ESOMEPRAZOL TECNIGEN 20 mg GASTRO-RESISTANT TABLETS

2. What you need to know before you take Esomeprazol Tecnigen

Do not takeEsomeprazol Tecnigen

• if you are allergic to esomeprazol or any other ingredients of this medicine (listed in section 6).
• if you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazol).
• if you are taking a medicine containing nelfinavir (used to treat HIV).
• if you have ever had a skin reaction after treatment with a medicine similar to esomeprazol that reduces stomach acid.

If any of the above apply to you, do not take esomeprazol. If you are not sure, talk to your doctor or pharmacist before taking esomeprazol.

Warnings and precautions

Talk to your doctor or pharmacist before taking esomeprazol

• 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 esomeprazol that reduces stomach acid.
• a specific blood test (Chromogranin A) is planned.

Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis have been reported with the use of esomeprazol. If you get any of the following symptoms, you should contact your doctor immediately: skin rash, blistering of the skin, mouth, eyes and/or genital areas, fever, confusion, swelling, swollen lymph nodes, abnormal blood test results.

Esomeprazol may hide the symptoms of other diseases. Therefore, if you notice any of the following before or while you are taking esomeprazol, contact your doctor immediately:

• you lose a lot of weight for no reason and have problems swallowing.
• you get stomach pain or indigestion.
• you start vomiting food or blood.
• your stools are black (due to bleeding).

If you have been prescribed esomeprazol only when you have symptoms, you should contact your doctor if your symptoms get worse or if you experience any new symptoms.

Taking a proton pump inhibitor like esomeprazol, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Skin rash and/or itching

If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible, as you may need to stop your treatment with esomeprazol. Remember to also mention any other symptoms that you may have, such as arthralgia (joint pain).

Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis have been reported (see section 4). The rash may be a sign of an allergic reaction. These reactions are rare but can be life-threatening.

Children under 12 years

This medicine should not be used in children under 12 years of age. Other formulations of esomeprazol are available for children aged 1-12 years (consult your doctor or pharmacist for more 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 that you can buy without a prescription. This is because esomeprazol can affect the way some medicines work and some medicines may affect the way esomeprazol works.

Do not take esomeprazol tablets if you are taking a medicine containing nelfinavir (used to treat HIV).

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

• atazanavir (used to treat HIV).
• clopidogrel (used to prevent blood clots).
• ketoconazole, itraconazole or voriconazole (used to treat fungal infections).
• erlotinib (used to treat cancer).
• citalopram, imipramine or clomipramine (used to treat depression).
• diazepam (used to treat anxiety, relax muscles or in epilepsy).
• phenytoin (used in epilepsy). If you are taking phenytoin, your doctor may need to monitor you when you start or stop taking esomeprazol.
• medicines that are used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking esomeprazol.
• cilostazol (used to treat intermittent claudication – a condition where the leg does not get enough blood when walking, leading to pain).
• cisapride (used for indigestion and heartburn).
• digoxin (used for heart problems).
• methotrexate (a chemotherapy medicine used to treat cancer) – if you are taking high doses of methotrexate, your doctor may need to temporarily stop your esomeprazol treatment.
• tacrolimus (used to prevent organ rejection after transplant).
• rifampicin (used to treat tuberculosis).
• St John’s Wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin with your esomeprazol for treatment of ulcers caused by Helicobacter pylori, it is very important that you tell your doctor about any other medicines you are taking.

Taking Esomeprazol Tecnigen with food and drink

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, 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 esomeprazol during this time.

It is not known if esomeprazol passes into breast milk. Therefore, you should not take esomeprazol during breast-feeding.

Driving and using machines

Esomeprazol is not likely to affect your ability to drive or use any tools or machines. However, side effects such as dizziness or blurred vision may uncommonly or rarely occur (see section 4). Do not drive or use any tools or machines if you are affected by these side effects.

Esomeprazol Tecnigen contains sugar

This medicine contains sugar spheres which contain sucrose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Esomeprazol Tecnigen contains sodium

This medicine contains less than 23 mg sodium (1 mmol) per gastro-resistant tablet, i.e. essentially ‘sodium-free’.

3. How to take Esomeprazol Tecnigen

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• If you are taking this medicine for a long time, your doctor will want to monitor you (especially if you are taking it for more than a year).
• If your doctor has told you to take this medicine as and when you need it, tell your doctor if your symptoms change.

How much to take

• Your doctor will tell you how many tablets to take and when to take them. This will depend on your condition, age and liver function.
• The recommended doses are described below:

Use in adults aged 18 years and above

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg gastro-resistant tablet of esomeprazol once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your oesophagus has not yet healed. Once the oesophagus has healed, the recommended dose is one 20 mg gastro-resistant tablet of esomeprazol once a day.
• If your oesophagus is not damaged, the recommended dose is one 20 mg gastro-resistant tablet of esomeprazol once a day.
• Once your condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one 20 mg gastro-resistant tablet of esomeprazol per day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of ulcers caused by Helicobacter pylori and to prevent them coming back:

• The recommended dose is one 20 mg gastro-resistant tablet of esomeprazol twice a day for one week. Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for you to take with this medicine.

For the treatment of stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is one 20 mg gastro-resistant tablet of esomeprazol once a day for 4-8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

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

For the treatment of too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 40 mg of esomeprazol twice a day.
• Your doctor will adjust the dose according to your needs and will also decide how long you will need to take the medicine for. The maximum dose is 80 mg twice a day.

Prevention of bleeding from ulcers in the stomach or duodenum, following treatment with esomeprazol given by injection:

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

Use in adolescents aged 12 years and above

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg gastro-resistant tablet of esomeprazol once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your oesophagus has not yet healed.
• Once your oesophagus has healed, the recommended dose is one 20 mg gastro-resistant tablet of esomeprazol once a day.
• If your oesophagus is not damaged, the recommended dose is one 20 mg gastro-resistant tablet of esomeprazol once a day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of ulcers caused by Helicobacter pylori and to prevent them coming back:

• The recommended dose is one 20 mg gastro-resistant tablet of esomeprazol twice a day for one week. Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for you to take with this medicine.

Taking this medicine

• You can take your tablets at any time of the day.
• You can take your tablets with food or on an empty stomach.
• Swallow your tablets whole with a glass of water. Do not chew or crush the tablets. This is because the tablets contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

What to do if you have difficulty swallowing

If you have difficulty swallowing the tablets:

• Put the tablets in a glass of water. Do not use other liquids.
• Stir until the tablets break up (the mixture will not be clear). You can take the mixture immediately or within 30 minutes. Always stir well before taking.
• To make sure that you have taken all of the medicine, rinse the glass with half a glass of water and drink. The solid pieces contain the medicine - do not chew or crush them.

If you cannot swallow at all, the tablets can be dispersed in water and given through a syringe (orally or through a nasogastric tube).

Use in children under 12 years of age

Esomeprazol Tecnigen gastro-resistant tablets are not recommended for children under 12 years of age. Other formulations of esomeprazol are available for children aged 1-12 years (consult your doctor or pharmacist for more information).

Elderly

No dose adjustment is necessary for elderly patients.

If you take more Esomeprazol Tecnigen than you should

If you take more esomeprazol than you should, talk to your doctor or pharmacist straight away.

In case of overdose, contact the national Poison Information Centre on 91 5620420, indicating the medicine and the amount taken.

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, skip the missed dose and continue as usual.

Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you have any further questions on 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 can affect up to 1 in 1,000 people.

• A 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 can affect up to 1 in 1,000 people.

• Sudden appearance of a severe skin rash or skin redness 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. This could be a "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms".

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

• Widespread rash, high body temperature, and increased lymph node size (DRESS syndrome or drug hypersensitivity syndrome), which is very rare.

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 yellow 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 blood cell count, 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 skin peeling. 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 treated with esomeprazol for more than three months, 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 in 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 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. Storage 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 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 you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Esomeprazol Tecnigen Composition

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

The other components (excipients) are:

Pellets: methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion (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).

Product Appearance and Package Contents

Esomeprazol Tecnigen 20 mg are gastro-resistant tablets, light pink in color, 6.55 x 13.6 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. 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 clogging the tube.

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

1. Hold the syringe with the tip up and check that the tip is not clogged.

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

1. Shake the syringe and place it with the tip down. Inject immediately 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be kept with the tip up to avoid clogging the tip).

1. Put the syringe back with the tip down 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 flush any sediment remaining in the syringe. For some tubes, 50 ml of water are necessary.