\n\n40 mg enteric capsules, hard
esomeprazole<\/p>\n\n\n\n
Esomeprazole Stada 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 Stada 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 Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions. Do not take Esomeprazole Stada if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazole Stada.<\/p>\n\n\n\n Warnings and cautions<\/strong><\/p>\n\n\n\n Talk to your doctor or pharmacist before taking Esomeprazole Stada:<\/p>\n\n\n\n Talk to your doctor before taking this medicine if you are going to have a specific blood test (chromogranin A). Esomeprazole Stada may mask symptoms of other diseases. Therefore, if any of the following occur before you take Esomeprazole Stada or while you are taking it, contact your doctor immediately:<\/strong><\/p>\n\n\n\n If you have been prescribed Esomeprazole Stada to take \u201cas needed\u201d, consult your doctor if your symptoms persist or change in nature. Using proton pump inhibitors such as Esomeprazole Stada and especially if you use Esomeprazole Stada for more than one year may increase the risk of hip, wrist, or vertebral fractures. 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 taking Esomeprazole Stada. Also remember to mention any other side effects, such as joint pain.<\/p>\n\n\n\n Children under 12 years<\/strong><\/p>\n\n\n\n Esomeprazole Stada should not be used in children under 12 years of age. There may be more suitable formulations of esomeprazole (ask your doctor or pharmacist if you need more information).<\/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 Stada can affect the way other medicines work and other medicines can affect the effect of Esomeprazole Stada. Do not take Esomeprazole STADA 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, in combination with esomeprazole Stada to treat ulcers caused by Helicobacter pylori – <\/em>infection, you must tell your doctor if you are also taking other medicines.<\/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. Your doctor will decide if you can take Esomeprazole Stada during that time. It is not known if Esomeprazole Stada passes into breast milk. Therefore, you should not take Esomeprazole Stada if you are breast-feeding.<\/p>\n\n\n\n Esomeprazole Stada 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 uncommon cases or rare 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 Stada contains sucrose, which is a type of sugar, propyl p-hydroxybenzoate (E216) and methyl p-hydroxybenzoate (E218)<\/p>\n\n\n\n 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 <\/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 ):<\/p>\n\n\n\n To treat ulcers caused by Helicobacter pylori – infection and to prevent the ulcer from occurring again:<\/strong><\/em><\/p>\n\n\n\n For the treatment of stomach ulcers caused by NSAIDs (Non-steroidal anti-inflammatory drugs):<\/strong><\/em><\/p>\n\n\n\n To prevent stomach ulcers if you are taking NSAIDs (Non-steroidal anti-inflammatory drugs):<\/strong><\/em><\/p>\n\n\n\n The recommended dose is an Esomeprazole Stada 20 mg * enteric capsule once daily. For the treatment of excess acid in the stomach caused by a tumor of the pancreas (Zollinger-Ellison syndrome):<\/strong><\/em><\/p>\n\n\n\n Continued treatment to prevent new bleeding from wounds after treatment with intravenous esomeprazole:<\/strong><\/em><\/p>\n\n\n\n Taking the medicine<\/strong><\/p>\n\n\n\n What you can do if you have difficulty swallowing the capsules<\/strong><\/p>\n\n\n\n Older<\/strong><\/p>\n\n\n\n Dose adjustment is not necessary for elderly patients.<\/p>\n\n\n\n Young people from 12 years<\/strong> For the treatment of heartburn caused by gastroesophageal reflux disease ( GERD ):<\/strong><\/em><\/p>\n\n\n\n To treat ulcers caused by Helicobacter pylori – infection and to prevent the ulcer from occurring again:<\/em><\/strong><\/p>\n\n\n\n Children under 12 years<\/strong><\/p>\n\n\n\n Esomeprazole Stada should not be used in children under 12 years of age. There may be more suitable formulations of esomeprazole (ask your doctor or pharmacist if you need more information).<\/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.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Esomeprazole Stada and contact your doctor immediately if you notice any of the following serious side effects: These side effects are rare and may affect up to 1 in 1,000 people. Esomeprazole Stada 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 be excluded by a blood test. It is important that you then information about your medication. Other side effects include: Common (may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n Rare (may affect 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 Has been reported (occurs in an unknown number of users)<\/strong><\/p>\n\n\n\n The active substance is esomeprazole.<\/p>\n\n\n\n Esomeprazole Stada enteric capsules are available in a dose containing 40 mg esomeprazole (as esomeprazole magnesium dihydrate). Other ingredients are:<\/p>\n\n\n\n Capsule contents:<\/em><\/p>\n\n\n\n sugar spheres (sucrose and maize starch), hypromellose, dimethicone emulsion 35% (containing dimethicone, propyl p-hydroxybenzoate (E216), methyl p-hydroxybenzoate (E218), sorbic acid, sodium benzoate, polyethylene glycol sorbitol glycol ethylene phenol monolaurin ethanol phenol ethanol, and 80) diacetylated monoglycerides, talc, methacrylic acid-ethyl acrylate copolymer (1: 1), dispersion30% (containing a copolymer of methacrylic acid and ethyl acrylate, sodium lauryl sulfate and polysorbate 80), triethyl citrate and stearoyl macrogol glycerides.<\/p>\n\n\n\n Capsule shell:<\/em><\/p>\n\n\n\n Black iron oxide (E172), shellac, gelatin, yellow iron oxide (E172), and titanium dioxide (E171)<\/p>\n\n\n\n Esomeprazole Stada 40 mg enteric capsules have an opaque yellow body and an opaque yellow body, marked with 40 mg in black on both halves. The capsules come in pack sizes of:<\/p>\n\n\n\n Jars of 28, 30, 90, or 98 capsules<\/p>\n\n\n\n Blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98 or 100 capsules. Not all pack sizes may be marketed.<\/p>\n\n\n\n Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n STADA Arzneimittel AG<\/p>\n\n\n\n Stadastrasse 2-18<\/p>\n\n\n\n D-61118 Bad Vilbel<\/p>\n\n\n\n Germany Other manufacturers<\/strong><\/p>\n\n\n\n ETHYPHARM<\/p>\n\n\n\n ZI de Saint-Arnoult<\/p>\n\n\n\n 28170 – Ch\u00e2teauneuf-en-Thymerais – France or ETHYPHARM<\/p>\n\n\n\n Chemin de la Poudri\u00e8re<\/p>\n\n\n\n 76120 – Grand-Quevilly – France or Lamp San Prospero SpA<\/p>\n\n\n\n Via della Pace, 25 \/ A<\/p>\n\n\n\n 41030 San Prospero (Modena)<\/p>\n\n\n\n Italy or DELPHARM REIMS<\/p>\n\n\n\n 10 rue Colonel Charbonneaux<\/p>\n\n\n\n 51100 Reims<\/p>\n\n\n\n France Local representative<\/strong><\/p>\n\n\n\n STADA Nordic ApS<\/p>\n\n\n\n Marielundvej 46 A<\/p>\n\n\n\n 2730 Herlev<\/p>\n\n\n\n Denmark 40 mg enteric capsules, hard
<\/p>\n\n\n\nWhat you need to know before you use Esomeprazole STADA<\/h2>\n\n\n\n
Do not use Esomeprazole STADA<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
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<\/p>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
Other medicines and Esomeprazole STADA<\/h2>\n\n\n\n
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<\/p>\n\n\n\nPregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
<\/p>\n\n\n\nEsomeprazole STADA contains sucrose, propyl p-hydroxybenzoate (E216), and methyl p-hydroxybenzoate (E218)<\/h2>\n\n\n\n
How to use Esomeprazole STADA<\/h2>\n\n\n\n
<\/p>\n\n\n\nUse for children and adolescents<\/h2>\n\n\n\n
<\/p>\n\n\n\nIf you use more Esomeprazole STADA then you should <\/h2>\n\n\n\n
If you forget to use Esomeprazole STADA<\/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 STADA<\/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
<\/p>\n\n\n\nWhat the medicine looks like and the 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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