PANTOPAN 20 mg Tabletki Powlekane

Treść ulotki

1. PANTOPAN 20 mg gastro-resistant tablets
   1. What Pantopan is and what it is used for
   2. What you need to know before taking Pantopan
   3. How to take Pantopan
   4. Possible side effects
   5. How to store Pantopan
   6. Package Contents and Other Information
2. PANTOPAN 40 mg gastro-resistant tablets
   1. What Pantopan is and what it is used for
   2. What you need to know before taking Pantopan
   3. How to take Pantopan
   4. Possible side effects
   5. How to store Pantopan
   6. Package contents and other information

PANTOPAN 20 mg gastro-resistant tablets

pantoprazole

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

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

Contents of this leaflet

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

1. What Pantopan is and what it is used for

Pantopan contains the active substance pantoprazole. Pantopan 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 intestines.
Pantopan is used for the treatment of adults and adolescents 12 years of age 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 esophagitis (inflammation of the esophagus accompanied by acid reflux from the stomach) and prevention of its recurrence.

Pantopan is used for the treatment of adults for

• Prevention of duodenal and stomach ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs, for example ibuprofen) in patients at risk who require continuous treatment with NSAIDs.

2. What you need to know before taking Pantopan

Do not take Pantopan

• If you are allergic (hypersensitive) 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 Pantopan

• If you have severe liver problems. Tell your doctor if you have ever had liver problems in the past. The doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantopan for long-term therapy. If liver enzymes increase, treatment must be discontinued.
• If you need continuous treatment with medicines called NSAIDs and are taking Pantopan because you have an increased risk of developing gastric and intestinal complications. Any increased risk will be assessed based on your personal risk factors such as age (65 years and over), a history of gastric or duodenal ulcers or gastrointestinal bleeding.
• If you have reduced body stores of vitamin B12 or risk factors for reduced vitamin B12 and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole can lead to reduced absorption of vitamin B12.
• If you are simultaneously taking HIV protease inhibitors 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 a period longer than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Tell your doctor if you have osteoporosis (reduced bone density) or if your doctor tells you that you are at risk of osteoporosis (for example, if you are taking steroids).
• If you have been taking Pantopan for more than three months, the levels of magnesium in your blood may decrease. Low levels of magnesium can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. Tell your doctor immediately 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. The 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 Pantopan 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 Pantopan. Also remember to report any other undesirable effects such as joint pain.
• If you are to undergo a specific blood test (Chromogranin A). Tell your doctor immediatelybefore or after taking this medicine, if you notice any of the following symptoms, which may be a sign of a more serious illness:
• unintentional weight loss
• vomiting, especially if repeated
• presence of blood in the vomit; this may appear as dark coffee grounds in the vomit
• appearance of blood in the stool which may appear dark or tarry
• difficulty swallowing or pain when swallowing
• appearing pale and feeling weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a modest increase in infectious diarrhea.

The doctor may decide that you need to undergo some tests to rule out a malignancy in
because pantoprazole also relieves the symptoms of cancer and could cause a delay in diagnosis. If
your symptoms persist despite treatment, further investigations should be considered.
If you take Pantopan for long-term treatment (more than 1 year) your doctor will likely
keep you under regular control. You should report any new or unusual symptom
whenever you meet the doctor.

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

Other medicines and Pantopan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including over-the-counter medicines.
Pantopan can affect the effectiveness of other medicines, so tell your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer) because Pantopan may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood thickening or thinning. You may need further checks.
• 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 suspend treatment with Pantopan because pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric illnesses) - 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 and breastfeeding and fertility
There are no adequate data regarding the use of pantoprazole in pregnant women. It has been reported
excretion in human breast milk.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
You should only use this medicine if the doctor considers the benefit for you greater than the potential risk
for the fetus or the baby.

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

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

3. How to take Pantopan

Take this medicine following exactly the instructions of 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 and swallow them whole with a
little water.
The recommended dose is:

Adults and adolescents 12 years and over

For the treatment of symptoms associated with gastroesophageal reflux disease (e.g., heartburn,

acid regurgitation, pain when swallowing)
The usual dose is one tablet a day. This dose normally provides relief in 2-4 weeks,
at most after another 4 weeks. Your doctor will tell you how long to continue taking the
medicine. After this, any recurrence of symptoms can be controlled by taking one
tablet a day, as needed.

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

Adults

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

Patients with liver problems
If you suffer from severe liver problems, you should not take more than one 20 mg tablet a day.

Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.

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

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

If you stop taking Pantopan
Do not stop treatment with these tablets without first consulting your doctor or
pharmacist.
If you have any further questions on the use of this medicine, ask your doctor, 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 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 1000 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 fast heartbeat and profuse sweating.
• Serious skin conditions (frequency not known: the frequency cannot be defined based on available data):you may notice one or more of the following manifestations - 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, especially in areas of skin exposed to light/sun. You may also have joint pain or flu-like symptoms, fever, swollen glands (e.g. under the armpit) and blood tests may show changes in the white blood cell count or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, Multiforme erythema, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).
• Other serious conditions(frequency not known):yellowing of the skin or the white of the eyes (serious damage to liver cells, jaundice) or fever, rash, enlargement of the kidneys sometimes with pain when urinating, and pain in the lower back (serious kidney inflammation), which can lead to possible kidney failure. Other side effects are :
• Common(may affect up to 1 in 10 people) Benign polyps in the stomach.
• Uncommon(may affect up to 1 in 100 people) Headache; dizziness; diarrhea; feeling sick, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; rash, exanthema, eruption; itching; feeling weak, tired or generally unwell; sleep disturbances; hip, wrist or spine fractures.
• Rare(may affect up to 1 in 1,000 people) Alteration or complete loss of the sense of taste; vision disorders 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; increase in breast volume in men.
• Very Rare(may affect up to 1 in 10,000 people) Disorientation.
• Not known(frequency cannot be estimated based on available data) Hallucinations, confusion (especially in patients with a history of these symptoms); sensation of tingling, pins and needles, burning sensation or numbness, erythema, possible joint pain, inflammation of the large intestine, causing persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100 people) an increase in liver enzymes
• Rare(may affect up to 1 in 1,000 people) an increase in bilirubin; increased levels of fats in the blood; drastic decrease in circulating granulocytes, associated with high fever.
• Very rare(may affect up to 1 in 10,000 people) a reduction in the number of platelets, which can cause bleeding or bruising more than normal; a reduction in the number of white blood cells, which can lead to more frequent infections; coexisting abnormal reduction in the number of red blood cells, white blood cells, and platelets.
• Not known(frequency cannot be estimated from available data) Decrease in the level of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. 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 Pantopan

Keep this medicine out of the sight and reach of children
Do not use this medicine after the expiry date which is stated on the package and container after
EXP. The expiry date refers to the last day of that month.
For bottles: do not use the tablets after 120 days from the first opening of the bottle.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in the 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 Pantopan contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sesquihydrate sodium).
• The other ingredients 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, triethyl citrate. Printing ink :shellac, red, black and yellow iron oxide (E172), concentrated ammonia solution.

Description of Pantopan’s appearance and package contents
Gastro-resistant tablet (tablet) yellow, oval, biconvex marked “P20” on one side.
Packs: bottles (container in high-density polyethylene with a low-density polyethylene screw cap) and blisters (ALU/ALU blisters) without cardboard reinforcement or with cardboard reinforcement (wallet blisters).
Pantopan is available in the following packs:
Bottles of 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100, 112, gastro-resistant tablets
Hospital packs of 50, 56, 84, 90, 112, 140, 140 (10x14 or 5x28), 150 (10x15), 280 (20x14 or
10x28), 500, 700 (5x140) gastro-resistant tablets.
Blister packs of 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100,
112, 168 gastro-resistant tablets.
Hospital packs of 50, 56, 84, 90, 112, 140, 50 (50x1), 140 (10x14 or 5x28),
150 (10x15), 280 (20x14 or 10x28), 500, 700 (5x140) gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Takeda Italia S.p.A., Via Elio Vittorini 129, 00144 Rome

Manufacturer
Takeda GmbH, Oranienburg Production Site
Lehnitzstraße 70 - 98
D-16515 Oranienburg
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
More detailed information on this medicine is available on the website of the Italian Medicines Agency ( www.aifa.gov.it ).

PANTOPAN 40 mg gastro-resistant tablets

pantoprazole

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

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

Contents of this leaflet

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

1. What Pantopan is and what it is used for

Pantopan contains the active substance pantoprazole. Pantopan 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 intestines.
Pantopan is used for the treatment of adults and adolescents 12 years of age and older for

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

Pantopan is used for the treatment of adults for

• An infection with a bacterium called Helicobacter pylori in patients with duodenal ulcer and gastric ulcer in combination with two antibiotics (eradication therapy). The purpose is to get rid of the bacteria in order to reduce the possibility that these ulcers will return.
• Ulcers of the stomach and duodenum.
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before taking Pantopan

Do not take Pantopan

• 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 Pantopan

• If you have severe liver problems. Tell your doctor if you have ever had liver problems in the past. The doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantopan for long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you have reduced body stores or risk factors for reduced vitamin B12 and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity,

pantoprazole can lead to reduced absorption of vitamin B12.

• If you are simultaneously taking HIV protease inhibitors 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 a period longer than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Tell your doctor if you have osteoporosis (reduced bone density) or if your doctor tells you that you are at risk of osteoporosis (for example, if you are taking steroids).
• If you have been taking Pantopan for more than three months, the levels of magnesium in your blood may decrease. Low levels of magnesium can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. Tell your doctor immediately 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 your magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantopan that reduces gastric acidity.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantopan that reduces gastric acidity.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to stop therapy with Pantopan. Also remember to report any other undesirable effects such as joint pain.
• If you are to undergo a specific blood test (Chromogranin A). Tell your doctor immediatelybefore or after taking this medicine if you notice any of the following symptoms, which may be a sign of a more serious illness:
• unintentional weight loss
• vomiting, especially if repeated
• presence of blood in the vomit; this may appear as dark coffee grounds in the vomit
• appearance of blood in the stools which may appear dark or tarry
• difficulty swallowing or pain when swallowing
• appearing pale and feeling weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a modest increase in infectious diarrhea

The doctor may decide that you need to undergo some tests to rule out a malignancy in
because pantoprazole also relieves the symptoms of cancer and could cause a delay in diagnosis. If
your symptoms persist despite treatment, further investigations should be considered.
If you take Pantopan for long-term treatment (more than 1 year) your doctor will likely
monitor you regularly. You should report any new or unusual symptom or circumstance
whenever you see your doctor.

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

Other medicines and Pantopan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including over-the-counter medicines.
Pantopan can affect the effectiveness of other medicines, so tell your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) as Pantopan may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood thickening or thinning. You may need further checks.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis or cancer) - if you are taking methotrexate, your doctor may temporarily suspend treatment with Pantopan because pantoprazole can increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric illnesses) - 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 and breastfeeding and fertility
There are no adequate data regarding the use of pantoprazole in pregnant women. Human milk excretion has been reported.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
You should only use this medicine if the doctor considers the benefit for you greater than the potential risk
to the fetus or the baby.

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

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

3. How to take Pantopan

Take this medicine following the instructions of your doctor or pharmacist exactly. 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 and swallow them whole with a
little water.
The recommended dose is:

Adults and adolescents 12 years and over

• For the treatment of reflux esophagitis, the usual dose is one tablet a day. Your doctor may tell you to increase the dose to 2 tablets a day. The treatment period for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will tell you how long to take the medicine.

Adults

For the treatment of an infection with a bacterium called Helicobacter pylori in patients with

duodenal ulcer and gastric ulcer in combination with two antibiotics (Eradication therapy).
One tablet, twice a day plus two tablets of an antibiotic between amoxicillin,
clarithromycin and metronidazole (or tinidazole), each taken twice a day with the tablet of
pantoprazole. 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 of
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 to take the medicine. The treatment period for gastric ulcers is generally between 4 and 8 weeks. The treatment period for duodenal ulcers is in
general between 2 and 4 weeks.

For the long-term treatment of Zollinger-Ellison syndrome and other conditions in which

too much acid is produced in the stomach.
The recommended initial dose is usually two tablets a day.
Take the two tablets 1 hour before a meal. Your doctor may subsequently adjust the
dosage, depending on the amount of gastric acid produced. If more than two tablets are prescribed
a day, the tablets must be taken twice a day.
If your doctor prescribes a daily dose of more than four tablets a day, you will be told
exactly when to stop taking the medicine.

Patients with kidney problems
If you have kidney problems, you should not take Pantopan for the eradication of Helicobacter pylori.

Patients with liver problems
If you suffer from severe liver problems, you should not take more than one 20 mg tablet of pantoprazole
a day (tablets containing 20 mg of pantoprazole are available for this purpose).
If you suffer from severe or moderate liver problems, you should not take Pantopan 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 Pantopan than you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take Pantopan
Do not take a double dose to make up for a missed dose. Take the normal dose
next time as scheduled.

If you stop taking Pantopan
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, 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 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 fast heartbeat and profuse sweating.
• Severe skin conditions (frequency not known: the frequency cannot be defined based on available data ):you may notice one or more of the following manifestations - 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, especially in areas of skin exposed to light/sun. You may also have joint pain or flu-like symptoms, fever, swollen glands (e.g. under the armpit) and blood tests may show changes in white blood cell count or liver enzymes (Stevens-Johnson syndrome,

Lyell's syndrome, Multiforme erythema, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).

• Other serious conditions(frequency not known): yellowing of the skin or the white of the eyes (severe liver cell damage, jaundice) or fever, rash, and enlargement of the kidneys sometimes with pain when urinating, and lower back pain (severe kidney inflammation), which can lead to possible kidney failure.

Other side effects are :

• Common(may affect up to 1 in 10 people) Benign polyps in the stomach.
• Uncommon(may affect up to 1 in 100 people) Headache; dizziness; diarrhea; feeling sick, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; rash, exanthema, eruption; itching; feeling weak, tired or generally unwell; sleep disturbances; hip, wrist or spine fractures.
• Rare(may affect up to 1 in 1,000 people) Alteration or complete loss of taste; vision 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; increase in breast volume in men.
• Very Rare(may affect up to 1 in 10,000 people) Disorientation.
• Not known(frequency cannot be estimated based on available data) Hallucinations, confusion (especially in patients with a history of these symptoms); sensation of tingling, pins and needles, burning or numbness, erythema, possible joint pain, inflammation of the large intestine, causing persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100 people) an increase in liver enzymes
• Rare(may affect up to 1 in 1,000 people) an increase in bilirubin; increased levels of fats in the blood; drastic decrease in circulating granulocytes, associated with high fever.
• Very Rare(may affect up to 1 in 10,000 people) a reduction in the number of platelets, which can cause more bleeding or bruising than normal; a reduction in the number of white blood cells, 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.
• Not known(frequency cannot be estimated from available data) Decrease in the level of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. 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 Pantopan

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

6. Package contents and other information

What Pantopan contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sesquihydrate sodium).
• The other ingredients 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, triethyl citrate. Printing ink :shellac, red, black and yellow iron oxide (E172), concentrated ammonia solution.

Description of the appearance of Pantopan and package contents
Gastro-resistant tablet (tablet) yellow, oval, biconvex marked “P40” on one side.
Packages: bottles (high-density polyethylene container with a low-density polyethylene screw cap) and blisters (ALU/ALU blisters) without cardboard reinforcement or with cardboard reinforcement (wallet blisters).
Pantopan is available in the following packages:
Bottles of 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100, 112, 168 gastro-resistant tablets.
Hospital packs of 50, 90, 100, 140, 140 (10x14), 150 (10x15), 700 (5x140) gastro-resistant tablets.
Blister packs of 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100,
112, 168 gastro-resistant tablets.
Hospital packs of 50, 90, 100, 140, 50 (50x1), 140 (10x14), 150 (10x15), 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

Manufacturer
Takeda GmbH, Oranienburg Production Site
Lehnitzstraße 70 - 98
D-16515 Oranienburg
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Member State
Name of the medicinal product
Austria
Belgium
Denmark
Zurcal 40 mg film-coated tablets
Zurcale
Pantoloc
More detailed information on this medicine is available on the website of the Italian Medicines Agency ( www.aifa.gov.it ).