VOLTAROL SUPPOSITORIES 100MG

Active substance: DICLOFENAC SODIUM

View full screen / Print PDF » Download PDF ⇩

Transcript
Dummy Code

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

VOLTAROL® Suppositories
12.5, 25, 50 and 100 mg

2.  hings to consider before you start to use
T
Voltarol Suppositories
3.  ow to use Voltarol Suppositories
H
4.  ossible side effects
P

(diclofenac sodium)

6. Further information

What you need to know about Voltarol
Suppositories

1.  hat Voltarol Suppositories are and
W
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.

•  oltarol Suppositories relieve pain, reduce
V
swelling and ease inflammation in conditions
affecting the joints, muscles and tendons
including:
‒ 
Rheumatoid arthritis, osteoarthritis, acute
gout, ankylosing spondylitis

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.

‒ 
Backache, sprains and strains, soft tissue
sports injuries, frozen shoulder, dislocations
and fractures

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.

•  hey are also used to treat pain and
T
inflammation associated with dental and
minor surgery.

‒ Tendonitis, tenosynovitis, bursitis.

899420_GB_p2_LFT.indd 1

Some people MUST NOT use Voltarol
Suppositories. Talk to your doctor if:
•  ou think you may be allergic to diclofenac
y
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
•  ou have now, or have ever had, a stomach
y
(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)
•  ou have had stomach or bowel problems
y
after you have taken other NSAIDs
• you have severe heart, kidney or liver failure

Dummy Code

The Maltings



Yes / 
899420

No

Leaflet_VOLTAREN_
SUP_12.5MG/25MG/50MG/100MG
_(2X5)_GB
899420_GB_LFT
5024455 GB 13 A/H
594 x 148 mm
5024455_GB_13_AH_TS_LFT

2

• n children aged over 6 they can also be
I
used alone, or in combination with other
painkillers, for the short term treatment of
any pain experienced after an operation.

2.  hings to consider before you start to
T
use Voltarol Suppositories

5.  ow to store Voltarol Suppositories
H

Patient Information Leaflet

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

9pt
01/10/2013

Delpharm
Stone, Christina
Black

Cutting
Dimensions

K.Jerrum

464727_0

Dummy Code

• f you have established heart disease and/or
i
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
• f you have or have had problems with your
i
blood circulation (peripheral arterial disease)
• you are more than six months pregnant
•  ou suffer from ineffectual straining to empty
y
the bowels, diarrhoea or rectal bleeding
You should also ask yourself these questions
before using Voltarol Suppositories:
•  o you suffer from any stomach or bowel
D
disorders including ulcerative colitis or
Crohn's disease?
•  o you have kidney or liver problems, or are
D
you elderly?
•  o you have a condition called porphyria?
D

•  o you have heart problems, or have you had
D
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
•  o you have Lupus (SLE) or any similar
D
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.

•  ardiac glycosides (for example digoxin), used
C
to treat heart problems
•  edicines known as SSRIs used to treat
M
depression
•  ral steroids (an anti-inflammatory drug)
O
•  edicines used to treat heart conditions or
M
high blood pressure, for example beta‒
blockers or ACE inhibitors.

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:

•  henytoin (a medicine used to treat seizures)
P

•  edicines to treat diabetes
M

•  olestipol/cholestyramine (used to lower
C
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.

•  nticoagulants (blood thinning tablets like
A
warfarin)
•  iuretics (water tablets)
D

•  ave you ever had asthma?
H

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

•  o you have angina, blood clots, high blood
D
pressure, raised cholesterol or raised
triglycerides

•  ifepristone (a medicine used to terminate
M
pregnancy)

•  oriconazole (a medicine used to treat
V
fungal infections).

•  o you suffer from any blood or bleeding
D
disorder? If you do, your doctor may ask you
to go for regular check-ups while you are
using these suppositories.
•  re you breast-feeding?
A

•  ny other NSAID or COX-2 (cyclo-oxgenase-2)
A
inhibitor, for example aspirin or ibuprofen

•  ithium (used to treat some mental problems)
L

Pregnancy

•  ethotrexate (for some inflammatory diseases
M
and some cancers)

•  re you pregnant or planning to become
A
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.

•  rimethoprim (a medicine used to prevent or
T
treat urinary tract infections)
•  uinolone antibiotics (for infections)
Q

Dummy Code

•  re you trying for a baby? Using Voltarol
A
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?

•  ecause it is an anti-inflammatory
B
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.

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

Other special warnings

3.  ow to use Voltarol Suppositories
H

•  ou should take the lowest dose of Voltarol
Y
for the shortest possible time, particularly if
you are underweight or elderly.
•  here is a small increased risk of heart
T
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.
•  hilst you are taking these medicines your
W
doctor may want to give you a check‑up
from time to time.
• f you have a history of stomach problems
I
when you are taking NSAIDs, particularly if
you are elderly, you must tell your doctor
straight away if you notice any unusual
symptoms.

•  OLTAROL Suppositories 12.5 mg are
V
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.
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
899420 _ GB _ LFT
drugs as well.

01/10/2013 09:54

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
•  mpty your bowels before inserting a suppository.
E

•  ash your hands.
W
•  ake out the strip of suppositories and tear
T
off one along the perforation.
•  hen take the suppository out of the plastic
T
wrapping by pulling back the loose end.

What if you forget to take a dose?
•  ie on one side with your knees pulled up
L
towards your chest.
•  ently push the suppository pointed end first
G
into your back passage (rectum) with your
finger. Push the suppository in as far as
possible as shown in the diagram.

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?

•  ower your legs and, if possible, stay still for a
L
few minutes.
• f you feel as if you need to push the
I
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.
•  ash your hands.
W

899420_GB_p2_LFT.indd 2

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.  ossible side effects
P
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.

Some side effects can be serious
Stop using the suppositories and tell your doctor
straight away if you notice:
•  tomach pain, indigestion, heartburn, wind,
S
nausea (feeling sick) or vomiting (being sick)
•  ny sign of bleeding in the stomach or intestine,
A
for example, when emptying your bowels, blood
in vomit or black, tarry faeces
•  llergic reactions which can include skin rash,
A
itching, bruising, painful red areas, peeling or
blistering

• 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):
•  tomach ulcers or bleeding (there have been
S
very rare reported cases resulting in death,
particularly in the elderly)
•  astritis (inflammation, irritation or swelling of
G
the stomach lining)

•  heezing or shortness of breath (bronchospasm)
W

•  omiting blood
V

•  wollen face, lips, hands or fingers
S

•  iarrhoea with blood in it or bleeding from the
D
back passage

•  ellowing of your skin or the whites of your eyes
Y
•  ersistent sore throat or high temperature
P
•  n unexpected change in the amount of urine
A
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):
•  tomach pain, heartburn , nausea, vomiting,
S
diarrhoea, indigestion, wind, loss of appetite
• Headache, dizziness, vertigo

•  lack, tarry faeces or stools
B
•  rowsiness, tiredness
D
•  ypotension (low blood pressure, symptoms
H
of which may include faintness, giddiness or
light headedness)
•  kin rash and itching
S
•  luid retention, symptoms of which include
F
swollen ankles
•  iver function disorders, including hepatitis
L
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 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.  ow to store Voltarol Suppositories
H
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
September 2013
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

899420 _ GB _ LFT

01/10/2013 09:54

The Maltings



Yes / 
899420

No

Leaflet_VOLTAREN_
SUP_12.5MG/25MG/50MG/100MG
_(2X5)_GB
899420_GB_LFT
5024455 GB 13 A/H
594 x 148 mm
5024455_GB_13_AH_TS_LFT

2

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.

9pt
01/10/2013

Delpharm
Stone, Christina
Black

Cutting
Dimensions

K.Jerrum

464727_0

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.

Hide
(web3)