Esomeprazole Mabo 40 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Esomeprazol MABO 40 mg gastro-resistant hard capsules EFG

Esomeprazole

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, consult 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 may 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.

Contents of the leaflet

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

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

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

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

Adults:

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

• Excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

• Continuation treatment to prevent re-bleeding from peptic ulcer following intravenous esomeprazole.

Adolescents aged 12 years and older:

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows 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 MABO

Do not take Esomeprazol MABO:

• If you are allergic to esomeprazole 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 (such as 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, skin peeling, blistering, or mouth ulcers after taking esomeprazole or other related medicines.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take 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 used to reduce stomach acid.
• if you are scheduled to have a specific blood test (Chromogranin A).

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

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

If Esomeprazol MABO has been prescribed only for use when symptoms occur, you should contact your doctor if your symptoms persist or change.

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

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

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

Use of Esomeprazol MABO 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 obtained without a prescription. This is because Esomeprazol MABO may affect how some medicines work, and some medicines may influence the effect of Esomeprazol MABO.

Do not take Esomeprazol MABO if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Inform 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 in cancer treatment).
• Citalopram, imipramine, 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 when you start or stop taking Esomeprazol MABO.
• Medicines used to make the blood less likely to clot, such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol MABO.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by poor 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 stop your Esomeprazol MABO treatment.
• Tacrolimus (organ transplant).
• Rifampicin (used to treat tuberculosis).
• St. John’s Wort (Hypericum perforatum) (used for depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin in addition to Esomeprazol MABO 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 MABO with food and drinks

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Your doctor will decide whether you can take Esomeprazol MABO during this time.

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

Driving and using machines

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

Esomeprazol MABO contains saccharose

Esomeprazol MABO contains sugar spheres that contain saccharose, a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Esomeprazol MABO

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 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 liver function.
• The recommended doses are indicated below.

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 slightly affected, the recommended dose is one capsule of Esomeprazol MABO 40 mg 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 one capsule of Esomeprazol MABO 40 mg 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 for prevention of rebleeding from peptic ulcer after intravenous esomeprazole:

• The recommended dose is one capsule of Esomeprazol MABO 40 mg 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 slightly affected, the recommended dose is one gastro-resistant capsule of Esomeprazol MABO 40 mg 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.

How to take this medicine

• You may take the capsules at any time of day.
• You may 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 stomach acid. 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 still (non-carbonated) water. Do not use any other liquids.

• Stir the mixture and drink it immediately or within 30 minutes. Always stir 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 granules can be mixed with a small amount of water and drawn into a syringe. They can then be administered 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.

Elderly patients

Dose adjustment is not necessary in elderly patients.

If you take more Esomeprazol MABO than you should

If you take more Esomeprazol MABO than your doctor has prescribed, consult your doctor or pharmacist immediately.

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

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 a missed 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 MABO and contact a doctor immediately:

• Sudden difficulty breathing, swelling of the lips, tongue, throat or entire body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Red skin with blistering or peeling. Severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. This could be a case of “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.
• Widespread rash, high body temperature, and swollen 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:

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 and numbness, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function changes.
• Skin rash, hives, skin itching.
• Fracture of hip, wrist, or spine (if Esomeprazole 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 decreased number of white blood cells or platelets. This may cause weakness, bruising, or increased risk of infections.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Taste disturbances.
• 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 fatigue.
• 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 patients)

• Changes in blood cell counts, including agranulocytosis (reduced number of white blood cells).
• Aggression.
• 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).
• 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 Esomeprazole MABO 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, consult your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Inflammation of the intestine (may lead to diarrhoea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazole MABO 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 health, 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, in this case, to inform your doctor about your medication.

Reporting of adverse effects

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

5. Storage of Esomeprazole MABO

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

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

-Blister packs: Do not store above 30°C. Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Esomeprazole MABO

-The active substance is esomeprazole.

Esomeprazole MABO capsules contain 40 mg of esomeprazole (as sodium salt).

The other components are:

Contents of the capsule:

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

Capsule coating:

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

Appearance of the product and contents of the pack

Esomeprazole MABO 40 mg are opaque pink hard capsules, size 2 (approximately 18 mm), printed (head ES/body 40), containing spherical granules.

Esomeprazole 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 pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

MABO-FARMA, S.A.

Calle Vía de los Poblados 3,

Building 6, 28033, Madrid,

Spain.

Manufacturer:

TOWA PHARMACEUTICAL EUROPE S.L.

C/ San Martí, 75-97,

Martorelles, 08107 Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: February 2025

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

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This information is intended for healthcare professionals only:

Administration via nasogastric or gastric tube

1. Add the contents of one capsule into approximately 25 ml or 50 ml of water. (For some tubes, dispersion in 50 ml of water is required to prevent the pellets from blocking the tube). Shake.
2. Empty the suspension into a syringe and add approximately 5 ml of air.
3. Immediately shake the syringe for about 2 minutes to disperse the pellets.
4. Hold the syringe with the tip pointing upwards and check that the tip is not blocked.
5. Connect the syringe to the tube while maintaining the previous position.
6. Shake the syringe and position it with the tip pointing downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it (the syringe must be kept with the tip pointing upwards to prevent blockage of the tip).
7. Reposition the syringe with the tip downwards and immediately inject 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 remaining sediment from the syringe. For some tubes, 50 ml of water may be required.

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