\n\n40 mg powder for solution for injection \/ infusion
esomeprazole<\/p>\n\n\n\n
Esomeprazole SUN Pharma contains a drug called esomeprazole. It belongs to a group of medicines called “proton pump inhibitors”. They work by reducing the amount of acid produced in the stomach.
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Esomeprazole SUN Pharma 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:
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Adults<\/strong><\/p>\n\n\n\n Children and adolescents 1-18 years<\/strong><\/p>\n\n\n\n Esomeprazole contained in Esomeprazole SUN Pharma may also be approved 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. You should not be given Esomeprazole SUN Pharma if any of the above apply to you. If you are not sure, talk to your doctor before taking this medicine.<\/p>\n\n\n\n Talk to your doctor before giving Esomeprazole SUN Pharma about:<\/p>\n\n\n\n Esomeprazole SUN <\/strong>Pharma <\/strong>may mask symptoms of other diseases. Talk to your doctor immediately if any of the following occur before or after you receive Esomeprazole SUN Pharma:<\/strong><\/p>\n\n\n\n The use of proton pump inhibitors such as Esomeprazole SUN Pharma and especially if you use Esomeprazole SUN for more than one year may increase the risk of hip, wrist, or vertebral fractures. Tell your doctor<\/strong> 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 SUN Pharma. 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, including medicines obtained without a prescription. This is because Esomeprazole SUN Pharma may affect the way other medicines work and other medicines may affect the effect of Esomeprazole SUN Pharma. You should not be given Esomeprazole SUN Pharma if you are taking a medicine containing nelfinavir<\/strong> (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 SUN Pharma during that time. It is not known if Esomeprazole SUN Pharma passes into breast milk. Therefore, you should not be given Esomeprazole SUN Pharma if you are breast-feeding.<\/p>\n\n\n\n Esomeprazole SUN Pharma 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. This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. Esomeprazole SUN Pharma can be given to children and adolescents aged 1 to 18 years and adults, including the elderly. Getting Esomeprazole SUN Pharma<\/strong><\/p>\n\n\n\n Adults<\/em><\/strong><\/p>\n\n\n\n Children aged 1-18 years<\/em><\/strong><\/p>\n\n\n\n Contact your doctor immediately if you think you have been given too much Esomeprazole SUN Pharma.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects are<\/strong><\/p>\n\n\n\n If you notice any of the following serious side effects, contact your doctor immediately:<\/strong><\/p>\n\n\n\n These side effects are rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 users). Other side effects are<\/strong><\/p>\n\n\n\n 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 In very rare cases, esomeprazole SUN Pharma can affect the white blood cells so that the immune system is weakened. You must contact a doctor immediately<\/strong> if you get an infection with symptoms such as fever and severe general malaise, fever with symptoms of local infection such as pain in the neck, throat, or mouth, or difficulty urinating so that any lack of white blood cells ( agranulocytosis ) can be ruled out through a blood test. It is important that you then information about your medication. 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 or vial after EXP. The expiration date is the last day of the specified month. Do not store above 30 \u00b0 C. Store in the original package. Sensitive to light.<\/p>\n\n\n\n After reconstitution: Store in a cool place.<\/p>\n\n\n\n The product should be used immediately. The doctor and pharmacist at the hospital are responsible for storing, using, and disposing of Esomeprazole SUN Pharma. Do not use this medicine if you notice a visual change of the medicine (only a clear solution should be used). 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.<\/p>\n\n\n\n Esomeprazole SUN Pharma is a white or almost white porous and uniform lyophilized powder. It is packaged in a colorless 10 ml glass vial with gray chlorobutyl rubber stopper and aluminum seal and contains 40 mg powder for solution for injection\/infusion.<\/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 Laboratories NORMON, SA<\/p>\n\n\n\n Ronda de Valdecarrizo 6<\/p>\n\n\n\n 28760 Tres Cantos, Madrid<\/p>\n\n\n\n Spain 40 mg powder for solution for injection \/ infusion
<\/p>\n\n\n\nWhat you need to know before you use Esomeprazole SUN Pharma<\/h2>\n\n\n\n
You should NOT be given Esomeprazole SUN Pharma if:<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
<\/p>\n\n\n\nOther medicines and Esomeprazole SUN Pharma<\/h2>\n\n\n\n
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<\/p>\n\n\n\nPregnancy and breastfeeding<\/h2>\n\n\n\n
<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
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<\/p>\n\n\n\nEsomeprazole SUN Pharma contains sodium<\/h2>\n\n\n\n
<\/p>\n\n\n\n3. How Esomeprazole SUN Pharma is given<\/h2>\n\n\n\n
<\/p>\n\n\n\nIf you are given too much 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 Pharma<\/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
Marketing Authorisation Holder<\/h2>\n\n\n\n
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