PANTOPRAZOL RECORDATI 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Pantoprazol Recordati 20 mg Gastro-Resistant Tablets EFG

Pantoprazol

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Pantoprazol Recordati and what is it used for
2. What you need to know before you take Pantoprazol Recordati
3. How to take Pantoprazol Recordati
4. Possible side effects
5. Storing Pantoprazol Recordati
6. Contents of the pack and other information

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

Pantoprazol Recordati 20 mg is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestine acid.

Pantoprazol Recordati is used for:

Adults and adolescents from 12 years:

• 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 patients at risk who require continued treatment with these types of drugs.

2. What you need to know before you take Pantoprazol Recordati

Do not take Pantoprazol Recordati

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

Warnings and precautions

• If you have severe liver problems. Tell 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 your liver enzymes increase, treatment should be discontinued.
• If you need to take non-steroidal 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 assessed according to your personal risk factors such as age (65 years or older), history of stomach or duodenal ulcers or bleeding from the stomach or intestine.
• If you have low body stores of vitamin B12 or risk factors for this and receive long-term treatment with pantoprazole. Like all medicines that reduce acid, pantoprazole may reduce the absorption of vitamin B12.

• Tell your doctor if you are taking any medicine that contains atazanavir (for the treatment of HIV infection) 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. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• If you are taking pantoprazole for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels can also produce a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Tell your doctor before starting to take Pantoprazol Recordati: if you have ever had a skin reaction after treatment with a medicine similar to Pantoprazol to reduce stomach acid.
• If you get a skin rash, especially in areas of the skin exposed to the sun, tell your doctor as soon as possible, as it may be necessary to stop treatment with Pantoprazol Recordati. Remember to mention any other symptoms you may notice, such as joint pain.
• it is planned that you will undergo a specific blood test (Chromogranin A)

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

• unintentional weight loss
• repeated vomiting, especially if it is repeated
• difficulty swallowing, or pain when swallowing
• blood in the vomit: it may appear as a dark coffee grounds-like substance in your vomit
• pale appearance and feeling of weakness (anemia)
  • blood in your stools, which may appear black or tarry
  • 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 any additional tests to rule out a malignant disease because pantoprazole may alleviate the symptoms of cancer and could delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you are taking pantoprazole for a prolonged period (more than a year), your doctor may monitor you regularly. You should tell your doctor about any symptoms and/or new or unexpected events 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 of age.

Taking Pantoprazol Recordati with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pantoprazol Recordati may affect the efficacy of other medicines, so tell your doctor if you are taking:

• Medicines 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 medicines not work properly.

• Warfarin and phenprocoumon, which affect blood coagulation. 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 stop 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 the dose.

• Rifampicin (used to treat infections)

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

Pregnancy, breastfeeding, and fertility

Ask your doctor or pharmacist for advice before taking any medicine.

There is not enough data on the use of pantoprazole in pregnant women. It has been reported that in humans, pantoprazole is excreted in breast milk. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Pantoprazol has no or negligible influence on the ability to drive or use machines. Do not drive or use machines if you experience side effects such as dizziness or blurred vision.

Pantoprazol Recordati contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Pantoprazol Recordati

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist again.

When and how should you take Pantoprazol Recordati?

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

Unless your doctor has told you otherwise, the usual dose is:

Adults and adolescents from 12 years:

To treat symptoms associated with gastroesophageal reflux disease(heartburn, acid regurgitation, pain when swallowing)

The usual dose is one 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 to take the medicine. If symptoms recur, you can control them by taking one tablet per day as needed.

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 the dose, in which case you can take Pantoprazol 40 mg once a day. After healing, you can reduce the dose back to one 20 mg tablet per day.

Adults:

For the prevention of duodenal and stomach ulcers in patients who require continued treatment with NSAIDs

The usual dose is one tablet per day.

Special patient groups:

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

If you take more Pantoprazol Recordati than you should

Tell your doctor or pharmacist or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. No symptoms of overdose are known.

If you forget to take Pantoprazol Recordati

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

If you stop taking Pantoprazol Recordati

Do not stop taking these tablets without consulting your doctor or pharmacist first. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The frequency of the possible side effects listed below is defined as:

very common (affects more than 1 in 10 people)

common (affects between 1 and 10 people in 100)

uncommon (affects between 1 and 10 people in 1,000)

rare (affects between 1 and 10 people in 10,000)

very rare (affects less than 1 in 10,000 people)

frequency not known (cannot be estimated from the available data)

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

• Severe allergic reactions (rare): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating.

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

• Other serious conditions (frequency not known): yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size with occasional pain when urinating, and lower back pain (severe kidney inflammation), which may cause kidney failure.

Other side effects are:

• Common: benign polyps in the stomach.

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

headache; dizziness; diarrhea; 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.

If you are taking proton pump inhibitors like Pantoprazol Recordati 20 mg, especially for more than a year, you may have a slightly increased risk of fractures of the hip, wrist, or spine. Tell 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 people in 10,000)

alteration or complete loss of taste; visual disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; high fever; increased body temperature; swelling in the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.

• Very rare (affects less than 1 in 10,000 people)

disorientation

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

hallucinations, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, tingling, pinching, numbness, burning sensation, or tingling, skin rash, possibly with joint pain, inflammation of the large intestine that causes persistent watery diarrhea.

If you are taking Pantoprazol Recordati 20 mg for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels can also produce a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

Side effects identified through blood tests:

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

increase in liver enzymes

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

increase in bilirubin; increase in blood fat levels; sharp drop in white blood cell count, associated with high fever.

• Very rare (affects less than 1 in 10,000 people)

reduction in the number of platelets that could cause bleeding or more bruising than usual; reduction in the number of white blood cells that could lead to more frequent infections; abnormal reduction in the balance between the number of red and white blood cells, as well as platelets.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Pantoprazol Recordati

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

This medicine in a bottle does not require special storage conditions. Keep the bottle tightly closed.

This medicine in blisters should be stored at a temperature below 30°C. Store in the original package.

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Pantoprazol Recordati 20 mg

• 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, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate (vegetal).

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

Product Appearance and Container Content

Yellow-ochre colored, elongated, gastro-resistant tablet.

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

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

Casen Recordati, S.L.

Autovía de Logroño, km. 13,300

50180 Utebo (Zaragoza)

Spain

Manufacturer:

Towa Pharmaceutical Europe, S.L.

c/ Sant Martí 75-97

08107 – Martorelles – Barcelona

Spain

Date of the Last Revision of this Prospectus: July 2019

Detailed and updated 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/