PANTOPRAZOL VIR PHARMA 20 mg GASTRO-RESISTANT TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazole Vir Pharma 20 mg gastro-resistant tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.

• If you experience any of the following serious side effects, tell your doctor immediately, or contact the emergency department of your nearest hospital:

Contents of the pack:

1. What Pantoprazole Vir Pharma is and what it is used for
2. Before taking Pantoprazole Vir Pharma
3. How to take Pantoprazole Vir Pharma
4. Possible side effects
5. Storage of Pantoprazole Vir Pharma
6. Further information

1. What Pantoprazole Vir Pharma is and what it is used for

Pantoprazole Vir Pharma is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used to treat diseases related to stomach and intestinal acid.

PantoprazoleVir Pharmais used for:

Adults and adolescents from 12 years:

• Treatment of symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, difficulty swallowing) caused by acid reflux from the stomach.
• Long-term treatment and prevention of relapses of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach).

Adults:

• Prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) in patients at risk who require continuous treatment with these types of drugs.

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 containing other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole)

Be cautious with Pantoprazole Vir Pharma

• If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will perform more frequent monitoring of liver enzymes, especially when you are on long-term treatment with pantoprazole. 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 pantoprazole, as there is a higher risk of developing stomach and intestinal 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 decreased body stores of vitamin B12 or risk factors for this and receive treatment with pantoprazole for a long period. Like all acid-reducing medicines, pantoprazole may reduce the absorption of vitamin B12.

• Consult your doctor if you are taking any medicine containing 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 stools
• 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 symptoms of cancer and delay its 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 perform regular monitoring. You should inform your doctor of any new symptoms and/or events each time you visit your doctor.

Use of other medicines

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

Tell your doctor or pharmacist if you are using or have recently used any 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, think you may be pregnant, or 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.

Consult your doctor or pharmacist before using 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 administration instructions of Pantoprazole Vir Pharma indicated by your doctor. Consult your doctor or pharmacist if you have 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 usual dose is:

Adults and adolescents from 12 years:

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

The usual 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 indicate how long you should continue taking the medicine. Subsequently, any recurring symptoms can be controlled as needed, taking one tablet per day.

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

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

Adults:

For the prevention of duodenal and stomach ulcers in patients who require continuous treatment with NSAIDs

The usual dose is one tablet per day.

Special patient groups:

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

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

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 on 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 1 to 10 people in 100)

uncommon (affects 1 to 10 people in 1,000)

rare (affects 1 to 10 people in 10,000)

very rare(affects less than 1 in 10,000 people)

frequency not known (cannot be estimated from the available data)

If you experience any of the following side effects, stop taking these tablets and inform 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), severe dizziness with rapid heartbeats and excessive 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 severe conditions (frequency not known): yellowing of the skin and 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)

Other side effects are:

• Uncommon(affects 1 to 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 1 to 10 people in 10,000)

vision changes such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling in the extremities (peripheral edema); allergic reactions; depression; breast enlargement in men.

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

increased liver enzymes

• Rare(affects 1 to 10 people in 10,000)

increased bilirubin; increased blood fat levels

• Very rare(affects less than 1 in 10,000 people)

reduction in platelet count that could cause bleeding or more bruising than usual; reduction in white blood cell count 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 one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you experience any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Pantoprazole Vir Pharma 20 mg in a polyethylene bottle: no special storage conditions are required.

Pantoprazole Vir Pharma 20 mg in an aluminum/aluminum blister: do not store above 30°C.

Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. By doing so, you will help protect the environment.

6. Further information

Composition of Pantoprazole Vir Pharma

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

The other ingredients (excipients) are:

Core:

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

Coating:

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

Appearance and packaging of the product

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

Packaging:

bottles (high-density polyethylene packaging with a polypropylene cap provided with a desiccant) and blisters (aluminum/aluminum blister).

Each packaging contains 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/