Leaflet: information for the user

Pantoprazol Recordati 20 mg gastro-resistant tablets EFG

Pantoprazol

Read this 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, and you should not give it 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.

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

2. What you need to know before taking Pantoprazol Recordati

3. How to take Pantoprazol Recordati

4. Possible side effects

5. Storage of Pantoprazol Recordati

6. Contents of the pack and additional information

Pantoprazol Recordati 20 mgis 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 Recordati is used for:

Adults and adolescents 12 years and older:

• Treatment of symptoms associated with gastroesophageal reflux disease (GERD) (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 nonsteroidal anti-inflammatory drug (NSAID)-induced gastric and duodenal ulcers in patients at risk who require continued treatment with this type of medication.

Do not take Pantoprazol Recordati

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

Warnings and Precautions

• 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 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 intestines. Any increased risk will be evaluated based on individual 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 long-term treatment with pantoprazole. Like all medications that reduce acid production, pantoprazole may reduce vitamin B12 absorption.

• Consult your doctor if you are taking any medication containing atazanavir (for HIV treatment) at the same time as pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, especially for more than a year, may increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• If you are taking pantoprazole for more than three months, it is possible that blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause decreased potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Consult your doctor before starting to take Pantoprazol Recordati: if you have ever had a skin reaction after treatment with a similar medication to Pantoprazol 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 treatment with Pantoprazol Recordati. Remember to mention any other symptoms you may notice, such as joint pain.
• You are scheduled to have a specific blood test (Cromogranin A)

Inform your doctor immediatelybefore or after taking this medication, if you notice any of the following symptoms, which may be signs of more serious underlying diseases:

-Unintentional weight loss

-Recurring vomiting, particularly if it is recurring

-Difficulty swallowing, or pain when swallowing

-Blood in the vomit: it may appear as a dark brown powder in your vomit

-Pale appearance and feeling of weakness (anemia)

• Blood in your stools, which may appear black or melena
• Severe or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea
• Chest pain
• Stomach pain

Your doctor will decide if you need additional testing to rule out cancer, 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 each time you visit your doctor.

Children and Adolescents

The use of Pantoprazol is not recommended in children, as it has not been tested in children under 12 years old.

Taking Pantoprazol Recordati with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pantoprazol Recordati 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 to treat certain types of cancer), as Pantoprazol Recordati may make these and other medications less effective.

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

• Atazanavir (used to treat HIV infection).

• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily discontinue treatment with Pantoprazol, as pantoprazole may increase methotrexate levels in the blood.

• Fluvoxamine (used to treat depression and other psychiatric disorders) if you are taking fluvoxamine, your doctor may reduce your dose.

• Rifampicin (used to treat infections)

• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

There is insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been excreted in human milk. If you are pregnant, breastfeeding, or suspect you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Pantoprazole has no influence or has a negligible influence on the ability to drive or operate machinery. Do not drive or operate machinery if you experience side effects such as dizziness or blurred vision.

Pantoprazol Recordati contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

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. In case of doubt, consult your doctor or pharmacist again.

When and how should you take Pantoprazol Recordati?

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

Unless your doctor has indicated another schedule, the usual 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 taking1 tablet per day.

For long-term treatment and prevention of esophagitis relapses due to reflux

The usual dose is 1 tablet per day. If the disease reappears, your doctor may double the dose, in which case you can take Pantoprazol 40 mg,onceper day. After healing, you can reduce the dose again to1 tabletof 20 mg per day.

Adults:

For preventing duodenal and stomach ulcers in patients requiring continued treatment with NSAIDs

The usual dose is 1 tablet per day.

Special patient groups:

- If you have severe liver problems,do not take more than1 tablet of 20 mg per day.

-Children under 12 years:This medication is not recommended for children under 12 years.

If you take more Pantoprazol Recordati than you should

Inform your doctor or pharmacist or call the Toxicological Information Service, phone91 562 04 20, indicating the medication and the amount ingested. No symptoms of overdose are known.

If you forget to take Pantoprazol Recordati

Do not take a double dose to compensate for the missed doses. 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 medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Very common (affects more than 1 in 10 patients)

Common (affects between 1 and 10 patients in 100)

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

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

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

Frequency not known (cannot be estimated from available data).

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

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

• Other severe conditions (frequency not known): yellowing of the skin and 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), possibly leading to renal failure.

Other side effects are:

• Common: benign polyps in the stomach.

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

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

If you are taking proton pump inhibitors such as Pantoprazol Recordati 20 mg, especially for a period of more than one year, you may slightly increase the risk of hip fracture, wrist fracture, and spinal column fracture. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

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

Alteration or complete absence of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; high fever; increased body temperature; swelling in the extremities (peripheral edema); allergic reactions; depression; gynecomastia in men.

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

disorientation

• Frequency not known (cannot be estimated from available data)

hallucination, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, sensation of tingling, pinpricks, numbness, burning, or numbness, skin rash, possibly with joint pain, intestinal inflammation causing persistent watery diarrhea.

If you are taking Pantoprazol Recordati 20 mg 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 cause decreased potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Side effects identified through blood tests:

• Uncommon (may affect up to 1 in 100 patients)

increased liver enzymes

• Rare (may affect up to 1 in 1,000 patients)

Increased bilirubin; increased levels of fats in the blood, sudden drop in granular white blood cells in circulation, associated with high fever.

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

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, abnormal imbalance between red and white blood cell counts, as well as platelet counts.

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear 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.

This medication in the bottle does not require special storage conditions. Keep the bottle perfectly closed.

This medication in blister packaging should be stored at a temperature below30°C. Store in the original packaging.

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.

Medications should not be disposed of through drains or inthe trash. Disposeof the packaging and medications you no longer need at the SIGREdrop-off point at the pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Pantoprazol Recordati 20 mg Composition

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

• The other components (excipients) are:

Core:Microcrystalline cellulose (E-460i), lactose monohydrate, croscarmellose sodium, anhydrous colloidal silica, magnesium stearate (vegetal).

Coating: mixture of color (opadry II 85F32081 yellow containingpartially hydrolyzed polyvinyl alcohol, macrogol/PEG 3350, titanium dioxide (E-171), talc (E-553b), yellow iron oxide (E-172) and quinoline yellow aluminum lake (E-104)), acid methacrylic copolymer (1:1) dispersion 30%, triethyl citrate (E1505), talc (E553b).

Product appearance and packaging contents

Yellow ochre-colored gastro-resistant elongated tablet.

It is presented in blister packs of 14 and 28 tablets, and clinical packaging of 504 tablets (blister) and 500 tablets (bottle).

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Casen Recordati, S.L.

Autovía de Logroño, km. 13,300

50180 Utebo (Zaragoza)

Spain

Responsible manufacturer:

Towa Pharmaceutical Europe, S.L.

c/ Sant Martí 75-97

08107 – Martorelles – Barcelona

Spain

Last review date of this leaflet: July 2019

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