SALAZOPYRIN EN-TABS 500 MG

Active substance: SULFASALAZINE

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Patient Information Leaflet
®

Salazopyrin EN-tabs 500 mg
(sulfasalazine)
This product is available in other forms
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
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.
1. What Salazopyrin EN-tabs are and what they are used for
The active substance in Salazopyrin EN-tabs is sulfasalazine which is
an anti-inflammatory drug and belongs to a group of medicines called
aminosalicylates.
Your doctor may give you Salazopyrin EN-tabs to treat and manage
inflammatory bowel disease or to treat rheumatoid arthritis.
Inflammatory bowel disease
The main forms of inflammatory bowel disease are Ulcerative Colitis
and Crohn’s disease. Although the diseases have some features in
common, there are some important differences.
Ulcerative Colitis is an inflammatory disease which affects only the
large bowel (colon and back passage). The lining of the bowel
becomes inflamed (red and swollen) and symptoms include 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.
Crohn’s disease is an inflammatory disease which may affect any part
of the digestive system from the mouth to the anus, but it most
commonly affects the last part of the small bowel and the first part of
the large bowel. Symptoms include abdominal pain and diarrhoea
(which may be bloody). Salazopyrin EN-tabs are used to control the
flare-ups of Crohn’s Disease.
Rheumatoid arthritis
Salazopyrin EN-tabs are usually given when a group of medicines
known as non-steroidal anti-inflammatory drugs (NSAIDs e.g. aspirin
and ibuprofen) are not working.
They help prevent damage to your joints and work slowly to reduce
swelling and stiffness in your joints.
2. Before you take Salazopyrin EN-tabs
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 EN-tabs.
• are allergic (hypersensitive) to salicylates (e.g. aspirin) or
sulfonamides (e.g. a certain type of antibiotic).
• have a disease known as porphyria (a rare blood pigment
disorder). Your doctor will have already told you if you have this
disease.
Salazopyrin EN-tabs are not to be used in children under 2 years of
age.
Take special care with Salazopyrin EN-tabs
If you answer YES to any of these questions tell your doctor or
pharmacist before taking this medicine:
• Have you ever had any problems with your liver or kidneys?
• Have you been told by your doctor that you have an inherited
condition in which the body doesn’t have enough of an enzyme
known as glucose-6-dehydrogenase which helps red blood cells
function normally?
• Have you ever had 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. 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,
• digoxin, used to treat heart failure,
• folate, sometimes taken during the first few weeks of pregnancy to
reduce the risk of neural tube defects, e.g. Spina Bifida,
• azathioprine and mercaptopurine – drugs used to help to suppress
your bodies immune response in organ transplantation and certain
chronic inflammations such as rheumatoid arthritis.
• methotrexate, used to treat 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 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-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.
• Maintenance dose to control your flare ups - Once the flare-up
is controlled the dose is slowly reduced to 4 tablets each day. Your
doctor will tell you how to reduce your dose.
This lower dose may be continued for some time to help stop other
flare-ups.
•
Children 2 years of age and over
Your doctor will tell you what dose your child will need to use.
This will be based on your child’s weight.
Crohn’s Disease
• Adults and the Elderly
• Severe Flare-Ups - 2-4 tablets four times a day, with other
medicines such as steroids. Do not leave more than 8 hours
between the evening and following morning dose.
• Mild/Moderate Flare-Up - 2-4 tablets four times a day, but not
always with other medicines.
• Children 2 years of age and over - Your doctor will tell you what
dose your child will need to use. This will be based on your child’s
weight.
For Rheumatoid arthritis
• Adults and the Elderly - Start on one tablet each day for the first
week. 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
Morning
1
Evening
1
1
*etc to a maximum of 6 tablets per day.

3rd Week
1
2

4th Week
2
2*

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).
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 can help provide more information on the
safety of this medicine.
5.
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•
•
•

How to store Salazopyrin EN-tabs
Do not store above 25°C.
Keep out of the sight and reach of children.
Do not use Salazopyrin EN-tabs after the expiry date. The expiry
date refers to the last day of that month.
Store in the original packaging.

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 contain
The active substance is sulfasalazine. Each enteric-coated tablet
contains 500 mg of sulfasalazine. Other ingredients are pregelatinised
starch, magnesium stearate, silicon dioxide anhydrous.
The tablet enteric coating contains cellulose acetate phthalate,
propylene glycol, talc, macrogol 20000, carnauba wax, beeswax white
and glyceryl monostearate self emulsifying.
What Salazopyrin EN-tabs looks like and contents of the pack
The tablets are yellow, oval shaped film-coated tablets with 'KPh'
imprinted on one side and '102' on the reverse.
Salazopyrin is supplied in bottles. Each bottle contains 100 tablets.
Manufacturer : Pfizer Health AB, Bjorkgatan 30, Uppsala, S-751 82
Sweden.
Procured from within the EU.
Product licence holder: Ecosse Pharmaceuticals limited,
3 Young Place, East Kilbride, G75 0TD
Re-packaged by: Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride, G75 0TD
POM
PL 19065/0367
This leaflet was revised 23/04/2014
E0367/2
® registered trade mark of Pfizer Health AB

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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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