PANTOPRAZOL RECORDATI 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Pantoprazol Recordati 40 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 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:

• Reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by acid regurgitation from the stomach.

Adults:

• Infection of a bacterium called Helicobacter pylori in patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacterium and thus reduce the likelihood of ulcer recurrence

• Stomach and duodenal ulcers

• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

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

Do not takePantoprazol 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 you more frequently for liver enzymes, especially when you are on long-term treatment with Pantoprazol Recordati. In case of an increase in liver enzymes, treatment should be discontinued.
• If you have decreased body reserves of vitamin B12 or risk factors for it 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 HIV infection 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 hip, wrist, or vertebral fractures. 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, increased heart rate. If you have any of these symptoms, go to the 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 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 discontinue treatment with Pantoprazol Recordati. Remember to mention any other symptoms you may notice, such as joint pain.
• A specific blood test (Chromogranin A) is planned

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

• unintentional weight loss
• 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)
  • if you notice 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 can alleviate the symptoms of cancer and may delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take Pantoprazol Recordati for a prolonged period (more than a year), your doctor may perform regular follow-up. You should tell your doctor about any new symptoms and/or events each time you visit your doctor.

Children and adolescents

The use of Pantoprazol Recordati 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 checks.

• 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 Recordati because 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Pantoprazol Recordati contains lactose, tartrazine, and sodium

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

This medicine may cause allergic reactions because it contains tartrazine. It can cause asthma, especially in patients allergic to acetylsalicylic acid.

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 indicated by your doctor. In case of doubt, 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 indicated otherwise, the normal dose is:

Adults and adolescents from 12 years:

For the treatment of reflux esophagitis:

The usual dose is one tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will indicate how long you should take this medicine.

Adults:

For the treatment of an infection with a bacterium calledHelicobacter pyloriin patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment).

One tablet twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each to be taken twice a day with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second 1 hour before dinner. Follow your doctor's instructions and make sure to read the leaflets of the antibiotics.

The duration of treatment is usually one to two weeks.

For the treatment of stomach and duodenal ulcers:

The usual dose is one tablet per day. The dose may be doubled by your doctor.

Your doctor will indicate how long you should take this medicine. The duration of treatment for stomach ulcers is usually between 4 and 8 weeks. The duration of treatment for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in stomach acid secretion

The recommended initial dose is two tablets per day. Take the two tablets 1 hour before a meal. Later, your doctor may adjust the dose, depending on the amount of acid secretion you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two doses per day. If you are prescribed more than four tablets per day, you will be told exactly when to finish the treatment.

Special patient groups:

• If you have kidney problems or moderate to severe liver problems, you should not take Pantoprazol Recordati for the eradication of Helicobacter pylori.

• If you have severe liver problems, you should not take more than one 20 mg pantoprazole tablet per day (for this case, 20 mg pantoprazole tablets are available).

• 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, phone 91 562 04 20, indicating the medicine and the amount ingested. 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 first talking to your doctor or pharmacist.

If you have any further questions on the use of this product, ask your doctor or 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, tell your doctor:

• Severe allergic reactions (rare; may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), intense dizziness with very rapid heartbeat and profuse sweating.

• Severe skin disorders (frequency not known; frequency cannot be estimated from the available data): 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 severe conditions (frequency not known; frequency cannot be estimated from the available data): yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increase in kidney size sometimes with pain when urinating and pain in the lower back (severe kidney inflammation), possibly leading to kidney failure.

Other side effects are:

• Common (may affect up to 1 in 10 people): benign polyps in the stomach.
• Uncommon (may affect up to 1 in 100 people): headache; dizziness; diarrhea; feeling of dizziness, vomiting; bloating and 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 40 mg, especially for more than a year, you may have a slightly increased risk of hip, wrist, or vertebral fractures. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• Rare (may affect up to 1 in 1,000 people): alteration or complete loss of taste, vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; 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): hallucination, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, tingling, pinching, numbness, burning sensation, skin rash, possibly with joint pain, inflammation of the large intestine that causes persistent watery diarrhea.

If you are taking Pantoprazol Recordati 40 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, increased heart rate. If you have any of these symptoms, go to the 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 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; sudden drop in white blood cells, associated with high fever.

• Very rare (may affect up to 1 in 10,000 people):

reduction in platelet count, which could cause bleeding or more bruising than usual; reduction in white blood cell count, which could lead to more frequent infections; abnormal reduction in the balance between red and white blood cell count, as well as platelets.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects 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. Storage of 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 perfectly closed.

This medicine in a blister pack: Do not store above 30°C.

Store in the original package.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition ofPantoprazol Recordati40 mg

• The active ingredient is Pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol (in the form of sodium sesquihydrate).

• The other components (excipients) are: microcrystalline cellulose (E460i), lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, vegetable magnesium stearate, color mixture (opadry II 85F32097 yellow), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate (E1505), talc (E553b).

Appearance of the product and package contents

Oval-shaped gastro-resistant tablet of yellow color. It is available in packages of 14 and 28 tablets in blister packs or bottles and 504 tablets (clinical package in blister packs) and 500 tablets (50 x 10) in bottles.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Casen Recordati, S.L.

Logroño Highway, 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.