Pantoprazole Aristo 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazole Aristo 20 mg gastro-resistant tablets EFG

Pantoprazole

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 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 you take Pantoprazole Aristo
3. How to take Pantoprazole Aristo
4. Possible side 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 stomach and intestinal disorders related to acid.

Pantoprazol Aristo 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 medicines.

2. What you need to know before taking Pantoprazole Aristo

Do not take Pantoprazole 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 taking Pantoprazole 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 Pantoprazole Aristo. If liver enzymes increase, treatment should be discontinued.
• If you need to take NSAIDs (non-steroidal anti-inflammatory drugs) continuously and are also taking Pantoprazole Aristo, 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 reduced body stores of vitamin B12 or risk factors for this condition and are receiving long-term treatment with pantoprazole. 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 blood magnesium levels. 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 Pantoprazole 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 Pantoprazole 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 (anemia)
• Blood in your stools
• Severe or persistent diarrhea, as Pantoprazole Aristo has been associated with a small increased risk of infectious diarrhea.

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

If you take Pantoprazole Aristo 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 and/or events at each visit.

Use of Pantoprazole with other medicines

Pantoprazole 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 Pantoprazole Aristo may reduce the effectiveness of these and other medicines.
• 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 using, have recently used, or might need to use any other medicines.

Pregnancy, breastfeeding, and fertility

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.

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 breastfeeding, 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.

Pantoprazole Aristo contains maltitol.

This medicine contains maltitol. If your doctor has diagnosed you with 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 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, at the latest 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 daily.

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 may take Pantoprazol Aristo 40 mg once daily. After healing, the dose may 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.

Special patient groups:

• If you have severe liver problems, you must not take more than one 20 mg tablet daily.
• 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 your 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 will experience them.

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

• Very common (may affect more than 1 in 10 patients)
• Common (may affect up to 1 in 10 patients)
• Uncommon (may affect up to 1 in 100 patients)
• Rare (may affect up to 1 in 1,000 patients)
• Very rare (may affect up to 1 in 10,000 patients)
• 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 of general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), and sensitivity to light.

Metabolic and nutritional disorders (frequency not known): If you are taking Pantoprazole 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, 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.

Fractures of the hip, wrist, and spine (uncommon): If you are taking proton pump inhibitors such as Pantoprazole Aristo, 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).

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)

Impaired 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 extremities (peripheral oedema); allergic reactions; depression; enlargement of the breasts in men.

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

Disorientation

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

Hallucination, confusion (especially in patients with a history of these symptoms), decreased levels of sodium in the blood. Skin rash, possibly with joint pain, tingling sensation, pins and needles, 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 levels of fat in the blood

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

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

If you experience any type of adverse effect, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through 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 Pantoprazol 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 containers 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 20 mg of pantoprazole.

• The other components are:

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

• Coating: ethylacrylate-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, coated tablet.

Pantoprazol Aristo 20 mg is available in the following pack sizes:

Packs containing 14, 28, 56 gastro-resistant tablets in aluminium/aluminium blisters.

Packs containing 14, 28, 56 gastro-resistant tablets in HDPE bottles with PP screw cap and a white desiccant capsule made of PE containing 2 g of silica gel.

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal: Pantoprazol Aristo 20 mg gastro-resistant tablets

Date of the latest review of this leaflet: September 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/