Pantoprazole Vir Pharma 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazole Vir Pharma 20 mg gastro-resistant tablets EFG

Read the entire 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.

• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

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

Pantoprazol Vir Pharma is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in the stomach. It is used for the treatment of acid-related disorders of the stomach and intestine.

Pantoprazol Vir Pharma is used for:

Adults and adolescents from 12 years of age:

• Treatment of symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when 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 at-risk patients who require ongoing treatment with these types of medicines.

2. Before taking Pantoprazol Vir Pharma

Do not take Pantoprazol Vir Pharma

• If you are allergic (hypersensitive) to pantoprazol or to any of the other components of Pantoprazol Vir Pharma (see section 6)
• If you are allergic to medicines containing 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 if you are on long-term pantoprazol treatment. If liver enzymes increase, treatment should be discontinued.

• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while taking pantoprazol, as there is an increased risk of developing stomach and intestinal complications. Any increase in risk will be assessed according to individual risk factors such as age (65 years or older), history of stomach or duodenal ulcer, or gastrointestinal bleeding.

• If you have reduced body stores of vitamin B12 or risk factors for this, and are receiving long-term pantoprazol treatment. Like all medicines that reduce acid production, pantoprazol may reduce the absorption of vitamin B12.

• Consult your doctor if you are taking a medicine containing atazanavir (for the treatment of HIV infection) at the same time as pantoprazol.

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

• unintentional weight loss
• repeated vomiting
• difficulty swallowing
• blood in vomit
• pale appearance and feeling weak (anemia)
• blood in your stools
• severe or persistent diarrhoea, as pantoprazol has been associated with a small increased risk of infectious diarrhoea.

Your doctor will decide whether you need additional tests to rule out malignancy, as pantoprazol may relieve cancer symptoms and could delay diagnosis. If your symptoms persist despite treatment, further investigations will be carried out.

If you take pantoprazol for a prolonged period (more than one year), your doctor will likely monitor you regularly. You must inform your doctor of any new or unexpected symptoms and/or events at each visit.

Use of other medicines

Pantoprazol Vir Pharma may affect the effectiveness of other medicines. Therefore, inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazol Vir Pharma may cause these and other medicines to be less effective.
• Warfarin and phenprocoumon, which affect blood clotting. You may require additional monitoring.
• Atazanavir (used for the treatment of HIV infection).

Inform 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 are insufficient data on the use of pantoprazol in pregnant women. It has been reported that pantoprazol is excreted in human breast milk. 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 outweighs the potential risk to the fetus or infant.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

3. How to take Pantoprazol Vir Pharma

Follow exactly the administration instructions for Pantoprazol Vir Pharma as prescribed by your doctor. Consult your doctor or pharmacist if you have any doubts.

When and how should you take Pantoprazol Vir Pharma?

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

Unless otherwise directed by your physician, the usual dosage is:

Adults and adolescents aged 12 years and older:

For treating symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, painful swallowing)

The usual dose is one tablet per day.

This dose generally provides relief within 2-\4 weeks, or at most within the following 4 weeks. Your doctor will advise you on how long you should continue taking the medicine. Subsequently, any recurring symptoms may be managed as needed by taking one tablet per day.

For long-\term treatment and prevention of relapses of reflux esophagitis

The usual dose is one tablet per day. If the condition recurs, your doctor may double your dose, in which case you may take Pantoprazole 40 mg once daily. After healing, the dose may be reduced again to one 20 mg tablet per day.

Adults:

For prevention of duodenal and gastric ulcers in patients requiring continuous treatment with NSAIDs

The usual dose is one tablet per day.

Special patient groups:

• If you have severe liver problems, you must 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 of age.

If you take more Pantoprazol Vir Pharma than you should

Inform your doctor or pharmacist or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested. Symptoms of overdose are not known.

If you forget to take Pantoprazol Vir Pharma

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

If you stop taking Pantoprazol Vir Pharma

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

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

4. Possible adverse effects

Like all medicines, Pantoprazol Vir Pharma may cause adverse effects, although not everyone experiences them.

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

very frequent (affects more than 1 in 10 people)
frequent (affects between 1 and 10 in 100 people)
uncommon (affects between 1 and 10 in 1,000 people)
rare (affects between 1 and 10 in 10,000 people)
very rare (affects fewer than 1 in 10,000 people)
frequency not known (cannot be estimated from available data)

If you experience any of the following adverse effects, stop taking these tablets immediately and contact your doctor or go to the nearest hospital emergency department:

• Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, facial swelling due to allergy (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.

• Severe skin disorders (frequency not known): skin blisters and rapid deterioration of general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), and photosensitivity.

• Other serious conditions (frequency not known): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, kidney enlargement with occasional pain when urinating and lower back pain (severe kidney inflammation).

Other adverse effects include:

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

headache; dizziness; diarrhoea; feeling of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; pain and discomfort in the abdomen; skin rash, exanthema, eruption; tingling; feeling of weakness, tiredness or general malaise; sleep disturbances.

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

vision disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling in the limbs (peripheral oedema); allergic reactions; depression; breast enlargement in men.

• Very rare (affects fewer than 1 in 10,000 people): disorientation
• Frequency not known (cannot be estimated from available data)

hallucinations, confusion (especially in patients with a history of these symptoms), decreased levels of sodium in the blood, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse effects identified through blood tests:

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

increase in liver enzymes

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

increase in bilirubin; increase in blood fat levels

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

reduction in platelet count, which may lead to bleeding or unusual bruising; reduction in white blood cell count, which may lead to more frequent infections.

Frequency not known:

If you are taking Pantoprazol Vir Pharma for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

If you are taking proton pump inhibitors such as Pantoprazol Vir Pharma, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (as these may increase the risk of osteoporosis).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Pantoprazol Vir Pharma

Keep this medicine out of the sight and reach of children.

Do not use Pantoprazol Vir Pharma after the expiry date stated on the packaging after EXP. The expiry date refers to 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 Aluminium/Aluminium blister: do not store above 30°C.

Keep in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Additional Information

Composition of Pantoprazole Vir Pharma

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

The other components (excipients) are:

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

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

Appearance of the medicinal product and contents of the container

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

Containers: bottles (high-density polyethylene bottle with polypropylene cap provided with desiccant) and blister packs (Alu/Alu blisters).

Each container contains 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:

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 summary of product characteristics was last approved in October 2020.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/