Pantoprazole Recordati 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazole Recordati 40 mg gastro-resistant tablets EFG

Pantoprazole

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

Pantoprazol Recordati is used for:

Adults and adolescents aged 12 years and older:

• Reflux esophagitis. This is inflammation of your esophagus (the tube connecting your throat to your stomach), accompanied by regurgitation of acid from the stomach.

Adults:

• Infection with a bacterium called Helicobacter pylori in patients with stomach and/or duodenal ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacteria and thereby reduce the likelihood of ulcer recurrence.

• Stomach and duodenal ulcers.

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

2. What you need to know before taking Pantoprazol Recordati

Do not take Pantoprazol Recordati:

• If you are allergic to pantoprazol or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing other proton pump inhibitors (e.g., omeprazole, lansoprazol, 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 if you are on long-term treatment with Pantoprazol Recordati. If liver enzymes increase, treatment should be discontinued.
• If you have low body stores of vitamin B12 or risk factors for this and are receiving pantoprazol treatment for a long period of time. Like all medicines that reduce acid, pantoprazol may reduce the absorption of vitamin B12.
• Consult your doctor if you are taking any medicine containing atazanavir (for treatment of HIV infection) at the same time as pantoprazol.
• Taking a proton pump inhibitor such as pantoprazol, particularly for more than one year, may increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• If you are taking pantoprazol for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to 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 medicine similar to Pantoprazol used to reduce stomach acidity.
• If you develop a skin rash, especially in areas of skin exposed to sunlight, 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 (Chromogranin A).

Immediately inform your doctor if you notice any of the following symptoms:

• unintentional weight loss

• vomiting, particularly if repeated

• difficulty swallowing, or pain when swallowing

• blood in vomit: may appear as dark coffee-ground material in your vomit

• pale appearance and feeling weak (anemia)

  • if you notice blood in your stools, which may appear black or tarry (melena)

• severe or persistent diarrhea, as pantoprazol has been associated with a small increased risk of infectious diarrhea

• chest pain

• stomach pain

Your doctor will decide whether you need further tests to rule out malignancy, as pantoprazol may relieve symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, additional investigations will be carried out.

If you take Pantoprazol Recordati for a prolonged period (more than one year), your doctor will likely monitor you regularly. You should inform your doctor of any new or unexpected symptoms or events at each visit.

Children and adolescents

The use of Pantoprazol Recordati is not recommended in children, as it has not been studied in children under 12 years of age.

Taking Pantoprazol Recordati with other medicines

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

Pantoprazol Recordati may affect the effectiveness of other medicines; therefore, inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazol Recordati may cause these and other medicines to not work properly.

• Warfarin and phenprocoumon, which affect blood clotting. You may require 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 pantoprazol may increase methotrexate blood levels.

• Fluvoxamine (used to treat depression and other psychiatric conditions). 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 medicine.

There are insufficient data on the use of pantoprazol in pregnant women. It has been reported that pantoprazol is excreted in human breast milk. If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Pantoprazol Recordati has no effect or its effect is negligible on the ability to drive or use machines. However, you should not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Pantoprazol Recordati contains lactose, tartrazine, and sodium

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

This medicine may cause allergic reactions because it contains tartrazine. It may provoke 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 exactly the instructions given by your doctor for taking this medicine. If in 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 told you otherwise, the normal dose is:

Adults and adolescents aged 12 years and older:

For the treatment of reflux esophagitis:

The usual dose is one tablet per day. Your doctor may instruct you to increase the dose to two tablets per day. The treatment duration for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will advise you on how long to take this medicine.

Adults:

For the treatment of infection with a bacterium called Helicobacter pylori in patients with stomach and/or duodenal ulcer, in combination with two antibiotics (eradication therapy).

One tablet twice daily, together with two antibiotic tablets—either amoxicillin, clarithromycin, and metronidazole (or tinidazole)—each to be taken twice daily along 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 package leaflets of the antibiotics.

The duration of treatment is normally one to two weeks.

For the treatment of gastric and duodenal ulcers:

The usual dose is one tablet per day. Your doctor may double the dose.

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

For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with increased gastric acid secretion:

The recommended initial dose is two tablets per day. Take both tablets 1 hour before a meal. Afterwards, your doctor may adjust your dose depending on the amount of gastric acid secreted. If more than two tablets per day are prescribed, you should take the tablets divided into two daily doses. If you are prescribed more than four tablets per day, you will be informed exactly when to stop 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 (20 mg pantoprazole tablets are available for this purpose).

• 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

Inform your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested. Symptoms of overdose are not known.

If you forget to take Pantoprazol Recordati

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

If you stop taking Pantoprazol Recordati

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

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

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

very common (affects more than 1 in 10 people)
common (affects between 1 and 10 in 100 people)
uncommon (affects between 1 and 10 in 1,000 people)
rare (affects between 1 and 10 in 10,000 people)
very rare (affects less than 1 in 10,000 people)
frequency not known (cannot be estimated from the available data).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.

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

• Severe skin disorders (frequency not known; frequency cannot be estimated from the available data): skin blisters and rapid deterioration in general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), photosensitivity.

• Other serious conditions (frequency not known; frequency cannot be estimated from the available data): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, kidney enlargement sometimes with pain when urinating and lower back pain (severe kidney inflammation), which may possibly lead to kidney failure.

Other adverse effects include:

• Common (may affect up to 1 in 10 patients): benign stomach polyps.

• Uncommon (may affect up to 1 in 100 patients): headache; dizziness; diarrhoea; feeling of dizziness, vomiting; bloating and flatulence; 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 such as Pantoprazol Recordati 40 mg, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

• Rare (may affect up to 1 in 1,000 patients): disturbance or complete loss of taste sensation, 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 less than 1 in 10,000 patients): disorientation.

• Frequency not known (cannot be estimated from the available data): hallucinations, confusion (particularly in patients with a history of these symptoms), decreased sodium levels in the blood, sensations of tingling, pricking, numbness, burning or stinging, skin rash, possibly with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

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, seizures, dizziness, increased heart rate. If you experience any of these symptoms, seek medical attention immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

Adverse effects identified through blood tests:

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

• Rare (may affect up to 1 in 1,000 patients):
  increased bilirubin; increased blood lipid levels; sudden drop in circulating granular white blood cells, associated with high fever.

• Very rare (may affect up to 1 in 10,000 patients):
  reduction in platelet count, which could lead to bleeding or increased bruising; reduction in white blood cell count, which could lead to more frequent infections; abnormal decrease in the balance between red blood cells, white blood cells, and platelets.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Recordati

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

This medicine in vial: no special storage conditions are required. Keep the vial tightly closed.

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

Store in the original packaging.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazol Recordati 40 mg

• The active substance is Pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).

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

Appearance of the product and contents of the pack

Yellow oval gastro-resistant tablet. It is available in packs of 14 and 28 tablets in blisters or bottles, and 504 tablets (clinical pack in blister) and 500 tablets (50 x 10) in 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.

Carrer Sant Martí 75-97

08107 – Martorelles – Barcelona

Spain

Date of the most recent review of this leaflet: July 2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.