ESOMEPRAZOL MABO-FARMA 20 mg GASTRO-RESISTANT TABLETS

2. What you need to know before you take Esomeprazol Mabo-Farma

Do not take Esomeprazol Mabo-Farma

• 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).
• If you have ever had a skin reaction after treatment with a medicine similar to esomeprazol that reduces stomach acid.

If any of the above apply to you, do not take esomeprazol. If you are not sure, talk to your doctor or pharmacist before taking esomeprazol.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 that reduces stomach acid.
• If you are due to have a specific blood test (Chromogranin A).

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

• You lose a lot of weight for no reason and have problems swallowing.
• You get stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools are black (blood-stained).

If your doctor has prescribed esomeprazol for you only when you have symptoms, you should contact your doctor if your symptoms persist or worsen.

Taking a proton pump inhibitor like esomeprazol, especially over a period of more than one year, may slightly increase your risk of fracture of 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. Also remember to mention any other symptoms that you may notice, such as fever, headache and swollen lymph nodes.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis have been reported with esomeprazol (see section 4). If you get any of the symptoms of these severe skin reactions, stop taking esomeprazol and contact your doctor or go to the hospital immediately.

Children under 12 years of age

Information on dosing for children aged 1 to 11 years is presented in the esomeprazol granules product information (consult your doctor or pharmacist if you need additional information).

Other medicines and Esomeprazol Mabo-Farma

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 may affect how these medicines work or they may affect how esomeprazol works.

Do not take esomeprazol tablets if you are taking a medicine containing nelfinavir (used to treat HIV).

Tell your doctor if you are taking any of the following medicines:

• Atazanavir (used to treat HIV).
• 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, relax muscles or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor may need to monitor you when you start or stop taking esomeprazol.
• Medicines used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking esomeprazol.
• Cilostazol (used to treat intermittent claudication – a condition where the leg does not get enough blood when walking).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used to treat cancer) – if you are taking high doses of methotrexate, your doctor may need to temporarily stop your esomeprazol treatment.
• Tacrolimus (used to prevent organ rejection after 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 with esomeprazol 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-Farma with food and drink

You can take your tablets at any time of the day, either with food or without food.

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 or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take esomeprazol during this time.

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

Driving and using machines

Esomeprazol is not likely to affect your ability to drive or use any tools or machines. However, side effects such as dizziness or blurred vision may uncommonly or rarely occur (see section 4). Do not drive or use any tools or machines if you are affected by these side effects.

Esomeprazol Mabo-Farma contains sugar

Esomeprazol contains sugar spheres which contain sucrose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Esomeprazol Mabo-Farma contains sodium

This medicine contains less than 23 mg sodium (1 mmol) per gastro-resistant tablet, i.e. essentially “sodium-free”.

3. How to take Esomeprazol Mabo-Farma

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• If you are taking this medicine for a long time, your doctor will want to monitor you (especially if you are taking it for more than a year).
• If your doctor has told you to take this medicine as and when you need it, tell your doctor if your symptoms change.

How much to take

• Your doctor will tell you how many tablets to take and how long to take them for. This will depend on your condition, age and liver function.
• The recommended doses are as follows:

Use in adults aged 18 years and above

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 40 mg gastro-resistant tablet of esomeprazol once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your oesophagus has not yet healed. Once the oesophagus has healed, the recommended dose is one 20 mg gastro-resistant tablet of esomeprazol once a day.
• If your oesophagus is not damaged, the recommended dose is one 20 mg gastro-resistant tablet of esomeprazol once a day.
• Once your condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one 20 mg gastro-resistant tablet of esomeprazol per day.
• If you have severe liver problems, your doctor may give you a lower dose.

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

• The recommended dose is one 20 mg gastro-resistant tablet of esomeprazol twice a day for one week. Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for you to take with esomeprazol.

For the treatment of stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is one 20 mg gastro-resistant tablet of esomeprazol once a day for 4-8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is one 20 mg gastro-resistant tablet of esomeprazol once a day.

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

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

Continuation of treatment after prevention of bleeding from ulcers with esomeprazol given by injection:

• The recommended dose is one 40 mg tablet of esomeprazol once a day for 4 weeks.

Use in adolescents aged 12 years and above

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 40 mg gastro-resistant tablet of esomeprazol once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your oesophagus has not yet healed.
• Once your oesophagus has healed, the recommended dose is one 20 mg gastro-resistant tablet of esomeprazol once a day.
• If your oesophagus is not damaged, the recommended dose is one 20 mg gastro-resistant tablet of esomeprazol once a day.
• If you have severe liver problems, your doctor may give you a lower dose.

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

• The recommended dose is one 20 mg gastro-resistant tablet of esomeprazol twice a day for one week. Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for you to take with esomeprazol.

Taking this medicine

• You can take your tablets at any time of the day.
• You can take your tablets with food or on an empty stomach.
• Swallow your tablets whole with a glass of water. Do not chew or crush the tablets. This is because the tablets contain coated granules which stop the medicine from being broken down by the acid in your stomach. It is important not to damage these granules.

What to do if you have difficulty swallowing

• If you have difficulty swallowing the tablets:

• Put the tablet in a glass of water. Do not use other liquids.
• Stir until the tablet breaks up (the mixture will not be clear). You can then drink the mixture. You must always stir the mixture just before you drink it.
• To make sure that you get all of the medicine, rinse the glass with half a glass of water and drink it. The solid pieces contain the medicine - do not chew or crush them.

• If you cannot swallow at all, the tablets can be dispersed in water and given through a syringe (a large syringe should be used to avoid blockage of the syringe) directly into the stomach via a tube.

Use in children under 12 years of age

Esomeprazol gastro-resistant tablets are not recommended for children under 12 years of age. Information on dosing for children aged 1 to 11 years is presented in the esomeprazol granules product information (consult your doctor or pharmacist if you need additional information).

Elderly

No dose adjustment is necessary for the elderly.

If you take more Esomeprazol Mabo-Farma than you should

If you take more esomeprazol than you should, talk to your doctor or pharmacist straight away.

In case of overdose, contact your doctor or pharmacist or go to the emergency room or accident and emergency department of your local hospital. Take the medicine pack with you.

If you forget to take Esomeprazol Mabo-Farma

• 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 and continue as usual.
• 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 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.
• Sleep disturbance (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 is used at high doses and for a long period).

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

• 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 yellowish 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 people)

• 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 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 esomeprazol for more than three months, your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have any of these symptoms, inform your doctor immediately. Low magnesium levels 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 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 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 report 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 does not appear 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-Farma

• Keep this medicine out of sight and reach of children.
• Do not store at a temperature above 30°C.
• 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.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol Mabo-Farma

• The active ingredient is esomeprazol. There are two concentrations of esomeprazol gastro-resistant tablets that contain 20 mg (as magnesium dihydrate salt).

• The other components are:

Tablet content: Copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion 30% (methacrylic acid, ethyl acrylate, polysorbate 80, and sodium lauryl sulfate), talc, triethyl citrate, hypromellose, sugar spheres (sucrose and cornstarch), magnesium stearate, hydroxypropyl cellulose, glycerol monostearate 40-55, polysorbate 80, microcrystalline cellulose, povidone, macrogol, crospovidone, sodium stearyl fumarate.

Tablet coating: Hypromellose, titanium dioxide (E171), macrogol, iron oxide red (E172), iron oxide yellow (E172).

Appearance of the Product and Package Contents

• Esomeprazol Mabo-Farma 20 mg gastro-resistant tablets are film-coated, biconvex, elliptical in shape, light pink in color, 6.55 x 13.6 mm.

• The tablets are presented in

Bottles of 28 and 56 tablets.

Blister packs in boxes and/or cartons of 28 and 56 tablets.

• It is possible that only some package sizes are marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain

Manufacturer:

BALKANPHARMA DUPNITSA AD

3 Samokovsko Shosse Str.

Dupnitsa 2600- Bulgaria

Date of the Last Revision of this Prospectus: February 2025

Other Sources of Information

Detailed 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 gastric tube

1. Insert 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, dispersion in 50 ml of water is required to prevent the pellets from clogging the tube.
2. Shake the syringe immediately for approximately 2 minutes to disperse the tablet.
3. Hold the syringe with the tip up and check that the tip is not clogged.
4. Connect the syringe to the tube while maintaining the previous position.
5. 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 prevent clogging the tip).
6. 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.
7. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to flush any sediment remaining in the syringe. For some tubes, 50 ml of water are required.