Pantoprazole Aurovitas 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Pantoprazole Aurovitas 20 mg gastro-resistant tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 Aurovitas is and what it is used for
2. What you need to know before taking Pantoprazole Aurovitas
3. How to take Pantoprazole Aurovitas
4. Possible side effects
5. How to store Pantoprazole Aurovitas
6. Contents of the pack and other information

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

Pantoprazol Aurovitas contains the active substance pantoprazol. Pantoprazol 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 disorders of the stomach and intestine.

Pantoprazol is used in adults and adolescents aged 12 years and older to treat:

• Symptoms (e.g., heartburn, acid regurgitation, pain when swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.
• Long-term treatment of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach) and prevention of relapses.

Pantoprazol is used in adults to treat:

• 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 medicines.

2. What you need to know before taking Pantoprazole Aurovitas

Do not take Pantoprazole Aurovitas

• If you are allergic to pantoprazole 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.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Pantoprazole Aurovitas.

• If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor will monitor your liver enzymes more frequently, especially if you are on long-term treatment with pantoprazole. If liver enzymes increase, treatment should be discontinued.

• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while taking pantoprazole, as there is an increased risk of developing stomach and intestinal complications. Any increased 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 reduced body stores of vitamin B12 or risk factors for this, and are receiving long-term treatment with pantoprazole. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12. Contact your doctor if you notice any of the following symptoms, which could indicate low vitamin B12 levels:

• Extreme tiredness or lack of energy

• Tingling sensation

• Sore or red tongue, mouth ulcers

• Muscle weakness

• Blurred vision

• Memory problems, confusion, depression

• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for treatment of HIV infection) at the same time as pantoprazole.

• Taking a proton pump inhibitor such as pantoprazole, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or have been told you are at risk of osteoporosis (for example, if you are taking steroids).

• If you are taking pantoprazole 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, 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 magnesium levels.

• If you have ever had a skin reaction after treatment with a medicine similar to pantoprazole used to reduce stomach acid.

• 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 pantoprazole. Remember to mention any other symptoms you may notice, such as joint pain.

  • Serious skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, associated with pantoprazole treatment. Stop using pantoprazole and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

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

Contact your doctor immediately, 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
• 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 (anaemia)
• If you notice blood in your stools, which may be black or tar-like
• Chest pain
• Stomach pain
• Severe or persistent diarrhoea, as this medicine has been associated with a small increased risk of infectious diarrhoea

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

If you take pantoprazole 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 pantoprazole is not recommended in children, as it has not been studied in children under 12 years of age.

Other medicines and Pantoprazole Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Pantoprazole may affect the effectiveness of other medicines. 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 pantoprazole may reduce the effectiveness of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting. You may require additional monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily discontinue your pantoprazole treatment, 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).

Talk to your doctor before taking pantoprazole if you need to undergo a specific urine test (for THC: tetrahydrocannabinol).

Pregnancy and breastfeeding

There are insufficient data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole 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.

This medicine should only be used if your doctor considers that the benefit to you outweighs the potential risk to the fetus or baby.

Driving and using machines

The effect of pantoprazole on the ability to drive and use machines is negligible or none.

You should not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Pantoprazole Aurovitas contains sodium

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

3. How to take Pantoprazol Aurovitas

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents aged 12 years and older

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

The usual dose is one tablet daily. This dose generally provides relief within 2–4 weeks, and if not, within a maximum of 4 additional weeks. Your doctor will tell you how long you should continue taking the medicine. Thereafter, any recurring symptoms can be managed by taking one tablet daily, as needed.

For long-term treatment and prevention of relapses of reflux esophagitis

The usual dose is one tablet daily. If the disease recurs, your doctor may double your dose, in which case you can take Pantoprazol Aurovitas 40 mg once daily. After healing, the dose can be reduced again to one 20 mg tablet daily.

Adults

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

The usual dose is one tablet daily.

Patients with liver problems

If you have severe liver problems, you must not take more than one 20 mg tablet daily.

Use in children and adolescents

Use of these tablets is not recommended in children under 12 years of age.

Method of administration

Take the tablets whole, without chewing or breaking them, with a little water, one hour before a meal.

If you take more Pantoprazol Aurovitas than you should

Inform your doctor or pharmacist. Symptoms of overdose are not known.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pantoprazol Aurovitas

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

If you stop taking Pantoprazol Aurovitas

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 everyone experiences them.

Stop using pantoprazole and seek immediate medical attention if you notice any of the following symptoms:

• Red, flat, non-elevated spots, target-shaped or circular rashes on the trunk, often with central blisters, peeling of the skin, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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

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

• Severe skin disorders (frequency not known: their frequency cannot be estimated from available data): you may notice one or more of the following – blisters on the skin and rapid deterioration in your general condition, erosion (including slight bleeding) of the eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g., in the armpit), and blood tests may show changes in certain white blood cells or liver enzymes.

• Other serious conditions (frequency not known): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice) or fever, rash, enlarged kidneys with occasional pain when urinating and lower back pain (severe kidney inflammation), which could possibly lead to kidney failure.

Other adverse effects are:

• Frequent (may affect up to 1 in 10 people)

benign gastric polyps.

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

headache; dizziness; diarrhoea; feeling of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; pain and discomfort in the abdomen; skin rash, exanthema, eruption; tingling; feeling of weakness, tiredness or general malaise; sleep disturbances; fracture of hip, wrist and spine.

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

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

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

disorientation.

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

hallucination, confusion (especially in patients with a history of these symptoms), sensation of tingling, pricking, numbness, burning or stiffness, skin rash, possibly with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse 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 circulating granular white blood cells associated with high fever.

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

reduction in the number of platelets which could lead to bleeding or more bruising than usual; reduction in the number of white blood cells which could lead to more frequent infections; coexistence of an abnormal decrease in red blood cells, white blood cells and platelets.

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

decrease in blood levels of sodium, magnesium, calcium or potassium (see section 2).

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 Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Aurovitas

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

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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be handed over to the SIGRE point at your pharmacy. If you are unsure, 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 Pantoprazole Aurovitas

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

Tablet core: sodium carbonate, mannitol (E421), crospovidone (type B), hydroxypropylcellulose, calcium stearate.

Coating: hypromellose, yellow iron oxide (E172), 30% dispersion of methacrylic acid-ethyl acrylate copolymer (1:1), sodium lauryl sulfate, polysorbate 80, triethyl citrate.

Appearance of the product and contents of the pack

Gastro-resistant tablet.

Enteric-coated, light yellow colored tablets, biconvex, oval and smooth on both sides of the tablet.

Blister pack: 14, 28, 56, 98 and 100 gastro-resistant tablets, and perforated unit-dose blister containing 100 x 1 gastro-resistant tablet.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: January 2024

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