Leaflet: Information for the User

Pantoprazol Aurovitas 40 mg gastro-resistant tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take Pantoprazol Aurovitas

3.How to take Pantoprazol Aurovitas

4.Possible side effects

5.Storage of Pantoprazol Aurovitas

6.Contents of the pack and additional information

Pantoprazol Aurovitas contains the active substance pantoprazol. Pantoprazol 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 is used in adults and adolescents aged 12 years and above to treat:

-Gastroesophageal reflux esophagitis. This is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by acid regurgitation from your stomach.

Pantoprazol is used in adults to treat:

-Infection with a bacteria called Helicobacter pylori in patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to eliminate the bacteria and thus reduce the likelihood of ulcer recurrence.

-Stomach and duodenal ulcers.

-Zollinger-Ellison syndrome and other diseases in which too much acid is produced in the stomach.

Do not take Pantoprazol Aurovitas

-If you are allergic to pantoprazole or any of the othercomponentsof this medication(including in section 6).

-If you are allergic to medications that contain other proton pump inhibitors.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to takePantoprazol Aurovitas.

-If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor will monitor your liver enzymes more frequently, especially when you are on long-term treatment with pantoprazole. 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 medications that reduce acid production, pantoprazole may reduce vitamin B12 absorption. Contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B12 levels:

- Fatigue or extreme lack of energy

- Tingling sensation

- Sore or inflamed tongue, mouth ulcers

- Muscle weakness

- Blurred vision

- Memory problems, confusion, depression

-Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV treatment) at the same time as pantoprazole.

-Taking a proton pump inhibitor like pantoprazole, especially for more than a year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of developing osteoporosis (for example, if you are taking steroids).

-If you are taking pantoprazole for more than three months, it is possible that blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause decreased potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

-If you have ever had a skin reaction after treatment with a similar medication to pantoprazole for reducing stomach acid.

-If you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue pantoprazole treatment. Remember to mention any other symptoms you may notice, such as joint pain.

• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, have been reported in association with pantoprazole treatment. Stop using pantoprazole and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

-If you are scheduled to have a specific blood test (Cromogranin A).

Inform your doctorimmediately before or after taking this medication,if you notice any of the following symptoms, which may be signs of more serious diseases:

-Unintentional weight loss

-Vomiting, particularly if repeated

-Difficulty swallowing or pain when swallowing

-Blood in vomit: may appear as dark coffee grounds in your vomit

-Pale appearance and feeling of weakness (anemia)

-Blood in stools, which may be black or tar-like

-Chest pain

-Abdominal pain

-Severe or persistent diarrhea, as this medication has been associated with a small increase in infectious diarrhea

Your doctor will decide if you need additional testing to rule out cancer, as pantoprazole may alleviate cancer symptoms and delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you take pantoprazole for a prolonged period (more than a 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.

Children and adolescents

The use of pantoprazole is not recommended in children as it has not been tested in children under 12 years.

Other medications and Pantoprazol Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Pantoprazole may affect the efficacy of other medications, inform your doctor if you are taking:

-Medications such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as pantoprazole may make these and other medications not work correctly.

-Warfarin and fenprocumon, which affect blood clotting. You may need additional monitoring.

-Medications used to treat HIV infection, such asatazanavir.

-Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily discontinue pantoprazole treatment due to the increased levels of methotrexate in the blood.

-Fluvoxamine (used to treat depression and other psychiatric disorders). If you are taking fluvoxamine, your doctor may reduce your dose.

-Rifampicin (used to treat infections).

-St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Consult your doctor before taking pantoprazole if you need to undergo a specific urine test (for THC: tetrahidrocannabinol).

Pregnancy and breastfeeding

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 breastfeeding, consult your doctor or pharmacist before using this medication.

Only use this medication if your doctor considers the benefit for you to be greater than the potential risk to the fetus or baby.

Driving and operating machines

Pantoprazole has no or negligible influence on the ability to drive and operate machines.

Do not drive or operate machines if you experience side effects such as dizziness or blurred vision.

Pantoprazol Aurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

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

The recommended dose is:

Adults and adolescents 12 years and older

For the treatment of gastroesophageal reflux esophagitis

The usual dose is one tablet per day.Your doctor may indicate an increase to 2 tablets per day. The treatment time for gastroesophageal reflux esophagitis 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 called Helicobacter pylori in 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), taken twice a day with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second 1 hour before dinner. Follow your doctor's instructions and make sure to read the prospectuses of these antibiotics. The treatment duration is usually 1 to 2 weeks.

For the treatment of stomach and duodenal ulcers

The recommended 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 normally between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other diseases in which there is an increase in stomach acid production

The initial recommended dose is two tablets per day.

Take the two tablets 1 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 your doctor prescribes more than four tablets per day, they will tell you exactly when to stop treatment.

Patients with kidney problems

If you have kidney problems, do not take pantoprazole for the elimination ofHelicobacter pylori.

Patients with liver problems

-If you have severe liver problems,do not take more thanone 20 mg pantoprazole tablet per day (for this case, 20 mg pantoprazole tablets are available).

-If you have moderate or severe liver problems, do not take pantoprazole for the elimination ofHelicobacter pylori.

Use in children and adolescents

Do not use these tablets in children under 12 years old.

Administration form

Take the tablets whole, without chewing or breaking them, with a little water, 1 hour before a meal.

If you take more Pantoprazol Aurovitas than you should

Inform your doctor or pharmacist. No symptoms of overdose are known.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Pantoprazol Aurovitas

Do not take a double dose to compensate for the missed doses. Take your next dose as usual.

If you interrupt treatment with Pantoprazol Aurovitas

Do not stop taking these tabletswithout consulting your doctor or pharmacist first.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Stop using pantoprazole and seek medical attention immediately if you notice any of the following symptoms:

- flat red spots, in the shape of a target or circles on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers.

These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). - generalized rash, elevated body temperature, and increased lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

If you experience any of the following side effects, stop taking these tablets and inform your doctor immediately, or contact the nearest hospital's emergency service:

-Severe allergic reactions(rare; may affect up to 1 in 1,000people): 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 alterations(frequency unknown: its frequency cannot be estimated with the available data):You may notice one or more of the following - skin blisters and a rapid deterioration of your general condition, erosion (including light bleeding) of eyes, nose, mouth/lips, or genitals, or skin sensitivity/eruption, particularly in areas of exposed skin to light/sun. You may also have joint pain or flu-like symptoms, fever, swollen lymph nodes (e.g., in the armpit), and blood tests may show changes in certain white blood cells or liver enzymes.

-Other severe conditions(frequency unknown: its frequency cannot be estimated with the available data):yellow discoloration of the skin and the white of the eyes (severe liver cell damage, jaundice) or fever, hives, swollen kidneys with occasional pain while urinating, and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other side effects are:

-Frequent(may affect up to 1 in10 people)

benign stomach polyps.

-Infrequent(may affect up to 1 in 100people)

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 discomfort; sleep disturbances; hip, wrist, and spinal column fractures.

-Rare(may affect up to 1 in 1,000people)

alteration or complete absence of taste;vision disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; elevated 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 10,000people)

disorientation.

-Frequency unknown(cannot be estimated from the available data)

hallucination, confusion (especially in patients with a history of these symptoms), sensation of tingling, pinching, numbness, burning, or numbness, skin eruption, possibly with joint pain, inflammatory bowel disease causing persistent watery diarrhea.

Side effects identified through blood tests:

-Infrequent(may affect up to 1 in 100people)

increase in liver enzymes.

-Rare(may affect up to 1 in 1,000 people)

increase in bilirubin; increase in blood fat levels; sudden drop in circulating granular white blood cells associated with high fever.

-Very rare(may affect up to 1 in 10,000people)

reduction in platelet count that could cause bleeding or more frequent bruising; reduction in white blood cell count that could lead to more frequent infections; coexistence of an abnormal decrease in red blood cells and white blood cells, as well as platelets.

• Frequency unknown(cannot be estimated from the available data)

decrease in blood sodium, magnesium, calcium, or potassium levels (see section 2).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition of Pantoprazol Aurovitas

-The active ingredient is pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol (in the form of sodium sesquihydrate).

-The other components are:

Tablet core:sodium carbonate, mannitol (E421), crospovidone (type B), hydroxypropylcellulose, calcium stearate.

Covering:hypromellose, yellow iron oxide (E172), dispersion at 30% of methacrylic acid-acrylate copolymer (1:1), sodium lauryl sulfate, polysorbate 80, triethyl citrate.

Appearance of the product and content of the container

Gastro-resistant tablet.

Yellow enteric-coated tablets, biconvex, oval, and smooth on both faces of the tablet.

Blister pack: 14, 28, 56, 98, and 100 gastro-resistant tablets and a single-dose perforated blister pack containing 56 x 1 gastro-resistant tablet.

Only some container sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta)Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: January 2024

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