PANTOPRAZOL QUALIGEN 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

PantoprazoleQualigen 40 mg Gastro-Resistant Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Pantoprazole Qualigen and what is it used for
2. What you need to know before you take Pantoprazole Qualigen
3. How to take Pantoprazole Qualigen

1. Possible side effects
2. Storage of Pantoprazole Qualigen
3. Contents of the pack and other information

1. What is Pantoprazole Qualigen and what is it used for

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

Pantoprazole is used for:

Adults and adolescents from 12 years:

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

Adults:

• Infection with a bacterium called Helicobacter pyloriin patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacterium and thus reduce the likelihood of ulcer recurrence
• Stomach and duodenal ulcers, and
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before you take Pantoprazole Qualigen

Do not take Pantoprazole Qualigen

• If you are allergic (hypersensitive) to pantoprazole or to any of the other ingredients of this medicine (included in section 6).
• If you are allergic to medicines that contain other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole)

Warnings and precautionsConsult your doctor or pharmacist before starting to take this medicine:

• If you have serious liver problems. Tell your doctor if you have ever had liver problems. Your doctor will perform more frequent monitoring of liver enzymes, especially when you are on long-term treatment with pantoprazole. In case of an increase in liver enzymes, treatment should be discontinued.

• If you have decreased body reserves of vitamin B12 or risk factors for it and receive treatment with pantoprazole for a long period. Like all medicines that reduce the amount of acid, pantoprazole could reduce the absorption of vitamin B12.

• Consult your doctor if you are taking any medicine that contains atazanavir (for HIV infection treatment) at the same time as pantoprazole.
• If you are taking proton pump inhibitors like pantoprazole, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If you take pantoprazole for more than three months, you may suffer from a decrease in magnesium levels in your blood. Symptoms of low magnesium levels can include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you have any of these symptoms, tell your doctor immediately. Additionally, low magnesium levels can cause a decrease in potassium and calcium levels in your blood. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to pantoprazole to reduce stomach acidity.
• It is planned that you will undergo a specific blood test (Chromogranin A)

If you suffer from a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with pantoprazole. Remember to mention any other symptoms you may notice, such as joint pain.

Tell 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 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 because pantoprazole can alleviate the symptoms of cancer and may delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take pantoprazole for a prolonged period (more than one year), your doctor will possibly monitor you regularly. You should inform your doctor of any symptoms and/or new or unexpected events each time you visit your consultation.

Other medicines and Pantoprazol Qualigen

Pantoprazole may influence the effectiveness of other medicines, so inform your doctor if you are taking

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as pantoprazole may cause these and other medicines to not work properly.
• Warfarin and fenprocoumon, which affect blood coagulation. You may need additional controls.
• Atazanavir (used to treat HIV infection).

Tell 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 is not enough data on the use of pantoprazole in pregnant women. It has been reported that in humans, pantoprazole is excreted in breast milk. If you are pregnant, or think you may be pregnant, or if you are breastfeeding, you should only use this medicine if your doctor considers that the benefit to you is greater than the potential risk to the fetus or baby.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Pantoprazole is unlikely to affect your ability to drive or use tools or machines. Side effects such as dizziness and visual disturbances (see section 4) may occur. If they do, you should not drive or use machines.

Pantoprazol Qualigen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Pantoprazole Qualigen

Follow exactly the administration instructions of this medicine indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

When and how should you take Pantoprazole Qualigen?

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

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

Adults and adolescents from 12 years:

For the treatment of reflux esophagitis:

The usual dose is one tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will indicate how long you should take this medicine.

For the treatment of an infection with a bacterium 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 to be 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 leaflets of the antibiotics.

The duration of treatment is usually one to two weeks.

For the treatment of stomach and duodenal ulcers:

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

Your doctor will indicate how long you should take this medicine. The treatment time for stomach ulcers is usually between 4 and 8 weeks. The treatment time for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in stomach acid secretion:

The recommended initial dose is two tablets per day.

Take the two tablets 1 hour before a meal. Later, your doctor may adjust the dose, depending on the amount of acid secretion you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two doses per day.

If you are prescribed more than four tablets per day, you will be told exactly when you should finish the treatment.

Special patient groups:

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

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

• Children (under 12 years): the use of these tablets is not recommended in children under 12 years.

If you take more Pantoprazole Qualigen than you should

Tell your doctor or pharmacist or call the Toxicology Information Service telephone 91 562 04 20, indicating the medicine and the amount ingested. There are no known symptoms of overdose.

If you forget to take Pantoprazole Qualigen

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

If you stop taking Pantoprazole Qualigen

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• very common (may affect more than 1 in 10 people)
• common (may affect up to 1 in 10 people)
• uncommon (may affect up to 1 in 100 people)
• rare (may affect up to 1 in 1,000 people)
• very rare (may affect up to 1 in 10,000 people)
• frequency not known (frequency cannot be estimated from the available data).

If you think you have any of the side effects that are serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist or contact the emergency department of the nearest hospital.

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

• Severe skin reactions(frequency not known):blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and sensitivity to light.

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

Other side effects are:

• Common

Benign stomach polyps

• Uncommon

headache; dizziness; diarrhea; feeling of dizziness, vomiting; swelling 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

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

• Very rare

disorientation

• Frequency not known

hallucination, confusion (especially in patients with a history of these symptoms), decrease in sodium levels in the blood, tingling sensation, paresthesia (tingling), burning, numbness, or inflammation of the large intestine that causes persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon

increase in liver enzymes

• Rare

increase in bilirubin; increase in blood fat levels

• Very rare

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

Frequency not known:

skin rash, possibly with joint pain.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Qualigen

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

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

Blister: Do not store above 30°C.

Bottle: No special storage conditions are required

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazole Qualigen

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

The other ingredients (excipients) are:

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

Coating: Hypromellose, triethyl citrate, sodium glycolate starch (derived from potato), methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion, and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Gastro-resistant tablet, yellow, oval, concave, smooth.

Packaging:

Bottles (high-density polyethylene packaging with a screw cap with a low-density polyethylene desiccant) and blisters (Alu/Alu blisters)

Packaging with 28 gastro-resistant tablets.

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

ManufacturerTeva Pharma, S.L.U.

Polígono Malpica, c/C, nº 4

50016 Zaragoza

Spain

Date of the last revision of this leaflet:June 2021

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/