ESOMEPRAZOL 40 mg Hard Gastro-Resistant Capsules

Contents of the leaflet

1. Introduction
2. What is Esomeprazol MABO and what is it used for
3. What you need to know before you take Esomeprazol MABO
4. How to take Esomeprazol MABO
5. Possible Adverse Effects
6. Conservation of Esomeprazol MABO
7. Package Contents and Additional Information

Introduction

Package Leaflet: Information for the Patient

Esomeprazol MABO 40 mg Gastro-Resistant Hard Capsules EFG

Esomeprazol

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

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

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

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

Esomeprazol MABO contains a medicine called esomeprazol. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that the stomach produces.

Esomeprazol MABO is used for the treatment of the following conditions:

Adults:

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.

• Excessive acid production in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Prevention of relapse of peptic ulcer bleeding in patients treated with esomeprazol intravenously.

Adolescents from 12 years of age:

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.

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 proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazol).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).
• If you have ever had a skin reaction after treatment with a medicine similar to Esomeprazol MABO that reduces stomach acid.

If any of the above apply to you, 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

• 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 MABO that reduces stomach acid.
• if you are due to have a specific blood test (Chromogranin A).

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

• You lose a lot of weight for no reason and have problems 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 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).

If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as you can, as you may need to stop your treatment with Esomeprazol MABO. Also 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 rash with eosinophilia and systemic symptoms (DRESS), have been reported with esomeprazol. Stop taking esomeprazol and contact your doctor immediately if you get any of the symptoms 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 may 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, clomipramine (used to treat depression).
• Diazepam (used to treat anxiety, as a muscle relaxant or to treat epilepsy).
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Esomeprazol MABO.
• Medicines used to 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 – a pain in the legs when walking which is caused by an insufficient blood supply).
• 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 (used 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 about any other medicines you are taking.

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 any tools or machines. However, side effects such as dizziness or blurred vision (see section 4) may uncommonly or rarely occur. Do not drive or use any tools or machines if you are affected in this way.

Esomeprazol MABO containssugar

Esomeprazol MABO contains sugar spheres which contain sucrose, a type of sugar. If your doctor has told you that you have an intolerance to some sugars, contact them 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 take Esomeprazol MABO for a long time, your doctor will want to regularly check your condition.

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

How much to take

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

Adults aged 18 years and over

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 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 gullet has not healed yet.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of excessive acid production in the stomach caused by a tumour 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 also decide how long you will need to take the medicine. The maximum dose is two Esomeprazol MABO 40 mg capsules per day.

Prevention of relapse of peptic ulcer bleeding in patients treated with esomeprazol intravenously:

• 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 gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) 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 gullet has not healed yet.
• If you have severe liver problems, your doctor may give you a lower dose.

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 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 capsules:

• Open the capsule and mix the contents with half a glass of water, non-fizzy water. Do not use other liquids.
• Stir the mixture and drink it immediately or within 30 minutes. Always stir the mixture just before drinking.
• To make sure that you have taken all of the medicine, rinse the glass with half a glass of water and drink. The solid particles contain the medicine – do not chew or crush them.
• If you cannot swallow at all, the granules can be mixed with a little water and put into a syringe. They can then be given through a nasogastric tube.

Children under 12 years of age

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

Elderly

No dose adjustment is necessary in elderly patients.

If you take more Esomeprazol MABO than you should

If you have taken more Esomeprazol MABO than you should, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the national toll free poison help line at 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, skip 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 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 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. 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.

Uncommon(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.
• Alteration of taste.
• 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).
• 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.
• Enlargement of the breasts in men.

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

• If you are treated with Esomeprazol MABO for more than three months, it is possible that the levels of magnesium in the blood may decrease. Low levels of magnesium can manifest as fatigue, muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, see a doctor immediately. Low levels of magnesium 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 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 the 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 about 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 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. Conservation of Esomeprazol MABO

-Keep this medicine out of 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 in 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 40 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 40 mg are hard pink opaque capsules, size 2 (approximately 18 mm) printed (head ES/body 40) and containing spherical granules.

Esomeprazol MABO 40 mg is available in:

Aluminum/Aluminum blisters:

7, 14, 15, 28, 30, 56, 60, 90 (2 x 45) and 100 (2 x 50) 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 on 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.