Leaflet: information for the user

PantoprazolQualigen 40 mg gastro-resistant tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

4.Undesirable effects

5.Storage of Pantoprazol Qualigen

6.Contents of the pack and additional information

Pantoprazol 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 acid and intestine.

Pantoprazol is used for:

Adults and adolescents 12 years and older:

-Gastroesophageal reflux esophagitis. This is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by regurgitation of acid from your stomach.

Adults:

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

Do not take Pantoprazol Qualigen

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

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

• 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 have decreased vitamin B12 reserves or risk factors for it and receive pantoprazole treatment 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 any medication that contains atazanavir (for HIV treatment) at the same time as pantoprazole.
• If you are taking proton pump inhibitors like pantoprazole, especially for more than a year, it may slightly increase the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may increase the risk of osteoporosis).
• 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 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 similar medication to pantoprazole for reducing stomach acid.
• You are scheduled to have a specific blood test (Cromogranin A).

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

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

-Unintentional weight loss

-Recurring vomiting

-Difficulty swallowing

-Blood in your 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 a 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.

Other medications and Pantoprazol Qualigen

Pantoprazol 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 may make these and other medications not work correctly.
• Warfarin and fenprocumon, which affect blood coagulation. 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 purchased without a prescription.

Pregnancy and breastfeeding

There is insufficient data on the use of pantoprazol in pregnant women.Pantoprazol is excreted in human breast 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 the benefit 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

Pantoprazol is unlikely to affect your ability to drive or use tools or machines. However, 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 medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

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

When and how should you take Pantoprazol Qualigen?

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

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

Adults and adolescents 12 years and older::

Treatment of esophagitis by reflux:

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

Treatment of an infection with a bacteria 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 taken twice a day, with your pantoprazole tablet. Take thefirstpantoprazole tablet 1 hour before breakfast and thesecond1 hour before dinner. Follow your doctor's instructions and make sure to read the antibiotic prospectuses.

The treatment duration is usually 1 to 2 weeks.

Treatment of stomach and duodenal ulcers::

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

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

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 a day.

Take the two tablets 1 hour before a meal. Your doctor may then adjust your dose, depending on the amount of stomach acid you produce. If you are prescribed more than two tablets a day, you should take the tablets twice a day.

If you are prescribed more than four tablets a day, you will be told exactly when to stop treatment.

Special patient groups:

• If you have kidney problems, or moderate or severe liver problems,do nottake pantoprazole for the elimination ofHelicobacter pylori.

• If you have severe liver problems, do not take more thanone 20 mg pantoprazole tablet a day(20 mg pantoprazole tablets are available for this case).

• Children(under 12 years):do notrecommend the use of these tablets in children under 12 years.

If you take more Pantoprazol Qualigen than you should

Inform your doctor or pharmacist or call the Toxicological Information Service at 91 562 04 20, indicating the medication and the amount taken. There are no known symptoms of overdose.

If you forget to take Pantoprazol Qualigen

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

If you interrupt treatment with Pantoprazol Qualigen

Do not stop taking these tablets without 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 medicines, this medicine may cause side effects, although not everyone will experience them.

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

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform 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, allergic swelling of the face (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and excessive sweating.

• Severe skin alterations(unknown frequency):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.

• Other severe conditions (unknown frequency):yellowing of the skin and eyes (severe liver cell damage, jaundice), or fever, hives, increased kidney size sometimes with painful urination and lower back pain (severe kidney inflammation)

Other side effects are:

• Common

Benign gastric polyps

• Uncommon

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

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; gynecomastia in men.

• Very rare

Disorientation

• Unknown frequency

Illusion, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, sensation of tingling, prickling, paresthesia (tingling), burning, numbness or inflammation of the large intestine causing persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon

Increased liver enzymes

• Rare

Increased bilirubin levels; increased levels of fat in the blood

• Very rare

Reduced platelet count, which could cause bleeding or more frequent bruising; reduced white blood cell count, which could lead to more frequent infections.

Unknown frequency:

Skin rash, possibly with joint pain.

Reporting of side effects

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

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

Do not use this medication 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 at a temperature above30°C.

Bottle: No special storage conditions are required.

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

Composition of Pantoprazol Qualigen

The active ingredient is pantoprazol.Each gastro-resistant tabletcontains 40 mg of pantoprazol(in the form of sodium sesquihydrate).

The other components (excipients) are:

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

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

Appearance of the product and content of the packaging

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

Containers:

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

Containers with 28 gastro-resistant tablets.

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsible for manufacturingTeva Pharma, S.L.U.

Malpica Industrial Estate, c/C, nº 4

50016 Zaragoza

Spain

Last review date of this leaflet:June 2021

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