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

• 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 is used to control the flare-ups of ulcerative colitis. It 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 is used to control flare-ups of Crohn’s Disease.

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:

• are allergic (hypersensitive) to any of the ingredients of Sulfasalazine Suspension
• are allergic (hypersensitive) to salicylates (e.g. aspirin) or sulfonamides (e.g. a certain type of antibiotic)
• have a disease known as porphyria (a rare blood pigment disorder). Your doctor will have already told you if you have this disease.

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:

• Have you ever had any problems with your liver or kidneys?
• 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 or any serious blood disorders?
• Have you ever had asthma?
• If you are a child and have arthritis?

Other medicines and Sulfasalazine

Tell your doctor or pharmacist if you are taking the following medicines as they may interact with Sulfasalazine:

• any medicine for high blood sugar/diabetes
• methenamine, an antibiotic for treating urinary tract infections
• digoxin, used to treat heart failure
• folate, folic acid or folinic acid, 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 suppress your body’s immune response in organ transplantation and certain chronic inflammations (e.g. rheumatoid arthritis)
• 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.

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:

• This medicine contains 4.7 mg of alcohol (ethanol) in each 5ml. The amount in 5 ml of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
• This medicine contains 5 mg sodium benzoate in each 5ml.
• This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially ‘sodium-free’.

®

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.

Continued overleaf

4. Possible side effects

5. How to store Sulfasalazine Suspension

6. Contents of the pack and other information

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

Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.

This leaflet was last revised in 10/2020. 15

Base Page 52mm x 144mm

Each 5ml contains 250mg Sulfasalazine.

The product also includes sodium benzoate (E211) and ethanol.

See leaflet for further information.

Administration: For oral use.

Shake the bottle well before use.

Read the package leaflet before use.

Storage: Do not store above 25°C.

Discard 1 month after first opening.

Keep out of the sight and reach of children.

Manufactured by the MA Holder: Rosemont Pharmaceuticals Ltd., Leeds LS11 9XE, UK.

PL 00427/0196

sulfasalazine

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

• 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 is used to control the flare-ups of ulcerative colitis. It 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 is used to control flare-ups of Crohn’s Disease.

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:

• are allergic (hypersensitive) to any of the ingredients of Sulfasalazine Suspension
• are allergic (hypersensitive) to salicylates (e.g. aspirin) or sulfonamides (e.g. a certain type of antibiotic)
• have a disease known as porphyria (a rare blood pigment disorder). Your doctor will have already told you if you have this disease.

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:

• Have you ever had any problems with your liver or kidneys?
• 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 or any serious blood disorders?
• Have you ever had asthma?
• If you are a child and have arthritis?

Other medicines and Sulfasalazine

Tell your doctor or pharmacist if you are taking the following medicines as they may interact with Sulfasalazine:

• any medicine for high blood sugar/diabetes
• methenamine, an antibiotic for treating urinary tract infections
• digoxin, used to treat heart failure
• folate, folic acid or folinic acid, 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 suppress your body’s immune response in organ transplantation and certain chronic inflammations (e.g. rheumatoid arthritis)
• 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.

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:

• This medicine contains 4.7 mg of alcohol (ethanol) in each 5ml. The amount in 5 ml of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
• This medicine contains 5 mg sodium benzoate in each 5ml.
• This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially ‘sodium-free’.

®

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.

Continued overleaf

4. Possible side effects

5. How to store Sulfasalazine Suspension

6. Contents of the pack and other information

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

Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.

This leaflet was last revised in 10/2020. 15

Base Page 52mm x 144mm

Each 5ml contains 250mg Sulfasalazine.

The product also includes sodium benzoate (E211) and ethanol.

See leaflet for further information.

Administration: For oral use.

Shake the bottle well before use.

Read the package leaflet before use.

Storage: Do not store above 25°C.

Discard 1 month after first opening.

Keep out of the sight and reach of children.

Manufactured by the MA Holder: Rosemont Pharmaceuticals Ltd., Leeds LS11 9XE, UK.

PL 00427/0196

Rossmant^ 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.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed only for you. 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. See section 4.

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

• 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 is used to control the flare-ups of ulcerative colitis. It 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 is used to control flare-ups of Crohn’s Disease.

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:

• are allergic (hypersensitive) to any of the ingredients of Sulfasalazine Suspension
• are allergic (hypersensitive) to salicylates (e.g. aspirin) or sulfonamides (e.g. a certain type of antibiotic)
• have a disease known as porphyria (a rare blood pigment disorder). Your doctor will have already told you if you have this disease.

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:

• Have you ever had any problems with your liver or kidneys?
• 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 or any serious blood disorders?
• Have you ever had asthma?
• If you are a child and have arthritis?

Other medicines and Sulfasalazine

Tell your doctor or pharmacist if you are taking the following medicines as they may interact with Sulfasalazine:

• any medicine for high blood sugar/diabetes
• methenamine, an antibiotic for treating urinary tract infections
• digoxin, used to treat heart failure
• folate, folic acid or folinic acid, 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 suppress your body’s immune response in organ transplantation and certain chronic inflammations (e.g. rheumatoid arthritis)
• 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.

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:

• This medicine contains 4.7 mg of alcohol (ethanol) in each 5ml. The amount in 5 ml of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
• This medicine contains 5 mg sodium benzoate in each 5ml.
• This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially ‘sodium-free’.

®

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.

Continued overleaf