\n\n20 mg, 40 mg enteric-tablet is
esomeprazole<\/p>\n\n\n\n
Esomeprazole SUN contains a drug substance called esomeprazole. It belongs to a group of medicines called “proton pump inhibitors”. These work by reducing the amount of acid produced in the stomach.
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Esomeprazole SUN is used to treat the following conditions:
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Adults<\/strong><\/p>\n\n\n\n Young people from 12 years<\/strong><\/p>\n\n\n\n Esomeprazole contained in Esomeprazole SUN may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions. Do not take Esomeprazole SUN if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazole SUN.<\/p>\n\n\n\n Talk to your doctor or pharmacist before taking Esomeprazole SUN if:<\/p>\n\n\n\n If you get a rash, especially in areas exposed to the sun, tell your doctor as soon as possible as you may need to stop treatment with Esomeprazole SUN. Also remember to mention any other side effects, such as joint pain. Esomeprazole SUN may mask the symptoms of other diseases. Therefore, if any of the following occur before you start taking Esomeprazole SUN or while you are taking it, contact your doctor immediately:<\/strong><\/p>\n\n\n\n If you have been prescribed Esomeprazole SUN to take \u201cas needed\u201d, consult your doctor if your symptoms persist or change in nature. Using a proton pump inhibitor such as Esomeprazole SUN and especially if you have been using Esomeprazole SUN for more than a year may increase the risk of a hip, wrist, or vertebral fracture (bone fracture). Tell your doctor if you have osteoporosis ( osteoporosis ) or if you use medicines called corticosteroids because they may increase the risk of osteoporosis.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Esomeprazole SUN can affect the way other medicines work and other medicines can affect the effect of Esomeprazole SUN. Do not take Esomeprazole SUN if you are also taking medicines containing nelfinavir (<\/strong> used to treat HIV ). Tell your doctor or pharmacist if you are taking any of the following medicines:<\/p>\n\n\n\n If the doctor has prescribed the antibiotics amoxicillin and clarithromycin, coupled with Esomeprazole SUN for the treatment of ulcers caused by Helicobacter pylori – <\/em>infection, you must tell your doctor if you take other medicines.<\/p>\n\n\n\n You can take your tablets with a meal or on an “empty stomach”.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Your doctor will decide if you can take Esomeprazole SUN during that time. It is not known if Esomeprazole SUN passes into breast milk. Therefore, you should not take Esomeprazole SUN if you are breast-feeding.<\/p>\n\n\n\n Esomeprazole SUN is unlikely to affect your ability to drive or handle tools or machines. However, side effects such as dizziness and visual disturbances may occur in uncommon or rare cases. (see section 4). If you are affected, do not drive or use machines.<\/p>\n\n\n\n You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n How much should you take?<\/strong><\/p>\n\n\n\n Adults from 18 years<\/strong><\/p>\n\n\n\n For the treatment of heartburn caused by gastroesophageal reflux disease ( GERD ):<\/strong><\/p>\n\n\n\n To treat ulcers caused by Helicobacter pylori<\/em> – infection and to prevent the ulcer from occurring again:<\/strong><\/p>\n\n\n\n For the treatment of stomach ulcers caused by NSAIDs (Non-steroidal anti-inflammatory drugs):<\/strong><\/p>\n\n\n\n To prevent stomach ulcers if you are taking NSAIDs (Non-steroidal anti-inflammatory drugs):<\/strong><\/p>\n\n\n\n For the treatment of excess acid in the stomach caused by a tumor of the pancreas (Zollinger-Ellison syndrome):<\/strong><\/p>\n\n\n\n Continued treatment to prevent new bleeding from wounds after treatment with intravenous Esomeprazole SUN:<\/strong><\/p>\n\n\n\n Young people from 12 years<\/strong> For the treatment of heartburn caused by gastroesophageal reflux disease ( GERD ):<\/strong><\/p>\n\n\n\n To treat ulcers caused by Helicobacter pylori<\/em> – infection and to prevent the ulcer from occurring again:<\/strong><\/p>\n\n\n\n Taking the medicine<\/strong><\/p>\n\n\n\n What you can do if you have difficulty swallowing the tablets<\/strong><\/p>\n\n\n\n Esomeprazole SUN enteric tablets are not recommended for children under 12 years of age. Older<\/strong><\/p>\n\n\n\n Dose adjustment is not necessary for elderly patients.<\/p>\n\n\n\n If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/strong><\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects are If you notice any of the following serious side effects, stop taking Esomeprazole SUN and contact your doctor immediately:<\/strong><\/p>\n\n\n\n These side effects are rare and occur in less than 1 in 1,000 people. Other side effects include: Common (affects less than 1 in 10 people)<\/em><\/strong><\/p>\n\n\n\n Uncommon (affects less than 1 in 100 people)<\/em><\/strong><\/p>\n\n\n\n Rare (affects less than 1 in 1,000 people)<\/em><\/strong><\/p>\n\n\n\n Very rare (affects less than 1 in 10,000 people)<\/em><\/strong><\/p>\n\n\n\n No known frequency (cannot be calculated from the available data)<\/em><\/strong><\/p>\n\n\n\n In very rare cases, esomeprazole SUN can affect the white blood cells so that the immune system is weakened. If you get an infection with symptoms such as fever and severe<\/strong> general malaise or fever with symptoms of local infection such as pain in the neck, throat, or mouth or difficulty urinating, you must contact a doctor as soon as possible so that any lack of white blood cells ( agranulocytosis ) can be excluded by a blood test. It is important that you then information about your medication. Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not store above 30 \u00b0 C.<\/p>\n\n\n\n Store in the original package (in blisters). Moisture sensitive.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the carton or blister (EXP). The expiration date is the last day of the specified month. The medicine 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.<\/p>\n\n\n\n The active substance is esomeprazole. Each tablet contains 20 mg and 40 mg of esomeprazole (as amorphous esomeprazole magnesium). Other ingredients are:<\/p>\n\n\n\n Tablet core:<\/em> Hydroxypropylcellulose (E463), crospovidone (type A)<\/p>\n\n\n\n Film coating:<\/em> Povidone (K30), macrogol 400, macrogol 4000, macrogol 6000, hypromellose phthalate (HP-55S), hypromellose phthalate (HP-50), diethyl phthalate, hydroxypropylcellulose, microcrystalline cellulose ( PH 101), microcrystalline cellulose crospovide Type B), sodium stearyl fumarate, Opadry 03B86651 brown (HMPC 2910 \/ Hypromellose 6cP, titanium dioxide (E171), macrogol \/ PEG 400, iron oxide red (E172), sugar spheres (sucrose and corn starch), talc (E553b). <\/p>\n\n\n\n Esomeprazole SUN 20 mg enteric tablets are brownish red, oval, biconvex, film-coated tablets marked ‘E5’ on one side and smooth on the other.<\/p>\n\n\n\n Esomeprazole SUN 40 mg enteric tablets are brownish red, oval, biconvex, film-coated tablets marked ‘E6’ on one side and smooth on the other.<\/p>\n\n\n\n The tablets are packaged in<\/p>\n\n\n\n Not all pack sizes may be marketed.<\/p>\n\n\n\n SUN Pharmaceutical Industries Europe BV<\/p>\n\n\n\n Polarisavenue 87<\/p>\n\n\n\n 2132 JH, Hoofddorp<\/p>\n\n\n\n Netherlands Manufacturer<\/strong><\/p>\n\n\n\n Sun Pharmaceutical Industries Europe BV,<\/strong> Polarisavenue 87, 2132JH Hoofddorp, The Netherlands<\/p>\n\n\n\n Terapia SA,<\/strong> 124 Fabricii Street, 400 632 Cluj Napoca, Romania This medicinal product is authorized under the European Economic Area under the names: Belgium: Esomeprazole AB<\/p>\n\n\n\n Germany: Esomeprazole Basics<\/p>\n\n\n\n Italy: Esomeprazolo SUN<\/p>\n\n\n\n Netherlands: Esomeprazole SUN<\/p>\n\n\n\n Portugal: Ezoclip<\/p>\n\n\n\n United Kingdom: Esomeprazole 20 mg, 40 mg enteric-tablet is
<\/p>\n\n\n\nWhat you need to know before taking Esomeprazole SUN<\/h2>\n\n\n\n
Do not take Esomeprazole SUN again<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
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<\/p>\n\n\n\nOther medicines and Esomeprazole SUN<\/h2>\n\n\n\n
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<\/p>\n\n\n\nEsomeprazole SUN with food, drink, and alcohol<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
Esomeprazole SUN contains sucrose<\/h2>\n\n\n\n
<\/p>\n\n\n\n3. How to use Esomeprazole SUN<\/h2>\n\n\n\n
<\/p>\n\n\n\nChildren under 12 years<\/h2>\n\n\n\n
<\/p>\n\n\n\nIf you take more Esomeprazole SUN then you should<\/h2>\n\n\n\n
If you forget to take Esomeprazole SUN<\/h2>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
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<\/p>\n\n\n\n5. How to store Esomeprazole SUN<\/h2>\n\n\n\n
<\/p>\n\n\n\n6. Contents of the packaging and other information<\/h2>\n\n\n\n
What Esomeprazole SUN 20 mg \/ 40 mg enteric tablets contain<\/h2>\n\n\n\n
<\/p>\n\n\n\nWhat the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
Marketing Authorisation Holder<\/h2>\n\n\n\n
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