PROSPECTO : INFORMATION FOR THE USER

Pantoprazol Aristo 40 mggastro-resistant tablets EFG

Pantoprazol

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 prospect. 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:

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

Adults:

• Infection caused by a bacteria called Helicobacter pylori in patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacteria and thus reduce the likelihood of ulcers reappearing
• Stomach and duodenal ulcers, and
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

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 containing 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 discontinued.
• If you have reduced vitamin B12 reserves or risk factors for it and receive long-term treatment with pantoprazole. Like all acid-reducing medications, 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 blood magnesium levels. 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 blood potassium and calcium levels. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.
• If you are scheduled to undergo 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 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 additional testing to rule out 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 (over one year), your doctor may regularly monitor you. 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 clotting. 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.

No sufficient data is available on the use of pantoprazole in pregnant women. Pantoprazole has been excreted 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 the treatment of esophagitis by reflux:

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

Adults:

For the treatment of an infection with a bacteria calledHelicobacter pyloriin patients with stomach and/or duodenal ulcer 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 must be 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 antibiotic prospectuses.

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 tell you for how long to 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 production:

The initial recommended dose is two tablets per day.

Take the two tablets one hour before a meal. Your doctor may then adjust your dose, depending on the amount of stomach acid you produce. If you are prescribed more than two tablets per day, you should take the tablets twice a 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 or severe liver problems, you should not take Pantoprazol Aristo for the elimination ofHelicobacter 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).
• 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 Toxicological Information Service (phone: 915 620 420). However, if the amount ingested is significant, go to your doctor without delay or to the nearest hospital emergency department and bring this prospectus with you.

If you forget 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 the possible side effects described below is classified in the following way:

• 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):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):skin blisters and a rapid deterioration of general 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 the levels of magnesium in the blood may decrease. Low levels of magnesium can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low levels of magnesium can also produce a decrease in the levels of potassium and calcium in the blood. 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 such as 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)

Other side effects are:

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

Benign polyps in the stomach.

• Uncommon (may affect up to 1 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.

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

Dizziness

Side effects identified through blood tests:

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

Increased liver enzymes

Increased bilirubin; increased levels of fat in the blood

Reduction in the number of platelets that could cause bleeding or more frequent bruising than usual; reduction in the 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 prospectus.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the notification system included in the Spanish System for the Pharmacovigilance of Medicines for Human Use.Website:www.notificaRAM.es

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

Pantoprazol Aristo Composition

• The active ingredient is pantoprazole sodium sesquihydrate, equivalent to 40 mg of pantoprazole.
• 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 contents of the packaging of Pantoprazol Aristo

Yellow, oval-shaped coated tablet.

Pantoprazol Aristo 40 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.

Not all packaging sizes may be commercially available.

Marketing Authorization Holder

Aristo Pharma Iberia S.L.

C/ Solana, 26

28850, Torrejón de Ardoz (Madrid)

Spain

Responsible for manufacturing

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 medicineis authorized in theMember States of theEuropean Economic Areawiththe following names:

Portugal: Pantoprazol Aristo40mg gastro-resistant tablets

Last review date of this leafletSeptember 2019

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