PANTOPRAZOL MABO 20 mg GASTRO-RESISTANT TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazole MABO 20 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
6. Contents of the pack and other 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 perform more frequent monitoring of liver enzymes, 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 NSAID medications continuously and take pantoprazole, as there is a higher 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 acid-reducing medicines, pantoprazole may reduce the absorption of vitamin B12.

• Consult your doctor if you are taking any medication that contains atazanavir (for HIV infection treatment) 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, as pantoprazole may alleviate cancer symptoms and could delay 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 perform regular monitoring. You should inform your doctor of any new or unexpected symptoms or 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 similar medicine 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 interrupt 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 magnesium levels in the blood. Low magnesium levels can cause 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 potassium and calcium levels in the blood. Your doctor may decide 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

Other medicines and Pantoprazole

Use of pantoprazole with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine, including those obtained without a prescription.

Pantoprazole may influence the effectiveness 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 phenprocoumon, 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, or think you may be pregnant, or if you 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 with 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:

To treat symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, difficulty swallowing)

The usual dose is one tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within a maximum of 4 weeks. Your doctor will indicate how long you should take the medicine. Afterward, any recurring symptoms can be controlled as needed, taking one tablet per day.

For long-term treatment and prevention of relapses of reflux esophagitis

The usual dose is one tablet per day. If the disease recurs, your doctor may double the dose, in which case you can take Pantoprazole 40 mg, once a day. After healing, you can reduce the dose back to one 20 mg tablet per day.

Adults:

For the prevention of duodenal and stomach ulcers in patients who require continuous treatment with NSAIDs

The usual dose is one tablet per day.

Special patient groups:

• If you have severe liver problems, you should not take more than one 20 mg tablet per day.

Use in children and adolescents:

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

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 taken. No symptoms of overdose are known.

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), intense dizziness with very rapid heartbeat and profuse sweating.

• Severe skin reactions (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 extremities (peripheral edema), allergic reactions, depression, breast enlargement 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, pricking, 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 pantoprazole for more than three months, it is possible that 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, inform your doctor immediately. Low magnesium levels can also produce 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 like pantoprazole, especially for a period of more than one 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 in platelet count that could cause bleeding or more bruising than usual, reduction in white blood cell count that could lead to more frequent infections.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are 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 stated on the packaging after EXP. 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 any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazole MABO

The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (in the form of sodium sesquihydrate

The other ingredients 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.

Appearance of the product and packaging contents

Gastro-resistant tablet, yellow-yellow brown in color, and oval in shape.

Packaging: blister pack (Al/Al)

Packaging with 28, 56, and 500 tablets

Marketing authorization holder

MABO-FARMA S.A.

Vía de los Poblados, 3, Edificio 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 leaflet:July 2022

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