Leaflet: Information for the user

Pantoprazol Aurovitas 20 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, do 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 acid and intestine.

Pantoprazol is used in adults and adolescents aged 12 years and above to treat:

-Symptoms (for example, stomach burning, acid regurgitation, difficulty swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.

-Long-term treatment of esophagitis caused by acid reflux (inflammation of the esophagus accompanied by acid regurgitation from the stomach) and prevention of relapses.

Pantoprazol is used in adults to treat:

-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 Aurovitas

-If you are allergic to pantoprazole or any of the other ingredients of this medication (listed in section 6).

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Pantoprazol 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 need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, 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. Contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B12 levels:

- Fatigue or extreme tiredness

- 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 (e.g., 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 doctor immediately, before or after taking this medication,if you notice any of the following symptoms, which may be signs of more serious underlying 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

-Stomach 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 any additional tests to rule out cancer, as pantoprazole may alleviate cancer symptoms and delay its 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 appointment.

Children and adolescents

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

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 for 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 for HIV treatment, such as atazanavir.

-Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily discontinue pantoprazole treatment, as pantoprazole may increase methotrexate levels 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

There is insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been reported to be excreted in human breast milk.

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

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

Pantoprazole has no or insignificant influence on the ability to drive and operate machinery.

Do not drive or operate machinery 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 treating symptoms associated with gastroesophageal reflux disease (stomach burning, 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 a maximum of 4 weeks. Your doctor will tell you how long you should continue taking the medication. Subsequently, any recurring symptoms can be controlled by takingone tablet per day,as needed.

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

The usual dose is one tablet per day. If the disease returns, your doctor may double your dose, in which case you can take Pantoprazol Aurovitas 40 mgonceper day. After healing, you can reduce the dose again toone tabletof 20 mg per day.

Adults

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

The usual dose is one tablet per day.

Patients with liver problems

If you have severe liver problems,do not take more thanonetablet of 20 mg per day.

Use in children and adolescents

These tablets are not recommended for use 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 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):yellowing 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 back pain in the lower part of the back (severe kidney inflammation), which may lead to kidney failure.

Other side effects are:

-Common(may affect up to 1 in10 people)

benign stomach polyps.

-Uncommon(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; skin hives, 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 loss 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, intestinal inflammation causing persistent watery diarrhea.

Side effects identified through blood tests:

-Uncommon(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, white blood cells, and 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 Medicines 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 conditions for conservation.

Medications should not be disposed of through drains or in the 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 20 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 contents of the packaging

Gastro-resistant tablet.

Yellowish-colored, biconvex, oval, and smooth on both faces of the tablet.

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

Only some packaging sizes may be commercially available.

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).