Sulfasalazine 500mg Gastro-Resistant Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
SULAZINE EC
SULFASALAZINE 500 mg GASTRO-RESISTANT TABLETS
/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 pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms 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.
THIS LEAFLET CONTAINS
1. What Sulazine EC is for
2. Before you take Sulazine EC
3. How to take Sulazine EC
4. Possible side effects
5. How to store Sulazine EC
6. Further information
1. WHAT SULAZINE EC IS FOR
Sulazine EC 500 mg Gastro-resistant Tablets contain the active ingredient sulfasalazine, which 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 SULAZINE EC
Do not take Sulazine EC 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 sulfonamides (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 Sulazine EC
Tell your doctor before you take this medicine if you:
• have problems with your liver or kidneys
• suffer from severe allergies or asthma
• have a blood disorder
• 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)
• are treating a child with the condition systemic onset juvenile rheumatoid arthritis
Tests on your liver, kidney and blood
Before you start treatment with Sulazine EC you will have a blood and urine test to check what your blood is doing and how well your kidneys are working. 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).
Other medicines and Sulazine EC
Tell your doctor or pharmacist if you are taking or have recently taken, or might take 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 Sulazine EC works:
• 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 Sulazine EC.
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 or pharmacist for advice before taking this medicine. You should avoid breastfeeding while taking Sulazine EC, as there have been reports of diarrhoea or blood in the stools of babies of breastfeeding mothers taking this medicine.
Driving and using machines
Sulazine EC should not affect your ability to drive or
use machines.
3. HOW TO TAKE SULAZINE EC
Always take Sulazine EC exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Do not crush or chew the tablets. 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 recommended 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.
M/7d flare-up. 2 tablets four times a day, with or without steroids.
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.
M/7d flare-up. 2 tablets four times a day, with or without steroids.
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 in divided doses.
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 Sulazine EC than you should
Contact your doctor or the nearest hospital casualty department immediately. Take this leaflet and the package with you so they know what has been taken.
If you forget to take Sulazine EC
Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Sulazine EC
Do not stop taking Sulazine EC without talking to your doctor first, even if your symptoms have improved.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Sulazine EC 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 ofthe 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 Sulazine EC, 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
• fever
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
• increase in liver enzymes, which can be seen on blood tests
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, fever or disorientation
• loss of co-ordination, change in mental state, nerve damage, changes in smell
• 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
• worsening of the symptoms of colitis, which may include diarrhoea, cramping abdominal pains, fatigue, loss of appetite, weight loss
• 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
• yellow discolouration of the skin and body fluids
• induction of autoantibodies, which may cause arthritis type symptoms and/or unexplained fevers, fatigue, muscle weakness or rashes
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE SULAZINE EC
Keep out of the sight and reach 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. FURTHER INFORMATION
What Sulazine EC Gastro-resistant Tablets contain
The active ingredient in Sulazine EC Gastro-resistant Tablets is sulfasalazine. Each tablet contains 500 mg of sulfasalazine.
The other ingredients are povidone, maize starch, magnesium stearate, stearic acid, crospovidone, methacrylic acid copolymer, triethyl citrate and glyceryl monostearate.
What Sulazine EC Gastro-resistant Tablets look like and contents of the pack
Sulazine EC 500 mg Gastro-resistant Tablets are oval orange with SULAZINE EC engraved on one side.
The tablets come in blister packs of 28, 56, 84, 100, 112, 224 and 500 tablets, and containers of 28, 56, 84, 100, 112, 224 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Chelonia Healthcare Limited,
11 Boumpoulinas, Nicosia, P.C. 1060, Cyprus
Manufacturer:
Haupt Pharma Berlin GmbH,
GradestraBe 13, MoosrosenstraBe 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 07/2016
CL0153/O/PIL1-Br/CL2
SULAZINE EC
SULFASALAZINE 500 mg GASTRO-RESISTANT TABLETS
/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 pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms 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.
THIS LEAFLET CONTAINS
1. What Sulazine EC is for
2. Before you take Sulazine EC
3. How to take Sulazine EC
4. Possible side effects
5. How to store Sulazine EC
6. Further information
1. WHAT SULAZINE EC IS FOR
Sulazine EC 500 mg Gastro-resistant Tablets contain the active ingredient sulfasalazine, which 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 SULAZINE EC
Do not take Sulazine EC 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 sulfonamides (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 Sulazine EC
Tell your doctor before you take this medicine if you:
• have problems with your liver or kidneys
• suffer from severe allergies or asthma
• have a blood disorder
• 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)
• are treating a child with the condition systemic onset juvenile rheumatoid arthritis
Tests on your liver, kidney and blood
Before you start treatment with Sulazine EC you will have a blood and urine test to check what your blood is doing and how well your kidneys are working. 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).
Other medicines and Sulazine EC
Tell your doctor or pharmacist if you are taking or have recently taken, or might take 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 Sulazine EC works:
• 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 Sulazine EC.
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 or pharmacist for advice before taking this medicine. You should avoid breastfeeding while taking Sulazine EC, as there have been reports of diarrhoea or blood in the stools of babies of breastfeeding mothers taking this medicine.
Driving and using machines
Sulazine EC should not affect your ability to drive or
use machines.
3. HOW TO TAKE SULAZINE EC
Always take Sulazine EC exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Do not crush or chew the tablets. 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 recommended 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.
M/7d flare-up. 2 tablets four times a day, with or without steroids.
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.
M/7d flare-up. 2 tablets four times a day, with or without steroids.
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 in divided doses.
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 Sulazine EC than you should
Contact your doctor or the nearest hospital casualty department immediately. Take this leaflet and the package with you so they know what has been taken.
If you forget to take Sulazine EC
Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Sulazine EC
Do not stop taking Sulazine EC without talking to your doctor first, even if your symptoms have improved.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Sulazine EC 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 ofthe 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 Sulazine EC, 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
• fever
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
• increase in liver enzymes, which can be seen on blood tests
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, fever or disorientation
• loss of co-ordination, change in mental state, nerve damage, changes in smell
• 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
• worsening of the symptoms of colitis, which may include diarrhoea, cramping abdominal pains, fatigue, loss of appetite, weight loss
• 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
• yellow discolouration of the skin and body fluids
• induction of autoantibodies, which may cause arthritis type symptoms and/or unexplained fevers, fatigue, muscle weakness or rashes
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE SULAZINE EC
Keep out of the sight and reach 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. FURTHER INFORMATION
What Sulazine EC Gastro-resistant Tablets contain
The active ingredient in Sulazine EC Gastro-resistant Tablets is sulfasalazine. Each tablet contains 500 mg of sulfasalazine.
The other ingredients are povidone, maize starch, magnesium stearate, stearic acid, crospovidone, methacrylic acid copolymer, triethyl citrate and glyceryl monostearate.
What Sulazine EC Gastro-resistant Tablets look like and contents of the pack
Sulazine EC 500 mg Gastro-resistant Tablets are oval orange with SULAZINE EC engraved on one side.
The tablets come in blister packs of 28, 56, 84, 100, 112, 224 and 500 tablets, and containers of 28, 56, 84, 100, 112, 224 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Chelonia Healthcare Limited,
11 Boumpoulinas, Nicosia, P.C. 1060, Cyprus
Manufacturer:
DDSA Pharmaceuticals Limited,
310 Old Brompton Road, London, SW5 9JQ
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 07/2016
CL0153/O/PIL2-Br/CL2