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SALAZOPYRIN EN 500MG TABLETS

Active substance(s): SULFASALAZINE

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Assessed against UK PIL dated September 2009
(PIL USER TEST BRIDGED)

Var. 06: To change the manufacturer’s name from (Pfizer Health AB) to (Kemwell AB) at Bjorkgatan 30, SE-75182 Uppsala, Sweden and Braille update

PATIENT INFORMATION LEAFLET

SALAZOPYRIN® EN 500MG TABLETS
(sulfasalazine)
Your medicine is available using the name Salazopyrin EN 500mg
Tablets but will be referred as Salazopyrin EN throughout the
leaflet.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Salazopyrin EN is and what it is used for
Before you take Salazopyrin EN
How to take Salazopyrin EN
Possible side effects
How to store Salazopyrin EN
Further information

Read all of this leaflet carefully before you
take this medicine
ƒ
ƒ
ƒ

ƒ

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.

1. What Salazopyrin EN is and what it is used
for
The active substance in Salazopyrin EN is sulfasalazine which is an
anti-inflammatory drug and belongs to a group of medicines called
aminosalicylates.
Your doctor may give you Salazopyrin EN 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.

By H Basher at 2:53 pm, Mar 26, 2012

Taking other medicines

Tell your doctor or pharmacist if you are taking the following
medicines as they may interact with Salazopyrin EN:
ƒ
any medicine for high blood sugar/diabetes,
ƒ
methenamine, an antibiotic for treating urinary tract
infections,
ƒ
digoxin, used to treat heart failure,
ƒ
folate, sometimes taken during the first few weeks of
pregnancy to reduce the risk of neural tube defects, e.g.
Spina Bifida,
ƒ
azathioprine and mercaptopurine – drugs used to help to
suppress your body’s immune response in organ
transplantation and certain chronic inflammations such as
rheumatoid arthritis.
ƒ
Methotrexate, used to treat rheumatoid arthritis

Rheumatoid arthritis

Salazopyrin EN is 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.

are allergic (hypersensitive) to any of the ingredients of
Salazopyrin EN.
ƒ
are allergic (hypersensitive) to salicylates (e.g. aspirin) or
sulfonamides (e.g. a certain type of antibiotic).
ƒ
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 is not to be used in children under 2 years of
age.

ƒ
ƒ

ƒ

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
ƒ

Salazopyrin EN 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.

Pregnancy

ƒ
ƒ

Breast-feeding

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

Tell your doctor if you are pregnant, planning to become pregnant
or become pregnant whilst taking this medicine.

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 is unlikely to affect your ability to drive or use
machinery.

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
ƒ

Adults and the elderly
ƒ
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.
ƒ
Mild/Moderate Flare-Up 2-4 tablets four times a
day, but not always with other medicines.
ƒ
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.

ƒ

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
ƒ

ƒ

Adults and the elderly
ƒ
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.
ƒ
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
ƒ

Adults and the elderly - Start on one tablet each day for
the first week. Then, increase the dose by one tablet a day
each week to a maximum of 6 tablets daily as shown in the
table.

Morning
Evening

Take special care with Salazopyrin EN

1st Week
1

2nd Week
1
1

3rd Week
1
2

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

Children - No recommendations.

Page 1 of 2

If you take more Salazopyrin EN 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

3. How to take Salazopyrin EN

ƒ

If you answer YES to any of these questions tell your doctor or
pharmacist before taking this medicine:
ƒ
Have you ever had any problems with your liver or kidneys?
ƒ
Have you been told by your doctor 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?
ƒ
Have you ever had asthma?
ƒ
If you are a child and have arthritis?

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

ƒ
ƒ

2. Before you take Salazopyrin EN
Do not take Salazopyrin EN if you

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

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.

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 EN is used to control the flare-ups of
ulcerative colitis. It 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 is used to
control the flare-ups of Crohn’s Disease.

How long should you use these tablets?

4th Week
2
2*

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
Like all medicines, Salazopyrin EN can cause side effects, although
not everybody gets them.
Stop taking Salazopyrin EN 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.
ƒ
An allergic reaction such as sudden wheeziness, difficulty in
breathing, swelling of eyelids, face or lips, rash or itching
(especially affecting the whole body).
ƒ
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 Johnsons Syndrome, or
toxic epidermal necrolysis (TEN). Your doctor will stop your
treatment in these cases.
ƒ
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.
ƒ
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:
ƒ
If you notice any unexplained bleeding.
ƒ
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.

Test 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.

Var. 06: To change the manufacturer’s name from (Pfizer Health AB) to (Kemwell AB) at Bjorkgatan 30, SE-75182 Uppsala, Sweden and Braille update

Other side-effects that may occur are:

Very common side-effects which may affect more than 1
person in 10 are listed below:
ƒ
Indigestion, heartburn
ƒ
Feeling sick (nausea)
Common side-effects which may affect more than 1 person
in 100 are listed below:
ƒ
Dizziness
ƒ
Difficulty sleeping
ƒ
Headache
ƒ
Changes in taste
ƒ
Abdominal pains
ƒ
Diarrhoea
ƒ
Being sick
ƒ
Ringing in the ears
ƒ
Blood shot eyes
ƒ
Inflamed mouth (stomatitis)
ƒ
Cough
ƒ
Itching of the skin
ƒ
Joint pain
ƒ
Protein in urine
ƒ
Fever
Uncommon side-effects which may affect more than 1
person in 1000 are listed below:
ƒ
Depression
ƒ
Fits, jerky, uncontrolled movements
ƒ
Loss of balance
ƒ
Shortness of breath
ƒ
Hair loss
ƒ
Hives
ƒ
Puffiness around the eyes and face
Since introduction to the market the following side-effects
have been reported:
ƒ
Inflammation of the lining of the brain
ƒ
Severe diarrhoea
ƒ
Other blood disorders including anaemia, enlarged glands
(lymph nodes)
ƒ
Blood vessel inflammation
ƒ
Loss of appetite
ƒ
Hallucinations
ƒ
Changes in mental state
ƒ
Changes in smell
Inflammation of the sac surrounding the heart (pericarditis)
ƒ
ƒ
Inflammation of the heart muscle (myocarditis)
ƒ
Bluish tint to skin due to poor circulation
ƒ
Lung complications with breathlessness
ƒ
Inflammation of the salivary glands on either side of the face
ƒ
Kidney inflammation and kidney pain
ƒ
Liver disease (hepatitis)
ƒ
Yellowing of the skin or whites of the eyes (jaundice)
ƒ
Inflammation of the pancreas, which causes severe pain in
the abdomen and face
ƒ
Rash, reddening or blistering of the skin, eczema
ƒ
Tingling, numbness, pain in hands and feet
ƒ
Blood in urine
ƒ
Urine or motions may become a yellow/orange colour which
is normal and harmless. (see section 6 General Advice for
further information)
ƒ
Temporary infertility in men. Fertility returns when
treatment is stopped. Normal contraception should still be
used.

6. Further information
What Salazopyrin EN contains

The active substance is sulfasalazine. Each enteric-coated tablet
contains 500mg Sulfasalazine. The other ingredients are: maize
starch, povidone, magnesium stearate, colloidal silicon dioxide,
cellulose acetate phthalate, propylene glycol, carnauba wax, talc,
glyceryl monostearate self emulsifying, macrogol and bees wax.

What Salazopyrin EN looks like and contents of the
pack

The tablets are orange/yellow and oval shaped film-coated gastroresistant tablets. They have "KPh" imprinted on one side and
"102", on the other. They are coated with a film, which stops
them breaking up until they leave the stomach. The tablets are
the colour of the medicine itself. They contain no artificial
colouring.
This medicine is available in a bottle containing 100 tablets.

Manufacturer

Salazopyrin EN is made by: Kemwell AB, Björkgatan 30,
SE-75182 Uppsala, Sweden.
Procured within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence Holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
POM

PL No: 08929/0542

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 EN 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. Dailywear 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.
Leaflet revision and issue date: 17.10.11
Salazopyrin® is a registered trademark of Pfizer Limited.

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
Check the “use by” date, which is printed on the pack. If it is out
of date do not use it and contact your pharmacist.
Keep out of the reach and sight of children.
Store in a dry place. Store in the original container.
Do not store above 25º C.
If your doctor decides to stop the treatment return any left over
medicine to the pharmacist. Only keep them if your doctor tells
you.
If your tablets appear to be discoloured or show any other signs of
deterioration, take them to your pharmacist who will advise you.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicine no longer
required. These measures will help to protect the environment.

Page 1 of 2

Var. 06: To change the manufacturer’s name from (Pfizer Health AB) to (Kemwell AB) at Bjorkgatan 30, SE-75182 Uppsala, Sweden and Braille update

PATIENT INFORMATION LEAFLET

SULFASALAZINE 500MG
GASTRO-RESISTANT TABLETS
(sulfasalazine)

Your medicine is available using the name Sulfasalazine 500mg
gastro-resistant Tablets but will be referred as Sulfasalazine
Tablets throughout the leaflet.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Sulfasalazine Tablets are and what they are used for
Before you take Sulfasalazine Tablets
How to take Sulfasalazine Tablets
Possible side effects
How to store Sulfasalazine Tablets
Further information

Read all of this leaflet carefully before you
take this medicine
ƒ
ƒ
ƒ

ƒ

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.

1. What Sulfasalazine Tablets are and what
they are used for
The active substance in Sulfasalazine Tablets is sulfasalazine
which is an anti-inflammatory drug and belongs to a group of
medicines called aminosalicylates.
Your doctor may give you Sulfasalazine Tablets to treat and
manage inflammatory bowel disease or to treat rheumatoid
arthritis.

Inflammatory bowel disease

Taking other medicines

Tell your doctor or pharmacist if you are taking the following
medicines as they may interact with Sulfasalazine Tablets:
ƒ
any medicine for high blood sugar/diabetes,
ƒ
methenamine, an antibiotic for treating urinary tract
infections,
ƒ
digoxin, used to treat heart failure,
ƒ
folate, sometimes taken during the first few weeks of
pregnancy to reduce the risk of neural tube defects, e.g.
Spina Bifida,
ƒ
azathioprine and mercaptopurine – drugs used to help to
suppress your body’s immune response in organ
transplantation and certain chronic inflammations such as
rheumatoid arthritis.
ƒ
Methotrexate, used to treat rheumatoid arthritis

For Rheumatoid arthritis
ƒ

Sulfasalazine Tablets 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.

Breast-feeding

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

Ask your doctor for advice before breast-feeding your baby.
Ask your doctor or pharmacist for advice before taking any
medicine.

If you take more Sulfasalazine Tablets than you
should

Driving and using machines

Sulfasalazine Tablets are unlikely to affect your ability to drive or
use machinery.

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.

3. How to take Sulfasalazine Tablets

If you miss a dose of Sulfasalazine Tablets

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:

ƒ

Adults and the elderly
ƒ
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.
ƒ
Mild/Moderate Flare-Up 2-4 tablets four times a
day, but not always with other medicines.
ƒ
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.

ƒ

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
ƒ

ƒ

Adults and the elderly
ƒ
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.
ƒ
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
ƒ

Adults and the elderly - Start on one tablet each day for
the first week. Then, increase the dose by one tablet a day
each week to a maximum of 6 tablets daily as shown in the
table.

Morning
Evening

Take special care with Sulfasalazine Tablets

1st Week
1

2nd Week
1
1

3rd Week
1
2

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

Children - No recommendations.

Page 1 of 2

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

For Inflammatory bowel disease:
Ulcerative Colitis

Do not take Sulfasalazine Tablets if you

If you answer YES to any of these questions tell your doctor or
pharmacist before taking this medicine:
ƒ
Have you ever had any problems with your liver or kidneys?
ƒ
Have you been told by your doctor 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?
ƒ
Have you ever had asthma?
ƒ
If you are a child and have arthritis?

ƒ

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.

ƒ
ƒ

Tell your doctor if you are pregnant, planning to become pregnant
or become pregnant whilst taking this medicine.

Sulfasalazine Tablets 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.

are allergic (hypersensitive) to any of the ingredients of
Sulfasalazine Tablets.
ƒ
are allergic (hypersensitive) to salicylates (e.g. aspirin) or
sulfonamides (e.g. a certain type of antibiotic).
ƒ
have a disease known as porphyria (a rare blood pigment
disorder). Your doctor will have already told you if you have
this disease.
Sulfasalazine Tablets are not to be used in children under 2
years of age.

ƒ
ƒ

Pregnancy

Rheumatoid arthritis

ƒ

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

ƒ
ƒ

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). Sulfasalazine Tablets 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.

2. Before you take Sulfasalazine Tablets

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

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.

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.

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 Tablets are
used to control the flare-ups of Crohn’s Disease.

How long should you use these tablets?

4th Week
2
2*

Stop taking Sulfasalazine Tablets 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.
ƒ
An allergic reaction such as sudden wheeziness, difficulty in
breathing, swelling of eyelids, face or lips, rash or itching
(especially affecting the whole body).
ƒ
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 Johnsons Syndrome, or
toxic epidermal necrolysis (TEN). Your doctor will stop your
treatment in these cases.
ƒ
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.
ƒ
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:
ƒ
If you notice any unexplained bleeding.
ƒ
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.

Test 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.

Var. 06: To change the manufacturer’s name from (Pfizer Health AB) to (Kemwell AB) at Bjorkgatan 30, SE-75182 Uppsala, Sweden and Braille update

Other side-effects that may occur are:

Very common side-effects which may affect more than 1
person in 10 are listed below:
ƒ
Indigestion, heartburn
ƒ
Feeling sick (nausea)
Common side-effects which may affect more than 1 person
in 100 are listed below:
ƒ
Dizziness
ƒ
Difficulty sleeping
ƒ
Headache
ƒ
Changes in taste
ƒ
Abdominal pains
ƒ
Diarrhoea
ƒ
Being sick
ƒ
Ringing in the ears
ƒ
Blood shot eyes
ƒ
Inflamed mouth (stomatitis)
ƒ
Cough
ƒ
Itching of the skin
ƒ
Joint pain
ƒ
Protein in urine
ƒ
Fever
Uncommon side-effects which may affect more than 1
person in 1000 are listed below:
ƒ
Depression
ƒ
Fits, jerky, uncontrolled movements
ƒ
Loss of balance
ƒ
Shortness of breath
ƒ
Hair loss
ƒ
Hives
ƒ
Puffiness around the eyes and face
Since introduction to the market the following side-effects
have been reported:
ƒ
Inflammation of the lining of the brain
ƒ
Severe diarrhoea
ƒ
Other blood disorders including anaemia, enlarged glands
(lymph nodes)
ƒ
Blood vessel inflammation
ƒ
Loss of appetite
ƒ
Hallucinations
ƒ
Changes in mental state
ƒ
Changes in smell
Inflammation of the sac surrounding the heart (pericarditis)
ƒ
ƒ
Inflammation of the heart muscle (myocarditis)
ƒ
Bluish tint to skin due to poor circulation
ƒ
Lung complications with breathlessness
ƒ
Inflammation of the salivary glands on either side of the face
ƒ
Kidney inflammation and kidney pain
ƒ
Liver disease (hepatitis)
ƒ
Yellowing of the skin or whites of the eyes (jaundice)
ƒ
Inflammation of the pancreas, which causes severe pain in
the abdomen and face
ƒ
Rash, reddening or blistering of the skin, eczema
ƒ
Tingling, numbness, pain in hands and feet
ƒ
Blood in urine
ƒ
Urine or motions may become a yellow/orange colour which
is normal and harmless. (see section 6 General Advice for
further information)
ƒ
Temporary infertility in men. Fertility returns when
treatment is stopped. Normal contraception should still be
used.

6. Further information
What Sulfasalazine Tablets contain

The active substance is sulfasalazine. Each enteric-coated tablet
contains 500mg Sulfasalazine. The other ingredients are: maize
starch, povidone, magnesium stearate, colloidal silicon dioxide,
cellulose acetate phthalate, propylene glycol, carnauba wax, talc,
glyceryl monostearate self emulsifying, macrogol and bees wax.

What Sulfasalazine Tablets look like and contents of
the pack

The tablets are orange/yellow and oval shaped film-coated gastroresistant tablets. They have "KPh" imprinted on one side and
"102", on the other. They are coated with a film, which stops
them breaking up until they leave the stomach. The tablets are
the colour of the medicine itself. They contain no artificial
colouring.
This medicine is available in a bottle containing 100 tablets.

Manufacturer

Sulfasalazine Tablets are made by: Kemwell AB, Björkgatan 30,
SE-75182 Uppsala, Sweden.
Procured within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence Holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
POM

PL No: 08929/0542

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 Sulfasalazine Tablets
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. Dailywear 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.
Leaflet revision and issue date: 17.10.11

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 Sulfasalazine Tablets
Check the “use by” date, which is printed on the pack. If it is out
of date do not use it and contact your pharmacist.
Keep out of the reach and sight of children.
Store in a dry place. Store in the original container.
Do not store above 25º C.
If your doctor decides to stop the treatment return any left over
medicine to the pharmacist. Only keep them if your doctor tells
you.
If your tablets appear to be discoloured or show any other signs of
deterioration, take them to your pharmacist who will advise you.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicine no longer
required. These measures will help to protect the environment.

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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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