PANTOPRAZOLO 40 mg Tabletki Powlekane

Treść ulotki

1. Pantoprazolo ABC
   1. What is Pantoprazolo ABC and what is it used for?
   2. What you need to know before taking Pantoprazolo ABC
   3. How to take Pantoprazolo ABC
   4. Possible side effects
   5. How to store Pantoprazolo ABC
   6. Package contents and other information
2. Pantoprazolo ABC
   1. POSSIBLE SIDE EFFECTS
   2. HOW TO STORE PANTOPRAZOLO ABC
   3. PACKAGE CONTENTS AND OTHER INFORMATION

Pantoprazolo ABC

20 mg hard 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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist See section 4

Contents of this leaflet:

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

1. What is Pantoprazolo ABC and what is it used for?

Pantoprazolo ABC contains the active ingredient pantoprazole. Pantoprazolo ABC is a selective proton pump inhibitor, a medicine that reduces acid production in the stomach. It is
used in the treatment of acid-related diseases of the stomach and intestines.

Pantoprazolo ABC is used to treat:

Adults and adolescents aged 12 years and over for:

• Treatment of symptoms associated with gastroesophageal reflux caused by acid reflux from the stomach (e.g. heartburn, acid regurgitation and pain when swallowing)
• Long-term treatment of reflux esophagitis (inflammation of the esophagus accompanied by acid reflux from the stomach) and prevention of relapses.

Pantoprazolo ABC is used in adults to treat:

• Prevention of gastric and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example ibuprofen) in patients at risk who need to take NSAIDs continuously.

2. What you need to know before taking Pantoprazolo ABC

Do not take Pantoprazolo ABC

• If you are allergic to pantoprazole or any of the excipients of this medicine (listed in section 6)
• If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions
Tell your doctor or pharmacist before taking Pantoprazolo ABC

• If you have severe liver problems. Tell your doctor if you have ever had liver problems in the past. They will check your liver enzymes more frequently, especially when you take Pantoprazolo ABC for long-term treatment. If an increase in liver enzymes occurs, treatment must be stopped.
• If you need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and are taking Pantoprazolo ABC because you are at a higher risk of developing complications in the stomach and intestines. Any increased risk will be assessed based on your personal risk factors such as age (65 years or older), a history of gastric or duodenal ulcers or gastrointestinal bleeding.
• If you have reduced body reserves or risk factors for vitamin B12 deficiency and are receiving long-term treatment with pantoprazole. Like all acid-reducing agents, pantoprazole can lead to reduced absorption of vitamin B12.
• Ask your doctor for specific advice if, together with pantoprazole, you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection).
• Taking a proton pump inhibitor such as PANTOPRAZOLO ABC, especially for a period of more than one year, may slightly increase the risk of fracture of the hip, wrist or spine. Tell your doctor if you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
• If you have been using pantoprazole for more than three months, the levels of magnesium (an essential mineral for human body functions) in the blood may decrease. Low levels of magnesium can cause fatigue, involuntary muscle contractions, confusion, convulsions, dizziness or increased heart rate. Immediately inform your doctor if you experience any of these symptoms. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazolo ABC 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 it may be necessary to stop therapy with Pantoprazolo ABC. Remember to also report any other unwanted effects such as joint pain.
• If you are to undergo a specific blood test (Chromogranin A)

Immediately inform your doctorbefore taking this medicine ,if you notice any of the
following symptoms, which may be a sign of more serious illnesses

• unintentional weight loss
• vomiting, especially if repeated
• vomiting with blood; this may appear in the vomit as dark coffee grounds
• blood in the stool; which may appear black or tarry
• difficulty or pain when swallowing
• being pale or weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a slight increase in infectious diarrhea.

The doctor may decide that you need some tests to rule out a malignancy
as pantoprazole also relieves the symptoms of cancer and can delay diagnosis. If your
symptoms persist despite treatment, further investigations should be considered.
If you take Pantoprazolo ABC for a long period (for more than 1 year) your doctor
may want to see you regularly. You should report any new or unusual symptom every
time you see your doctor.
Children and adolescents
The use of pantoprazole is not recommended in children as efficacy has not been demonstrated
in children under 12 years of age.

Pantoprazolo ABC and other medicines:
Tell your doctor if you are taking, have recently taken or may take any other
medicines, including over-the-counter medicines.
This is because Pantoprazolo ABC may 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 ABC may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which make the blood thicker or more fluid. You may need further checks.
• Medicines used for the treatment of HIV infection such as Atazanavir Methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer) if you are taking methotrexate your doctor may temporarily interrupt treatment with Pantoprazolo ABC because pantoprazole can increase levels of methotrexate in the blood.
• Fluvoxamine (used to treat depression and other psychiatric conditions - if you are taking fluvoxamine your doctor may reduce the dose.
• Rifampicin (an antibiotic used to treat tuberculosis).
• St. John's Wort ( Hypericum perforatum) used to treat depression and also present in some food supplements.

Pregnancy and breastfeeding
There are no adequate data on the use of pantoprazole in pregnant women. Excretion
in breast milk has been reported. If you are pregnant, think you may be or are planning a
pregnancy or if you are breastfeeding ask your doctor or pharmacist for advice
before taking this medicine.
This medicine should only be used if your doctor believes that the benefit of treatment for
you is greater than the potential risk to the fetus or infant.

Driving and using machines
Pantoprazole does not alter or negligibly alters the ability to drive vehicles and operate
machinery. If you experience side effects such as dizziness or visual disturbances, you should not drive or
operate machinery.

3. How to take Pantoprazolo ABC

Always take this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, ask your doctor or pharmacist.

Method of administration
Take the tablets 1 hour before a meal without chewing or crushing them and swallow them whole with
a little water.
The recommended dose is:

Adults and adolescents aged 12 years and over

For the treatment of symptoms associated with gastroesophageal reflux disease (e.g. heartburn,
acid regurgitation and pain when swallowing)
The usual dose is one tablet a day. Generally this dose provides relief within 2 –
4 weeks – at most after another 4 weeks. Your doctor will tell you how long to continue to
take the medicine. After that, if symptoms recur, they can be controlled by taking

one tablet a day, as needed.

For long-term treatment and for the recurrence of reflux esophagitis
The usual dose is one tablet a day. If the symptom returns, your doctor may double the
dose, in which case you can use Pantoprazolo ABC 40 mg tablets, once a day.
Once healing is achieved, you can reduce the dose again to one 20 mg tablet
per day.

Adults

Prevention of gastric and duodenal ulcers in patients who need to continuously take
NSAIDs.
The recommended dose is one tablet a day.

Patients with liver problems

• If you have severe liver problems, you should not take more than one 20 mg tablet a day. Use in children and adolescents
• The use of these tablets is not recommended in children under 12 years of age.

If you take more Pantoprazolo ABC than you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take Pantoprazolo ABC
Do not take a double dose to make up for a missed dose. Take the next
dose at the scheduled time.

If you stop taking Pantoprazolo ABC
Do not stop treatment with these tablets without first consulting your doctor or
pharmacist.
If you have any questions about using 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.

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

• Severe allergic reactions (rare frequency: may affect up to 1 in 1,000 people swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic facial swelling (angioedema/Quincke's edema), severe dizziness with a very high heart rate and profuse sweating.
• Severe skin conditions (frequency not known:the frequency cannot be established based on available data ):skin rashes 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 serious conditions (frequency not knownthe frequency cannot be established based on available data): yellowing of the skin or whites of the eyes (serious damage to liver cells, jaundice) or fever, rash and enlarged kidneys with, sometimes, pain when urinating and back pain (severe kidney inflammation), which can lead to kidney failure

Other side effects are:

• Common(may affect up to 1 in 10 people)
• Uncommon (may affect up to 1 in 100 people) Headache; dizziness; diarrhea; feeling unwell, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; itching; feeling weak, exhausted or generally unwell; sleep disturbances. Taking a proton pump inhibitor such as pantoprazole, especially for a period of over one year, may slightly increase the risk of hip, wrist or spine fracture. Tell your doctor if you suffer from osteoporosis and are taking corticosteroids (which may increase the risk of osteoporosis).
• Rare (may affect up to 1 in 1,000 people) alteration or complete loss of taste, visual disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the extremities (peripheral edema); allergic reactions; depression; increased breast volume in men.
• Very rare(may affect up to 1 in 10,000 people)
• disorientation
• Not known(the frequency cannot be established based on available data) hallucinations, confusion (especially in patients with a history of these symptoms); decreased sodium level in the blood, decrease in magnesium level in the blood (see section 2), sensation of tingling, itching, pins and needles, burning or numbness erythema, possible joint pains.

Side effects identified through blood tests:

• Uncommon (may affect up to 1 in 100 people) Increased liver enzymes
• Rare (may affect up to 1 in 1,000 people) Increased bilirubin; increased fat levels in the blood; severe decrease in circulating granulocytes, associated with high fever.
• Very rare(may affect up to 1 person out of 10,000) Reduction in the number of blood platelets, which can cause more bleeding or bruising than usual; a reduction in the number of white blood cells in the blood, which can lead to more frequent infections; coexisting abnormal reduction in the number of red blood cells and white blood cells, as well as platelets.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 ABC

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and on the container after
“EXP.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
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. Package contents and other information

What Pantoprazolo ABC contains
The active ingredient is pantoprazole (as pantoprazole sesquihydrate).
Each gastro-resistant tablet contains 20 mg of pantoprazole.
The excipients are:
Tablet core: mannitol 25 (E421), crospovidone (type B), anhydrous sodium carbonate,
hydroxypropylcellulose (7.5-14.0 cps), calcium stearate
Coating: hypromellose (3cps), titanium dioxide (E 171), yellow iron oxide (E 172), propylene
glycol.
Gastro-resistant coating: acrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%,
triethyl citrate, talc.
Printing ink (Opacode S-1-16530 brown): shellac glaze, butyl alcohol, isopropyl alcohol, black iron oxide (E 172), red iron oxide (E 172), propylene glycol, yellow iron oxide
(E 172), ammonium hydroxide 28%

Description of the appearance of Pantoprazolo ABC and contents of the pack
Pantoprazolo ABC are yellow, oval-shaped, enteric-coated tablets, with
“20” imprinted on one side and smooth on the other side.
Pantoprazolo ABC is available in aluminum-aluminum blister packs
Original packs of 14, 28 and 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
ABC Farmaceutici S.p.A.
Corso Vittorio Emanuele II, 72
10121 Turin - Italy

Manufacturer responsible for batch release
ABC Farmaceutici S.p.A.
Canton Moretti, 29
10090 San Bernardo d’Ivrea (TO) - Italy

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Netherlands: Pantoprazol Heumann 20 mg maagsapresistente tabletten
Italy: Pantoprazolo ABC 20 mg gastro-resistant hard tablets
Lithuania: Pantoprazole Torrent 20 mg skrandyje neirios tabletés
United Kingdom: Pantoprazole 20 mg gastro-resistant tablets

Pantoprazolo ABC

40 mg gastro-resistant compressed tablets
Pantoprazolo
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, speak to your
doctor or pharmacist. See section 4
Contents of this leaflet:

• 1. What is Pantoprazolo ABC and what it is used for
• 2. What you need to know before you take Pantoprazolo ABC
• 3. How to take Pantoprazolo ABC
• 4. Possible side effects
• 5. How to store Pantoprazolo ABC
• 6. Contents of the pack and other information
• 1. WHAT IS PANTOPRAZOLO ABC AND WHAT IT IS USED FOR

Pantoprazolo ABC contains the active ingredient pantoprazole. Pantoprazolo ABC 40 mg gastro-resistant tablets is a “selective proton pump inhibitor”, a medicine that reduces the
amount of acid produced in the stomach. It is used for the treatment of stomach and
intestinal diseases associated with acidity.

Pantoprazolo ABC is used to treat:

Adults and adolescents aged 12 years and over:

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

Pantoprazolo ABC is used in adults:An infection caused by a bacterium called

Helicobacter pyloriin patients with duodenal ulcer and gastric ulcer in combination with two
antibiotics (eradication therapy). The goal is to get rid of the bacterium and reduce the probability
that the ulcer will recur.

• Gastric and duodenal ulcers.
• Zollinger-Ellison syndrome and other disorders in which an excessive amount of acid is produced in the stomach.
• 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE

Do not take Pantoprazolo ABC 40 mg gastro-resistant tablets

• If you are allergic to pantoprazole, or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines that contain other proton pump inhibitors.

Warnings and precautions
Tell your doctor or pharmacist before taking Pantoprazolo ABC

• If you suffer from a severe liver disease. Tell your doctor if you have had liver problems in the past. The doctor will check your liver enzymes more frequently, especially if you are taking Pantoprazolo ABC 40 mg gastro-resistant tablets as long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you have reduced body stores or risk factors that reduce the absorption of vitamin B12 and are undergoing long-term therapy with pantoprazole. Like all medicines that reduce acidity, pantoprazole can reduce the absorption of vitamin B12.
• If you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) at the same time as Pantoprazolo ABC, ask your doctor for advice.
• Taking a proton pump inhibitor such as PANTOPRAZOLO ABC, especially for a period of over one year, may slightly increase the risk of fracture of the hip, wrist or spine. Tell your doctor if you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
• If you are using Pantoprazolo ABC for more than three months, it is possible that the levels of magnesium (an essential mineral for human body functions) in the blood may decrease. Low levels of magnesium can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. Immediately inform your doctor if you experience any of these symptoms. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazolo ABC 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 it may be necessary to stop treatment with Pantoprazolo ABC. Also remember to report any other side effects such as joint pain.
• If you are to undergo a specific blood test (Chromogranin A)

Tell your doctor immediatelybefore taking this medicine ,if you notice any of the
following symptoms that could be a sign of more serious illnesses:

• unintentional weight loss
• vomiting, especially if repeated
• vomiting with blood; this may appear in the vomit as dark coffee grounds
• if you notice blood in your stools; which may appear black or tarry
• difficulty swallowing and pain when swallowing
• paleness and weakness (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a slight increase in infectious diarrhea.

Your doctor may decide to perform some tests to rule out the presence of a malignant tumor,
as pantoprazole also relieves the symptoms of tumors and may delay diagnosis. If symptoms
persist despite treatment, further investigations will be considered.
If you take Pantoprazolo ABC 40 mg gastro-resistant tablets as long-term treatment (more than 1 year), your doctor will probably subject you to regular check-ups. Report any new or unusual symptoms and circumstances to your doctor.
Children and adolescents
The use of pantoprazole is not recommended in children as efficacy has not been demonstrated
in children under 12 years of age.

Pantoprazolo ABC and other medicines
Tell your doctor if you are taking, have recently taken or might take any other medicines, including
over-the-counter medicines.
This is because Pantoprazolo ABC 40 mg may affect the effectiveness of other medicines; therefore, 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), as Pantoprazolo may block the correct functioning of these and other medicines.
• Warfarin and phenprocoumone, which allow you to modify the viscosity or fluidity of the blood. It may be necessary to perform further checks.
• Medicines used for the treatment of HIV infection such as Atazanavir, methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer) - if you are taking methotrexate your doctor may temporarily interrupt treatment with Pantoprazolo ABC because pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric conditions) - if you are taking fluvoxamine your doctor may reduce the dose.
• Rifampicin (an antibiotic used to treat tuberculosis).
• St. John's Wort (Hypericum perforatum) used to treat depression and also present in some food supplements.

Pregnancy and breastfeeding
There are no adequate data on the use of pantoprazole in pregnant women. Excretion in breast milk has
been reported.
If you are pregnant, think you may be pregnant or are breastfeeding, ask your doctor or pharmacist for
advice before taking this medicine.
This medicine should only be used if the doctor considers that the benefit of treatment for you is greater
than the potential risk to the fetus or infant.

Driving and using machines
Pantoprazole does not alter or negligibly alters the ability to drive vehicles and use
machinery.
If you experience side effects such as dizziness or blurred vision, you should not drive or use
machinery.

• 3. HOW TO TAKE PANTOPRAZOLO ABC

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your
doctor or pharmacist.

How to administerTake the tablets 1 hour before a meal without chewing or
breaking them, but swallow them whole with some water.
The recommended dose is:

Adults and adolescents aged 12 years and over:

For the treatment of reflux esophagitis
The usual dose is one tablet a day. Your doctor may ask you to increase the dose to
2 tablets a day. The treatment of reflux esophagitis usually lasts from 4 to 8
weeks. Your doctor will tell you how long you should take the medicine.

Adults

For the treatment of an infection caused by a bacterium calledHelicobacter pyloriin patients
with duodenal ulcer in association with two antibiotics (eradication therapy).
One tablet twice a day plus two antibiotic tablets (amoxicillin, clarithromycin and
metronidazole or tinidazole), each to 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 dinner. Follow your doctor's instructions and read the leaflets
of the antibiotics.

The usual treatment lasts from one to two weeks.

For the treatment of gastric and duodenal ulcers.
The usual dose is one tablet a day. After consulting your doctor, the dose may be
doubled.
Your doctor will tell you how long you should take the medicine. The treatment of gastric
ulcers usually lasts from 4 to 8 weeks. The treatment of duodenal ulcers usually lasts
from 2 to 4 weeks.

For the long-term treatment of Zollinger-Ellison syndrome and other disorders in which an
excessive amount of acid is produced in the stomach.
The recommended initial dose is usually two tablets a day.
Take the two tablets 1 hour before meals. Subsequently, your doctor may modify the
dose, depending on the amount of acid produced in the stomach. If you have been prescribed more than two
tablets a day, take them twice a day.
If your doctor prescribes a daily dose greater than four tablets, they will tell you
exactly when to stop taking the medicine.

• Patients with kidney problemsIf you have kidney problems, you should not take Pantoprazolo ABC to eradicate Helicobacter pylori.
• Patients with liver problemsIf you suffer from severe liver problems, you should not take more than 20 mg of pantoprazole a day (tablets containing 20 mg of pantoprazole are available for this purpose). If you suffer from moderate to severe liver problems, you should not take Pantoprazolo to eradicate Helicobacter pylori.
• Use in children and adolescents
• The use of these tablets is not recommended in children under 12 years of age.

If you take more Pantoprazolo ABC than you should
Contact your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take Pantoprazolo ABCDo not take a double dose to make up for a
missed dose. Take the next regular dose at the usual time.

If you stop taking Pantoprazolo ABCDo not stop taking these
tablets without consulting your doctor or pharmacist.
If you have any questions about taking this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Pantoprazolo can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking these tablets and immediately tell your doctor or go to the nearest hospital emergency room.

• Severe allergic reactions (rare frequency:can affect up to 1 in 1,000 people ):swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the face (angioedema/Quincke's edema), severe dizziness with increased heartbeat and profuse sweating.
• Severe skin disorders (frequency not known:the frequency cannot be estimated based on available data ):formation of blisters on the skin and rapid worsening of general condition, erosion (including slight bleeding) of the surface of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, multiforme erythema) and light sensitivity.
• Other serious disorders (frequency not known:the frequency cannot be estimated based on available data): yellowing of the skin or the whites of the eyes (severe damage to liver cells, jaundice) or fever, rash and enlargement of the kidneys sometimes associated with pain when urinating and lower back pain (severe kidney inflammation), which can lead to kidney failure

Other side effects are:

• Common(may affect up to 1 in 10 people)
• Uncommon (may affect up to 1 in 100 people) headache, dizziness, diarrhea, nausea, vomiting, flatulence (gas in the stomach), constipation, dry mouth, abdominal pain and discomfort, rash, exanthema, eruption, itching, weakness, feeling of fatigue or general malaise, sleep disturbances. Taking a proton pump inhibitor such as pantoprazolo, especially for a period of over one year, may slightly increase the risk of hip, wrist or spine fracture. Tell your doctor if you suffer from osteoporosis and are taking corticosteroids (which can increase the risk of osteoporosis).
• Rare (may affect up to 1 in 1,000 people) alteration or complete loss of taste, visual disturbances, such as blurred vision; hives, joint pain, muscle pain, weight change, increased body temperature, high fever, swelling of the extremities (peripheral edema), allergic reactions, depression, breast enlargement in men.
• Very rare(may affect up to 1 in 10,000 people) disorientation.
• Not known(the frequency cannot be estimated based on available data) hallucinations, confusion (particularly in patients who have had these symptoms in the past), reduced levels of sodium in the blood, decreased level of magnesium in the blood (see section 2), sensation of tingling, itching, pins and needles, burning or numbness, erythema, possible joint pains.

Side effects detected with blood tests:

• Uncommon: (may affect up to 1 in 100 people) increase in liver enzymes.
• Rare(may affect up to 1 in 1,000 people)
• increase in bilirubin; increase in blood fat levels; marked decrease in circulating granulocytes, associated with high fever.
• Very rare(may affect up to 1 in 10,000 people)
• reduction in the number of blood platelets, which may increase the possibility of bleeding and bruising, reduction in the number of white blood cells, which may lead to an increased frequency of infections; coexisting abnormal reduction in the number of red blood cells and white blood cells, as well as platelets.

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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

5. HOW TO STORE PANTOPRAZOLO ABC

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 packaging. The expiry
date refers to the last day of the month.
Do not store at a temperature above 30 °C.
Shelf life after first opening (for HDPE bottle): 100 days
Medicines should not be disposed of 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 ABC contains
The active ingredient is pantoprazole (as pantoprazole sodium sesquihydrate).
Each gastro-resistant tablet contains 40 mg of pantoprazole.
The other ingredients are:
Tablet core: mannitol 25 (E421), crospovidone (Type B), anhydrous sodium carbonate,
hydroxypropylcellulose (cps 7.5-14.0), calcium stearate.
Sealing coating: hypromellose (3 cps), titanium dioxide (E171), yellow iron oxide
(E172), propylene glycol.
Enteric coating: methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%,
triethyl citrate, talc.
Printing ink (opacode S-1-16530 brown): shellac, black iron oxide (E172),
red iron oxide (E172), propylene glycol, yellow iron oxide (E172), ammonium hydroxide 28%.

Description of the appearance of Pantoprazolo ABC and package contents
Pantoprazolo ABC 40 mg hard gastro-resistant tablets are yellow, oval,
biconvex, have an enteric coating and bear the inscription “40” on one side and are smooth
on the other side.
Pantoprazolo ABC 40 mg hard gastro-resistant tablets are available in blister packs
made of aluminum/aluminum containing 14, 15, 28, 30, 49, 50, 56, 60 or 98 gastro-resistant tablets and
HDPE bottles containing 100 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
ABC FARMACEUTICI S.P.A.
Corso Vittorio Emanuele II, 72
10121 Turin
Italy
Telephone: +39 (0) 125 240111
Telefax: +39 (0) 125 240179
E-Mail : regulatoryåbcfarmaceutici.it

Manufacturer
ABC FARMACEUTICI S.p.A.
Canton Moretti, 29
10090 San Bernardo d’Ivrea (TO)

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
Germany: Pantoprazol-Heu 40 mg magensaftresistente Tabletten
Netherlands: Pantoprazol Heumann 40 mg maagsapresistente tabletten
Italy: Pantoprazolo ABC 40 mg compresse dure gastro-resistenti
Lithuania: Pantoprazole Torrent 40 mg skrandyje neirios tabletės
United Kingdom: Pantoprazole 40 mg gastro-resistant Tablets