40 mg powder for solution for injection / infusion 
esomeprazole

Read all of this leaflet carefully before you start using 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.

In this leaflet: 
1. What Esomeprazole SUN Pharma is and what it is used for 
2. What you need to know before you take Esomeprazole SUN Pharma 
3. How Esomeprazole SUN Pharma is given 
4. Possible side effects 
5. How Esomeprazole SUN Pharma should be stored 
6. Contents of the packaging and other information 

What Esomeprazole SUN Pharma is and what it is used for

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.

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:

Adults

  • 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 SUN Pharma can also be used to prevent stomach ulcers when you are taking NSAIDs.
  • Prevent new bleeding in adults after treatment 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 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.

What you need to know before you use Esomeprazole SUN Pharma

You should NOT be given Esomeprazole SUN Pharma if:

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

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.

Warnings and cautions

Talk to your doctor before giving Esomeprazole SUN Pharma about:

  • you have severe liver problems
  • you have severe kidney problems.
  • you have ever had a skin reaction after treatment with a medicine similar to Esomeprazole SUN Pharma that reduces stomach acid.
  • you should undergo a specific blood test (chromogranin A).

Esomeprazole SUN Pharma 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:

  • 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.

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 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.

Other medicines and Esomeprazole SUN Pharma

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 (used to treat HIV – infection ).

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

  • atazanavir (used in 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, for muscle relaxation, or for epilepsy )
  • phenytoin (used in epilepsy ). If you are taking phenytoin, your doctor will need to monitor when you start or stop taking Esomeprazole SUN Pharma.
  • drugs used for blood thinning, such as warfarin. Your doctor may need to monitor when you start or stop receiving Esomeprazole SUN Pharma.
  • Cilostazol (used to treat window disease – pain in the legs when walking due to insufficient blood supply to the legs)
  • cisapride (used for digestive problems or heartburn)
  • Digoxin (used for heart problems)
  • Methotrexate (a chemotherapeutic drug used in high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may pause your treatment with Esomeprazole SUN Pharma
  • Tacrolimus (used in organ transplantation)
  • Rifampicin (used to treat tuberculosis )
  • St. John’s wort – Hypericum perforatum (used to treat depression).

Pregnancy and breastfeeding

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.

Driving and using machines

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.

Esomeprazole SUN Pharma contains sodium

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

3. How Esomeprazole SUN Pharma is given

Esomeprazole SUN Pharma can be given to children and adolescents aged 1 to 18 years and adults, including the elderly.

Getting Esomeprazole SUN Pharma

Adults

  • Esomeprazole SUN Pharma 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 (drip) 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 given over 3 days. If you have severe liver problems, the dose for continuous infusion may be reduced to 4 mg per hour for 3 days.

Children aged 1-18 years

  • You will receive Esomeprazole SUN Pharma from 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 one 20 or 40 mg once daily,
  • The drug is given as an injection or infusion (drip) into a vein (a blood vessel). It takes up to 30 minutes.

If you are given too much Esomeprazole SUN

Contact your doctor immediately if you think you have been given too much Esomeprazole SUN Pharma.

4. Possible side effects

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

Serious side effects are

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

  • 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. These may be symptoms of “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
  • yellowed skin, dark urine, and fatigue, which can be symptoms of liver problems.

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

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 in the stomach.

Uncommon (may affect up to 1 in 100 people)

  • swelling in the feet and ankles
  • sleep disorders (insomnia)
  • dizziness, tingling, drowsiness
  • vertigo ( vertigo )
  • vision problems, such as blurred vision
  • dry mouth
  • changes in the blood picture that show the function of the liver
  • skin rash, hives, and itching
  • Hip, wrist, or vertebral fractures (if Esomeprazole SUN Pharma 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.
  • the feeling of upset, confusion, or depression
  • taste changes
  • sudden wheezing or shortness of breath ( bronchospasm )
  • inflammation of the oral cavity
  • a fungal infection called “cod” that can affect the gut
  • 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 blood count including agranulocytosis (lack of white blood cells )
  • aggression
  • hallucinations (see, feel, or hear things that do not exist)
  • severe liver problems leading to liver failure and encephalitis
  • muscle weakness
  • severe kidney problems
  • Enlargement of the mammary glands in men

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

  • Low levels of magnesium in the blood can manifest as fatigue, involuntary muscle movements, confusion, cramps, dizziness, and rapid heartbeat. This is more likely if you have used Esomeprazole SUN Pharma for more than three months. 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).
  • Skin rash, possibly with joint pain.

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 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.

5. How to store Esomeprazole SUN Pharma

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 ° C. Store in the original package. Sensitive to light.

After reconstitution: Store in a cool place.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is esomeprazole sodium. Each bottle 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 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.

  • pack of 1 vial
  • pack of 10 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer

Laboratories NORMON, SA

Ronda de Valdecarrizo 6

28760 Tres Cantos, Madrid

Spain

Muhammad Nadeem

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