20 mg hard enteric capsules. 40 mg hard enteric capsules. 
esomeprazole

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Esomeprazole Mylan is and what it is used for 
2. What you need to know before you use Esomeprazole Mylan 
3. How to use Esomeprazole Mylan 
4. Possible side effects 
5. How to store Esomeprazole Mylan 
6. Package contents and other information 

What Esomeprazole Mylan is and what it is used for

Esomeprazole Mylan 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.

Esomeprazole Mylan is used to treat the following conditions:

Adults and adolescents from 12 years:

  • Gastroesophageal reflux disease ( GERD ). This is when acid from the stomach leaks into the esophagus (the connection between the mouth and the stomach) and causes pain, inflammation, and heartburn.
  • Ulcers in the stomach or upper intestine are infected by a bacterium called ” Helicobacter pylori”. If you have such wounds, your doctor may also prescribe antibiotics to treat the infection and to allow wound healing.

Adults:

  • A gastric ulcer is caused by so-called NSAIDs (Non-steroidal anti-inflammatory drugs). Esomeprazole Mylan can also be used to prevent stomach ulcers when taking NSAIDs.
  • Too much acid in the stomach is caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
  • Continued treatment to prevent new bleeding from wounds after treatment with intravenous Esomeprazole Mylan.

Esomeprazole contained in Esomeprazole Mylan 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.

What you need to know before you use Esomeprazole Mylan

Do not use Esomeprazole Mylan

  • if you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to a group of medicines called benzimidazoles that include other proton pump inhibitors (eg pantoprazole, lansoprazole, rabeprazole, omeprazole) and other types of medicines.
  • if you are taking a medicine containing nelfinavir (used to treat HIV – infection ).

Do not take Esomeprazole Mylan if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazole Mylan.

Warnings and cautions

Talk to your doctor or pharmacist before taking Esomeprazole Mylan:

  • if you have severe liver problems.
  • if you have severe kidney problems.
  • if you have ever had a skin reaction after treatment with medicine like Esomeprazole Mylan that reduces stomach acid.
  • if you are going to have a specific blood test (chromogranin A)

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 Mylan. Also, remember to mention any other side effects such as joint pain.

The use of proton pump inhibitors such as esomeprazole and especially if you use esomeprazole for more than a year may increase the risk of a hip, wrist, or vertebral fracture. Tell your doctor if you have osteoporosis ( osteoporosis ) or if you use medicines called corticosteroids because they may increase the risk of osteoporosis.

Esomeprazole Mylan may also reduce the uptake of vitamin B-12, especially during long-term treatment.

Esomeprazole Mylan may mask the symptoms of other diseases. If any of the following occur before you start taking this medicine or while you are taking it, you should contact your doctor immediately:

  • You lose a lot of weight for no reason and have trouble swallowing.
  • You get stomach pains or indigestion.
  • You start vomiting food or blood.
  • You get black (blood-mixed) stools.

If your doctor has prescribed Esomeprazole Mylan to take “as needed”, contact your doctor if your symptoms persist or change in nature.

Other medicines and Esomeprazole Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This is because Esomeprazole Mylan may affect the way other medicines work and other medicines may affect the effect of Esomeprazole Mylan.

Do not take Esomeprazole Mylan if you are taking nelfinavir-containing medicines (used to treat HIV ) at the same time.

Tell your doctor or pharmacist if you are taking any of the following medicines:

  • Atazanavir (used to treat HIV ).
  • Ketoconazole , itraconazole or voriconazole (used to treat fungal infections).
  • Erlotinib (used to treat cancer)
  • Citalopram, imipramine, or clomipramine (used to treat depression).
  • Diazepam (used to treat anxiety, muscle relaxation, or epilepsy ).
  • Phenytoin (used in epilepsy ). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Esomeprazole Mylan.
  • Drugs used for blood thinning, e.g. warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazole Mylan.
  • Cilostazol (used to treat intermittent claudication – a pain in the legs when walking caused by an insufficient blood supply).
  • Cisapride (used for indigestion or heartburn).
  • Clopidogrel (used to prevent blood clots).
  • Digoxin (used for heart problems).
  • Tacrolimus (used to suppress the immune system to prevent rejection of transplanted organs or to treat skin reactions such as eczema ).
  • Methotrexate (a high-dose cytotoxic drug used to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your treatment with Esomeprazole Mylan.
  • Rifampicin (used to treat tuberculosis ).
  • St. John’s wort – Hypericum perforatum (used to treat depression).

If your doctor has prescribed antibiotics amoxicillin and clarithromycin, coupled with Esomeprazole Mylan to treat ulcers caused by Helicobacter pylori – infection, you must tell your doctor if you are also taking other medicines.

Pregnancy and breastfeeding

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. Your doctor will decide if you can take Esomeprazole Mylan during that time.

It is not known if esomeprazole passes into breast milk. Therefore, you should not take Esomeprazole Mylan if you are breast-feeding.

Driving and using machines

Esomeprazole Mylan may cause side effects such as dizziness or blurred vision. If you are affected, do not drive or use any tools or machines.

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.

Esomeprazole Mylan contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, such as sucrose, talk to your doctor before taking this medicine.

3. How to use Esomeprazole Mylan

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

  • Esomeprazole Mylan is not recommended for children under 12 years of age.
  • If you use this medicine for a long time, your doctor will want to follow up on your treatment (especially if you are taking the medicine for more than a year).
  • If you have been told by your doctor that you must take this medicine, tell your doctor if your symptoms change.

Taking the medicine

  • You can take the capsules at any time of the day.
  • You can take the capsules with food or on an empty stomach.
  • Swallow your capsules whole along with water. Do not chew or crush the capsules. This is because the capsules contain coated granules that prevent the medicine from being broken down by the acid in the stomach. The granules mustn’t be damaged.

What you can do if you have difficulty swallowing the capsules

If you have problems swallowing the capsules:

  • Open the capsule and empty the granules into half a glass (not carbonated) water. Do not use other liquids.
  • Drink mixture immediately or within 30 minutes. Always stir the mixture immediately before drinking it.
  • To be sure that you have ingested all the medicine, rinse the glass thoroughly with another half glass of water and drink it up. The solid particles contain the medicine – do not chew or crush them.

If you can not swallow at all, the capsules can be mixed with a little water and placed in a syringe. Mixture one can then be given directly into the stomach via a probe.

How much should you take?

Your doctor will tell you how many capsules to take and how long to take them. This depends on your condition, how old you are, and how well your liver is working. If you have a severe hepatic impairment, your doctor may recommend a lower dose.

The recommended dose is listed below.

For the treatment of heartburn caused by gastroesophageal reflux disease ( GERD ):

Adults and children from 12 years:

  • If your doctor has found that your esophagus is slightly damaged, the recommended dose is one Esomeprazole Mylan 40 mg capsule once daily for 4 weeks. Your doctor may recommend that you take the same dose for another 4 weeks if the damage to your esophagus is not healed.
  • The recommended dose after the esophagus has healed is an Esomeprazole Mylan 20 mg capsule once daily.
  • If your esophagus is not damaged, the recommended dose is one Esomeprazole Mylan 20 mg capsule once daily. When your condition is under control, your doctor may recommend that you take the medicine up to a maximum of one Esomeprazole Mylan 20 mg capsule once daily if necessary.

To treat ulcers caused by Helicobacter pylori – infection and to prevent the ulcer from occurring again:

  • Adults and adolescents from 12 years of age: the recommended dose is an Esomeprazole Mylan 20 mg capsule twice daily for one week.
  • Your doctor will also recommend that you take antibiotics called amoxicillin and clarithromycin.

For the treatment of stomach ulcers caused by NSAIDs (Non-steroidal anti-inflammatory drugs):

  • Adults from 18 years of age: the recommended dose is an Esomeprazole Mylan 20 mg capsule once daily for 4 to 8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (Non-steroidal anti-inflammatory drugs):

  • Adults from 18 years of age: the recommended dose is an Esomeprazole Mylan 20 mg capsule once daily.

For the treatment of excess acid in the stomach caused by a tumor of the pancreas (Zollinger-Ellison syndrome):

  • Adults from 18 years of age: the recommended dose is an Esomeprazole Mylan 40 mg capsule twice daily.
  • Your doctor will adjust the dose according to your needs and will also decide how long you should take the medicine. The maximum dose is 80 mg twice daily.

Continued treatment to prevent new bleeding from wounds after treatment with intravenous esomeprazole:

  • Adults from 18 years of age: The recommended dose is an Esomeprazole Mylan 40 mg capsule once daily for 4 weeks.

If you take more Esomeprazole Mylan then you should

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 Mylan

  • If you forget to take a dose, take it as soon as you notice it. If it is near the time of the next dose – skip the missed dose.
  • Do not take a double dose (two doses at the same time) to compensate for a missed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Esomeprazole Mylan and contact your doctor immediately if you notice any of the following serious side effects:

Less common (may affect up to 1 in 100 people):

  • Hip, wrist, or vertebral fractures (if Esomeprazole Mylan is used in high doses and for a long time).

Rare (may affect up to 1 in 1,000 people):

  • Sudden wheezing, swelling of the lips, tongue, and throat or body, rash, fainting, or difficulty swallowing or breathing (severe allergic reaction ).
  • Yellowed skin, dark urine, light stools with fever, nausea or vomiting, and fatigue which may be signs of liver problems.
  • Low white blood cell counts, which may lead to severe general malaise or fever with symptoms of local infection, such as pain in the neck, throat, or mouth or difficulty urinating.

Very rare (may affect up to 1 in 10,000 people):

  • Redness of the skin with blistering or flaking. Severe blistering and bleeding on the lips, eyes, mouth, nose,e, and genitals with joint pain and high fever may also occur. This can be “erythema multiforme”, “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
  • Changes in the number of certain blood cells causing fatigue, weakness, or pallor (low red blood cell count ), bruising, and bleeding more often than usual, or bleeding lasting longer than normal (low platelet count ).
  • Decreased amount of urine or inability to urinate, blood or mucus in the urine, pain in the lower back possibly with skin rash, fever, nausea, or vomiting. These can be signs of kidney problems.
  • Patients with liver problems may have worsening symptoms that can lead to brain swelling. This can cause changes in concentration, personality or behavior, concentration or thought problems, drowsiness, or drowsiness.

No known frequency (cannot be calculated from the available data):

  • Inflammation of the intestine causes pain and (possibly bloody) diarrhea.
  • Skin rash, possibly with joint pain.

Other side effects include:

Common (may affect up to 1 in 10 people)

  • Headache.
  • Effects on the stomach or intestines: diarrhea, abdominal pain, constipation, flatulence, benign polyps in the stomach.
  • Nausea or vomiting.

Less common (may affect up to 1 in 100 people)

  • Swelling of the feet and ankles.
  • Sleep disorders (insomnia).
  • Dizziness, tingling, drowsiness.
  • Scams ( vertigo ).
  • Dry mouth.
  • Changes in the blood picture show the function of the liver.
  • Skin rash, hives, and itching.

Rare (may affect up to 1 in 1,000 people)

  • Low levels of sodium in the blood. This can cause weakness, vomiting, and cramps.
  • Feeling of agitation, confusion, or depression.
  • Taste changes.
  • Vision problems, such as blurred vision.
  • Sudden wheezing or shortness of breath ( bronchospasm ).
  • Inflammation of the oral cavity.
  • A fungal infection called “cod” can affect the intestines.
  • Hair loss ( alopecia ).
  • Skin rash when sunbathing.
  • Joint pain ( arthralgia ) or muscle pain ( myalgia ).
  • General malaise and lack of energy.
  • Increased sweating.

Very rare (may affect up to 1 in 10,000 people)

  • Aggression.
  • Hallucinations (seeing, feeling or h, hearing things that do not exist).
  • Muscle weakness.
  • Enlargement of the mammary glands in men.

No known frequency (cannot be calculated from the available data)

  • If you use Esomeprazole Mylan for more than three months, your blood magnesium levels may drop. Low levels of magnesium can manifest as fatigue, involuntary muscle movements, confusion, cramps, dizziness, and rapid heartbeat. If you get any of these symptoms, consult a doctor immediately. Low levels of magnesium can also lead to decreased levels of potassium and calcium in the blood. Your doctor may measure the level of magnesium in your blood using regular blood tests.

5. How to store Esomeprazole Mylan

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 can label, carton or blister after EXP. The expiration date is the last day of the specified month.

Blister: Do not store above 25 ° C. Store in the original package. Moisture sensitive.

Jar: Do not store above 25 ° C. Close the jar tightly. Moisture sensitive. Used within 3 months after opening.

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.

6. Contents of the packaging and other information

What Esomeprazole Mylan contains

The active substance is esomeprazole. Esomeprazole Mylan hard enteric capsules are available in two strengths containing 20 mg or 40 mg of esomeprazole (as esomeprazole magnesium).

Other ingredients are:

  • Core: sugar spheres (sucrose and corn starch), crospovidone, hydroxypropylcellulose, sodium hydroxide
  • Inner shell: mannitol, sucrose
  • Gastric juice resistant shell: methacrylic acid-ethyl acrylate polymer (1: 1) dispersion 30%, triethyl citrate, glycerol monostearate, polysorbate 80
  • Lubricant: talc

Other ingredients in the capsule shell are red iron oxide E 172, yellow iron oxide E 172 (only 40 mg), titanium dioxide E171, gelatin, sodium lauryl sulfate.

Other ingredients in the label ink are shellac, propylene glycol, black iron oxide E 172, and potassium hydroxide.

What the medicine looks like and contents of the pack

Esomeprazole Mylan 20 mg are hard gelatin capsules with a pink top and bottom, marked with ‘Mylan’ over ‘EM 20’ with black ink on the top and bottom, filled with white to off-white grains.

Manufacturer:

McDermott Laboratories Ltd t / a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Generics [UK] Ltd, Station Close, Potters Bar, EN6 1TL, UK.

Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary

Muhammad Nadeem

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