PANTOPRAZOL DAVUR 20 mg GASTRO-RESISTANT TABLETS

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

Do not take Pantoprazol Davur

• 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 (e.g. omeprazole, lansoprazole, rabeprazole, esomeprazole)

Warnings and precautions

Consult your doctor or pharmacist before starting to take pantoprazol

• If you have severe liver problems. Tell your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently, especially when you are on long-term treatment with pantoprazol. If there is 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 your personal risk factors such as age (65 years or older), history of stomach or duodenal ulcers or stomach or intestinal bleeding.
• If you have decreased body reserves of vitamin B12 or risk factors for this and receive long-term treatment with pantoprazol. Like all acid-reducing medicines, pantoprazol may reduce the absorption of vitamin B12.
• Consult 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 more than a year, may increase the risk of hip, wrist, or spine fractures. Tell your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of osteoporosis (e.g. if you are taking corticosteroids).

• If you have ever had a skin reaction after treatment with a medicine similar to pantoprazol 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 discontinue treatment with pantoprazol. Remember to mention any other symptoms you may notice, such as joint pain.
• A specific blood test (Chromogranin A) is scheduled.
• If you take pantoprazol for more than three months, you may suffer from a decrease in magnesium levels in the blood. Symptoms of low magnesium levels can include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you have any of these symptoms, tell your doctor immediately. Additionally, low magnesium levels can cause a decrease in potassium and calcium levels in the blood. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.

Tell your doctor immediatelyif you notice any of the following symptoms:

• unintentional weight loss
• repeated vomiting
• difficulty swallowing, or pain when swallowing
• blood in the vomit
• pale appearance and feeling of weakness (anemia)
• blood in your stools
• severe or persistent diarrhea, as pantoprazol 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 may delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take pantoprazol for a prolonged period (more than a year), your doctor may monitor you regularly. You should inform your doctor of any new symptoms and/or unexpected events each time you visit your doctor.

Taking Pantoprazol Davur with other medicines

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 Davur may affect the efficacy of other medicines, so tell 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 checks.
• Medicines 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 need to temporarily stop treatment with pantoprazol.
• Fluvoxamine (used to treat depression and other psychiatric disorders) 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).

Pregnancy, breastfeeding, and fertility

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

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

Pantoprazol Davur contains sodium

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

3. How to take Pantoprazol Davur

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.

Method of administration

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

Unless your doctor has indicated otherwise, the recommended dose is:

Adults and adolescents from 12 years:

To treat symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, difficulty swallowing)

The recommended 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 medicine. After that, 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 recommended dose is one tablet per day. If the disease recurs, your doctor may double the dose, in which case you can take pantoprazol 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 recommended dose is one tablet per day.

Patients with liver problems

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

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

Tell your doctor or pharmacist or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. No symptoms of overdose are known.

If you forget to take Pantoprazol Davur

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

If you stop taking Pantoprazol Davur

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 or pharmacist.

4. Possible side effects

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

The frequency of the possible side effects listed below is defined as:

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 the available data).

If you get any of the following side effects, stop taking these tablets and tell your doctor immediately, or contact the emergency department of the nearest hospital:

• Severe allergic reactions (rare):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):blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and sensitivity to light.

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 (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).

• Other serious conditions (frequency not known):yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased 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

benign stomach polyps.

• Uncommon

headache; dizziness; diarrhea; feeling of dizziness, nausea, 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

alteration or complete loss of taste, vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling in the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.

• Very rare

disorientation

• Frequency not known

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

Side effects identified through blood tests:

• Uncommon:

increased liver enzymes

• Rare:

increased bilirubin; increased blood fat levels; sharp decrease in circulating granulocytes.

• Very rare:

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

• Frequency not known: 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 or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazol Davur

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.

HDPE bottle:

This medicine does not require any special storage conditions.

Aluminum/Aluminum blister:

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazol Davur

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).

The other ingredients (excipients) are: Core: disodium phosphate anhydrous (E-339), mannitol (E-421), microcrystalline cellulose (E-460), sodium croscarmellose, magnesium stearate (E-470b), hypromellose, triethyl citrate, sodium carboxymethyl starch (type A) (potato), methacrylic acid-ethyl acrylate copolymer (1:1), dispersion 30%, and yellow iron oxide (E172).

Appearance of the product and pack contents

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

Each pack contains 7, 14, or 28 gastro-resistant tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

Anabel Segura 11 Edificio B

28108 Alcobendas Madrid (Spain)

Manufacturer

Teva Pharma S.L.U.

Polígono Malpica c/ C, 4.

50016 Zaragoza

Spain

Date of last revision of this leaflet: May 2023

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/