PANTOPRAZOL ARISTO 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Pantoprazol Aristo 20 mggastro-resistant EFG tablets

Pantoprazol

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Pantoprazol Aristo and what is it used for
2. What you need to know before taking Pantoprazol Aristo
3. How to take Pantoprazol Aristo
4. Possible side effects
5. Storage of Pantoprazol Aristo
6. Package contents and additional information

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

Pantoprazol Aristo is a selective inhibitor of the "proton pump", a medication that reduces the amount of acid produced in your stomach. It is used to treat diseases related to stomach and intestinal acid.

Pantoprazol Aristo 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 continuous treatment with these types of drugs.

2. What you need to know before taking Pantoprazol Aristo

Do not take Pantoprazol Aristo:

• If you are allergic to pantoprazol or any of the other components of this medication (listed in section 6)
• If you are allergic to medications that contain other proton pump inhibitors

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pantoprazol Aristo.

• 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 during long-term treatment with Pantoprazol Aristo. If liver enzyme levels increase, treatment should be discontinued.
• If you need to take NSAIDs continuously and take Pantoprazol Aristo, as there is a higher risk of developing stomach and intestinal complications. Any increased 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 stores of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazol. Like all medications that reduce acid, pantoprazol may reduce vitamin B12 absorption.
• Consult your doctor if you are taking any medication containing atazanavir (for HIV infection treatment) at the same time as pantoprazol.
• If you take pantoprazol for more than three months, you may experience a decrease in 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 a decrease in potassium and calcium levels in your blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• If you are scheduled to undergo a specific blood test (Chromogranin A).
• If you have ever had a skin reaction after treatment with a medication similar to Pantoprazol Aristo to reduce stomach acid.

If you experience 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 Pantoprazol Aristo. Remember to mention any other symptoms you may notice, such as joint pain.

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 of weakness (anemia)
• blood in stools
• severe or persistent diarrhea, as Pantoprazol Aristo 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 pantoprazol may alleviate cancer symptoms and delay diagnosis. If your symptoms persist despite treatment, further tests will be performed.

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

Using Pantoprazol with other medications

Pantoprazol Aristo 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 to treat certain types of cancer), as Pantoprazol Aristo may cause these and other medications to not work properly.
• Warfarin and fenprocoumon, which affect blood coagulation. You may need additional monitoring.
• Atazanavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and using machines

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

Pantoprazol Aristo contains maltitol.

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.

3. How to take Pantoprazol Aristo

Follow the administration instructions indicated by your doctor or pharmacist exactly. If in doubt, consult your doctor or pharmacist again.

Take the tablets whole, without chewing or crushing, with a little water, one 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 the following 4 weeks. Your doctor will indicate how long you should continue taking the medication. If symptoms recur, you can control them by taking one tablet per day as needed.

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 Pantoprazol Aristo 40 mg once a day. After healing, you can reduce the dose back to one 20 mg tablet per day.

Adults:

To prevent 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, do not take more than one 20 mg tablet per day.
• Children under 12 years: The use of these tablets is not recommended in children under 12 years.

If you take more Pantoprazol Aristo than you should

If you have taken more tablets than you should, consult your doctor or pharmacist immediately or the Toxicology Information Service (telephone: 915 620 420). However, if the amount ingested is significant, go to the doctor without delay or to the emergency department of the nearest hospital and bring this package leaflet with you.

If you forget to take Pantoprazol Aristo

Do not take a double dose to make up for forgotten doses.

Take your next dose as usual.

If you stop taking Pantoprazol Aristo

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

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

• Very common (may affect more than 1 in 10 patients)
• Common (may affect up to 1 in 10 patients)
• Uncommon (may affect up to 1 in 100 patients)
• Rare (may affect up to 1 in 1,000 patients)
• Very rare (may affect up to 1 in 10,000 patients)
• Frequency not known (cannot be estimated from available data)

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

Metabolic and nutritional disorders (frequency not known):If you take Pantoprazol Aristo for more than three months, your magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, consult 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.

Hip, wrist, and spine fractures (uncommon):If you take proton pump inhibitors like Pantoprazol Aristo, 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 are taking corticosteroids (which may increase the risk of osteoporosis).

Other serious 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(may affect up to 1 in 10 patients)

Benign stomach polyps.

• Uncommon(may affect up to 1 in 100 patients)

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(may affect up to 1 in 1,000 patients)

Alteration or complete loss of taste; vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the extremities (peripheral edema); allergic reactions; depression; breast enlargement in men.

• Very rare(may affect up to 1 in 10,000 patients)

Disorientation

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

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

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100 patients)

Increased liver enzymes

• Rare(may affect up to 1 in 1,000 patients)

Increased bilirubin; increased fat levels in the blood

• Very rare(may affect up to 1 in 10,000 patients)

Decreased platelet count, which may cause bleeding or more bruising than usual; decreased white blood cell count, which may lead to more frequent infections

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this package leaflet.

Reporting 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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use. Website: www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Pantoprazol Aristo

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

Do not use this medication after the expiration date stated on the packaging after EXP.

The expiration date is the last day of the month indicated.

Do not store above 25°C.

Do not use this medication if you notice visible signs of deterioration.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Packaging Content and Additional Information

Pantoprazol Aristo Composition

• The active ingredient is pantoprazol sodium sesquihydrate, equivalent to 20 mg of pantoprazol.
• The other components are:

• Core:Maltitol, crospovidone, sodium carmellose, sodium carbonate, calcium stearate
• Coating:ethyl acrylate-methacrylic acid copolymer (1:1), triethyl citrate, sodium carbonate, polyvinyl alcohol, talc, titanium dioxide, macrogol, lecithin, yellow iron oxide.

Appearance of the Product and Packaging Content of Pantoprazol Aristo

Yellow, oval, film-coated tablet.

Pantoprazol Aristo 20 mg is available in the following package sizes:

Packages with 14, 28, 56 gastro-resistant tablets in Aluminum/Aluminum blisters.

Packages with 14, 28, 56 gastro-resistant tablets in HDPE bottles with a PP screw cap and a white desiccant capsule of PE containing 2 g of silica gel.

Not all package sizes may be marketed.

Marketing Authorization Holder

Aristo Pharma Iberia S.L.

C/ Solana, 26

28850, Torrejón de Ardoz (Madrid)

Spain

Manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10, 13435 Berlin, Germany

or

Laboratorios Medicamentos Internacionales S.A. (MEDINSA)

Calle la Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

or

Advance Pharma GmbH

Wallenroder Strasse 12-14

13435 Berlin

Germany

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

Portugal: Pantoprazol Aristo 20 mg gastro-resistant tablets

Dateof the last revision of this leafletSeptember 2019

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