Pantoprazole Recordati 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazole Recordati 20 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, 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 other people, even if they have the same symptoms as you, because it may 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 adverse 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 20 mg is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of conditions related to stomach and intestinal acid.

Pantoprazol Recordati is used for:

Adults and adolescents aged 12 years and older:

• Treatment of symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, painful 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 at-risk patients who require ongoing treatment with these types of medicines.

2. What you need to know before starting to take 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, rabeprazol, esomeprazol).

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 pantoprazol treatment. If liver enzymes increase, treatment should be discontinued.

• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while taking pantoprazol, as there is an increased risk of developing stomach and intestinal complications. Any increase in risk will be assessed according to personal risk factors such as age (65 years or older), history of stomach or duodenal ulcer, or gastrointestinal bleeding.

• If you have low body stores of vitamin B12 or risk factors for this and are receiving pantoprazol treatment for a long period. Like all medicines that reduce acid levels, pantoprazol may reduce the absorption of vitamin B12.

• Consult your doctor if you are taking a medicine containing atazanavir (for treatment of HIV infection) at the same time as pantoprazol.

• Taking a proton pump inhibitor such as pantoprazol, especially 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 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.

• if you are scheduled to have a specific blood test (Chromogranin A)

Immediately inform your doctor before or after taking this medicine, if you notice any of the following symptoms, which may be signs of more serious conditions:

• unintentional weight loss
• repeated vomiting, particularly if persistent
• difficulty swallowing, or pain when swallowing
• blood in vomit: may appear as dark coffee-ground-like material in your vomit
• pale appearance and feeling weak (anemia)
  • blood in your stools, which may appear black or tarry (melena)
  • severe or persistent diarrhea, as pantoprazol has been associated with a slight increase in infectious diarrhea
  • chest pain
  • stomach pain

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

If you take pantoprazol for a prolonged period (more than one year), your doctor may 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 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 be less effective.

• Warfarin and fenprocoumon, which affect blood clotting. You may require additional monitoring.

• Atazanavir (used for the treatment of 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 pantoprazol may increase methotrexate levels in the blood.

• 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 may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Pantoprazol has no effect or an insignificant effect on the ability to drive or operate machinery. However, you should not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Pantoprazol Recordati contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; thus, it is essentially “sodium-free”.

3. How to take Pantoprazol Recordati

Follow exactly the instructions for use of this medicine as given by your doctor. 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 instructed you otherwise, the usual dose is:

Adults and adolescents aged 12 years and older:

To treat symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, painful swallowing):

The usual dose is one tablet per day.

This dose generally provides relief within 2–4 weeks, and if not, at most within the following 4 weeks. Your doctor will advise you on how long you should continue taking the medicine. Afterwards, any recurring symptoms can be managed as needed by taking one tablet per day.

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 your dose, in which case you may take Pantoprazole 40 mg once daily. After healing, the dose may be reduced again to one 20 mg tablet per day.

Adults:

For prevention of duodenal and gastric ulcers in patients requiring ongoing treatment with NSAIDs:

The usual dose is one tablet per day.

Special patient groups:

• If you have severe liver problems, you must 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

Inform your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine 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 missed doses. Take your next dose as usual.

If you stop taking Pantoprazol Recordati

Do not stop taking these tablets without first consulting your doctor or pharmacist. 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 everybody gets 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 available data)

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

• Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), breathing difficulties, allergic swelling of the face (Quincke's oedema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.

• Severe skin disorders (frequency not known): blisters on the skin 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): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, kidney enlargement with occasional pain when urinating and lower back pain (severe kidney inflammation), which may possibly lead to kidney failure.

Other adverse effects are:

• Common: benign gastric polyps.

• Uncommon (affects between 1 and 10 in 1,000 people):
  headache; dizziness; diarrhoea; nausea, vomiting; bloating and flatulence; constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; feeling of weakness, tiredness or general malaise; sleep disturbances.

If you are taking proton pump inhibitors such as Pantoprazol Recordati 20 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 if you are taking corticosteroids (which may increase the risk of osteoporosis).

• Rare (affects between 1 and 10 in 10,000 people):
  disturbance or complete loss of taste sensation; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; high fever; increased body temperature; swelling of the extremities (peripheral oedema); 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 available data):
  hallucinations, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, sensations of tingling, pricking, numbness, burning or numbness, skin eruption, possibly with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

If you have been taking Pantoprazol Recordati 20 mg for more than three months, 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, see 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 your magnesium levels.

Adverse 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 blood lipid levels; sudden drop in granular white blood cells, associated with high fever.

• Very rare (affects less than 1 in 10,000 patients):
  reduction in the number of platelets, which could lead to bleeding or unusual bruising; reduction in the number of white blood cells, which could lead to more frequent infections; abnormal imbalance in the levels of red blood cells, white blood cells, and platelets.

Reporting of adverse effects

If you experience any 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 a bottle does not require special storage conditions. Keep the bottle tightly closed.

This medicine in blister packs must be stored at a temperature below 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 containers at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Pantoprazole Recordati 20 mg

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).

• The other components (excipients) are:

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

Coating: Colouring 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 quinoline yellow aluminium lake (E-104)), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate (E1505), talc (E553b).

Appearance of the product and contents of the container

Yellowish gastro-resistant elongated tablet.

Packaged in blister packs or bottles containing 14 and 28 tablets; 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.

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 medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/