VOLTAREN RETARD 100MG TABLETS

Active substance: DICLOFENAC SODIUM

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DATE:

CUSTOMER
APPROVED:

UK PIL MARCH 2012

6464/0306B

06/12/12
DATE OF PROOF:
CODE:

DT
ARTWORKER:

04-1957
PRE-PRESS NO.:

DATE:

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.

PRODUCT:

Q.A.
APPROVED:

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 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? (These tablets contain sucrose).

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 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 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 Tablets. 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
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.

WARNING!

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.

WARNING!

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CRESTOR 6464/2069 2070

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 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.
2. Things to consider before you start to take Voltarol Tablets
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
• you are more than six months pregnant.

CUSTOMER: Waymade

Voltarol Retard 100mg tabs

These tablets will usually be called Voltarol Tablets in this leaflet
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

PROOF HISTORY:
v.1 - waymade - 06/12/12

Leaflet Flat Size = 148 x 432

27mm

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.

VOLTAROL® RETARD 100mg TABLETS/
VOLTAREN® RETARD 100mg TABLETS
(Diclofenac sodium)
Patient Information Leaflet

Leaflet Flat Size = 148 x 432

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ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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 Tablets are suitable for most people, but, like all medicines, they can sometimes cause side effects.

PROOF HISTORY:
v.1 - waymade - 06/12/12

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.
If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell
your doctor.

DATE:
06/12/12

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).

DATE OF PROOF:

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).

UK PIL MARCH 2012

6464/0306B
CODE:

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

Voltarol Retard 100mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

DATE:

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.

PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

04-1957

CUSTOMER
APPROVED:

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.

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 of 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.






5. How to store Voltarol Tablets
Voltarol Retard 100mg Tablets/Voltaren Retard 100mg tablets need no special storage conditions.
Do not use after the expiry date printed on the carton, label or blister strip.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for
safe disposal. Only keep the tablets if your doctor tells you to. Do not throw them away with
your normal household water or waste. This will help to protect the environment.
If the tablet becomes discoloured or shows signs of any deterioration, you should seek the advice
of your pharmacist who will tell you what to do.

6. Further information
Your medicine is called Voltarol Retard 100mg Tablets/Voltaren Retard 100mg Tablets. Each tablet contains
100mg of the active ingredient, diclofenac sodium, in a pale red biconvex, film-coated, sustained release
tablet, which is plain on both sides.
Voltarol Retard 100mg Tablets/Voltaren Retard 100mg Tablets also contain the following:
colloidal anhydrous silica, polysorbate 80, magnesium stearate, povidone, sucrose, cetyl alcohol,
hydroxypropylmethylcellulose, red iron oxide (E172), titanium dioxide (E171) and talc.
Voltarol Retard 100mg Tablets/Voltaren Retard 100mg Tablets are available as blister packs of 21 or 28
tablets.
POM

PL No: 6464/0306

This product is manufactured by Novartis Farma S.p.A., Officina di Torre Annunziate (NA), Italy and is
procured from within the EU and repackaged by the Product Licence holder who is:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 6.12.2012
Voltarol and Voltaren are registered trademarks of Novartis AG.

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.

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.

WARNING!

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.

WARNING!

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.

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.

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.

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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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