40 mg powder for solution for injection / infusion 
esomeprazole (in the form of sodium salt)

Read all of this leaflet carefully before you are given 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 may harm them, even if they show symptoms 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 Accord is and what it is used for 
2. What you need to know before you are given Esomeprazole Accord 
3. How to take Esomeprazole Accord 
4. Possible side effects 
5. How to store Esomeprazole Accord 
6. Contents of the packaging and other information 

1. What Esomeprazole Accord is and what it is used for

Esomeprazole Accord 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 Accord is used for short-term treatment of certain conditions that can not be treated orally. It is used to treat the following conditions:

Adults

  • Gastroesophageal reflux disease ( GERD ). This is a condition where stomach acid leaks into the esophagus (the tube that connects the throat to the stomach) and causes pain, inflammation, and heartburn.
  • A gastric ulcer caused by so-called NSAIDs (Non‑ Steroid Anti-Inflammatory Drugs). Esomeprazole can also be used to prevent the onset of stomach ulcers if you are taking NSAIDs.
  • Prevention of new bleeding after therapeutic endoscopy for acute, bleeding stomach ulcers or duodenal ulcers.

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 the Esomeprazole Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you are given Esomeprazole Accord

You should not be given Esomeprazole Accord

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

You must not be given esomeprazole if you are taking any of the above medicines. 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 Accord:

  • 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 Accord that reduces stomach acid
  • if you are going to have a specific blood test (chromogranin A).

Esomeprazole may mask symptoms of other diseases. Therefore, if any of the following occur before or after you receive esomeprazole, talk to your doctor straight away:

  • You lose a lot of weight for no reason and have trouble swallowing
  • You get a stomach ache or have problems with digestion
  • You start vomiting food or blood.
  • You have black stools (blood in the stools).

Ingestion of proton pump inhibitors such as Esomeprazole may slightly increase the risk of fractures in the hip and wrists and spine, especially if taken for more than a year. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which 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 Accord. Also remember to mention any other side effects, such as joint pain.

Other medicines and Esomeprazole Accord

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines. You should do this because esomeprazole may affect the way some medicines work and because some medicines may affect esomeprazole.

You must not be given Esomeprazole if you are taking any 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, as a muscle relaxant, or for epilepsy ).
  • Phenytoin (used in epilepsy ). If you are taking phenytoin, your doctor must monitor you when you start and stop taking esomeprazole.
  • Drugs are used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start and stop taking esomeprazole.
  • Cilostazol (used to treat intermittent claudication, “peephole” – pain in the legs when walking due to insufficient blood supply).
  • Cisapride (used for digestive problems and heartburn).
  • Digoxin (used for heart problems).
  • Methotrexate ( a high-dose chemotherapy drug used to treat cancer).
  • Tacrolimus (organ transplantation).
  • Rifampicin (used to treat tuberculosis ).
  • St. John’s wort (Hypericum perforatum) (used to treat depression).

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 Accord during that time.

It is not known whether esomeprazole passes into breast milk or not. You must therefore not be given esomeprazole if you are breast-feeding.

Driving and using machines

Esomeprazole is unlikely to affect your ability to drive or use other 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 Accord contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free’. is almost “sodium-free”.

How to take Esomeprazole Accord

Esomeprazole can be given to children and adolescents aged 1‑18 years as well as to adults including the elderly.

Getting Esomeprazole Accord

Use for adults

  • Esomeprazole will be given by your doctor to determine how much you need.
  • The recommended dose is 20 mg or 40 mg once a day.
  • If you have severe liver problems, the maximum dose is 20 mg a day ( GERD ).
  • The medicine is given as an injection or infusion into one of your blood vessels. This takes up to 30 minutes.
  • The recommended dose to prevent new bleeding from gastrointestinal ulcers is 80 mg, which is administered as an intravenous infusion over 30 minutes, followed by a continuous infusion of 8 mg / h given over 3 days. If you have severe liver problems, a continuous infusion of 4 mg / h given over 3 days may be sufficient.

Children and young people

  • Esomeprazole will be given by your doctor to determine how much you need.
  • Children 1‑11 years: the recommended dose is 10 or 20 mg once a day.
  • Children 12‑18 years: the recommended dose is 20 or 40 mg once a day.
  • The drug is given in the form of an injection or infusion into a blood vessel. This takes up to 30 minutes.

If you are given too much Esomeprazole Accord

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 think you have been given too much esomeprazole, talk to your doctor immediately.

4. Possible side effects

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

If you notice any of the following serious side effects, stop taking esomeprazole and contact your doctor immediately:

  • Sudden wheezing, swelling of the lips, tongue, and throat or body, rash, fainting, or difficulty swallowing (severe allergic reaction ).
  • Reddening of the skin with blisters or scaling. Severe blisters and bleeding from the lips, eyes, mouth, nose, and genitals may also occur. This could be “Steven Johnson’s syndrome” or “toxic epidermal necrolysis”.
  • Yellow skin, dark urine, and fatigue may 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 stomach or intestines: diarrhea, stomach 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)

  • Swollen feet and ankles.
  • Poor sleep (difficulty sleeping).
  • Dizziness, tingling, and tingling, drowsiness.
  • Spinning sensation ( vertigo ).
  • Vision problems such as blurred vision.
  • Dry mouth.
  • Altered liver function values.
  • Skin rash, hives, and itching.
  • Fracture of the hip, wrist, or spine (if esomeprazole is used in high doses for a long time).

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

  • Blood problems such as decreased number of white blood cells or platelets. This can lead to weakness and an increased tendency to get bruises and infections.
  • Low sodium levels in the blood. This can lead to weakness, vomiting, and cramps.
  • Feeling anxious, confused, or depressed.
  • Taste changes.
  • Sudden onset of wheezing or shortness of breath ( bronchospasm ).
  • Inflammation of the mouth.
  • A fungal infection that can affect the gastrointestinal tract and is caused by yeast.
  • Liver problems including jaundice which can cause yellow skin, dark urine, and fatigue.
  • Hair loss ( alopecia ).
  • Skin rash on exposure to the sun.
  • 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)

  • Altered blood counts including agranulocytosis (lack of white blood cells )
  • Aggression.
  • Visual, sensory, and hearing disorders (hallucinations).
  • Severe liver problems leading to liver failure and encephalitis.
  • Sudden onset of skin rash, blisters, or scaly skin. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis ).
  • Muscle weakness.
  • Serious kidney problems.
  • Breast augmentation in men.

Has been reported (occurs in an unknown number of people)

  • If you are on esomeprazole for more than three months, your blood magnesium levels may drop. Low magnesium levels can manifest themselves as extreme fatigue, involuntary muscle contractions (muscle contractions), disorientation, convulsions (spasmodic muscle twitching), dizziness, and increased heart rate. If you get any of these symptoms, please tell your doctor right away. Low magnesium levels can also lead to lowered potassium and calcium levels in the blood. Your doctor may decide to take regular blood tests to monitor your magnesium levels.
  • Inflammation of the gastrointestinal tract (leading to diarrhea).
  • Skin rash, possibly with joint pain.

In very rare cases, esomeprazole can affect the white blood cells, leading to a weakened immune system. 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 throwing water, you must contact your doctor as soon as possible, so that on white blood cells ( agranulocytosis ) can be ruled out by a blood test. You must provide information about your medication on such an occasion.

5. How to store Esomeprazole Accord

Keep this medicine out of the sight and reach of children.

The doctor and the hospital pharmacy are responsible for ensuring that the Esopremazole Accord is stored and delivered correctly.

Do not use this medicine after the expiry date which is stated on the carton or vial. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Keep the vial in the outer carton to protect it from light. However, the vials can be stored without an outer carton in normal indoor light for up to 24 hours.

Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 12 hours at 25 ° C. From a microbiological point of view, the drug should be used immediately. If not used immediately, in-use storage times and conditions before use are the responsibility of the user and would normally not be longer than 12 hours at 2-8 ° C, unless reconstitution has taken place under controlled and validated aseptic conditions.

Do not use this medicine if you notice that the medicine has deteriorated, eg if the porous cake has collapsed and the reconstituted solution contains small particles.

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

Content declaration

Esomeprazole Accord contains the active substance esomeprazole sodium.

Each vial of powder for solution for injection/infusion contains 42.5 mg of esomeprazole sodium, equivalent to 40 mg of esomeprazole.

The other ingredients are disodium edetate and sodium hydroxide. For further information on the sodium content, see section 2.

What the medicine looks like and the contents of the pack

Esomeprazole Accord is a white to off-white, porous cake or powder. This is mixed into a solution before it is given to you.

Esomeprazole Accord is available in 6 ml clear glass type I vials according to the European Pharmacopoeia, sealed with a gray bromobutyl rubber stopper and a purple aluminum detachable seal.

Pack sizes:

1 vial

10 vials

50 vials

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Manufacturer

Accord Healthcare Limited

Sage House,

319 Pinner Road,

North Harrow,

Middlesex, HA1 4HF,

UK

Wessling Hungary Kft.

Foot out 56

1047 Budapest

Hungary

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Muhammad Nadeem

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