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VOLTAROL RAPID 50MG TABLETS

Active substance(s): DICLOFENAC POTASSIUM

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

VOLTAROL® RAPID 50 mg TABLETS
(diclofenac potassium)
Patient Information Leaflet

This product is known as the above name but will usually be referred to as Voltarol Rapid Tablets throughout this leaflet.
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.

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.

WARNING!

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.)

UK PIL DATED SEPTEMBER 2013
REPORTING OF SIDE EFFECTS

TVT CHECKED

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.

MANUFACTURER:

DATE:
29/05/14
DATE OF PROOF:
6464/2192F
CODE:

DATE:

DT
ARTWORKER:
Voltarol Rapid 50mg tabs
PRODUCT:

CUSTOMER
APPROVED:
04-1957
PRE-PRESS NO.:
Waymade
CUSTOMER:

Q.A.
APPROVED:

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

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 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 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.

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WARNING!

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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

PROOF HISTORY:
v.1 - waymade - 29/05/14

Leaflet Flat Size = 180 x 429

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

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.

DATE:
TVT CHECKED

WARNING!

Effects on the liver or kidneys:
Kidney or severe liver disorders including liver failure, presence of blood or protein in the urine.

UK PIL DATED SEPTEMBER 2013
REPORTING OF SIDE EFFECTS

6464/2192F
CODE:

MANUFACTURER:

ARTWORKER:
Voltarol Rapid 50mg tabs
PRODUCT:

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).

PRE-PRESS NO.:

29/05/14

DATE:

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).

Waymade

DT

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.

DATE OF PROOF:

CUSTOMER
APPROVED:
Q.A.
APPROVED:

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.

CUSTOMER:

04-1957

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.

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.
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
Voltarol Rapid 50 mg tablets should not be stored above 30°C. Store in a dry place, in the original package.
Keep out of the sight and reach of children.
Do not take Voltarol Rapid 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
Your medicine is called Voltarol Rapid 50 mg tablets.
Each tablet contains 50 mg of the active ingredient, diclofenac potassium, in a red-brown, round, sugar-coated, unmarked tablet.
Voltarol Rapid 50 mg tablets also contain the following:
calcium phosphate, magnesium stearate, povidone, sucrose, colloidal anhydrous silica, maize starch, croscarmellose sodium,
microcrystalline cellulose, red iron oxide (E172), titanium dioxide (E171), macrogol 8000 and talc.
Voltarol Rapid 50 mg tablets are available as blister packs of 30 tablets.
POM

PL No: 6464/2192

This product is manufactured by Novartis Farmacéutica S.A., Barberà del Vallès, Spain, or, Novartis Ürüleri, Kurtköy, Turkey, or,
Novartis Farma S.p.A., Officina di Torre Annunciata (NA), Italy and is procured from within the EU and repackaged by the Product
Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex. SS14 3FR
Leaflet revision and issue date (Ref.) 29.05.2014
Voltarol is a registered trademark of Novartis AG

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ËSifT

WARNING!

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ARIAL BOLD
FONT SIZE 8
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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.

PROOF HISTORY:
v.1 - waymade - 29/05/14

Leaflet Flat Size = 180 x 429

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

27mm

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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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