PATIENT INFORMATION LEAFLET

Pantoprazol Vir 20 mg gastro-resistant tablets EFG

Pantoprazol

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can report it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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 and intestinal acid.

Pantoprazol Vir is used for:

Adults and adolescents 12 years and older:

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

Adults:

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

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 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 evaluated based on individual risk factors such as age (65 years or older), history of stomach or duodenal ulcers, or gastrointestinal bleeding.
• If you have decreased vitamin B12 reserves or risk factors for it and receive pantoprazole treatment for a long period. Like all medications that reduce acid production, pantoprazole may reduce vitamin B12 absorption.
• Inform your doctor if you are taking 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 treatment with Pantoprazol Vir may need to be interrupted. 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 magnesium levels in your blood. 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 potassium and calcium levels in the blood. 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 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. You should 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 less effective.

• 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 has been excreted in human breast milk. If you are pregnant, or think you may be pregnant, or are breastfeeding, you should only use this medication if your doctor considers the benefits 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 side 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 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, theusual doseis:

Adults and adolescents 12 years and older:

For treating symptoms associated with gastroesophageal reflux disease(stomach burning, 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 symptoms can be controlled as needed,by taking1 tablet per day.

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

The usual dose is 1 tablet per day. If the disease returns, your doctor may double the dose, in which case you can take Pantoprazol 40 mg,onceper day. After healing, you can reduce the dose again to1 tabletof 20 mg per day.

Adults:For preventing duodenal and stomach ulcers in patients requiring long-term 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:This medication is not recommended for children under 12 years.

If you take morePantoprazol Virthan you should

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

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 tabletswithout 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 cause side effects, although not everyone will experience them.

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

Very common (affects more than 1 in 10 patients)

Common (affects between 1 and 10 patients in 100)

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

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

Very rare (affects fewer than 1 in 10,000 patients)

Frequency cannot be estimated (cannot be estimated from available data).

If you experience any of the following side effects, stop taking these tablets and inform your doctor immediately

• 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 cannot be estimated):skin blisters and rapid deterioration of general condition, erosion (including mild 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 cannot be estimated):yellowing of the skin and white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased kidney size with occasional pain while urinating and lower back pain (severe kidney inflammation)

Other side effects are:

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

Benign stomach polyps

• Uncommon(affects between 1 and 10 patients in 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 discomfort; sleep disturbances.

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

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

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

Disorientation

• Frequency cannot be estimated(cannot be estimated from available data)

hallucination, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood.sensation of 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 1,000))

Increased liver enzymes

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

Increased bilirubin; increased levels of fats in the blood

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

Decreased platelet count, which could cause bleeding or more frequent bruising; decreased 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 that does not appear 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 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.

Do not store above30°C.

Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines that you do not need in the SIGRE collection pointof your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition ofPantoprazol Vir

The active ingredient is pantoprazol. Each gastro-resistant tablet contains 20 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

Gastro-resistant, yellowish round tablet.

Packages with 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 leaflet 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/