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Active substance(s): SULPHASALAZINE

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500 mg Tablets

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Genethics Europe

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148 x 297 mm


Genethics Europe

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Final Preparation Date For Submission: 15/12/2017

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TABLETS 500 mg

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
- Keep this leaflet. You may need to read it
- If you have any further questions, ask your
doctor or pharmacist.
- This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their symptoms
are the same as yours.
- If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet, see section 4.

1. What Sulfasalazine is for
2. Before you take Sulfasalazine
3. How to take Sulfasalazine
4. Possible side effects
5. How to store Sulfasalazine
6. Further information

Sulfasalazine belongs to a group of medicines called
the aminosalicylates.
It is used to reduce pain and swelling in joint diseases
(rheumatoid arthritis) or gut diseases (Crohn's
disease or ulcerative colitis).
If you are not sure why you have been prescribed
these tablets then please ask your doctor.

Do not take Sulfasalazine and tell your doctor if
 are allergic to sulfasalazine or any of the other
ingredients in the tablets (listed in section 6 of
this leaflet)
 are allergic to salicylates (e.g. aspirin) or
sulfonamides (e.g. sulfadiazine)
 suffer from inherited iron disorders (porphyrias)
Do not use this medicine in children under 2
years of age.
Take special care with Sulfasalazine
Tell your doctor before you take this medicine if you:
 have problems with your liver or kidneys
 suffer from severe allergies or asthma
 have a blood disorder
 have been told that you suffer from glucose-6phosphate dehydrogenase (G6PD) deficiency, as
there is an increased risk of red blood cell
breakdown in the body (haemolytic anaemia)
 are treating a child with the condition systemic
onset juvenile rheumatoid arthritis
Tests on your liver, kidney and blood
Before you start treatment with Sulfasulazine you will
have a blood and urine test to check what your blood
is doing and how well your kidneys are working.
While taking Sulfasalazine your doctor will check how
well your liver, kidneys and blood are working by
taking blood and urine samples periodically during
your treatment.
As this medicine may have effects on the blood and
liver, tell your doctor immediately if you have
unexplained bleeding, bruising, purple spots,
sore throat, general illness, fever or jaundice (see
section 4 of this leaflet).
Other medicines and Sulfasalzine
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, even
medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are
taking any of the following medicines, as they may
affect how Sulfasalazine works:
 medicines used to treat diabetes (e.g. gliclazide or
 digoxin, used to treat heart problems
 folic acid, used during pregnancy
 antibiotics, used to treat infections
 azathioprine, used to suppress the immune
system and stop the rejection of organs after
 mercaptopurine or methotrexate, used in the
treatment of cancer
If you go into hospital or have treatment for other
conditions, tell the doctor that you are taking
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 or pharmacist for advice before taking this
medicine. You should avoid breastfeeding while
taking Sulfasalazine, as there have been reports of
diarrhoea or blood in the stools of babies of breastfeeding mothers taking this medicine.
Driving and using machines
Sulfasalazine should not affect your ability to drive or
use machines.

Always take Sulfasalazine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Take these tablets by mouth. Swallow them whole
with a glass of water. You can take them with or
without food.
Whilst taking this medicine ensure that you drink
adequate fluids to remain well hydrated, especially
after severe or prolonged episodes of vomiting and/or
diarrhoea, high fever or heavy sweating. This is to
avoid problems with your kidneys.
Your doctor will decide your dose and length of
treatment, as it depends on your condition. The
recommended doses are;
Adults and the elderly:
Ulcerative colitis:
Severe/Moderate flare-up: 2 - 4 tablets four times a
day, usually with other medicines such as steroids.
Do not leave more than 8 hours between the evening
dose and that of the next morning.
Maintenance dose: once the flare-up is controlled,
your doctor may gradually lower your dose, as your
condition improves, to 4 tablets a day. This lower
dose should be continued to prevent further flare-ups.
Crohn’s disease:
Severe/Moderate flare-up: 2-4 tablets four times a
day, usually with other medicines such as steroids.
Do not leave more than 8 hours between the evening
dose and that of the next morning.
Rheumatoid arthritis:
Start with 1 tablet each day for the first week of
treatment. Then, increase the dose by 1 tablet a day
each week to a maximum of 6 tablets a day in divided
Children 2 years of age and over:
Ulcerative colitis and Crohn’s disease:
Your doctor will tell you what dose your child needs to
take depending on their bodyweight.
Rheumatoid arthritis:
Not recommended.
Do not give to children under 2 years old.
If you take more Sulfasalazine than you should
Contact your doctor or the nearest hospital casualty
department immediately. Take this leaflet and the
package with you so they know what has been taken.

If you forget to take Sulfasalazine
Don't worry, just take your next scheduled dose at the
correct time. Do not take a double dose to make up
for a forgotten dose.
If you stop taking Sulfasalazine
Do not stop taking Sulfasalazine without talking to
your doctor first, even if your symptoms have
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Like all medicines, Sulfasalazine can cause side
effects, although not everybody gets them.
If you get any of the following serious side
effects, STOP taking this medicine and tell your
doctor immediately or go to the nearest hospital emergency department:
 an allergic reaction, which may cause itching,
rashes, red raised lumps (hives), swelling of the
face, tongue or throat which may cause difficulty
breathing and wheezing, skin sensitivity to
sunlight, fever, joint or muscle pain.
 potentially life-threatening skin rashes (StevensJohnson syndrome, toxic epidermal necrolysis),
appearing initially as reddish target-like spots or
circular patches often with central blisters. The
rash may progress to widespread blistering or
peeling of the skin. Additional signs include ulcers
in the mouth, throat, nose or genitals, red swollen
eyes (conjunctivitis) and flu-like symptoms. The
highest risk of occurrence is within the first weeks
of treatment. If you develop these conditions with
Sulfasalazine, you must not restart taking this
medicine at any time.
 blood problems such as altered numbers of white
blood cells, red blood cells or blood platelets.
These may cause symptoms including
unexplained bleeding, bruising, increased risk of
infections, sore throat, fever, weakness,
breathlessness, pale skin or general illness. A
blood test can be taken to check.
If you get any of the following side effects, see
a doctor straight away:
 inflammation of the liver (hepatitis), which may
cause yellowing of the skin or whites of the eyes
(jaundice), darker urine or paler stools
 inflammation of the pancreas (pancreatitis), which
causes severe pain in the abdomen and back
Tell your doctor or pharmacist if you get any of
the following side effects:
Very common side effects (affecting more than 1
in 10 people):
 indigestion, heartburn, feeling sick (nausea)
Common side effects (affecting less than 1 in 10
 difficulty sleeping
 dizziness, headache, changes in taste
 bloodshot eyes
 ringing in the ears
 cough
 abdominal pain, diarrhoea, being sick (vomiting),
inflammation of the mouth
 itching sensation
 fever
Uncommon side effects (affecting less than 1 in
100 people)
 depression
 fits
 a feeling of dizziness or "spinning" (vertigo)
 shortness of breath
 hair loss
 puffiness of the face
 inflammation of the blood vessels that may
appear as purple spots on the skin
 increase in liver enzymes, which can be seen on
blood tests
Side effects for which frequency cannot be
estimated from the available data
 an infection of the colon, with symptoms including
severe diarrhoea, fever and abdominal pain or

 enlarged lymph nodes
 loss of appetite
 hallucinations
 aseptic meningitis, which may cause stiff neck,
headache, nausea, vomiting, fever or disorientation
 loss of co-ordination, change in mental state,
nerve damage, changes in smell
 some soft contact lenses may be stained
 inflammation of the heart muscle (myocarditis), or
the sac surrounding the heart (pericarditis)
 blue colouration of the skin due to a lack of
oxygen in the blood
 lung disease with difficulty breathing
 worsening of the symptoms of colitis, which may
include diarrhoea, cramping abdominal pains,
fatigue, loss of appetite, weight loss
 inflammation of the salivary glands
 liver failure
 crystals in the urine (crystalluria), which may be
seen as cloudy urine or cause difficulty in passing
urine, blood in the urine, kidney problems
including inflammation or damage, urine may be
coloured orange
 low sperm count in men, this is temporary and
reversible on stopping treatment
 yellow discolouration of the skin and body fluids
 induction of autoantibodies, which may cause
arthritis type symptoms and/or unexplained
fevers, fatigue, muscle weakness or rashes
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 at By
reporting side effects you can help provide more
information on the safety of this medicine.

Keep out of the sight and reach of children.
Store below 25°C in a dry place. Store in the original
container and keep the container tightly closed.
Do not use these tablets after the expiry date, which
is stated on the container. The expiry date refers to
the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

What Sulfasalazine Tablets contain
The active ingredient in this medicine is sulfasalazine.
Each tablet contains 500 mg of the active substance.
The other ingredients are povidone, maize starch,
magnesium stearate, stearic acid, crospovidone.
What Sulfasalazine Tablets look like and contents
of the pack
Sulfasalazine 500 mg Tablets are flat orange-brown
bevelled tablets with a break line engraved on one
side and MP42 on the other.
The tablets come in blister packs and containers of
28, 30, 50, 56, 60, 84, 100, 112, 250, 500 and 1000
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Genethics Europe Limited,
41 – 43 Klimentos, Klimentos Tower,
Nicosia 1061, Cyprus
DDSA Pharmaceuticals Limited,
84 Pembroke Road,
London, W8 6NX, UK
For more information about this product, please
contact the Marketing Authorisation Holder.
This leaflet was last revised in 12/2017

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.