SALAZOPYRIN EN 500MG TABLETS

Active substance: SULFASALAZINE

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PRE-PRESS NO.:

02-1808

PRODUCT:

Salazopyrin EN 500mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/2681 E

DATE OF PROOF:

04/06/14

DATE:

PROOF HISTORY:
v1 - waymade - 04/06/14

DATE:

CUSTOMER: Waymade

Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED DECEMBER 2013
REPORTING OF SIDE EFFECTS

Pg 4





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.

5. How to store Salazopyrin EN






Keep out of the sight and reach of children.
Do not use Salazopyrin EN after the expiry date which is stated on the carton and bottle. The
expiry date refers to the last day of that month.
Do not store above 30°C. Store in a dry place.
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.
If the tablets become discoloured or show any other signs of deterioration, you should seek the
advice of your pharmacist.

6. Further information
What Salazopyrin EN Tablets contain:
Each enteric coated tablet contains 500mg of the active ingredient sulfasalazine.
Salazopyrin EN Tablets also contain the following: maize starch, magnesium stearate and colloidal silicon
dioxide.
The tablet enteric coating contains propylene glycol, carnauba wax, glyceryl monostearate, cellulose acetate
phthalate, talc, macrogol and beeswax white.
What Salazopyrin EN Tablets looks like and contents of the pack
The tablets are yellow elliptical-shaped enteric coated tablets marked ‘102’ on one side and ‘KPh’ on the
other side.
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
Salazopyrin EN tablets are supplied in bottles. Each bottle contains 100 tablets.
Product Licence Holder and Manufacturer:
POM

PL No: 6464/2681

This product is manufactured by Kenwell AB, Uppsala, Sweden and procured from within the EU and
repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 3.6.2014
Salazopyrin is a registered trademark of Pfizer Health AB
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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SALAZOPYRIN® EN 500 mg TABLETS/

SULFASALAZINE 500 mg ENTERIC-COATED TABLETS
(sulfasalazine)
Patient Information Leaflet
This product is known as any of the above names but will usually be referred to as Salazopyrin EN 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 are and what they are used for
2. Before you take Salazopyrin EN
3. How to take Salazopyrin EN
4. Possible side effects
5. How to store Salazopyrin EN
6. Further information

1. What Salazopyrin EN are and what they are 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.
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 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 are used to control the flare-ups of Crohn’s Disease.
Rheumatoid arthritis
Salazopyrin EN 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
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 if you
• are allergic (hypersensitive) to any of the ingredients of Salazopyrin EN.
• 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 are not to be used in children under 2 years of age.
Take special care with Salazopyrin EN
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 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.

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WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade
Salazopyrin EN 500mg tabs
PRODUCT:

PRE-PRESS NO.:

02-1808

ARTWORKER:

DT

Q.A.
APPROVED:

CODE:

DATE OF PROOF:

04/06/14

DATE:

PROOF HISTORY:
v1 - waymade - 04/06/14

CUSTOMER
APPROVED:
DATE:

6464/2681 E

Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED DECEMBER 2013
REPORTING OF SIDE EFFECTS

Pg 2

Taking other medicines
Tell your doctor or pharmacist if you are taking the following medicines as they may interact with Salazopyrin
EN:
• 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 breastfeeding mothers taking
Salazopyrin EN.

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.
3rd Week

If you miss a dose of Salazopyrin EN
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.




3. How to take Salazopyrin EN

2nd Week

Please take this leaflet and these tablets with you to the hospital casualty department or to your doctor.



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

1st Week

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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.

4th Week

Morning

-

1

1

2

Evening

1

1

2

2*




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

* 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 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.

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

Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

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.

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