20 mg, 40 mg enteric-tablet is 
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 or pharmacist

– 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 or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Esomeprazole SUN is and what it is used for 
2. What you need to know before taking Esomeprazole SUN 
3. How to use Esomeprazole SUN 
4. Possible side effects 
5. How to store Esomeprazole SUN 
6. Contents of the packaging and other information 

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

Esomeprazole SUN 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 SUN 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.
  • 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.
  • A gastric ulcer is caused by so-called NSAIDs (Non-steroidal anti-inflammatory drugs). Esomeprazole SUN can also be used to prevent the appearance of stomach ulcers or ulcers in the upper intestine 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.

Young people 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.

Esomeprazole contained in Esomeprazole SUN 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.

What you need to know before taking Esomeprazole SUN

Do not take Esomeprazole SUN again

  • 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, lanzoprazole, rabeprazole, omeprazole).
  • you are taking a medicine that contains nelfinavir (used to treat HIV ).

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Esomeprazole SUN if:

  • 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 that reduces stomach acid.
  • you should undergo 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 treatment with Esomeprazole SUN. Also remember to mention any other side effects, such as joint pain.

Esomeprazole SUN may mask the symptoms of other diseases. Therefore, if any of the following occur before you start taking Esomeprazole SUN or while you are taking it, 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 you have been prescribed Esomeprazole SUN to take “as needed”, consult your doctor if your symptoms persist or change in nature.

Using a proton pump inhibitor such as Esomeprazole SUN and especially if you have been using Esomeprazole SUN for more than a year may increase the risk of a hip, wrist, or vertebral fracture (bone fracture). Tell your doctor if you have osteoporosis ( osteoporosis ) or if you use medicines called corticosteroids because they may increase the risk of osteoporosis.

Other medicines and Esomeprazole SUN

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Esomeprazole SUN can affect the way other medicines work and other medicines can affect the effect of Esomeprazole SUN.

Do not take Esomeprazole SUN if you are also taking medicines containing nelfinavir ( used to treat HIV ).

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

  • Atazanavir (used to treat HIV ).
  • 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 you when you start or stop taking Esomeprazole SUN.
  • Drugs used for blood thinning, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazole SUN. 
  • Cilostazol (used to treat window disease – pain in the legs when walking due to insufficient blood supply to the legs)
  • Cisapride (used for indigestion 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
  • Tacrolimus (organ transplant)
  • Rifampicin (used to treat tuberculosis )
  • St. John’s wort – Hypericum perforatum (used to treat depression)

If the doctor has prescribed the antibiotics amoxicillin and clarithromycin, coupled with Esomeprazole SUN for the treatment of ulcers caused by Helicobacter pylori – infection, you must tell your doctor if you take other medicines.

Esomeprazole SUN with food, drink, and alcohol

You can take your tablets with a meal or on an “empty stomach”.

Pregnancy, breastfeeding, and fertility

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 SUN during that time.

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

Driving and using machines

Esomeprazole SUN is unlikely to affect your ability to drive or handle tools or machines. However, side effects such as dizziness and visual disturbances may occur in uncommon or rare 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 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 SUN contains sucrose

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

3. How to use Esomeprazole SUN

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

  • 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.

How much should you take?

  • Your doctor will tell you how many tablets to take and how long to take them. Dosage one depends on your condition, how old you are, and how well your liver is working.
  • Normal doses are given below.

Adults from 18 years

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

  • If your doctor has found that your esophagus is slightly damaged, the recommended dose is one Esomeprazole SUN 40 mg enteric tablet 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 one after the esophagus is healed is an Esomeprazole SUN 20 mg enteric tablet once daily.
  • If your esophagus is not damaged, the recommended dose is one Esomeprazole SUN 20 mg enteric tablet once daily. When your condition is under control, your doctor may recommend that you take the medicine up to a maximum of one Esomeprazole SUN 20 mg enteric tablet once a day if necessary.
  • If you have a severe hepatic impairment, your doctor may recommend a lower dose.

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

  • The recommended dose is an Esomeprazole SUN 20 mg enteric tablet twice daily for one week.
  • Your doctor will also recommend that you take antibiotics such as amoxicillin and clarithromycin.

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

  • The recommended dose is an Esomeprazole SUN 20 mg enteric tablet once daily for 4 to 8 weeks.

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

  • The recommended dose is one Esomeprazole SUN 20 mg enteric tablet once daily.

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

  • The recommended dose is Esomeprazole SUN 40 mg 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 SUN:

  • The recommended dose is an Esomeprazole SUN 40 mg enteric tablet once daily for 4 weeks.

Young people from 12 years

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

  • If your doctor has found that your esophagus is slightly damaged, the recommended dose is one Esomeprazole SUN 40 mg enteric tablet 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 one after the esophagus is healed is an Esomeprazole SUN 20 mg enteric tablet once daily.
  • If your esophagus is not damaged, the recommended dose is one Esomeprazole SUN 20 mg enteric tablet once daily.
  • If you have a severe hepatic impairment, your doctor may recommend a lower dose.

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

  • The recommended dose is an Esomeprazole SUN 20 mg enteric tablet twice daily for one week.
  • Your doctor will also recommend that you take antibiotics such as amoxicillin and clarithromycin.

Taking the medicine

  • You can take the tablets at any time of the day.
  • You can take the tablets with food or on an empty stomach.
  • Swallow your tablets whole along with a little water. Do not chew or crush the tablets. This is because the tablets 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 tablets

  • If you have problems swallowing the tablets:
    • Put them in glass (not carbonated) water. Do not use other liquids.
    • Stir until the tablets break ( mixture one will not be ready). Drink the mixture immediately or within 30 minutes. Always stir the mixture immediately before drinking it.
    • Put them in glass (not carbonated) water. Do not use other liquids.
    • 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 tablets 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.

Children under 12 years

Esomeprazole SUN enteric tablets are not recommended for children under 12 years of age.

Older

Dose adjustment is not necessary for elderly patients.

If you take more Esomeprazole SUN then you should

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Esomeprazole SUN

  • 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.

Serious side effects are

If you notice any of the following serious side effects, stop taking Esomeprazole SUN and 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. 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 occur in less than 1 in 1,000 people.

Other side effects include:

Common (affects less than 1 in 10 people)

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

Uncommon (affects less than 1 in 100 people)

  • Swelling of the feet and ankles.
  • Sleep disorders (insomnia).
  • Dizziness, tingling, drowsiness.
  • Scams ( vertigo ).
  • Dry mouth.
  • Changes in blood test results that show liver function.
  • Skin rash, hives, and itching.
  • Hip, wrist, or vertebral fractures (if Esomeprazole SUN is used in high doses and for a long time).

Rare (affects less than 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.
  • 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.
  • 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 (affects less than 1 in 10,000 people)

  • Changes in the blood picture including agranulocytosis (lack of white blood cells ).
  • Aggression.
  • Hallucinations (seeing, feeling, or hearing things that do not exist).
  • 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.

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

  • If you use Esomeprazole SUN 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, or 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).
  • Skin rash, possibly with joint pain.

In very rare cases, esomeprazole SUN can 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.

5. How to store Esomeprazole SUN

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

Do not store above 30 ° C.

Store in the original package (in blisters). Moisture sensitive.

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

The medicine 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 SUN 20 mg / 40 mg enteric tablets contain

The active substance is esomeprazole. Each tablet contains 20 mg and 40 mg of esomeprazole (as amorphous esomeprazole magnesium).

Other ingredients are:

Tablet core: Hydroxypropylcellulose (E463), crospovidone (type A)

Film coating: Povidone (K30), macrogol 400, macrogol 4000, macrogol 6000, hypromellose phthalate (HP-55S), hypromellose phthalate (HP-50), diethyl phthalate, hydroxypropylcellulose, microcrystalline cellulose ( PH 101), microcrystalline cellulose crospovide Type B), sodium stearyl fumarate, Opadry 03B86651 brown (HMPC 2910 / Hypromellose 6cP, titanium dioxide (E171), macrogol / PEG 400, iron oxide red (E172), sugar spheres (sucrose and corn starch), talc (E553b). 

What the medicine looks like and the contents of the pack

Esomeprazole SUN 20 mg enteric tablets are brownish red, oval, biconvex, film-coated tablets marked ‘E5’ on one side and smooth on the other.

Esomeprazole SUN 40 mg enteric tablets are brownish red, oval, biconvex, film-coated tablets marked ‘E6’ on one side and smooth on the other.

The tablets are packaged in

  • OPA-Al-PE-desiccant-HDPE / Al blister in the following pack sizes: 7, 14, 15, 28, 30, 56, 60, 90 and 100 tablets.
  • OPA-Al-PVC / Al blisters in pack sizes of 7, 14, 15, 28, 30, 56, 60, 90 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

SUN Pharmaceutical Industries Europe BV

Polarisavenue 87

2132 JH, Hoofddorp

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe BV, Polarisavenue 87, 2132JH Hoofddorp, The Netherlands

Terapia SA, 124 Fabricii Street, 400 632 Cluj Napoca, Romania

This medicinal product is authorized under the European Economic Area under the names:

Belgium: Esomeprazole AB

Germany: Esomeprazole Basics

Italy: Esomeprazolo SUN

Netherlands: Esomeprazole SUN

Portugal: Ezoclip

United Kingdom: Esomeprazole

Muhammad Nadeem

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