Pantoprazole Qualigen 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazole Qualigen 20 mg gastro-resistant tablets EFG

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

• 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 only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Pantoprazole Qualigen is and what it is used for
2. What you need to know before taking Pantoprazole Qualigen
3. How to take Pantoprazole Qualigen
4. Possible adverse effects
5. How to store Pantoprazole Qualigen
6. Contents of the pack and other information

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

Pantoprazole 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.

Pantoprazole is used for:

Adults and adolescents from 12 years of age:

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

2. What you need to know before taking Pantoprazol Qualigen

Do not take Pantoprazol Qualigen

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Pantoprazol Qualigen:

• 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 pantoprazole. If liver enzymes increase, treatment should be discontinued.
• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while also taking pantoprazole, as there is an increased risk of developing stomach and intestinal complications. Any increase in risk will be assessed according to personal 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 pantoprazole treatment for a long period of time. Like all medicines that reduce acid production, pantoprazole 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 pantoprazole.
• If you are taking proton pump inhibitors such as pantoprazole, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• If you take pantoprazole for more than three months, you may experience a decrease in blood magnesium levels. 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 lead to decreased levels of potassium and calcium in the blood. Your doctor may 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 used to reduce stomach acid.
• If you are scheduled to have a specific blood test (chromogranin A)

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with pantoprazole. 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
• Repeated vomiting
• Difficulty swallowing
• Blood in vomit
• Pale appearance and feeling weak (anemia)
  • Blood in your stools
  • Severe or persistent diarrhea, as pantoprazole has been associated with a small increased risk of infectious diarrhea.

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

If you take pantoprazole for a prolonged period (more than one year), your doctor may monitor you regularly. You should report any new or unexpected symptoms or events to your doctor at each visit.

Other medicines and Pantoprazol Qualigen

Pantoprazole 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 pantoprazole may reduce the effectiveness of these and other medicines.
• 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 breastfeeding

There are insufficient data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in human breast milk. If you are pregnant, think you might 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

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

Pantoprazol Qualigen contains sodium

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

3. How to take Pantoprazol Qualigen

Follow exactly the instructions for use of this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

When and how should you take Pantoprazol Qualigen?

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 dosage is:

Adults and adolescents aged 12 years and older:

To treat symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, painful swallowing):

The usual dose is one tablet daily.

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. Afterwards, any recurring symptoms can be managed as needed by taking one tablet daily.

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

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

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

The usual dose is one tablet daily.

Special patient groups:

• If you have severe liver problems, you must not take more than one 20 mg tablet daily.
• Children under 12 years: The use of these tablets is not recommended in children under 12 years of age.

If you take more Pantoprazol Qualigen than you should

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

If you forget to take Pantoprazol Qualigen

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

If you stop taking Pantoprazol Qualigen

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 Qualigen may produce adverse effects, although not everyone experiences them.

The frequency of the possible adverse 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 (the frequency cannot be estimated from available data).

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

• 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 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 are:

• Common

Benign gastric polyps

• Uncommon

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, fatigue or general malaise; sleep disturbances.

• Rare

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

• Very rare

disorientation

• Frequency not known

Hallucination, 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 diarrhoea.

Adverse effects identified through blood tests:

• Uncommon

increased liver enzymes

• Rare

increased bilirubin; increased levels of fats in the blood

• Very rare

reduction in the number of platelets which could lead to bleeding or more bruising than usual; reduction in the number of white blood cells which could lead to more frequent infections.

• Frequency not known:

Skin rash, possibly with joint pain.

Reporting of adverse effects

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

5. Storage of Pantoprazole Qualigen

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Blister: Do not store above 30°C.

Bottle: No special storage conditions required.

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

6. Contents of the pack and other information

Composition of PantoprazolQualigen

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

The other components (excipients) are:

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

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

Appearance of the product and contents of the pack

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

Packs:

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

Packs containing 28 gastro-resistant tablets.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer

Teva Pharma, S.L.U.

Polígono Malpica, c/C, nº 4

50016 Zaragoza

Spain

Date of the most recent revision of this summary: June 2021

Detailed 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/