PANTOPRAZOLO 20 mg Enteric-Coated Tablet

Зміст інструкції

1. Pantoprazolo Aristo Pharma 20 mg gastro-resistant tablets
   1. What is PANTOPRAZOLO ARISTO PHARMA 20 mg and what is it used for
   2. What you need to know before taking PANTOPRAZOLO ARISTO PHARMA 20
   3. How to take PANTOPRAZOLO ARISTO PHARMA 20 mg
   4. Possible side effects
   5. How to store PANTOPRAZOLO ARISTO PHARMA 20 mg
   6. Package contents and other information
2. Pantoprazolo Aristo Pharma 40 mg gastro-resistant tablets
   1. What is PANTOPRAZOLO ARISTO PHARMA 40 mg and what is it used for?
   2. What you need to know before taking PANTOPRAZOLO ARISTO PHARMA 40
   3. How to take PANTOPRAZOLO ARISTO PHARMA 40 mg
   4. Possible side effects
   5. How to store PANTOPRAZOLO ARISTO PHARMA 40 mg
   6. Contents of the pack and other information

Pantoprazolo Aristo Pharma 20 mg gastro-resistant tablets

Generic medicine

Read this 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Pantoprazolo Aristo Pharma 20 mg is and what it is used for
• 2. What you need to know before you take Pantoprazolo Aristo Pharma 20 mg
• 3. How to take Pantoprazolo Aristo Pharma 20 mg
• 4. Possible side effects
• 5. How to store Pantoprazolo Aristo Pharma 20 mg
• 6. Contents of the pack and other information

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

Pantoprazolo Aristo Pharma 20 mg is a medicine that reduces the production of acid in the
stomach (selective proton pump inhibitor). It is used for the treatment of
acid-related diseases of the stomach and intestines.
Pantoprazolo Aristo Pharma 20 mg is used for the treatment of:

Adults and adolescents 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 stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who require continuous treatment with NSAIDs.

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

mg
Do not take Pantoprazolo Aristo Pharma 20 mg
If you are allergic (hypersensitive) to pantoprazole, to soya lecithin or to any of the
other ingredients of Pantoprazolo 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 Pantoprazolo Aristo Pharma:

• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazolo Aristo Pharma that reduces stomach acid.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as you may need to stop treatment with Pantoprazolo Aristo Pharma. Also remember to report any other unwanted effects such as joint pain.
• If you are going to undergo a specific blood test (Chromogranin A)
• If you take pantoprazole for more than three months, it is possible that a reduction in blood magnesium levels may occur. A reduction in magnesium levels can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Pay particular attention with Pantoprazolo Aristo Pharma 20 mg

• If you have severe liver problems. Tell your doctor if you have had liver problems in the past. The doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazolo Aristo Pharma 20 mg for long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you need continuous treatment with NSAIDs and are taking Pantoprazolo Aristo Pharma 20 mg because you have an increased risk of developing gastric and intestinal complications. Any increased risk will be assessed based on your personal risk factors such as age (65 years and over), a history of gastric or duodenal ulcers or gastrointestinal bleeding.
• If you have Zollinger-Ellison syndrome, reduced body stores or risk factors for reduced vitamin B12 and are undergoing long-term treatment with pantoprazole. As with all acid-reducing agents, pantoprazole can 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 take a proton pump inhibitor such as Pantoprazolo Aristo Pharma, especially for a period 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 can increase the risk of osteoporosis) consult your doctor.

Tell your doctor immediatelyif you notice any of the following symptoms:

• an involuntary weight loss
• recurrent vomiting
• difficulty swallowing
• presence of blood in vomit
• appear pale and feel weak (anemia)
• presence of blood in the stool
• severe and/or persistent diarrhea, because Pantoprazolo Aristo Pharma 20 mg has been associated with a modest increase in infectious diarrhea.

The doctor may decide that you need to undergo some tests to rule out a
malignant disease as pantoprazole also relieves the symptoms of cancer and may cause
a delay in diagnosis. If your symptoms persist despite treatment, further investigations must be
considered.
If you take Pantoprazolo Aristo Pharma 20 mg for long-term treatment (longer than
1 year) your doctor will probably keep you under regular control. You should report any
new or unusual symptom or circumstance whenever you meet your doctor.

Other medicines and Pantoprazolo Aristo Pharma
Pantoprazolo Aristo Pharma 20 mg can affect the effectiveness of other medicines, so tell
your doctor if you are taking

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer) because Pantoprazolo Aristo Pharma 20 mg may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon ,which affect blood clotting or thinning. You may need further checks.
• Atazanavir (used to treat HIV infection)
• Methotrexate (used to treat some types of cancer or psoriasis)

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

Pregnancy and breastfeeding
There are no adequate data regarding the use of pantoprazole in pregnant women. Excretion
in human breast milk has been reported. If you are pregnant, or think you may be
pregnant, or are breastfeeding, you should use this medicine only if the doctor considers the
benefit for 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 side effects such as dizziness or visual disturbances, you should not drive or use
machinery.

Important information about some ingredients of Pantoprazolo Aristo Pharma 20 mg
If your doctor has told you that you have an intolerance to some sugars, contact your doctor
before taking this medicine.

Pantoprazolo Aristo Pharma 20 mg contains soya lecithin. If you are allergic to peanuts or
soy, do not use this medicine.

3. How to take PANTOPRAZOLO ARISTO PHARMA 20 mg

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.

When and how should you take Pantoprazolo Aristo Pharma 20 mg?
Take the tablets 1 hour before a meal without chewing or crushing them and swallow
them whole with a little water.
Unless otherwise informed by your doctor, the recommended dose is:

Adults and adolescents of 12 years and over

For the treatment of symptoms associated with gastroesophageal reflux disease (e.g. heartburn,
acid regurgitation, pain when swallowing)
The recommended dose is one tablet a day. This dose normally brings relief in

• 2 - 4 weeks - at most after another 4 weeks. The doctor will tell you how long to continue taking the medicine. After that, any recurrence of symptoms can be controlled by taking onetablet a day, as needed.

For long-term treatment and for the prevention of recurrent reflux esophagitis
The recommended dose is one tablet a day. If the symptom returns, your doctor may
double the dose, in which case you can instead use Pantoprazolo Aristo Pharma 40 mg
tablets, one a day. After healing, you can reduce the dose back to one
20 mg tablet a day.

Adults

For the prevention of duodenal and gastric ulcers in patients who require continuous
treatment with NSAIDs
The recommended dose is one tablet a day.

Particular groups of patients:

• If you suffer from severe liver problems, you should not take more than one 20 mg tablet a day.
• Use in children under 12 years. These tablets are not recommended for use in children under 12 years of age.

If you take more Pantoprazolo Aristo Pharma 20 mg than you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

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

If you stop taking Pantoprazolo Aristo Pharma 20 mg
Do not stop treatment with these tablets without first consulting your doctor or
pharmacist.
If you have any further questions on 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 everybody 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 (the frequency cannot be estimated from the available data)

If you experience any of the following side effects, stop taking these
tablets and consult your doctor immediately, or contact the nearest hospital emergency
room:

• Severe allergic reactions (rare): swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the face (angioedema/Quincke's edema), severe dizziness with a very fast heartbeat and heavy sweating
• Severe skin conditions (frequency not known): blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, Multiforme erythema) and light sensitivity
• Other severe conditions (frequency not known): yellowing of the skin or whites of the eyes (severe damage to liver cells, jaundice) or fever, rash, and enlargement of the kidneys sometimes with pain when urinating or lower back pain (severe kidney inflammation), which can lead to kidney failure

Other side effects are:

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

Side effects identified through blood tests:

• Uncommon(affects 1 to 10 in 1,000 people) an increase in liver enzymes
• Rare (affects 1 to 10 in 10,000 people) an increase in bilirubin; increased fats in the blood; reduction of some types of mature white blood cells (neutrophils)
• Very Rare (affects less than 1 in 10,000 people)

a reduction in the number of platelets, which can cause bleeding or bruising more than
normal; a reduction in the number of white blood cells, which can lead to more
frequent infections; a reduction in the number of red blood cells, which can cause a
reduction in hemoglobin

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through 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 package, bottle and
blister after “EXP”. The expiry date refers to the last day of that month.
For tablets packaged in plastic bottles: PANTOPRAZOLO ARISTO PHARMA 20 mg can
be used for three months after the first opening of the container.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to eliminate medicines that 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 ingredient is: pantoprazole.
Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium
sesquihydrate).
The other ingredients are:

Tablet core
Maltitol (E 965), crospovidone type B, sodium carboxymethylcellulose, anhydrous sodium carbonate (E 500),
magnesium stearate

Tablet coating
Polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), macrogol 3350, soybean lecithin, iron
oxide yellow (E 172), anhydrous sodium carbonate (E 500), acrylic acid-ethyl
acrylate copolymer (1:1), triethyl citrate (E 1505)

Description of the appearance of Pantoprazolo Aristo Pharma 20 mg and package contents:
The gastro-resistant tablets of Pantoprazolo Aristo Pharma 20 mg are oval and yellow.
Pantoprazolo Aristo Pharma 20 mg is available in packs of 7, 10, 14, 15, 20, 28, 28
(2x14), 30, 50, 56, 60, 98, 100 tablets in blister packs and in packs of 14, 28, 100
tablets in HDPE containers.
Not all pack sizes may be marketed.

Marketing authorisation 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 Cacêm
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 authorised in the Member States of the European Economic Area
under the following names:
Italy: Pantoprazolo Aristo Pharma 20 mg gastro-resistant tablets

This leaflet was last updated on

Pantoprazolo Aristo Pharma 40 mg gastro-resistant tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Pantoprazolo Aristo Pharma 40 mg is and what it is used for
• 2. What you need to know before you take Pantoprazolo Aristo Pharma 40 mg
• 3. How to take Pantoprazolo Aristo Pharma 40 mg
• 4. Possible side effects
• 5. How to store Pantoprazolo Aristo Pharma 40 mg
• 6. Contents of the pack and other information

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

Pantoprazolo Aristo Pharma 40 mg is a medicine that reduces the production of acid in the
stomach (selective proton pump inhibitor). It is used for the treatment of
acid-related diseases of the stomach and intestines.
Pantoprazolo Aristo Pharma 40 mg is used for the treatment of:

Adults and adolescents 12 years and older:

• Reflux esophagitis. Inflammation of the esophagus (the tube connecting the throat to the stomach) accompanied by acid regurgitation.

Adults:

• An infection caused by a bacterium called Helicobacter pyloriin patients with duodenal and gastric ulcers in combination with two antibiotics (eradication therapy). The purpose is to eliminate the bacterium and therefore reduce the likelihood of these ulcers returning
• Gastric and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before taking PANTOPRAZOLO ARISTO PHARMA 40

mg
Do not take Pantoprazolo Aristo Pharma 40 mg
If you are allergic (hypersensitive) to pantoprazole, to soy lecithin or to any of the
other ingredients of Pantoprazolo 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 Pantoprazolo Aristo Pharma
If you have ever had a skin reaction after treatment with a medicine similar to
Pantoprazolo Aristo Pharma that reduces stomach acid.
If you notice the appearance of a skin rash, especially in areas exposed to sunlight,
contact your doctor as soon as possible, as you may need to
stop therapy with Pantoprazolo Aristo Pharma. Also remember to report
any other undesirable effects such as joint pain.
If you are going 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. A reduction in magnesium levels can
manifest with fatigue, involuntary muscle contractions, disorientation,
seizures, dizziness or increased heart rate. Tell your doctor immediately if you experience any of these symptoms. Low magnesium levels can
also lead to a reduction in potassium or calcium levels in the blood. Your doctor
may decide to periodically perform blood tests to monitor
magnesium levels.

Pay particular attention with Pantoprazolo Aristo Pharma 40 mg

• If you have severe liver problems. Tell your doctor if you have had liver problems in the past. The doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazolo Aristo Pharma for long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you have Zollinger-Ellison syndrome, reduced body reserves or risk factors for reduced vitamin B12 and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole can lead to reduced absorption of vitamin B12.
• If you are simultaneously taking a medicine containing atazanavir (for the treatment of HIV infection) with pantoprazole, ask your doctor for specific advice.
• If you take a proton pump inhibitor such as Pantoprazolo Aristo Pharma, especially for a period 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 can increase the risk of osteoporosis) consult your doctor.

Tell your doctor immediatelyif you notice any of the following symptoms:

• an involuntary weight loss
• recurrent vomiting
• difficulty swallowing
• presence of blood in the vomit
• appear pale and feel weak (anemia)
• presence of blood in the stool
• severe and/or persistent diarrhea, because Pantoprazolo Aristo Pharma 40 mg has been associated with a modest increase in infectious diarrhea.

The doctor may decide that you need to undergo some tests to rule out a
malignant disease as pantoprazole also relieves the symptoms of cancer and may cause
a delay in diagnosis. If your symptoms persist despite treatment, further
investigations must be considered.
If you take Pantoprazolo Aristo Pharma 40 mg for long-term treatment (longer
than 1 year) your doctor will probably keep you under regular control. You must report every
new or exceptional symptom and circumstance whenever you meet the doctor.

Other medicines and Pantoprazolo Aristo Pharma
Pantoprazolo Aristo Pharma 40 mg can affect the effectiveness of other medicines, so tell
your doctor if you are taking

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer) because Pantoprazolo Aristo Pharma 40 mg may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood thickening or dilution. You may need further checks.
• Atazanavir (used to treat HIV infection)
• Methotrexate (used to treat some types of cancer or psoriasis)

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

Pregnancy and breastfeeding
There is no adequate data regarding the use of pantoprazole in pregnant women. Human milk excretion has been
reported. If you are pregnant, or think you may be, or are breastfeeding, you should use this medicine only if the 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 operating machinery
If you experience side effects such as dizziness or visual disturbances, you should not drive or operate
machinery.

Important information about some ingredients of Pantoprazolo Aristo Pharma 40 mg
If your doctor has told you that you have an intolerance to some sugars, contact your doctor
before taking this medicine.

Pantoprazolo Aristo Pharma 40 mg contains soy lecithin.If you are allergic to peanuts or
soy, do not use this medicine.

3. How to take PANTOPRAZOLO ARISTO PHARMA 40 mg

Take this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.

When and how should you take Pantoprazolo Aristo Pharma 40 mg?
Take the tablets 1 hour before a meal without chewing or crushing them and swallow
them whole with a little water.
Unless otherwise informed by your doctor, the recommended dose is:

Adults and adolescents 12 years and over

For the treatment of reflux esophagitis
The recommended dose is one tablet a day. Your doctor may tell you to increase the
dose to 2 tablets a day. The treatment period for reflux esophagitis is
usually between 4 and 8 weeks. Your doctor will tell you 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 a day plus two antibiotic tablets:
amoxicillin + clarithromycin or
amoxicillin or clarithromycin + metronidazole (or tinidazole)
each of which should be taken twice a day 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 for
two weeks.

For the treatment of gastric and duodenal ulcers
The recommended dose is one tablet a day. After consulting your doctor, the dose
may be doubled.
Your doctor will tell you how long to take the medicine. The treatment period for
gastric ulcers is typically between 4 and 8 weeks. The treatment period for duodenal
ulcers is typically between 2 and 4 weeks.

For the long-term treatment of Zollinger-Ellison syndrome and other
conditions in which too much acid is produced in the stomach
The recommended starting dose is usually two tablets a day.
Take the two 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 are prescribed per day, the tablets should be taken twice a day.
If your doctor prescribes a daily dose of more than four tablets a day, you will be
told exactly when to stop taking the medicine.

Particular groups of patients:

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

If you take more PANTOPRAZOLO ARISTO PHARMA 40 mg than you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take PANTOPRAZOLO ARISTO PHARMA 40 mg
Do not take a double dose to make up for a missed dose. Take the normal
next dose at the scheduled time.

If you stop taking PANTOPRAZOLO ARISTO PHARMA 40 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 everybody 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 people in 100)
• uncommon (affects 1 to 10 people in 1,000)
• rare (affects 1 to 10 people in 10,000)
• very rare (affects less than 1 in 10,000 people)
• not known (the frequency cannot be estimated from the available data)

If you experience any of the following side effects, stop taking these
tablets and consult your doctor immediately, or contact the nearest hospital
emergency room:

• Severe allergic reactions (rare): swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the face (angioedema/Quincke's edema), severe dizziness with a very fast heartbeat and profuse sweating
• Severe skin conditions (frequency not known): appearance of skin blisters and rapid deterioration of your general condition, erosion (including slight bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, Multiforme erythema) and sensitivity to light
• Other severe conditions (frequency not known): yellowing of the skin or whites of the eyes (severe damage to liver cells, jaundice) or fever, rash, and enlargement of the kidneys sometimes with pain when urinating or lower back pain (severe kidney inflammation), which can lead to kidney failure

Other side effects are:

• Common(affects 1 to 10 patients in 100) benign polyps in the stomach
• Uncommon(affects 1 to 10 patients in 1,000) headache; dizziness; diarrhea; feeling of nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; rash, exanthema, eruption; itching; feeling of weakness, fatigue or general malaise; sleep disorders
• Rare (affects 1 to 10 patients in 10,000) visual disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities (peripheral edema); allergic reactions; depression, increased breast volume in men, altered taste
• Very Rare (affects less than 1 in 10,000 people)

disorientation

• Not known(the frequency cannot be estimated from the available data): Hallucinations, confusion (especially in patients with a history of these symptoms); decreased levels of sodium in the blood, decreased levels of magnesium in the blood (see section 2), sensation of tingling, prickling, pinpricks, burning or numbness, sudden, involuntary and severe muscle contraction or shortening of muscles due to changes in electrolyte levels, erythema, possible joint pain, inflammation of the large intestine, causing persistent watery diarrhea

Side effects identified through blood tests:

• Uncommon(affects 1 to 10 patients in 1,000) an increase in liver enzymes
• Rare (affects 1 to 10 patients in 10,000) an increase in bilirubin; increased fats in the blood; reduction of some types of mature white blood cells (neutrophils)
• Very Rare (affects less than 1 in 10,000 people) a reduction in the number of platelets, which can cause bleeding or bruising more than normal; a reduction in the number of white blood cells, which can lead to more frequent infections; a reduction in the number of red blood cells, which can cause a decrease in hemoglobin

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly through 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 40 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 package, bottle and
blister after “EXP”. The expiry date refers to the last day of that month.
For tablets packaged in plastic bottles: PANTOPRAZOLO ARISTO PHARMA 40 mg can
be used for three months after the first opening of the container.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pantoprazolo Aristo Pharma 40 mg contains:
The active ingredient is: pantoprazole.
Each gastro-resistant tablet contains 40 mg of pantoprazole (as pantoprazole
sesquihydrate sodium).
The other ingredients are:

Tablet core
Maltitol (E 965), crospovidone type B, sodium carboxymethylcellulose, anhydrous sodium carbonate (E 500),
magnesium stearate

Tablet coating
Polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), macrogol 3350, soybean lecithin, iron
oxide yellow (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 contents of the
pack:
Pantoprazolo Aristo Pharma 40 mg gastro-resistant tablets are oval 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 blisters and 14, 28, 100
tablets in HDPE containers.
Not all pack sizes may be marketed.

Marketing Authorisation 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 Cacêm
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 authorised 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