Package Insert:Patient Information

Esomeprazol Stada 20 mg gastro-resistant tablets 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 questions, consult your doctor or pharmacist.
• This medicine 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 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 known as "proton pump inhibitors". These act by reducing the amount of acid produced by the stomach.

Esomeprazole 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.

•Ulcers in the stomach or upper part of the small intestine (duodenum) that are infected by a bacteria calledHelicobacter pylori. If you have this disorder, it is likely that your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.

•Ulcers caused by medications called nonsteroidal anti-inflammatory drugs (NSAIDs). Esomeprazole may also be used to prevent the formation of ulcers or ulcers in the upper part of the small intestine if you are taking NSAIDs.

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

•Continuation treatment for the prevention of bleeding from peptic ulcers induced with esomeprazole intravenous.

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.

•Ulcers in the stomach or upper part of the small intestine (duodenum) that are infected by a bacteria calledHelicobacter pylori. If you have this disorder, it is likely that 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 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 find yourself 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 to reduce 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 a symptom, you should contact your doctor if the symptoms of your disease persist or change.

If you are taking proton pump inhibitors such as esomeprazole, especially for a period of more than one year, you 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 eruptions and symptoms

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

Severe skin eruptions have been reported in patients taking esomeprazole (see also section 4). The eruption may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These severe skin eruptions usually occur after symptoms similar to the flu, such as fever, headache, and body aches. The eruption 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 eruption or any of these skin symptoms, 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 purchased 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 – leg pain caused by poor blood circulation).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (chemotherapy used at high doses for cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily discontinue 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. Esomeprazole should not be taken during pregnancy unless your doctor decides that the benefits outweigh the risks.

It is not known if esomeprazole passes into breast milk. Therefore, do not take esomeprazole during breastfeeding.

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 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 them 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 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 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.

•Once your esophagus has healed, the recommended dose is one tablet of esomeprazole 20 mg once a day.

•If your esophagus is not affected, the recommended dose is one tablet of esomeprazole 20 mg once a day. Once your condition has been controlled, your doctor may indicate that you take your medicine only when you notice some symptoms, up to a maximum of one tablet 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 tablet of esomeprazole 20 mg twice a day for one week.

•Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

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

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

For the prevention of gastric ulcers or ulcers in the upper part of the intestine if you are taking NSAIDs:

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

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 once a 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 gastro-resistant 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 your esophagus has healed is one tablet of esomeprazole 20 mg once a day.
• If your esophagus is not affected, the recommended dose is one tablet of esomeprazole 20 mg once a 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 gastro-resistant tablet of esomeprazole 20 mg twice a day for one week.
• Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

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 (gastrostomy tube).

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 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, contact the Toxicology 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 there is little time left 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 medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

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.

Infrequent (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 Esomeprazole 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 and is caused by a fungus.

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

-Loss of hair (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.

-Increased size of the breasts in men.

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

• If you are taking esomeprazole 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, esomeprazole 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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 pack 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 disposed of through 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 20 mg Composition

-The active ingredient is esomeprazol.

Each tablet contains 20 mg of esomeprazol (as esomeprazol magnesium amorphous).

-The other components are:

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

Coating:Povidone (K30), Macrogol 400, Macrogol 4000, Macrogol 6000, Phthalate (HP-55S), Phthalate (HP-50), Diethyl phthalate, Hydroxypropylcellulose, Microcrystalline cellulose (PH 101), Microcrystalline cellulose (PH 112), Crospovidone (Type B), Sodium fumarate, Opadry 03B86651 Brown (HMPC 2910/Hydroxypropylcellulose 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 20 mg gastro-resistant EFG tablets are film-coated, oval, biconvex, and red brick to brown in color, with the inscription “E5” in relief on one face and smooth on the other face.

The medicine is presented in the following types of packaging:

Blisterof OPA-Al-PE-desiccant-HDPE/ Aluwith7, 14, 15, 28, 30, 50, 56, 60, 90, 98 and 100 tablets.

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

Only some packaging sizes may be commercially marketed.

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

Detailed and updated information on this medicine is available on 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 pointing 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 pointing downwards. Inject immediately 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be kept with the tip pointing upwards to prevent the tip from becoming blocked).

6.Place the syringe with the tip pointing 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.