PANTOPRAZOL VIR PHARMA 40 mg GASTRO-RESISTANT TABLETS

2. Before taking Pantoprazole Vir Pharma

Do not take Pantoprazole Vir Pharma

• If you are allergic (hypersensitive) to pantoprazole or any of the other components of Pantoprazole Vir Pharma (see section 6).

• If you are allergic to medicines that contain other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole)

Be especially carefulwithPantoprazoleVir Pharma

• If you have serious 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 pantoprazole. If there is an increase in liver enzymes, treatment should be discontinued.

• If you have decreased body reserves 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.

• Tell your doctor if you are taking any medicine that contains atazanavir (for HIV infection treatment) at the same time as pantoprazole.

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

• unintentional weight loss
• repeated vomiting
• difficulty swallowing
• blood in vomit
• pale appearance and feeling of weakness (anemia)
• blood in your stool
• severe or persistent diarrhea, as pantoprazole 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, as pantoprazole may alleviate cancer symptoms and could delay diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take pantoprazole for a prolonged period (more than a year), your doctor may monitor you regularly. You should tell your doctor about any new or unexpected symptoms or events each time you visit your doctor.

Use of other medicines

Pantoprazole Vir Pharma 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 Pantoprazole Vir Pharma may cause these and other medicines to not work properly.
• Warfarin and fenprocoumon, which affect blood coagulation. You may need additional checks.
• Atazanavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

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 think you may be pregnant, or if you are breastfeeding, 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.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

3. How to take Pantoprazole Vir Pharma

Follow the instructions for taking Pantoprazole Vir Pharma exactly as indicated by your doctor. Ask your doctor or pharmacist if you have any doubts.

When and how should you take Pantoprazole Vir Pharma?

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

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

Adults and adolescents from 12 years:

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 pyloriin 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 to 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 leaflets of the antibiotics.

The treatment duration is usually 1 to 2 weeks.

For the treatment of stomach and duodenal ulcers:

The usual 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 conditions in which there is an increase in gastric acid secretion:

The recommended initial dose is 2 tablets per day. Take the two tablets 1 hour before a meal.

Later, your doctor may adjust the dose, depending on the amount of acid secretion you produce. If you are prescribed more than 2 tablets per day, you should take the tablets divided into two doses per day.

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

Special patient groups:

• If you have kidney problems or moderate to severe liver problems, you should not take pantoprazole for Helicobacter pylorieradication.

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

If you take more Pantoprazole Vir Pharma 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. There are no known symptoms of overdose.

If you forget to take Pantoprazole Vir Pharma

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

If you stop taking Pantoprazole Vir Pharma

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

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

4. Possible side effects

Like all medicines, Pantoprazole Vir Pharma can cause side effects, although not everybody gets them.

The frequency of the possible side effects described below is classified as follows:

very common(affects more than 1 in 10 people)

common (affects between 1 and 10 people in 100)

uncommon (affects between 1 and 10 people in 1,000)

rare (affects between 1 and 10 people in 10,000)

very rare(affects less than 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 tell your doctor immediately, or contact the emergency department of your nearest hospital:

• Severe allergic reactions (rare frequency): 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): 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.
• 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 pain in the lower back (severe kidney inflammation)

Other side effects are:

• Uncommon(affects between 1 and 10 people in 1,000)

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

• Rare(affects between 1 and 10 people in 10,000)

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; increased breast size in men.

• Very rare(affects less than 1 in 10,000 people)
• Frequency not known(cannot be estimated from available data)

hallucination, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, inflammation of the large intestine that causes persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon(affects between 1 and 10 people in 1,000)

increased liver enzymes

• Rare(affects between 1 and 10 people in 10,000)

increased bilirubin; increased blood fat levels

• Very rare(affects less than 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.

Unknown frequency:

If you are taking Pantoprazole Vir Pharma for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, increased 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 are taking proton pump inhibitors like Pantoprazole Vir Pharma, especially for a period of more than a year, you may have a slightly increased risk of hip, wrist, and spine fractures. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. Storage of Pantoprazole Vir Pharma

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

Do not use Pantoprazole Vir Pharma after the expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated.

Pantoprazole Vir Pharma 40 mg in a polyethylene bottle: no special storage conditions are required.

Pantoprazole Vir Pharma 40 mg in Aluminum/Aluminum blisters: do not store above 30°C.

Store in the original package.

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

6. Further information

Composition of Pantoprazole Vir Pharma

The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).

The other components (excipients) are:

Core: mannitol (E-421), microcrystalline cellulose, anhydrous disodium phosphate, sodium croscarmellose, magnesium stearate.

Coating: hypromellose, sodium starch glycolate, triethyl citrate, methacrylic acid-ethyl acrylate copolymer (1:1), yellow iron oxide (E-172).

Appearance of the product and packaging content

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

Packaging: bottles (high-density polyethylene packaging with a polypropylene cap provided with a desiccant) and blisters (Alu/Alu blisters). Each package contains 14 or 28 gastro-resistant tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-70. Polígono Industrial URTINSA II.

28923 (Alcorcón) Madrid

Spain

Manufacturer:

TEVA PHARMA S.L.U.

Polígono Malpica C/ C, 4

50016 Zaragoza

Spain

or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-70. Polígono Industrial URTINSA II.

28923 (Alcorcón) Madrid

Spain

This leaflet was approved in October 2020.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/