SALAZOPYRIN EN TABLETS

Active substance: SULPHASALAZINE

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SALAZOPYRIN EN TABLETS
(sulfasalazine)
Patient Information Leaflet
Your medicine is known by the above name but will be referred to as
Salazopyrin EN-tabs throughout this 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.
In this leaflet:
1) What Salazopyrin EN-tabs are and what they are used for
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

1) What Salazopyrin EN-tabs are and what they are used for
The active substance in Salazopyrin EN-tabs is sulfasalazine which is an antiinflammatory 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 abdominal 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.

 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
body’s 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. You should avoid breastfeeding while taking this medicine. There
have been reports of diarrhoea or blood in the stools of babies of breastfeeding mothers taking Salazopyrin EN-tabs.
Driving and using machines
Salazopyrin EN-tabs is unlikely to affect your ability to drive or use machinery.

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:
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.

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.

 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.

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.

 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.

2) Before you take Salazopyrin EN-tabs

 Adults and the Elderly

Your doctor will perform complete blood counts and liver function tests before
starting Salazopyrin 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-tabs if you
 are allergic (hypersensitive) to any of the ingredients of Salazopyrin ENtabs.
 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.

This lower dose may be continued for some time to help stop other flare-ups.

Crohn’s Disease

 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.
Then, increase the dose by one tablet a day each week to a maximum of 6
tablets daily as shown in table.

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-6dehydrogenase which helps red blood cells function normally?
 Have you ever had asthma?
 If you are a child and have arthritis?
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 Salazopyrin EN-tabs:
 any medicine for high blood sugar/diabetes,
 methenamine, an antibiotic for treating urinary tract infections,

Morning

1st Week
-

2nd Week
1

3rd Week
1

4th Week
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
medicine. This is to avoid problems with your kidneys.
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.

4) Possible side effects
Like all medicines, Salazopyrin EN-tabs can cause side effects, although not
everybody gets them.
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.
 If you are breast feeding stop taking this medicine, once you notice blood in
stools or diarrhoea in newborn.
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.
Discontinue treatment with Salazopyrin while awaiting the results of blood
tests
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
 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
 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
 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.
Very rarely sulfasalazine has caused permanent staining of extended wear
soft contact lenses. (See section 6 General Advice for further information).
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 can help provide
more information on the safety of this medicine.
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






Do not use after the expiry date printed on the carton label or blister strip.
Do not store above 25°C. Store in a dry place.
Keep all medicines out of the sight and reach of children.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6) Further information
What Salazopyrin EN-tabs contains
The active substance is sulfasalazine. Each enteric coated tablet contains
500mg of the active ingredient, Sulfasalazine.
Salazopyrin EN Tablets also contain the following: maize starch, povidone,
magnesium stearate, colloidal hydrated silica, cellulose acetate phthalate,
white beeswax, Carnauba wax, propylene glycol, polyethylene glycol 20,000,
talc and glyceryl monostearate.
What Salazopyrin EN-tabs looks like and contents of the pack
The tablets are orange- yellow in colour and oval in shape. They have ‘KPh’
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 and hence contain no artificial colouring.
Salazopyrin EN Tablets are available as blister packs of 100 tablets.
PL No: 10383/0198

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Pfizer Health AB, Bjorkgatan 30, S-75182
Uppsala, Sweden. Procured from within the EU and repackaged by the
Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate,
Northolt, Middlesex UB5 5QS.
Leaflet date: 26.02.2014
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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