ESOMEPRAZOL MABO 20 mg HARD GASTRO-RESISTANT CAPSULES

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

Do not take Esomeprazol MABO:

• If you are allergic to esomeprazol or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines of the same group of medicines (proton pump inhibitors) such as pantoprazole, lansoprazole, rabeprazole, or omeprazole.
• If you are taking a medicine that contains nelfinavir (used to treat HIV infection).
• If you have ever had a severe skin reaction or blistering of the skin, mouth, or eyes after taking esomeprazol or other medicines of the same group.

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

Warnings and precautions

Consult your doctor or pharmacist before taking Esomeprazol MABO

Esomeprazol MABO may hide the symptoms of other diseases. Therefore, if you notice any of the following before or while taking Esomeprazol MABO, 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 are black (blood-stained).

If you have been prescribed Esomeprazol MABO only when you notice symptoms, you should contact your doctor if your symptoms persist or change.

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

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 it may be necessary to stop treatment with Esomeprazol MABO. Remember to mention any other symptoms that you may notice, such as joint pain.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported 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.

Using Esomeprazol MABO 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 MABO can affect how some medicines work and some medicines can affect how Esomeprazol MABO works.

Do not take Esomeprazol MABO 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 (used to treat fungal infections).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine, or clomipramine (used to treat 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 Esomeprazol MABO.
• Medicines that thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazol MABO.
• Cilostazol (used to treat 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 (a chemotherapy medicine used at high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Esomeprazol MABO.
• Tacrolimus (after organ transplantation).
• 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 Esomeprazol MABO to treat ulcers caused by Helicobacter pylori, it is very important that you tell your doctor if you are taking any other medicine.

Taking Esomeprazol MABO with food and drink

You can take the capsules 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 for advice before taking this medicine. Your doctor will decide whether you can take Esomeprazol MABO during this time.

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

Driving and using machines

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

Esomeprazol MABO containssucrose

Esomeprazol MABO 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 your doctor before taking this medicine.

3. How to take Esomeprazol MABO

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

• If you are taking this medicine for a long time, your doctor will need to keep an eye on you (especially if you are taking it for more than one year).

• If your doctor has told you to take this medicine only when you notice symptoms, tell your doctor if your symptoms change.

How much to take

• Your doctor will have told you how many capsules to take and when to take them. This will depend on your condition, age, and how well your liver is working.
• The recommended doses are given below.

Adults aged 18 years and over

For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has found that your gullet (esophagus) is slightly damaged, the recommended dose is one Esomeprazol MABO 40 mg capsule per day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your esophagus has not yet healed.
• Once your esophagus has healed, the recommended dose is one Esomeprazol MABO 20 mg capsule per day.
• If your esophagus is not damaged, the recommended dose is one Esomeprazol MABO 20 mg capsule per day. Once your condition has been controlled, your doctor may tell you to take your medicine only when you notice symptoms, up to a maximum of one Esomeprazol MABO 20 mg capsule per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

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

• The recommended dose is one Esomeprazol MABO 20 mg capsule twice a day for one week. Your doctor will also prescribe antibiotics called, for example, amoxicillin and clarithromycin.

For the treatment of stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is one Esomeprazol MABO 20 mg capsule per day for 4 to 8 weeks.

To prevent stomach ulcers if you are taking non-steroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is one Esomeprazol MABO 20 mg capsule per day.

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

• The recommended dose is one Esomeprazol MABO 40 mg capsule twice a day. Your doctor will adjust the dose according to your needs and will also decide how long you need to take this medicine. The maximum dose is 80 mg twice a day.

Continuation of prevention of rebleeding of gastric or duodenal ulcers with esomeprazol intravenous:

• The recommended dose is one Esomeprazol MABO 40 mg capsule per day for 4 weeks.

Use in adolescents aged 12 years and over

For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

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

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

• The recommended dose is one Esomeprazol MABO 20 mg gastro-resistant capsule twice a day for one week. Your doctor will also prescribe antibiotics called, for example, amoxicillin and clarithromycin.

Taking this medicine

• You can take the capsules at any time of the day.
• You can take the capsules with food or on an empty stomach.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules. This is because the capsules contain granules that prevent the medicine from being destroyed by the acid in the stomach. It is important not to damage the granules.

What to do if you have difficulty swallowing

• If you have difficulty swallowing the capsules:

• Open the capsule and empty the granules into half a glass of water. Do not use other liquids.
• Stir the mixture and drink it immediately or within 30 minutes. Always stir just before drinking.
• To make sure you have taken all the medicine, rinse the glass 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 granules can be mixed with a little water and injected directly into the stomach through a tube (gastric tube).

Children under 12 years of age

Esomeprazol MABO is not recommended for children under 12 years of age.

Older people

No dose adjustment is necessary in older people.

If you take more Esomeprazol MABO than you should

If you take more Esomeprazol MABO than you should, talk to your doctor or pharmacist immediately.

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

If you forget to take Esomeprazol MABO

• 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 missed doses.

If you have any further questions on the use of this product, 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 MABO and contact a doctor immediately:

• A sudden difficulty breathing, swelling of 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. Important blisters and 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 that can be symptoms of liver problems.
• Widespread rash, high body temperature, and enlargement of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rare.

These effects are rare and may affect up to 1 in 1,000 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.
• Disruption 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 MABO 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 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 feeling 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).
• Dermatitis due to sun exposure.
• Pain in the joints (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).
• Aggressiveness.
• 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 pain in the joints. (Erythema multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis).
• Muscle weakness.
• Severe kidney disorders.
• Enlargement of the breasts in men.

Frequency Not Known(frequency cannot be estimated from available data)

• If you are being treated with Esomeprazol MABO for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels can also lead to a reduction in blood potassium or calcium levels. 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 pain in the joints.

In very rare cases, Esomeprazol MABO can affect 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) through a blood test. It is important that, in this case, you inform your doctor about 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 is not listed 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 MABO

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

-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.

-Blister:Do not store at a temperature above 30°C. Keep in the 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 of 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. Package Contents and Additional Information

Composition of Esomeprazol MABO

-The active ingredient is esomeprazol.

Esomeprazol MABO capsules contain 20 mg of esomeprazol (as sodium salt).

The other components are:

Contents of the capsule:

Sugar spheres (cornstarch and sucrose), methylcellulose, talc, titanium dioxide (E171), glycerol monostearate, polysorbate 80, sodium lauryl sulfate, methacrylic acid copolymer, and triethyl citrate.

Capsule shell:

Carrageenan, potassium chloride, red iron oxide (E-172), titanium dioxide (E171), hypromellose, and printing ink (containing shellac, potassium hydroxide, and black iron oxide E-172).

Appearance of the Product and Package Contents

Esomeprazol MABO 20 mg are hard, light pink, opaque capsules, size 4 (approximately 14 mm), printed (head ES/body 20), and containing spherical granules.

Esomeprazol MABO 20 mg is available in:

Aluminum/Aluminum blisters:

7, 14, 15, 28, 30, 56, 60, 90 (2x45), and 100 (2x50) capsules

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

MABO-FARMA, S.A.

Calle Rejas 2, planta 1

28821 Coslada, Madrid

Spain

Manufacturer:

TOWA PHARMACEUTICAL EUROPE S.L.

C/ San Martí, 75-97,

Martorelles, 08107 Barcelona

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Date of the Last Revision of this Prospectus:February 2025

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

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This information is intended only for healthcare professionals:

Administration through a nasogastric or gastric tube

1. Add the contents of a capsule to approximately 25 ml or 50 ml of water. (For some tubes, dispersion in 50 ml of water is required to avoid clogging the tube). Shake.
2. Empty the suspension into a syringe and add approximately 5 ml of air.
3. Shake the syringe immediately for approximately 2 minutes to disperse the pellets.
4. Hold the syringe with the tip up and check that the tip is not clogged.
5. Connect the syringe to the tube while maintaining the previous position.
6. 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).
7. 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.
8. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 6 if necessary to flush any sediment remaining in the syringe. For some tubes, 50 ml of water are required.

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.