Package Insert: Information for the Patient

Esomeprazole Tecnigen 20 mg Gastric-Resistant Tablets EFG

Read this 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 read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may 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.

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

Esomeprazoleis 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.
• Ulcers in the stomach or upper part of the small intestine (duodenum) that are infected by a bacteria calledHelicobacter pylori.If you have this condition, 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).Esomeprazolemay also be used to prevent the formation of ulcers 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 withesomeprazoleintravenously.

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 condition, it is likely that your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not takeEsoméprazol Tecnigen

• if you are allergic to esoméprazol or any of the other ingredients of this medication (listed in section 6).
• if you are allergic to other medications in the group of proton pump inhibitors (e.g. pantoprazol, lansoprazol, rabeprazol, omeprazol).
• if you are taking a medication 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 esoméprazol or other related medications.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take esoméprazol

• 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 medication to esoméprazol to reduce stomach acid.
• if you are scheduled to have a specific blood test (Cromogranina A).

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with esoméprazol treatment. Stop taking esoméprazol and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Esomeprazol may mask symptoms of other diseases.Therefore, if you notice any of the following events before taking or while taking esoméprazol, 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 esoméprazol only when you notice symptoms, you should contact your doctor if your disease symptoms persist or change.

Taking a proton pump inhibitor such as esoméprazol, especially for more than one year, may slightly increase the risk of breaking a hip, wrist or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Skin eruptions and symptoms

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

Severe skin eruptions have occurred in patients taking esoméprazol (see also section 4). The eruption may include mouth ulcers, throat, nose, genital, and conjunctivitis (red and swollen eyes). These severe skin eruptions usually appear 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 medication and contact your doctor immediately.

Children under 12 years

This medication should not be used in children under 12 years. There are other forms of administration that are more suitable (consult your doctor or pharmacist if you need additional information).

Use of Esoméprazol Tecnigen with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications purchased without a prescription. This is because esoméprazol may affect how some medications work and some medications may influence the effect of esoméprazol.

Do not take esoméprazol tablets if you are taking a medication that containsnelfinavir(used for HIV treatment).

Inform your doctor if you are using any of the following medications:

• Atazanavir (used for HIV treatment).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (for fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramine, clomipramine (for depression treatment).
• Diazepam (used for anxiety, muscle relaxation, or epilepsy).
• Fenitoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor when you start or stop taking esoméprazol.
• Medications used to make blood thinner, such as warfarin. Your doctor may need to monitor when you start or stop taking esoméprazol.
• Cilostazol (used for intermittent claudication – leg pain caused by poor blood circulation).
• Cisaprida (used for indigestion and heartburn).
• Digoxina (used for heart problems).
• Metotrexato (chemotherapy medication used at high doses for cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily interrupt your esoméprazol treatment.
• Tacrolimus (organ transplant).
• Rifampicina (used for tuberculosis treatment).
• St. John's Wort (Hypericum perforatum) (used for depression treatment).

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

Taking Esoméprazol with food and drinks

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

Pregnancy, breastfeeding, and fertility

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

The passage of esoméprazol into breast milk is unknown. Therefore, do not take esoméprazol during breastfeeding.

Driving and operating machinery

Esomeprazol 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 Tecnigen contains saccharose

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

Esomeprazol Tecnigen contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per gastro-resistant tablet; 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 (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 one 40 mg gastro-resistant esomeprazole tablet once a 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 20 mg gastro-resistant esomeprazole tablet once a day.
• If your esophagus is not affected, the recommended dose is one 20 mg gastro-resistant esomeprazole tablet 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 20 mg gastro-resistant esomeprazole tablet 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 20 mg gastro-resistant esomeprazole tablet 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 20 mg gastro-resistant esomeprazole tablet once a day for 4 to 8 weeks.

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

• The recommended dose is one 20 mg gastro-resistant esomeprazole tablet once a day.

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

• The recommended dose is 40 mg of esomeprazole 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 40 mg esomeprazole tablet 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 40 mg gastro-resistant esomeprazole tablet once a 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 20 mg gastro-resistant esomeprazole tablet once a day.
• If your esophagus is not affected, the recommended dose is one 20 mg gastro-resistant esomeprazole tablet 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 20 mg gastro-resistant esomeprazole tablet 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).

Use in children under 12 years of age

Esomeprazole Tecnigen gastro-resistant tablets are not recommended for children under 12 years of age. There are other authorized pharmaceutical forms of esomeprazole for children aged 1-12 years in sachets (consult your doctor or pharmacist if you need additional information).

Older patients

No dose adjustment is necessary for older patients.

If you take more esomeprazole than you should

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Telephone 91 5620420, indicating the medication and the amount ingested.

If you forget to take esomeprazole

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 (two doses at once) to compensate for the missed dose.

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 esomeprazol and contact a doctor immediately:

• Yellow skin, dark urine, and fatigue that may be symptoms of liver problems.

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

• Sudden difficulty breathing, swelling of the lips, tongue, and throat or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction).

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

• Sudden appearance of a severe skin rash or redness of the skin with blisters or peeling, even after several weeks of treatment. Blisters may also appear and bleeding from the lips, eyes, mouth, nose, and genitals may occur. Skin rashes may become severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially fatal consequences. It could be a “multiforme erythema”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis”, or “drug reaction with eosinophilia and systemic symptoms”.

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

• Widespread rash, high body temperature, and enlargement of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rarely observed.

Other side effects include:

Frequent (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestines: stomach pain, constipation, diarrhea, gas (flatulence).
• Nausea or vomiting.
• Benign stomach polyps.

Occasional (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling, and numbness, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, urticaria, itching skin.
• Fracture of the hip, wrist, or spine (if esomeprazol is used at high doses and for a long 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, 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 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.
• Hair loss (alopecia).
• Dermatitis caused by exposure to sunlight.
• Pain in the joints (arthritis) or muscle pain (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 failure 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, 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 your magnesium levels in the blood will decrease. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic tests to monitor your magnesium levels.
• Inflammation in the intestine (may cause diarrhea).
• Skin rash, possibly with joint pain.

In rare cases, esomeprazol may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as 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 store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store this medication in its original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Deposit the 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 the containers and medications you no longer need. By doing so, you will help protect the environment.

Esomeprazol Tecnigen Composition

The active ingredient is esomeprazole.Each gastro-resistant tablet contains 20 mg of esomeprazole (in the form of esomeprazole magnesium dihydrate).

The other components (excipients) are:

Pellets: copolymer of methacrylic acid and ethyl acrylate (1:1), dispersion of, at 30% (contains polisorbate 80 and sodium lauryl sulfate), talc, triethyl citrate, hypromellose, sugar spheres (sucrose and cornstarch), magnesium stearate, hydroxypropylcellulose, mono- and diglycerides of fatty acids, polisorbate 80.

Tablet core: microcrystalline cellulose, povidone, macrogol, crospovidone, stearate and sodium fumarate.

Capsule coating material:hypromellose, titanium dioxide (E171), macrogol, iron oxide red (E172), iron oxide yellow (E172).

Product appearance and packaging contents

Esomeprazol Tecnigen 20 mg are gastro-resistant tablets of a light pink color, 6.55 x 13.6 mm in size, elliptical in shape and biconvex.

They are presented in a blister (Al/Al) with 28 or 56 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Balkanpharma Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

Last review date of this leaflet:February 2025

More detailed information about 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.

1. Immediately agitate the syringe for approximately 2 minutes to disperse the tablet.

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

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

1. Agitate the syringe and place it with the tip pointing downwards. Immediately inject 5-10 ml into the tube. Invert the syringe after injection and agitate (the syringe must be kept with the tip pointing upwards to prevent the tip from becoming blocked).

1. 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.

1. 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.