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1. Sulazine Ec 500mg Gastro-Resistant Tablets
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PATIENT INFORMATION LEAFLET

SULAZINE-EC 500 mg Gastro-Resistant Tablets

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 belongs to a group of medicines called the aminosalicylates. It is used to reduce pain and swelling in joint disease (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

•    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)

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).

While taking Sulazine EC tablets you should have regular blood, liver and kidney tests.

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 Sulazine EC 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 Sulazine EC 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

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

Do not take Sulazine EC 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 Sulazine EC tablets

Tell your doctor before you take this medicine if you:

•    have problems with your liver or kidneys

•    suffer from severe allergies or asthma

3. HOW TO TAKE SULAZINE EC

Always take Sulazine EC tablets exactly as your doctor has told you.

Do not crush or chew the tablets. Swallow them whole with a glass of water. You can take them with or without food.

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.

Mild 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.

Mild 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.

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 tablets 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 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, Sulazine EC 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 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

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, fever 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 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 SULAZINE EC

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 Sulazine EC tablets contain

The active ingredient in Sulazine EC 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 tablets look like and contents of the pack

Sulazine EC 500 mg tablets are oval with 'SULAZINE EC' engraved on one side.

SULAZINE-EC is available in blister packs of 28, 56, 84, 112 & 224 tablets, and containers of 28, 56, 84, 100, 112, 224 & 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Chelonia Healthcare Limited,

Boumpoulinas 11, 3^rd Floor Nicosia, P.C. 1060 Cyprus

Manufacturer:

DDSA Pharmaceuticals Limited,

Chatfield Road, Off York Road,

London SW11 3SE

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was revised in December 2011