VOLTAROL SUPPOSITORIES 12.5MG

In this leaflet:
1. What Voltarol Suppositories are, and what
they are used for

VOLTAROL® Suppositories
12.5, 25, 50 and 100 mg

2. Things to consider before you start to use
Voltarol Suppositories
3. How to use Voltarol Suppositories
4. Possible side effects

(diclofenac sodium)

5. How to store Voltarol Suppositories

Patient Information Leaflet

6. Further information

What you need to know about Voltarol
Suppositories

1. What Voltarol Suppositories are and
what they are used for

Your doctor has decided that you need this
medicine to help treat your condition.

Diclofenac sodium, the active ingredient in Voltarol
Suppositories, is one of a group of medicines called
non-steroidal anti‑inflammatory drugs (NSAIDs).
NSAIDs reduce pain and inflammation.

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
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.

• 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.

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• 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 operation.

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 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

• 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)?

• if you have or have had problems with your
blood circulation (peripheral arterial disease)

• Do you smoke

• you are more than six months pregnant
• you suffer from ineffectual straining to empty
the bowels, diarrhoea or rectal bleeding
You should also ask yourself these questions
before using Voltarol Suppositories:

• Do you have diabetes
• 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 Suppositories
might not be the right medicine for you.
Are you taking other medicines?

• Do you suffer from any stomach or bowel
disorders including ulcerative colitis or
Crohn’s disease?

Some medicines can interfere with your
treatment. Tell your doctor or pharmacist if you
are taking any of the following:

• Do you have kidney or liver problems, or are
you elderly?

• Medicines to treat diabetes

• Do you have a condition called porphyria?

• Anticoagulants (blood thinning tablets like
warfarin)

• 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.

• Diuretics (water tablets)

• Have you ever had asthma?

• Ciclosporin and tacrolimus (used to treat some
inflammatory diseases and after transplants)

• Are you breast-feeding?
• Do you have angina, blood clots, high blood
pressure, raised cholesterol or raised
triglycerides

• Lithium (used to treat some mental problems)
• Methotrexate (for some inflammatory diseases
and some cancers)

• 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 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 pregnant.
Will there be any problems with driving or using
machinery?

• 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.

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.

• VOLTAROL Suppositories 50 mg and
100 mg are not suitable for children.

Other special warnings

3. How to use Voltarol Suppositories

• 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.

• VOLTAROL Suppositories 12.5 mg are
not used for adults.

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.

• Whilst you are taking these medicines your
doctor may want to give you a check‑up
from time to time.

Suppositories are designed for insertion into
the back passage (rectum). Never take them
by mouth.

• 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.

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.
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• In children aged 1 to 12 Voltarol
Suppositories 12.5 and 25 mg are used to
treat juvenile chronic arthritis.

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Adults
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.
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 Suppositories are not affecting your
stomach, particularly during the first 4 weeks that
you are using the suppositories.
Children
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 suppository.

• 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.

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 out.
What if you forget to take a dose?

• 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.

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.

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 (bronchospasm)
• Swollen face, lips, hands or fingers
• Yellowing of your skin or the whites of your eyes
• Persistent sore throat or high temperature

What if you use too many suppositories?

• An unexpected change in the amount of urine
produced and/or its appearance.

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.

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

4. Possible side effects

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

Voltarol Suppositories 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.

Voltarol Suppositories may also occasionally cause
itching or burning in your back passage or make
any haemorrhoids (piles) worse.

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• 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
• 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):

rashes which may be made worse by exposure to
sunlight.

Effects on the nervous system:

Hair loss.

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.

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.

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).
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, Lyell’s syndrome and other skin

Do not be alarmed by this list - most people
use Voltarol Suppositories 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 Suppositories
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
pack.
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.

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.
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 manufactured by
Novartis Pharmaceuticals UK Ltd,
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

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The side effects listed below have also been
reported.
Common side effects (These may affect between
1 and 10 in every 100 patients):

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