Leaflet: information for the user

Pantoprazol Recordati 40 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, consult 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 starting to take 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 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.

Pantoprazol Recordati is used for:

Adults and adolescents 12 years and older:

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

Adults:

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

- Stomach and duodenal ulcers

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

Do not takePantoprazol Recordati:

• If you are allergic to pantoprazole or any of the other ingredients in 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 taking Pantoprazol Recordati for a long time. If liver enzyme levels increase, treatment should be discontinued.
• 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 levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Consult your doctor before starting 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.
• A specific blood test (Cromogranina A) is planned.

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

-unintentional weight loss

-vomiting, particularly if repeated

-difficulty swallowing, or pain when swallowing

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

-pale appearance and feeling of weakness (anemia)

• if you notice blood in your stool, 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 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 takePantoprazol Recordatifor a prolonged period (more than a year), your doctor may regularly monitor you. You should inform your doctor of any new or unexpected symptoms and/or events each time you attend your consultation.

Children and adolescents

The use of Pantoprazol Recordati 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), asPantoprazol Recordatimay 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 Recordati, 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 is excreted in human breast milkIf you are pregnant, breastfeeding, or suspect you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Pantoprazol Recordati has no influence or insignificant influence on the ability to drive or operate machinery. Do not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Pantoprazol Recordati contains lactose, tartrazine, 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 may cause allergic reactions due to the presence of tartrazine. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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 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 otherwise, the normal dose is:

Adults and adolescents 12 years and older:

Treatment of esophagitis by reflux:

The usual dose is 1 tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for esophagitis by reflux usually lasts between 4 and 8 weeks. Your doctor will tell you for how long to take this medication.

Adults:

Treatment of an infection with a bacteria called Helicobacter pylori in patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication treatment).

1 tablet twice a day, plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each 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 antibiotic leaflets.

The treatment duration is usually 1 to 2 weeks.

Treatment of stomach and duodenal ulcers:

The usual dose is 1 tablet per day. The dose may be doubled by your doctor.

Your doctor will tell you for how long to take this medication. The treatment duration for stomach ulcers is usually between 4 and 8 weeks, and for duodenal ulcers, it is usually between 2 and 4 weeks.

Long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in stomach acid production:

The initial recommended dose is 2 tablets per day. Take the two tablets 1 hour before a meal. Your doctor may then adjust your dose, depending on the amount of stomach acid you produce. If you are prescribed more than 2 tablets per day, you should take the tablets twice a day. If you are prescribed more than 4 tablets per day, you will be told exactly when to stop treatment.

Special patient groups:

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

• If you have severe liver problems, you should not take more than 1 tablet of 20 mg of pantoprazole per day (for this case, tablets of 20 mg of pantoprazole are available).

• Children (under 12 years):do not recommend the use of these tablets in children under 12 years.

If you take more Pantoprazol Recordati 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 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 Recordati:

Do not stop taking these tablets without first consulting your doctor or pharmacist.

If you have any other doubts about the use of this medication, ask your doctor or 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 in 100 and 1 in 10 patients)

Uncommon (affects between 1 in 1,000 and 1 in 100 patients)

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

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

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

• 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, allergic swelling of the face (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and excessive sweating.

• Severe skin disorders (frequency cannot be estimated; its frequency cannot be estimated with available data):blisters on the skin and a rapid deterioration of general conditions, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), light sensitivity.

• Other severe conditions (frequency cannot be estimated; its frequency cannot be estimated with available data):yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased size of the kidneys sometimes with painful urination and lower back pain (severe kidney inflammation), possibly leading to renal failure.

Other side effects are:

• Common (may affect up to 1 in 10 patients):benign polyps in the stomach.
• Uncommon (may affect up to 1 in 100 patients):headache; dizziness; diarrhea; sensation of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; hives on the skin, exanthema, rash; tingling; feeling of weakness, fatigue, or general malaise; sleep disturbances.
• If you are taking proton pump inhibitors such as Pantoprazol Recordati 40 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 (may affect up to 1 in 1,000 patients):alteration or complete absence of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the extremities (peripheral edema); allergic reactions; depression; breast enlargement in men.
• Very rare (affects fewer than 1 in 10,000 patients):disorientation.

• Frequency cannot be estimated (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, persistent watery diarrhea due to inflammation of the large intestine.

If you are taking Pantoprazol Recordati 40 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, seek medical attention 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.

Side effects identified through blood tests:

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

increase in liver enzymes

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

increase in bilirubin; increase in blood fat levels; sudden drop in granular white blood cells in circulation, associated with high fever.

• Very rare (may affect up to 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 reduction in the balance between red and white blood cells, as well as platelets.

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 a bottle: does not require special storage conditions. Keep the bottle perfectly closed.

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

Store in the original packaging.

Do not usethis medicationafter 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 through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. Please ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Pantoprazol Recordati 40 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, magnesium stearate (vegetal), color mixture (opadry II 85F32097 yellow), acid methacrylic copolymer (1:1) dispersion 30%, triethyl citrate (E1505), talc (E553b).

Appearance of the product and content of the packaging

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

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Casen Recordati, S.L.

Autovía de Logroño, km. 13,300

50180 Utebo (Zaragoza)

Spain

Responsible for manufacturing:

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