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SULPHASALAZINE TABLETS 500MG

Active substance(s): SULPHASALAZINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SULFASALAZINE
TABLETS 500 MG

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 Sulfasalazine is for
2. Before you take Sulfasalazine
3. How to take Sulfasalazine
4. Possible side effects
5. How to store Sulfasalazine
6. Further information

1. WHAT SULFASALAZINE IS FOR
Sulfasalazine 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 SULFASALAZINE
Do not take Sulfasalazine 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 Sulfasalazine 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 Sulfasulazine 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 Sulfasalazine 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
Sulfasalazine 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
Sulfasalazine tablets should not affect your ability to
drive or use machines.

3. HOW TO TAKE SULFASALAZINE
Always take Sulfasalazine tablets exactly as
your doctor has told you.
Take these tablets by mouth. 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.
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.
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 Sulfasalazine 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 Sulfasalazine 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, Sulfasalazine 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 Sulfasalazine, 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 SULFASALAZINE
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 Sulfasalazine tablets contain
The active ingredient in Sulfasalazine tablets is
sulfasalazine. Each tablet contains 500 mg of the
active substance. The other ingredients are
povidone, maize starch, magnesium stearate,
stearic acid and crospovidone.
What Sulfasalazine tablets look like and contents
of the pack
Sulfasalazine 500 mg tablets are flat orange-brown
bevelled tablets with a break line engraved on one
side and MP42 on the other.
The tablets come in blister packs and containers of
28, 30, 50, 56, 60, 84, 100, 112, 250, 500 and 1000
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Metwest Pharmaceuticals Limited,
15 Runnelfield, Harrow on the Hill,
Middlesex HAI 3NY
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 11/2012

M0042/O/PIL/G4

PACKAGE LEAFLET: INFORMATION FOR THE USER

SULFASALAZINE
TABLETS 500 MG

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 Sulfasalazine is for
2. Before you take Sulfasalazine
3. How to take Sulfasalazine
4. Possible side effects
5. How to store Sulfasalazine
6. Further information

1. WHAT SULFASALAZINE IS FOR
Sulfasalazine 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 SULFASALAZINE
Do not take Sulfasalazine 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 Sulfasalazine 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

In particular, tell your doctor or pharmacist if you are
taking any of the following medicines, as they may
affect how Sulfasalazine 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
Sulfasalazine 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
Sulfasalazine tablets should not affect your ability to
drive or use machines.

3. HOW TO TAKE SULFASALAZINE
Always take Sulfasalazine tablets exactly as
your doctor has told you.
Take these tablets by mouth. 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.
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.
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.

Tests on your liver, kidney and blood
Before you start treatment with Sulfasulazine 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).

Do not give to children under 2 years old.

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.

If you take more Sulfasalazine tablets than you
should
Contact your doctor or the nearest hospital casualty
department immediately.

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.

Take this leaflet and the package with you so they
know what has been taken.
If you forget to take Sulfasalazine 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, Sulfasalazine 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 Sulfasalazine, 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 to due 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 SULFASALAZINE
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 Sulfasalazine tablets contain
The active ingredient in Sulfasalazine tablets is
sulfasalazine. Each tablet contains 500 mg of the
active substance. The other ingredients are
povidone, maize starch, magnesium stearate,
stearic acid and crospovidone.
What Sulfasalazine tablets look like and contents
of the pack
Sulfasalazine 500 mg tablets are flat orange-brown
bevelled tablets with a break line engraved on one
side and MP42 on the other.
The tablets come in blister packs and containers of
28, 30, 50, 56, 60, 84, 100, 112, 250, 500 and 1000
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Metwest Pharmaceuticals Limited,
15 Runnelfield, Harrow on the Hill,
Middlesex HAI 3NY
Manufacturer:
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London SW5 9JQ, United Kingdom
For more information about this product, please
contact the Marketing Authorisation Holder.
This leaflet was last revised in 11/2012
M0042/O/PIL/G4

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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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