\n\n20 mg and 40 mg enteric tablets are
esomeprazole<\/p>\n\n\n\n
Esomeprazole Actavis contains a medicine 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 Actavis 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 Actavis may also be authorized for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions. Do not take Esomeprazole Actavis if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazole Actavis.<\/p>\n\n\n\n Talk to your doctor or pharmacist before taking Esomeprazole Actavis:<\/p>\n\n\n\n Esomeprazole Actavis may mask the symptoms of other diseases. Therefore, if any of the following occur before you start taking Esomeprazole Actavis or while you are taking it, contact your doctor immediately:<\/strong><\/p>\n\n\n\n If you have been prescribed Esomeprazole Actavis to take \u201cas needed\u201d, consult your doctor if your symptoms persist or change in nature. Talk to your doctor if you have severe or persistent diarrhea; esomeprazole has been associated with a small increased risk of infectious diarrhea. Using proton pump inhibitors such as Esomeprazole Actavis, and especially if you use it 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. 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 Actavis. Also remember to mention any other side effects, such as joint pain. Children under 12 years<\/em><\/p>\n\n\n\n Esomeprazole Actavis should not be used in children under 12 years of age. More suitable formulations of this drug may be available.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Esomeprazole Actavis can affect the way other medicines work and other medicines can affect the effect of Esomeprazole Actavis. Do not take Esomeprazole Actavis if you are taking a medicine containing nelfinavir<\/strong>(used to treat HIV – infection ). 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 Actavis gastro you to treat ulcers caused by Helicobacter pylori<\/em> – infection, you must tell your doctor if you are also taking other medicines. Esomeprazole Actavis with food and drink<\/strong><\/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, 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 Actavis during that time.<\/p>\n\n\n\n It is not known if esomeprazole passes into breast milk. Therefore, you should not take Esomeprazole Actavis if you are breast-feeding.<\/p>\n\n\n\n Esomeprazole Actavis is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and visual disturbances may occur in less common cases. (see section 4). If you are affected, do not drive or use machines. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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 Esomeprazole Actavis contains sodium<\/strong><\/p>\n\n\n\n This medicine contains less than 1 mmol (23 mg) sodium per enteric-tablet, ie essentially ‘sodium-free ‘. Esomeprazole Actavis <\/strong>contains sucrose<\/strong><\/p>\n\n\n\n This medicine contains sugar spheres, which contain sucrose, which is a type of sugar. 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 Use for <\/strong>adults over 18 years<\/strong><\/em><\/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:<\/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:<\/strong><\/p>\n\n\n\n Use for young people from 12 years<\/em><\/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 <\/strong>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 Use for children under 12 years<\/strong><\/p>\n\n\n\n Esomeprazole Actavis should not be used in children under 12 years of age. More suitable formulations of this drug may be available. Older<\/strong><\/p>\n\n\n\n Dose adjustment is not necessary for elderly patients. If you take more Esomeprazole Actavis then you should<\/strong><\/p>\n\n\n\n If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. If you forget to take Esomeprazole Actavis gastro s<\/strong><\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Esomeprazole Actavis and contact your doctor immediately, if you notice any of the following serious side effects:<\/strong><\/p>\n\n\n\n Other side effects include: Common (affects up to 1 in 10 people)<\/strong><\/p>\n\n\n\n Uncommon (affects up to 1 in 100 people)<\/strong><\/p>\n\n\n\n Rare (affects up to 1 in 1,000 people):<\/strong><\/p>\n\n\n\n Very rare (may affect up to 1 in 10,000 people)<\/strong><\/p>\n\n\n\n No known frequency (cannot be calculated from the available data)<\/strong><\/p>\n\n\n\n Esomeprazole Actavis can in very rare cases 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 excluded by a blood test. It is important that you then inform about your medication. Esomeprazole Actavis 20 mg enteric tablets are light pink, oblong, biconvex film-coated tablets, 6.55 x 13.6 mm.<\/p>\n\n\n\n Esomeprazole Actavis 40 mg enteric tablets are pink, oblong, biconvex film-coated tablets, 8.2 x 17 mm. Pack sizes<\/em> :<\/p>\n\n\n\n Plastic jar with tablets, desiccant and plastic lid: 30, 100, 250 or 500 tablets. Do not swallow the desiccant.<\/p>\n\n\n\n Blister packs: 7, 14, 28, 30, 50, 56, 60, 90, 98, 100 or 140 tablets. (Packages 7, 14 and 28 are over-the-counter) Not all pack sizes may be marketed.<\/p>\n\n\n\n Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n Actavis Group PTC ehf.<\/p>\n\n\n\n Reykjavikurvegur 76-78<\/p>\n\n\n\n 220 Hafnarfjordur<\/p>\n\n\n\n Iceland Manufacturer<\/strong><\/p>\n\n\n\n Balkanpharma Dupnitsa AD<\/p>\n\n\n\n 3 Samokovsko Shose Str.<\/p>\n\n\n\n Dupnitsa 2600<\/p>\n\n\n\n Bulgaria 20 mg and 40 mg enteric tablets are
<\/p>\n\n\n\nWhat you need to know before you use Esomeprazole Actavis<\/h2>\n\n\n\n
Do not use Esomeprazole Actavis<\/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 Actavis<\/h2>\n\n\n\n
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<\/p>\n\n\n\nPregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
<\/p>\n\n\n\nEsomeprazole Actavis contains sodium and sucrose<\/h2>\n\n\n\n
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<\/p>\n\n\n\nHow to use Esomeprazole Actavis<\/h2>\n\n\n\n
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<\/p>\n\n\n\n4. Possible side effects<\/h2>\n\n\n\n
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<\/p>\n\n\n\n5. How to store Esomeprazole Actavis<\/h2>\n\n\n\n
6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
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<\/p>\n\n\n\nMarketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
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