PANTOPRAZOL AUROVITAS 20 mg GASTRO-RESISTANT TABLETS

2. What you need to know before you take Pantoprazole Aurovitas

Do not take Pantoprazole Aurovitas

• If you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines that contain other proton pump inhibitors.

Warnings and precautions

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

• If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor will perform more frequent monitoring of liver enzymes, especially when you are on long-term treatment with pantoprazol. In case of an increase in liver enzymes, treatment should be discontinued.
• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazol, as there is a greater risk of developing stomach and intestine complications. Any increased risk will be assessed according to personal risk factors such as age (65 years or older), history of stomach or duodenal ulcers, or stomach or intestinal bleeding.
  • If you have reduced body reserves of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazol. Like all medicines that reduce acid, pantoprazol may reduce the absorption of vitamin B12. Contact your doctor if you notice any of the following symptoms, which may indicate low levels of vitamin B12:

• Extreme fatigue or lack of energy
• Numbness or tingling sensation
• Painful or inflamed tongue, mouth ulcers
• Muscle weakness
• Altered vision
• Memory problems, confusion, depression
• Tell your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV infection treatment) at the same time as pantoprazol.
• Taking a proton pump inhibitor like pantoprazol, especially for a period of more than one year, may slightly increase the risk of hip, wrist, or spine fractures. Inform your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of osteoporosis (for example, if you are taking steroids).
• If you are taking pantoprazol for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, rapid 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.
• If you have ever had a skin reaction after treatment with a medicine similar to pantoprazol to reduce stomach acid.
• If you suffer a skin rash, especially in areas of skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with pantoprazol. Remember to mention any other symptoms you may notice, such as joint pain.
  • Severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, in association with pantoprazol treatment. Stop using pantoprazol and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

• If you are scheduled to undergo a specific blood test (Chromogranin A).

Tell your doctor immediately, before or after taking this medicine, 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 the vomit: it may appear as dark coffee grounds in your vomit
• pale appearance and feeling of weakness (anemia)
• chest pain
• stomach pain
• severe or persistent diarrhea, as this medicine 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 because pantoprazol can alleviate the symptoms of cancer and could delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take pantoprazol 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 or events each time you visit your doctor.

Children and adolescents

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

Other medicines and Pantoprazole Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Pantoprazol may affect the efficacy of other medicines. Inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as pantoprazol may make these and other medicines not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional tests.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily discontinue your treatment with pantoprazol, as pantoprazol 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).

Talk to your doctor before taking pantoprazol if you need to undergo a specific urine test (for THC: tetrahydrocannabinol).

Pregnancy and breastfeeding

There is not enough data on the use of pantoprazol in pregnant women. It has been reported that pantoprazol is excreted in human breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should only use this medicine if your doctor considers that the benefit for you is greater than the potential risk to the fetus or baby.

Driving and using machines

Pantoprazol has no or negligible influence on the ability to drive and use machines.

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

Pantoprazole Aurovitas contains sodium

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

3. How to take Pantoprazole Aurovitas

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents from 12 years of age

To treat symptoms associated with gastroesophageal reflux disease (heartburn, acid reflux, pain when swallowing)

The usual dose is one tablet per day. This dose usually provides relief within 2-4 weeks, and if not, at most, within the following 4 weeks. Your doctor will tell you how long you should continue taking the medicine. Any recurring symptoms can be controlled by taking one tablet per day as needed.

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

The usual dose is one tablet per day. If the disease returns, your doctor may double the dose, in which case you can take Pantoprazole Aurovitas 40 mg once a day. After healing, you can reduce the dose back to one 20 mg tablet per day.

Adults

To prevent duodenal and stomach ulcers in patients who require continued treatment with NSAIDs

The usual dose is one tablet per day.

Patient with liver problems

If you have severe liver problems, you should not take more than one 20 mg tablet per day.

Use in children and adolescents

The use of these tablets is not recommended in children under 12 years of age.

Method of administration

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

If you take more Pantoprazole Aurovitas than you should

Tell 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pantoprazole Aurovitas

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

If you stop taking Pantoprazole Aurovitas

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

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using pantoprazol and seek immediate medical attention if you notice any of the following symptoms:

• red spots, not raised, in a target or circular shape on the trunk, often with central blisters, skin peeling, mouth ulcers, ulcers on the genitals and eyes. These severe skin reactions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). - generalized rash, high body temperature, and swollen lymph nodes (DRESS 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 emergency department of the nearest hospital:

• Severe allergic reactions (rare; may affect up to 1 in 1,000 people): 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 heartbeat and profuse sweating.

• Severe skin reactions (frequency not known: cannot be estimated from the available data): you may notice one or more of the following - blisters on the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals, or sensitivity/skin rash, particularly in areas of skin exposed to light/sun. You may also have joint pain or flu-like symptoms, fever, swollen glands (e.g., in the armpit), and blood tests may show changes in certain white blood cells or liver enzymes.

• Other serious conditions (frequency not known): yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice) or fever, rash, increase in kidney size with occasional pain when urinating, and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other side effects are:

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

benign polyps in the stomach.

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

headache; dizziness; diarrhea; feeling of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling sensation; feeling of weakness, fatigue, or general malaise; sleep disturbances; hip, wrist, and spine fractures.

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

alteration 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 people)

disorientation.

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

hallucination, confusion (especially in patients with a history of these symptoms), tingling sensation, pinching, numbness, burning sensation, or tingling, skin rash, possibly with joint pain, inflammation of the large intestine that causes persistent watery diarrhea.

Side effects identified through blood tests:

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

increased liver enzymes.

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

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

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

reduction in the number of platelets that could lead to bleeding or more bruising than usual; reduction in the number of white blood cells that could lead to more frequent infections; coexistence of an abnormal decrease in the number of red blood cells, white blood cells, and platelets.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Aurovitas

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Pantoprazol Aurovitas Composition

• 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.

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

Product Appearance and Container Content

Gastro-resistant tablet.

Tablets with enteric coating of light yellow color, biconvex, oval and smooth on both sides of the tablet.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet: January 2024

Detailed 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).