PANTOPRAZOL AUROVITAS 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Pantoprazole Aurovitas 40 mg gastro-resistant tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Pantoprazole Aurovitas and what is it used for
2. What you need to know before you take Pantoprazole Aurovitas
3. How to take Pantoprazole Aurovitas
4. Possible side effects
5. Storage of Pantoprazole Aurovitas
6. Contents of the pack and other information

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

Pantoprazole Aurovitas contains the active substance pantoprazole. Pantoprazole is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestine acid.

Pantoprazole is used in adults and adolescents aged 12 years and older to treat:

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

Pantoprazole is used in adults to treat:

• Infection with a bacterium 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 ulcer recurrence.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other diseases in which too much acid is produced in the stomach.

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. Tell 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. In case of an increase in liver enzymes, treatment should be discontinued.
• If you have decreased body stores of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazole. Like all acid-reducing medicines, pantoprazole may reduce the absorption of vitamin B12. Contact your doctor if you notice any of the following symptoms, which could indicate low levels of vitamin B12:

• Extreme fatigue or lack of energy
• Numbness or tingling sensation
• Sore 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 pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, 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 pantoprazole 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, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also produce 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 pantoprazole to reduce stomach acid.
• If you get a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with pantoprazole. 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 pantoprazole treatment. Stop using pantoprazole 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 have 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 it is 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 pantoprazole 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 pantoprazole for a prolonged period (more than one year), your doctor may perform regular follow-up. You should inform your doctor of any symptoms and/or new or unexpected events each time you visit your doctor.

Children and adolescents

The use of pantoprazole 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.

Pantoprazole 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 pantoprazole may make these and other medicines not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional checks.
• 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 stop treatment with pantoprazole because pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric diseases). If you are taking fluvoxamine, your doctor may reduce the dose.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

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

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

Pantoprazole has no influence 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 aged 12 years and older

For the treatment of 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 reflux esophagitis is usually between 4 and 8 weeks. Your doctor will indicate how long you should take this medicine.

Adults

For the treatment of an infection with a bacterium 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), each 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 leaflets of these antibiotics. The duration of treatment is usually one to two 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 indicate how long you should take this medicine. 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 diseases in which there is an increase in stomach acid secretion

The initial recommended dose is two tablets per day.

Take the two tablets 1 hour before a meal. Subsequently, your doctor may adjust the dose, depending on the amount of acid secretion you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two doses per day.

If your doctor prescribes more than four tablets per day, he will tell you exactly when you should finish the treatment.

Patients with kidney problems

If you have kidney problems, you should not take pantoprazole for the eradication of Helicobacter pylori.

Patients with liver problems

• 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).
• If you have moderate or severe liver problems, you should not take pantoprazole for the eradication of Helicobacter pylori.

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

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 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 medicine, 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 pantoprazole and seek immediate medical attention if you notice any of the following symptoms:

• red spots, target-like or circular on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, 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), intense dizziness with very rapid heartbeats and profuse sweating.

• Severe skin disorders (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: cannot be estimated from the available data): 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:

• Frequent (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; 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 numbness, 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)

increase in liver enzymes.

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

increase in bilirubin; increase in 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 cause 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 them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazol 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 CAD. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pantoprazol Aurovitas

• The active substance is pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol (as sodium sesquihydrate).
• The other ingredients 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.

Appearance of the Product and Package Contents

Gastro-resistant tablet.

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

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

Not all 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 medicine 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).