PROSPECTO : INFORMATION FOR THE USER

Pantoprazol MABO 20 mg gastro-resistant tablets EFG

Read this prospect carefully before starting to take the medicine, because it contains important information for you

.

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

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

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

3. How to take Pantoprazol MABO

4. Possible adverse effects

5. Storage of Pantoprazol MABO

6. Contents of the package and additional information

Pantoprazole 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 and intestinal acid.

Pantoprazole is used for:

Adults and adolescents 12 years and older:

• Treatment of symptoms associated with gastroesophageal reflux disease (stomach burning, acid regurgitation, difficulty swallowing) caused by acid reflux from the stomach.

• Long-term treatment and prevention of recurrences of esophagitis caused by acid reflux (inflammation of the esophagus accompanied by acid regurgitation from the stomach).

Adults:

• Prevention of gastroduodenal ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who require continued treatment with this type of medication.

Do not take Pantoprazol

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take PantoprazolIf 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 discontinued

• If you need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a higher risk of developing complications in the stomach and intestine. Any increased risk will be evaluated based on your personal risk factors, such as age (65 years or older), history of stomach or duodenal ulcers, or gastrointestinal bleeding

• 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 atazanavir (for HIV treatment) at the same time as pantoprazole

Inform your doctor immediatelyif you notice any of the following symptoms:

- unintended 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 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 one year), your doctor may regularly monitor you. You should inform your doctor of any new or unexpected symptoms and/or events each time you visit your doctor

Consult your doctor before starting to take Pantoprazol MABO

• If you have ever had a skin reaction after treatment with a similar medication to pantoprazole for reducing stomach acid
• If you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue pantoprazole treatment. Remember to mention any other symptoms you may notice, such as joint pain
• If you take pantoprazole for more than three months, you may experience decreased 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 decreased potassium and calcium levels in your blood. Your doctor will decide to perform periodic blood tests to monitor magnesium levels

Inform your doctor before taking this medication if:

• You are scheduled to undergo a specific blood test (Cromogranin A)

Other medications and pantoprazole

Use of pantoprazole with other medications. Inform your doctor or pharmacist if you are taking, have recently used, or may need to take any other medication, including those purchased without a prescription

Pantoprazole may affect the efficacy of other medications, so inform your doctor if you are taking,

• Medications such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as pantoprazole may make these and other medications less effective

• Warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring

• Atazanavir (used to treat HIV infection)

Pregnancy and lactation

No sufficient data is available on the use of pantoprazole in pregnant women. Pantoprazole has been excreted in human 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 benefits 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

You should not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision

Pantoprazol MABO contains soy lecithin

This medication contains soy lecithin. Do not use it if you are allergic to peanuts or soy

Pantoprazol MABO contains maltitol (E-965)

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

Pantoprazol MABO 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 as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

When and how should you take Pantoprazol?

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

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

Adults and adolescents 12 years and older:

For treating symptoms associated with gastroesophageal reflux disease (stomach burning, acid regurgitation, difficulty swallowing)

The usual dose is 1 tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within a maximum of 4 weeks. Your doctor will tell you how long you should continue taking the medication. Subsequently, any recurring symptoms can be controlled as needed, by taking 1 tablet per day.1 tablet per day.

For long-term treatment and prevention of esophagitis relapses

The usual dose is 1 tablet per day. If the disease recurs, your doctor may double the dose, in which case you can take Pantoprazol 40 mg, once a day. After recovery, you can reduce the dose again to 1 tablet of 20 mg per day.

Adults:

For preventing duodenal and stomach ulcers in patients requiring long-term treatment with NSAIDs

The usual dose is 1 tablet per day.

Special patient groups:

- If you have severe liver problems, do not take more than 1 tablet of 20 mg per day.

Use in children and adolescents:

This medication is not recommended for use in children under 12 years.

If you take more Pantoprazol than you should

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

If you forget to take Pantoprazol

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

If you interrupt treatment with Pantoprazol

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

Likewise, all medications, pantoprazol may produce adverse effects, although not all people suffer from them.

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

Very frequent (affects more than one patient in every 10)

Frequent (affects between 1 and 10 patients in every 100)

Uncommon (affects between 1 and 10 patients in every 1,000)

Rare (affects between 1 and 10 patients in every 10,000)

Very rare (affects fewer than 1 patient in every 10,000)

Unknown frequency (cannot be estimated from available data).

If you experience any of the following adverse effects, stop taking these tablets and inform your doctor immediately, or contact the emergency service at 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):blistering of the skin and rapid deterioration of general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and sensitivity to light.

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

Other adverse effects are:

• Frequent(affects between 1 and 10 patients in every 100: benign polyps in the stomach.
• Uncommon(affects between 1 and 10 patients in every 1,000)

headache, dizziness, diarrhea, sensation of dizziness, vomiting, swelling and flatulence (gas), constipation, dry mouth, abdominal pain and discomfort, hives on the skin, exanthema, rash, itching, sensation of weakness, fatigue or general malaise, sleep disturbances.

• Rare(affects between 1 and 10 patients in every 10,000)

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

• Very rare(affects fewer than 1 patient in every 10,000)

disorientation

• Unknown frequency(cannot be estimated from available data)

hallucination, confusion (especially in patients with a history of these symptoms), decrease in sodium levels in the blood,sensation of tingling, prickling, paresthesia (tingling), burning or numbness, skin rash, possibly with joint pain, severe inflammation of the large intestine causing persistent watery diarrhea.

If you are taking pantoprazol for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also produce a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors such as pantoprazol, especially for a period of more than one year, you may slightly increase the risk of hip, wrist, and spinal column fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may increase the risk of osteoporosis).

Adverse effects identified through blood tests:

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

increase in liver enzymes

• Rare(affects between 1 and 10 patients in every 10,000)

increase in bilirubin, increase in fat levels in the blood

• Very rare(affects fewer than 1 patient in every 10,000)

reduction in platelet count that could cause bleeding or more frequent bruising, reduction in white blood cell count that could lead to more frequent infections.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment

Composition of Pantoprazol MABO

The active ingredient is pantoprazol. Each gastro-resistant tablet contains 20 mg of pantoprazol (in the form of sodium sesquihydrate

The other components are: Core: maltitol, crospovidone, sodium carmelose, anhydrous sodium carbonate, calcium stearate.

Coating: polyvinyl alcohol, talc, titanium dioxide, macrogol 4000, soy lecithin, yellow iron oxide, anhydrous sodium carbonate, copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion at 30% and triethyl citrate.

Appearance of the product and content of the packaging

Gastro-resistant tabletof yellow-yellow brown color and oval shape.

Packaging: blister (Al/Al)

Packaging with 28, 56, and 500 tablets

Holder of the marketing authorization

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Responsible for manufacturing

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, Alcala de Henares, Madrid

Spain

Last review date of this leaflet:July 2022

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