Peptazol

Patient Information Leaflet

Peptazol 20 mg gastro-resistant tablets

pantoprazole
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Peptazol is and what it is used for

Peptazol contains the active substance pantoprazole. Peptazol 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
acid-related diseases of the stomach and intestine.
Peptazol is used in adults and adolescents aged 12 years and older for:

• 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 oesophagitis (inflammation of the oesophagus accompanied by acid regurgitation from the stomach) and prevention of its recurrence.

Peptazol is used in adults for:

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

2. What you should know before taking Peptazol

Do not take Peptazol

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Peptazol

• If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Peptazol for long-term therapy. If your liver enzymes increase, treatment should be discontinued.

• If you require ongoing treatment with medicines called NSAIDs and are taking Peptazol because you are at increased risk of developing gastric or intestinal complications. Any increased risk will be assessed based on your personal risk factors such as age (65 years and 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 undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12.

• If you are concurrently taking protease inhibitors for HIV, such as atazanavir (for treatment of HIV infection), consult your doctor for specific advice.

• 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 (reduced bone density) or if your doctor has told you that you are at risk of osteoporopenia (for example, if you are taking steroids).

• If you have been taking Peptazol for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.

• If you have ever had a skin reaction after treatment with a medicine similar to Peptazol that reduces gastric acidity.

• If you develop a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to discontinue treatment with Peptazol. Remember to 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 or after taking this medicine if you notice any of the following symptoms, which may indicate a more serious condition:

• unintentional weight loss

• vomiting, particularly if repeated

• presence of blood in vomit; this may appear as dark coffee-ground-like material in the vomit

• appearance of blood in stools, which may look dark or tarry

• difficulty swallowing or pain when swallowing

• looking pale and feeling 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 certain tests to rule out malignant disease, since pantoprazole relieves symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you are taking Peptazol for long-term treatment (over 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances whenever you see your doctor.
Children and adolescents
The use of Peptazol is not recommended in children, as its efficacy has not been demonstrated in children under 12 years of age.
Other medicines and Peptazol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.
Peptazol may affect the effectiveness of other medicines, so inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Peptazol 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.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily discontinue treatment with Peptazol because 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 (used to treat infections).
• St John’s wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy, breastfeeding, and fertility
There are insufficient data on the use of pantoprazole in pregnant women. Excretion into human breast milk has been reported.
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should use this medicine only if your doctor considers the benefit to you to outweigh the potential risk to the fetus or infant.
Driving and using machines
Peptazol does not affect or affects negligibly the ability to drive or use machinery.
If you experience adverse effects such as dizziness or visual disturbances, you must not drive or use machinery.
Peptazol contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Peptazol

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Method of administration
Take the tablets 1 hour before meals 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 disease (e.g. heartburn, acid regurgitation,
pain on swallowing)
The usual dose is one tablet daily. This dose usually provides relief within 2–4 weeks, and at most within a further 4 weeks. Your doctor will advise you on how long to continue taking the medicine.
After this, any recurrence of symptoms can be managed by taking one tablet daily, as needed.
For long-term treatment and prevention of recurrence of reflux esophagitis
The usual dose is one tablet daily. If the disease recurs, your doctor may double the dose; in this case, you may use Peptazol 40 mg tablets, one tablet daily. After healing, the dose may be reduced back to one 20 mg tablet daily.
Adults
For the prevention of duodenal and gastric ulcers in patients requiring continuous treatment with NSAIDs
The usual dose is one tablet daily.
Patients with liver problems
If you have severe liver impairment, you must not take more than one 20 mg tablet daily.
Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.
If you take more Peptazol than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Peptazol
Do not take a double dose to make up for the missed dose. Take the next dose at the usual scheduled time.
If you stop taking Peptazol
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

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 taking this medicine immediately and
contact your doctor, or go to the nearest hospital emergency department:

• 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, allergic swelling of the face (Quincke's oedema / angioedema), severe dizziness with rapid heartbeat and profuse sweating.
• Serious skin disorders (frequency not known: frequency cannot be estimated from the available data): you may notice one or more of the following symptoms – appearance of blisters on the skin and rapid deterioration of your general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arm), and blood tests may show changes in white blood cell count or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).
• Other serious disorders (frequency not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash, and kidney enlargement sometimes with pain on urination and lower back pain (severe kidney inflammation), which may lead to possible kidney failure.

Other side effects include:

• Common (may affect up to 1 in 10 people): benign gastric polyps.
• Uncommon (may affect up to 1 in 100 people):

Headache; dizziness; diarrhoea; nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash, exanthema, eruption; itching; feeling of weakness, fatigue or general malaise; sleep disorders; fractures of the hip, wrist or spine.

• Rare (may affect up to 1 in 1,000 people): altered or complete loss of taste; visual disturbances 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 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 with a history of these symptoms); tingling sensation, pins and needles, burning or numbness; erythema; possible joint pain; inflammation of the large intestine causing persistent watery diarrhoea.

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 blood lipid levels; a drastic decrease in circulating granulocytes, associated with high fever.
• Very rare (may affect up to 1 in 10,000 people): reduced platelet count, which may cause bleeding or bruising more than normal; reduced white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red and white blood cells as well as platelets.
• Not known (frequency cannot be estimated from the available data): decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. 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 Peptazol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and container after Exp.
The expiry date refers to the last day of that month.
For bottles: do not use the tablets more than 120 days after first opening the bottle.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Peptazol contains

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
• The other components are:
  Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate.
  Coating: hypromellose, povidone K25, titanium dioxide (E171), iron oxide yellow (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate.
  Printing ink: shellac, red, black and yellow iron oxide (E172), concentrated ammonia solution.

Description of the appearance of Peptazol and pack contents
Yellow, oval, biconvex gastro-resistant tablet (tablet) marked “P20” on one side.
Packs: bottles (high-density polyethylene container with low-density polyethylene screw cap) and
blister packs (ALU/ALU blisters) without cardboard support or with cardboard support (wallet blister).
Peptazol is available in the following pack sizes:
Bottles containing 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100, 112 gastro-resistant tablets.
Hospital packs containing 50, 56, 84, 90, 112, 140, 140 (10x14 or 5x28), 150 (10x15), 280 (20x14 or 10x28), 500, 700 (5x140) gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Takeda Italia S.p.A.
Via Elio Vittorini 129 – 00144 Rome, Italy

Distributor
Recordati S.p.A.
Via M. Civitali 1
20148 Milan, Italy

Manufacturer
Takeda GmbH
Oranienburg site
Lehnitzstrasse 70 - 98
16515 Oranienburg, Germany

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

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (www.aifa.gov.it).

Patient Information Leaflet

Peptazol 40 mg gastro-resistant tablets

pantoprazole
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 questions, ask your doctor, pharmacist, or nurse.
• 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 side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Peptazol is and what it is used for

Peptazol contains the active substance pantoprazole. Peptazol is a selective "proton pump inhibitor",
a medicine that reduces the amount of acid produced in the stomach. It is used to treat acid-related diseases of the stomach and intestine.
Peptazol is used in adults and adolescents aged 12 years and above for

• Gastroesophageal reflux disease (GERD). Inflammation of the oesophagus (the tube connecting the throat to the stomach) associated with regurgitation of gastric acid.

Peptazol is used in adults for

• Infection with a bacterium called Helicobacter pylori in patients with duodenal ulcer and gastric ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacteria in order to reduce the likelihood of these ulcers recurring.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which excessive stomach acid is produced.

2. What you need to know before taking Peptazol

Do not take Peptazol

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Peptazol

• If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor may arrange for more frequent monitoring of your liver enzymes, especially if you are taking Peptazol for long-term treatment. If liver enzymes increase, treatment should be discontinued.
• If you have low body stores or risk factors for vitamin B12 deficiency and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12.
• If you are taking protease inhibitors for HIV, such as atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
• 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 (reduced bone density) or if your doctor has told you that you are at risk of osteoporosis (e.g., if you are taking steroids).
• If you have been taking Peptazol for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Peptazol that reduces gastric acidity.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Peptazol. Remember to 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 or after taking this medicine, if you notice any of the following symptoms, which may be signs of a more serious underlying condition:

• unintentional weight loss
• vomiting, especially if repeated
• presence of blood in vomit; this may appear as dark, coffee-ground-like material in the vomit
• appearance of blood in stools, which may appear dark or tarry
• difficulty swallowing or pain when swallowing
• looking pale and feeling 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 certain tests to rule out malignancy, since pantoprazole may also relieve symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.

If you are taking Peptazol for long-term treatment (more than 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances each time you see your doctor.

Children and adolescents
The use of Peptazol is not recommended in children, as its efficacy has not been demonstrated in children under 12 years of age.

Other medicines and Peptazol
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.

Peptazol may affect the effectiveness of other medicines, so inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Peptazol may prevent these and other medicines from working properly.
• Warfarin and fenprocoumon, which affect blood clotting or thinning. You may need additional monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily discontinue treatment with Peptazol because 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 (used to treat infections).
• St. John’s Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy, breastfeeding, and fertility
There are insufficient data on the use of pantoprazole in pregnant women. Excretion into human milk has been reported.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should use this medicine only if your doctor considers the benefit to you greater than the potential risk to the fetus or infant.

Driving and using machines
Peptazol does not affect, or has a negligible effect on, the ability to drive or use machinery.
However, if you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.

Peptazol contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Peptazol

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Method of administration
Take the tablets 1 hour before meals, without chewing or crushing them, swallowing them whole with some
water.
The recommended dose is:
Adults and adolescents aged 12 years and older
For the treatment of reflux esophagitis
The usual dose is one tablet daily. Your doctor may instruct you to increase the dose to 2 tablets
daily. 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 infection with a bacterium called Helicobacter pylori in patients with duodenal
ulcer and gastric ulcer, in combination with two antibiotics (Eradication therapy)
One tablet twice daily plus two tablets of an antibiotic—either amoxicillin, clarithromycin, or
metronidazole (or tinidazole)—each taken twice daily together with the pantoprazole tablet. Take the
first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before the
evening meal. Follow your doctor's instructions and make sure to read the package leaflet for these
antibiotics. The usual treatment duration is one or two weeks.
For the 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. The treatment period for gastric ulcers is
generally between 4 and 8 weeks. The treatment period for duodenal ulcers is generally between 2 and 4
weeks.
For long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much
stomach acid is produced
The recommended starting dose is usually two tablets daily.
Take both tablets 1 hour before a meal. Your doctor may subsequently adjust the dosage depending on the
amount of gastric acid produced. If more than two tablets daily are prescribed, the tablets should be taken twice
daily.
If your doctor prescribes a daily dosage of more than four tablets, you will be given specific instructions on when
to stop taking the medicine.
Patients with kidney problems
If you have renal impairment, you must not take Peptazol for the eradication of Helicobacter pylori.
Patients with liver problems
If you suffer from severe liver disease, you must not take more than one 20 mg pantoprazole tablet per
day (tablets containing 20 mg of pantoprazole are available for this purpose).
If you suffer from severe or moderate liver disease, you must not take Peptazol for the eradication
of Helicobacter pylori.
Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.
If you take more Peptazol than you should
Consult your doctor or pharmacist. Overdose symptoms are not known.
If you forget to take Peptazol
Do not take a double dose to make up for a forgotten dose. Take your next dose at the scheduled time.
If you stop taking Peptazol
Do not stop treatment with these tablets without first consulting your doctor, pharmacist, or nurse.
If you have any questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

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 taking this medicine immediately and
consult your doctor, or contact the nearest hospital emergency department:

• Severe allergic reactions (rare frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's edema / angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Severe skin disorders (frequency not known: frequency cannot be estimated from available data): you may notice one or more of the following symptoms – appearance of skin blisters and rapid deterioration of your general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arm), and blood tests may show changes in white blood cell count or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, Erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).
• Other serious disorders (frequency not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, skin rash, and kidney enlargement sometimes with painful urination and lower back pain (severe kidney inflammation), which may lead to possible kidney failure.

Other side effects include:

• Common (may affect up to 1 in 10 people): benign gastric polyps.
• Uncommon (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash, exanthema, eruption; itching; feeling of weakness, fatigue or general malaise; sleep disorders; fractures of the hip, wrist or spine.
• Rare (may affect up to 1 in 1,000 people): altered or complete loss of taste; visual disturbances 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 men.
• Very rare (may affect up to 1 in 10,000 people): disorientation.
• Not known (frequency cannot be estimated from available data): hallucinations, confusion (especially in patients with a history of these symptoms); tingling sensation, pins and needles, burning or numbness, erythema, possible joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

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 blood lipid levels; a drastic decrease in circulating granulocytes, associated with high fever.
• Very rare (may affect up to 1 in 10,000 people): reduced platelet count, which may cause bleeding or bruising more than normal; reduced white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red and white blood cells as well as platelets.
• Not known (frequency cannot be estimated from available data): decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

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

5. How to store Peptazol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton and container after Exp.
The expiry date refers to the last day of that month.
For bottles: do not use the tablets more than 100 days after first opening the bottle.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Peptazol contains

• The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).
• The other components are: Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate. Coating: hypromellose, povidone K25, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate. Printing ink: shellac, red, black and yellow iron oxides (E172), concentrated ammonia solution.

Description of the appearance of Peptazol and package contents
Yellow, oval, biconvex gastro-resistant tablet (tablet) marked "P40" on one side.
Packaging: bottles (containers made of high-density polyethylene with low-density polyethylene screw caps) and blisters (ALU/ALU blisters) without cardboard box or with cardboard carton (wallet blister).
Peptazol is available in the following pack sizes:
Bottles containing 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100 gastro-resistant tablets.
Hospital packs containing 50, 90, 100, 140, 140 (10x14), 150 (10x15), 700 (5x140) gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Takeda Italia S.p.A. Via Elio Vittorini 129 – 00144 Rome, Italy

Selling Agent
Recordati S.p.A.
Via M. Civitali 1
20148 Milan, Italy

Manufacturer
Takeda GmbH
Oranienburg site
Lehnitzstrasse 70 - 98
16515 Oranienburg, Germany

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

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (www.aifa.gov.it).