Package Insert:Patient Information

Esomeprazol Stada 40 mg Gastric-Resistant Capsules EFG

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, 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 is Esomeprazol Stada and what is it used for

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

Esomprazole Stada contains a medicine called esomeprazole that belongs to a group of medicines called “proton pump inhibitors”. These work by reducing the amount of acid produced by the stomach.

Esomeprazole 40 mg is used for the treatment of the following disorders:

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.

•Excessive stomach acid produced by a tumor in the pancreas (Zollinger-Ellison syndrome).

•Continuation treatment for the prevention of bleeding from a peptic ulcer induced with esomeprazole administered intravenously.

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.

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 proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).

-if you are taking a medicine that contains nelfinavir used in the treatment of HIV infection.

• If you have ever developed a severe skin rash or skin peeling, blistering, or ulcers in the mouth after taking esomeprazole or other related medicines.

If you are in any of these 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 Esomeprazol Stada if:

• You have severe liver problems.
• You have severe kidney problems.
• You have ever had a skin reaction after treatment with a similar medicine to esomeprazole for reducing stomach acid. Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with esomeprazole treatment. Stop taking esomeprazole and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
• You are due to have a specific blood test (Cromogranin A).

Esomeprazole may mask the symptoms of other diseases.Therefore, if you notice any of the following events before taking 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 (blood-stained).

If you have been prescribed esomeprazole only when you notice symptoms, you should contact your doctor if your symptoms persist or change.

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

Skin rashes and symptoms

If you develop 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 rashes have been reported in patients taking esomeprazole (see also section 4). The rash may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These severe skin rashes usually appear after 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 you develop a rash or any of these skin symptoms at any time during treatment (even after several weeks), stop taking this medicine and contact your doctor immediately.

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 includes medicines bought without a prescription.

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 containsnelfinavir(used for 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 (for fungal infections).
• Erlotinib (used in the treatment of cancer).
• Citalopram, imipramine, clomipramine (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 Esomeprazol Stada.
• Medicines used to make the blood thinner, such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol.
• Cilostazol (used for the treatment of intermittent claudication – pain in the legs when walking caused by poor blood circulation).
• 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 Esomeprazol.
• 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 Esomeprazol STADA to treat ulcers caused byHelicobacter pylori, it is very important to inform your doctor if you are taking any other medicine.

Taking Esomeprazol Stada with food and drinks

You can take the tablets with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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, your doctor will decide if you can take esomeprazole during this period.

Esomeprazole passes into breast milk. Therefore, do not take esomeprazole during breastfeeding.

Driving and operating machines

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 may occur (see section 4). Do not drive or use machines if you notice any of these side effects.

Esomeprazol Stada contains saccharose

Esomeprazol Stada contains sugar spheres containing saccharose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Esomeprazol Stada contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

Follow exactly the administration instructions of this medication 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 (especially if you take it for more than a year).

•If your doctor has indicated that you should take this medication only when you notice some symptoms, inform your doctor if the symptoms change.

How much to take

• Your doctor will have indicated how many tablets you should take and when to take them. This will depend on your situation, age, and liver function.

•The recommended doses are indicated below.

Use in adults aged 18 years and older

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 40 mg per day for 4 weeks. Your doctor may indicate that you take the same dose for another 4 weeks if your esophagus has not yet healed.

•If you have severe liver problems, your doctor may prescribe a lower dose.

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

•The recommended dose is 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 tablet of esomeprazole 40 mg per day for 4 weeks.

Use in adolescents aged 12 years and older

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 tablet of esomeprazole 40 mg per day for 4 weeks. Your doctor may indicate that you take the same dose for another 4 weeks if your esophagus has not yet healed.

•The recommended dose once the esophagus has healed is one tablet of esomeprazole 20 mg per day.

•If your esophagus is not affected, the recommended dose is one tablet of esomeprazole 20 mg per day.

•If you have severe liver problems, your doctor may prescribe a lower dose.

How to take this medication

•You can take the tablets at any time of the day.

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

•Swallow the tablets whole with a glass of water. Do not chew or crush the tablets. This is because the tablets contain coated granules that prevent the medication from being destroyed by the stomach acid. It is essential not to damage the granules.

What to do if you have difficulty swallowing

•If you have difficulty swallowing the tablets:

-Put the tablets in a glass of water without gas. Do not use other liquids.

-Stir until the tablets disintegrate (the solution will not be transparent). You can drink the mixture immediately or within 30 minutes. Stir always just before drinking.

-To ensure that you have taken all the medication, rinse the glass well with half a glass of water and drink. The solid particles contain the medication – do not chew or crush the granules.

•If you cannot swallow at all, the tablets can be dispersed in water and introduced into a syringe. They can then be administered directly into the stomach through a tube (gastric tube).

Children under 12 years of age

No esomeprazole is recommended for children under 12 years of age.

Older adults

No dose adjustment is necessary for older adults.

If you take more Esomeprazol Stada than you should

If you take more esomeprazole than your doctor has prescribed, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 5620420.

If you forget to take Esomeprazol 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 to compensate for the missed doses.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

These effects are very rare and may affect up to 1 in 10,000 people.

Other side effects include:

Frequent (may affect up to 1 in 10 patients)

-Headache.

-Effects on the stomach or intestines: stomach pain, constipation, diarrhea, gas (flatulence).

-Feeling unwell (nausea) or feeling unwell (vomiting).

• Benign polyps in the stomach.

Rare (may affect up to 1 in 100 patients)

-Swelling of the feet and ankles.

-Sleep disturbance (insomnia).

-Dizziness, numbness, and tingling, drowsiness.

-Dizziness.

-Dry mouth.

-Alteration of blood tests that determine liver function.

-Skin rash, urticaria, itching skin.

-Fracture of the hip, wrist, or spine (if Esomeprazol Stada is used at high doses and for a long period).

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

-Blood disorders such as a decrease in the number of white blood cells or platelets. This may cause weakness, bruising, or increase the risk of infections.

-Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.

-Restlessness, confusion, or depression.

-Alteration of taste.

-Eye disorders such as blurred vision.

-Sudden feeling of lack of air or difficulty breathing (bronchospasm).

-Inflammation in the interior of the mouth.

-A fungal infection known as "candidiasis" that may affect the esophagus.

-Liver problems including jaundice that may cause yellow skin, dark urine, and fatigue.

-Hair loss (alopecia).

-Sunlight-induced dermatitis.

-Joint pain (arthralgia) or muscle pain (myalgia).

-General feeling of unwellness and lack of energy.

-Increased sweating.

Very rare (may affect up to 1 in 10,000 patients)

• Changes in the number of blood cells, including agranulocytosis (decrease in the number of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Liver disorders that may lead to liver failure or brain inflammation.

• 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, drug reaction with eosinophilia and systemic symptoms).

• Muscle weakness.
• Severe kidney disorders.

-Enlargement of the breasts in men.

Frequency not known (the frequency cannot be estimated from the available data)

• If you are taking esomeprazol for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, see a doctor immediately. Low magnesium levels may also cause a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Intestinal inflammation (may cause diarrhea).
• Rash, possibly with joint pain.

In very rare cases, esomeprazol may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as 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 inform your doctor about your medication in this case.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaRAM.es. By reporting side 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 use this medication after the expiration date that appears on the box and blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.This will help protect the environment.

Esomeprazol Stada 40 mg Composition

-The active ingredient is esomeprazol.

Each tablet contains 40 mg of esomeprazol (as esomeprazol magnesium amorphous).

-The other components are:

Tablet core: Hydroxypropylcellulose (E-463), Crospovidone (Type A).

Capsule coatingPovidone (K30), Macrogol 400, Macrogol 4000, Macrogol 6000, Hypromellose phthalate (HP-55S), Hypromellose phthalate (HP-50), Diethyl phthalate, Hydroxypropylcellulose, Microcrystalline cellulose (PH 101), Microcrystalline cellulose (PH 112), Crospovidone (Type B), Sodium stearate fumarate, Opadry 03B86651 Brown (HMPC 2910/Hypromellose 6cP, titanium dioxide (E171), Macrogol/PEG 400, iron oxide red (E172)),Sugar spheres (sucrose and cornstarch), Talc (E553b).

Product appearance and packaging content

Esomeprazol Stada 40 mg gastro-resistant EFG tablets are film-coated, oval, biconvex, and red brick to brown in color, with the inscription “E6” in relief on one face and smooth on the other face.

The medicine is presented in the following types of packaging:

OPA-Al-PE-desiccant-HDPE/Al blister with 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, and 100 tablets.

Laminated cold-formed Poliamida-Al-PVC/Al blister with 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, and 100 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing Authorization Holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

or

Terapia S.A.

124 Fabricii Street

400 632 Cluj Napoca

Romania

Last review date of this leaflet:February 2025

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

Administration via gastric tube

1.Insert the tablet into a suitable syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air. For some tubes, a dispersion in 50 ml of water is required to prevent the pellets from blocking the tube.

2.Shake the syringe immediately for approximately 2 minutes to disperse the tablet.

3.Hold the syringe with the tip upwards and check that the tip has not become blocked.

4.Connect the syringe to the tube while maintaining the previous position.

5.Shake the syringe and place it with the tip downwards. Inject immediately 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be kept with the tip upwards to prevent the tip from becoming blocked).

6.Place the syringe with the tip downwards and inject immediately another 5-10 ml into the tube. Repeat this procedure until the syringe is empty.

7.Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to draw any sediment remaining in the syringe. For some tubes, 50 ml of water is required.