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VOLTFAST 50MG TABLETS

Active substance: DICLOFENAC POTASSIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Voltfast 50mg Tablets / Voltarol® Rapid 50mg Tablets
(diclofenac potassium)
This product is available in the above name but will be referred
to as Voltarol Rapid Tablets for the remainder of this leaflet.
It is also available in ‘’50mg’’ strength.
What you need to know about Voltarol Rapid 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 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 Rapid Tablets are and what they are used for
2. Things to consider before you start to take Voltarol Rapid
Tablets
3. How to take Voltarol Rapid Tablets
4. Possible side effects
5. How to store Voltarol Rapid Tablets
6. Further information
1. What Voltarol Rapid Tablets are and what they are used
for
Diclofenac potassium, the active ingredient in Voltarol Rapid
Tablets, is one of a group of medicines called non-steroidal anti
-inflammatory drugs (NSAIDs). NSAIDs reduce pain and
inflammation.
Voltarol Rapid Tablets relieve pain, reduce swelling and ease
inflammation in:
 Rheumatoid arthritis, osteoarthrosis, acute gout, low back
pain, ankylosing spondolytis
 Migraine
 Conditions affecting the joints and muscles such as 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 orthopaedic, dental and other minor surgery.
2. Things to consider before you start to take Voltarol
Rapid Tablets
Some people MUST NOT take Voltarol Rapid Tablets. Talk
to your doctor if:
 you think you may be allergic to diclofenac potassium,
aspirin, ibuprofen or any other NSAID, or to any of the other
ingredients of Voltarol Rapid 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 Rapid 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
 Do you have Lupus (SLE) or any similar condition?
 Do you have an intolerance to some sugars such as
sucrose? (Voltarol Rapid Tablets contain sucrose.)
If the answer to any of these questions is YES, discuss
your treatment with your doctor or pharmacist because
Voltarol Rapid 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-oxgenase-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 betablockers 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 Rapid Tablets during
the last 3 months of pregnancy as it may affect the baby’s
circulation.
 Are you trying for a baby? Taking Voltarol Rapid 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 Rapid
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 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.
3. How to take Voltarol Rapid Tablets
The doctor will tell you how many Voltarol Rapid 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.
Voltarol Rapid Tablets are specially formulated to act quickly.
Swallow the tablets whole with a drink of water. Do not crush or
chew them.
The usual doses are:
Adults
75 mg to 150 mg daily divided into two or three doses. The
number of tablets you take will depend on the strength the
doctor has given you.
For the relief of migraine in adults:
Take 50 mg at the first signs of an attack. If the migraine has
not gone after 2 hours, take another 50 mg. You can take
further doses at intervals of 4 to 6 hours if necessary, but you
must not take more than 200 mg in a day.
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 Rapid Tablets are not
affecting your stomach.
Children over 14
75 mg to 100 mg daily divided into two or three doses.
Voltarol Rapid Tablets are not recommended for children
under 14. They are not recommended for the treatment of
migraine in children of any age.

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 (three 50 mg tablets or six 25
mg tablets) 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.
4. Possible side effects
Voltarol Rapid 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 Rapid 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.
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 1 in
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, visual disturbances
such as 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 and
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 (menigitis), stroke, throat
disorders, confusion, hallucinations, malaise (general feeling of
discomfort), inflammation of the nerves in the eye.

Medicines such as diclofenac may be associated with a small
increased risk of heart attack or stroke.
Do not be alarmed by this list - most people take Voltarol
Rapid Tablets without any problems.
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 Rapid tablets
Do not store above 30°C. Protect from moisture.
Keep the tablets in their original pack.
Keep out of the sight and reach of children.
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.
If you notice signs of your medicine deteriorating, consult your
pharmacist.
6. Further information
Each tablet contains 50 mg of the active ingredient, diclofenac
potassium.
The tablets also contain the following inactive ingredients:
Silica colloidal anhydrous, Calcium phosphate, magnesium
stearate, Maize starch, Povidone, Sodium starch glycollate,
Cellulose microcrystalline, Iron oxide red (E172), Macrogol
8000, Sucrose, Talc, Titanium dioxide (E171). Each 50mg
tablet contains 0.1496 millimoles of potassium
These tablets are terracotta coloured, round and unmarked.
Your tablets come in blister packs of 30 tablets
This product is manufactured by:
Novartis Urunleri, Kurtkoy, Turkey.
Or
Novartis Farma S.p.A. – Officina di Torre Annunziata, Italy.
Procured from within the EU and repackaged by the Product
Licence holder: G Pharma Ltd, Salford M50 2PU
POM

PL No: 16369/0943
Revision Date: 20/03/2014
‘Voltarol Rapid’ is a registered trademark of Novartis AG.

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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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