PROSPECTO: INFORMATION FOR THE USER

Pantoprazol Vir 40 mg gastro-resistant tablets EFG

Pantoprazol

Read this prospect carefully before starting to take the medicine.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospect, inform your doctor or pharmacist. See section 4.

Pantoprazol Vir is a selective proton pump inhibitor, a medication that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach acid and intestine.

Pantoprazol Vir is used for:

Adults and adolescents 12 years and older:

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

Adults:

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

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

Do not takePantoprazol Vir

• If you are allergic (hypersensitive) to pantoprazole or to any of the other components of Pantoprazol Vir (see section 6).
• If you are allergic to medications that contain other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole).

Be especially careful withPantoprazol Vir

• If you have severe liver problems. Inform 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 liver enzyme levels increase, treatment should be interrupted.
• If you have reduced vitamin B12 reserves or risk factors for it and receive pantoprazole treatment for a long period. Like all medications that reduce acid levels, pantoprazole may reduce vitamin B12 absorption.
• Consult your doctor if you are taking a medication that contains atazanavir (for HIV treatment) at the same time as pantoprazole.
• If you have ever had a skin reaction after treatment with a similar medication to Pantoprazol Vir for reducing stomach acid. If you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt Pantoprazol Vir treatment. 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 to perform periodic blood tests to monitor magnesium levels.

Inform your doctor before taking this medication if:

• You are scheduled to have a specific blood test (Cromogranin A).

Inform your doctor immediately if you notice any of the following symptoms:

-Unintentional weight loss

-Recurring vomiting

-Difficulty swallowing

-Blood in vomit

-Pale appearance and feeling of weakness (anemia)

• Blood in your stools

• Severe or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need additional testing to rule out a malignant disease, as pantoprazole may alleviate cancer symptoms and potentially delay its diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you take pantoprazole for a prolonged period (more than one year), your doctor may regularly monitor you. Inform your doctor of any new or unexpected symptoms and/or events each time you attend your consultation.

Use of other medications

Pantoprazol Vir may affect the efficacy of other medications, so inform your doctor if you are taking

• Medications such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections, as Pantoprazol Vir may make these and other medications not work correctly.
• Warfarin and fenprocoumon, which affect blood clotting. You may need additional monitoring.
• Atazanavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Pregnancy and breastfeeding

There is insufficient data on the use of pantoprazole in pregnant women.Pantoprazole is excreted in human breast milkIf you are pregnant, or think you may be pregnant, or if you are breastfeeding, you should only use this medication if your doctor considers the benefit for you to be greater than the potential risk to the fetus or baby.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

You should not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Follow exactly the administration instructions for 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 whole tablets, 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 12 years and older:

Treatment of esophagitis by reflux:

The usual dose is 1 tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for esophagitis by reflux usually ranges from 4 to 8 weeks. Your doctor will indicate for how long you should take this medication.

Adults:

Treatment of an infection with a bacteria 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 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 antibiotic prospectuses.

The treatment duration is usually 1 to 2 weeks.

Treatment of stomach and duodenal ulcers:

The usual dose is 1 tablet per day. The dose may be doubled by your doctor.

Your doctor will indicate for how long you should take this medication. The treatment duration for stomach ulcers is usually 4 to 8 weeks, and for duodenal ulcers, it is usually 2 to 4 weeks.

Long-term treatment of Zollinger-Ellison Syndrome and other conditions with increased stomach acid secretion:

The recommended initial dose is 2 tablets per day.

Take the 2 tablets 1 hour before a meal. Your doctor may then adjust your dose, depending on the amount of stomach acid you produce. If you are prescribed more than 2 tablets per day, you should take the tablets twice a day.

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

Special patient groups:

• If you have kidney problems, or moderate or severe liver problems,do nottake pantoprazole for the elimination ofHelicobacter pylori.

• If you have severe liver problems, do not take more than1 tablet of 20 mg of pantoprazole per day(for this case, tablets of 20 mg of pantoprazole are available).

• Children(under 12 years):do notrecommend the use of these tablets in children under 12 years.

If you take morePantoprazol Virthan you should

Tell your doctor or pharmacist or call the Toxicological Information Service at phone 91 562 04 20, indicating the medication and the amount ingested. There are no known symptoms of overdose.

If you forget to takePantoprazol Vir

Do not take a double dose to compensate for the missed doses. Take your next dose as usual.

If you interrupt treatment with Pantoprazol Vir

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

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

Like all medications, Pantoprazol Vir may have side effects, although not everyone will experience them.

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

Very common (affects more than one patient in every 10)

Common (affects between 1 and 10 patients in every 100)

Uncommon (affects between 1 and 10 patients in every 1,000)

Rare (affects between 1 and 10 patients in every 10,000)

Very rare (affects fewer than one patient in every 10,000)

Frequency unknown (cannot be estimated from available data).

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

• Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and excessive sweating.

• Severe skin alterations (frequency unknown):blistering of the skin and rapid deterioration of general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and light sensitivity.skin rash, possibly with joint pain.

• Other severe conditions (frequency unknown):yellowing of the skin and white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased kidney size sometimes with painful urination and lower back pain (severe kidney inflammation)

Other side effects are:

• Common(affects between 1 and 10 patients in every 100)

Benign polyps in the stomach

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

headache; dizziness; diarrhea; sensation of dizziness, 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.

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

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

• Very rare(affects fewer than one patient in every 10,000)

disorientation

• Frequency unknown(cannot be estimated from available data)

hallucination, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood.tingling, prickling, paresthesia (tingling), burning or numbness.inflammatory bowel disease causing persistent watery diarrhea.

Side effects identified through blood tests:

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

increased liver enzymes

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

increased bilirubin; increased levels of fat in the blood

• Very rare(affects fewer than one patient in every 10,000)

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use Pantoprazol Vir after the expiration date that appears on the packaging after CAD. 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 thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition ofPantoprazol Vir

The active ingredient is pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol (in the form of sodium sesquihydrate)

The other components are:

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

Coating: hypromellose(E-464), triacetin(E-1518), titanium dioxide(E-171), copolymer of methacrylic acid and ethyl acrylate (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 contents of the package

Pantoprazol Virgastro-resistant tablet, red-brown, round.

Containers with 14 or 28 gastro-resistant tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna, 66-70

Urtinsa II Industrial Estate

28923 Alcorcón (Madrid)

Spain

Responsible for manufacturing

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

This prospectus was approved in July 2019

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/