Document: leaflet MAH GENERIC_PL 17521-0042 change

• leaflet MAH GENERIC_PL 17521-0042
• leaflet MAH GENERIC_PL 42976-0026

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SULFASALAZINE TABLETS 500 MG

THIS LEAFLET CONTAINS

1.    What Sulfasalazine is for

2.    Before you take Sulfasalazine

3.    How to take Sulfasalazine

4.    Possible side effects

5.    How to store Sulfasalazine

6.    Further information

1. WHAT SULFASALAZINE IS FOR

Sulfasalazine belongs to a group of medicines called the aminosalicylates.

It is used to reduce pain and swelling in joint diseases (rheumatoid arthritis) or gut diseases (Crohn's disease or ulcerative colitis).

If you are not sure why you have been prescribed these tablets then please ask your doctor.

2. BEFORE YOU TAKE SULFASALAZINE

Do not take Sulfasalazine tablets and tell your doctor if you:

•    are allergic to sulfasalazine or any of the other ingredients in the tablets (listed in section 6 of this leaflet)

•    are allergic to salicylates (e.g. aspirin) or sulphonamides (e.g. sulfadiazine)

•    suffer from inherited iron disorders (porphyrias)

Do not use this medicine in children under 2 years of age.

Take special care with Sulfasalazine tablets

Tell your doctor before you take this medicine if you:

•    have problems with your liver or kidneys

•    suffer from severe allergies

•    have been told that you suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency, as there is an increased risk of red blood cell breakdown in the body (haemolytic anaemia

Tests on your liver, kidney and blood

Before you start treatment with Sulfasulazine you will have a blood and urine test to check how well your kidneys are working and what you blood is doing. During treatment your doctor will check how well your liver, kidneys and blood are working by taking blood and urine samples periodically during your treatment.

As this medicine may have effects on the blood and liver, tell your doctor immediately if you have unexplained bleeding, bruising, purple spots, sore throat, general illness, fever or jaundice (see section 4 of this leaflet).

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Sulfasalazine tablets work:

•    medicines used to treat diabetes (e.g. gliclazide or tolbutamide)

•    digoxin, used to treat heart problems

•    folic acid, used during pregnancy

•    antibiotics, used to treat infections

•    azathioprine, used to suppress the immune system and stop the rejection of organs after transplants

•    mercaptopurine or methotrexate, used in the treatment of cancer

If you go into hospital or have treatment for other conditions, tell the doctor that you are taking Sulfasalazine tablets.

Pregnancy and breast-feeding

Although this medicine is not known to harm babies, make sure your doctor knows if you are pregnant, planning a pregnancy or breast-feeding and follow their advice.

Driving and using machines

Sulfasalazine tablets should not affect your ability to drive or use machines.

3. HOW TO TAKE SULFASALAZINE

Always take Sulfasalazine tablets exactly as your doctor has told you.

Take these tablets by mouth. Swallow them whole with a glass of water. You can take them with or without food.

Whilst taking this medicine ensure that you drink adequate fluids to remain well hydrated, especially after severe or prolonged episodes of vomiting and/or diarrhoea, high fever or heavy sweating. This is to avoid problems with your kidneys.

Dosage

Your doctor will decide your dose and length of treatment, as it depends on your condition. The usual doses are;

Adults and the elderly:

Ulcerative colitis:

Severe/Moderate flare-up: 2 - 4 tablets four times a day, usually with other medicines such as steroids. Do not leave more than 8 hours between the evening dose and that of the next morning.

Maintenance dose: once the flare-up is controlled, your doctor may gradually lower your dose, as your condition improves, to 4 tablets a day. This lower dose should be continued to prevent further flare-ups.

Crohn’s disease:

Severe/Moderate flare-up: 2 - 4 tablets four times a day, usually with other medicines such as steroids. Do not leave more than 8 hours between the evening dose and that of the next morning.

Rheumatoid arthritis:

Start with 1 tablet each day for the first week of treatment. Then, increase the dose by 1 tablet a day each week to a maximum of 6 tablets a day.

Children 2 years of age and over:

Ulcerative colitis and Crohn’s disease:

Your doctor will tell you what dose your child needs to take depending on their bodyweight.

Rheumatoid arthritis:

Not recommended.

Do not give to children under 2 years old.

If you take more Sulfasalazine tablets than you should

Contact your doctor or the nearest hospital casualty department immediately.

If you forget to take Sulfasalazine tablets

Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Sulfasalazine tablets can cause side effects, although not everybody gets them.

If you get any of the following serious side effects, STOP taking this medicine and tell your doctor immediately or go to the nearest hospital emergency department:

•    an allergic reaction, which may cause itching, rashes, red raised lumps (hives), swelling of the face, tongue or throat which may cause difficulty breathing and wheezing, skin sensitivity to sunlight, fever, joint or muscle pain.

•    potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), appearing initially as reddish target-like spots or circular patches often with central blisters. The rash may progress to widespread blistering or peeling of the skin. Additional signs include ulcers in the mouth, throat, nose or genitals, red swollen eyes (conjunctivitis) and flu-like symptoms. The highest risk of occurrence is within the first weeks of treatment. If you develop these conditions with Sulfasalazine, you must not restart taking this medicine at any time

•    blood problems such as altered numbers of white blood cells, red blood cells or blood platelets. These may cause symptoms including unexplained bleeding, bruising, increased risk of infections, sore throat, fever, weakness, breathlessness, pale skin or general illness. A blood test can be taken to check.

If you get any of the following side effects, see a doctor straight away:

•    inflammation of the liver (hepatitis), which may cause yellowing of the skin or whites of the eyes (jaundice), darker urine or paler stools.

•    inflammation of the pancreas (pancreatitis), which causes severe pain in the abdomen and back.

Tell your doctor or pharmacist if you get any of the following side effects:

Very common side effects (affecting more than 1 in 10 people):

•    indigestion, heartburn, feeling sick (nausea)

Common side effects (affecting less than 1 in 10 people):

•    difficulty sleeping

•    dizziness, headache, changes in taste

•    bloodshot eyes

•    ringing in the ears

•    cough

•    abdominal pain, diarrhoea, being sick (vomiting), inflammation of the mouth

•    itching sensation

Uncommon side effects (affecting less than 1 in 100 people)

•    depression

•    fits

•    a feeling of dizziness or "spinning" (vertigo)

•    shortness of breath

•    hair loss

•    puffiness of the face

•    inflammation of the blood vessels that may appear as purple spots on the skin

Side effects for which frequency cannot be estimated from the available data

•    an infection of the colon, with symptoms including severe diarrhoea, fever and abdominal pain or cramps

•    enlarged lymph nodes

•    loss of appetite

•    hallucinations

•    aseptic meningitis, which may cause stiff neck, headache, nausea, vomiting or disorientation

•    loss of co-ordination, change in mental state, nerve damage, changes in smell

•    eye problems including puffiness around the eyes, some soft contact lenses may be stained

•    inflammation of the heart muscle (myocarditis), or the sac surrounding the heart (pericarditis)

•    blue colouration of the skin due to a lack of oxygen in the blood

•    lung disease with difficulty breathing

•    inflammation of the salivary glands

•    liver failure

•    crystals in the urine (crystalluria), which may be seen as cloudy urine or cause difficulty in passing urine, blood in the urine, kidney problems including inflammation or damage, urine may be coloured orange

•    low sperm count in men, this is temporary and reversible on stopping treatment

If any of the side effects become serious, or if

you notice any side effects not listed in this

leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE SULFASALAZINE

Keep out of the reach and sight of children.

Store below 25°C in a dry place. Store in the original container and keep the container tightly closed.

Do not use these tablets after the expiry date, which is stated on the container. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Sulfasalazine tablets contain

The active ingredient in Sulfasalazine tablets is sulfasalazine. Each tablet contains 500 mg of the active substance. The other ingredients are povidone, maize starch, magnesium stearate, stearic acid and crospovidone.

What Sulfasalazine tablets look like and contents of the pack

Sulfasalazine 500 mg tablets are flat orange-brown bevelled tablets with a break line engraved on one side and MP42 on the other.

The tablets come in blister packs and containers of 28, 30, 50, 56, 60, 84, 100, 112, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Metwest Pharmaceuticals Limited,

15 Runnelfield, Harrow on the Hill,

Middlesex HAI 3NY

Manufacturer:

Haupt Pharma Berlin GmbH,

Gradestrale 13, Moosrosenstrale 5 and Britzer Damm 120, 12347 Berlin, Germany For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 11/2012

M0042/O/PIL/G4

PACKAGE LEAFLET: INFORMATION FOR THE USER

SULFASALAZINE TABLETS 500 MG

THIS LEAFLET CONTAINS

1.    What Sulfasalazine is for

2.    Before you take Sulfasalazine

3.    How to take Sulfasalazine

4.    Possible side effects

5.    How to store Sulfasalazine

6.    Further information

1. WHAT SULFASALAZINE IS FOR

Sulfasalazine belongs to a group of medicines called the aminosalicylates.

It is used to reduce pain and swelling in joint diseases (rheumatoid arthritis) or gut diseases (Crohn's disease or ulcerative colitis).

If you are not sure why you have been prescribed these tablets then please ask your doctor.

2. BEFORE YOU TAKE SULFASALAZINE

Do not take Sulfasalazine tablets and tell your doctor if you:

•    are allergic to sulfasalazine or any of the other ingredients in the tablets (listed in section 6 of this leaflet)

•    are allergic to salicylates (e.g. aspirin) or sulphonamides (e.g. sulfadiazine)

•    suffer from inherited iron disorders (porphyrias)

Do not use this medicine in children under 2 years of age.

Take special care with Sulfasalazine tablets

Tell your doctor before you take this medicine if you:

•    have problems with your liver or kidneys

•    suffer from severe allergies

•    have been told that you suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency, as there is an increased risk of red blood cell breakdown in the body (haemolytic anaemia

Tests on your liver, kidney and blood

Before you start treatment with Sulfasulazine you will have a blood and urine test to check how well your kidneys are working and what you blood is doing. During treatment your doctor will check how well your liver, kidneys and blood are working by taking blood and urine samples periodically during your treatment.

As this medicine may have effects on the blood and liver, tell your doctor immediately if you have unexplained bleeding, bruising, purple spots, sore throat, general illness, fever or jaundice (see section 4 of this leaflet).

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Sulfasalazine tablets work:

•    medicines used to treat diabetes (e.g. gliclazide or tolbutamide)

•    digoxin, used to treat heart problems

•    folic acid, used during pregnancy

•    antibiotics, used to treat infections

•    azathioprine, used to suppress the immune system and stop the rejection of organs after transplants

•    mercaptopurine or methotrexate, used in the treatment of cancer

If you go into hospital or have treatment for other conditions, tell the doctor that you are taking Sulfasalazine tablets.

Pregnancy and breast-feeding

Although this medicine is not known to harm babies, make sure your doctor knows if you are pregnant, planning a pregnancy or breast-feeding and follow their advice.

Driving and using machines

Sulfasalazine tablets should not affect your ability to drive or use machines.

3. HOW TO TAKE SULFASALAZINE

L    A

Always take Sulfasalazine tablets exactly as your doctor has told you.

Take these tablets by mouth. Swallow them whole with a glass of water. You can take them with or without food.

Whilst taking this medicine ensure that you drink adequate fluids to remain well hydrated, especially after severe or prolonged episodes of vomiting and/or diarrhoea, high fever or heavy sweating. This is to avoid problems with your kidneys.

Dosage

Your doctor will decide your dose and length of treatment, as it depends on your condition. The usual doses are;

Adults and the elderly:

Ulcerative colitis:

Severe/Moderate flare-up: 2 - 4 tablets four times a day, usually with other medicines such as steroids. Do not leave more than 8 hours between the evening dose and that of the next morning.

Maintenance dose: once the flare-up is controlled, your doctor may gradually lower your dose, as your condition improves, to 4 tablets a day. This lower dose should be continued to prevent further flare-ups.

Crohn’s disease:

Severe/Moderate flare-up: 2-4 tablets four times a day, usually with other medicines such as steroids. Do not leave more than 8 hours between the evening dose and that of the next morning.

Rheumatoid arthritis:

Start with 1 tablet each day for the first week of treatment. Then, increase the dose by 1 tablet a day each week to a maximum of 6 tablets a day.

Children 2 years of age and over:

Ulcerative colitis and Crohn’s disease:

Your doctor will tell you what dose your child needs to take depending on their bodyweight.

Rheumatoid arthritis:

Not recommended.

Do not give to children under 2 years old.

If you take more Sulfasalazine tablets than you should

Contact your doctor or the nearest hospital casualty department immediately.

If you forget to take Sulfasalazine tablets

Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Sulfasalazine tablets can cause side effects, although not everybody gets them.

If you get any of the following serious side effects, STOP taking this medicine and tell your doctor immediately or go to the nearest hospital emergency department:

•    an allergic reaction, which may cause itching, rashes, red raised lumps (hives), swelling of the face, tongue or throat which may cause difficulty breathing and wheezing, skin sensitivity to sunlight, fever, joint or muscle pain.

•    potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), appearing initially as reddish target-like spots or circular patches often with central blisters. The rash may progress to widespread blistering or peeling of the skin. Additional signs include ulcers in the mouth, throat, nose or genitals, red swollen eyes (conjunctivitis) and flu-like symptoms. The highest risk of occurrence is within the first weeks of treatment. If you develop these conditions with Sulfasalazine, you must not restart taking this medicine at any time

•    blood problems such as altered numbers of white blood cells, red blood cells or blood platelets. These may cause symptoms including unexplained bleeding, bruising, increased risk of infections, sore throat, fever, weakness, breathlessness, pale skin or general illness. A blood test can be taken to check.

If you get any of the following side effects, see a doctor straight away:

•    inflammation of the liver (hepatitis), which may cause yellowing of the skin or whites of the eyes (jaundice), darker urine or paler stools.

•    inflammation of the pancreas (pancreatitis), which causes severe pain in the abdomen and back.

Tell your doctor or pharmacist if you get any of the following side effects:

Very common side effects (affecting more than 1 in 10 people):

•    indigestion, heartburn, feeling sick (nausea)

Common side effects (affecting less than 1 in 10 people):

•    difficulty sleeping

•    dizziness, headache, changes in taste

•    bloodshot eyes

•    ringing in the ears

•    cough

•    abdominal pain, diarrhoea, being sick (vomiting), inflammation of the mouth

•    itching sensation

Uncommon side effects (affecting less than 1 in 100 people)

•    depression

•    fits

•    a feeling of dizziness or "spinning" (vertigo)

•    shortness of breath

•    hair loss

•    puffiness of the face

•    inflammation of the blood vessels that may appear as purple spots on the skin

Side effects for which frequency cannot be estimated from the available data

•    an infection of the colon, with symptoms including severe diarrhoea, fever and abdominal pain or cramps

•    enlarged lymph nodes

•    loss of appetite

•    hallucinations

•    aseptic meningitis, which may cause stiff neck, headache, nausea, vomiting or disorientation

•    loss of co-ordination, change in mental state, nerve damage, changes in smell

•    eye problems including puffiness around the eyes, some soft contact lenses may be stained

•    inflammation of the heart muscle (myocarditis), or the sac surrounding the heart (pericarditis)

•    blue colouration of the skin to due a lack of oxygen in the blood

•    lung disease with difficulty breathing

•    inflammation of the salivary glands

•    liver failure

•    crystals in the urine (crystalluria), which may be seen as cloudy urine or cause difficulty in passing urine, blood in the urine, kidney problems including inflammation or damage, urine may be coloured orange

•    low sperm count in men, this is temporary and reversible on stopping treatment

If any of the side effects become serious, or if

you notice any side effects not listed in this

leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE SULFASALAZINE

Keep out of the reach and sight of children.

Store below 25°C in a dry place. Store in the original container and keep the container tightly closed.

Do not use these tablets after the expiry date, which is stated on the container. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Sulfasalazine tablets contain

The active ingredient in Sulfasalazine tablets is sulfasalazine. Each tablet contains 500 mg of the active substance. The other ingredients are povidone, maize starch, magnesium stearate, stearic acid and crospovidone.

What Sulfasalazine tablets look like and contents of the pack

Sulfasalazine 500 mg tablets are flat orange-brown bevelled tablets with a break line engraved on one side and MP42 on the other.

The tablets come in blister packs and containers of 28, 30, 50, 56, 60, 84, 100, 112, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Metwest Pharmaceuticals Limited,

15 Runnelfield, Harrow on the Hill,

Middlesex HAI 3NY

Manufacturer:

DDSA Pharmaceuticals Limited,

310 Old Brompton Road,

London SW5 9jQ, United Kingdom

For more information about this product, please

contact the Marketing Authorisation Holder.

This leaflet was last revised in 11/2012

M0042/O/PIL/G4