40 mg enteric capsules, hard 
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 can harm them, even if they show signs of illness 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 STADA is and what it is used for 
2. What you need to know before you take Esomeprazole STADA 
3. How to use 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 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 Stada 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.

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 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 you use Esomeprazole STADA

Do not use Esomeprazole STADA

  • 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 containing nelfinavir (used to treat HIV – infection ).

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

Warnings and cautions

Warnings and cautions

Talk to your doctor or pharmacist before taking Esomeprazole Stada:

  • if you have severe liver problems
  • if you have severe kidney problems
  • if you have ever had a skin reaction after treatment with a medicine similar to Esomeprazole Stada that reduces stomach acid.

Talk to your doctor before taking this medicine 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 you take Esomeprazole Stada 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 Stada to take “as needed”, consult your doctor if your symptoms persist or change in nature.

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.

Children and young people

Children under 12 years

Esomeprazole Stada should not be used in children under 12 years of age. There may be more suitable formulations of esomeprazole (ask your doctor or pharmacist if you need more information).

Other medicines and Esomeprazole STADA

Tell your doctor or pharmacist 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.

Do not take Esomeprazole STADA if you are taking a medicine containing nelfinavir(used to treat HIV – infection ).

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

  • Atazanavir or saquinavir (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,e, 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 you when you start or stop taking Esomeprazole Stada.
  • 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 Stada.
  • 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, in combination with esomeprazole Stada to treat ulcers caused by Helicobacter pylori – infection, you must tell your doctor if you are also taking other medicines.

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 take Esomeprazole Stada during that time.

It is not known if Esomeprazole Stada passes into breast milk. Therefore, you should not take 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 uncommon cases 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 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 sucrose, propyl p-hydroxybenzoate (E216), and methyl p-hydroxybenzoate (E218)

Esomeprazole Stada contains sucrose, which is a type of sugar, propyl p-hydroxybenzoate (E216) and methyl p-hydroxybenzoate (E218)

  • If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
  • Parahydroxybenosates may cause allergic reactions (possibly delayed).

How to use Esomeprazole STADA

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

  • Esomeprazole Stada 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.

How much should you take?

  • Your doctor will tell you how many capsules 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.
  • The recommended 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 an Esomeprazole Stada 40 mg enteric 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 one after the esophagus is healed is an Esomeprazole Stada 20 mg * enteric capsule once daily.
  • If your esophagus is not damaged, the recommended dose is an Esomeprazole Stada 20 mg * enteric 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 Stada 20 mg * enteric capsule 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 Stada 20 mg * enteric capsule 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 Stada 20 mg * enteric capsule 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 an Esomeprazole Stada 20 mg * enteric capsule 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 an Esomeprazole Stada 40 mg enteric 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:

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

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 a glass of water. Do not chew or crush the capsules or their contents. 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:
  • Carefully open the capsule above a glass of still (not carbonated) water and empty the contents of the capsule ( granules one) into the glass. Do not use other liquids.
  • Stir. Drink mixture one at a time or within 30 minutes. Always stir the mixture before drinking it.
  • To make sure you have taken all the medicine, rinse the glass thoroughly with another half glass of water and drink. The solid particles contain the medicine – do not chew or crush them.
  • If you can not swallow at all, the contents of the capsule 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.

Older

Dose adjustment is not necessary for elderly patients.

Use for children and adolescents

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 an Esomeprazole Stada 40 mg enteric 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 one after the esophagus is healed is an Esomeprazole Stada 20 mg * enteric capsule once daily.
  • If your esophagus is not damaged, the recommended dose is an Esomeprazole Stada 20 mg * enteric capsule 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 Stada 20 mg * enteric capsule twice daily for one week.
  • Your doctor will also recommend that you take antibiotics such as amoxicillin and clarithromycin.

Children under 12 years

Esomeprazole Stada should not be used in children under 12 years of age. There may be more suitable formulations of esomeprazole (ask your doctor or pharmacist if you need more information).

If you use more Esomeprazole STADA 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 use Esomeprazole STADA

  • 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 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, which can be symptoms of liver problems.

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

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.

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.
  • 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 ).
  • 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 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.
  • 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 (may affect up to 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.

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.
  • Very low levels of magnesium can correlate with very low levels of calcium, and cause e.g. severe seizures.
  • Inflammation of the intestine (causes diarrhea).
  • Skin rash, possibly with joint pain.

5. How to store Esomeprazole STADA

  • Keep this medicine out of the sight and reach of children.
  • Do not store above 25 ° C.
  • Store the medicine in its original packaging (blister) or keep the jar tightly closed (jar) to protect it from moisture.
  • Do not use this medicine after the expiry date which is stated on the carton, jar, or blister. The expiration date is the last day of the specified month.
  • Jar: After the jar has been opened, the capsules should be used within 3 months.
  • 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.

Esomeprazole Stada enteric capsules are available in a dose containing 40 mg esomeprazole (as esomeprazole magnesium dihydrate).

Other ingredients are:

Capsule contents:

sugar spheres (sucrose and maize starch), hypromellose, dimethicone emulsion 35% (containing dimethicone, propyl p-hydroxybenzoate (E216), methyl p-hydroxybenzoate (E218), sorbic acid, sodium benzoate, polyethylene glycol sorbitol glycol ethylene phenol monolaurin ethanol phenol ethanol, and 80) diacetylated monoglycerides, talc, methacrylic acid-ethyl acrylate copolymer (1: 1), dispersion30% (containing a copolymer of methacrylic acid and ethyl acrylate, sodium lauryl sulfate and polysorbate 80), triethyl citrate and stearoyl macrogol glycerides.

Capsule shell:

Black iron oxide (E172), shellac, gelatin, yellow iron oxide (E172), and titanium dioxide (E171)

What the medicine looks like and the contents of the pack

Esomeprazole Stada 40 mg enteric capsules have an opaque yellow body and an opaque yellow body, marked with 40 mg in black on both halves.

The capsules come in pack sizes of:

Jars of 28, 30, 90, or 98 capsules

Blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98 or 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

Other manufacturers

ETHYPHARM

ZI de Saint-Arnoult

28170 – Châteauneuf-en-Thymerais – France

or

ETHYPHARM

Chemin de la Poudrière

76120 – Grand-Quevilly – France

or

Lamp San Prospero SpA

Via della Pace, 25 / A

41030 San Prospero (Modena)

Italy

or

DELPHARM REIMS

10 rue Colonel Charbonneaux

51100 Reims

France

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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