PROSPECTO : INFORMATION FOR THE USER

PantoprazolMABO 40 mg gastro-resistant tablets EFG

Read this prospectus carefully before starting to take the medicine,because it contains important information for you

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

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

2.What you need to know before starting to take Pantoprazol MABO

3.How to take Pantoprazol MABO

4.Possible adverse effects

5Storage of Pantoprazol MABO

6.Contents of the package and additional information

Pantoprazol is a selective proton pump inhibitor, a medication that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach acid and intestine.

Pantoprazol is used for:

Adults and adolescents 12 years and older:

• Treatment of symptoms associated with gastroesophageal reflux disease (stomach burning, acid regurgitation, difficulty swallowing) caused by acid reflux from the stomach.

• Long-term treatment and prevention of recurrences of esophagitis caused by acid reflux (inflammation of the esophagus accompanied by acid regurgitation from the stomach).

Adults:

• Prevention of gastroduodenal ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who require continued treatment with this type of medication.

Do not take Pantoprazol

• If you are allergic (hypersensitive) to pantoprazole, soy lecithin, or any of the other components of pantoprazole (see section 6)
• If you are allergic to medications that contain other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole)

Warnings and precautions

Consult your doctor or pharmacist before starting to take pantoprazole if you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently, especially when you are on long-term treatment with pantoprazole. If liver enzyme levels increase, treatment should be discontinued

• If you need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a higher risk of developing complications in the stomach and intestine. Any increased risk will be evaluated based on individual risk factors such as age (65 years or older), history of stomach or duodenal ulcers, or gastrointestinal bleeding.

• If you have decreased vitamin B12 reserves or risk factors for it and receive pantoprazole treatment for a long period of time. Like all medications that reduce acid production, pantoprazole may reduce vitamin B12 absorption.

• Consult your doctor if you are taking atazanavir (for HIV treatment) at the same time as pantoprazole.

Inform your doctor immediatelyif you notice any of the following symptoms:

- Unintentional weight loss

- Repeated vomiting

- Difficulty swallowing

- Blood in vomit

- Pale appearance and feeling weak (anemia)

- Blood in your stools

- Severe or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need additional testing to rule out a malignant disease, as pantoprazole may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you take pantoprazole for a prolonged period (over one year), your doctor may regularly monitor you. You should inform your doctor of any new or unexpected symptoms and/or events each time you visit your doctor.

Consult your doctor before starting to take Pantoprazol MABO

• If you have ever had a skin reaction after treatment with a similar medication to pantoprazole for reducing stomach acid.
• If you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue pantoprazol treatment. Remember to mention any other symptoms you may notice, such as joint pain.
• If you take pantoprazol for more than three months, you may experience decreased magnesium levels in your blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Additionally, low magnesium levels may cause decreased potassium and calcium levels in your blood. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.

Inform your doctor if:

• You are scheduled to undergo a specific blood test (Cromogranin A)

Other medications and pantoprazol

Inform your doctor or pharmacist if you are taking, have recently used, or may need to take any other medication, including those purchased without a prescription.

Pantoprazol may affect the efficacy of other medications, so inform your doctor if you are taking

• Medications such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as pantoprazol may make these and other medications less effective.

• Warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring.

• Atazanavir (used to treat HIV infection).

Pregnancy and breastfeeding

There is insufficient data on the use of pantoprazol in pregnant women. Pantoprazol has been excreted in human milk. If you are pregnant, or think you may be pregnant, or if you are breastfeeding

you should only use this medication if your doctor considers the benefits for you to be greater than the potential risk to the fetus or baby.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

You should not drive or operate machinery if you experience side effects such as dizziness or blurred vision.

Pantoprazol MABO contains soy lecithin.

This medication contains soy lecithin. It should not be used in case of allergy to peanuts or soy.

Pantoprazol MABO contains maltitol (E-965)

This medication contains maltitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Pantoprazol MABO contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

When and how should you take Pantoprazol?

Take the whole tablets, without chewing or crushing, with a little water, 1 hour before a meal.

Unless your doctor has indicated otherwise, the recommended dose is:

Adults and adolescents 12 years and older:

Treatment of esophagitis by reflux:

The usual dose is 1 tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for esophagitis by reflux usually ranges from 4 to 8 weeks. Your doctor will indicate for how long you should take this medication.

Adults:

Treatment of an infection with a bacteria called Helicobacter pylori in patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication treatment)

1 tablet twice a day, plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each taken twice a day, with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second 1 hour before dinner. Follow your doctor's instructions and make sure to read the antibiotic prospectuses.

The treatment duration is usually 1 to 2 weeks.

Treatment of stomach and duodenal ulcers:

The usual dose is 1 tablet per day. The dose may be doubled by your doctor.

Your doctor will indicate for how long you should take this medication. The treatment duration for stomach ulcers is usually 4 to 8 weeks, and for duodenal ulcers, it is usually 2 to 4 weeks.

Long-term treatment of Zollinger-Ellison Syndrome and other conditions with increased stomach acid secretion:

The initial recommended dose is 2 tablets per day.

Take the 2 tablets 1 hour before a meal. Your doctor may adjust your dose depending on the amount of stomach acid you produce. If you are prescribed more than 2 tablets per day, you should take the tablets twice a day.

If you are prescribed more than 4 tablets per day, you will be told exactly when to stop treatment.

Special patient groups:

• If you have kidney problems, or moderate or severe liver problems, you should not take pantoprazole for the elimination of Helicobacter pylori.

• If you have severe liver problems, you should not take more than 1 tablet of 20 mg of pantoprazole per day (for this case, 20 mg pantoprazole tablets are available).

Use in children and adolescents:

• These tablets are not recommended for children under 12 years old.

If you take more Pantoprazol than you should:

Inform your doctor or pharmacist or call the Toxicological Information Service at phone 91 562 04 20, indicating the medication and the amount ingested. No known symptoms of overdose.

If you forget to take Pantoprazol:

Do not take a double dose to compensate for the missed doses. Take your next dose as usual.

If you interrupt treatment with Pantoprazol:

Do not stop taking these tablets without consulting your doctor or pharmacist first.

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

Like all medications, Pantoprazol may cause side effects, although not everyone will experience them.

The frequency of the possible side effects described below is classified as follows:

Very common (affects more than 1 in 10 patients)

Common (affects between 1 and 10 patients in every 100)

Uncommon (affects between 1 and 10 patients in every 1,000)

Rare (affects between 1 and 10 patients in every 10,000)

Very rare (affects fewer than 1 in 10,000 patients)

Frequency not known (cannot be estimated from available data).

If you experience any of the following side effects, stop taking these tablets and inform your doctor immediately, or contact the nearest hospital emergency service:

• Severe allergic reactions (rare): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), intense dizziness with very rapid heartbeat and excessive sweating.

• Severe skin alterations (frequency not known):skin blisters and rapid deterioration of general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and sensitivity to light.

• Other severe conditions (frequency not known):yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased size of the kidneys with occasional pain when urinating and lower back pain (severe kidney inflammation)

Other side effects are:

• Common(affects between 1 and 10 patients in every 100: benign stomach polyps.
• Uncommon(affects between 1 and 10 patients in every 1,000)

headache, dizziness, diarrhea, sensation of dizziness, vomiting, bloating and flatulence (gas), constipation, dry mouth, abdominal pain and discomfort, hives on the skin, exanthema, rash, itching, sensation of weakness, fatigue or general malaise, sleep disturbances.

• Rare(affects between 1 and 10 patients in every 10,000)

vision disturbances such as blurred vision, hives, joint pain, muscle pain, weight changes, increased body temperature, swelling in the extremities (peripheral edema), allergic reactions, depression, breast enlargement in men

• Very rare(affects fewer than 1 in 10,000 patients)

disorientation

• Frequency not known(cannot be estimated from available data)

hallucination, confusion (especially in patients with a history of these symptoms), decrease in sodium levels in the blood,sensation of tingling, pins and needles, paresthesia (tingling), burning or numbness, skin rash, possibly with joint pain, severe inflammation of the large intestine causing persistent watery diarrhea.

If you are taking this medication for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors such as this medication, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Side effects identified through blood tests:

• Uncommon(affects between 1 and 10 patients in every 1,000)

increase in liver enzymes

• Rare(affects between 1 and 10 patients in every 10,000)

increase in bilirubin, increase in blood fats

• Very rare(affects fewer than 1 in 10,000 patients)

reduction in platelet count which could cause bleeding or more frequent bruising, reduction in white blood cell count which could lead to more frequent infections.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use pantoprazol after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pantoprazol MABO

The active ingredient is pantoprazol.Each gastro-resistant tablet contains 40 mg of pantoprazol (in the form of sodium sesquihydrate).

Theother componentsare:

Core: maltitol, crospovidone, sodium carmellose, anhydrous sodium carbonate, calcium stearate.

Coating:polyvinyl alcohol, talc, titanium dioxide, macrogol 4000, soy lecithin, yellow iron oxide, anhydrous sodium carbonate, copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion at 30% and triethyl citrate.

Appearance of the product and contents of the packaging

Gastro-resistanttabletof yellow-yellow brown color and oval shape.

Packaging: blister (Al/Al)

Packaging with 14, 28, 56 or 500 gastro-resistant tablets.

Holder of the marketing authorization

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Responsible for manufacturing

Sofarimex. Industria Química e Farmaceutica Lda. Av. das Industrias. Alto do Colaride, Agalva 2735-213 Cacem, Portugal.

Or

MEDREICH PLC,

Warwick House, Plane Tree Crescent, Feltham, TW13 7HF, United Kingdom

Or

MEIJI PHARMA SPAIN, S.A.

Avda. de Madrid, 94,

28802, Alcalá de Henares, Madrid

Spain

Last date of review of this leaflet:July 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/