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DICLOFENAC 100 MG SUPPOSITORIES

Active substance(s): DICLOFENAC SODIUM

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500918/PL1e

Diclofenac 100 mg Suppositories
(diclofenac sodium)
Patient Information Leaflet
The name of your medicine is Diclofenac 100 mg
Suppositories, throughout this leaflet it will be referred to as
Diclofenac Suppositories. Other strengths are available.
What you need to know about Diclofenac Suppositories
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 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 Diclofenac Suppositories are, and what they are
used for
2) Things to consider before you start to use Diclofenac
Suppositories
3) How to use Diclofenac Suppositories
4) Possible side effects
5) How to store Diclofenac Suppositories
6) Further information
1) WHAT DICLOFENAC SUPPOSITORIES ARE AND
WHAT THEY ARE USED FOR
Diclofenac sodium, the active ingredient in Diclofenac
Suppositories, is one of a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs
reduce pain and inflammation.






Diclofenac 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 Diclofenac 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 operation.

2) THINGS TO CONSIDER BEFORE YOU START TO USE
DICLOFENAC SUPPOSITORIES
Some people MUST NOT use Diclofenac 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 Diclofenac 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
• if you have or have had problems with your blood
circulation (peripheral arterial disease)
• 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 Diclofenac Suppositories:
• 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 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 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
Diclofenac 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 beta-blockers 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 Diclofenac
Suppositories during the last 3 months of pregnancy as
it may affect the baby’s circulation.
• Are you trying for a baby? Using Diclofenac
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?
Very occasionally people have reported that Diclofenac
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 Diclofenac 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 Diclofenac. 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,
Diclofenac 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 Diclofenac.
• DICLOFENAC Suppositories 50 mg and 100 mg are
not suitable for children.
• DICLOFENAC Suppositories 12.5 mg are not used
for adults.
3) HOW TO USE DICLOFENAC SUPPOSITORIES
The doctor will tell you how to use Diclofenac 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.
Adults
Diclofenac Suppositories are normally inserted one, two or
three times a day up to a maximum total daily dose of 150 mg.
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 Diclofenac 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 Diclofenac 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.
Continued overleaf

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.
• 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 out.
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
Diclofenac 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.
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
• 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.
Diclofenac Suppositories may also occasionally cause itching
or burning in your back passage or make any haemorrhoids
(piles) worse.
The side effects listed below have also been reported.

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 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 use
Diclofenac 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine.
5) HOW TO STORE DICLOFENAC SUPPOSITORIES
• Store in the original package.
• Store in a dry place.
• Do not store above 30°C.
• Keep out of the sight and reach 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.
• If you notice any sign of discolouration or deterioration
of the suppositories, please consult your pharmacist
immediately.
6) FURTHER INFORMATION
Each suppository contains 100 mg of diclofenac sodium.
They are white to yellowish, torpedo-shaped, with smooth
surfaces and a slightly fatty odour, in an aluminium foil, PVC,
low density PE blister. They come in foil packs of 10
suppositories.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturers:
Novartis Pharma S.A.S., 2 et 4, rue Lionel Terray, 92500
Rueil Malmaison, France.
Novartis Pharma S.A.S., 26 Rue de la Chapelle, F-68330
Huningue, France.
Diclofenac 100 mg Suppositories
PL No: 18067/0315
POM
th

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

This leaflet was revised on 25 March 2014.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

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.

500918/PL1e

500920/PL1e

®

Voltarene 100 mg Suppositories
(diclofenac sodium)
Patient Information Leaflet

®

The name of your medicine is Voltarene 100 mg
Suppositories, throughout this leaflet it will be referred to as
®
Voltarene Suppositories. Other strengths are available.
®

What you need to know about Voltarene Suppositories
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 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 Voltarene Suppositories are, and what they are
used for
®
2) Things to consider before you start to use Voltarene
Suppositories
®
3) How to use Voltarene Suppositories
4) Possible side effects
®
5) How to store Voltarene Suppositories
6) Further information
®

1) WHAT VOLTARENE SUPPOSITORIES ARE AND
WHAT THEY ARE USED FOR
®
Diclofenac sodium, the active ingredient in Voltarene
Suppositories, is one of a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs
reduce pain and inflammation.

• Voltarene® 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 Voltarene 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 operation.

2) THINGS TO CONSIDER BEFORE YOU START TO USE
®
VOLTARENE SUPPOSITORIES
®
Some people MUST NOT use Voltarene 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 Voltarene 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
• if you have or have had problems with your blood
circulation (peripheral arterial disease)
• 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 Voltarene Suppositories:
• 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 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 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
®
Voltarene 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 beta-blockers 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 Voltarene
Suppositories during the last 3 months of pregnancy as
it may affect the baby’s circulation.
• Are you trying for a baby? Using Voltarene®
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?
®
Very occasionally people have reported that Voltarene
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 Voltarene® 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 Voltarene . 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,
®
Voltarene 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 Voltarene .
• VOLTARENE Suppositories 50 mg and 100 mg are
not suitable for children.
• VOLTARENE Suppositories 12.5 mg are not used
for adults.
®

3) HOW TO USE VOLTARENE SUPPOSITORIES
®
The doctor will tell you how to use Voltarene 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.
Adults
®
Voltarene Suppositories are normally inserted one, two or
three times a day up to a maximum total daily dose of 150 mg.
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 Voltarene 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 Voltarene 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.
Continued overleaf

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.
• 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 out.
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
®
Voltarene 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.
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
• 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.
®

Voltarene Suppositories may also occasionally cause itching
or burning in your back passage or make any haemorrhoids
(piles) worse.
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.
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):
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).
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 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 use
®
Voltarene 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine.
®

5) HOW TO STORE VOLTARENE SUPPOSITORIES
• Store in the original package.
• Store in a dry place.
• Do not store above 30°C.
• Keep out of the sight and reach 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.
• If you notice any sign of discolouration or deterioration
of the suppositories, please consult your pharmacist
immediately.
6) FURTHER INFORMATION
Each suppository contains 100 mg of diclofenac sodium.
They are white to yellowish, torpedo-shaped, with smooth
surfaces and a slightly fatty odour, in an aluminium foil, PVC,
low density PE blister. They come in foil packs of 10
suppositories.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturers:
Novartis Pharma S.A.S., 2 et 4, rue Lionel Terray, 92500
Rueil Malmaison, France.
Novartis Pharma S.A.S., 26 Rue de la Chapelle, F-68330
Huningue, France.
®

Voltarene 100 mg Suppositories
PL No: 18067/0315
POM
®

Voltarene is a registered trademark.
th

This leaflet was revised on 25 March 2014.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

500920/PL1e

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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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