Ref: 0716/081113/1/F

Salazopyrin EN-tabs 500mg Tablets

(sulfasalazine)

Patient Information Leaflet

Read all of this leaflet carefully before you take this medicine

*    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

*    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is called Salazopyrin EN-tabs 500mg Tablets but will be called Salazopyrin EN-tabs throughout this leaflet.

In this leaflet:

™ What Salazopyrin EN-tabs are and what they are used for ^ Before you take Salazopyrin EN-tabs ,3^ How to take Salazopyrin EN-tabs Possible side effects ,5 How to store Salazopyrin EN-tabs ^ Further information

*    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 such as 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.

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 for advice before taking this medicine.

Driving and using machines

Salazopyrin EN-tabs is unlikely to affect your ability to drive or use machinery.

What Salazopyrin EN-tabs are and what they are used for

The active substance in Salazopyrin EN-tabs is sulfasalazine which is an anti-inflammatory drug and belongs to a group of medicines called aminosalicylates.

Your doctor may give you Salazopyrin EN-tabs to treat and manage inflammatory bowel disease or to treat rheumatoid arthritis.

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). Salazopyrin EN-tabs 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). Salazopyrin EN-tabs are used to control the flare-ups of Crohn's Disease.

Rheumatoid arthritis

Salazopyrin EN-tabs are usually given when a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs e.g. aspirin and ibuprofen) are not working. They help prevent damage to your joints and work slowly to reduce swelling and stiffness in your joints.

[£) Before you take Salazopyrin EN-tabs

Your doctor will perform complete blood counts and liver function tests before starting Salazopyrin 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 Salazopyrin. Thereafter, monitoring will be performed as your doctor requires

Do not take Salazopyrin EN-tabs if you

_*    are allergic (hypersensitive) to any of the ingredients of Salazopyrin EN-tabs.

*    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.

Salazopyrin EN-tabs are not to be used in children under 2 years of age.

Take special care with Salazopyrin EN-tabs

If you answer YES to any of these questions 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?

*    Have you ever had asthma?

*    If you are a child and have arthritis?

Tests on your blood, kidneys, liver and urine

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) before you start treatment and at regular intervals.

They may also test your urine for protein and blood.

Taking other medicines

Tell your doctor or pharmacist if you are taking the following medicines as they may interact with Salazopyrin EN-tabs:

Salazopyrin EN-tabs 500mg Tablets

(sulfasalazine)

Patient Information Leaflet (continued)

If you take more Salazopyrin EN-tabs than you should

Contact your nearest hospital casualty department or tell your doctor immediately, if you have taken too many tablets (an overdose) or if a child has taken your medicine.

Please take this leaflet and these tablets with you to the hospital casualty department or to your doctor.

If you miss a dose of Salazopyrin EN-tabs

If you forget to take a dose, just take the next dose as usual. Do not double the next dose to make up for a missed one.

^4 Possible side effects

Like all medicines, Salazopyrin EN-tabs can cause side effects, although not everybody gets them.

Stop taking Salazopyrin EN-tabs and tell 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.

_*    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 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.

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.

_*    If you notice 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 cells, white cells or platelets. Your doctor will take regular blood samples to test for these effects.

Discontinue treatment with Salazopyrin while awaiting the results of blood tests

Other side-effects that may occur are:

Very common side-effects which may affect more than 1 person in 10 are listed below:

*    Indegestion, heartburn

*    Feeling sick (nausea)

Common side-effects which may affect more than 1 person in 100 are listed below:

*    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

_*    Joint pain

*    Protein in urine

*    Fever

Uncommon side-effects which may affect more than 1 person in 1000 are listed below:

*    Depression

*    Fits, jerky, uncontrolled movements

_*    Loss of balance

*    Shortness of breath

*    Hair loss

_*    Hives

*    Puffiness around the eyes and face

Since introduction to the market the following side-effects have been reported:

*    Inflammation of the lining of the brain

*    Servere diarrhoea

*    Other blood disorders including anaemia, enlarged glands (lymph nodes)

*    Blood vessel inflammation

*    Loss of appetite

*    Hallucinations

*    Changes in mental state

*    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 inflammation and kidney pain,

_*    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. (see section 6 General Advice for further information)

*    Temporary infertility in men. Fertility returns when treatment is stopped. Normal contraception should still be used.

Very rarely sulfasalazine has caused permanent staining of extended wear soft contact lenses. (See section 6 General Advice for further information).

If any of the side effects gets 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 and 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 Card Scheme at www.mhra.gov.uk/yellowcard.

By reporting side effects, you help provide more information on the safety of this medicine.

[p How to store Salazopyrin EN-tabs

Keep out of the sight and reach of children.

Do not use Salazopyrin EN-tabs after the expiry date which is stated on the box/bottle/label. The expiry date refers to the last day of the month.

Tablets should not be thrown in your bin or put down the drain. If they are out of date, or no longer suitable for you, return them to your pharmacist. Do not store above 30°C.

Store in the original container

If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.

3 Further information

What this medicine contains:

Each film-coated tablet contains 500mg sulfasalazine as the active ingredient. They also contain the following inactive ingredients: Povidone, maize starch, magnesium stearate, colloidal silicon dioxide, cellulose acetate phthalate, propylene glycol, beeswax, carnauba wax, glyceryl monosterate, talc and macrogol.

What this medicine looks like and contents of the pack

Salazopyrin EN-tabs are yellow film-coated, ovoid gastro-resistant tablets embossed “KPh” on one side and "102” on the other.

They are available in bottles containing 100 tablets.

Manufacturer and Licence Holder

Your tablets are manufactured by Kemwell AB, Bjorkgatan 30, 751 82 Uppsala, Sweden and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 15184/0716

Salazopyrin is a registered trademark of Pfizer Health AB Revision date: 08/11/13

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

General Advice

Because the tablets are coloured yellow they may cause your urine or motions to become a yellow/orange colour. This is normal and harmless but can stain fabric. Any Salazopyrin soiled fabric should be put in to soak. Difficult stains may be removed with a solution of washing soda. Always test the effect of soda on a small piece of the fabric first. Then apply a mild acid such as white vinegar.

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.

Where can I get more advice about Ulcerative Colitis and Crohn's Disease?

The National Association for Colitis and Crohn's Disease (NACC) has local groups which offer meetings, events and information for patients. They may be contacted at NACC, P.O. Box 205, St. Albans, Herts, AL1 1AB.

Sulfasalazine 500mg Enteric Coated Tablets

Patient Information Leaflet

Read all of this leaflet carefully before you take this medicine

*    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

*    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is called Sulfasalazine 500mg Enteric Coated Tablets but will be called Sulfasalazine throughout this leaflet.

In this leaflet:

3 What Sulfasalazine is and what it is used for 3 Before you take Sulfasalazine 3 How to take Sulfasalazine 3 Possible side effects 3 How to store Sulfasalazine 3 Further information

3 What Sulfasalazine is and what it is used for

The active substance in Sulfasalazine 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 or to treat rheumatoid arthritis.

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 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 are used to control the flare-ups of Crohn's Disease.

Rheumatoid arthritis

Sulfasalazine are usually given when a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs e.g. aspirin and ibuprofen) are not working. They help prevent damage to your joints and work slowly to reduce swelling and stiffness in your joints.

3 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. 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

_*    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 are not to be used in children under 2 years of age.

Take special care with Sulfasalazine

If you answer YES to any of these questions 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?

*    Have you ever had asthma?

*    If you are a child and have arthritis?

Tests on your blood, kidneys, liver and urine

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) before you start treatment and at regular intervals. They may also test your urine for protein and blood.

Taking other medicines

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

Sulfasalazine 500mg Enteric Coated Tablets

Patient Information Leaflet (continued)

Ensure that you drink adequate fluids whilst you are taking this medicines. 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 many tablets (an overdose) or if a child has taken your medicine.

Please take this leaflet and these tablets with you to the hospital casualty department or to your doctor.

If you miss a dose of Sulfasalazine

If you forget to take a dose, just take the next dose as usual. Do not double the next dose to make up for a missed one.

3 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. Although they are 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 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.

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.

*    If you notice 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 cells, white cells or platelets. Your doctor will take regular blood samples to test for these effects.

Discontinue treatment with Sulfasalazine while awaiting the results of blood tests

Other side-effects that may occur are:

Very common side-effects which may affect more than 1 person in 10 are listed below:

*    Indegestion, heartburn

_*    Feeling sick (nausea)

Common side-effects which may affect more than 1 person in 100 are listed below:

_*    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

_*    Joint pain

_*    Protein in urine

_*    Fever

Uncommon side-effects which may affect more than 1 person in 1000 are listed below:

_*    Depression

_*    Fits, jerky, uncontrolled movements

_*    Loss of balance

_*    Shortness of breath

_*    Hair loss

_*    Hives

_*    Puffiness around the eyes and face

Since introduction to the market the following side-effects have been reported:

_*    Inflammation of the lining of the brain

*    Servere diarrhoea

*    Other blood disorders including anaemia, enlarged glands (lymph nodes)

*    Blood vessel inflammation

_*    Loss of appetite

*    Hallucinations

*    Changes in mental state

*    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 inflammation and kidney pain,

_*    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. (see section 6 General Advice for further information)

*    Temporary infertility in men. Fertility returns when treatment is stopped. Normal contraception should still be used.

Very rarely sulfasalazine has caused permanent staining of extended wear soft contact lenses. (See section 6 General Advice for further information).

If any of the side effects gets 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 and 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 Card Scheme at www.mhra.gov.uk/vellowcard.

By reporting side effects, you help provide more information on the safety of this medicine.

& How to store Sulfasalazine

Keep out of the sight and reach of children.

Do not use Sulfasalazine after the expiry date which is stated on the box/bottle/label. The expiry date refers to the last day of the month. Tablets should not be thrown in your bin or put down the drain. If they are out of date, or no longer suitable for you, return them to your pharmacist. Do not store above 30°C.

Store in the original container

If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.

Further information

What this medicine contains:

Each film-coated tablet contains 500mg sulfasalazine as the active ingredient. They also contain the following inactive ingredients: Povidone, maize starch, magnesium stearate, colloidal silicon dioxide, cellulose acetate phthalate, propylene glycol, beeswax, carnauba wax, glyceryl monosterate, talc and macrogol.

What this medicine looks like and contents of the pack

Sulfasalazine are yellow film-coated, ovoid gastro-resistant tablets embossed “KPh” on one side and "102” on the other.

They are available in bottles containing 100 tablets.

Manufacturer and Licence Holder

Your tablets are manufactured by Kemwell AB, Bjorkgatan 30, 751 82 Uppsala, Sweden and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

|POM| PL 15184/0716

Revision date: 08/11/13

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

General Advice

Because the tablets are coloured yellow they may cause your urine or motions to become a yellow/orange colour. This is normal and harmless but can stain fabric. Any Salazopyrin soiled fabric should be put in to soak. Difficult stains may be removed with a solution of washing soda. Always test the effect of soda on a small piece of the fabric first. Then apply a mild acid such as white vinegar.

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.

Where can I get more advice about Ulcerative Colitis and Crohn's Disease?

The National Association for Colitis and Crohn's Disease (NACC) has local groups which offer meetings, events and information for patients. They may be contacted at NACC, P.O. Box 205, St. Albans, Herts, AL1 1AB.