\n\n40 mg powder for solution for injection \/ infusion
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 for short-term treatment of certain conditions when you can not be treated with oral ingestion. It is used to treat the following conditions:<\/p>\n\n\n\n
Children and adolescents 1-18 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. You should not be given Esomeprazole Stada:<\/strong><\/p>\n\n\n\n You should not be given Esomeprazole Stada if any of the above apply to you. If you are not sure, talk to your doctor or nurse before taking this medicine.<\/p>\n\n\n\n Talk to your doctor or nurse before giving Esomeprazole Stada about: Esomeprazole Stada may mask symptoms of other diseases. Therefore, if any of the following occur before or after you are given Esomeprazole Stada, contact your doctor immediately:<\/strong><\/p>\n\n\n\n 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 Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n This is because Esomeprazole Stada can affect the way other medicines work and other medicines can affect the effect of Esomeprazole Stada. You should not be given Esomeprazole STADA if you are taking a medicine containing nelfinavir (used to treat HIV – infection ). Tell your doctor or nurse if you are taking any of the following 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 be given Esomeprazole Stada during that time. It is not known if esomeprazole passes into breast milk. Therefore, you should not be given 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 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 This medicine contains less than 1 mmol (23 mg) sodium per vial before reconstitution, ie. Is next to “sodium-free”. Adults<\/em><\/p>\n\n\n\n <\/p>\n\n\n\n <\/p>\n\n\n\n Children aged 1 to 18 years<\/em><\/p>\n\n\n\n Contact your doctor immediately if you think you have been given too much Esomeprazole Stada. If you have ingested too much medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Do this even if you \/ the child does not notice any symptoms.<\/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:<\/strong> These side effects are rare and may affect up to 1 in 1,000 people. Other side effects include: Common<\/strong> (may affect up to 1 in 10 people)<\/p>\n\n\n\n Uncommon<\/strong>(may affect up to 1 in 100 people)<\/p>\n\n\n\n Rare<\/strong>(may affect up to 1 in 1,000 people)<\/p>\n\n\n\n <\/p>\n\n\n\n Very rare<\/strong>(may affect up to 1 in 10,000 people)<\/p>\n\n\n\n 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 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. Has been reported<\/strong> (occurs in an unknown number of users):<\/p>\n\n\n\n Do not worry about this list of possible side effects. You may not be affected by any of them. Keep this medicine out of the sight and reach of children. The doctor and pharmacy staff at the hospital are responsible for the correct storage, use, and disposal of Esomeprazole Stada. Do not use this medicine after the expiry date which is stated on the carton or vial after EXP. The expiration date is the last day of the specified month. Do not store above 30 \u00b0 C. Keep the vial in the outer carton. Sensitive to light. However, the vials can be stored outside the carton exposed to normal indoor light for up to 24 hours.<\/p>\n\n\n\n Esomeprazole Stada is a white to off-white powder cake or powder. This is made into a solution before it is given to you.<\/p>\n\n\n\n 10 ml vial of colorless borosilicate glass, type I. Stopper of bromobutyl rubber latex. aluminum cap and plastic flip-off seal.<\/p>\n\n\n\n Pack sizes: 1 vial , 1 x 10 vials. Not all pack sizes may be marketed.<\/p>\n\n\n\n STADA Arzneimittel AG<\/p>\n\n\n\n Stadastrasse 2-18<\/p>\n\n\n\n 61118 Bad Vilbel<\/p>\n\n\n\n Germany 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 powder for solution for injection \/ infusion
<\/p>\n\n\n\nWhat you need to know before using 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\nOther 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
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<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
<\/p>\n\n\n\nEsomeprazole Stada contains sodium<\/h2>\n\n\n\n
<\/p>\n\n\n\nHow to use Esomeprazole Stada<\/h2>\n\n\n\n
Use for children and adolescents<\/h2>\n\n\n\n
If you use more Esomeprazole Stada than you should <\/h2>\n\n\n\n
<\/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 Stada<\/h2>\n\n\n\n
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<\/p>\n\n\n\n6. 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 the contents of the pack<\/h2>\n\n\n\n
<\/p>\n\n\n\nMarketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
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