PANTOPRAZOL VIR 20 mg GASTRO-RESISTANT TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazole Vir 20 mg gastro-resistant tablets

Pantoprazole

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 side effects, talk to your doctor or pharmacist. See section 4.

Contents of the pack:

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

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

Pantoprazole Vir 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 Vir is 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 20 mg gastro-resistant tablets

Do not takePantoprazole Vir

• If you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of Pantoprazole Vir (see section 6).
• If you are allergic to medicines containing other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole)

Be cautious withPantoprazole Vir

• 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. In case of 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 intestine 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 intestine bleeding.
• If you have low body reserves of vitamin B12 or risk factors for it 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.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Vir to reduce stomach acid.
• If you experience 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 Pantoprazole Vir. Remember to mention any other symptoms you may notice, such as joint pain.
• If you take pantoprazole for more than three months, you may experience a decrease in blood magnesium levels. 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 blood potassium and calcium levels. Your doctor will decide whether to perform periodic blood tests to monitor magnesium levels.

Before taking this medicine, inform your doctor if:

• A specific blood test (Chromogranin A) is scheduled.

Inform 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 cancer symptoms and delay 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 new or unexpected symptoms or events each time you visit your doctor.

Use of other medicines

Pantoprazole Vir may affect the efficacy of other medicines, so inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections), as Pantoprazole Vir may cause these and other medicines to not work properly.

• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional monitoring.

• Atazanavir (used to treat HIV infection).

Informyour doctor or pharmacist if you are using or have recently used other medicines, includingthose 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 pantoprazole is excreted in breast milk in humans. 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 20 mg gastro-resistant tablets

Follow the administration instructions of Pantoprazole Vir indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

When and how should you take Pantoprazole Vir?

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, takingone 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, do 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 morePantoprazole Virthan you should

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

If you forget to takePantoprazole Vir

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

If you stop taking Pantoprazole Vir

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 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

• 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 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. Skin rash, possibly with joint pain.

• 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:

• Common(affects 1 to 10 people in 100)

Benign polyps in the stomach

• 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 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)

disorientation

• Frequency not known(cannot be estimated from the available data)

hallucinations, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood. feeling of tingling, prickling, paresthesia (tingling), burning, or numbness. 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)

reduced platelet count, which may cause bleeding or more bruising than usual; reduced white blood cell count, which may lead to more frequent infections.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are 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 Pantoprazole Vir 20 mg gastro-resistant tablets

Keep out of the reach and sight of children.

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

Do not store above 30°C.

Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your usual 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 ofPantoprazole Vir

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

The other ingredients are:

Core: mannitol (E-421), sodium carbonate (E-500ii), pregelatinized corn starch, crospovidone, calcium stearate (E-470a).

Coating: hypromellose (E-464), triacetin (E-1518), titanium dioxide (E-171), methacrylic acid - ethyl acrylate copolymer (1:1), dispersion 30%, talc (E-553b), triethyl citrate (E-1505), red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance and packaging of the product

Gastro-resistant tablet, round, yellowish in color.

Packaging with 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

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

This leaflet was approved in July 2019

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/