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SULFSALAZINE 500MG GASTRO-RESISTANT TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SULAZINE EC 500 mg
GASTRO-RESISTANT
TABLETS
SULFASALAZINE
Read all of this leaflet carefully before
you start taking 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 become serious, or
if you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.

THIS LEAFLET CONTAINS
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

1. WHAT SULAZINE EC IS FOR
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.

2. BEFORE YOU TAKE SULAZINE EC
Do not take Sulazine EC Gastro-resistant
Tablets and tell your doctor if you:
 are allergic to sulfasalazine or any of the other
ingredients in the tablets (listed in section 6 of
this leaflet)
 are allergic to salicylates (e.g. aspirin) or
sulphonamides (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 Gastroresistant Tablets
Tell your doctor before you take this medicine if you:
 have problems with your liver or kidneys
 suffer from severe allergies
 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
Tests on your liver, kidney and blood
Before you start treatment with Sulazine EC you will
have a blood and urine test to check how well your
kidneys are working and what you blood is doing.
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).
Taking other medicines
Tell your doctor or pharmacist if you are taking or

have recently taken 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 EC Sulazine Gastro-resistant Tablets
work:
 medicines used to treat diabetes (e.g. gliclazide
or tolbutamide)
 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
transplants
 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 EC Gastro-resistant Tablets.
Pregnancy and breast-feeding
Although this medicine is not known to harm babies,
make sure your doctor knows if you are pregnant,
planning a pregnancy or breast-feeding and follow
their advice.
Driving and using machines
Sulazine Gastro-resistant EC Tablets should not
affect your ability to drive or use machines.

3. HOW TO TAKE SULAZINE EC
Always take Sulazine EC Gastro-resistant
Tablets exactly as your doctor has told you.
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.
Dosage
Your doctor will decide your dose and length of
treatment, as it depends on your condition. The
usual 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 steroids.
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 steroids.
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.
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 Gastro-resistant
Tablets 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 Gastroresistant Tablets
Don't worry, just take your next scheduled dose at
the correct time. Do not take a double dose to make
up for the one you have missed.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Sulazine EC Gastro-resistant
Tablets 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
people):
 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
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

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 cramps
 enlarged lymph nodes
 loss of appetite
 hallucinations
 aseptic meningitis, which may cause stiff neck,
headache, nausea, vomiting or disorientation
 loss of co-ordination, change in mental state,
nerve damage, changes in smell
 eye problems including puffiness around the
eyes, 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
 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 orange
 low sperm count in men, this is temporary and
reversible on stopping treatment
If any of the side effects become serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE SULAZINE EC
Keep out of the reach and sight 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.
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 Sulazine EC Gastro-resistant Tablets
contain
The active ingredient in Sulazine EC
Gastro-resistant Tablets is sulfasalazine. The other
ingredients are povidone, maize starch, magnesium
stearate, stearic acid, crospovidone, methacrylic
acid copolymer, triethyl citrate and glyceryl
monostearate.
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:
Chatfield Pharmaceuticals Limited,
Kramer Mews, London SW5 9JL
Manufacturer:
Haupt Pharma Berlin GmbH,
Gradestraße 13, Moosrosenstraße 5 and Britzer
Damm 120, 12347 Berlin, Germany
For more information about this product, please
contact the Marketing Authorisation Holder.
This leaflet was last revised in 03/2013

CF0009-SULAZINE/O/PIL/G5

PACKAGE LEAFLET: INFORMATION FOR THE USER

SULAZINE EC 500 mg
GASTRO-RESISTANT
TABLETS
SULFASALAZINE
Read all of this leaflet carefully before
you start taking 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 become serious, or
if you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.

THIS LEAFLET CONTAINS
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

1. WHAT SULAZINE EC IS FOR
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.

2. BEFORE YOU TAKE SULAZINE EC
Do not take Sulazine EC Gastro-resistant
Tablets and tell your doctor if you:
 are allergic to sulfasalazine or any of the other
ingredients in the tablets (listed in section 6 of
this leaflet)
 are allergic to salicylates (e.g. aspirin) or
sulphonamides (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 Gastroresistant Tablets
Tell your doctor before you take this medicine if you:
 have problems with your liver or kidneys
 suffer from severe allergies
 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

have recently taken 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 Gastro-resistant Tablets
work:
 medicines used to treat diabetes (e.g. gliclazide
or tolbutamide)
 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
transplants
 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 EC Gastro-resistant Tablets.
Pregnancy and breast-feeding
Although this medicine is not known to harm babies,
make sure your doctor knows if you are pregnant,
planning a pregnancy or breast-feeding and follow
their advice.
Driving and using machines
Sulazine Gastro-resistant EC Tablets should not
affect your ability to drive or use machines.

3. HOW TO TAKE SULAZINE EC
Always take Sulazine EC Gastro-resistant
Tablets exactly as your doctor has told you.
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.
Dosage
Your doctor will decide your dose and length of
treatment, as it depends on your condition. The
usual 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 steroids.
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 steroids.

Tests on your liver, kidney and blood
Before you start treatment with Sulazine EC you will
have a blood and urine test to check how well your
kidneys are working and what you blood is doing.
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).

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.

Taking other medicines
Tell your doctor or pharmacist if you are taking or

Do not give to children under 2 years old.

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.

If you take more Sulazine EC Gastro-resistant
Tablets 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 Gastroresistant Tablets
Don't worry, just take your next scheduled dose at
the correct time. Do not take a double dose to make
up for the one you have missed.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Sulazine EC Gastro-resistant
Tablets 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
people):
 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
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

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 cramps
 enlarged lymph nodes
 loss of appetite
 hallucinations
 aseptic meningitis, which may cause stiff neck,
headache, nausea, vomiting or disorientation
 loss of co-ordination, change in mental state,
nerve damage, changes in smell
 eye problems including puffiness around the
eyes, 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
 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 orange
 low sperm count in men, this is temporary and
reversible on stopping treatment
If any of the side effects become serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE SULAZINE EC
Keep out of the reach and sight 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.
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 Sulazine EC Gastro-resistant Tablets
contain
The active ingredient in Sulazine EC
Gastro-resistant Tablets is sulfasalazine. The other
ingredients are povidone, maize starch, magnesium
stearate, stearic acid, crospovidone, methacrylic
acid copolymer, triethyl citrate and glyceryl
monostearate.
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:
Chatfield Pharmaceuticals Limited,
Kramer Mews, London SW5 9JL
Manufacturer:
DDSA Pharmaceuticals Limited,
310 Old Brompton Road, London SW5 9JQ
For more information about this product, please
contact the Marketing Authorisation Holder.
This leaflet was last revised in 03/2013

CF0009-SULAZINE/O/PIL/G5

Expand Transcript

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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