PANTOPRAZOL MABO 40 mg GASTRO-RESISTANT TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

PantoprazoleMABO 40 mg gastro-resistant tablets EFG

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 and other information:

1. What is Pantoprazole MABO and what is it used for
2. What you need to know before you take Pantoprazole MABO
3. How to take Pantoprazole MABO
4. Possible side effects

5 Storage of Pantoprazole MABO

1. Contents of the pack and further information

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

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

Pantoprazole is used for:

Adults and adolescents from 12 years:

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

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

Adults:

• Prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) in patients at risk who require continued treatment with these types of drugs.

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

Do not take Pantoprazole

• 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 medicines 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. In case of an increase in liver enzymes, treatment should be discontinued

• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a greater risk of developing complications in the stomach and intestine. Any increase in risk will be assessed according to personal risk factors such as age (65 years or older), history of stomach or duodenal ulcers, or stomach or intestinal bleeding.

• If you have decreased body reserves of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazole. Like all medicines that reduce acid, pantoprazole may reduce the absorption of vitamin B12.

• Consult your doctor if you are taking any medicine that contains atazanavir (for the treatment of HIV infection) at the same time as pantoprazole.

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

• unintentional weight loss
• repeated vomiting
• difficulty swallowing
• blood in vomit
• pale appearance and feeling of weakness (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 any additional tests to rule out a malignant disease because pantoprazole can alleviate the symptoms of cancer and may delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

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

Consult your doctor before starting to take Pantoprazole MABO

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

Before taking this medicine, inform your doctor if:

• A specific blood test (Chromogranin A) is scheduled for you

Other medicines and pantoprazole.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Pantoprazole may affect the efficacy of other medicines, so inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as pantoprazole may cause these and other medicines to not work properly.

• Warfarin and fenprocoumon, which affect blood coagulation. You may need additional monitoring.

• Atazanavir (used to treat HIV infection).

Pregnancy and breastfeeding

There is not enough data on the use of pantoprazole in pregnant women. It has been reported that in humans, pantoprazole is excreted in breast milk. If you are pregnant, think you may be pregnant, or are breastfeeding, you should only use this medicine if your doctor considers that the benefit to you is greater than the potential risk to the fetus or baby.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Pantoprazole MABO contains soy lecithin.

This medicine contains soy lecithin. It should not be used in case of peanut or soy allergy.

Pantoprazole MABO contains maltitol (E-965)

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

Pantoprazole MABO contains sodium

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

3. How to take Pantoprazole MABO

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

When and how should you take Pantoprazole?

Take the tablets whole, 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 from 12 years:

For the treatment of reflux esophagitis:

The usual dose is one tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will indicate how long you should take this medicine.

Adults:

For the treatment of an infection with a bacterium calledHelicobacter pyloriin patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment)

One tablet twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each to be 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 leaflets of the antibiotics.

The duration of treatment is usually one to two weeks.

For the treatment of stomach and duodenal ulcers:

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

Your doctor will indicate how long you should take this medicine. The duration of treatment for stomach ulcers is usually between 4 and 8 weeks. The duration of treatment for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison Syndrome and other conditions in which there is an increase in stomach acid secretion:

The initial recommended dose is two tablets per day.

Take the two tablets 1 hour before a meal. Later, your doctor may adjust the dose, depending on the amount of acid secretion you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two doses per day.

If you are prescribed more than four tablets per day, you will be told exactly when you should finish the treatment.

Special patient groups:

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

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

Use in children and adolescents

• The use of these tablets is not recommended in children under 12 years of age.

If you take more Pantoprazole than you should

Inform your doctor or pharmacist or call the Toxicology Information Service telephone 91 562 04 20, indicating the medicine and the amount ingested. There are no known symptoms of overdose.

If you forget to take Pantoprazole

Do not take a double dose to make up for forgotten doses. Take your next dose as usual.

If you stop taking Pantoprazole

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pantoprazole can cause side effects, although not everybody gets them.

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

very common (affects more than 1 in 10 people)

common (affects between 1 and 10 people in 100)

uncommon (affects between 1 and 10 people in 1,000)

rare (affects between 1 and 10 people in 10,000)

very rare (affects less than 1 in 10,000 people)

frequency not known (cannot be estimated from the available data).

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

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

• Severe skin disorders (frequency not known): blisters on the skin and rapid deterioration of general conditions, erosion (including slight 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 whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size with occasional pain when urinating, and lower back pain (severe kidney inflammation)

Other side effects are:

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

headache, dizziness, diarrhea, feeling of dizziness, vomiting, swelling, and flatulence (gas), constipation, dry mouth, abdominal pain and discomfort, skin rash, exanthema, eruption, tingling, feeling of weakness, fatigue, or general malaise, sleep disturbances.

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

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

• Very rare(affects less than 1 in 10,000 people)

disorientation

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

hallucination, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, tingling, numbness, paresthesia (tingling), burning, or numbness, skin rash, possibly with joint pain, inflammation of the large intestine that causes persistent watery diarrhea.

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

If you are taking proton pump inhibitors like this medicine, especially for a period of more than a year, you may have a slightly increased risk of hip, wrist, and spine 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 people in 1,000)

increased liver enzymes

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

increased bilirubin, increased blood fat levels

• Very rare(affects less than 1 in 10,000 people)

reduction of platelet count that could cause bleeding or more bruising than usual, reduction of white blood cell count that could lead to more frequent infections.

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole MABO

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

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

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in 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. Container Content and Additional Information

Pantoprazol MABO Composition

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

The other components are:

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, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30% and triethyl citrate.

Product Appearance and Container Content

Yellow-yellow brown gastro-resistant tablet with an oval shape.

Packaging: blister pack (Al/Al)

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

Marketing Authorization Holder

MABO-FARMA S.A.

Vía de los Poblados Street, 3, Building 6

28033 Madrid,

Spain.

Manufacturer

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, Alcala de Henares, Madrid

Spain

Date of the Last Revision of this Prospectus:July 2022

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