Pantoprazole Aurovitas 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Pantoprazole Aurovitas 40 mg gastro-resistant tablets EFG

Read all of this 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 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

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 for the treatment of acid-related diseases of the stomach and intestine.

Pantoprazol is used in adults and adolescents from 12 years of age to treat:

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

Pantoprazol is used in adults to treat:

• Infection with a bacterium called Helicobacter pylori in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacterium and thereby reduce the likelihood of ulcer recurrence.
• Gastric and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which excessive stomach acid is produced.

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 starting to take 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 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 experience 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, disorientation, 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 your magnesium levels.

• If you have ever had a skin reaction after treatment with a medicine similar to pantoprazole 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 stop treatment with pantoprazole. Remember to mention any other symptoms you may notice, such as joint pain.

  • Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, have been reported in association 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, especially if recurrent
• Difficulty swallowing or pain when swallowing
• Blood in vomit: this may appear as dark coffee-ground-like material
• Pale appearance and feeling weak (anaemia)
• 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 every 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

Inform 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 cause these and other medicines to be less effective.
• 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 pantoprazole treatment, as pantoprazole 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).

Talk to your doctor before taking pantoprazole if you are due 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 may 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 infant.

Driving and using machines

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

Do 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; therefore, it is essentially “sodium-free”.

3. How to take Pantoprazole Aurovitas

Follow exactly the instructions for use of 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

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 an infection with a bacterium called Helicobacter pylori in patients with gastric 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 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 these antibiotics. The treatment duration is normally one to two weeks.

For the treatment of gastric and duodenal ulcers

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

Your doctor will advise you on how long to 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 in which there is an 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 you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two daily doses.

If your doctor prescribes more than four tablets per day, he or she will tell you exactly when to stop treatment.

Patients with kidney problems

If you have kidney problems, you should not take pantoprazole for the eradication of Helicobacter pylori.

Patients with liver problems

• 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).
• If you have moderate or severe liver problems, you should not take pantoprazole for the eradication of Helicobacter pylori.

Use in children and adolescents

The 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, 1 hour before a meal.

If you take more Pantoprazole 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 telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pantoprazole Aurovitas

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

If you stop taking Pantoprazole 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 will experience them.

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

• Red, non-elevated, target-shaped or circular skin rashes on the trunk, often with central blisters, skin peeling, 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). - Generalized 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 emergency department of the nearest hospital:

• 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), 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: cannot be estimated from available data): you may notice one or more of the following – skin blisters 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: cannot be estimated from available data): 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 include:

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

benign stomach polyps.

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

headache; dizziness; diarrhoea; feeling of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; 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)

taste disturbance or complete loss of taste; vision disorders such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of 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), tingling sensation, pricking, numbness, burning or tingling sensation, 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)

increased liver enzymes.

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

increased bilirubin; increased 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 platelet count which could lead to bleeding or unusual bruising; reduction in white blood cell count 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)

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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 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. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines 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 40 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 container

Gastro-resistant tablet.

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

Blister pack: 14, 28, 56, 98 and 100 gastro-resistant tablets, and a perforated unit-dose blister containing 56 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 about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).