PANTOPRAZOL VIR 40 mg GASTRO-RESISTANT TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazol Vir 40 mg gastro-resistant tablets EFG

Pantoprazol

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

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

Pantoprazol 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.

Pantoprazol Vir is used for:

Adults and adolescents from 12 years:

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

Adults:

• Infection with a bacterium called Helicobacter Pylori in patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacterium and thus reduce the likelihood of ulcer recurrence.
• Stomach and duodenal ulcers, and

Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. Before taking Pantoprazol Vir

Do not takePantoprazol Vir

• If you are allergic (hypersensitive) to pantoprazol or any of the other components of Pantoprazol Vir (see section 6).
• If you are allergic to medicines that contain other proton pump inhibitors (e.g., omeprazol, lansoprazol, rabeprazol, esomeprazol).

Be careful withPantoprazol Vir

• If you have serious liver problems. Tell your doctor if you have ever had liver problems. Your doctor will monitor you more frequently for liver enzymes, especially when you are on long-term treatment with pantoprazol. In case of 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 pantoprazol. Like all medicines that reduce acid, pantoprazol 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 pantoprazol.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazol Vir to reduce stomach acidity. 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 Pantoprazol Vir. Remember to mention any other symptoms you may notice, such as joint pain.
• If you take pantoprazol for more than three months, you may experience a decrease in magnesium levels in your blood. Symptoms of low magnesium levels can include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you experience 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 whether to perform periodic blood tests to monitor magnesium levels.

Before taking this medicine, tell your doctor if:

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

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 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 cancer symptoms 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 one year), your doctor may monitor you regularly. You should tell your doctor about any new symptoms and/or unexpected events each time you visit your doctor.

Use of other medicines

Pantoprazol Vir 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, as Pantoprazol Vir may cause them and other medicines to not work properly.
• Warfarin and fenprocoumon, which affect blood coagulation. You may need additional tests.
• 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 pantoprazol in pregnant women. It has been reported that in humans, pantoprazol 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.

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 Pantoprazol Vir

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

When and how should you take Pantoprazol 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 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 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 to be taken twice a day with your pantoprazol tablet. Take the first pantoprazol 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 one to two 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 stomach acid secretion:

The recommended initial dose is two 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 two tablets per day, you should take the tablets divided into two doses per day.

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

Special patient groups:

• If you have kidney problems or moderate or severe liver problems, you should not take pantoprazol for Helicobacter pylori eradication.

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

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

If you take morePantoprazol Virthan 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 takePantoprazol Vir

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

If you stop taking Pantoprazol 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, Pantoprazol Vir can have side effects, although not everyone 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 consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

• 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 very rapid heartbeats 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. Skin rash, possibly with joint pain.

• Other severe conditions (frequency not known):yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increase in kidney size sometimes with pain when urinating and pain in the lower back (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; increase in 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)

hallucination, confusion (especially in patients with a history of these symptoms), decrease in sodium levels in the blood. Feeling of tingling, pricking, 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)

increase in liver enzymes

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

increase in bilirubin; increase in blood fat levels

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

reduction in platelet count, which could lead to bleeding or more bruising than usual; reduction in white blood cell count, which could lead to more frequent infections.

Reporting of side effects

If you experience any side effect, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazol Vir

Keep Pantoprazol Vir out of the reach and sight of children.

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

No special storage conditions are required.

Store in the original packaging.

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

6. Further information

Composition ofPantoprazol Vir

The active substance is pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol (in the form of 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), glycerol triacetate (E-1518), titanium dioxide (E-171), methacrylic acid - ethyl acrylate copolymer (1:1), 30% dispersion, talc (E-553b), triethyl citrate (E-1505), red iron oxide (E-172) and yellow iron oxide (E-172)

Appearance of the product and packaging content

Pantoprazol Vir gastro-resistant tablet, round and reddish in color.

Packaging with 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

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/