Package Insert: Information for the User

Pantoprazol Aristo 20 mgDelayed-Release Gastric Tablets EFG

Pantoprazol

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, 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 any adverse effects, consult your doctor or pharmacisteven if they are not listed in this package insert. See section 4.

Pantoprazol Aristo 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 and intestinal acid.

Pantoprazol Aristo 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 relapses 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 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 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 when you are on long-term treatment with Pantoprazol Aristo.If liver enzyme levels increase, treatment should be interrupted.
• If you need to take NSAIDs continuously and take Pantoprazol Aristo, as there is a higher risk of developing complications in the stomach and intestines.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 long-term treatment with pantoprazole. Like all medications that reduce acid production, pantoprazole may reduce vitamin B12 absorption.
• Consult your doctor if you are taking any medication containing atazanavir (for HIV treatment) at the same time as pantoprazole.
• If you take pantoprazole for more than three months, you may experience a decrease in magnesium levels in the 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 the blood. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.
• If you are scheduled to have a specific blood test (Cromogranin A).
• If you have ever had a skin reaction after treatment with a similar medication to Pantoprazol Aristo for reducing stomach acid.

If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Pantoprazol Aristo. Remember to mention any other symptoms you may notice, such as joint pain.

Inform your doctor immediately if 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 stool
• Severe or persistent diarrhea, as Pantoprazol Aristo 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 Pantoprazol Aristo for a prolonged period (more than one year), your doctor may perform regular follow-up. You should inform your doctor of any new or unexpected symptoms and/or events each time you attend your consultation.

Use of Pantoprazol with other medications

Pantoprazol Aristo mayaffect the efficacy of other medications, so inform your doctor if you are taking,

• Medications such as ketoconazole, itraconazole, and posaconazole (used for fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazol Aristo may make these and other medications less effective.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional monitoring.
• Atazanavir (used for HIV treatment).

Inform your doctor or pharmacist if you are using, have used recently, 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 insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been detected in human breast milk. If you are pregnant, or think you may be, 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.

Driving and operating machinery

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

Pantoprazol Aristo contains maltitol.

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

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

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

Unless your doctor has indicated another schedule, the recommended dose is:

Adults and adolescents 12 years and older:

For treating symptoms associated with gastroesophageal reflux disease (stomach burning, acid regurgitation, difficulty swallowing)

The usual dose is one tablet a day. This dose usually provides relief within 2-4 weeks, and if not, within a maximum of 4 weeks. Your doctor will tell you how long you should continue taking the medication. Subsequently, any recurring symptom can be controlled as needed by taking one tablet a day.

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

The usual dose is one tablet a day. If the disease reappears, your doctor may double the dose, in which case you can take Pantoprazol Aristo 40 mg once a day. After recovery, you can reduce the dose again to one 20 mg tablet a day.

Adults:

For the prevention of duodenal and stomach ulcers in patients requiring continued treatment with NSAIDs

The usual dose is one tablet a day.

Special patient groups:

• If you have severe liver problems, do not take more than one 20 mg tablet a day.
• Children under 12 years old: This medication is not recommended for children under 12 years old.

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 Toxicological Information Service (phone: 915 620 420). However, if the amount ingested is significant, go to your doctor as soon as possible or to the emergency service of the nearest hospital and bring this leaflet with you.

If you forgot to take Pantoprazol Aristo

Do not take a double dose to compensate for the missed doses.

Take your next dose as usual.

If you interrupt treatment with Pantoprazol Aristo

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• Very common (may affect more than 1 in 10 patients)
• Common (may affect up to1 in 10 patients)
• Uncommon (may affect up to1 in 100 patients)
• Rare (may affect up to1in every 1,000 patients)
• Very rare (Possible side effects may affect up to1 in 10,000 patients)
• Frequency not known(the frequency cannot be estimated from available data).

Severe allergic reactions (rare frequency):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 heartbeats and excessive sweating.

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

Metabolic and nutritional disorders (frequency not known):If you are taking Pantoprazol Aristo for more than three months, it is possible that blood magnesium levels 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 blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Fractures of the hip, wrist, and spine (uncommon):If you are taking proton pump inhibitors like Pantoprazol Aristo, especially for a period of more than one year, you may slightly increase the risk of fractures of the hip, wrist, and spine. 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 the white of the eyes (severe liver cell damage, jaundice), or fever, hives, occasional kidney enlargement with pain when urinating and lower back pain (severe kidney inflammation)

Otherside effects are:

• Common(may affect up to 1 in 10 patients)

Benign polyps in the stomach.

• Uncommon(may affect up to1 in 100 patients)

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

• Rare(may affect up to1in every 1,000 patients)

Alteration orcomplete loss of taste; visual disturbances such asblurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the extremities (peripheral edema); allergic reactions; depression; gynecomastia in men.

• Very rare(may affect up to1 in 10,000 patients)

Disorientation

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

Illusion, confusion (especially in patients with a history of thesesymptoms), decreased sodium levels in the blood. Skin rash, possibly with joint pain, sensation of tingling, prickling, paresthesia (tingling), burning or numbness, inflammation of the large intestine causing persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon(may affect up to1 in 100 patients)

Increased liver enzymes

• Rare(may affect up to1in every 1,000 patients)

Increased bilirubin levels; increased levels of fat in the blood

• Very rare(may affect up to1 in 10,000 patients)

Reduced number of platelets that could cause bleeding or more frequent bruising than usual; reduced number of white blood cells that could lead to more frequent infections

If you experience any type of side effect,consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet.

Reporting of side effects

If you experience any type of side effect, consultyour doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly tothrough the notification system included in the Spanish System of

Pharmacovigilance of Medicines for Human Use.Website:www.notificaRAM.es

By reportingside effects, you can contribute to providing more information about thesafety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD.

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

Do not store at a temperature above 25°C.

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

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

Pantoprazole Aristo Composition

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

• Core:Maltitol, crospovidone, sodium carmellose, sodium carbonate, calcium stearate
• Covering: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 contents of the packaging of Pantoprazole Aristo

Yellow-coated, oval-shaped tablet.

Pantoprazole Aristo 20 mg is available in the following packaging sizes:

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

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

They may not be commercially available in all packaging sizes.

Marketing Authorization Holder

Aristo Pharma Iberia S.L.

C/ Solana, 26

28850, Torrejón de Ardoz (Madrid)

Spain

Responsible 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 Strade 12-14

13435 Berlin

Germany

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

Portugal: Pantoprazole Aristo 20 mg gastro-resistant tablets

Revision date of this leafletSeptember 2019

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