Package Insert: Information for the User

Esomeprazol Stada 20 mg Hard Gastrorresistant Capsules EFG

Esomeprazol Stada 40 mg Hard Gastrorresistant Capsules EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What Esomeprazol Stada is and for what it is used

2. What you need to know before starting to take Esomeprazol Stada

3. How to take Esomeprazol Stada

4. Possible adverse effects

5. Storage of Esomeprazol Stada

6. Contents of the package and additional information

Esomeprazol Stada contains a medication called esomeprazole that belongs to a group of medications called “proton pump inhibitors”. These work by reducing the amount of acid that your stomach produces.

Esomeprazole is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.
• Stomach ulcers or upper small intestine ulcers infected by a bacteria called “Helicobacter pylori”. If you have this condition, your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Stomach ulcers caused by medications called nonsteroidal anti-inflammatory drugs (NSAIDs). Esomeprazole can also be used to prevent stomach ulcers if you are taking NSAIDs.
• Excessive stomach acid produced by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent bleeding from peptic ulcers induced with intravenous esomeprazole.

Adolescents 12 years of age and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.

Stomach ulcers or upper small intestine ulcers infected by a bacteria called “Helicobacter pylori”. If you have this condition, your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take Esomeprazol 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 medicines in the group of proton pump inhibitors (such as pantoprazole, lansoprazole, rabeprazole, omeprazole);
• if you are taking a medicine that contains nelfinavir (used for the treatment of HIV infection).

If you are in any of the above situations, do not take esomeprazole. If you are unsure, consult your doctor or pharmacist before taking esomeprazole.

Warnings and precautions

Consult your doctor or pharmacist before taking esomeprazole:

• if you have severe liver problems;
• if you have severe kidney problems.
• if you have ever had a skin reaction after treatment with a similar medicine to esomeprazole for reducing stomach acid.
• if you are due to have a specific blood test (Cromogranin A).

Esomeprazole may mask the symptoms of other diseases.Therefore, if you experience any of the following situations before starting to take or while taking esomeprazole, contact your doctor immediately:

• You lose a lot of weight without reason and have trouble swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (bloodstained).

If you have been prescribed esomeprazole "on demand" (only when you notice some symptoms), you should contact your doctor if the symptoms of your disease persist or change.

If you are taking esomeprazole for more than three months, it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have any of these symptoms, inform your doctor immediately. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.

If you are taking proton pump inhibitors such as esomeprazole, especially for a period of more than one year, it may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Skin rash and skin symptoms

If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with esomeprazole. Remember to mention any other symptoms you may notice, such as joint pain.

Severe skin reactions have occurred in patients treated with esomeprazole (see also section 4). The rash may include mouth ulcers, throat, nose, genital, and conjunctivitis (red and swollen eyes). These severe skin reactions often follow symptoms similar to the flu, such as fever, headache, and body aches. The rash may cover large areas of the body with blisters and skin peeling.

If at any time during treatment (even after several weeks) you develop a skin rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

Children under 12 years

Esomeprazole is not recommended for children under 12 years.

Use of Esomeprazol Stada with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is because esomeprazole may affect the way some medicines work and some medicines may influence the effect of esomeprazole.

Do not take esomeprazole if you are taking a medicine that contains nelfinavir (used in the treatment of HIV infection).

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

• Atazanavir (used for the treatment of HIV infection).
• Clopidogrel (used for the prevention of blood clots).
• Ketoconazole, itraconazole, or voriconazole (used for the treatment of fungal infections).
• Erlotinib (used in the treatment of cancer).
• Citalopram, imipramine, or clomipramine (used for the treatment of depression).
• Diazepam (used for the treatment of anxiety, as a muscle relaxant, or for epilepsy).
• Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor when you start or stop taking esomeprazole.
• Medicines used to make the blood thinner, such as warfarin.

Your doctor may need to monitor when you start or stop taking esomeprazole.

• Cilostazol (used for the treatment of intermittent claudication – a disease where the inadequate supply of blood to the muscles of the legs causes pain and difficulty walking).

• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (chemotherapy used at high doses in the treatment of cancer) – if you are taking high doses of methotrexate, your doctor may temporarily interrupt your treatment with esomeprazole.
• Tacrolimus (organ transplant).
• Rifampicin (used for the treatment of tuberculosis).
• St. John's Wort (Hypericum perforatum)(used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin in addition to esomeprazole to treat ulcers caused byHelicobacter pylori, it is very important to inform your doctor if you are taking any other medicine.

Use of Esomeprazol Stada with food and drinks

You can take the capsules with food or on an empty stomach.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide if you can take esomeprazole during this period.

The safety of esomeprazole for use during pregnancy has not been established. Therefore, do not take esomeprazole during pregnancy.

Driving and operating machinery

Esomeprazole is unlikely to affect your ability to drive or use tools or machines. However, rare or very rare side effects such as dizziness or blurred vision (see section 4) may occur. Do not drive or use machines if you notice any of these side effects.

Esomeprazol Stada contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; that is, it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• If you take this medication for a long period of time, your doctor will need to monitor you (in particular, if you take it for more than a year).
• If your doctor has told you to take this medication only when you notice some symptoms, inform your doctor if the symptoms change.

How much to take

• Your doctor will have told you how many capsules to take and when to take them. This will depend on your situation, age, and liver function.
• The recommended doses are detailed below:

Use in adults aged 18 and over

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

• If your doctor has determined that your esophagus is slightly affected, the recommended dose is one capsule of esomeprazole 40 mg once a day for 4 weeks. Your doctor may tell you to continue taking the same dose for another 4 weeks if your esophagus has not yet healed.
• Once your esophagus has healed, the recommended dose is one capsule of esomeprazole 20 mg once a day.
• If your esophagus is not affected, the recommended dose is one capsule of esomeprazole 20 mg per day. Once your condition has been controlled, your doctor may tell you to take the medication only when needed, up to a maximum of one capsule of esomeprazole 20 mg per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one capsule of esomeprazole 20 mg twice a day for one week.
• Your doctor will also prescribe antibiotics such as amoxicillin and clarithromycin.

For the treatment of gastric ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is one capsule of esomeprazole 20 mg once a day for 4-8 weeks.

For the prevention of gastric ulcers if you are taking NSAIDs:

• The recommended dose is one capsule of esomeprazole 20 mg once a day.

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

• The recommended dose is one capsule of esomeprazole 40 mg twice a day.
• Your doctor will adjust the dose according to your needs and also decide for how long you should take this medication. The maximum dose is 80 mg twice a day.

Continuation treatment for the prevention of bleeding from peptic ulcers induced with esomeprazole intravenously:

• The recommended dose is one capsule of esomeprazole 40 mg once a day for 4 weeks.

Use in adolescents aged 12 and over

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

• If your doctor has determined that your esophagus is slightly affected, the recommended dose is one capsule of esomeprazole 40 mg once a day for 4 weeks. Your doctor may tell you to continue taking the same dose for another 4 weeks if your esophagus has not yet healed.
• Once your esophagus has healed, the recommended dose is one capsule of esomeprazole 20 mg once a day.
• If your esophagus is not affected, the recommended dose is one capsule of esomeprazole 20 mg per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one capsule of esomeprazole 20 mg twice a day for one week.
• Your doctor will also prescribe antibiotics such as amoxicillin and clarithromycin.

How to take this medication

• You can take the capsules at any time of the day.
• You can take the capsules with food or on an empty stomach.
• Swallow the capsules whole 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 medication from being destroyed by stomach acid. It is essential not to damage the granules.

What to do if you have difficulty swallowing the capsules

If you have difficulty swallowing the capsules:

• Open the capsule and disperse the contents in a quarter glass of water without gas. Do not use other liquids.
• Shake the mixture and drink it immediately or within the next 30 minutes. Always shake the mixture just before drinking it. The mixture will not be transparent.
• To ensure that you have taken all the medication, rinse the glass by filling it with water up to the middle and drinking it. The solid particles contain the medication, do not chew or crush the granules.

Use in children under 12 years of age

Esomeprazole is not recommended for children under 12 years of age.

Older adults

No dose adjustment is necessary for older adults.

If you take more Esomeprazole Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Esomeprazole Stada

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose.
• Do not take a double dose (two doses at once) to make up for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Likewise, all medications, esomeprazol may produce adverse effects, although not all people suffer from them.

If you observe any of the following severe adverse effects, stop taking esomeprazol and contact a doctor immediately:

• Yellow skin, dark urine, and fatigue that may be symptoms of liver problems. These effects are rare and may affect up to 1 in 1,000 people.
• Sudden difficulty breathing, swelling of lips, tongue, and throat or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction). These effects are rare and may affect up to 1 in 1,000 people.
• The sudden appearance of a severe rash or redness of the skin with blisters or peeling may occur even after several weeks of treatment. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals. Skin rashes may become severe and generalized skin damage (peeling of the epidermis and superficial mucous membranes) with potentially fatal consequences. This could be 'erythema multiforme', 'Stevens-Johnson syndrome', 'toxic epidermal necrolysis', or 'pharmacological reaction with eosinophilia and systemic symptoms'. These effects are very rare and may affect up to 1 in 10,000 people.

Other adverse effects include::

Frequent:may affect up to 1 in 10 people

• Headache

• Effects on the stomach or intestine: diarrhea, stomach pain, constipation, gas (flatulence)
• Nausea or vomiting
• Benign polyps in the stomach

Less frequent:may affect up to 1 in 100 people

• Swelling of feet and ankles
• Sleep disturbance (insomnia)
• Dizziness, tingling, numbness, somnolence
• Sensation of vertigo
• Dry mouth
• Alteration of blood tests that determine liver function
• Skin rash, urticaria, itching skin
• Fracture of hip, wrist, or spine (if esomeprazol is used in high doses or for a prolonged period)

Rare:may affect up to 1 in 1,000 people

• Blood disorders such as a decrease in the number of white blood cells or platelets. This may cause weakness, bruises, or increase the risk of infections
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps
• Agitation, confusion, or depression
• Alteration of taste
• Eye problems, such as blurred vision
• Sudden sensation of lack of air or difficulty breathing (bronchospasm)
• Inflammation in the interior of the mouth
• A known infection called "candidiasis" that may affect the esophagus and is caused by a fungus
• Liver problems including jaundice that may cause yellow skin, dark urine, and fatigue
• Loss of hair (alopecia)
• Dermatitis caused by exposure to sunlight
• Pain in the joints (arthralgia) or muscles (myalgia)
• General feeling of discomfort and lack of energy
• Increased sweating

Very rare::may affect up to 1 in 10,000 people

• Changes in the number of cells in the blood, including agranulocytosis (decrease in the number of white blood cells)
• Aggression
• To see, feel, or hear things that do not exist (hallucinations)
• Liver disorders that may lead to liver insufficiency or inflammation of the brain
• Sudden appearance of severe skin rash, blisters, or peeling of the skin.

These symptoms may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, pharmacological reaction with eosinophilia and systemic symptoms).

• Muscle weakness
• Severe kidney disorders
• Increased breast size in men

Unknown:frequency cannot be estimated from available data

• Inflammation of the intestine (may cause diarrhea).
• Skin rash, possibly with joint pain.
• Low magnesium levels in the blood (hypomagnesemia) (see section 2 "Warnings and precautions").

In very rare cases, esomeprazol may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as high fever with severe worsening of the general condition or fever with symptoms of a local infection such as neck pain, throat pain, mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a decrease in the number of white blood cells (agranulocytosis) through a blood test. It is essential to report the medication you are taking at the time in this case.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not store at a temperature above 25°C.
• Store this medication in the original packaging (blister) or keep the container tightly closed to protect it from moisture.
• Do not use this medication after the expiration date that appears on the container and in the blister or bottle, after CAD. The expiration date is the last day of the month indicated.
• Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Esomeprazol Stada

• The active ingredient is esomeprazole. There are two different doses of Esomeprazol Stada hard-gastroresistant capsules containing 20 mg or 40 mg of esomeprazole (as magnesium dihydrate salt).

• The other components are:

Content of the capsules:

Granules:Kappa-Carragenina Ph. Eur.microcrystalline cellulose, mannitol, sodium hydroxide, sodium hydrogen carbonate

Isolating coating:copolymer of polyethylene glycol-polyvinyl alcohol, sodium hydroxide, talc, titanium dioxide (E171), hydrated colloidal silica

Gastro-resistant coating:copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion at 30 %, triethyl citrate, talc, titanium dioxide (E171)

Capsule:

Esomeprazol Stada 20 mg hard-gastroresistant capsules

Crown:gelatin, titanium dioxide (E171), yellow iron oxide (E172)

Body:gelatin, titanium dioxide (E171)

Esomeprazol Stada 40 mg hard-gastroresistant capsules

Crown:gelatin, red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172)

Body:gelatin, titanium dioxide (E171)

Appearance of the product and contents of the package

Esomeprazol Stada 20 mg hard-gastroresistant capsules

Hard-gastroresistant capsule (capsule size 3), with white opaque body and yellow opaque crown, containing white or almost white gastro-resistant granules.

The hard capsules may have a characteristic odor that does not affect the quality of the product.

Esomeprazol Stada 40 mg hard-gastroresistant capsules

Hard-gastroresistant capsule (capsule size 1), with white opaque body and orange opaque crown, containing white or almost white gastro-resistant granules.

The hard capsules may have a characteristic odor that does not affect the quality of the product.

The capsules are presented in HDPE plastic bottles with a desiccant capsule and a PP cap or in polyamide-aluminum-PVC/aluminum blisters. Do not ingest the desiccant capsule.

Package sizes:

Blister packs

Esomeprazol Stada 20 mg hard-gastroresistant capsules

7, 14, 15, 28, 30, 50, 56, 60, 90, 98, and 100 capsules.

Esomeprazol Stada 40 mg hard-gastroresistant capsules

14, 15, 28, 30, 50, 56, 60, 90, 98, and 100 capsules.

HDPE plastic bottles

14, 15, 28, 30, 50, 56, 60, 90, 98, and 100 capsules.

Only some package sizes may be commercially available.

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Medinsa (Laboratorios Medicamentos Internacionales S.A.)

c/ Solana, 26

28850 Torrejón de Ardoz (Madrid)

Spain

Last review date of this leaflet:April 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.