Patient leaflet - SULFASALAZINE 500 MG TABLETS
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this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Sulfasalazine Tablets can cause side effects, although not everybody gets them.
STOP taking the tablets and contact 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:
- difficulty breathing, sudden wheezing, itching or rashes (especially affecting the whole body), swelling of eyelids, face or lips- these may be signs of a severe allergic reaction
- 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.
- liver disease (hepatitis) – symptoms include yellowing of the skin and whites of the eyes (jaundice)
Contact your doctor IMMEDIATELY if you experience any of the following symptoms after taking this medicine as they will stop treatment in these cases:
- severe sore throat, fever, severe tiredness, pallor (paleness), unexplained bleeding, bruising easily or generally feeling unwell. These may be the first signs of a serious blood
disorder, including decreases in the number of red cells, white cells or platelets. Your doctor may take regular blood samples to test for these effects.
Other side effects that may occur are:
Very common effects (may affect more than 1 in 10people):
- feeling sick (nausea), indigestion, heartburn.
Common effects (may affect more than 1 in 100 people):
- diarrhoea, being sick, abdominal pain, inflamed mouth (stomatitis), change in taste
- headache, dizziness, high temperature (fever), difficulty sleeping
- ringing in the ears, bloodshot eyes
- cough, joint pain, itching of the skin, protein in the urine.
Uncommon effects (may affect more than 1 in 1000 people):
- depression
- fits, jerky, uncontrolled movements
- feeling dizziness or ‘spinning’
- shortness of breath
- hair loss
- loss of balance
- blood vessel inflammation
Not known (side effects for which frequency cannot be estimated from the available data):
- severe diarrhoea
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| be coloured yellow/orange which is normal and harmless
| glands. Your urine may become yellow/orange in colour when you are taking Sulfasalazine Tablets, this is normal and harmless but can stain fabric. Very rarely Sulfasalazine Tablets have caused permanent staining of extended wear soft contact lenses. Daily-wear soft contact lenses and gas permeable lenses respond to standard cleaning if this happens. 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 |
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| Card Scheme at: or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. |
5. How to store Sulfasalazine Tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original package in order to protect from light and moisture.
Do not use this medicine after the expiry date. The expiry date refers to the last day of the 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.
6. Contents of the pack and other information
What Sulfasalazine Tablets contain
The active substance is Sulfasalazine.
Each tablet contains 500 mg of sulfasalazine.
The other ingredients are magnesium stearate, povidone, sodium starch glycolate and iron oxide yellow (E172).
What Sulfasalazine Tablets look like and contents of the pack
The tablets are round, yellow-brown in colour with company logo on one side and a break-line and „A333“ on the other side. They are available in pack size of 28,42,50,56,84,100,112,250,500
and 1000 tablets.
(Not all pack sizes may be marketed.)
Marketing Authorisation Holder:
Crescent Pharma Limited, Key House, Sarum Hill, Basingstoke, RG21 8SR, UK
Manufacturer:
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hampshire, RG25 3ED, UK This leaflet was last revised in February 2021.
If you would like this leaflet in a different format, please contact the license holder at the above address.
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| PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SULFASALAZINE Tablets SOOmg Read all of this leaflet carefully before you start taking this medicine because it contains important information for you
| What is in this leaflet:
1. What Sulfasalazine Tablets are and what they are used for Sulfasalazine belongs to a group of medicines called aminosalicylates which reduce inflammation in the bowel. Sulfasalazine Tablets are used in the treatment of ulcerative colitis | and Crohn’s Disease which are two kinds of inflammatory bowel disease. |
2. What you need to know 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 take these tablets is:
- you are allergic to salicylates (e.g. aspirin), sulfonamide antibiotics (e.g. sulfamethoxazole trimethoprim), or to any of the ingredients in the tablets which are listed in Section 6 (An allergic reaction may be recognised as shortness of breath, blocked nose, rash, itching, swollen face or lips)
- you suffer from porphyria (a rare blood pigment disorder). Your doctor will have already told you if you have this disease.
These tablets should not be taken by children under 2 years of age.
Warnings and precautions
Tell your doctor if you are taking or have recently taken Sulfasalazine, or any other sulfasalazine containing products, because they may affect results of blood and urine tests.
Check with your doctor before taking these tablets if:
- you have a history of allergies or asthma
- you suffer from liver, kidney problems or blood disorders
- you suffer from a lack of glucose 6-phosphate-dehydrogenase (G6PD) in your body (which helps red blood cells function normally)
- you are a child and have arthritis
- you have a folic acid deficiency.
Tests on your liver, kidney and blood
Before you start treatment with sulfasalazine you will have a blood and urine test to check how well your kidneys are working and what your blood is doing. During treatment your doctor will check how well your liver, kidney and blood are working by taking blood and urine samples periodically during your treatment. Your doctor will also measure substances produced known as enzymes (liver function tests) before you start treatment and at regular intervals. They may also test your urine for protein and blood.
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 and yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice) (see section 4 of this leaflet).
Other medicines and Sulfasalazine Tablets
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Sulfasalazine Tablets and other medicines you may be taking may affect how each other work. Make sure your doctor or pharmacist know you are taking any other medicines, particularly:
- anticoagulants (to prevent blood clotting) such as warfarin
- medicines used to treat high blood sugar/diabetes
- phenytoin or hydantoin (for epilepsy)
- methotrexate used to treat rheumatoid arthritis
- digoxin (used to treat heart failure)
- antibiotics, used to treat infections
- folate (usually taken when planning a pregnancy and during the first few months of pregnancy to reduce the risk of neural tube defects, e.g. Spina Bifida)
- phenylbutazone (for treating arthritis)
- azathioprine, mercaptopurine, or ciclosporin (used to prevent organ rejection after a transplant and certain chronic inflammatoiy diseases, e.g. rheumatoid arthritis).
Pregnancy, breast-feeding and fertility
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 in infants of breast-feeding mothers taking sulfasalazine.
Low sperm count and infertility may occur in men treated with sulfasalazine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
There are no reports of this medicine affecting your ability to perform skilled tasks such as driving or operating machinery.
Sulfasalazine Tablets contain sodium
This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially ‚sodium-free‘.
3. How to take Sulfasalazine Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Swallow the tablets whole with a glass of water. Do not crush or chew the tablets.
Whilst taking this medicine ensure 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.
The usual doses for the following conditions are:
Adults and Elderly
Ulcerative colitis:
- Severe/Moderate flare-ups: Two to four tablets four times a day, taken in conjunction with a steroid medicine. Do not leave more than 8 hours between the evening dose and the following morning’s dose.
- Mild flare-ups: One to two tablets four times a day, sometimes a steroid medicine may be given, but not always when the attack
is milder.
Maintenance dose to control your flare-ups: Once the flare-up is controlled your doctor will slowly reduce your dose to four tablets each day. This lower dose may be continued for some time to help stop other flare-ups.
Crohn’s disease:
Severe/Moderate flare-ups: Iwo to four tablets four times a day, taken in conjunction with a steroid medicine. Do not leave more than 8 hours between the evening dose and the following morning’s dose.
Mild flare-ups: One to two tablets four times a day, sometimes a steroid medicine may be given, but not always when the attack is
milder.
Children 2 years of age and over
Ulcerative colitis and Crohn’s disease:
The dose required will be dependent on the child's weight, so it should be taken as directed by the doctor.
Do not give to children under 2 years of age.
The tablets should start to work in a few days.
If you take more Sulfasalazine Tablets than you should
If you think you have taken too many tablets, contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and this leaflet so that the medicine can be identified.
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Crescent
Unvarnished area for placement of 2D code/unique identifier information
– includes BN and EXP date
Crescent Pharma Ltd, Key House, Sarum Hill, Basingstoke, RG21 8SR, UK.
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Pharma code
ref: xxx