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SULFASALAZINE TABLETS 500MG

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Package Leaflet: Information for the patient
Sulfasalazine 500 mg Tablets
Sulfasalazine
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 again.
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 signs of illness 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.
What is in this leaflet
1.
What Sulfasalzine is and what it is used for
2.
What you need to know before you take Sulfasalzine
3.
How to take Sulfasalzine
4.
Possible side effects
5.
How to store Sulfasalzine
6.
Contents of the pack and other information
1. What Sulfasalazine is and what it is used for
Sulfasalazine 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. What you need to know before you take Sulfasalazine
Your doctor will perform complete blood counts and liver function tests before starting
sulfasalazine 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 take Sulfasalazine:
If you are allergic to sulfasalazine or any of the other ingredients of this medicine (listed in
Section 6)
Warnings and precautions
Potentially life-threatening skin rashes (Stevens- Johnson syndrome toxic epidermal

necrolysis) have been reported with the use of sulfasalazine, appearing initially
as reddish target-like spots or circular patches often with central blisters on the
trunk.
Additional signs to look for include ulcers in the mouth, throat, nose, genitals and
conjunctivitis (red and swollen eyes).
These potentially life-threatening skin rashes are often accompanied by flu-like symptoms.
The rash may progress to widespread blistering or peeling of the skin. The highest risk for
occurrence of serious skin reactions is within the first weeks of treatment. If you have
developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of
Sulfasalzine Tablets, you must not be re-started on Sulfasalazine Tablets at any time.
If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell
him that you are taking this medicine.
Talk to your doctor or pharmacist before taking Sulfasalazine tablets if:
• you are pregnant or intend to become pregnant
• you are allergic to salicylates (e.g. aspirin) or sulfonamides (a certain type of antibiotic)
• you have liver or kidney disease
• you know your body lacks the enzyme, glucose-6-phosphate dehydrogenase (G6PD) which
helps red blood cells function properly
• you have asthma
• you have noticed your skin or whites of your eyes yellowing (jaundice)
• you have a condition called porphyria (a rare blood pigment disorder). Your doctor would
have already told you if you have this disease.
• you are a child and have arthritis (disease mainly affecting the joints with pain and swelling)
Tests on your blood, kidneys, liverand 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.
It is also important that you drink fluids to avoid kidney problems.
Children
Sulfasalazine Tablets are not recommended for children under 2 years.
Other medicines and Sulfasalazine Tablets
Tell your doctor or pharmacist if you are taking, have taken or might take any other
medicines, especially:

• 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 (e.g. rheumatoid
arthritis).
• methotrexate, used to treat rheumatoid arthritis.
Sulfasalazine Tablets with food and drink
Sulfasalazine Tablets should be taken with food and a full glass of water. Your doctor will
adjust your dose of Sulfasalazine Tablets according to the severity of your disease.
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
breast-feeding while taking this medicine. There have been reports of diarrhoea or blood in
the stools of babies of breast-feeding mothers taking Sulfasalazine Tablets.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Sulfasalazine Tablets are unlikely to affect your ability to drive or use machinery.
Sulfasalazine Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
3. How to take Sulfasalazine Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Posology
The recommended dose for adults and the elderly to treat Ulcerative Colitis or Crohn's
Disease:
- Mild: 1-2 tablets four times a day
- Moderate/Severe attacks: 2-4 tablets four times a day
- Maintenance dose: gradually reduce to 1 tablet four times a day.
At night-time, do not wait longer than 8 hours between doses. Your doctor may also prescribe
a course of steroids for you. For Ulcerative Colitis, even when you appear to have no
symptoms, your doctor will usually prescribe 4 tablets a day. This is to reduce the likelihood
of further attacks occurring.
Whilst taking this medicine ensure you drink adequate fluids to remain well hydrated. This is
to avoid problems with your kidneys.

Use in Children over 2 years and adolescents
Your doctor will prescribe a dose dependent upon the child's weight. To treat the disease the
dose is usually 40-60 mg/kg per day whilst a dose of 20-30 mg/kg a day would usually be
prescribed to prevent the disease.
The tablet should be taken with a glass of water and should be swallowed whole. Do not crush
or chew the tablet.
If you take more Sulfasalazine than you should
If you take more Sulfasalazine Tablets than you should contact your nearest hospital or tell
your doctor immediately.
If you forget to take Sulfasalazine Tablets
Do not take a double the dose to make up for forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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:
Although 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 the
tongue). These may be signs of a condition called known as Stevens Johnson Syndrome, or
toxic epidermal necrolysis (TEN).
 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 maybe triggered or aggravated by sunlight.
 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.
 If you notice any unexplained bleeding or you notice any 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 blood cells, white cells or platelets. Your
doctor may take regular blood samples to test for these effects.
Very common side effects (which may affect more than 1 person in 10)
 Indigestion, heartburn
 Feeling sick (nausea)
Common side effects (which may affect more than 1 person in 100)
 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
Painful, swollen joint (arthralgia)
Protein in urine
Fever

Uncommon side effects (which may affect more than 1 person in 1000)
 Depression
 Fits, jerky, uncontrolled movements
 Loss of balance
 Shortness of breath
 Hair loss
 Hives
 Puffiness around the eyes and face
Very Rare side effects
 Permanent staining of extended wear soft contact lenses
Not known side effects but seen since introduction of product in the market
 Inflammation of the lining of the brain
 Severe diarrhoea
 Other blood disorders including anaemia, enlarged glands (lymph nodes)
 A type of blood vessel inflammation (polyarteritis nodosa)
 Loss of appetite
 Hallucinations
 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 disease ( inflammation, pain and renal failure)
 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.
 Temporary infertility in men caused by low sperm count (oligospermia), abnormal process
of making sperm (abnormal spermatogenesis) and inability to get or maintain an erection
(impotence).Fertility returns when treatment is stopped. Normal contraception should still be
used.

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.
Also you can help to make sure that medicines remain as safe as possible by reporting any
unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can
call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in
a paper form available from your local pharmacy.

5. How to store Sulfasalazine Tablets
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date which is stated on the label. The expiry date
refers to the last day of that month.
Do not use throw away any medicines via wastewater. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Sulfasalazine Tablets contain
The active ingredient is sulfasalazine.
Other ingredients- Lactose, Cellulose, microcrystalline, Povidone K30, Lake Brown CL9301,
Maize Starch, Magnesium Stearate, Sodium Starch Glycolate and Chloroform Spirit.
What Sulfasalazine looks like and contents of the pack
Light brown, convex tablets marked “SE”; breakline; “500” on one side and “G” on the
reverse
Amber glass bottles with wadless plastic caps in packs of 100 and 500 tablets.
Polypropylene pots with white polyethylene caps and optional polyethylene ullage filler in
packs of 50, 100, 112, 224, 250 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Generics UK Ltd. t/a Mylan
Station Close, Potters Bar,
Hertfordshire, EN6 1TL
United Kingdom
Manufacturer
Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
This leaflet was last revised in 05/2014

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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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