Package Insert: Information for the Patient

Esomeprazole Tecnigen 40 mg Gastric-Resistant Capsules 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 refer to 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 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 acid from the stomach 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 to prevent bleeding from a peptic ulcer induced withesomeprazoleintravenously.

Adolescents 12 years of age and older

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

Do not takeEsoméprazol Tecnigen

• 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 (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 starting to take 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).

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.

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 begin to vomit food or blood.
• Your stools appear black (bloodstained).

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

Taking a proton pump inhibitor like esomeprazole, especially for more than a 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 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 reactions 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 reactions 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 at any time during treatment (even after several weeks) you develop a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

Children under 12 years

This medicine 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 Esomeprazol Tecnigen 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 obtained 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 tablets if you are taking a medicine that containsnelfinavir(used for the treatment of HIV infection).

Inform your doctor if you are using 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 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 – pain in the legs when walking caused by poor blood circulation).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (chemotherapy medicine 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.

Taking Esomeprazol 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 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, this medicine should not be used during pregnancy unless considered necessary by your doctor.

The safety of esomeprazole for use during breastfeeding has not been established. Therefore, this medicine should not be used during breastfeeding.

Driving and using 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 Tecnigen contains saccharose

This medicine contains sugar spheres that contain 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 Tecnigen contains sodium

This medicine 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.
• 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 40 mg of esomeprazole twice a day.
• Your doctor will adjust the dose according to your needs and also decide 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 ulcer 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.
• 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 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

Esomeprazol 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 adults

No dose adjustment is necessary for older adults.

If you take more Esomeprazol Tecnigen 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, contact the Toxicological Information Service. Telephone 91 5620420, indicating the medication and the amount ingested.

If you forget to take Esomeprazol Tecnigen

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 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 esomeprazole 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 can turn into 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".
• Widespread rash, high body temperature, and enlargement of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rare.

These side 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 people)

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

Infrequent (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Insomnia (sleep disturbance).
• Dizziness, tingling, and numbness, somnolence.
• Vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, urticaria, itching skin.
• Fracture of the hip, wrist, or spine (if esomeprazole 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 can cause weakness, bruising, or increase the risk of infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and muscle cramps.
• Agitation, 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 can affect the esophagus.
• Liver problems including jaundice that can cause yellow skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Sunlight-induced dermatitis.
• Joint pain (arthralgia) 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.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Liver disorders that can 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. (Multiforme erythema, 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 esomeprazole for more than three months, it is possible that your magnesium levels in the blood will decrease. Low magnesium levels can 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 can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular tests to monitor your magnesium levels.
• Inflammation in the intestine (may cause diarrhea).
• Skin rash, possibly with joint pain.

In rare cases, esomeprazole 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 high 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 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 40 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.

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

Product appearance and packaging contents

Esomeprazol Tecnigen 40 mg are gastro-resistant tablets of pink color, 8.2 x 17 mm, elliptical and biconvex.

They are presented in 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

The detailed information of this medicine is available on the website of the Spanish Agency of 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. Agitate the syringe immediately for approximately 2 minutes to disperse the tablet.

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

1. 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.

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.