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SULFASALAZINE 500MG TABLETS

Active substance(s): SULFASALAZINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Sulfasalazine 500mg Tablets
Your medicine is available using the name Sulfasalazine 500mg
Tablets but will be referred to as Sulfasalazine Tablets throughout
this leaflet.

Read all of this leaflet carefully before you take this
medicine.
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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:
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What Sulfasalazine Tablets are and what they are used for
Before you take Sulfasalazine Tablets
How to take Sulfasalazine Tablets
Possible side effects
How to store Sulfasalazine Tablets
Further information

1. What Sulfasalazine Tablets are and what
they are used for
The active substance in Sulfasalazine Tablets is sulfasalazine
which is an anti-inflammatory drug and belongs to a group of
medicines called aminosalicylates.
Your doctor may give you Sulfasalazine Tablets to treat and
manage 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). Sulfasalazine 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 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). Sulfasalazine Tablets are
used to control the flare-ups of Crohn’s Disease.

2. Before you take Sulfasalazine Tablets
Your doctor will perform complete blood counts and liver function
tests before starting Sulfasalazine Tablets 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 Sulfasalazine Tablets.
Thereafter, monitoring will be performed as your doctor requires.

Do not use Sulfasalazine Tablets if you

are allergic (hypersensitive) any of the ingredients of
Sulfasalazine Tablets.
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are allergic (hypersensitive) to salicylates (e.g. aspirin)
or sulfonamides (e.g. a certain type of antibiotic).
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have a disease known as porphyria (a rare blood pigment
disorder). Your doctor will have already told you if you have
this disease.
Sulfasalazine Tablets are not to be used in children under 2
years of age.
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Take special care with Sulfasalazine Tablets

If the answer is YES to any of these questions tell you doctor or
pharmacist before taking this medicine:
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Have you ever had any problems with your liver or kidneys?
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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?
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Have you ever had asthma?
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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, 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 Sulfasalazine Tablets:
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any medicine for high blood sugar/diabetes,
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methenamine, an antibiotic for treating urinary tract
infections,
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digoxin, used to treat heart failure,
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folate, sometimes taken during the first few weeks of
pregnancy to reduce the risk of neural tube defects,
e.g. Spina Bifida,
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azathioprine and mercaptopurine, drugs used to help to
suppress your bodies immune response in organ
transplantation and certain chronic inflammations
(e.g. rheumatoid arthritis).
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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 maybe pregnant
or are planning to have a baby, ask your doctor for advice before
taking this medicine.
Ask your doctor or pharmacist for advice before taking any
medicine.

Driving and using machines

Salazopyrin Tablets are unlikely to affect your ability to drive or
use machinery.
Page 1 of 2

3. How to take Sulfasalazine Tablets
The tablets should be taken with a glass of water and should be
swallowed whole. Do not crush or chew the tablets.
Unless your doctor has told you otherwise, the usual doses for the
following conditions are:

Ulcerative Colitis

Adults and the Elderly
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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.
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Mild/Moderate Flare-Up
2-4 tablets four times a day, but not always with other
medicines.
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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
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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.
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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.
How long should you use these tablets?
How long you use these tablets depends on how well the tablets
suit you.

For Ulcerative Colitis and Crohn’s Disease
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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.

Ensure that you drink adequate fluids whilst you are taking
this medicine.
This is to avoid problems with your kidneys.

If you take more Sulfasalazine Tablets 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 Sulfasalazine Tablets

If you forget to take a dose, just take the next dose as usual. Do
not double dose the next dose to make up for a missed one.

4. Possible side effects
Like all medicines, Sulfasalazine Tablets can cause side effects,
although not everybody gets them.
Stop taking Sulfasalazine 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.
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An allergic reaction such as sudden wheeziness, difficulty in
breathing, swelling of eyelids, face or lips, rash or itching
(especially affecting the whole body).
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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.
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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.
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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.
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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:
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If you notice any unexplained bleeding.
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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
may take regular blood samples to test for these effects.
Discontinue treatment with Sulfasalazine Tablets 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:
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Indigestion, heartburn
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

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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).
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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme, website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information
on the safety of this medicine.
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5. How to store Sulfasalazine Tablets
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Keep out of the sight and reach of children.
Do not use Sulfasalazine Tablets after the expiry date which
is stated on the carton and bottle labels. The expiry date
refers to the last day of that month.
Do not store above 25°C.
If your doctor decides to stop treatment, return any leftover
tablets to the pharmacist. Only keep them if the doctor tells
you to.
If your medicine appears to be discoloured or shows any
other signs of deterioration, please return to your
pharmacist who will advise you.
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 Sulfasalazine Tablets contain

The active substance is sulfasalazine.
Each tablet contains 500mg of sulfasalazine.
Other ingredients are: maize starch, povidone,
magnesium stearate and colloidal silicon dioxide.

What Sulfasalazine Tablets look like and contents of
the pack
Sulfasalazine are yellow, round tablets embossed 'KPh' on one
side and '101' and a score line on the reverse.
Sulfasalazine Tablets are supplied in packs of 50 tablets (1 bottle)
and 100 tablets (2 bottles of 50 tablets).

Manufacturer

Manufactured by: Kemwell AB, Bjokgatan 30, Uppsala SE-751 82,
Sweden.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0576

POM

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 Sulfasalazine Tablets 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 happens 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.
Leaflet issue and revision date (Ref): 20.01.14

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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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