SALAZOPYRIN EN TABLETS

Active substance: SULPHASALAZINE

View full screen / Print PDF » Download PDF ⇩

Transcript
Salazopyrin EN Tablets
Label & Patient Information Leaflet
28pp kleerformat Booklet
48x155mm (finished size)
Self adhesive backed
Printed Black

48mm

®

Final cutter guide

salazopyrin en
Tablets

Colour bleed
Maximum text area
Glue area - no print

Base Label 130mm

Leaflet revision date:

03/12/13

Each enteric-coated tablet contains 500mg sulfasalazine.
Also contains propylene glycol.

Please read Patient Information leaflet before use. To be swallowed whole, not
chewed or broken. To be taken by mouth. Store in a dry place.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
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. Manufactured by Pfizer Health AB, 75182 Uppsala,
Sweden. Salazopyrin is a registered trademark of Pharmacia Aktiebolag

page 28 - 115mm

48mm

5. How to store Salazopyrin EN tablets

The active substance in Salazopyrin EN tablets is sulfasalazine which is an anti-inflammatory
drug and belongs to a group of medicines called aminosalicylates.

Expiry Date
Do not use this medicine after the expiry date shown on the pot label. If your doctor tells you to
stop taking this medicine, return any unused tablets to your pharmacist for safe disposal.
Only keep this medicine if your doctor tells you to. If your tablets become discoloured or show
any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.

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.

Storing your medicine
Store in a dry place. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

page 4 - 115mm

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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects, you help provide more information on the safety of this medicine.

Taking other medicines
Tell your doctor or pharmacist if you are taking the following medicines as they may interact
with Salazopyrin EN tablets:
• any medicine for high blood sugar/diabetes,
• methenamine, an antibiotic for treating urinary tract infections,
• digoxin, used to treat heart failure,

page 8 - 115mm

(sulfasalazine)

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 tablets are used to control the flare-ups of Crohn’s Disease.
Rheumatoid arthritis
Salazopyrin EN 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.

Important
Remember this medicine is for you. It can only be prescribed by a doctor. Never give your
medicine to other people. It may harm them, even if their symptoms are the same as yours.
This leaflet does not tell you everything about your medicine. If you have any questions or are
not sure about anything, ask your doctor or pharmacist (chemist). He/she 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

page 21 - 115mm

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

page 27 - 115mm

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.
• 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 tablets are called Salazopyrin EN Tablets and will be referred to as Salazopyrin EN tablets
throughout this leaflet.

page 26 - 115mm

2. Before you take Salazopyrin EN tablets
Your doctor will perform complete blood counts and liver function tests before starting
Salazopyrin EN tablets and every second week during the first three months of therapy. During
the second three months, the same tests should be done once monthly and thereafter once
every three months, and as clinically indicated. Urine analysis and an assessment of kidney
function should also be done periodically during treatment with Salazopyrin. Thereafter,
monitoring will be performed as your doctor requires
Do not take Salazopyrin EN tablets if you
• are allergic (hypersensitive) to any of the ingredients of Salazopyrin EN tablets.
• are allergic (hypersensitive) to salicylates (e.g. aspirin) or sulfonamides (e.g. a certain type of
antibiotic).

page 6 - 115mm



Blood shot eyes
Inflamed mouth (stomatitis)
Cough
Itching of the skin
Joint pain
Protein in urine
Fever

Manufacturer
Your tablets are manufactured by Pfizer Health AB, 75182 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.

It may harm them, even if their symptoms are the same as yours.

6. Further information

page 5 - 115mm









What Salazopyrin EN tablets looks like and contents of the pack
Salazopyrin EN Tablets are yellow film-coated, ovoid gastro-resistant tablets embossed “KPh”
on one side and “102” on the other.
They are available in pots containing 100 tablets.

page 2 - 140mm

page 25 - 115mm

page 24 - 115mm

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) before you start treatment and at regular intervals.
They may also test your urine for protein and blood.

Salazopyrin EN Tablets

In this leaflet:
1. What Salazopyrin EN tablets are and
what they are used for
2. Before you take Salazopyrin EN tablets
3. How to take Salazopyrin EN tablets
4. Possible side effects
5. How to store Salazopyrin EN tablets
6. Further information

What Salazopyrine EN tablets contain
The active substance is sulfasalazine. 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, traces of bees wax, carnauba wax, glyceryl monostearate, talc and macrogol.

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 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.

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

®

Front Cover 140mm

1. What Salazopyrin EN tablets are and what they are used for
Your doctor may give you Salazopyrin EN tablets to treat and manage inflammatory bowel
disease or to treat rheumatoid arthritis.

Ref: 905/031213/BL/02

(sulfasalazine)
100 enteric-coated Tablets

PL No: 15184/0950
ECMA: 05705

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.

Patient Information Leaflet

®

POM

48mm

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.

Salazopyrin EN Tablets
salazopyrin en
Tablets

Braille label will be applied to
the front cover of the booklet
style bottle label
Please accept this as a written assurance for the Braille code: the imprint of the
Braille code will not affect the legibility of labels/cartons by sighted people and
that the label will be the same (materials, etc) as those already approved by the
MHRA.
The Braille label to be applied conforms to Marburg medium specification and
to the sample approved by MHRA

PDF has been reduce by 74%.

soda. Always test the effect of soda on a small piece of the fabric first. Then apply a mild acid
such as white vinegar.

Information in Braille: Salazopyrin EN Tablets

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
• Severe diarrhoea
• 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

page 22 - 115mm

page 3 - 115mm

• Lung complications with breathlessness
• Inflammation of the salivary 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)

• Temporary infertility in men. Fertility returns when treatment is stopped. Normal
contraception should still be used.

page 23 - 115mm

• 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 tablets are not to be used in children under 2 years of age.
Take special care with Salazopyrin EN tablets
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 asthma?

• If you are a child and have arthritis?

page 7 - 115mm

• 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 rheumatoid arthritis




Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor for advice before taking this medicine.

Other side-effects that may occur are:
Very common side-effects which may affect more than 1 person in 10 are listed below:
• Indigestion, 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

page 9 - 115mm

page 20 - 115mm

Driving and using machines
Salazopyrin EN tablets are unlikely to affect your ability to drive or use machinery.

3. How to take Salazopyrin EN 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:
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.

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.

page 19 - 115mm





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.
If you are breast feeding stop taking this medicine, once you notice blood in stools or
diarrhoea in newborn.

page 11 - 115mm




page 18 - 115mm

4. Possible side effects

• 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.

page 12- 115mm

1

1

2

2*

Do not take more than 6 tablets a day.

• Children - No recommendations

page 13 - 115mm

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.

Ensure that you drink adequate fluids whilst you are taking this medicine. This is to
avoid problems with your kidneys.
If you take more Salazopyrin EN tablets 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 tablets
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.

page 16 - 115mm

For Rheumatoid arthritis
• Salazopyrin EN 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.

Discontinue treatment with Salazopyrin EN tablets while awaiting the results of blood tests



Crohn’s Disease

Evening

* etc to a maximum of 6 tablets per day.

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

page 10 - 115mm




For Rheumatoid arthritis
• 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 table.
1st Week
2nd Week
3rd Week
4th Week
Morning
2
1
1

Like all medicines, Salazopyrin EN tablets can cause side effects, although not everybody gets
them.
Stop taking Salazopyrin EN 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.
• An allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of eyelids,
face or lips, rash or itching (especially affecting the whole body).

page 17 - 115mm

page 14 - 115mm

page 15 - 115mm

Sulfasalazine Tablets 500mg
48mm

Label & Patient Information Leaflet
28pp kleerformat Booklet
48x155mm (finished size)
Self adhesive backed
Printed Black

Information in Braille: Sulfasalazine Tablets 500mg
Final cutter guide
Colour bleed
Maximum text area
Glue area - no print

Sulfasalazine
Tablets #ejj mg

PDF has been reduce by 74%.

Braille label will be applied to
the front cover of the booklet
style bottle label
Please accept this as a written assurance for the Braille code: the imprint of the
Braille code will not affect the legibility of labels/cartons by sighted people and
that the label will be the same (materials, etc) as those already approved by the
MHRA.
The Braille label to be applied conforms to Marburg medium specification and
to the sample approved by MHRA

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 date:

03/12/13

100 enteric-coated Tablets

Each enteric-coated tablet contains 500mg sulfasalazine.
Also contains propylene glycol.

Please read Patient Information leaflet before use. To be swallowed whole, not
chewed or broken. To be taken by mouth. Store in a dry place.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
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.
Manufactured by Pfizer Health AB, 75182 Uppsala, Sweden

page 28 - 115mm

Ref: 950/031213/BL/01

48mm

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.

Sulfasalazine Tablets 500mg
Sulfasalazine
Tablets #ejj mg

POM

soda. Always test the effect of soda on a small piece of the fabric first. Then apply a mild acid
such as white vinegar.

PL No: 15184/0950
ECMA: 05705

Base Label 130mm

What Sulfasalazine 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 pots containing 100 tablets.

Patient Information Leaflet

Sulfasalazine Tablets 500mg
In this leaflet:
1. What Sulfasalazine are and what they
are used for
2. Before you take Sulfasalazine
3. How to take Sulfasalazine
4. Possible side effects
5. How to store Sulfasalazine
6. Further information

48mm

5. How to store Sulfasalazine

The active substance in Sulfasalazine is sulfasalazine which is an anti-inflammatory drug and
belongs to a group of medicines called aminosalicylates.

Expiry Date
Do not use this medicine after the expiry date shown on the pot label. If your doctor tells you to
stop taking this medicine, return any unused tablets to your pharmacist for safe disposal.
Only keep this medicine if your doctor tells you to. If your tablets become discoloured or show
any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.

Important
Remember this medicine is for you. It can only be prescribed by a doctor. Never give your
medicine to other people. It may harm them, even if their symptoms are the same as yours.
This leaflet does not tell you everything about your medicine. If you have any questions or are
not sure about anything, ask your doctor or pharmacist (chemist). He/she will have additional
information about this medicine and will be able to advise you.

Storing your medicine
Store in a dry place. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

6. Further information

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.

page 4 - 115mm

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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects, you help provide more information on the safety of this medicine.

page 25 - 115mm

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.

page 24 - 115mm

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) before you start treatment and at regular intervals.
They may also test your urine for protein and blood.
Taking other medicines
Tell your doctor or pharmacist if you are taking the following medicines as they may interact
with Sulfasalazine:
• any medicine for high blood sugar/diabetes,
• methenamine, an antibiotic for treating urinary tract infections,
• digoxin, used to treat heart failure,

page 8 - 115mm

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

page 21 - 115mm

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.
• 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 tablets are called Sulfasalazine Tablets 500mg and will be referred to as Sulfasalazine
throughout this leaflet.

page 26 - 115mm

2. Before you take Sulfasalazine
Your doctor will perform complete blood counts and liver function tests before starting
Sulfasalazine and every second week during the first three months of therapy. During the
second three months, the same tests should be done once monthly and thereafter once every
three months, and as clinically indicated. Urine analysis and an assessment of kidney function
should also be done periodically during treatment with Sulfasalazine. Thereafter, monitoring
will be performed as your doctor requires
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).

page 5 - 115mm









page 27 - 115mm

It may harm them, even if their symptoms are the same as yours.

What sulfasalazine contain
The active substance is sulfasalazine. 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, traces of bees wax, carnauba wax, glyceryl monostearate, talc and macrogol.

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 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.

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
soiled fabric should be put in to soak. Difficult stains may be removed with a solution of
washing

page 2 - 140mm

Front Cover 140mm

1. What Sulfasalazine are and what they are used for
Your doctor may give you Sulfasalazine to treat and manage inflammatory bowel
disease or to treat rheumatoid arthritis.

Manufacturer
Your tablets are manufactured by Pfizer Health AB, 75182 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.

page 6 - 115mm



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
• Severe diarrhoea
• 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

page 22 - 115mm

page 3 - 115mm

• Lung complications with breathlessness
• Inflammation of the salivary 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)

• Temporary infertility in men. Fertility returns when treatment is stopped. Normal
contraception should still be used.

page 23 - 115mm

• have a disease known as porphyria (a rare blood pigment disorder). Your doctor will have
already told you if you have this disease.
Sulfasalazine are not to be used in children under 2 years of age.
Take special care with Sulfasalazine
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 asthma?
• If you are a child and have arthritis?

page 7 - 115mm

• 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 rheumatoid arthritis

Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor for advice before taking this medicine.

Other side-effects that may occur are:
Very common side-effects which may affect more than 1 person in 10 are listed below:
• Indigestion, 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

page 9 - 115mm

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

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.

page 20 - 115mm

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.

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.

page 19 - 115mm




• 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.




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.
If you are breast feeding stop taking this medicine, once you notice blood in stools or
diarrhoea in newborn.

page 11 - 115mm

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

• Adults and the Elderly
• Severe Flare-Ups - 2-4 tablets four times a day, with other medicines such as steroids.



page 18 - 115mm

4. Possible side effects

Crohn’s Disease

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.

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.
• An allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of eyelids,
face or lips, rash or itching (especially affecting the whole body).

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.

page 12- 115mm

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

page 13 - 115mm

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.

Ensure that you drink adequate fluids whilst you are taking this medicine. 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.

page 16 - 115mm

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.

Discontinue treatment with Sulfasalazine while awaiting the results of blood tests

page 10 - 115mm

• 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

For Rheumatoid arthritis
• 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 table.
1st Week
2nd Week
3rd Week
4th Week
Morning
2
1
1

page 17 - 115mm

page 14 - 115mm

page 15 - 115mm

Expand view ⇕

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.

Hide
(web1)