Active substance: DICLOFENAC SODIUM

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Voltarol Sup 12.5mg GB
28 Mar 2012
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VOLTAROL® Suppositories
12.5, 25, 50 and 100 mg
(diclofenac sodium)
Patient Information Leaflet
What you need to know about Voltarol
Your doctor has decided that you need this
medicine to help treat your condition.
Please read this leaflet carefully before you
start to use these suppositories. It contains
important information. Keep the leaflet in
a safe place because you may want to read it
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.

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In this leaflet:
1. What Voltarol Suppositories are, and what
they are used for
2. Things to consider before you start to use
Voltarol Suppositories
3. How to use Voltarol Suppositories
4. Possible side effects
5. How to store Voltarol Suppositories
6. Further information

1. What Voltarol Suppositories are and
what they are used for
Diclofenac sodium, the active ingredient in
Voltarol Suppositories, is one of a group of
medicines called non-steroidal antiinflammatory drugs (NSAIDs). NSAIDs
reduce pain and inflammation.
• Voltarol Suppositories 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.

• In children aged 1 to 12 Voltarol
Suppositories 12.5 and 25 mg are used to
treat juvenile chronic arthritis.
• In children aged over 6 they can also be
used alone, or in combination with other
painkillers, for the short term treatment
of any pain experienced after an

2. Things to consider before you start
to use Voltarol Suppositories
Some people MUST NOT use Voltarol
Suppositories. 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 Suppositories.
(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
• 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
• you are more than six months pregnant
• you suffer from ineffectual straining to
empty the bowels, diarrhoea or rectal
You should also ask yourself these
questions before using Voltarol
• 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 using these suppositories.
• 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
If the answer to any of these questions is
YES, discuss your treatment with your
doctor or pharmacist because Voltarol

Suppositories 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
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.
• 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 use
Voltarol Suppositories during the last
3 months of pregnancy as it may affect
the baby’s circulation.
• Are you trying for a baby? Using Voltarol
Suppositories 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
Will there be any problems with driving or
using machinery?
Very occasionally people have reported that
Voltarol Suppositories 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
• 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.
• VOLTAROL Suppositories 50 mg and
100 mg are not suitable for children.
• VOLTAROL Suppositories 12.5 mg are
not used for adults.

3. How to use Voltarol Suppositories
The doctor will tell you how to use Voltarol
Suppositories. 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 using the suppositories
for as long as you have been told, unless you
have any problems. In that case, check with
your doctor. Suppositories are designed for
insertion into the back passage (rectum).
Never take them by mouth.
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.
Voltarol Suppositories are normally inserted
one, two or three times a day up to a maximum
total daily dose of 150mg. The number of
suppositories you need will depend on the
strength which the doctor has given you.
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 Suppositories
are not affecting your stomach, particularly
during the first 4 weeks that you are using
the suppositories.
398437 GB

For the treatment of chronic juvenile arthritis
in children aged 1 to 12:
Doses vary with age, but are usually between
1 and 3 mg/kg body weight every day divided
into 2 or 3 doses.
For the treatment of post-operative pain in
children aged 6 and over:
Doses vary with age, but are usually between
1 and 2 mg/kg body weight per day divided
into 2 or 3 doses for no more than 4 days.
Your child’s doctor will work out the dose
that is suitable for your child and will tell you
how many Voltarol Suppositories to use and
how often. Follow his/her instructions
carefully. If you are not sure about the dose,
check with your doctor or pharmacist.
How to insert the suppositories
• Empty your bowels before inserting a
• Wash your hands.
• Take out the strip of suppositories and
tear off one along the perforation.
• Then take the suppository out of the plastic
wrapping by pulling back the loose end.

• Lie on one side with your knees pulled up
towards your chest.
• Gently push the suppository pointed end
first into your back passage (rectum) with
your finger. Push the suppository in as far
as possible as shown in the diagram.

• Lower your legs and, if possible, stay still
for a few minutes.
• If you feel as if you need to push the
suppository out, try to resist this by lying
still with your buttocks pressed together.
It is important to keep the suppository in
the rectum to allow it to melt and the
medicine to be absorbed. Pushing the
suppository high into the rectum with
your finger will help to reduce this feeling.
• Wash your hands.
The procedure is the same for a child. Once
they have emptied their bowels, get them to
lie down on their front or side. Gently push
the suppository into the child’s back
passage until it disappears. Try and stop
the child moving around for a few minutes to
reduce the risk of the suppository coming

What if you forget to take a dose?
If you forget to use a suppository, do not worry.
Use 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 the next dose to make up for
the one you missed. Do not insert 2 suppositories
at the same time. The total dose should not be
more than 150 mg each day if you are an adult.
Children should not take more than the dose
that is prescribed by their doctor.
What if you use too many suppositories?
You should not take more than 150 mg in
one day if you are an adult. Children should
not take more than the dose that is
prescribed by their doctor.
If you accidentally use too many
suppositories or use them too often, tell your
doctor or go to your nearest casualty
department straight away.

4. Possible side effects
Voltarol Suppositories are suitable for most
people, but, like all medicines, they can
sometimes cause side effects.
Some side effects can be serious
Stop using the suppositories 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
• 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.
Voltarol Suppositories may also occasionally
cause itching or burning in your back
passage or make any haemorrhoids (piles)
The side effects listed below have also been
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
• Irritation where the suppository is inserted.
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
• 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 mouth or
lips, taste changes, lower gut disorders
(including inflammation of the colon) or
worsening of ulcerative colitis or Crohn's
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 StevensJohnson 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 in the eye.

6. Further information
The suppositories come in four strengths
containing either 12.5, 25, 50 or 100 mg
of the active ingredient, diclofenac sodium
in a hard, fatty suppository base.
They come in foil packs of 10.

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.

The Product licence holder is
Novartis Pharmaceuticals UK Limited
trading as Geigy Pharmaceuticals,
Frimley Business Park, Frimley, Camberley,
Surrey GU16 7SR, England.
Voltarol suppositories are made by.
Delpharm Huningue S.A.S.
26, rue de la Chapelle
68330 Huningue

5. How to store Voltarol Suppositories

This leaflet was revised in
March 2012.

Do not be alarmed by this list - most people
use Voltarol Suppositories without any

Store in a dry place, below 30°C. Keep the
suppositories in their original pack.
Keep out of the reach and sight of children.
Do not use the suppositories after the expiry
date which is printed on the outside of the
If your doctor tells you to stop using them,
please take any unused suppositories 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.

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

398437 GB

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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.