Pantoprazole Mabo 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazole MABO 20 mg gastro-resistant tablets EFG

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

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• 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 personally. Do not pass it on to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What PANTOPRAZOLE MABO 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, 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 medicines.

2. What you need to know before starting to take Pantoprazole MABO

Do not take Pantoprazole

• If you are allergic (hypersensitive) to pantoprazole, to soybean lecithin, or to any of the other components of pantoprazole (see section 6)
• If you are allergic to medicines containing other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pantoprazole 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 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 you are receiving pantoprazole treatment for a long period of time. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12.

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

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 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 malignant disease, 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 inform your doctor of any new or unexpected symptoms or events at each visit.

Consult your doctor before starting to take Pantoprazole MABO:

• If you have ever had a skin reaction after treatment with a medicine similar to pantoprazole used to reduce stomach acidity.
• 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 pantoprazole treatment. Remember to mention any other symptoms you may experience, such as joint pain.
• 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, confusion, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. In addition, 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.

Before taking this medicine, inform your doctor if:

• A specific blood test (Chromogranin A) is planned

Other medicines and pantoprazole

Use of pantoprazole with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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 for the treatment of HIV infection).

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 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 use of machines

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

Pantoprazole MABO contains soybean lecithin.

This medicine contains soybean lecithin. It should not be used if you are allergic to peanuts or soy.

Pantoprazole MABO contains maltitol (E-965)

This medicine contains maltitol. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Pantoprazole MABO 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 MABO

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

When and how should you take Pantoprazole?

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 recommended dose 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 per day.

This dose generally provides relief within 2–4 weeks, and if not, within a maximum of 4 additional weeks. Your doctor will tell you how long you should continue taking the medicine. Afterwards, any recurring symptoms can 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 disease recurs, your doctor may double your dose; in this 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 ongoing 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.

Use in children and adolescents:

The use of these tablets is not recommended in children under 12 years of age.

If you take more Pantoprazole 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 Pantoprazole

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

If you stop taking Pantoprazole

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, pantoprazole may cause adverse effects, although not everyone experiences them.

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

very common (affects more than 1 in 10 people)
common (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 inform your doctor, or contact the nearest hospital's emergency service:

• Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), breathing difficulties, 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, enlarged kidneys with occasional pain when urinating and lower back pain (severe kidney inflammation).

Other adverse effects are:

• Common (affects between 1 and 10 in 100 patients): benign polyps in the stomach.

• Uncommon (affects between 1 and 10 in 1,000 patients):
  headache, dizziness, diarrhoea, feeling of dizziness, vomiting, bloating 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 (affects between 1 and 10 in 10,000 patients):
  vision disturbances such as blurred vision, urticaria, joint pain, muscle pain, weight changes, increased body temperature, swelling in the limbs (peripheral edema), allergic reactions, depression, breast enlargement in men.

• Very rare (affects fewer than 1 in 10,000 patients):
  disorientation.

• Frequency not known (cannot be estimated from available data):
  hallucinations, confusion (especially in patients with a history of these symptoms), decreased sodium levels in blood, sensation of tingling, prickling, paresthesia (tingling), burning or numbness, skin rash, possibly with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

If you are taking pantoprazole 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, contact your doctor immediately. Low magnesium levels may also lead to reduced 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 pantoprazole, especially for a period longer than one year, your risk of fractures of the hip, wrist, and spine may slightly increase. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Adverse effects identified through blood tests:

• Uncommon (affects between 1 and 10 in 1,000 patients):
  increased liver enzymes.

• Rare (affects between 1 and 10 in 10,000 patients):
  increased bilirubin, increased blood fat levels.

• Very rare (affects fewer than 1 in 10,000 patients):
  reduction in platelet count, which could lead to bleeding or more bruising than usual; reduction in white blood cell count, which could lead to more frequent infections.

Reporting of adverse effects

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

5. Storage of Pantoprazole MABO

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

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazole MABO

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

The other components are:
Core: maltitol, crospovidone, sodium carmellose, anhydrous sodium carbonate, calcium stearate.
Coating: polyvinyl alcohol, talc, titanium dioxide, macrogol 4000, soybean lecithin, yellow iron oxide, anhydrous sodium carbonate, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate.

Appearance of the medicine and contents of the pack

Yellow to brownish-yellow, oval-shaped gastro-resistant tablet.

Packaging: blister packs (Al/Al)

Packs containing 28, 56 and 500 tablets.

Marketing Authorization Holder

MABO-FARMA S.A.
Calle Vía de los Poblados, 3, Edificio 6
28033 Madrid,
Spain.

Manufacturer

Sofarimex. Industria Química e Farmaceutica Lda.
Av. das Industrias. Alto do Colaride, Agalva
2735-213 Cacem, Portugal.

Or

MEDREICH PLC,
Warwick House, Plane Tree Crescent, Feltham, TW13 7HF, United Kingdom

Or

MEIJI PHARMA SPAIN, S.A.
Avda. de Madrid, 94,
28802 Alcalá de Henares, Madrid
Spain

Date of the most recent review of this leaflet: July 2022

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