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Active substance(s): SULFASALAZINE

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Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
- Keep this leaflet. You may need to read it
- If you have any further questions, ask your
doctor or pharmacist.
- This medicine has been prescribed for
you only. Do not pass it on to others. It may
harm them, even if their symptoms are the
same as yours.
- If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.

1. What Sulazine EC is for
2. Before you take Sulazine EC
3. How to take Sulazine EC
4. Possible side effects
5. How to store Sulazine EC
6. Further information

Sulazine EC 500 mg Gastro-resistant Tablets contain
the active ingredient sulfasalazine, which belongs to a
group of medicines called the aminosalicylates.
It is used to reduce pain and swelling in joint diseases
(rheumatoid arthritis) or gut diseases (Crohn's
disease or ulcerative colitis).
If you are not sure why you have been prescribed
these tablets then please ask your doctor.

Do not take Sulazine EC and tell your doctor if
 are allergic to sulfasalazine or any of the other
ingredients in the tablets (listed in section 6 of this
 are allergic to salicylates (e.g. aspirin) or
sulfonamides (e.g. sulfadiazine)
 suffer from inherited iron disorders (porphyrias)
Do not use this medicine in children under 2 years
of age.
Take special care with Sulazine EC
Tell your doctor before you take this medicine if you:
 have problems with your liver or kidneys
 suffer from severe allergies or asthma
 have a blood disorder
 have been told that you suffer from glucose-6phosphate dehydrogenase (G6PD) deficiency, as
there is an increased risk of red blood cell
breakdown in the body (haemolytic anaemia)
 are treating a child with the condition systemic
onset juvenile rheumatoid arthritis
Tests on your liver, kidney and blood
Before you start treatment with Sulazine EC you will
have a blood and urine test to check what your blood
is doing and how well your kidneys are working.
During treatment your doctor will check how well your
liver, kidneys and blood are working by taking blood
and urine samples periodically during your treatment.
As this medicine may have effects on the blood and
liver, tell your doctor immediately if you have
unexplained bleeding, bruising, purple spots,
sore throat, general illness, fever or jaundice (see
section 4 of this leaflet).
Other medicines and Sulazine EC
Tell your doctor or pharmacist if you are taking or have
recently taken, or might take any other medicines,
even medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are
taking any of the following medicines, as they may
affect how Sulazine EC works:
 medicines used to treat diabetes (e.g. gliclazide or
 digoxin, used to treat heart problems
 folic acid, used during pregnancy
 antibiotics, used to treat infections
 azathioprine, used to suppress the immune
system and stop the rejection of organs after
 mercaptopurine or methotrexate, used in the
treatment of cancer
If you go into hospital or have treatment for other
conditions, tell the doctor that you are taking Sulazine
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 or pharmacist for advice before taking this
medicine. You should avoid breastfeeding while
taking Sulazine EC, as there have been reports of
diarrhoea or blood in the stools of babies of breastfeeding mothers taking this medicine.
Driving and using machines
Sulazine EC should not affect your ability to drive or
use machines.

Always take Sulazine EC exactly as your doctor
has told you. Check with your doctor or pharmacist if you are not sure.
Do not crush or chew the tablets. Swallow them whole
with a glass of water. You can take them with or
without food.
Whilst taking this medicine ensure that you drink
adequate fluids to remain well hydrated, especially
after severe or prolonged episodes of vomiting and/or
diarrhoea, high fever or heavy sweating. This is to
avoid problems with your kidneys.
Your doctor will decide your dose and length of
treatment, as it depends on your condition. The
recommended doses are;
Adults and the elderly:
Ulcerative colitis:
Severe/Moderate flare-up: 2 - 4 tablets four times a
day, usually with other medicines such as steroids. Do
not leave more than 8 hours between the evening
dose and that of the next morning.
Mild flare-up: 2 tablets four times a day, with or without
Maintenance dose: once the flare-up is controlled,
your doctor may gradually lower your dose, as your
condition improves, to 4 tablets a day. This lower dose
should be continued to prevent further flare-ups.
Crohn’s disease:
Severe/Moderate flare-up: 2-4 tablets four times a
day, usually with other medicines such as steroids. Do
not leave more than 8 hours between the evening
dose and that of the next morning.
Mild flare-up: 2 tablets four times a day, with or without
Rheumatoid arthritis:
Start with 1 tablet each day for the first week of
treatment. Then, increase the dose by 1 tablet a day
each week to a maximum of 6 tablets a day in divided
Children 2 years of age and over:
Ulcerative colitis and Crohn’s disease:
Your doctor will tell you what dose your child needs to
take depending on their bodyweight.
Rheumatoid arthritis:
Not recommended.
Do not give to children under 2 years old.
If you take more Sulazine EC than you should
Contact your doctor or the nearest hospital casualty
department immediately. Take this leaflet and the
package with you so they know what has been taken.

If you forget to take Sulazine EC
Don't worry, just take your next scheduled dose at the
correct time. Do not take a double dose to make up for
a forgotten dose.
If you stop taking Sulazine EC
Do not stop taking Sulazine EC without talking to your
doctor first, even if your symptoms have improved.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Like all medicines, Sulazine EC can cause side
effects, although not everybody gets them.
If you get any of the following serious side
effects, STOP taking this medicine and tell your
doctor immediately or go to the nearest hospital emergency department:
 an allergic reaction, which may cause itching,
rashes, red raised lumps (hives), swelling of the
face, tongue or throat which may cause difficulty
breathing and wheezing, skin sensitivity to
sunlight, fever, joint or muscle pain.
 potentially life-threatening skin rashes (StevensJohnson syndrome, toxic epidermal necrolysis),
appearing initially as reddish target-like spots or
circular patches often with central blisters. The
rash may progress to widespread blistering or
peeling of the skin. Additional signs include ulcers
in the mouth, throat, nose or genitals, red swollen
eyes (conjunctivitis) and flu-like symptoms. The
highest risk of occurrence is within the first weeks
of treatment. If you develop these conditions with
Sulazine EC, you must not restart taking this
medicine at any time.
 blood problems such as altered numbers of white
blood cells, red blood cells or blood platelets.
These may cause symptoms including
unexplained bleeding, bruising, increased risk of
infections, sore throat, fever, weakness,
breathlessness, pale skin or general illness. A
blood test can be taken to check.
If you get any of the following side effects, see
a doctor straight away:
 inflammation of the liver (hepatitis), which may
cause yellowing of the skin or whites of the eyes
(jaundice), darker urine or paler stools.
 inflammation of the pancreas (pancreatitis), which
causes severe pain in the abdomen and back.
Tell your doctor or pharmacist if you get any of
the following side effects:
Very common side effects (affecting more than 1
in 10 people):
 indigestion, heartburn, feeling sick (nausea)
Common side effects (affecting less than 1 in 10
 difficulty sleeping
 dizziness, headache, changes in taste
 bloodshot eyes
 ringing in the ears
 cough
 abdominal pain, diarrhoea, being sick (vomiting),
inflammation of the mouth
 itching sensation
 fever
Uncommon side effects (affecting less than 1 in
100 people)
 depression
 fits
 a feeling of dizziness or "spinning" (vertigo)
 shortness of breath
 hair loss
 puffiness of the face
 inflammation of the blood vessels that may appear
as purple spots on the skin
 increase in liver enzymes, which can be seen on
blood tests
Side effects for which frequency cannot be
estimated from the available data
 an infection of the colon, with symptoms including
severe diarrhoea, fever and abdominal pain or

 enlarged lymph nodes
 loss of appetite
 hallucinations
 aseptic meningitis, which may cause stiff neck,
headache, nausea, vomiting, fever or disorientation
 loss of co-ordination, change in mental state, nerve
damage, changes in smell
 some soft contact lenses may be stained
 inflammation of the heart muscle (myocarditis), or
the sac surrounding the heart (pericarditis)
 blue colouration of the skin due to a lack of oxygen
in the blood
 lung disease with difficulty breathing
 worsening of the symptoms of colitis, which may
include diarrhoea, cramping abdominal pains,
fatigue, loss of appetite, weight loss
 inflammation of the salivary glands
 liver failure
 crystals in the urine (crystalluria), which may be
seen as cloudy urine or cause difficulty in passing
urine, blood in the urine, kidney problems including
inflammation or damage, urine may be coloured
 low sperm count in men, this is temporary and
reversible on stopping treatment
 yellow discolouration of the skin and body fluids
 induction of autoantibodies, which may cause
arthritis type symptoms and/or unexplained fevers,
fatigue, muscle weakness or rashes
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.
You can also report side effects directly via the Yellow
Card Scheme at By
reporting side effects you can help provide more
information on the safety of this medicine.

Keep out of the sight and reach of children.
Store below 25°C in a dry place. Store in the original
container and keep the container tightly closed.
Do not use these tablets after the expiry date, which is
stated on the container. The expiry date refers to the
last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

What Sulazine EC Gastro-resistant Tablets contain
The active ingredient in Sulazine EC Gastro-resistant
Tablets is sulfasalazine. Each tablet contains 500 mg
of sulfasalazine.
The other ingredients are povidone, maize starch,
magnesium stearate, stearic acid, crospovidone,
methacrylic acid copolymer, triethyl citrate and glyceryl
What Sulazine EC Gastro-resistant Tablets look
like and contents of the pack
Sulazine EC 500 mg Gastro-resistant Tablets are oval
orange with SULAZINE EC engraved on one side.
The tablets come in blister packs of 28, 56, 84, 100,
112, 224 and 500 tablets, and containers of 28, 56, 84,
100, 112, 224 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Chelonia Healthcare Limited,
11 Boumpoulinas, Nicosia, P.C. 1060, Cyprus
DDSA Pharmaceuticals Limited,
84 Pembroke Road, London, W8 6NX, UK
For more information about this product, please
contact the Marketing Authorisation Holder.
This leaflet was last revised in 12/2017

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.