40 mg powder for solution for injection / infusion 
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.
  • 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.

This leaflet contains information about: 
1. What Esomeprazole Stada is and what it is used for 
2. What you need to know before you take Esomeprazole Stada 
3. How to take Esomeprazole Stada 
4. Possible side effects 
5. How to store Esomeprazole Stada 
6. Contents of the pack and other information 

What Esomeprazole Stada is and what it is used for

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.

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:

  • 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
  • A gastric ulcer is caused by so-called NSAIDs (Non-steroidal anti-inflammatory drugs). Esomeprazole Stada may also be used to prevent the formation of ulcers when taking NSAIDs -läkemedel
  • Prevent new bleeding after therapeutic endoscopy in acute bleeding wounds in the stomach or duodenum

Children and adolescents 1-18 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.

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.

What you need to know before using Esomeprazole Stada

Do not use Esomeprazole Stada

You should not be given Esomeprazole Stada:

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

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.

Warnings and cautions

Talk to your doctor or nurse before giving Esomeprazole Stada about:

  • you have severe liver problems
  • you have severe kidney problems
  • if you have ever had a skin reaction after treatment with medicine like Esomeprazole Stada that reduces stomach acid
  • 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 or after you are given Esomeprazole Stada, 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.

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.

Other medicines and Esomeprazole Stada

Tell your doctor or nurse 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.

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:

  • Atazanavir (used for the treatment of HIV – infection ).
  • Clopidogrel (used to prevent blood clots).
  • 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 when you start or stop taking Esomeprazole Stada.
  • Drugs used for blood thinning, such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazole Stada.
  • Cilostazol (used to treat window disease –
  • Cisapride (used for indigestion or heartburn).
  • Digoxin (used for heart problems).
  • Methotrexate (a high-dose chemotherapy drug used to treat cancer) – If you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Esomeprazole Stada.
  • Tacrolimus (organ transplantation).
  • Rifampicin (used to treat tuberculosis ).
  • St. John’s wort – Hypericum perforatum (used to treat mild depression and mild anxiety).

Pregnancy, breastfeeding, and fertility

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.

Driving and using machines

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.

Esomeprazole Stada contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per vial before reconstitution, ie. Is next to “sodium-free”.

How to use Esomeprazole Stada

Adults

  • Esomeprazole Stada will be given to you by a doctor who will decide how much you need.
  • The recommended dose is 20 mg or 40 mg once daily.
  • If you have severe liver problems, the maximum dose is 20 mg daily ( GERD ).
  • The medicine will be given to you as an injection or infusion into one of your veins. This will last for up to 30 minutes.
  • The recommended dose to prevent new bleeding in ulcers of the stomach or duodenum is 80 mg given as an intravenous infusion over 30 minutes followed by a continuous infusion of 8 mg per hour for 3 days.
  • If you have severe liver problems, the dose for continuous infusion may be reduced to 4 mg per hour for 3 days.

Use for children and adolescents

Children aged 1 to 18 years

  • You will be given Esomeprazole Stada by your doctor, who will decide how much you need.
  • For children aged 1 to 11 years, the recommended dose is 10 or 20 mg once daily.
  • For children aged 12 to 18 years, the recommended dose is 20 or 40 mg once daily.
  • The medicine is given to you as an injection or infusion into a vein (a blood vessel). It takes up to 30 minutes.

If you use more Esomeprazole Stada than you should  

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.

4. Possible side effects

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:

  • Sudden wheezing, swelling of the lips, tongue, and throat or body, rash, fainting, or difficulty swallowing (severe allergic reaction ).
  • Redness of the skin with blistering or flaking. Severe blistering and bleeding on the lips, eyes, mouth, nose, and genitals may also occur. This can be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
  • Yellowed skin, dark urine, and fatigue can be symptoms of liver problems.

These side effects are rare and may affect up to 1 in 1,000 people.

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.
  • Nausea or vomiting.
  • The reaction at the injection site.
  • Benign polyps are in the stomach.

Uncommon(may affect up to 1 in 100 people)

  • Swelling of the feet and ankles.
  • Sleep disorders (insomnia).
  • Dizziness, tingling, drowsiness.
  • Scams ( vertigo ).
  • Vision problems, such as blurred vision.
  • Dry mouth.
  • Changes in the blood picture show the function of the liver.
  • Skin rash, hives, and itching.
  • Hip, wrist, or vertebral fractures (if Esomeprazole Stada is used in high doses and for a long time).

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

  • Altered blood count such as reduced number of white blood cells or platelets. This may cause weakness, bruising, or susceptibility to infection.
  • Low levels of sodium in the blood. This can cause weakness, vomiting, and cramps.
  • Feeling of agitation, confusion, or depression.
  • Taste changes.
  • Sudden wheezing or shortness of breath ( bronchospasm ).
  • Inflammation of the oral cavity.
  • A fungal infection called “cod” can affect the intestines.
  • Liver problems including jaundice, which can cause yellowing of the skin, dark urine, and fatigue.
  • 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)

  • Changes in the blood picture including agranulocytosis (lack of white blood cells ).
  • Aggression.
  • See, feel or hear things that do not exist (hallucinations).
  • Severe liver problems leading to liver failure and encephalitis.
  • Sudden onset of severe rash, blistering or flaky skin. This may be associated with high fever and joint pain (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis ).
  • Muscle weakness.
  • Severe kidney problems.
  • Enlargement of the mammary glands in men.

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 (occurs in an unknown number of users):

  • If you use Esomeprazole Stada 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, contact your doctor immediately. Low levels of magnesium can also lead to decreased levels of potassium or calcium in the blood. Your doctor may measure the level of magnesium in your blood using regular blood tests.
  • Inflammation of the intestine (causes diarrhea).
  • If you have very low levels of magnesium, you may also have low levels of calcium in your blood.
  • Skin rash, possibly with joint pain.

Do not worry about this list of possible side effects. You may not be affected by any of them.

5. How to store Esomeprazole Stada

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 ° 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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is esomeprazole sodium. Each vial of powder for solution for injection or infusion contains 42.5 mg of esomeprazole sodium, equivalent to 40 mg of esomeprazole.
  • The other ingredients are disodium edetate and sodium hydroxide (for adjustment).

What the medicine looks like and the contents of the pack

Esomeprazole Stada is a white to off-white powder cake or powder. This is made into a solution before it is given to you.

10 ml vial of colorless borosilicate glass, type I. Stopper of bromobutyl rubber latex. aluminum cap and plastic flip-off seal.

Pack sizes: 1 vial , 1 x 10 vials.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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