VOLTAREN 50MG SUPPOSITORIES

Active substance: DICLOFENAC SODIUM

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• 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 vision
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 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 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.

PATIENT INFORMATION LEAFLET

5. HOW TO STORE VOLTAROL
SUPPOSITORIES
Expiry Date
Do not use this medicine after the expiry date
shown on the carton or Suppository label. If your
doctor tells you to stop taking this medicine, return
any unused medicine to your pharmacist for safe
disposal. Only keep this medicine, if your doctor
tells you to. If your medicine becomes discoloured
or shows any other signs of deterioration, consult
your pharmacist who will tell you what to do.
Storage
• KEEP OUT OF THE REACH AND SIGHT OF
CHILDREN
• Do not store above 30°C
• Protect from heat
Important
Remember this medicine is for you. Only a doctor
can prescribe it. Never give your medicine to other
people. It may harm them, even if their symptoms
are the same as yours. This leaflet does not tell
you everything about your medicine. If you have
any questions or are not sure about anything, ask
your doctor or pharmacist. He/she will have
additional information about this medicine and will
be able to advise you.
6. FURTHER INFORMATION
What Voltarol Suppositories contains
Each suppository contains 50mg of diclofenac
sodium in a hard fatty suppository base.
What Voltarol Suppositories looks like and
contents of the pack
Voltarol Suppositories are a white to yellowish,
torpedo-shaped, with smooth surface and slightly
fatty odour.
Voltarol Suppositories comes in packs of 10.
Manufacturer and Licence Holder
This medicine is manufactured by Famar ABE,
Greece and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/0266

Voltarol is a registered trademark of Novartis AG.
Leaflet revision date: 13/02/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: 0266/130212/1/F

®

Voltarol 50mg Suppositories
(diclofenac sodium)
What you need to know about Voltarol
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.
Your medicine is called Voltarol 50mg
Suppositories but will be referred to as Voltarol
Suppositories throughout this leaflet.
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 anti-inflammatory 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 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
• 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 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
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?
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)
• 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
• Sulfinpyrazone (a medicine used to treat gout) or
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?
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 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 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.

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.

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

3. HOW TO USE VOLTAROL SUPPOSITORIES

• Lie on one side with your knees pulled up
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.
Adults
Voltarol 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 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.

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.

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.

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 faces
• 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.
Voltarol 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
• Drowsiness, tiredness

Ref: 0266/130212/1/B

• 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 vision
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 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.

PATIENT INFORMATION LEAFLET

5. HOW TO STORE VOLTAROL
SUPPOSITORIES
Expiry Date
Do not use this medicine after the expiry date
shown on the carton or Suppository label. If your
doctor tells you to stop taking this medicine, return
any unused medicine to your pharmacist for safe
disposal. Only keep this medicine, if your doctor
tells you to. If your medicine becomes discoloured
or shows any other signs of deterioration, consult
your pharmacist who will tell you what to do
Storage
• KEEP OUT OF THE REACH AND SIGHT OF
CHILDREN
• Do not store above 30°C
• Protect from heat
Important
Remember this medicine is for you. Only a doctor
can prescribe it. Never give your medicine to other
people. It may harm them, even if their symptoms
are the same as yours. This leaflet does not tell
you everything about your medicine. If you have
any questions or are not sure about anything, ask
your doctor or pharmacist. He/she will have
additional information about this medicine and will
be able to advise you.
6. FURTHER INFORMATION
What Voltaren Suppositories contains
Each suppository contains 50mg of diclofenac
sodium in a hard fatty suppository base.
What Voltaren Suppositories looks like and
contents of the pack
Voltaren Suppositories are a white to yellowish,
torpedo-shaped, with smooth surface and slightly
fatty odour.
Voltaren Suppositories comes in packs of 10.
Manufacturer and Licence Holder
This medicine is manufactured by Famar ABE,
Greece and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/0266

Do not be alarmed by this list - most people
use Voltaren Suppositories without any
problems.

Voltaren is a registered trademark of Novartis AG.

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.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: 0266/130212/2/F

®

Voltaren 50mg Suppositories
(diclofenac sodium)
What you need to know about Voltarol
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.
Your medicine is called Voltaren 50mg
Suppositories but will be referred to as Voltaren
Suppositories throughout this leaflet.
In this leaflet:
1. What Voltaren Suppositories are, and what they
are used for
2. Things to consider before you start to use
Voltaren Suppositories
3. How to use Voltaren Suppositories
4. Possible side effects
5. How to store Voltaren Suppositories
6. Further information
1. WHAT VOLTAREN SUPPOSITORIES ARE,
AND WHAT THEY ARE USED FOR
Diclofenac sodium, the active ingredient in
Voltaren Suppositories, is one of a group of
medicines called non-steroidal anti-inflammatory
drugs (NSAIDs). NSAIDs reduce pain and
inflammation.
• Voltaren 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.



Leaflet revision date: 13/02/12




They are also used to treat pain and
inflammation associated with dental and minor
surgery.
In children aged 1 to 12 Voltaren 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 VOLTAREN SUPPOSITORIES
Some people MUST NOT use Voltaren
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 Voltaren
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
• 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 Voltaren 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 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
condition?
If the answer to any of these questions is YES,
discuss your treatment with your doctor or
pharmacist because Voltaren 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)
• 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
• Sulfinpyrazone (a medicine used to treat gout) or
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 Voltaren Suppositories during the
last 3 months of pregnancy as it may affect the
baby’s circulation.
• Are you trying for a baby? Using Voltaren
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
Voltaren 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 Voltaren 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
Voltaren. 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,
Voltaren 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
Voltaren.
VOLTAREN Suppositories 50 mg and 100 mg
are not suitable for children.
VOLTAREN Suppositories 12.5 mg are not
used for adults.

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.

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

3. HOW TO USE VOLTAREN SUPPOSITORIES

• Lie on one side with your knees pulled up
The doctor will tell you how to use Voltaren
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
Voltaren 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 Voltaren 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
Voltaren 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.

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.

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.

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 faces
• 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.
Voltaren 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
• Drowsiness, tiredness

Ref: 0266/130212/2/B

• 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 vision
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 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 sodium 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.

PATIENT INFORMATION LEAFLET

5. HOW TO STORE DICLOFENAC SODIUM
SUPPOSITORIES
Expiry Date
Do not use this medicine after the expiry date
shown on the carton or Suppository label. If your
doctor tells you to stop taking this medicine, return
any unused medicine to your pharmacist for safe
disposal. Only keep this medicine, if your doctor
tells you to. If your medicine becomes discoloured
or shows any other signs of deterioration, consult
your pharmacist who will tell you what to do.
Storage
• KEEP OUT OF THE REACH AND SIGHT OF
CHILDREN
• Do not store above 30°C
• Protect from heat
Important
Remember this medicine is for you. Only a doctor
can prescribe it. Never give your medicine to other
people. It may harm them, even if their symptoms
are the same as yours. This leaflet does not tell
you everything about your medicine. If you have
any questions or are not sure about anything, ask
your doctor or pharmacist. He/she will have
additional information about this medicine and will
be able to advise you.
6. FURTHER INFORMATION
What Diclofenac sodium Suppositories
contains
Each suppository contains 50mg of diclofenac
sodium in a hard fatty suppository base.
What Diclofenac sodium Suppositories looks
like and contents of the pack
Diclofenac sodium Suppositories are a white to
yellowish, torpedo-shaped, with smooth surface
and slightly fatty odour.
Diclofenac sodium Suppositories comes in packs
of 10.
Manufacturer and Licence Holder
This medicine is manufactured by Famar ABE,
Greece and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/0266

What you need to know about Voltarol
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.
Your medicine is called Diclofenac sodium 50mg
Suppositories but will be referred to as Diclofenac
sodium Suppositories throughout this leaflet.
In this leaflet:
1. What Diclofenac sodium Suppositories are, and
what they are used for
2. Things to consider before you start to use
Diclofenac sodium Suppositories
3. How to use Diclofenac sodium Suppositories
4. Possible side effects
5. How to store Diclofenac sodium Suppositories
6. Further information
1. WHAT DICLOFENAC SODIUM
SUPPOSITORIES ARE, AND WHAT THEY
ARE USED FOR
Diclofenac sodium, the active ingredient in
Diclofenac sodiumSuppositories, is one of a group
of medicines called non-steroidal anti-inflammatory
drugs (NSAIDs). NSAIDs reduce pain and
inflammation.
• Diclofenac sodiumSuppositories 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.



Leaflet revision date: 13/02/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: 0266/130212/3/F

Diclofenac Sodium 50mg Suppositories




They are also used to treat pain and
inflammation associated with dental and minor
surgery.
In children aged 1 to 12 Diclofenac sodium
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 SODIUM
SUPPOSITORIES
Some people MUST NOT use Diclofenac
sodium 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
sodium 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
• 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 sodium 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 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
condition?
If the answer to any of these questions is YES,
discuss your treatment with your doctor or
pharmacist because Diclofenac sodium
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

• Whilst you are taking these medicines your

and some cancers)

• Ciclosporin and tacrolimus (used to treat some
inflammatory diseases and after transplants)
• 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
• Sulfinpyrazone (a medicine used to treat gout) or
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 sodium Suppositories
during the last 3 months of pregnancy as it may
affect the baby’s circulation.
• Are you trying for a baby? Using Diclofenac
sodium 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.








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 sodium 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 sodium.
DICLOFENAC SODIUM Suppositories 50 mg
and 100 mg are not suitable for children.
DICLOFENAC SODIUM Suppositories
12.5 mg are not used for adults.

Your child’s doctor will work out the dose that is
suitable for your child and will tell you how many
Diclofenac sodium 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.

3. HOW TO USE DICLOFENAC SODIUM
SUPPOSITORIES
The doctor will tell you how to use Diclofenac
sodium 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 sodium 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.

Will there be any problems with driving or
using machinery?
Very occasionally people have reported that
Diclofenac sodium 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.

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

Other special warnings
• You should take the lowest dose of Diclofenac
sodium 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 sodium. 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.

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.

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.

• 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.

4. POSSIBLE SIDE EFFECTS
Diclofenac sodium 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 faces
• 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.

• 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.

Diclofenac sodium 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.
Up to 1 in 10 people have experienced:
• 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)
Ref: 0266/130212/3/B

Expand view ⇕

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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