Pantoprazole Aristo Pharma: detailed information

PACKAGE LEAFLET

Pantoprazole Aristo Pharma 20 mg gastro-resistant tablets

Generic medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Pantoprazole Aristo Pharma 20 mg is and what it is used for
What you need to know before taking Pantoprazole Aristo Pharma 20 mg
How to take Pantoprazole Aristo Pharma 20 mg
Possible side effects
How to store Pantoprazole Aristo Pharma 20 mg
Contents of the pack and other information

1. What is PANTOPRAZOLE ARISTO PHARMA 20 mg and what is it used for?

Pantoprazole Aristo Pharma 20 mg is a medicine that reduces the production of acid in the
stomach (a selective proton pump inhibitor). It is used for the treatment of acid-related
diseases of the stomach and intestine.
Pantoprazole Aristo Pharma 20 mg is used for the treatment of:
Adults and adolescents aged 12 years and older:

Treatment of 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 its recurrence.
Adults:
Prevention of duodenal and gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in at-risk patients who require continuous treatment with NSAIDs.

2. What you need to know before taking PANTOPRAZOLE ARISTO PHARMA 20 mg

Do not take Pantoprazole Aristo Pharma 20 mg

If you are allergic (hypersensitive) to pantoprazole, to soybean lecithin, or to any of the
other components of Pantoprazole Aristo Pharma 20 mg (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 Pharma:

If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Aristo Pharma that reduces gastric acidity.
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to stop treatment with Pantoprazole Aristo Pharma. Remember to also report any other adverse effects such as joint pain.
If you are due to undergo a specific blood test (Chromogranin A).
If you take pantoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause symptoms such as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or rapid heartbeat. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to carry out periodic blood tests to monitor your magnesium levels.

Take special care with Pantoprazole Aristo Pharma 20 mg

If you have severe liver problems. Inform your doctor if you have previously had liver problems. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazole Aristo Pharma 20 mg for long-term treatment. If liver enzymes increase, treatment must be discontinued.
If you require ongoing treatment with NSAIDs and are taking Pantoprazole Aristo Pharma 20 mg because you are at increased risk of developing gastrointestinal complications. Any increased risk will be assessed based on your personal risk factors such as age (65 years or older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
If you have Zollinger-Ellison syndrome, reduced body reserves, or risk factors for low vitamin B12 levels and are undergoing long-term treatment with pantoprazole. As with all agents that reduce gastric acidity, pantoprazole may lead to reduced absorption of vitamin B12.
If you are taking a medicine containing atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
If you are taking a proton pump inhibitor such as Pantoprazole Aristo Pharma, especially for longer than one year, there may be a slight increase in the risk of hip, wrist, or spine fractures. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

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

Unintentional weight loss
Recurrent vomiting
Difficulty swallowing
Blood in vomit
Paleness and weakness (anemia)
Blood in stools
Severe and/or persistent diarrhea, as Pantoprazole Aristo Pharma 20 mg has been associated with a slight increase in infectious diarrhea.

Your doctor may decide that you need certain tests to rule out malignancy, as pantoprazole can also relieve symptoms of cancer and may therefore delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you take Pantoprazole Aristo Pharma 20 mg for long-term treatment (more than 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances at every visit to your doctor.

Other medicines and Pantoprazole Aristo Pharma

Pantoprazole Aristo Pharma 20 mg may affect the effectiveness of other medicines, so 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 Pharma 20 mg may prevent these and other medicines from working properly.
Warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring.
Atazanavir (used to treat HIV infection)
Methotrexate (used to treat certain types of cancer or psoriasis)

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

Pregnancy and breastfeeding

There are insufficient data on the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported. If you are pregnant, think you may be pregnant, or are breastfeeding, you should use this medicine only if your doctor considers the benefit to you greater than the potential risk to the fetus or infant.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

If you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.

Important information about some components of Pantoprazole Aristo Pharma 20 mg

If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Pantoprazole Aristo Pharma 20 mg contains soybean lecithin. If you are allergic to peanuts or soy, do not use this medicine.

3. How to take PANTOPRAZOLE ARISTO PHARMA 20 mg

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

When and how should you take Pantoprazole Aristo Pharma 20 mg?
Take the tablets 1 hour before a meal. Do not chew or crush them; swallow the tablets whole with some water.

Unless otherwise instructed by your doctor, the recommended dose is:

Adults and adolescents aged 12 years and older

For the treatment of symptoms associated with gastroesophageal reflux disease (e.g. heartburn, acid regurgitation, pain on swallowing)
The recommended dose is one tablet daily. This dose usually provides relief within 2–4 weeks, and at most within a further 4 weeks. Your doctor will advise you on how long to continue taking the medicine. After that, any recurrence of symptoms can be managed by taking one tablet daily as needed.

For long-term treatment and prevention of recurrence of reflux esophagitis
The recommended dose is one tablet daily. If symptoms recur, your doctor may double the dose; in this case, you may alternatively use Pantoprazole Aristo Pharma 40 mg tablets, one tablet daily. After healing, the dose may be reduced back to one 20 mg tablet daily.

Adults

For the prevention of duodenal and gastric ulcers in patients requiring continuous treatment with NSAIDs
The recommended 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.
Use in children under 12 years: These tablets are not recommended for use in children under 12 years of age.

If you take more Pantoprazole Aristo Pharma 20 mg than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.

If you forget to take Pantoprazole Aristo Pharma 20 mg
Do not take a double dose to make up for the missed dose. Take the next dose at the scheduled time.

If you stop taking Pantoprazole Aristo Pharma 20 mg
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The frequency of the possible side effects listed below is defined using the following convention:

very common (affects more than 1 in 10 people)
common (affects 1 to 10 in 100 people)
uncommon (affects 1 to 10 in 1,000 people)
rare (affects 1 to 10 in 10,000 people)
very rare (affects less than 1 in 10,000 people)
not known (frequency cannot be estimated from the available data)

If you experience any of the following side effects, stop taking this medicine and contact your doctor immediately, or go to the nearest hospital emergency department:

Severe allergic reactions (frequency: rare): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's oedema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating
Serious skin disorders (frequency: not known): development of skin blisters and rapid deterioration in general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), and light sensitivity
Other serious disorders (frequency: not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, skin rash, and kidney enlargement sometimes with painful urination or back pain (severe kidney inflammation), which may lead to kidney failure

Other side effects include:

Common (affects 1 to 10 in 100 people): benign polyps in the stomach
Uncommon (affects 1 to 10 in 1,000 people): headache; dizziness; diarrhoea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash, exanthema, eruption; itching; feeling of weakness, fatigue or general malaise; sleep disturbances
Rare (affects 1 to 10 in 10,000 people): vision disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities (peripheral oedema); allergic reactions; depression, breast enlargement in men, altered taste
Very rare (affects less than 1 in 10,000 people): disorientation
Not known (frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients with prior experience of these symptoms); decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), tingling sensation, pricking, pins and needles, burning or numbness, sudden, severe, involuntary muscle contractions or shortening of muscles due to changes in electrolyte levels, erythema, possible joint pain, inflammation of the large intestine causing persistent watery diarrhoea

Side effects identified through blood tests:

Uncommon (affects 1 to 10 in 1,000 people): increased liver enzymes
Rare (affects 1 to 10 in 10,000 people): increased bilirubin; increased blood lipids; reduction in certain types of mature white blood cells (neutrophils)
Very rare (affects less than 1 in 10,000 people):
reduction in platelet count, which may cause abnormal bleeding or bruising; reduction in white blood cell count, which may lead to more frequent infections; reduction in red blood cells which may cause decreased haemoglobin

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PANTOPRAZOLO ARISTO PHARMA 20 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, on the bottle, and
on the blister after "EXP". The expiry date refers to the last day of that month.
For tablets packed in plastic bottles: Pantoprazolo Aristo Pharma 20 mg can be used for three
months after first opening the container.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pantoprazolo Aristo Pharma 20 mg contains:
The active substance is: pantoprazole.
Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium pantoprazole
sesquihydrate).
The other components are:
Tablet core
Maltitol (E 965), crospovidone type B, sodium carmellose, anhydrous sodium carbonate (E 500),
calcium stearate
Tablet coating
Polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), macrogol 3350, soy lecithin, yellow iron oxide (E 172), anhydrous sodium carbonate (E 500), methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E 1505)
Description of the appearance of Pantoprazolo Aristo Pharma 20 mg and contents of the
package:
Pantoprazolo Aristo Pharma 20 mg gastro-resistant tablets are oval and yellow.
Pantoprazolo Aristo Pharma 20 mg is available in packages containing 7, 10, 14, 15, 20, 28, 28 (2x14), 30, 50, 56, 60, 98, 100 tablets in blister packaging, and 14, 28, 100 tablets in HDPE container packaging.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Aristo Pharma GmbH
Wallenroder Straße 8 - 10
13435 Berlin
Germany
Responsible for batch release
Sofarimex – Indústria Química e Farmacêutica, S.A.
Av. das Indústrias, Alto de Colaride, Agualva
2735-213 Cacém
Portugal
Lamp San Prospero S.p.A.
Via della Pace, 25/A
41030 San Prospero (MO)
Italy
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A.
Via Follereau, 25
24027 Nembro (Bergamo)
Italy
Lachifarma S.r.l
Laboratorio Chimico Salentino
S.S. 16 Zona Industriale
73010 Zollino (LE)
Italy
This medicinal product is authorized in the European Economic Area countries
under the following names:
Italy: Pantoprazolo Aristo Pharma 20 mg gastro-resistant tablets
This leaflet was last updated on

PACKAGE LEAFLET

Pantoprazolo Aristo Pharma 40 mg gastro-resistant tablets

Equivalent medicinal product
Please read this entire leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Pantoprazolo Aristo Pharma 40 mg is and what it is used for
What you need to know before taking Pantoprazolo Aristo Pharma 40 mg
How to take Pantoprazolo Aristo Pharma 40 mg
Possible side effects
How to store Pantoprazolo Aristo Pharma 40 mg
Contents of the pack and other information

1. What is PANTOPRAZOLE ARISTO PHARMA 40 mg and what is it used for?

Pantoprazole Aristo Pharma 40 mg is a medicine that reduces the production of acid in the stomach (a selective proton pump inhibitor). It is used for the treatment of acid-related diseases of the stomach and intestine.
Pantoprazole Aristo Pharma 40 mg is used to treat:
Adults and adolescents 12 years of age and older:

Gastroesophageal reflux esophagitis. An inflammation of the esophagus (the tube connecting the throat to the stomach), accompanied by regurgitation of gastric acid.

Adults:

Infection caused by a bacterium called Helicobacter pylori in patients with duodenal and gastric ulcers, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacterium and thereby reduce the likelihood of these ulcers recurring.
Gastric and duodenal ulcers.
Zollinger-Ellison syndrome and other conditions characterized by excessive acid production in the stomach.

2. What you should know before taking PANTOPRAZOLE ARISTO PHARMA 40 mg

Do not take Pantoprazole Aristo Pharma 40 mg
If you are allergic (hypersensitive) to pantoprazole, to soybean lecithin, or to any of the
other components of Pantoprazole Aristo Pharma 40 mg (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 Pharma
If you have ever had a skin reaction after treatment with a medicine similar to
Pantoprazole Aristo Pharma that reduces gastric acidity.
If you notice the appearance of a skin erythema, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue therapy with Pantoprazole Aristo Pharma. Remember to also report any other adverse effects such as joint pain.
If you are due to undergo a specific blood test (Chromogranin A)
If you take pantoprazole for more than three months, a reduction in blood magnesium levels may occur. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or rapid heartbeat. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Exercise particular caution with Pantoprazole Aristo Pharma 40 mg

If you have severe liver problems. Inform your doctor if you have previously had liver problems. Your doctor may arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazole Aristo Pharma for long-term therapy. If liver enzymes increase, treatment must be discontinued.
If you have Zollinger-Ellison syndrome, reduced body reserves, or risk factors for vitamin B12 deficiency and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12.
If you are simultaneously taking a medicine containing atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
If you are taking a proton pump inhibitor such as Pantoprazole Aristo Pharma, especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

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

Unintentional weight loss
Recurrent vomiting
Difficulty swallowing
Blood in vomit
Looking pale and feeling weak (anemia)
Blood in stools
Severe and/or persistent diarrhea, as Pantoprazole Aristo Pharma 40 mg has been associated with a slight increase in infectious diarrhea.

Your doctor may decide that you need further tests to exclude malignancy, as pantoprazole can relieve symptoms of cancer and may delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you take Pantoprazole Aristo Pharma 40 mg for long-term treatment (longer than 1 year), your doctor will likely monitor you regularly. You should report any new or unusual symptoms or circumstances at every medical visit.

Other medicines and Pantoprazole Aristo Pharma
Pantoprazole Aristo Pharma 40 mg may affect the effectiveness of other medicines, so 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 Pharma 40 mg may prevent these and other medicines from working properly.
Warfarin and phenprocoumon, which affect blood clotting or thinning. You may require additional monitoring.
Atazanavir (used to treat HIV infection)
Methotrexate (used to treat certain types of cancer or psoriasis)

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

Pregnancy and breastfeeding
There are inadequate data regarding the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported. If you are pregnant, think you might be pregnant, or are breastfeeding, you should use this medicine only if your doctor considers the benefit to you greater than the potential risk to the fetus or infant.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
If you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.

Important information about some components of Pantoprazole Aristo Pharma 40 mg
If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
Pantoprazole Aristo Pharma 40 mg contains soybean lecithin. If you are allergic to peanuts or soy, do not use this medicine.

3. How to take PANTOPRAZOLE ARISTO PHARMA 40 mg

Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
When and how should you take Pantoprazole Aristo Pharma 40 mg?
Take the tablets 1 hour before a meal, without chewing or crushing them, swallowing them
whole with some water.
Unless otherwise instructed by your doctor, the recommended dose is:
Adults and adolescents aged 12 years and older
For the treatment of reflux esophagitis
The recommended dose is one tablet per day. Your doctor may instruct you to increase the
dose to two tablets per day. The treatment period for reflux esophagitis is
usually between 4 and 8 weeks. Your doctor will advise you on how long to take the medicine.
Adults
For the treatment of an infection caused by a bacterium called Helicobacter pylori
in patients with duodenal and gastric ulcers, in combination with two antibiotics
(eradication therapy)
One tablet twice daily plus two antibiotic tablets:
amoxicillin + clarithromycin or
amoxicillin or clarithromycin + metronidazole (or tinidazole),
each of which must be taken twice daily together with the pantoprazole tablet.
Take the first pantoprazole tablet 1 hour before breakfast and the second
pantoprazole tablet 1 hour before the evening meal. Follow your doctor's instructions and
make sure to read the package leaflet for the antibiotics. The usual treatment duration is one
or two weeks.
For the treatment of gastric and duodenal ulcers
The recommended dose is one tablet per day. After consulting your doctor, the dose
may be doubled.
Your doctor will advise you on how long to take the medicine. The treatment period for
gastric ulcers is generally between 4 and 8 weeks. The treatment period for
duodenal ulcers is generally between 2 and 4 weeks.
For long-term treatment of Zollinger-Ellison syndrome and other
conditions in which excessive stomach acid is produced
The usual recommended initial dose is two tablets per day.
Take both tablets 1 hour before a meal. Your doctor may subsequently adjust
the dosage depending on the amount of gastric acid produced. If more than two
tablets per day are prescribed, the tablets should be taken twice daily.
If your doctor prescribes a daily dose of more than four tablets per day, you will
be given specific instructions on when to stop taking the medicine.
Special patient groups:

If you have severe liver problems, you must not take more than one 20 mg pantoprazole tablet per day (for this purpose, tablets containing 20 mg of pantoprazole are available).
Use in children under 12 years: These tablets are not recommended for use in children under 12 years of age.

If you take more Pantoprazole Aristo Pharma 40 mg than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantoprazole Aristo Pharma 40 mg
Do not take a double dose to make up for the missed dose. Take your next
scheduled dose at the usual time.
If you stop taking Pantoprazole Aristo Pharma 40 mg
Do not stop treatment with these tablets without first consulting your doctor or
pharmacist.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The frequency of the possible side effects listed below is defined using the following convention:

very common (affects more than 1 in 10 people)
common (affects 1 to 10 in 100 people)
uncommon (affects 1 to 10 in 1,000 people)
rare (affects 1 to 10 in 10,000 people)
very rare (affects fewer than 1 in 10,000 people)
not known (frequency cannot be estimated from the available data)

If you experience any of the following side effects, stop taking this medicine immediately,
contact your doctor or go to the nearest hospital emergency department:

Severe allergic reactions (frequency: rare): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and profuse sweating
Serious skin disorders (frequency: not known): appearance of skin blisters and rapid deterioration of general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), and light sensitivity
Other serious disorders (frequency: not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash, and kidney enlargement sometimes with painful urination or back pain (severe kidney inflammation), which may lead to kidney failure

Other side effects include:

Common (affects 1 to 10 in 100 people): benign gastric polyps
Uncommon (affects 1 to 10 in 1,000 people): headache; dizziness; diarrhoea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash, exanthema, eruption; itching; feeling of weakness, fatigue or general malaise; sleep disturbances
Rare (affects 1 to 10 in 10,000 people): visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities (peripheral oedema); allergic reactions; depression, breast enlargement in men, altered taste
Very rare (affects fewer than 1 in 10,000 people): disorientation
Not known (frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients with prior experience of these symptoms); decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), sensations of tingling, pricking, pins and needles, burning or numbness, sudden, severe, involuntary muscle contraction or shortening of muscles due to changes in electrolyte levels, erythema, possible joint pain, inflammation of the large intestine causing persistent watery diarrhoea

Side effects identified through blood tests:

Uncommon (affects 1 to 10 in 1,000 people): increased liver enzymes
Rare (affects 1 to 10 in 10,000 people): increased bilirubin; increased blood lipids; reduction in certain types of mature white blood cells (neutrophils)
Very rare (affects fewer than 1 in 10,000 people): reduced platelet count, which may cause increased bleeding or bruising; reduced white blood cell count, which may lead to more frequent infections; reduced number of red blood cells, which may cause decreased haemoglobin

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PANTOPRAZOLO ARISTO PHARMA 40 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle, and blister after "EXP". The expiry date refers to the last day of that month.
For tablets packed in plastic bottles: Pantoprazolo Aristo Pharma 40 mg can be used for three months after first opening the container.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pantoprazolo Aristo Pharma 40 mg contains:
The active substance is: pantoprazole.
Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
The other components are:
Tablet core
Maltitol (E 965), crospovidone type B, sodium carmellose, anhydrous sodium carbonate (E 500), calcium stearate
Tablet coating
Polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), macrogol 3350, soybean lecithin, yellow iron oxide (E 172), anhydrous sodium carbonate (E 500), methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E 1505)
Description of the appearance of Pantoprazolo Aristo Pharma 40 mg and package contents:
Pantoprazolo Aristo Pharma 40 mg gastro-resistant tablets are oval-shaped and yellow.
Pantoprazolo Aristo Pharma 40 mg is available in packs of 7, 10, 14, 15, 20, 28, 28 (2x14), 30, 50, 56, 60, 98, 100 tablets in blister packaging, and in packs of 14, 28, 100 tablets in HDPE container packaging.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Aristo Pharma GmbH
Wallenroder Straße 8 - 10
13435 Berlin
Germany
Manufacturers responsible for batch release
Sofarimex – Indústria Química e Farmacêutica, S.A.
Av. das Indústrias, Alto de Colaride, Agualva
2735-213 Cacém
Portugal
Lamp San Prospero S.p.A.
Via della Pace, 25/A
41030 San Prospero (MO)
Italy
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A.
Via Follereau, 25
24027 Nembro (Bergamo)
Italy
Lachifarma S.r.l
Laboratorio Chimico Salentino
S.S. 16 Zona Industriale
73010 Zollino (LE)
Italy
This medicinal product is authorized in the Member States of the European Economic Area
under the following names:
Italy: Pantoprazolo Aristo Pharma 40 mg gastro-resistant tablets
This leaflet was last updated on