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SULFASALAZINE EN 500MG TABLETS

Active substance(s): SULFASALAZINE

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PATIENT INFORMATION LEAFLET

Salazopyrin® EN Tablets / Sulfasalazine EN 500mg Tablets

Pregnancy and breast-feeding

This medicine is available as either of the above names but will be referred to as
Salazopyrin EN Tablets throughout the following patient information leaflet.

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
breast-feeding while taking this medicine. There have been reports of diarrhoea or
blood in the stools of babies of breast-feeding mothers taking Salazopyrin EN-tablets.

Read all of this leaflet carefully before you take this medicine

Driving and using machines

ƒ Keep this leaflet. You may need to read it again.
ƒ If you have any further questions, ask your doctor or pharmacist.
ƒ This medicine has been prescribed for you. Do not pass it on to others. It may

Salazopyrin EN Tablets is unlikely to affect your ability to drive or use machinery.

(sulfasalazine)

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

ƒ 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 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

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

1. What Salazopyrin EN Tablets are and what they are used for

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

The active substance in Salazopyrin EN Tablets is sulfasalazine which is an antiinflammatory drug and belongs to a group of medicines called aminosalicylates.

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Your doctor may give you Salazopyrin EN Tablets to treat and manage inflammatory
bowel disease or to treat rheumatoid arthritis.

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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.

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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.

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.

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

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

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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

Rheumatoid arthritis
Salazopyrin EN Tablets are usually given when a group of medicines known as nonsteroidal 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.

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 table.
1st Week

2nd Week

3rd Week

4th Week

2. Before you take Salazopyrin EN Tablets

Morning

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1

1

2

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.

Evening

1

1

2

2*

ƒ Children - No recommendations.

Do not take Salazopyrin EN Tablets if you

How long should you use these tablets?

ƒ are allergic (hypersensitive) to any of the ingredients of Salazopyrin EN Tablets.
ƒ are allergic (hypersensitive) to salicylates (e.g. aspirin) or sulfonamides (e.g. a

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

certain type of antibiotic).

ƒ have a disease known as porphyria (a rare blood pigment disorder). Your doctor

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

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

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.

ƒ The tablets should start to work in a few days.
ƒ If they work well, you may be using them for some time because inflammatory

Take special care with Salazopyrin EN Tablets

ƒ Don’t stop using the tablets just because you feel better without talking to your

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 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?
ƒ Have you ever had asthma?
ƒ 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.

bowel disease may be a life long condition.
doctor.

For Rheumatoid arthritis

ƒ Salazopyrin EN Tablets may take some months to have a full effect, so you should
keep taking them.

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

ƒ If they work well, you may be using them for some time.
ƒ 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.

Taking other medicines

If you take more Salazopyrin EN Tablets than you should

Tell your doctor or pharmacist if you are taking the following medicines as they may
interact with Salazopyrin EN 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 bodies
immune response in organ transplantation and certain chronic inflammations such
as rheumatoid arthritis.
ƒ 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.

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.

4. Possible side effects

Reporting of side effects

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

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

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

By reporting side effects, you can help provide more information on the safety of this
medicine.
5. How to store Salazopyrin EN Tablets

ƒ Check the expiry date, which is printed on the pack, if it is out of date do not use it
and contact your pharmacist.

ƒ Keep out of the sight and reach of children. Your medicine could harm them.
ƒ Store your medicine in a dry place.
ƒ If your doctor decides to stop the treatment return any left over medicine to the
pharmacist. Only keep them if your doctor tells you.

ƒ If the tablets become discoloured or show any other signs of deterioration, you
should seek the advice of your pharmacist.

ƒ 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

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.
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:

ƒ Indigestion, heartburn
ƒ Feeling sick (nausea)
Common side-effects which may affect more than 1 person in 100 are listed
below:

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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:

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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:

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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).

Your medicine is called Salazopyrin EN tablets. Each enteric coated tablet contains
500mg of the active ingredient, Sulfasalazine.
Salazopyrin EN Tablets also contain the following: maize starch, povidone,
magnesium stearate, colloidal silicon dioxide, cellulose acetate phthalate, beeswax,
Carnauba wax, propylene glycol, macrogol 20000, talc and glyceryl monostearate.
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 in bottles of 100 tablets.
POM

PL No: 15814/0874

This product is manufactured by Pfizer A.S, Postboks 3, 1324 Lysaker, Norway and is
procured from within the EU by the Product Licence holder: O.P.D Laboratories Ltd.,
Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 28.03.2014.
Salazopyrin is a registered Trade Mark of Pfizer Health AB, Sweden.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
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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