Pantoprazole Aristo 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazole Aristo 40 mg gastro-resistant tablets EFG

Pantoprazole

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, consult 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 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.

Contents of the leaflet

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

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

Pantoprazol Aristo 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 Aristo is used for:

Adults and adolescents aged 12 years and older:

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

Adults:

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

2. What you need to know before taking Pantoprazol Aristo

Do not take Pantoprazol Aristo:

• 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 or pharmacist before starting to take Pantoprazol Aristo.

• 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 Aristo. 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 pantoprazole treatment for a prolonged period. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12.
• Consult your doctor if you are taking a medicine containing atazanavir (for the treatment of HIV infection) at the same time as pantoprazole.
• If you take pantoprazole for more than three months, you may experience a decrease in magnesium levels in the blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, confusion, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. In addition, low magnesium levels may 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 are scheduled to have a specific blood test (Chromogranin A).
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazol Aristo 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 Aristo. Remember to mention any other symptoms you may notice, such as joint pain.

Contact your doctor immediately if you notice any of the following symptoms:

• Unintentional weight loss
• Repeated vomiting
• Difficulty swallowing
• Blood in vomit
• Pale appearance and feeling weak (anaemia)
• Blood in your stools
• Severe or persistent diarrhoea, as Pantoprazol Aristo 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 Pantoprazol Aristo for a prolonged period (more than one year), your doctor will likely monitor you regularly. You must inform your doctor of any new or unexpected symptoms and/or events at each visit.

Use of Pantoprazol with other medicines

Pantoprazol Aristo 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 Aristo may cause these and other medicines to be less effective.
• Warfarin and phenprocoumon, which affect blood clotting. You may require additional monitoring.
• Atazanavir (used for the treatment of HIV infection).

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

Pregnancy, breast-feeding, and fertility

If you are pregnant, breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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, think you might be pregnant, or are breast-feeding, you should only use this medicine if your doctor considers that the benefit to you outweighs the potential risk to the fetus or infant.

Driving and use of machines

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

Pantoprazol Aristo contains maltitol.

This medicine contains maltitol. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Pantoprazol Aristo

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

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

Unless your doctor has instructed you otherwise, the recommended dose is:

Adults and adolescents from 12 years of age:

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 tell you how long to take this medicine.

Adults:

For the treatment of an infection with a bacterium calledHelicobacter pyloriin patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy):

One tablet twice daily, plus 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 one hour before breakfast and the second one 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 tell you 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 one 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 them divided into two doses per day.

If you are prescribed more than four tablets per day, you will be told exactly when to stop treatment.

Special patient groups:

• If you have kidney problems, or moderate to severe liver problems, you should not take Pantoprazol Aristo 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 case).
• Children (under 12 years): the use of these tablets is not recommended in children under 12 years of age.

If you take more Pantoprazol Aristo than you should

If you have taken more tablets than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone: 915 620 420). However, if the amount ingested is significant, go to the doctor or the nearest hospital emergency department without delay and take this leaflet with you.

If you forget to take Pantoprazol Aristo

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

If you stop taking Pantoprazol Aristo

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 or pharmacist.

4. Possible adverse effects

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

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

• Very common (may affect more than 1 in 10 people)
• Common (may affect up to 1 in 10 people)
• Uncommon (may affect up to 1 in 100 people)
• Rare (may affect up to 1 in 1,000 people)
• Very rare (may affect up to 1 in 10,000 people)
• Frequency not known (frequency cannot be estimated from the available data)

Severe allergic reactions (rare frequency): 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): 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), and photosensitivity.

Metabolism and nutrition disorders (frequency not known): If you are taking Pantoprazol Aristo 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, consult 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.

Fractures of the hip, wrist, and spine (uncommon): If you are taking proton pump inhibitors such as Pantoprazol Aristo, especially for a period longer 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).

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).

Other adverse effects are:

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

Benign gastric polyps.

• Uncommon (may affect up to 1 in 100 patients): 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.
• Rare (may affect up to 1 in 1,000 patients): altered or complete loss of taste; vision disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in men.
• Very rare (may affect up to 1 in 10,000 patients): disorientation
• Frequency not known (cannot be estimated from the available data): hallucinations, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood. Skin rash, possibly with joint pain, tingling, prickling, paresthesia (tingling), burning or numbness, inflammation of the large intestine causing persistent watery diarrhoea.

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
• Very rare (may affect up to 1 in 10,000 patients): reduced platelet count, which could lead to bleeding or more bruising than usual; reduced white blood cell count, which could lead to more frequent infections

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the reporting system included in the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Aristo

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 refers to the last day of the month indicated.

Do not store above 25°C.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazol Aristo

• The active substance is pantoprazole sodium sesquihydrate, equivalent to 40 mg of pantoprazole.

• The other components are:

• Core: Maltitol, crospovidone, sodium carmellose, sodium carbonate, calcium stearate

• Coating: ethyl acrylate-methacrylic acid copolymer (1:1), triethyl citrate, sodium carbonate, polyvinyl alcohol, talc, titanium dioxide, macrogol, lecithin, yellow iron oxide.

Appearance of the product and contents of the pack of Pantoprazol Aristo

Yellow, oval, film-coated tablet.

Pantoprazol Aristo 40 mg is available in the following pack sizes:

Blister packs of 14, 28, 56 gastro-resistant tablets in aluminum/aluminum foil.

Bottles of 14, 28, 56 gastro-resistant tablets made of HDPE with a white polypropylene screw cap and a 2 g silica gel desiccant capsule made of PE.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Aristo Pharma Iberia S.L.

C/ Solana, 26

28850, Torrejón de Ardoz (Madrid)

Spain

Manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10, 13435 Berlin, Germany

or

Laboratorios Medicamentos Internacionales S.A. (MEDINSA)

Calle la Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

or

Advance Pharma GmbH

Wallenroder Strade 12-14

13435 Berlin

Germany

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

Portugal: Pantoprazol Aristo 40 mg gastro-resistant tablets

Date of the latest revision of this leaflet: September 2019

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