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SALAZOPYRIN EN-TABS

Active substance(s): SULFASALAZINE

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MA holder: Pfizer Limited, Ramsgate Road,
Sandwich, Kent, CT13 9NJ, UK.
PL 00057/1041
MA Holder MALTA: Pfizer Hellas S.A.,
243 Messoghion Ave. Neo Psychiko,
Athens, Greece.
MA 505/01002

31

Salazopyrin

®

EN-tabs 500 mg
Sulfasalazine

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.

POM

112 Enteric-coated tablets
27

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.

6. Further information
What Salazopyrin EN-tabs contain
The active substance is sulfasalazine. Each tablet contains 500mg of sulfasalazine. Other ingredients
are maize starch, povidone, magnesium sterate, colloidal silicon dioxide.
The tablet enteric coating contains cellulose acetate phthalate, PVP (propylene glycol), bees wax,
carnauba wax, self emulsifying glyceryl monostearate and talc.
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4

• 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.
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• 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
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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
1
1
2
Evening
1
1
2
2*

Each enteric-coated tablet
contains sulfasalazine 500 mg.
Use as directed by a doctor.
Oral use.
To be swallowed whole,
not chewed or broken.
Store in a dry place.
Read the leaflet before use.
Keep out of the reach and sight
of children.

* etc to a maximum of 6 tablets per day.

Do not take more than 6 tablets a day.

MA holder: Pfizer Limited, Ramsgate Road,
Sandwich, Kent, CT13 9NJ, UK.
PL 00057/1041
MA Holder MALTA: Pfizer Hellas S.A.,
243 Messoghion Ave. Neo Psychiko,
Athens, Greece.
MA 505/01002

12

Salazopyrin

®

EN-tabs 500 mg
Sulfasalazine

1573

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

enteric-coated tablets
sulfasalazine

Where can I get more advice about Ulcerative Colitis and Crohn’s Disease?

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.

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.

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).
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2. Before you take Salazopyrin EN-tabs

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

5

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.

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Date: 24 Mar 2016 Time: 14:20
Supplier Nº 2181036
Perigord Nº 268436
Supplier Kemwell
Barcode Nº As Supplied
Smallest

BODY TEXT Size Body Text: 7 pt; Cover: 5.5 pt

Dimensions 46 × 157 mm
Notes N/A
PAR Number PAR-2015-0030647

Market UK
Proof Nº 04
Component Label Leaflet
Pharma Code 1573
Drawing Nº 653

2

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

3. How to take Salazopyrin EN-tabs

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.

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:

5. How to store Salazopyrin EN-tabs
Keep out of the reach and sight of children.
This leaflet was last revised in 03/2016

SZ 15_0 En-Tabs UK
26

• 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.

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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?
6

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.

What Salazopyrin EN-tabs looks like and contents of the pack
The tablets are yellow in colour, and are oval-shaped. They have “Kph” imprinted 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. They contain no artificial colouring.
Salazopyrin is supplied in bottles. Each bottle contains 112 tablets.

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,
7

Marketing Authorisation Holder and Manufacturer
The marketing authorisation for Salazopyrin EN-tabs is held by: Pfizer Limited, Ramsgate Road,
Sandwich, Kent, CT13 9NJ, UK.Salazopyrin EN-tabs are made by: Kemwell AB, 75182 Uppsala,
Sweden.
For any information about this medicinal product, please contact the local representative of the
Marketing Authorisation Holder.
24

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

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

9

• 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)
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Do not use Salazopyrin EN-tabs after the expiry date which is stated on the bottle. The expiry date
refers to the last day of that month.
22

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.

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• 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.
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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
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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.

• 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 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)
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Ensure that you drink adequate fluids whilst you are taking this medicines. 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.
14

Colours
Printing

Non-Printing

Black

Profile

PMS 134 C

Braille
Varnish with
Silicone

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.
3

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• 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.
11

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
20

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).
15

Each enteric-coated tablet
contains sulfasalazine 500 mg.
Use as directed by a doctor.
Oral use.
To be swallowed whole,
not chewed or broken.
Store in a dry place.
Read the leaflet before use.
Keep out of the reach and sight
of children.

• 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.
16

BN:/Exp:

Patient Information Leaflet

500 mg

POM

112 Enteric-coated tablets

1573

Salazopyrin® EN-tabs

2181036

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.
2181036

Each enteric-coated tablet
contains sulfasalazine 500 mg.
Use as directed by a doctor.
Oral use.
To be swallowed whole,
not chewed or broken.
Store in a dry place.
Read the leaflet before use.
Keep out of the reach and sight
of children.

MA holder: Pfizer Limited, Ramsgate Road,
Sandwich, Kent, CT13 9NJ, UK.
PL 00057/1041
MA Holder MALTA: Pfizer Hellas S.A.,
243 Messoghion Ave. Neo Psychiko,
Athens, Greece.
MA 505/01002

Salazopyrin

®

EN-tabs 500 mg
Sulfasalazine

POM

112 Enteric-coated tablets
2181036

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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