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VOLTARENE 100MG SUPPOSITORIES

Active substance(s): DICLOFENAC SODIUM

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Voltarene 100mg Suppositories
Voltarol 100mg Suppositories
Diclofenac Sodium 100mg Suppositories
(Diclofenac Sodium)
This product is available using any of the above names but will be referred
to as Voltarol Suppositories throughout the following:
Patient Information Leaflet
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.
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, 12.5 and 25 mg strengths 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 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 betablockers 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.
 Suppositories of 50 mg and 100 mg strength are not suitable for
children.
 Suppositories of 12.5 mg strength are not used for adults.

3) How to use Voltarol Suppositories
The doctor will tell you how to use Voltarol Suppositories. Always follow
his/her instructions carefully. The dose will be on the pharmacist’s label.
Check the label carefully. If you are not sure, ask your doctor or pharmacist.
Keep using the suppositories for as long as you have been told, unless you
have any problems. In that case, check with your doctor.
Suppositories are designed for insertion into the back passage (rectum).
Never take them by mouth.
The doctor may also prescribe another drug to protect the stomach to be
taken at the same time, particularly if you have had stomach problems
before, or if you are elderly, or taking certain other drugs as well.
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.
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.

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.

Rare side effects (These may affect between 1 in every 1000 to 1 in
every 10,000 patients):
 Stomach ulcers or bleeding (there have been very rare reported cases
resulting in death, particularly in the elderly)
 Gastritis (inflammation, irritation or swelling of the stomach lining)
 Vomiting blood
 Diarrhoea with blood in it or bleeding from the back passage
 Drowsiness, tiredness
 Hypotension (low blood pressure, symptoms of which may include
faintness, giddiness or light headedness)
 Skin rash and itching
 Fluid retention, symptoms of which include swollen ankles
 Liver function disorders, including hepatitis and jaundice.
Very rare side effects (These may affect less than 1 in every 10,000
patients):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, visual disturbances such as
blurred or double vision, hearing loss or impairment, tinnitus (ringing in the
ears), sleeplessness, nightmares, mood changes, depression, anxiety,
mental disorders, disorientation and loss of memory, fits, headaches
together with a dislike of bright lights, fever and a stiff neck, disturbances in
sensation.
Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers, inflammation of the
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) How to store Voltarol Suppositories.
4) Possible side effects
Voltarol Suppositories are suitable for most people, but, like all medicines,
they can sometimes cause side effects.
Some side effects can be serious
Stop using the suppositories and tell your doctor straight away if you
notice:
 Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or
vomiting (being sick)
 Any sign of bleeding in the stomach or intestine, for example, when
emptying your bowels, blood in vomit or black, tarry faeces
 Allergic reactions which can include skin rash, itching, bruising, painful
red areas, peeling or blistering
 Wheezing or shortness of breath (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

 Keep all medicines out of the reach and sight of children.
 Voltarene Suppositories should be protected from heat and stored below
30°C.
 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
What Voltarol Suppositories contains
Each suppository contains 100mg of the active ingredient Diclofenac
Sodium.
Voltarene Suppositories also contain the following: saturated acid
triglycerides
What Voltarol Suppositories looks like and the contents of the pack
Voltarene Suppositories are off-white, fatty, torpedo-shaped suppository.
Each pack of 10 suppositories contains two strips of 5 suppositories.
PL 10383/0448

POM

Who makes and repackages your medicine:
Your medicine is manufactured by Laboratoires Ciba-Geigy 26, Rue de la
Chapelle, BP 151 68330 Huningue, France. Procured from within the EU
and repackaged by the Product Licence holder: Primecrown Ltd. 28 Sarum
Complex, Uxbridge, Middlesex, UB8 2RZ.
Leaflet date: 19.08.2011

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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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