, or anyone else, accidentally takes too
much, tell your doctor or your nearest hospital
casualty department. Take your medicine pack
with you so that people can see what you have
taken.

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 effects (These may affect
between 1 and 10 in every 100 patients):
• Stomach pain, heartburn, nausea, vomiting,
diarrhoea, indigestion, wind, loss of appetite
• Headache, dizziness, vertigo
• Skin rash or spots
• Raised levels of liver enzymes in the blood.
Rare side effects (These may affect between 1
in every 1000 to 1 in every 10,000 patients):
• 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 side effects (These may affect less
than 1 in every 10,000 patients):
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
inflammation 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:
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 Voltarol Tablets without any problems.
If any of the symptoms become troublesome,
or if you notice anything else not mentioned
here, please go and see 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 Voltarol Tablets
Store in the original package.
Protect from moisture and heat.
Do not store above 30°C.
Keep out of the sight and reach of children.
Take as directed by your doctor.
Do not chew or crush.
Do not take Voltarol Tablets after the expiry date
which is printed on the outside of the pack.
If your doctor tells you to stop taking the tablets,
please take any unused tablets back to your
pharmacist to be destroyed. Do not throw them
away with your normal household water or waste.
This will help to protect the environment.

6. Further information
Each slow release, film-coated tablet contains
75 mg diclofenac sodium as the active ingredient.
The tablets also contain the inactive ingredients
colloidal anhydrous silica, cetyl alcohol, sucrose,
povidone, magnesium stearate, hypromellose,
polysorbate 80, talc, titanium dioxide (E171), and
red iron oxide (E172).
Voltarol SR Tablets are pale pink triangular
tablets marked ‘CG’ on one side and ‘ID’ on the
other, containing 75 mg of the active ingredient,
diclofenac sodium.
The tablets come in blister packs containing 30
tablets.
Manufactured by: Novartis Farma S.p.A. –
Officina di Torre Annunziata, Italy.
Procured from within the EU & repackaged by
Product Licence holder: Kosei Pharma UK Ltd,
956 Buckingham Avenue, Slough Trading Estate,
Slough, SL1 4NL, UK
Voltarol® 75 mg SR Tablets,
POM
PL: 39352/0087
®
Voltarol is a registered trademark of Novartis
Pharmaceuticals UK Limited.
Leaflet date: 09/06/2017

To listen to or request
a copy of this leaflet in
Braille, large print or
audio please call,
01753515054 (UK only)

Expand Transcript

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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