ESOMEPRAZOL TEVA 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Esomeprazol Teva 20 mg Gastro-Resistant Tablets EFG

Esomeprazol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 14 days.

Contents of the Package Leaflet:

1. What is Esomeprazol Teva and what is it used for
2. What you need to know before you take Esomeprazol Teva
3. How to take Esomeprazol Teva
4. Possible side effects
5. Storage of Esomeprazol Teva
6. Contents of the pack and further information

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

Esomeprazol Teva contains a medicine called esomeprazol, which belongs to a group of medicines called “proton pump inhibitors”. These work by reducing the amount of acid produced by the stomach.

Esomeprazol Teva is used for the short-term treatment of symptoms of reflux (such as heartburn and acid regurgitation).

Reflux occurs when stomach acid rises up into the esophagus (the tube that goes from the throat to the stomach), which can become inflamed and painful. This can cause symptoms such as a painful sensation in the chest that rises up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

You may experience relief from acid reflux symptoms and heartburn after the first day of taking this medicine, but it does not mean you will feel immediate relief. You may need to take the tablets for 2-3 consecutive days before you feel better. You should consult a doctor if your symptoms worsen or do not improve after 14 days.

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

Do not take Esomeprazol Teva

• If you are allergic (hypersensitive) to esomeprazol 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.
• 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 esomeprazol or other related medicines.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take esomeprazol if:

• You have had stomach ulcers or stomach surgery in the past.
• You have been receiving continuous treatment for reflux or heartburn for 4 weeks or more.
• You have jaundice (yellowing of the skin or eyes) or severe liver problems.
• You have severe kidney problems.
• You are over 55 years old and have new or recently changed symptoms of reflux or need to take non-prescription treatment for indigestion or heartburn every day.
• You have ever had a skin reaction after treatment with a medicine similar to esomeprazol that reduces stomach acid.
• You are scheduled to have a specific blood test (Chromogranin A)

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

Esomeprazol Teva may mask the symptoms of other diseases. Therefore, if you observe any of the following events before taking or while taking Esomeprazol Teva, contact your doctor immediately:

• You lose a lot of weight without reason and have difficulty swallowing.
• You experience stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (blood-stained).

Seek urgent medical attention if you experience chest pain with dizziness, sweating, fainting, or shoulder pain with difficulty breathing. This could be a sign of a serious heart condition.

Tell your doctor before taking this medicine if:

• You are going to have an endoscopy or a breath test with urea.
• You are going to have a specific blood test (Chromogranin A).

If you are in any of the above situations (or are unsure), consult your doctor immediately.

You should consult a doctor if your symptoms worsen or do not improve after 14 days.

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

Children and adolescents

This medicine should not be used by children and adolescents under 12 years old.

Other medicines and Esomeprazol Teva

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including those obtained 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 if you are taking:

• A medicine that contains nelfinavir(used to treat HIV infection).

Tell your doctor if you are taking 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 to treat cancer)
• 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 when you start or stop taking Esomeprazol Teva.
• Medicines used to make blood more fluid, such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol Teva.
• 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 Esomeprazol Teva
• Tacrolimus (organ 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 in addition to Esomeprazol Teva to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicine.

Esomeprazol Teva with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

It is not known if Esomeprazol Teva passes into breast milk. Therefore, Esomeprazol Teva should not be taken during breastfeeding.

Driving and using machines

Esomeprazol Teva is unlikely to affect your ability to drive or use tools or machines. However, rare or uncommon side effects such as dizziness or blurred vision (see section 4) may occur. Do not drive or use machines if you notice any of these effects.

Esomeprazol Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Esomeprazol Teva

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

Taking this medicine

• The recommended dose is one capsule per day
• Do not take more than one capsule per day (20 mg), even if you do not feel immediate improvement.
• You may need to take the capsules for 2 or 3 consecutive days before your reflux symptoms improve (such as heartburn and acid regurgitation).
• The duration of treatment is up to 14 days
• You can take the tablets at any time of day
• You can take the tablets with food or on an empty stomach.
• When your reflux symptoms have completely disappeared, you should stop taking this medicine.
• If your reflux symptoms worsen or do not improve after taking this medicine for 14 consecutive days, you should consult a doctor.
• 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 transparent). You can drink the mixture immediately or within 30 minutes. Always stir just before drinking.
  • To ensure 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 are unable to 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).

If you take more Esomeprazol Teva than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Esomeprazol Teva

• 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 to make up for missed doses.

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

4. Possible side effects

Like all medicines, Esomeprazol Teva can cause side effects, although not everyone gets them.

If you notice any of the following serious side effects, stop taking Esomeprazol Teva and contact a doctor immediately:

• Sudden difficulty breathing, swelling of the lips, tongue, and throat, or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blisters or peeling. Blisters or bleeding of the lips, eyes, mouth, nose, and genitals may also appear. This could be a “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”
• Yellow skin, dark urine, and fatigue, which can be symptoms of liver problems.
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome), which is very rare.

These effects are rare, occurring in between 1 and 10 out of every 10,000 patients.

Other side effects include:

Common (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

• Swelling of the feet and ankles.
• Disorders of sleep (insomnia).
• Dizziness, tingling, and numbness, drowsiness.
• Feeling of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, hives, itching of the skin.
• Fracture of the hip, wrist, or spine (if Esomeprazol Teva is used at high doses and for a long period)

Rare (may affect up to 1 in 1,000 patients)

• 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 cramps.
• Agitation, confusion, or depression.
• Alteration of taste.
• Eye disorders such as blurred vision.
• Sudden 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, which can cause yellow skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis due to sun exposure.
• 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 patients)

• 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).
• Muscle weakness.
• Severe kidney disorders.
• Increased size of the breasts in men.
• Low magnesium levels in the blood. This can cause weakness, nausea (vomiting), cramps, tremors, and arrhythmias (heart rhythm disorders)

Frequency not known

• Low magnesium levels in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, see a doctor immediately. Low magnesium levels can lead to a decrease in potassium and calcium levels in the blood.
• Inflammation of the intestine (can lead to diarrhea)
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Teva can affect the white blood cells, causing an immune deficiency. If you have an infection with symptoms such as fever with a severe worsening of your general condition or fever with symptoms of a local infection such as pain in the 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) with a blood test. It is important that you inform your doctor about your medication.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazol Teva

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

Do not use this medicine after the expiration date that appears on the label, the blister pack after EXP. The expiration date is the last day of the month indicated.

Blisters

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Bottles:

Do not store above 30°C.

Shelf life after first opening of the bottle: 100 days

Keep the bottle tightly closed to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol Teva

• The active ingredient is esomeprazole. There are two concentrations of Esomeprazol Teva gastro-resistant tablets that contain 20 mg or 40 mg of esomeprazole (as sodium salt).

• The other components are:
• • Core:Microcrystalline cellulose spheres (microcrystalline cellulose and water), hypromellose (E464), talc (E553b), titanium dioxide (E171), glycerol monostearate, polysorbate 80, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion at 30% (sodium lauryl sulfate, polysorbate 80, and methacrylic acid-ethyl acrylate copolymer), triethyl citrate (E1505), macrogol, microcrystalline cellulose (E460i), crospovidone (type A), and sodium stearyl fumarate.

• Coating:Opadry II Light Blue 85F30663 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, talc, aluminum lake carmine indigo/blue FD&C #2 (E132), and yellow iron oxide (E172)).

Appearance of the Product and Package Contents

• Esomeprazol Teva 20 mg gastro-resistant tablets are oval, blue-colored tablets.
• Esomeprazol Teva 20 mg is available in packs of 14 tablets in blisters.
• Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

The holder is:

Teva Pharma S.L.U.

Anabel Segura Street, 11, Albatros Building, 1st floor

28108 Alcobendas – Madrid

Spain

The manufacturer is:

Towa Pharmaceutical Europe S.L.

San Martí Street, 75-97

Martorelles, 08107 Barcelona

Spain

Date of the Last Revision of this Leaflet: September 2025

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

You can access detailed and updated information about this medicinal product by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75066/P_75066.html