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SALAZOPYRIN SUPPOSITORIES

Active substance(s): SULPHASALAZINE

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FPO
2011-0013888 /1

PATIENT INFORMATION LEAFLET

Salazopyrin™

500 mg Suppositories
sulfasalazine

Read all of this leaflet carefully before
you are given this medicine

• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are 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 Salazopyrin Suppositories are and
what they are used for
2. Before you use Salazopyrin Suppositories
3. How to use Salazopyrin Suppositories
4. Possible side effects
5. How to store Salazopyrin Suppositories
6. Further information

1. What Salazopyrin Suppositories are
and what they are used for
The active substance in Salazopyrin
Suppositories is sulfasalazine which is an
anti-inflammatory medicine and belongs to a
group of medicines called aminosalicylates.
Your doctor may give you Salazopyrin
Suppositories to treat and manage
inflammatory bowel disease.
The main forms of inflammatory bowel disease
are Ulcerative Colitis and Crohn’s disease.
Although the diseases have some features in
common, there are some important differences.
Ulcerative Colitis is an inflammatory disease
which affects only the large bowel (colon and
back passage). The lining of the bowel becomes
inflamed (red and swollen) and symptoms

include abdominal pain and diarrhoea (which
may contain blood and mucus). Salazopyrin
Suppositories act locally in the end part of
the bowel (the back passage) to reduce the
inflammation and are used to control the flareups of ulcerative colitis.
Crohn’s disease is an inflammatory disease
which may affect any part of the digestive
system from the mouth to the anus, but it
most commonly affects the last part of the
small bowel and the first part of the large
bowel. Symptoms include abdominal pain and
diarrhoea (which may be bloody). Salazopyrin
Suppositories act locally in the end part of
the bowel (the back passage) and are used to
control the flare-ups of Crohn’s Disease.

2. Before you use Salazopyrin
Suppositories
Your doctor will perform complete blood
counts and liver function tests before starting
Salazopyrin and every second week during
the first three months of therapy. During the
second three months, the same tests should
be done once monthly and thereafter once
every three months, and as clinically indicated.
Urine analysis and an assessment of kidney
function should also be done periodically
during treatment with Salazopyrin. Thereafter,
monitoring will be performed as your doctor
requires
Do not use Salazopyrin Suppositories if you:
• are allergic (hypersensitive) to any of the
ingredients of Salazopyrin Suppositories.
• are allergic (hypersensitive) to salicylates
(e.g. aspirin) or sulfonamides (e.g. a certain
type of antibiotic).
•  have a disease known as porphyria (a
rare blood pigment disorder). Your doctor
will have already told you if you have this
disease.
Salazopyrin Suppositories are not to be used in
children under 2 years of age.
Take special care with Salazopyrin
Suppositories
If the answer is YES to any of these questions
tell you doctor or pharmacist before taking this
medicine:
• Have you ever had any problems with your
liver or kidneys?
• Have you been told by your doctor that you
have an inherited condition in which the

body doesn’t have enough of an enzyme
known as glucose-6-dehydrogenase which
helps red blood cells function normally?
• Have you ever had asthma?
• If you are a child and have arthritis?
Tests on your blood, kidneys, liver and urine
Your doctor will be taking blood tests to check
your blood, your kidneys before you start
treatment and regularly during treatment. They will
also measure substances produced by your liver
known as enzymes (liver function tests) before you
start treatment and at regular intervals. They may
also test your urine for protein and blood.
Taking other medicines
Tell your doctor or pharmacist if you are taking
the following medicines as they may interact
with Salazopyrin Suppositories:
• any medicine for high blood sugar/diabetes,
• methenamine, an antibiotic for treating
urinary tract infections,
• digoxin, used to treat heart failure,
• folate, sometimes taken during the first few
weeks of pregnancy to reduce the risk of
neural tube defects, e.g. Spina Bifida.
• azathioprine and mercaptopurine medicines used to help to suppress
your bodies immune response in organ
transplantation and certain chronic
inflammations such as rheumatoid arthritis.
• methotrexate, used to treat rheumatoid
arthritis
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have a
baby, ask your doctor for advice before taking
this medicine. You should avoid breast-feeding
while taking this medicine. There have been
reports of diarrhoea or blood in the stools
of babies of breastfeeding mothers taking
Salazopyrin Suppositories.
Driving and using machines
Salazopyrin Suppositories is unlikely to affect
your ability to drive or use machinery.

3. How to use Salazopyrin Suppositories
Do not swallow Salazopyrin Suppositories.
Salazopyrin Suppositories must be inserted into
the back passage.

Firstly empty your bowel if possible, then using
your finger, push the suppositories well into the
back passage. You may have the urge to pass
the suppositories out again, but this should
ease after a few minutes when they have melted.
The suppositories melt at body temperature so
handle them as little as possible.
Unless your doctor has told you otherwise, the
usual doses for the following conditions are:
Ulcerative Colitis and Crohns’ Disease
• Adults and the Elderly
As described above insert two
suppositories in the morning and two at
bedtime, after emptying your bowel.
 After about three weeks your doctor may
tell you to reduce the dose.
• Children 2 years of age and over
 Your doctor will tell you what dose your
child will need to use. This will be based
on your child’s weight.
You may be given a medicine by mouth as
well as these suppositories to control your
condition
How long should you use these suppositories?
How long you use these suppositories depends
on how well the suppositories suit you.
• The suppositories should start to work in a
few days.
• If they work well, you may be using them
for some time because inflammatory bowel
disease may be a life long condition.
• Don’t stop using the suppositories just
because you feel better without talking to
your doctor.
If you use more Salazopyrin Suppositories
than you should
Contact your nearest hospital casualty
department or tell your doctor immediately, if
you have taken too many suppositories (an
overdose) or if a child has taken your
medicine.
Please take this leaflet and these suppositories
with you to the hospital casualty department or
to your doctor.
Ensure that you drink adequate fluids whilst
you are taking this medicine. This is to avoid
problems with your kidneys.
If you miss a dose of Salazopyrin
Suppositories
If you forget to take a dose, just take the next
dose as usual. Do not double dose the next
dose to make up for a missed one.

4. Possible side effects

Like all medicines, Salazopyrin Suppositories
can cause side effects, although not everybody
gets them. Side effects with Salazopyrin
Suppositories are fewer than the equivalent
treatment by mouth.
Stop taking Salazopyrin Suppositories and
tell your doctor immediately if you experience
any of the following symptoms after taking this
medicine. Although they are very rare, these
symptoms can be serious.
• A
 n allergic reaction such as sudden
wheeziness, difficulty in breathing, swelling
of eyelids, face or lips, rash or itching
(especially affecting the whole body).
• If you develop a severe skin rash that
causes blistering, (this can affect the mouth
and tongue). These may be signs of a
condition known as Stevens Johnson
Syndrome, or toxic epidermal necrolysis
(TEN). Your doctor will stop your treatment
in these cases.
• If you have a serious skin condition with a
rash (sometimes confined to the cheeks and
bridge of the nose) peeling skin or blistering.
It may be triggered or aggravated by
sunlight. Should this occur, stop taking this
medicine, avoid strong sunlight and contact
your doctor promptly.
• If you are generally feeling unwell, have a
fever, have pains in your joints, hives,
swollen glands, rash and itching. These
may be signs of a condition known as
serum sickness. Your doctor will stop your
treatment in these cases.
• If you are breast feeding stop taking this
medicine, once you notice blood in stools or
diarrhoea in newborn.
Tell your doctor immediately if you
experience any of the following symptoms
after taking this medicine as they will stop
treatment in these cases:
• If you notice any unexplained bleeding.
• If you notice bruising, fever, rash, pallor
(paleness), a severe sore throat or
tiredness. These may be the first signs
of an abnormality of the blood, including
decreases in the number of red cells, white
cells or platelets. Your doctor will take
regular blood samples to test for these
effects.
Discontinue treatment with Salazopyrin while
awaiting the results of blood tests

• I nflammation of pancreas which causes
severe pain in the abdomen and face
• Rash, reddening or blistering of the skin,
eczema,
• Tingling, numbness, pain in hands and feet
• Blood in urine
• Urine or motions may become a yellow/
orange colour which is normal and
harmless. (See section 6 General Advice for
further information)
• Temporary infertility in men. Fertility
returns when treatment is stopped. Normal
contraception should still be used.
Very rarely sulfasalazine has caused
permanent staining of extended wear soft
contact lenses. (See section 6 General Advice
for further information).
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.

Other side-effects that may occur are:
Very common side-effects which may affect
more than 1 person in 10 are listed below:
• Indigestion, heartburn
• Feeling sick (nausea)
Common side-effects which may affect more
than 1 person in 100 are listed below:
• Dizziness
• Difficulty sleeping
• Headache
• Changes in taste
• Abdominal pains
• Diarrhoea
• Being sick
• Ringing in the ears
• Blood shot eyes
• Inflamed mouth (stomatitis)
• Cough
• Itching of the skin
• Joint pain
• Protein in urine
• Fever
Uncommon side-effects which may affect
more than 1 person in 1000 are listed below:
• Depression
• Fits, jerky, uncontrolled movements
• Loss of balance
• Shortness of breath
• Hair loss
• Hives
• Puffiness around the eyes and face
Since introduction to the market the
following side-effects have been reported:
• Inflammation of the lining of the brain
• Severe diarrhoea
• Other blood disorders including anaemia,
enlarged glands (lymph nodes)
• Blood vessel inflammation
• Loss of appetite
• Hallucinations
• Changes in mental state
• Changes in smell
• Inflammation of the sac surrounding the
heart (pericarditis)
• Inflammation of the heart muscle
(myocarditis)
• Bluish tint to skin due to poor circulation
• Lung complications with breathlessness
• Inflammation of the salivary glands on
either side of the face
• Kidney inflammation and kidney pain,
• Liver disease (hepatitis)
• Yellowing of the skin or whites of the eyes
(jaundice)

5. How to store Salazopyrin
Suppositories
Keep out of the reach and sight of children.
Do not use Salazopyrin Suppositories after the
expiry date which is stated on the pack.The
expiry date refers to the last day of that month.
Do not store the medicine above 25°C.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Further information
What Salazopyrin Suppositories contain
The active substance is sulfasalazine. Each
suppository contains 500mg of sulfasalazine.
Other ingredients are hard fat, PVP (povidone).
What Salazopyrin Suppositories looks like
and contents of the pack

Marketing Authorisation Holder and
Manufacturer
The marketing authorisation for Salazopyrin
Suppositories is held by:
Pfizer Limited,
Ramsgate Road,
Sandwich,
Kent,
CT13 9NJ,
United Kingdom.
Salazopyrin Suppositories are made
by:Kemwell AB, 75182 Uppsala, Sweden.
For any information about this medicinal
product, please contact the local representative
of the Marketing Authorisation Holder:
General Advice
Because the suppositories are coloured yellow /
orange they may cause your urine or motions
to become a yellow/orange colour. This is
normal and harmless but can stain fabric. Any
Salazopyrin soiled fabric should be put in to
soak. Difficult stains may be removed with a
solution of washing soda. Always test the
effect of soda on a small piece of the fabric first.
Then apply a mild acid such as white vinegar.
Sulfasalazine has caused permanent staining
of extended wear soft contact lenses. Although
this happens very rarely. Daily-wear soft contact
lenses and gas permeable lenses respond to
standard cleaning if this happens.
Where can I get more advice about
Ulcerative Colitis and Crohn’s Disease?
The National Association for Colitis and
Crohn’s Disease (NACC) has local groups
which offer meetings, events and information
for patients. They may be contacted at: NACC,
P.O. Box 205, St. Albans, Herts, AL1 1AB.
This leaflet was last revised 01/2014
Ref: SZ 10_5 Supp UK

The suppositories are yellow/orange in colour,
have no smell and are torpedo shaped.
The suppositories are the colour of the
medicine itself. They contain no artificial
colouring.
This medicine is available in packs containing
either 10 or 50 suppositories.
2011-0013888 /1

FPO

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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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