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SULFASALAZINE 250MG/5ML ORAL SUSPENSION

Active substance(s): SULFASALAZINE

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Page 2
52mm x 97mm
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

SUGAR FREE

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 L1472

Page 3

52mm x 98mm
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.

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.
● An allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips,
rash or itching (especially affecting the whole body)
● Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have
been reported (see section 2). Frequency: very rare (affects less than 1 person in 10,000)
● 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 immediately
● 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.

Page 1

Page 10

Peel Here But Do Not Remove

SUGAR FREE

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

Base Page

52mm x 144mm

52mm x 98mm

Page 5

52mm x 98mm

Page 6

52mm x 96mm

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.
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

Page 11

Unknown side effects which have been reported since marketing this product
● loss of appetite
● inflammation of the pancreas
● yellowing of the skin or whites of the eyes
● skin colour change (to a light blue)
(jaundice)
● blood vessel inflammation
● tingling, numbness, pains in hands and feet ● blood in urine
● fits, jerky uncontrolled movements
● urine or motions may become a
● seeing and hearing things that are not there
yellow/orange colour which is normal
(hallucinations)
and harmless
● inflammation of the lining of the brain
● lung complications with breathlessness
● inflammation of the sac surrounding the
● impaired folic acid absorption
heart (pericarditis)
● eczema of the skin
● severe diarrhoea
● kidney inflammation and kidney pain
● changes in smell
● liver disease (hepatitis)
● change in mental state, loss of memory
● temporary infertility in men. Fertility returns
● inflammation of the salivary glands on either
when treatment is stopped. Normal
side of the face
contraception should still be used
● inflammation of the heart muscle
● other blood disorders including anaemia
(myocarditis)
and enlarged glands (lymph nodes).

Page 12

52mm x 98mm

Base Label:

52mm x 144mm

Leaflet Page 1:

52mm x 100mm

Left Hand Opening

Product:

Sulfasalazine 250mg/5ml Oral Suspension

Date:

12.08.14

Strength:

250mg/5ml

Proof Number:

TWO

New Item Code:

L1472

Page:

1 of: 3

Overall Leaflet Size:
Page Widths:

52mm x 781mm

100 98 98 96 96 98 98 97

New Pharmacode:

L1306

Design

Gastro IS

Sugar-Free

Cutter Ref:

-

Pack Size

Dimensions:

Base Label:
Leaflet Page 1:

500ml

Core size:76.2mm. Max dia of reel:270 800 labels

Number of
colours used:

Black

7474

Left Hand Opening
576

Braille

52mm x 98mm

Third Party Approval Required YES

■ NO ■

Date:

Regulatory Sign-off
Name:

Barcode:
5 016119 220593 >
Keyline

Guides

Tick
applicable
box

Artwork produced by:

Name:
Signature:

Signature:

Date:

Page 8

Page 9

52mm x 98mm

52mm x 100mm

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.

5. How to store Sulfasalazine Suspension
● Keep out of the sight and reach of children.
● Do not use Sulfasalazine Suspension after the expiry date which is stated on the bottle. The expiry
date refers to the last day of that month. Take back to the pharmacy 1 month after you first open it.
● Store your medicine below 25°C in a dry place.
● Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. These measures will help to protect the environment.

14

Page 14

385

YES

52 x 144mm
52mm x 100mm

Right Hand Opening

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.

52mm x 96mm

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval

L1472

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 ethanol:
This medicine contains small amounts of ethanol (alcohol), less than 100mg per 5ml.

Page 13

52mm x 96mm

Previous Item Code:

52mm x 98mm

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.

Common side effects which may affect more than 1 person in 100:
● dizziness
● joint pain
● headache
● mouth ulcers
● changes in taste
● difficulty sleeping
● ringing in ears
● fever
● cough
● diarrhoea
● itching of the skin
● being sick
● protein in urine
● inflamed mouth (stomatitis)
● abdominal pain
● blood shot eyes and eye infections.
● severe chills
Uncommon side effects which may affect more than 1 person in 1000:
● depression
● hives
● shortness of breath
● puffiness around the eyes and face
● hair loss
● loss of balance.

Very common side effects which may affect more than 1 person in 10:
● indigestion, heartburn
● feeling sick (nausea)
● stomach pain.

Page 7

52mm x 96mm

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?

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.

5 0 16 11 9 2 20 59 3 >

52mm x 100mm

Page 4

Tel: 0113 261 3172

info@ptarmigan-design.co.uk

Page 15

52mm x 98mm

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

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
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
15
This leaflet was last revised in 08/2014.

Page 16

52mm x 97mm

Page 2
52mm x 97mm
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

SUGAR FREE

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 L1472

Sulfasalazine
#250 mg/#5 ml
oral suspension

Page 3

52mm x 98mm
1. What Sulfasalazine Suspension is and what it is used for

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.
● An allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips,
rash or itching (especially affecting the whole body)
● Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have
been reported (see section 2). Frequency: very rare (affects less than 1 person in 10,000)
● 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 immediately
● 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.

Page 10

Peel Here But Do Not Remove

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

Base Page

52mm x 144mm

52mm x 98mm

5 0 16 11 9 2 20 59 3 >

52mm x 100mm

Page 5

52mm x 98mm

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.

Page 1

SUGAR FREE

Page 4

52mm x 96mm

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.
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

Page 11

Unknown side effects which have been reported since marketing this product
● loss of appetite
● inflammation of the pancreas
● yellowing of the skin or whites of the eyes
● skin colour change (to a light blue)
(jaundice)
● blood vessel inflammation
● tingling, numbness, pains in hands and feet ● blood in urine
● fits, jerky uncontrolled movements
● urine or motions may become a
● seeing and hearing things that are not there
yellow/orange colour which is normal
(hallucinations)
and harmless
● inflammation of the lining of the brain
● lung complications with breathlessness
● inflammation of the sac surrounding the
● impaired folic acid absorption
heart (pericarditis)
● eczema of the skin
● severe diarrhoea
● kidney inflammation and kidney pain
● changes in smell
● liver disease (hepatitis)
● change in mental state, loss of memory
● temporary infertility in men. Fertility returns
● inflammation of the salivary glands on either
when treatment is stopped. Normal
side of the face
contraception should still be used
● inflammation of the heart muscle
● other blood disorders including anaemia
(myocarditis)
and enlarged glands (lymph nodes).

Page 12

52mm x 98mm

52mm x 96mm

L1472

Base Label:

52mm x 144mm

Leaflet Page 1:

52mm x 100mm

Left Hand Opening

Sulfasalazine 250mg/5ml Oral Suspension

Date:

12.08.14

Strength:

250mg/5ml

Proof Number:

TWO

New Item Code:

L1472

Page:

2 of: 3

Overall Leaflet Size:

52mm x 781mm

100 98 98 96 96 98 98 97

New Pharmacode:

L1306

Design

Gastro IS

Sugar-Free

Cutter Ref:

-

Pack Size

Dimensions:

Base Label:
Leaflet Page 1:

500ml

Core size:76.2mm. Max dia of reel:270 800 labels

Number of
colours used:

Black

7474

Left Hand Opening
576

Braille

52mm x 98mm

Third Party Approval Required YES

■ NO ■

Date:

Regulatory Sign-off
Name:

Barcode:
5 016119 220593 >
Keyline

Guides

Tick
applicable
box

Artwork produced by:

Name:
Signature:

Signature:

Date:

Page 8

Page 9

52mm x 98mm

52mm x 100mm

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.

5. How to store Sulfasalazine Suspension
● Keep out of the sight and reach of children.
● Do not use Sulfasalazine Suspension after the expiry date which is stated on the bottle. The expiry
date refers to the last day of that month. Take back to the pharmacy 1 month after you first open it.
● Store your medicine below 25°C in a dry place.
● Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. These measures will help to protect the environment.

14

Page 14

385

YES

52 x 144mm
52mm x 100mm

Right Hand Opening

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.

52mm x 96mm

Product:

Previous Item Code:

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 ethanol:
This medicine contains small amounts of ethanol (alcohol), less than 100mg per 5ml.

Page 13

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval

Sulfasalazine
#250 mg/#5 ml
oral suspension

52mm x 98mm

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.

Common side effects which may affect more than 1 person in 100:
● dizziness
● joint pain
● headache
● mouth ulcers
● changes in taste
● difficulty sleeping
● ringing in ears
● fever
● cough
● diarrhoea
● itching of the skin
● being sick
● protein in urine
● inflamed mouth (stomatitis)
● abdominal pain
● blood shot eyes and eye infections.
● severe chills
Uncommon side effects which may affect more than 1 person in 1000:
● depression
● hives
● shortness of breath
● puffiness around the eyes and face
● hair loss
● loss of balance.

Very common side effects which may affect more than 1 person in 10:
● indigestion, heartburn
● feeling sick (nausea)
● stomach pain.

Page 7

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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?

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.

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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

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
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
15
This leaflet was last revised in 08/2014.

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Sulfasalazine
#250 mg/#5 ml
oral suspension
Page 1

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Leaflet Page 1:

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Left Hand Opening

Sulfasalazine 250mg/5ml Oral Suspension

Date:

12.08.14

Strength:

250mg/5ml

Proof Number:

TWO

New Item Code:

L1472

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3 of: 3

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100 98 98 96 96 98 98 97

New Pharmacode:

L1306

Design

Gastro IS

Sugar-Free

Cutter Ref:

-

Pack Size

Dimensions:

Base Label:
Leaflet Page 1:

500ml

Core size:76.2mm. Max dia of reel:270 800 labels

Number of
colours used:

Black

7474

Left Hand Opening
576

Braille

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Third Party Approval Required YES

■ NO ■

Signature:

Date:

Regulatory Sign-off
Name:

Barcode:
5 016119 220593 >
Keyline

Guides

Tick
applicable
box

Artwork produced by:

Name:

385

YES

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Product:

Previous Item Code:

Base Label:

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Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval

Sulfasalazine
#250 mg/#5 ml
oral suspension
Base Page

Page 12

Signature:

Date:

Tel: 0113 261 3172

info@ptarmigan-design.co.uk

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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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