PANTOPRAZOLE ABC

Patient Information Leaflet: Information for the User

Pantoprazole ABC

20 mg gastro-resistant hard tablets
Equivalent medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may 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:

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

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

Pantoprazole ABC contains the active substance pantoprazole. Pantoprazole 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 disorders of the stomach and intestine.

Pantoprazole ABC is used to treat:

In adults and adolescents aged 12 years and older:

• Treatment of symptoms associated with gastro-oesophageal reflux disease caused by the backflow of acid from the stomach (e.g. heartburn, acid regurgitation, and pain when swallowing)
• Long-term treatment of reflux oesophagitis (inflammation of the oesophagus accompanied by acid regurgitation from the stomach) and prevention of relapses.

Pantoprazole ABC is used in adults to treat:

• Prevention of gastric and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in at-risk patients who require continuous NSAID therapy.

2. What you should know before taking Pantoprazole ABC

Do not take Pantoprazole ABC

• If you are allergic to pantoprazole or to 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
Inform your doctor or pharmacist before taking Pantoprazole ABC

• If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your liver enzymes will be monitored more frequently, especially if you are taking Pantoprazole ABC for long-term treatment. If liver enzymes increase, treatment should be discontinued.
• If you need to take painkillers called NSAIDs continuously and are taking Pantoprazole ABC because you are at higher risk of developing stomach or intestinal 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 low body reserves or risk factors for vitamin B12 deficiency and are receiving long-term treatment with pantoprazole. Like all acid-reducing agents, pantoprazole may lead to reduced absorption of vitamin B12.
• Ask your doctor for specific advice if you are taking protease inhibitors for HIV, such as atazanavir, together with pantoprazole.
• Taking a proton pump inhibitor such as PANTOPRAZOLE ABC, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If you have been taking pantoprazole for more than three months, your blood levels of magnesium (an essential mineral for human body functions) may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels can also lead to reduced levels of potassium or calcium 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 Pantoprazole ABC that reduces gastric acidity.
• If you notice a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazole ABC. Remember to also report any other adverse effects such as joint pain.
• If you need to undergo a specific blood test (Chromogranin A).

Inform your doctor immediately before taking this medicine if you notice any of the
following symptoms, which could be signs of more serious diseases:

• unintentional weight loss
• vomiting, especially if repeated
• vomiting blood; this may appear in vomit as dark, coffee-ground-like material
• blood in the stools; which may appear black or tarry
• difficulty or pain when swallowing
• you are 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.

Your doctor may decide that you need further tests to rule out malignant tumors,
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 ABC for a long time (more than 1 year), your doctor may
want to see you regularly. You must report any new or unusual symptoms or circumstances
each 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.

Pantoprazole ABC and other medicines:
Inform your doctor if you are taking, have recently taken, or might take any other
medicines, including over-the-counter medicines.
This is because Pantoprazole ABC may affect the effectiveness of other medicines; therefore,
inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), because Pantoprazole ABC may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring.
• Medicines used to treat HIV infection such as atazanavir, and methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily discontinue treatment with Pantoprazole ABC, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders) – 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 dietary supplements.

Pregnancy and breastfeeding
There are insufficient data on the use of pantoprazole in pregnant women. Excretion into breast milk has been reported. If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine should be used only if your doctor considers that the benefit of treatment to you outweighs the potential risk to the fetus or nursing infant.

Driving and using machines
Pantoprazole does not affect, or affects only slightly, the ability to drive vehicles or use machinery. However, if you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.

3. How to take Pantoprazolo ABC

Always take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Method of administration
Take the tablets 1 hour before a meal, without chewing or crushing them, swallowing them whole with
a little water.
The recommended dose is:
Adults and adolescents aged 12 years and older
For the treatment of symptoms associated with gastroesophageal reflux disorders (e.g. heartburn,
acid regurgitation, and pain when swallowing)
The usual dose is one tablet per day. Relief is generally achieved within 2–4 weeks, and at the latest within a further 4 weeks. Your doctor will advise you on how long to continue taking the medicine. After that, any recurrence of symptoms may be managed by taking one tablet per day as needed.
For long-term treatment and for recurrence of reflux esophagitis
The usual dose is one tablet per day. If symptoms return, your doctor may double the dose; in this case, you may use Pantoprazolo ABC 40 mg tablets once daily.
Once healing is achieved, the dose may be reduced again to one 20 mg tablet per day.
Adults
Prevention of gastric and duodenal ulcers in patients who need to take NSAIDs continuously .
The recommended dose is one tablet per day.
Patients with liver problems

• If you have severe liver problems, you must not take more than one 20 mg tablet per day. Use in children and adolescents
• This tablet is not recommended for use in children under 12 years of age.

If you take more Pantoprazolo ABC than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantoprazolo ABC
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 Pantoprazolo ABC
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, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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 department:

• Severe allergic reactions (uncommon: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic facial swelling (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and intense sweating.
• Severe skin conditions (frequency not known: frequency cannot be estimated from the 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, erythema multiforme), and light sensitivity.
• Other serious conditions (frequency not known: frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, rash and swollen kidneys, sometimes accompanied by pain when urinating and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other side effects include:

• Common (may affect up to 1 in 10 people)
• Uncommon (may affect up to 1 in 100 people): Headache; dizziness; diarrhoea; 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 more than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• Rare (may affect up to 1 in 1,000 people): altered or complete loss of taste sensation, vision disorders such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males.
• Very rare (may affect up to 1 in 10,000 people)
• disorientation
• Not known (frequency cannot be estimated from the available data): hallucinations, confusion (particularly in patients with prior experience of such symptoms); decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), tingling sensation, itching, pins and needles, burning or numbness sensations, erythema, possible joint pain.

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 levels of fat in the blood; severe reduction in circulating granulocytes, associated with high fever.
• Very rare (may affect up to 1 in 10,000 people): Reduced number of blood platelets, which may cause increased bleeding or bruising; reduced number of white blood cells in the blood, which may lead to more frequent infections; concomitant abnormal reduction in the number of red blood cells and white blood cells, as well as platelets.

Reporting of side effects
If you experience any side effect, 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 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 Pantoprazole ABC

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and container after "EXP.". The expiry date refers to the last day of that month.
Do not store above 30°C.
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 ABC contains
The active substance is pantoprazole (as sodium 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 (3 cps), titanium dioxide (E 171), yellow iron oxide (E 172), propylene glycol.
Gastro-resistant coating: methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate, talc.
Printing ink (Opacode S-1-16530 brown): shellac glazing agent, butyl alcohol, isopropyl alcohol, black iron oxide (E 172), red iron oxide (E 172), propylene glycol, yellow iron oxide (E 172), 28% ammonium hydroxide.

Description of the appearance of Pantoprazolo ABC and contents of the pack
Pantoprazolo ABC are yellow, oval-shaped, enteric-coated tablets, marked "20" on one side and smooth on the other.
Pantoprazolo ABC is available in aluminum-aluminum foil blisters.
Original pack sizes contain 14, 28, and 30 tablets.
Not all pack sizes may be marketed.

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

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

This medicinal product is authorized in the European Economic Area countries under the following names:
Netherlands: Pantoprazol Heumann 20 mg maagsapresistente tabletten
Italy: Pantoprazolo ABC 20 mg compresse dure gastro-resistenti
Lithuania: Pantoprazole Torrent 20 mg skrandyje neirios tabletés
United Kingdom: Pantoprazole 20 mg gastro-resistant tablets

This package leaflet was last approved in the month of……………..
PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazole ABC

40 mg gastro-resistant tablets
Pantoprazole
Generic medicine
Please 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 doubts, consult 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 could 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:

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

1. WHAT PANTOPRAZOLE ABC IS AND WHAT IT IS USED FOR

Pantoprazole ABC contains the active substance pantoprazole. Pantoprazole ABC 40 mg gastro-resistant tablets belong to a group of medicines called “proton pump inhibitors”, which reduce the amount of acid produced in the stomach. It is used to treat stomach and intestinal disorders related to acid overproduction.

Pantoprazole ABC is used for:
Adults and adolescents aged 12 years and older for:

• Gastroesophageal reflux disease (GERD) with esophagitis. Inflammation of the esophagus (the tube connecting the throat to the stomach), associated with acid regurgitation from the stomach.

Pantoprazole ABC is used in adults for:

• Helicobacter pylori infection in patients with duodenal or gastric ulcers, in combination with two antibiotics (eradication therapy). The goal is to eliminate the bacteria and reduce the risk of ulcer recurrence.

• Gastric and duodenal ulcers.

• Zollinger-Ellison syndrome and other conditions characterized by excessive gastric acid production.

2. WHAT YOU NEED TO KNOW BEFORE TAKING PANTOPRAZOLE ABC

Do not take Pantoprazole ABC 40 mg gastro-resistant tablets if:

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

Warnings and precautions
Inform your doctor or pharmacist before taking Pantoprazole ABC:

• If you have severe liver disease. Inform your doctor if you have previously had liver problems. Your doctor may monitor liver enzymes more frequently, especially if you are taking Pantoprazole ABC 40 mg gastro-resistant tablets long-term. If liver enzymes increase, treatment should be discontinued.
• If you have low body stores or risk factors that reduce vitamin B12 absorption and are on long-term pantoprazole therapy. Like all acid-reducing medicines, pantoprazole may reduce vitamin B12 absorption.
• If you are taking HIV protease inhibitors such as atazanavir (for HIV infection treatment) together with Pantoprazole ABC. Consult your doctor for advice.
• Taking a proton pump inhibitor such as PANTOPRAZOLE ABC, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• If you have been taking Pantoprazole ABC for more than three months, your blood magnesium levels (an essential mineral for human body functions) may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced 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 Pantoprazole ABC that reduces stomach acid.
• If you develop a skin rash, especially in sun-exposed areas, contact your doctor promptly, as treatment with Pantoprazole ABC may need to be stopped. Remember to report any other adverse effects such as joint pain.
• If you are scheduled for a specific blood test (Chromogranin A).

Contact your doctor immediately before taking this medicine if you notice any of the following symptoms, which could indicate more serious underlying conditions:

• Unintentional weight loss
• Vomiting, especially if repeated
• Vomiting blood; this may appear in vomit as dark, coffee-ground-like material
• Blood in stools; stools may appear black or tarry
• Difficulty or pain when swallowing
• Pallor 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 perform tests to rule out the presence of malignant tumors, as pantoprazole can relieve tumor-related symptoms and potentially delay diagnosis. If symptoms persist despite treatment, further investigations may be considered.
If you are taking Pantoprazole ABC 40 mg gastro-resistant tablets long-term (more than 1 year), your doctor will likely schedule regular check-ups. Report any new or unusual symptoms or 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.

Pantoprazole ABC and other medicines
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines.

Pantoprazole ABC 40 mg may affect the effectiveness of other medicines. Inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, or posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as pantoprazole may interfere with their proper function.
• Warfarin or fenprocoumon, which affect blood viscosity or fluidity. You may require additional monitoring.
• Medicines used to treat HIV infection such as atazanavir, or methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily discontinue Pantoprazole ABC, as pantoprazole may increase methotrexate blood levels.
• Fluvoxamine (used to treat depression and other psychiatric disorders). 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 present in some dietary supplements.

Pregnancy and breastfeeding
There are insufficient 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, consult your doctor or pharmacist before taking this medicine.
This medicine should only be used if your doctor considers that the benefit of treatment outweighs the potential risk to the fetus or infant.

Driving and using machines
Pantoprazole does not affect or affects negligibly the ability to drive or use machinery.
However, if you experience side effects such as dizziness or blurred vision, do not drive or operate machinery.

3. HOW TO TAKE PANTOPRAZOLE ABC

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

Method of administration
Take the tablets 1 hour before a meal. Do not chew or crush them; swallow whole with some water.

Recommended dose:
Adults and adolescents aged 12 years and older:

For treatment of reflux esophagitis
The usual dose is one tablet daily. Your doctor may instruct you to increase the dose to two tablets daily. Treatment for reflux esophagitis usually lasts 4 to 8 weeks. Your doctor will tell you how long to take the medicine.

Adults only:

For treatment of Helicobacter pylori infection in patients with duodenal ulcer, in combination with two antibiotics (eradication therapy)
One tablet twice daily, plus two antibiotic tablets (amoxicillin, clarithromycin, and metronidazole or tinidazole), each taken twice daily 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 package leaflets of the antibiotics. The usual treatment duration is 1 to 2 weeks.

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

For long-term treatment of Zollinger-Ellison syndrome and other conditions with excessive gastric acid production
The recommended initial dose is usually two tablets daily.
Take both tablets 1 hour before meals. Your doctor may adjust the dose depending on the amount of acid produced in the stomach. If you are prescribed more than two tablets daily, take them in two divided doses.
If your doctor prescribes a daily dose exceeding four tablets, he or she will provide specific instructions on when to stop taking the medicine.

• Patients with renal impairment
  If you have kidney problems, do not take Pantoprazole ABC for Helicobacter pylori eradication.

• Patients with hepatic impairment
  If you have severe liver disease, do not take more than 20 mg of pantoprazole per day (20 mg tablets are available for this purpose). If you have moderate to severe liver disease, you should not take Pantoprazole ABC for Helicobacter pylori eradication.

• Use in children and adolescents
  Use of these tablets is not recommended in children under 12 years of age.

If you take more Pantoprazole ABC than you should
Contact your doctor or pharmacist. Symptoms of overdose are not known.

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

If you stop taking Pantoprazole ABC
Do not stop taking these tablets without consulting your doctor or pharmacist.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Pantoprazole may cause adverse reactions, although not everyone experiences them.
If you experience any of the following adverse reactions, stop taking these tablets immediately
and contact your doctor or go to the nearest hospital emergency department without delay.

• Severe allergic reactions (uncommon frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, facial swelling due to allergy (Quincke's edema/angioedema), severe dizziness with increased heart rate and profuse sweating.
• Severe skin disorders (frequency not known: frequency cannot be estimated from the available data): blistering of the skin and rapid worsening of general condition, erosion (including mild bleeding) of the surfaces of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), and photosensitivity.
• Other severe disorders (frequency not known: frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash and kidney enlargement sometimes associated with pain during urination and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other side effects include:

• Common (may affect up to 1 in 10 people)
• Uncommon (may affect up to 1 in 100 people): headache, dizziness, diarrhoea, nausea, vomiting, flatulence (gas in the stomach), constipation, dry mouth, abdominal pain and discomfort, skin rash, exanthema, rash, pruritus, weakness, feeling of fatigue or general malaise, sleep disturbances. The use of a proton pump inhibitor such as pantoprazole, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• Rare (may affect up to 1 in 1,000 people): altered or complete loss of taste sensation, visual disturbances such as blurred vision, urticaria, joint pain, muscle pain, weight changes, increased body temperature, high fever, swelling of extremities (peripheral oedema), allergic reactions, depression, breast enlargement in men.
• Very rare (may affect up to 1 in 10,000 people): disorientation.
• Not known (frequency cannot be estimated from the available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms), decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), tingling sensation, pruritus, tingling, burning or numbness, erythema, possible joint pain.

Adverse reactions detected 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 blood lipid levels; marked decrease in circulating granulocytes, associated with high fever.
• Very rare (may affect up to 1 in 10,000 people): reduced number of blood platelets, which may increase the risk of bleeding and bruising; reduced number of white blood cells, which may lead to increased frequency of infections; concomitant abnormal reduction in red and white blood cells as well as platelets.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, inform your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

5. HOW TO STORE PANTOPRAZOLE ABC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Do not store above 30 °C.
Shelf life after first opening (for HDPE bottle): 100 days
Medicines must 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. PACK CONTENTS AND OTHER INFORMATION

What Pantoprazolo ABC contains
The active substance is pantoprazole (as sodium pantoprazole sesquihydrate).
Each gastro-resistant tablet contains 40 mg of pantoprazole.
The other components 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 pack contents
Pantoprazolo ABC 40 mg hard gastro-resistant tablets are yellow, oval, biconvex, enteric-coated tablets with the number "40" printed on one side and smooth on the other side.
Pantoprazolo ABC 40 mg hard gastro-resistant tablets are available in aluminum/aluminum blisters containing 14, 15, 28, 30, 49, 50, 56, 60 or 98 gastro-resistant tablets, and in HDPE bottles containing 100 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
ABC FARMACEUTICI S.P.A.
Corso Vittorio Emanuele II, 72
10121 Torino
Italy
Telephone: +39 (0) 125 240111
Telefax: +39 (0) 125 240179
E-Mail: [email protected]

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

This medicinal product is authorized in the European Economic Area countries under the
following names:
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

This summary of product characteristics was last approved on