Pantoprazole Vir Pharma 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazole Vir Pharma 40 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 you should not give it 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 effect 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 you take 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 your stomach. It is used for the treatment of acid-related diseases of the stomach and intestine.

Pantoprazol Vir Pharma is used for:

Adults and adolescents aged 12 years and older:

• Reflux esophagitis. This is inflammation of your esophagus (the tube connecting your throat to your stomach), accompanied by regurgitation of acid 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 therapy). The aim is to eliminate the bacterium and thereby reduce the likelihood of ulcer recurrence.
• Stomach and duodenal ulcers, and
• Zollinger-Ellison syndrome and other conditions in which excessive stomach acid is produced.

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. omeprazol, lansoprazol, rabeprazol, esomeprazol).

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 treatment with pantoprazol. If liver enzymes increase, treatment should be discontinued.

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

• Consult your doctor if you are taking a medicine containing atazanavir (used to treat 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 slightly increased risk of infectious diarrhoea.

Your doctor will decide whether you need additional tests to rule out malignancy, as pantoprazol may relieve symptoms of cancer 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 should 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 to treat 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 breast-feeding

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 might be pregnant, or are breast-feeding, you should only use this medicine if your doctor considers that the benefit to you outweighs the potential risk to the foetus 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 given 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 your doctor has instructed you otherwise, the usual dose is:

Adults and adolescents from 12 years of age:

For the treatment of reflux esophagitis:

The usual dose is one tablet per day. Your doctor may instruct you to increase this to two tablets per day.

The treatment duration for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will advise you on how long to take this medicine.

Adults:

For the treatment of an infection with a bacterium called Helicobacter pylori in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy):

One tablet twice daily, plus two antibiotic tablets—either amoxicillin, clarithromycin, and metronidazole (or tinidazole)—each to be taken twice daily along 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 package leaflets of the antibiotics.

The treatment duration is normally one to two weeks.

For the treatment of gastric and duodenal ulcers:

The usual dose is one tablet per day.

Your doctor may double the dose.

Your doctor will advise you on how long you should take this medicine. The treatment duration for gastric ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is normally between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which increased gastric acid secretion occurs:

The recommended initial dose is two tablets per day. Take both tablets 1 hour before a meal.

Subsequently, your doctor may adjust your dose depending on the amount of gastric acid you produce. If more than two tablets per day are prescribed, you should take them in two divided doses.

If more than four tablets per day are prescribed, you will be given specific instructions on when to stop treatment.

Special patient groups:

• If you have kidney problems or moderate to severe liver problems, you should not take pantoprazole for the eradication of Helicobacter pylori.

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

• 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. There are no known symptoms of overdose.

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, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with 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 during urination and lower back pain (severe kidney inflammation).

Other adverse effects are:

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

headache; dizziness; diarrhoea; feeling of dizziness, vomiting; bloating and flatulence; constipation; dry mouth; abdominal pain and discomfort; 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 of 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)
  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 diarrhoea.

Adverse effects identified through blood tests:

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

• Rare (affects between 1 and 10 in 10,000 people)
  increased bilirubin; increased 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 unknown:

If you are taking Pantoprazol Vir Pharma for more than three months, 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 (which 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 is the last day of the month indicated.

Pantoprazol Vir Pharma 40 mg in polyethylene bottle: no special storage conditions required.

Pantoprazol Vir Pharma 40 mg in aluminium/aluminium blister pack: do not store above 30°C.

Keep in the original container.

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

6. Additional Information

Composition of Pantoprazol Vir Pharma

The active substance is pantoprazole. Each gastro-resistant tablet contains 40 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 glycolate of potato starch, triethyl citrate, methacrylic acid-ethyl acrylate copolymer (1:1), yellow iron oxide (E-172).

Appearance of the product and contents of the pack

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

Packaging: bottles (high-density polyethylene container with polypropylene cap provided with desiccant) and blisters (Alu/Alu blisters). Each pack contains 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:

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 patient information leaflet was approved in October 2020.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/