VOLTAROL SR 75MG TABLETS

Active substance: DICLOFENAC SODIUM

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S1512 LEAFLET Voltarol 20120911

PACKAGE LEAFLET: INFORMATION FOR THE USER

VOLTAROL® SR 75mg TABLETS
(diclofenac sodium)

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)

If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.



Trimethoprim (a medicine used to prevent or treat urinary tract
infections)

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.



Quinolone antibiotics (for infections)



Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for
example aspirin or ibuprofen

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.



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)

The name of your medicine is Voltarol SR 75mg Tablets (called
Voltarol Tablets throughout 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.

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 nonsteroidal anti-inflammatory drugs
(NSAIDs). NSAIDs reduce pain and inflammation. Voltarol SR tablets
and Voltarol Retard Tablets are specially formulated to release the
diclofenac sodium slowly.


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.

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



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.

Tendonitis, tenosynovitis, bursitis.

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

Will there be any problems with driving or using machinery?

2. THINGS TO CONSDIER BEFORE YOU START TO TAKE
VOLTAROL TABLETS

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.

Some people MUST NOT take Voltarol Tablets. Talk to your
doctor if:

Other special warnings



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 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.

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)



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.





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 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?



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.

Are you breast-feeding?

Take the tablets with or after food.



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)?

Swallow the tablets whole with a glass of water. Do not crush or
chew them as this will affect the special ‘slow release’ system.



Do you have Lupus (SLE) or any similar condition?



Do you have an intolerance to some sugars 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.

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.

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

Effects on the heart, chest or blood:

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.

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).

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.

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:

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.

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.

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.

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.

4. POSSIBLE SIDE EFFECTS
Voltarol Tablets are suitable for most people, but, like all medicines,
they can sometimes cause side effects.

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.

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



Swollen face, lips, hands or fingers



Yellowing of your skin or the whites of your eyes



Do not store above 30°C.



Store in the original package to protect from moisture.



Keep out of the sight and reach of children.



Do not use Voltarol Tablets after the expiry date which is printed
on the outside of the pack.



If the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who
will tell you what to do.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

Persistent sore throat or high temperature





Wheezing or shortness of breath (bronchospasm)



5. HOW TO STORE VOLTAROL TABLETS

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 10 in
every 100 patients):

6. FURTHER INFORMATION
What Voltarol Tablets contains


Each tablet contains 75mg diclofenac sodium in a sustained
release formulation.



Voltarol tablets also contain the following inactive ingredients:
colloidal anhydrous silica, cetyl alcohol, sucrose, povidone,
magnesium stearate, hypromellose, polysorbate 80, talc, titanium
dioxide (E171) and red iron oxide (E172).



Stomach pain, heartburn, nausea, vomiting, diarrhoea,
indigestion, wind, loss of appetite



Headache, dizziness, vertigo



Skin rash or spots

What Voltarol Tablets looks like and contents of the pack



Raised levels of liver enzymes in the blood.



Tablets are pale pink, triangular film-coated tablets embossed C
and G on one face, I D on the other.



Voltarol Tablets are available as blister packs of 30 tablets.

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

Manufacturer



Black tarry faeces or stools



Drowsiness, tiredness

This product is manufactured by Novartis Farma S.p.A., I-80058
Naples, Italy.



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).

Product Licence holder
Procured from within the EU and repackaged by the Product Licence
holder: S&M Medical Ltd, Chemilines House, Wembley, HA0 1DX.

POM

PL No: 19488/1512

Leaflet revision date: 11 September 2012
Voltarol is a trademark of Novartis AG.
S1512 LEAFLET Voltarol 20120911

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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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