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VOLTAROL 50MG RAPID TABLETS

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Voltarol® 50 mg Rapid Tablets
Diclofenac Potassium 50mg Rapid
Tablets

1089
19.03.13[12]

(diclofenac potassium)
PATIENT INFORMATION LEAFLET
This product is available as one of the above names but will be referred to
as Voltarol Rapid Tablets throughout this leaflet
Other strength (25mg) is also available.
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 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 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
- 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 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 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 or 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 beta- blockers or ACE inhibitors.
- Voriconazole (a medicine used to treat fungal infections).
- Phenytoin (a medicine used to treat seizures)
- Colestipol/cholestryramine (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 Rapid Tablets 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 Rapid 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 Rapid Tablets.
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 50mg tablets or six 25mg
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.
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 (meningitis), 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.
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.
5. HOW TO STORE VOLTAROL RAPID TABLETS
The expiry date for these tablets is given on the carton.
Do not take the tablets after this date.
Keep your tablets out of sight and reach of children.
Do not store above 30°C.
Store in the original pack and protect from moisture.
If your tablets become discoloured or show any other signs of deterioration,
consult your doctor or pharmacist who will tell you what to do and return
any unused tablets to your pharmacist.
Do not throw them away with your normal household water or waste. This
will help to protect the environment.
6. FURTHER INFORMATION
What Voltarol Rapid Tablets contains
Voltarol Rapid Tablets contain 50mg of diclofenac potassium as the active
ingredient.
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.
What Voltarol Rapid Tablets looks like and contents of the pack
Voltarol Rapid tablets are available as light brown, round, biconvex, coated
tablets and come in blister packs of 30 tablets
MANUFACTURER AND PRODUCT LICENCE HOLDER
Voltarol Rapid Tablets are manufactured by Novartis Farma S.p.A., Officina
di Torre Annunziata (NA), Italy and are procured from within the EU by
Product Licence holder: Star Pharmaceuticals Ltd, 5 Sandridge Close,
Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/1089

Leaflet revision and issue date (Ref) 19.03.13[12]
®

Voltarol is a 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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