SALAZOPYRIN EN-TABS 500MG TABLETS

Active substance: SULFASALAZINE

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Ref: 0716/290113/1/F

®

Salazopyrin EN-tabs 500mg Tablets
(sulfasalazine)
Patient Information Leaflet
Read all of this leaflet carefully before you take 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.
Your medicine is called Salazopyrin EN-tabs 500mg Tablets but will be called
Salazopyrin EN-tabs throughout this leaflet.
In this leaflet:
1 What Salazopyrin EN-tabs are and what they are used for

Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Pregnancy
Tell your doctor if you are pregnant, planning to become pregnant or become
pregnant whilst taking this medicine.
Breast-feeding
Ask your doctor for advice before breast-feeding your baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Salazopyrin EN-tabs is unlikely to affect your ability to drive or use
machinery.

2 Before you take Salazopyrin EN-tabs
3 How to take Salazopyrin EN-tabs
4 Possible side effects
5 How to store Salazopyrin EN-tabs
6 Further information

3

How to take Salazopyrin EN-tabs

The tablets should be taken with a glass of water and should be swallowed
whole. Do not crush, break or chew the tablets.
Unless your doctor has told you otherwise, the usual doses for the following
conditions are:

1

What Salazopyrin EN-tabs are and what they are used
for

The active substance in Salazopyrin EN-tabs is sulfasalazine which is an
anti-inflammatory drug and belongs to a group of medicines called
aminosalicylates.
Your doctor may give you Salazopyrin EN-tabs to treat and manage
inflammatory bowel disease or to treat rheumatoid arthritis.
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 adominal pain and diarrhoea (which
may contain blood and mucus). Salazopyrin EN-tabs are used to control the
flare-ups of ulcerative colitis. They may also be used at lower doses to
prevent more flare-ups 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 EN-tabs are used to control the flare-ups of Crohn’s Disease.
Rheumatoid arthritis
Salazopyrin EN-tabs are usually given when a group of medicines known as
non-steroidal anti-inflammatory drugs (NSAIDs e.g. aspirin and ibuprofen)
are not working. They help prevent damage to your joints and work slowly to
reduce swelling and stiffness in your joints.

For Inflammatory bowel disease:
Ulcerative Colitis

* Adults and the Elderly
* Severe Flare-Ups 2-4 tablets four times a day, with other medicines

such as steroids. Do not leave more than 8 hours between the evening
and following morning dose.
* Mild/Moderate Flare-Up 2-4 tablets four times a day, but not always with
other medicines.
* Maintenance dose to control your flare ups - Once the flare-up is
controlled the dose is slowly reduced to 4 tablets each day. Your doctor
will tell you how to reduce your dose.
This lower dose may be continued for some time to help stop other
flare-ups

* 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

Crohn’s Disease

* Adults and the Elderly
* Severe Flare-Ups - 2-4 tablets four times a day, with other medicines

such as steroids. Do not leave more than 8 hours between the evening
and following morning dose.
* Mild/Moderate Flare-Up - 2-4 tablets four times a day, but not always
with other medicines.
* 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.
For Rheumatoid arthritis

* Adults and the Elderly - Start on one tablet each day for the first week.
2

Before you take Salazopyrin EN-tabs

Do not take Salazopyrin EN-tabs if you

* are allergic (hypersensitive) to any of the ingredients of Salazopyrin
EN-tabs.

* 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 EN-tabs are not to be used in children under 2 years of age.
Take special care with Salazopyrin EN-tabs
If you answer YES to any of these questions tell your 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 astma?
If you are a child and have arthritis?

Taking other medicines
Tell your doctor or pharmacist if you are taking the following medicines as
they may interact with Salazopyrin EN-tabs:

* 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 – drugs used to help to suppress your
*

bodies immune response in organ transplantation and certain chronic
inflammations such as rheumatoid arthritis.
methotrexate, used to treat rheumatiod arthritis

Then, increase the dose by one tablet a day each week to a maximum of
6 tablets daily as shown in table.
1st Week
2nd Week
4th Week
3rd Week
1
Morning
1
2
Evening

1

1

2

2*

* etc to a maximum of 6 tablets per day.
Do not take more than 6 tablets a day.

* Children - No recommendations.
How long should you use these tablets?
How long you use these tablets depends on how well the tablets suit you.
For Inflammatory bowel disease (Ulcerative Colitis and Crohn’s
Disease)

* The tablets 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 tablets just because you feel better without talking to
your doctor.

For Rheumatoid arthritis

* Salazopyrin EN-tabs may take some months to have a full effect, so you
should keep taking them.

* You may notice some effect after a few weeks.
* When they start to work you will feel less stiffness in your joints, especially
in the mornings.

* If they work well, you may be using them for some time.
* Don’t stop using the tablets just because you feel better without talking to
your doctor.

Ensure that you drink adequate fluids whilst you are taking this
medicines. This is to avoid problems with your kidneys.

Ref: 0716/290113/1/B

®

Salazopyrin EN-tabs 500mg Tablets
(sulfasalazine)
Patient Information Leaflet (continued)
If you take more Salazopyrin EN-tabs than you should
Contact your nearest hospital casualty department or tell your doctor
immediately, if you have taken too many tablets (an overdose) or if a child
has taken your medicine.
Please take this leaflet and these tablets with you to the hospital casualty
department or to your doctor.
If you miss a dose of Salazopyrin EN-tabs
If you forget to take a dose, just take the next dose as usual. Do not double
the next dose to make up for a missed one.

* 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 salivay 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)
* Inflammation of pancreas, which causes severe pain in the abdomen and
face

4

Possible side effects

Like all medicines, Salazopyrin EN-tabs can cause side effects, although not
everybody gets them.

* 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.

Stop taking Salazopyrin EN-tabs 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.

* An 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.

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.

5

How to store Salazopyrin EN-tabs

Keep out of the sight and reach of children.
Do not use Salazopyrin EN-tabs after the expiry date which is stated on the
box/bottle/label. The expiry date refers to the last day of the month.
Tablets should not be thrown in your bin or put down the drain. If they are
out of date, or no longer suitable for you, return them to your pharmacist.
Do not store above 30°C.
Store in the original container
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.

Tell your doctor immediately if you experience any of the following
symptoms after taking this medicine as they will stop treatment in these
cases:
6

* 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.

Tests on your blood, kidneys, liver and urine
Your doctor will be taking blood tests to check your blood and 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) at regular intervals. They may also test your urine for protein
and blood.

Further information

What this medicine contains:
Each film-coated tablet contains 500mg sulfasalazine as the active
ingredient. They also contain the following inactive ingredients: Povidone,
maize starch, magnesium stearate, colloidal silicon dioxide, cellulose acetate
phthalate, propylene glycol, beeswax, carnauba wax, glyceryl monosterate,
talc and macrogol.
What this medicine looks like and contents of the pack
Salazopyrin EN-tabs are yellow film-coated, ovoid gastro-resistant tablets
embossed “KPh” on one side and “102” on the other.
They are available in bottles containing 100 tablets.

Other side-effects that may occur are:
Very common side-effects which may affect more than 1 person in 10
are listed below:
* Indegestion, heartburn
* Feeling sick (nausea)

Manufacturer and Licence Holder
Your tablets are manufactured by Kemwell AB, Bjorkgatan 30, 751 82
Uppsala, Sweden and are procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.

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

If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

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
* Servere diarrhoea
* Other blood disorders including anaemia, enlarged glands (lymph nodes)
* Blood vessel inflammation

POM

PL 15184/0716

Salazopyrin is a registered trademark of Pfizer Health AB
Revision date: 29/01/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.
General Advice
Because the tablets are coloured yellow 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 happened 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.

Ref: 0716/290113/2/F

Sulfasalazine 500mg Enteric Coated Tablets
inflammations such as rheumatoid arthritis.

Patient Information Leaflet
Read all of this leaflet carefully before you take 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.
Your medicine is called Sulfasalazine 500mg Enteric Coated Tablets but will
be called Sulfasalazine throughout this leaflet.

Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Pregnancy
Tell your doctor if you are pregnant, planning to become pregnant or become
pregnant whilst taking this medicine.
Breast-feeding
Ask your doctor for advice before breast-feeding your baby.
Ask your doctor or pharmacist for advice before taking any medicine.

In this leaflet:
1 What Sulfasalazine are and what they are used for

Driving and using machines
Sulfasalazine is unlikely to affect your ability to drive or use machinery.

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 are and what they are used
for

The active substance in Sulfasalazine is sulfasalazine which is an
anti-inflammatory drug and belongs to a group of medicines called
aminosalicylates.
Your doctor may give you Sulfasalazine to treat and manage inflammatory
bowel disease or to treat rheumatoid arthritis.
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 adominal pain and diarrhoea (which
may contain blood and mucus). Sulfasalazine are used to control the
flare-ups of ulcerative colitis. They may also be used at lower doses to
prevent more flare-ups of ulcerative colitis.

3

How to take Sulfasalazine

The tablets should be taken with a glass of water and should be swallowed
whole. Do not crush, break or chew the tablets.
Unless your doctor has told you otherwise, the usual doses for the following
conditions are:
For Inflammatory bowel disease:
Ulcerative Colitis

* Adults and the Elderly
* Severe Flare-Ups 2-4 tablets four times a day, with other medicines

such as steroids. Do not leave more than 8 hours between the evening
and following morning dose.
* Mild/Moderate Flare-Up 2-4 tablets four times a day, but not always with
other medicines.
* Maintenance dose to control your flare ups - Once the flare-up is
controlled the dose is slowly reduced to 4 tablets each day. Your doctor
will tell you how to reduce your dose.
This lower dose may be continued for some time to help stop other
flare-ups

* 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

Crohn’s Disease
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).
Sulfasalazine are used to control the flare-ups of Crohn’s Disease.
Rheumatoid arthritis
Sulfasalazine are usually given when a group of medicines known as
non-steroidal anti-inflammatory drugs (NSAIDs e.g. aspirin and ibuprofen)
are not working. They help prevent damage to your joints and work slowly to
reduce swelling and stiffness in your joints.

* Adults and the Elderly
* Severe Flare-Ups - 2-4 tablets four times a day, with other medicines

such as steroids. Do not leave more than 8 hours between the evening
and following morning dose.
* Mild/Moderate Flare-Up - 2-4 tablets four times a day, but not always
with other medicines.
* 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.
For Rheumatoid arthritis

* Adults and the Elderly - Start on one tablet each day for the first week.
2

Before you take Sulfasalazine

Do not take Sulfasalazine if you

* are allergic (hypersensitive) to any of the ingredients of Sulfasalazine
* 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.

Then, increase the dose by one tablet a day each week to a maximum of
6 tablets daily as shown in table.
1st Week
2nd Week
4th Week
3rd Week
1
Morning
1
2
Evening

1

1

2

2*

* etc to a maximum of 6 tablets per day.
Do not take more than 6 tablets a day.

Sulfasalazine are not to be used in children under 2 years of age.

* Children - No recommendations.

Take special care with Sulfasalazine
If you answer YES to any of these questions tell your doctor or pharmacist
before taking this medicine:

How long should you use these tablets?
How long you use these tablets depends on how well the tablets suit you.

* 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 astma?
If you are a child and have arthritis?

* 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 tablets 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 tablets just because you feel better without talking to
your doctor.

Taking other medicines
Tell your doctor or pharmacist if you are taking the following medicines as
they may interact with Sulfasalazine:

*

For Inflammatory bowel disease (Ulcerative Colitis and Crohn’s
Disease)

the risk of neural tube defects, e.g. Spina Bifida,
azathioprine and mercaptopurine – drugs used to help to suppress your
bodies immune response in organ transplantation and certain chronic
methotrexate, used to treat rheumatiod arthritis

For Rheumatoid arthritis

* Sulfasalazine may take some months to have a full effect, so you should
keep taking them.

* You may notice some effect after a few weeks.
* When they start to work you will feel less stiffness in your joints, especially
in the mornings.

* If they work well, you may be using them for some time.
* Don’t stop using the tablets just because you feel better without talking to
your doctor.

Ref: 0716/290113/2/B

Sulfasalazine 500mg Enteric Coated Tablets
Patient Information Leaflet (continued)
Ensure that you drink adequate fluids whilst you are taking this
medicines. This is to avoid problems with your kidneys.
If you take more Sulfasalazine than you should
Contact your nearest hospital casualty department or tell your doctor
immediately, if you have taken too many tablets (an overdose) or if a child
has taken your medicine.
Please take this leaflet and these tablets with you to the hospital casualty
department or to your doctor.
If you miss a dose of Sulfasalazine
If you forget to take a dose, just take the next dose as usual. Do not double
the next dose to make up for a missed one.

4

Possible side effects

* 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 salivay 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)
* Inflammation 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)

Like all medicines, Sulfasalazine can cause side effects, although not
everybody gets them.

* Temporary infertility in men. Fertility returns when treatment is stopped.

Stop taking Sulfasalazine 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.

Very rarely sulfasalazine has caused permanent staining of extended wear
soft contact lenses. (See section 6 General Advice for further information).

* An 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.

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.

Tests on your blood, kidneys, liver and urine
Your doctor will be taking blood tests to check your blood and 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) at regular intervals. They may also test your urine for protein
and blood.
Other side-effects that may occur are:
Very common side-effects which may affect more than 1 person in 10
are listed below:
* Indegestion, 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
* Servere diarrhoea

Normal contraception should still be used.

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.

5

How to store Sulfasalazine

Keep out of the sight and reach of children.
Do not use Sulfasalazine after the expiry date which is stated on the
box/bottle/label. The expiry date refers to the last day of the month.
Tablets should not be thrown in your bin or put down the drain. If they are
out of date, or no longer suitable for you, return them to your pharmacist.
Do not store above 30°C.
Store in the original container
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.

6

Further information

What this medicine contains:
Each film-coated tablet contains 500mg sulfasalazine as the active
ingredient. They also contain the following inactive ingredients: Povidone,
maize starch, magnesium stearate, colloidal silicon dioxide, cellulose acetate
phthalate, propylene glycol, beeswax, carnauba wax, glyceryl monosterate,
talc and macrogol.
What this medicine looks like and contents of the pack
Sulfasalazine are yellow film-coated, ovoid gastro-resistant tablets embossed
“KPh” on one side and “102” on the other.
They are available in bottles containing 100 tablets.
Manufacturer and Licence Holder
Your tablets are manufactured by Kemwell AB, Bjorkgatan 30, 751 82
Uppsala, Sweden and are procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0716

Revision date: 29/01/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.
General Advice
Because the tablets are coloured yellow 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 happened 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.

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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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