PANTOPRAZOL ARISTO 40 mg GASTRO-RESISTANT TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Pantoprazole Aristo 40 mggastro-resistant EFG tablets

Pantoprazole

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

• Keep this patient information leaflet, as you may need to read it again.
• If you have any questions, 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 patient information leaflet. See section 4.

Contents of the Patient Information Leaflet

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

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

Pantoprazole 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.

Pantoprazole Aristo is used for:

Adults and adolescents from 12 years:

• Reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by acid reflux from the stomach.

Adults:

• Infection with a bacterium called Helicobacter pyloriin patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to eliminate the bacterium and thus reduce the likelihood of ulcer recurrence.
• Stomach and duodenal ulcers, and
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before taking Pantoprazole Aristo

Do not take Pantoprazole Aristo:

• If you are allergic to pantoprazole 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 Pantoprazole 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 when you are on long-term treatment with Pantoprazole Aristo. If there is an increase in liver enzymes, treatment should be discontinued.
• If you have decreased body stores of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazole. As with all medications that reduce acid, 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.
• If you take pantoprazole for more than three months, you may experience 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 experience any of these symptoms, inform your doctor immediately. Additionally, low magnesium levels can cause a decrease in blood potassium and calcium levels. 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 Pantoprazole 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 Pantoprazole 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 Pantoprazole 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 pantoprazole may alleviate cancer symptoms and delay diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take Pantoprazole 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 Pantoprazole with other medications

Pantoprazole 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 Pantoprazole Aristo may cause these and other medications to not work properly.
• Warfarin and phenprocoumon, 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 pantoprazole in pregnant women. It has been reported that pantoprazole 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.

Pantoprazole 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 Pantoprazole Aristo

Follow the administration instructions indicated by your doctor or pharmacist exactly. If you have any doubts, 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:

For the treatment of reflux esophagitis:

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

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 taken twice a day with your pantoprazole tablet. Take the first pantoprazole tablet one hour before breakfast and the second one hour before dinner. Follow your doctor's instructions and make sure to read the patient information leaflets of the antibiotics.

The treatment duration 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 medication. The treatment duration for stomach ulcers is usually between 4 and 8 weeks. The treatment duration 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 one hour before a meal. Your doctor may then 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 to stop treatment.

Special patient groups:

• If you have kidney problems or moderate to severe liver problems, you should not take Pantoprazole Aristo 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 (20 mg pantoprazole tablets are available for this case).
• Children (under 12 years): the use of these tablets is not recommended in children under 12 years.

If you take more Pantoprazole Aristo than you should

If you have taken more tablets than you should, consult your doctor or pharmacist immediately or contact 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 patient information leaflet with you.

If you forget to take Pantoprazole Aristo

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

If you stop taking Pantoprazole 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 (the frequency cannot be estimated from the available data).

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

Hip, wrist, and spine fractures (uncommon):If you are taking proton pump inhibitors like Pantoprazole 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 if you are taking corticosteroids (which can 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 bloating (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) altered 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 limbs (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 the 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, numbness, burning, or prickling sensation, 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 blood fat levels
• Very rare(may affect up to 1 in 10,000 patients) reduced platelet count, which may cause bleeding or more bruising than usual; reduced white blood cell count, which may lead to more frequent infections

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this patient information leaflet.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this patient information leaflet. You can also report them directly through the Spanish Medicines Monitoring System. Website: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Pantoprazole 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. Place the packaging and any unused medication in the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container Content and Additional Information

Pantoprazol Aristo Composition

• The active ingredient is pantoprazol sodium sesquihydrate, equivalent to 40 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 Container Content of Pantoprazol Aristo

Yellow, oval, film-coated tablet.

Pantoprazol Aristo 40 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

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 productis authorized in the Member States of the European Economic Area under the following names:

Portugal: Pantoprazol Aristo 40 mg gastro-resistant tablets

Date of 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/