ESOMEPRAZOL TECNIGEN 40 mg GASTRO-RESISTANT TABLETS

2. What you need to know before taking Esomeprazol Tecnigen

Do not takeEsomeprazol 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 of the same group (e.g., pantoprazole, lansoprazole, rabeprazole, omeprazole).
• if you are taking a medicine that contains nelfinavir (used to treat HIV infection).
• If you have ever developed a severe skin rash, blistering, or peeling after taking esomeprazole or other medicines similar to esomeprazole.

If you are in any of these situations, do not take esomeprazole. If you are not sure, 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 medicine similar to esomeprazole to reduce stomach acid.
• If you are due to have a specific blood test (Chromogranin A).

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in relation to esomeprazole treatment. Stop taking esomeprazole and seek immediate medical attention 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 difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (stained with blood).

If you have been prescribed esomeprazole only when you notice 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 one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).

Skin rashes and symptoms

If you get a skin rash, especially in areas exposed to the sun, 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 occurred in patients taking esomeprazole (see also section 4). The rash can include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These severe skin rashes usually appear after symptoms similar to those of the flu, such as fever, headache, and body aches. The rash can cover large areas of the body with blisters and peeling skin. 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 of age

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

Using Esomeprazol Tecnigen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription. This is because esomeprazole can affect how some medicines work and some medicines can affect the action of esomeprazole.

Do not take esomeprazole tablets if you are taking a medicine that contains nelfinavir(used to treat HIV infection).

Tell your doctor if you are using any of the following medicines:

• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (for fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramine, clomipramine (for depression).
• Diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy).
• Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking esomeprazole.
• Medicines used to make the blood more fluid, such as warfarin. Your doctor may need to monitor you when you start or stop taking esomeprazole.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by insufficient blood pumping).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (chemotherapy medicine used at high doses in cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with esomeprazole.
• Tacrolimus (organ transplant).
• Rifampicin (used to treat tuberculosis).
• St. John's Wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin along with esomeprazole to treat ulcers caused by Helicobacter pylori, it is very important that you 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take esomeprazole during this period.

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

Driving and using machines

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

Esomeprazol Tecnigen contains sucrose

This medicine contains sugar spheres that contain sucrose, a type of sugar. If your doctor has told you that you have an intolerance to some 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; this is essentially “sodium-free”.

3. How to take Esomeprazol Tecnigen

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• If you take this medicine for a long 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 medicine only when you notice symptoms, inform your doctor if the symptoms change.

How much to take

• Your doctor will have told you how many tablets to 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 from 18 years of age

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 esomeprazole gastro-resistant tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your esophagus has not healed yet.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of excessive acidity in the stomach 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 medicine. The maximum dose is 80 mg twice a day.

Continuation of prevention of rebleeding from peptic ulcer with esomeprazole intravenous:

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

Use in adolescents from 12 years of age

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 esomeprazole gastro-resistant tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your esophagus has not healed yet.
• If you have severe liver problems, your doctor may prescribe a lower dose.

Taking this medicine

• 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 medicine from being destroyed by stomach acid. It is important 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 still water. Do not use other liquids.
• Stir until the tablets disintegrate (the solution will not be clear). You can drink the mixture immediately or within 30 minutes. Always stir just before drinking.
• To make sure you have taken all the medicine, rinse the glass well with half a glass of water and drink. The solid particles contain the medicine – 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).

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 from 1 to 12 years of age in sachets (consult your doctor or pharmacist if you need additional information).

Elderly patients

No dose adjustment is necessary in elderly patients.

If you take more Esomeprazol Tecnigen 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 Toxicology Information Service. Telephone 91 5620420, indicating the medicine 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 the same time) to make up for the missed dose.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• Yellow skin, dark urine, and fatigue that can 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.

• Sudden appearance of a severe skin rash or redness of the skin with blisters or peeling, even after several weeks of treatment. Important blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also appear. Skin rashes can become severe and widespread skin damage (exfoliation of the epidermis and superficial mucous membranes) with potentially fatal consequences. It could be a "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms".
• Widespread rash, high body temperature, and increased lymph node size (DRESS syndrome or drug hypersensitivity syndrome), which is very rare.

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

Infrequent (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling sensation, and numbness, drowsiness.
• Vertigo sensation.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, hives, skin itching.
• 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 can cause weakness, bruising, or increase the likelihood of infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste alteration.
• Eye disorders such as blurred vision.
• Sudden sensation of shortness of breath or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• An infection known as "candidiasis" that can affect the esophagus and is caused by a fungus.
• Liver problems including jaundice that can cause yellowish skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Phototoxic 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 can 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 breast size in men.

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

• If you are being treated with esomeprazol for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have 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 periodic tests to monitor your magnesium levels.
• Inflammation of the intestine (can lead to diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, esomeprazol can affect white blood cells, causing an immune deficiency. If you have an infection with symptoms such as fever with a severeworsening of the general condition or fever with symptoms of a local infection such as neck, throat, mouth, 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 important that, in this case, you report your medication.

Reporting of 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Esomeprazol Tecnigen

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 30°C.

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

Keep this medicine in its original packaging to protect it from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Esomeprazol Tecnigen

The active ingredient is esomeprazol. Each gastro-resistant tablet contains 40 mg of esomeprazol (in the form of esomeprazol magnesium dihydrate).

The other components (excipients) are:

Pellets: copolymer of methacrylic acid and ethyl acrylate (1:1), dispersion of, at 30% (contains polysorbate 80 and sodium lauryl sulfate), talc, triethyl citrate, hypromellose, sugar spheres (sucrose and cornstarch), magnesium stearate, hydroxypropylcellulose, glycerol monostearate 40-55, polysorbate 80.

Core of the tablet: microcrystalline cellulose, povidone, macrogol, crospovidone, sodium and stearic acid fumarate.

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

Appearance of the Product and Packaging Contents

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

They are presented in blister packs (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

Date of the Last Revision of this Prospectus:February 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals:

Administration through a gastric tube

1. Introduce 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 avoid clogging the tube.

1. Shake 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 clogged.

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

1. 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 avoid clogging the tip).

1. Put the syringe back 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 drag any sediment that remains in the syringe. For some tubes, 50 ml of water are necessary.