PATIENT INFORMATION LEAFLET

Pantoprazol Vir Pharma 20 mg gastro-resistant tablets EFG

Read this leaflet carefully before you start taking the medicine.

• Keep this leaflet, 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 side effects you are experiencing are serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

2.Before taking Pantoprazol Vir Pharma

3.How to take Pantoprazol Vir Pharma

4.Possible side effects

5.Storage of Pantoprazol Vir Pharma

6.Additional information

PantoprazolVir Pharmaisaselectiveinhibitorof the“proton pump”, amedicationthatreducestheamountofacidproduced in thestomach.Itisused for the treatment of diseases related tostomachandintestineacid.

PantoprazolVir Pharmais used for:

Adults and adolescents 12 years and older:

• Treatment of symptoms associated withgastroesophageal reflux disease(stomachburning, acidregurgitation, difficulty swallowing)caused by acidreflux from thestomach.
• Treatment of long-term and prevention of relapses of esophagitis by reflux (inflammation of theesophagusaccompanied by acidregurgitation from thestomach).

Adults:

• Prevention of gastroduodenal ulcers induced bynonsteroidal anti-inflammatory drugs(NSAIDs, for example, ibuprofen)in patients at risk who require continued treatment with this type ofdrug.

Do not take Pantoprazol Vir Pharma

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

Take special care with Pantoprazol Vir Pharma

• 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 need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a higher risk of developing complications in the stomach and intestine. Any increased risk will be assessed based on individual risk factors such as age (65 years or older), history of stomach or duodenal ulcers or stomach or intestinal bleeding.
• If you have reduced vitamin B12 stores or risk factors for it and receive treatment with pantoprazole for a long period of time. Like all medications that reduce acid production, pantoprazole may reduce vitamin B12 absorption.

• Consult your doctor if you are taking atazanavir (for HIV treatment) at the same time as pantoprazole.

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

• Unintentional weight loss
• Recurring vomiting
• Difficulty swallowing
• Blood in the 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 any additional tests to rule out a malignant disease, as pantoprazole may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you take pantoprazole for a prolonged period (over one year), your doctor may regularly monitor you. You should inform your doctor of any new or unexpected symptoms and/or events each time you attend your appointment.

Use of other medications

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

• Medications such as ketoconazole, itraconazole, and posaconazole (used for fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazol Vir Pharma may make these and other medications less effective.
• Warfarin and fenprocoumon, which affect blood clotting. You may need additional monitoring.
• Atazanavir (used for HIV treatment).

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

Pregnancy and breastfeeding

There is insufficient data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in human milk. If you are pregnant, or think you may be pregnant, or if you are breastfeeding, you should only use this medication if your doctor considers that the benefits for you outweigh 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 PantoprazolVir Pharmaas indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

When and how should you takePantoprazolVir Pharma?

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

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

Adults and adolescents 12 years and older:

To treatsymptoms associatedwith gastroesophageal reflux disease(heartburn,acid regurgitation, difficulty swallowing)

The usual dose is 1 tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within a maximum of 4 weeks. Your doctor will tell you how long you should continue taking the medication. Subsequently, any recurring symptom can be controlled as needed,by taking1 tablet per day.

For long-term treatmentand prevention of esophagitis relapses

Theusual dose is1 tablet per day.If the disease recurs, your doctor may double the dose, in which case you cantakePantoprazol 40mg,once a day. Afterhealing, you can reduce the doseagain to1 tabletof 20 mgper day.

Adults:

For the preventionof duodenal and gastric ulcersin patientsrequiring continuous treatment with NSAIDs

The usual dose is 1 tablet per day.

Special patient groups:

- If you have severe liver problems,do not take more than1 tablet of 20 mg per day.

-Children under 12 years:Nouse of these tablets is recommended in children under 12years.

If you take more Pantoprazol Vir Pharma than you should

Inform your doctor or pharmacist or call the Toxicological Information Service, phone91 562 04 20,indicating the medication and the amountingested.Nosymptoms of overdose are known.

If you forget to take Pantoprazol Vir Pharma

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

If you interrupt treatment with PantoprazolVir Pharma

Do not stop taking these tabletswithout consulting your doctor or pharmacist first.

If you have any other doubts about the useof thisproduct,ask your doctor or pharmacist.

Like all medications, PantoprazolVir Pharmamayproduceside effects, although not everyone will experience them.

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

veryfrequent(affects more than one patient in every 10)

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

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

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

veryrare(affects fewer than 1 patient in every 10,000)

frequency unknown (cannot be estimated from 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 the nearest hospital:

• Severe allergic reactions (rare frequency): swelling ofthe tongue and/orthroat, difficultyswallowing, hives (urticaria), difficultybreathing, swellingof the face of allergic origin(Quincke's edema/angioedema), intense dizzinesswith very rapid heartbeats and abundant sweating.

• Severe skin alterations (unknown frequency):blistering of the skin and a rapid deterioration of the general condition, erosion (including light bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and sensitivity to light.
• Other serious conditions (unknown frequency):yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased size of the kidneys with occasional pain when urinating and lower back pain (severe kidney inflammation)

Other side effectsare:

• Infrequent(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; hives on the skin, exanthema, rash; tingling; feeling of weakness, fatigue or general discomfort; 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; breast enlargement in men.

• Very rare(affects fewer than 1 patient in every 10,000)disorientation
• Unknown frequency(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 causing persistent watery diarrhea.

Side effects identified through blood tests:

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

increase in liver enzymes

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

increase in bilirubin; increase in blood fats

• Very rare(affects fewer than 1 patient in every 10,000)

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

Unknown frequency:

If you are taking PantoprazolVir Pharmafor more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary 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 potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors such as PantoprazolVir Pharma, especially for a period of more than one year, it may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may increase the risk of osteoporosis).

If you consider that any of the side effects you are experiencing is severeor if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep this medication out of the reach of children.

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

Pantoprazol Vir Pharma 20 mg in polyethylene bottle: no special storage conditions required.

Pantoprazol Vir Pharma 20 mg in Aluminio/Aluminio blister: do not store above 30°C.

Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. By doing so, you will help protect the environment.

Pantoprazole Vir Pharma Composition

The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole(in the form ofsodium sesquihydrate).

The other components (excipients) are:

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

Coating:hydroxypropyl methylcellulose (hypromellose), sodium glycolate of potato starch,trietil citrate, copolymerof methacrylic acid-ethyl acrylate (1:1),yellow iron oxide (E-172).

Product Appearance and Packaging Contents

Yellow, oval, concave, and smooth gastro-resistant tablet.

Packaging: bottles (HDPE container with a polypropylene cap provided with a desiccant) and blisters (Alu/Alu blister).

Each package contains 28 gastro-resistant tablets.

Marketing Authorization Holder andResponsible for Manufacturing

Marketing Authorization Holder:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

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

28923 (Alcorcón) Madrid

Spain

Responsible for Manufacturing:

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