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VOLTAROL DISPERSIBLE TABLETS 50MG

Active substance(s): DICLOFENAC FREE ACID / DICLOFENAC FREE ACID / DICLOFENAC FREE ACID

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VOLTAROL® Dispersible Tablets 50 mg
(diclofenac sodium)
Patient Information Leaflet
What you need to know about Voltarol Dispersible 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 Dispersible Tablets are, and what they are used for
2.
Things to consider before you start to take Voltarol Dispersible Tablets
3.
How to take Voltarol Dispersible Tablets
4.
Possible side effects
5.
How to store Voltarol Dispersible Tablets
6.
Further information

1. What Voltarol Dispersible Tablets are, and what they are used for
Diclofenac sodium, the active ingredient in Voltarol Dispersible Tablets, is one of a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and
inflammation.
Voltarol Dispersible Tablets act quickly and so are used to treat short term painful conditions
affecting the joints and muscles. They are especially useful for the treatment of sprains,
strains and back pain. They should not be taken for more than three months.

2. Things to consider before you start to take Voltarol Dispersible Tablets
Some people MUST NOT take Voltarol Dispersible 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 Dispersible 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 Dispersible 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 you a smoker)?
 Do you have diabetes
 Do you smoke
 Do you have Lupus (SLE) or any similar condition?
If the answer to any of these questions is YES, discuss your treatment with your doctor
or pharmacist because Voltarol Dispersible 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 Dispersible Tablets during the last 3 months of pregnancy as it
may affect the baby’s circulation.
 Are you trying for a baby? Taking Voltarol Dispersible 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 Dispersible 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 Dispersible 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 Dispersible 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
Dispersible Tablets.
Voltarol Dispersible Tablets are not suitable for children.

The tablets contain erythrosine and may be unsuitable for some people.

3. How to take Voltarol Dispersible Tablets
The doctor will tell you how many Voltarol Dispersible 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 before or with food.
Drop the tablets into a glass of water, and stir. Drink the pink, blackcurrant-flavoured liquid
at once. To make sure you get all of the medicine, rinse the glass round with a small amount
of water and drink this as well.

The usual doses are:
Adults
One tablet two or three times 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 Dispersible Tablets are
not affecting your stomach.
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.

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 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 Dispersible 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 Dispersible 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.
 Mild cramping and tenderness of the abdomen, starting shortly after the start of the
treatment with Voltarol Dispersible Tablets and followed by rectal bleeding or bloody
diarrhoea usually within 24 hours of the onset of abdominal pain.

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):





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), stroke.
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.
Do not be alarmed by this list - most people take Voltarol Dispersible 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 Dispersible Tablets

Store in a dry place, below 30°C. Keep the tablets in their original pack.
Keep out of the reach and sight of children.
Do not take Voltarol Dispersible 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

Voltarol Dispersible Tablets contain 50 mg of the active ingredient, diclofenac sodium. The
tablets also contain the inactive ingredients avicel, croscarmellose sodium, sodium starch
glycollate, sodium saccharin, hydrogenated castor oil, talc, aerosol, blackcurrant flavouring
and red colouring.
They come in aluminium blister packs containing either 3 or 21 tablets. Not all of the pack
sizes may be marketed.
The Product licence holder is Novartis Pharmaceuticals UK Limited trading as Geigy
Pharmaceuticals, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, England.
Voltarol Dispersible Tablets are manufactured by Novartis Pharmaceuticals UK Limited,
Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom.
This leaflet was revised in August 2016
If you would like any more information, or would like the leaflet in a different format, please
contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276
698370.
VOLTAROL is a registered trade mark

Copyright Novartis Pharmaceuticals UK Limited

Expand Transcript

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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