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What Azulfidine is and what it is used for
The active substance in Salazopyrin EN-tabs is sulfasalazine which is an antiinflammatory 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 nonsteroidal 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.
How to take Azulfidine
The tablets should be taken with a glass of water and should be swallowed whole. Do not
crush, break or chew the tablets.
Unless your doctor has told you otherwise, the usual doses for the following conditions
For Inflammatory bowel disease:
• Adults and the Elderly
• Severe Flare-Ups 2-4 tablets four times a day, with other medicines such as steroids. Do not leave more than 8 hours between the evening and following morning dose.
• Mild/Moderate Flare-Up 2-4 tablets four times a day, but not always with other medicines.
• Maintenance dose to control your flare ups
•Once the flare-up is controlled the dose is slowly reduced to 4 tablets 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. Crohn’s Disease
• Adults and the Elderly
• Severe Flare-Ups
•2-4 tablets four times a day, with other medicines such as steroids. Do not leave more than 8 hours between the evening and following morning dose.
• Mild/Moderate Flare-Up
•2-4 tablets four times a day, but not always with other medicines.
• 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. For Rheumatoid arthritis
• Adults and the Elderly
•Start on one tablet each day for the first week. Then, increase the dose by one tablet a day each week to a maximum of 6 tablets daily as shown in table. 1 st Week 2 nd Week 3 rd Week 4 th Week Morning
•1 1 2 Evening 1 1 2 2* *etc to a maximum of 6 tablets per day. Do not take more than 6 tablets a day.
•No recommendations. How long should you use these tablets? How long you use these tablets depends on how well the tablets suit you. For Inflammatory bowel disease (Ulcerative Colitis and Crohn’s Disease)
• The tablets should start to work in a few days.
• If they work well, you may be using them for some time because inflammatory bowel disease may be a lifelong condition.
• Don’t stop using the tablets just because you feel better without talking to your doctor. For Rheumatoid arthritis
• Salazopyrin EN-tabs may take some months to have a full effect, so you should keep taking them.
• You may notice some effect after a few weeks.
• When they start to work you will feel less stiffness in your joints, especially in the mornings.
• If they work well, you may be using them for some time.
• Don’t stop using the tablets just because you feel better without talking to your doctor. Ensure that you drink adequate fluids whilst you are taking this medicines. This is to avoid problems with your kidneys. 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.
Possible side effects
Like all medicines, Salazopyrin EN-tabs can cause side effects, although not everybody
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 may 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:
• Indigestion, heartburn
• Feeling sick (nausea)
Common side-effects which may affect more than 1 person in 100 are listed below:
• Difficulty sleeping
• Changes in taste
• Abdominal pains
• Being sick
• Ringing in the ears
• Blood shot eyes
• Inflamed mouth (stomatitis)
• Itching of the skin
• Joint pain
• Protein in urine
Uncommon side-effects which may affect more than 1 person in 1000 are listed below:
• Fits, jerky, uncontrolled movements
• Loss of balance
• Shortness of breath
• Hair loss
• 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
• Severe diarrhoea
• Other blood disorders including anaemia, enlarged glands (lymph nodes)
• Blood vessel inflammation
• Loss of appetite
• 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
How to Store Azulfidine
Keep out of the reach and sight of children. Do not use Salazopyrin EN-tabs after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month. Store in a dry place. 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
2 to 3 weeks on average
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