1. What this product is and what it is used for PENTASA Xtend 2g Sachets is used for the treatment of mild to moderate attacks of ulcerative colitis and to help maintain freedom from further attacks. Ulcerative colitis is an inflammatory bowel disease in which the lining of the intestine becomes inflamed and develops many tiny breaks in its surface (ulcers) which may bleed. PENTASA Xtend 2g Sachets contains granules that slowly release the active ingredient (mesalazine). This helps reduce the inflammation and the painful symptoms. 2. What you need to know before you use this product Do not take PENTASA Xtend 2g Sachets - if you are allergic (hypersensitive) to mesalazine or any of the other ingredients of this medicine (see Section 6); - if you are allergic to other salicylates e.g. acetylsalicylic acid; - if you have severe liver and/or kidney problems. Warnings and Precautions Talk to your doctor or pharmacist before taking PENTASA Xtend 2g Sachets: - if you are allergic to sulphasalazine (risk of allergy to salicylates); - if you currently have or have previously had liver and/or kidney disease; - if you have a medical condition that can make you prone to bleeding; - if you have an active peptic ulcer (stomach ulcer or duodenal ulcer); - if you are on medication that may affect kidney function e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid; - if you have lung problems, in particular asthma; - if you suddenly develop abdominal cramps, abdominal pain, fever, severe headache and rash. In such circumstances you should stop taking PENTASA immediately. While you are on treatment with this medicine, your doctor will normally arrange blood tests to check your kidney function especially at the beginning of treatment. Other medicines and PENTASA Xtend 2g Sachets Tell your doctor or pharmacist if you are using, or have recently used, any other medicines, including medicines obtained without a prescription. This is especially important if you are taking any of the following: - azathioprine (used after transplantations or to treat auto‑immune diseases); - 6-mercaptopurine or thioguanine (chemotherapy, used to treat leukaemia); - Certain agents that inhibit blood clotting (medicines for thrombosis or to thin your blood). Pregnancy, breast-feeding and fertility 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. There is limited experience with the use of mesalazine during pregnancy and breastfeeding. Blood disorders have been reported in newborns of mothers being treated with this medicine. The newborn may develop allergic reactions after breast-feeding, e.g. diarrhoea. If the newborn develops diarrhoea, breast-feeding should be discontinued. Driving and using machines This medicine is not known to affect the ability to drive and/or use machines. Note: The risk of colorectal cancer (CRC) is slightly increased in ulcerative colitis. Observed effects of mesalazine in experimental models and patient biopsies support the role of mesalazine in prevention of colitis-associated CRC, with downregulation of both inflammation dependent and non-inflammation dependent signaling pathways involved in the development of colitis-associated CRC. 3. How to use this product. Always take PENTASA Xtend 2g Sachets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Adults: To treat an attack of Ulcerative colitis, your doctor will usually prescribe a dose of up to 4 g mesalazine a day to be taken either once a day or in divided doses. This may be taken as two sachets PENTASA Xtend 2g Sachets once daily. To help maintain freedom from further attacks of Ulcerative colitis, your doctor will usually prescribe 2 g mesalazine a day to be taken either once a day or in divided doses. This may be taken as one sachet of PENTASA Xtend 2g Sachets or two sachets of PENTASA 1g Sachets Prolonged Release Granules. Use in children and adolescents: Children 6 years of age and older: There is only limited documentation for an effect in children (age 6‑18 years). The dose for children will be calculated by your doctor and depends on the child’s weight. It is generally recommended that half the adult dose is given to children up to 40 kg of body weight and the normal adult dose to children above 40 kg of body weight. You should take the granules orally (by mouth), immediately after opening the sachet, as described below. Do not chew the granules. 1. Open the foil sachet 2. Empty the contents of the sachet onto the tongue 3. Wash the granules down immediately with some water or orange juice ensuring that none remain in the mouth. If you take more PENTASA Xtend 2g Sachets than you should In the event of overdose, contact your doctor or nearest casualty department immediately. If you forget to take PENTASA Xtend 2g Sachets If you have forgotten to take a dose, then take it as soon as you remember, and then take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines this medicine can cause side effects, although not everybody gets them. There have been very few reports of a severe allergic reaction (including severe skin erosions that may affect the skin as the protective barrier of the body). The allergic reaction might lead to swelling of the face and neck and/or difficulty in breathing or swallowing (Quincke´s oedema). If this happens contact your doctor or nearest casualty department immediately. The following common side effects may affect up to 1 of 10 patients treated: - Diarrhoea; - abdominal pain; - nausea; - vomiting; - headache - rash; - flatulence (passing wind). The following rare side effects may affect up to 1 of 1,000 patients treated: - inflammation of some areas of the heart (myocarditis and pericarditis) which can cause shortness of breath and chest pain or palpitations (rapid or irregular heart beats); - inflammation of the pancreas (pancreatitis); symptoms include back and/or stomach pain; - increased amylase (enzyme that helps digest carbohydrates); - dizziness; - increased sensitivity of your skin to sun and ultraviolet light (photosensitivity). The following very rare side effects may affect up to 1 of 10,000 patients: - anaemia and other blood disorders (decrease in the numbers of certain blood cells, which can cause unexplained bleeding, bruising, fever or sore throat); - liver disorders (symptoms include jaundice (yellowing of the skin and/or eyes) and/or pale bowel motions); - kidney disorders (symptoms include blood in the urine, and/or oedema (swelling due to build up of fluid)); - peripheral neuropathy (a condition affecting the nerves of the hands and feet symptoms include tingling and numbness); - allergic and fibrotic lung reactions, inflammation of the lining of the lungs or lung scarring (symptoms include coughing, bronchial cramps (bronchospasm), chest discomfort or pain in breathing, breathing difficulties, bloody and/or excessive phlegm); - Pancolitis (a kind of inflammatory bowel disorder (IBD) that affects the entire internal lining of the large bowel); - hair loss (this is reversible); \muscle or joint pain; - inflammation which can affect different parts of the body such as joints, skin, kidneys, heart etc. (symptoms include painful joints, fatigue, fever, abnormal or unexplained bleeding (e.g. nose bleeds), bruising, purple discoloration of the skin (including severe skin erosions and severe blistering that may affect the skin as the protective barrier of the body)); - accumulation of fluid around the heart (pericardial effusion) which can cause chest pain or pressure; - change in urine colour; - semen with a low concentration of sperm (oligospermia) (this is reversible); - severe diarrhoea and abdominal pain because of an allergic reaction to this medicine within the bowel; - allergic reactions and fever may occasionally occur. There have been very few reports of benign intracranial hypertension (build up of fluid around the brain) in adolescents. Symptoms include headache, nausea, vomiting, and/or visual or hearing disturbances. 5. How to store this product Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and foil sachet. The expiry date refers to the last day of that month. Store at room temperature (below 30°C), in the original packaging away from light. 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 a. What this product contains The active ingredient is Mesalazine. Each sachet of PENTASA Xtend 2g Sachets Prolonged Release Granules contains Mesalazine 2g. The other ingredients are: ethylcellulose, povidone. b. What this product looks like and contents of the pack This medicine contains prolonged release granules. The granules are white‑grey to pale white‑brown. PENTASA Xtend 2g Sachets is available in aluminium foil sachets in packs of 60 sachets.

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