Esomeprazole Tecnigen 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Esomeprazole Tecnigen 40 mg gastro-resistant tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Esomeprazole Tecnigen is and what it is used for
2. What you need to know before taking Esomeprazole Tecnigen
3. How to take Esomeprazole Tecnigen
4. Possible side effects
5. How to store Esomeprazole Tecnigen
6. Contents of the pack and other information

1. What Esomeprazol Tecnigen is and what it is used for

Esomeprazol Tecnigen contains a medicine called esomeprazole, which belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced by the stomach.

Esomeprazole is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid moves up into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Excess stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuing treatment to prevent rebleeding from peptic ulcer after initial treatment with intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid moves up into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

2. What you need to know before taking Esomeprazol Tecnigen

Do not take Esomeprazol Tecnigen

• if you are allergic to esomeprazol or to 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 containing nelfinavir (used in the treatment of HIV infection).
• If you have ever developed a severe skin rash, peeling skin, blistering, or mouth ulcers after taking esomeprazol or other related medicines.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 used to reduce stomach acid.
• If you are scheduled 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 association with esomeprazol treatment. Stop taking esomeprazol and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

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

Taking a proton pump inhibitor such as esomeprazol, 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 if you are taking corticosteroids (which may increase the risk of osteoporosis).

Skin rashes and skin symptoms

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with esomeprazol. Remember to mention any other symptoms you may notice, such as joint pain.

Severe skin rashes have occurred in patients taking esomeprazol (see also section 4). The rash may include mouth, throat, nose, genital ulcers, and conjunctivitis (red, swollen eyes). These severe skin rashes usually appear after flu-like symptoms such as fever, headache, and body pain. The rash may cover large areas of the body with blistering 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 of age. There are other more appropriate dosage forms available (consult your doctor or pharmacist if you need further information).

Taking Esomeprazol Tecnigen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines purchased without a prescription. This is because esomeprazol can affect how some medicines work, and some medicines can influence the effect of esomeprazol.

Do not take esomeprazol tablets if you are taking a medicine containing nelfinavir (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 to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (for fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramine, clomipramine (for the treatment of depression).
• Diazepam (used for 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.
• Medicines used to thin the blood 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 while walking caused by insufficient blood flow).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used at high doses in cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily discontinue your esomeprazol treatment.
• 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 to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicines.

Taking Esomeprazol with food and drinks

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

Pregnancy, breastfeeding, and fertility

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

It is unknown whether esomeprazol passes into breast milk. Therefore, esomeprazol should not be taken during breastfeeding.

Driving and using machines

Esomeprazol is unlikely to affect your ability to drive or use tools or machinery. However, adverse effects such as dizziness or blurred vision may occur infrequently or rarely (see section 4). Do not drive or use machinery if you experience any of these effects.

Esomeprazol Tecnigen contains sucrose

This medicine contains sugar spheres containing sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, consult him 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 for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• If you take this medicine for a long period of time, your doctor will need to monitor you (especially if you take it for more than one year).
• If your doctor has instructed you to take this medicine only when you experience symptoms, inform your doctor if the symptoms change.

How much to take

• Your doctor will have advised 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 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 mildly affected, the recommended dose is one 40 mg esomeprazole gastro-resistant tablet once daily for 4 weeks. Your doctor may instruct you to continue 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 pancreatic tumor (Zollinger-Ellison syndrome):

• The recommended dose is 40 mg of esomeprazole twice daily.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take this medicine. The maximum dose is 80 mg twice daily.

Continuation treatment to prevent re-bleeding from peptic ulcer induced with intravenous esomeprazole:

• The recommended dose is one 40 mg esomeprazole tablet once daily 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 mildly affected, the recommended dose is one 40 mg esomeprazole gastro-resistant tablet per day for 4 weeks. Your doctor may instruct you to continue 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 medicine

• You may take the tablets at any time of day.
• You may 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:

• Place the tablets in a glass of non-carbonated water. Do not use any other liquids.
• Stir until the tablets disintegrate (the solution will not be clear). You may drink the mixture immediately or within 30 minutes. Always stir again just before drinking.
• To ensure you have taken all the medicine, rinse the glass thoroughly with half a glass of water and drink it. The solid particles contain the medicine – do not chew or crush the granules.

If you cannot swallow at all, the tablets may be dispersed in water and drawn 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. Other authorized pharmaceutical forms of esomeprazole are available for children aged 1–12 years in sachets (consult your doctor or pharmacist if you need further information).

Elderly patients

Dose adjustment is not 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, contact the Toxicology Information Service at telephone number 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 a forgotten dose.

If you have any further 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 everyone will experience them.

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

• Yellowing of the skin, dark urine, and tiredness, which may be symptoms of liver problems.

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

• Sudden difficulty breathing, swelling of the lips, tongue, throat or entire body, 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 blistering or peeling, even after several weeks of treatment. Severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may progress to serious and widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This could be "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms" (DRESS).

• Widespread rash, high body temperature, and enlarged lymph nodes (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:

Common (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal effects: stomach pain, constipation, diarrhoea, gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling or numbness sensation, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function.
• Skin rash, hives, itching of the skin.
• Fracture of 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 decreased number of white blood cells or platelets. This may cause weakness, bruising, or increase the likelihood of infections.
• Low levels of sodium in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Altered taste.
• Eye disorders such as blurred vision.
• Sudden sensation of breathlessness or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• A fungal infection known as "candidiasis" that may affect the oesophagus.
• Liver problems including jaundice, which may cause yellow skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Dermatitis due to exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of malaise and lack of energy.
• Increased sweating.

Very rare (may affect up to 1 in 10,000 people)

• Changes in blood cell counts, including agranulocytosis (reduction in the number of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Liver disorders that may lead to liver failure or brain inflammation.
• Sudden onset of severe skin rash, blisters, or skin peeling. 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 (frequency cannot be estimated from available data)

• If you are taking esomeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present 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 reduced levels of potassium or calcium in the blood. Your doctor may decide to carry out periodic blood tests to monitor your magnesium levels.
• Inflammation of the intestine (which may lead to diarrhoea).
• Skin rash, possibly with joint pain.

In very rare cases, esomeprazole may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by a severe deterioration in general condition, or fever with signs of a local infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a reduced number of white blood cells (agranulocytosis) through a blood test. It is important that, in such cases, you inform your doctor about the medication you are taking.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazol Tecnigen

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If you are unsure, please consult your pharmacist on how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Esomeprazol Tecnigen

The active substance is esomeprazole. Each gastro-resistant tablet contains 40 mg of esomeprazole (as esomeprazole magnesium dihydrate).

The other components (excipients) are:

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

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

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

Appearance of the product and contents of the container

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

It is available in blisters (Al/Al) containing 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 most recent revision of this leaflet: February 2025

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

This information is intended for healthcare professionals only:

Administration via gastric tube

1. Place 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. Immediately shake the syringe vigorously for about 2 minutes to disperse the tablet.

3. Hold the syringe with the tip pointing upwards and check that the tip is not blocked.

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

5. Shake the syringe and position it with the tip pointing downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe, shake it (the syringe must be kept with the tip pointing upwards to prevent blockage of the tip).

6. Reposition the syringe with the tip pointing downwards and immediately inject 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 flush any remaining residue from the syringe. For some tubes, 50 ml of water may be required.