Package Insert: Information for the Patient

Pantoprazol Davur 40 mg Gastrorresistant Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Pantoprazol Davur and how is it used

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

3. How to take Pantoprazol Davur

4. Possible adverse effects

5. Storage of Pantoprazol Davur

6. Contents of the package and additional information

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 inadultos and adolescents aged 12 years and above to treat:

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

Pantoprazol is used in adultos to treat:

- Infection caused by a bacteria calledHelicobacter pyloriin 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 Davur

- 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 that contain other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazol, esomeprazole).

Warnings and precautions

Consult your doctor or pharmacist before starting to take pantoprazole.

• • If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor your liver enzyme levels 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 pantoprazole treatment for a long period of time. Like all medications that reduce acid production, pantoprazole may reduce vitamin B12 absorption.
• Consult 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 more than a year, may 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 corticosteroids).

• 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.
• A specific blood test (chromogranin A) will be performed.
• If you take pantoprazole for more than three months, you may experience a decrease in magnesium levels in the blood. 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 potassium and calcium levels in the blood. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.

Inform your doctor immediately if you notice any of the following symptoms:

- Unintentional weight loss

- Repeated vomiting

- Difficulty swallowing or pain when swallowing

- Blood in vomit

-Pale appearance and feeling of weakness (anemia)

- Blood in your stools

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

Your doctor will decide if you need additional testing to rule out a 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 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.

Taking Pantoprazol Davur with other medications

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.

Pantoprazol Davur may affect the efficacy of other medications, so 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 Pantoprazol Davur may make these and other medications less effective.

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

- Medications used to treat HIV infection, such as atazanavir.

- Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking a high dose of methotrexate, your doctor may temporarily discontinue pantoprazole treatment.

• 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).

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication. This medication should only be used 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 Davur 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.

Administration Form

Take the whole tablets, without chewing or crushing, with a little water, 1 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 recommended dose is 1 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 indicate for how long you should 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 1 hour before breakfast and the second 1 hour before dinner. Follow your doctor's instructions and make sure to read the antibiotic prospectuses.

The treatment duration is usually 1 to 2 weeks.

For the treatment of stomach and duodenal ulcers

The recommended dose is 1 tablet per day. The dose may be doubled by your doctor. Your doctor will indicate for how long you should 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 2 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 2 tablets per day, you should take the tablets twice a day.

If you are prescribed more than 4 tablets per day, you will be told exactly when to stop treatment.

Patients with kidney problems

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

Patients with liver problems

If you have severe liver problems, you should not take more than 1 tablet of 20 mg of pantoprazole per day (for this case, tablets of 20 mg of pantoprazole are available).

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

Use in children and adolescents

Children (under 12 years): The use of these tablets is not recommended in children under 12 years.

If you take more Pantoprazol Davur than you should

Inform your doctor or pharmacist or call the Toxicological Information Service phone 91 562 04 20, indicating the medication and the amount ingested. There are no known symptoms of overdose.

If you forgot to take Pantoprazol Davur

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

If you interrupt treatment with Pantoprazol Davur

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

If you have any other doubts 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 as follows:

Very common (may affect more than 1 in 10 people)

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

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

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

Frequency not known (cannot be estimated from available data).

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 frequency):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 not known):Blisters on the skin and rapid deterioration of overall condition, erosion (including mild bleeding) of eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and light sensitivity.

You may also experience joint pain or symptoms similar to the flu, fever, swollen lymph nodes (e.g., in the armpit) and blood tests may show changes in certain white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).

• Other severe conditions (frequency not known):Yellow discoloration of the skin and white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased kidney size with occasional pain while urinating and lower back pain (severe kidney inflammation), possibly leading to renal failure.

Other side effects are:

• Common

Benign polyps in the stomach.

• Uncommon

Headache; dizziness; diarrhea; sensation of dizziness, nausea, 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; fractures of the hip, wrist, and spine.

• Rare

Alteration or complete loss of taste, visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling in the extremities (peripheral edema); allergic reactions; depression; gynecomastia in men.

• Very rare

Disorientation

• Frequency not known

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

Side effects identified through blood tests:

• Uncommon:

Increased liver enzymes

• Rare:

Increased bilirubin; increased levels of fats in the blood, sudden drop in circulating granulocytes.

• Very rare:

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 reduction in the number of red blood cells, white blood cells, and platelets.

-Frequency not known:Decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting of 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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://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.

HDPE Bottle:

This medication does not require special storage conditions.

Aluminum/Aluminum Blister:

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Pantoprazol Davur

• The active ingredient is pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol (in the form of sodium sesquihydrate).
• The other components (excipients) are: Core: anhydrous sodium phosphate (E-339), mannitol (E-421), microcrystalline cellulose (E-460), sodium croscarmellose, magnesium stearate (E-470b), hypromellose, triethyl citrate, sodium carboxymethylcellulose (type A) (from potato), copolymer of methacrylic acid-ethyl acrylate (1:1), 30% dispersion and yellow iron oxide (E172).

Appearance of the product and contents of the packaging

Gastro-resistant tablet of yellow color, oval, concave, smooth.

Each package contains 14 or 28 gastro-resistant tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

Teva Pharma, S.L.U.

Anabel Segura 11 Building B

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Teva Pharma S.L.U.

Malpica Industrial Estate c/ C, 4.

50016 Zaragoza

Spain

Last review date of this leaflet: May 2023

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