Active ingredient
- sulfasalazine
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00427/0196.
Sulfasalazine 250mg/5ml Oral Suspension
Package leaflet: Information for the user
Sulfasalazine 250mg/5ml Oral Suspension
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 Suspension is and what it is used for
2. What you need to know before you take Sulfasalazine Suspension
3. How to take Sulfasalazine Suspension
4. Possible side effects
5. How to store Sulfasalazine Suspension
6. Contents of the pack and other information
1. What Sulfasalazine Suspension is and what it is used for
The active ingredient in Sulfasalazine Suspension is sulfasalazine which is an anti-inflammatory drug and belongs to a group of medicines called aminosalicylates.
Your doctor may give you Sulfasalazine to treat and manage inflammatory bowel disease.
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
2. What you need to know before you take Sulfasalazine Suspension
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. Thereafter, monitoring will be performed as your doctor requires. Tell your doctor if you are taking or have recently taken Sulfasalazine Suspension, or any other sulfasalazine containing products, because they may affect results of blood and urine tests.
Do not take Sulfasalazine if you:
Sulfasalazine should not be used in children under 2 years of age.
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 sulfasalazine, you must not be re-started on sulfasalazine at any time. If you develop a rash or these skin symptoms, stop taking sulfasalazine, seek urgent advice from a doctor and tell him that you are taking this medicine.
Warnings and precautions
If you answer YES to any of the questions below tell your doctor or pharmacist before taking this medicine:
Other medicines and Sulfasalazine
Tell your doctor or pharmacist if you are taking the following medicines as they may interact with Sulfasalazine:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Sulfasalazine Suspension with food and drink
Sulfasalazine Suspension should be taken with or after food.
Pregnancy
Tell your doctor if you are pregnant, planning to become pregnant or become pregnant whilst taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Sulfasalazine is unlikely to affect your ability to drive or use machines.
Sulfasalazine Suspension contains:
3. How to take Sulfasalazine Suspension
The suspension should be taken with food. The doses should be evenly divided during the day. Unless your doctor has told you otherwise, the usual doses for the following conditions are:
Ulcerative Colitis and Crohn’s Disease
Adults and the Elderly
Severe flare-ups: 20-40 ml four times a day, with other medicines such as steroids. Do not leave more than 8 hours between the evening and the following morning dose.
Mild/Moderate flare-ups: 20-40 ml four times a day, but not always with other medicines
Ulcerative Colitis
Maintenance: Once the flare-up is controlled the dose is slowly reduced to 40 ml 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.
How long should you use Sulfasalazine?
This depends on how well the suspension suits you. The suspension starts to work in a few days. If it works well, you may be using it for some time. Do not stop using the suspension just because you feel better without first 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 than you should
Contact your nearest hospital casualty department or tell your doctor immediately, if you have taken too much suspension or if a child has taken your medicine.
Please take this leaflet and the suspension with you to the hospital casualty department or to your doctor.
If you forget to take Sulfasalazine
If you forget to take a dose, take the next dose as usual. Do not take a double dose to make up for a missed one.
4. Possible side effects
Like all medicines, Sulfasalazine can cause side effects, although not everybody gets them.
Stop taking Sulfasalazine and tell your doctor immediately if you experience any of the following symptoms after taking this medicine.
Your doctor will stop your treatment in these cases.
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 or bruising, paleness, tiredness, fever, rash, severe sore throat, bleeding under the skin, difficulty getting over an infection and generally feeling unwell.
These may be the first signs of an abnormality of the blood, including decreases in the number of red and white blood 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:
Common side effects which may affect more than 1 person in 100:
Uncommon side effects which may affect more than 1 person in 1000:
Unknown side effects which have been reported since marketing this product
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) at regular intervals.
They may also test your urine for protein and blood.
Very rarely Sulfasalazine has caused permanent staining of extended wear soft contact lenses (see section 6 for further information).
If any of the side effects get 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 at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Sulfasalazine Suspension
6. Contents of the pack and other information
What Sulfasalazine Suspension contains
The active substance is sulfasalazine. Each 5ml of suspension contains 250mg of the active ingredient sulfasalazine.
The other ingredients are xanthan gum (E415), dispersible cellulose, acesulfame K (E950), orange flavour (containing ethanol and butylated hydroxyanisole (E320)), lemon flavour, polysorbate 80, sodium benzoate (E211), citric acid monohydrate (E330), sodium citrate (E331) and water.
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.
What Sulfasalazine Suspension looks like and contents of the pack
The suspension is orange/yellow in colour, with an orange-lemon flavour. The medicine comes in a brown glass bottle which contains 500ml of suspension. The suspension is the colour of the medicine itself. Contains no artificial colouring.
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in 10/2020
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
+44 (0)113 244 1400
+44 (0)800 919 312
+44 (0)113 245 3567
+44 (0)795 762 3515