PANTECTA 20 mg Gastro-Resistant Tablet

Зміст інструкції

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

Pantecta 20 mg gastro-resistant tablets

Pantoprazole

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

1. What Pantecta is and what it is used for

Pantecta contains the active ingredient pantoprazole. Pantecta 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.
Pantecta is used for the treatment of adults and adolescents aged 12 years and over 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 regurgitation from the stomach) and prevention of its recurrence.

Pantecta is used for the treatment of adults for

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

2. What you need to know before taking Pantecta

Do not take Pantecta

• 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 Pantecta

• If you have severe liver problems. Tell your doctor if you have ever had liver problems. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantecta for long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you need continuous treatment with medicines called NSAIDs and are taking Pantecta 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 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 or are taking corticosteroids (which can increase the risk of osteoporosis).
• If you have been taking Pantecta 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 Pantecta that reduces stomach acid.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as you may need to stop treatment with Pantecta. Remember to report any other unwanted 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:

• an unintentional weight loss
• vomiting, particularly 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
• appear pale and feel weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a modest increase in infectious diarrhea.

Your doctor may decide that you need to undergo some tests to rule out malignancy
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 Pantecta for long-term treatment (more than 1 year) your doctor will probably
keep you under regular control. You should report any new or unusual symptom
whenever you see your doctor.

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

Other medicines and Pantecta
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines without a prescription.
Pantecta 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 Pantecta may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood clotting 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 Pantecta 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
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 your doctor considers the benefit to you greater than the potential
risk to the fetus or infant.

Driving and using machines
Pantecta 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.

3. How to take Pantecta

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 the latest after another 4 weeks. Your doctor will tell you how long to continue taking the medicine. After this, each recurrence of symptoms can be controlled by taking onetablet a day, as needed.
• For long-term treatment and prevention of recurrent reflux esophagitisThe usual dose is one tablet a day. If the disease recurs, your doctor may double the dose, in which case you can instead use Pantecta 40 mg tablets, one a day. After healing, the dose can be reduced back to one 20 mg tablet a day.

Adults

• For the prevention of duodenal and gastric ulcers in patients who require continuoustreatment with NSAIDsThe 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 Pantecta than you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take Pantecta
Do not take a double dose to make up for a missed dose. Take the normal dose
next time it is due.

If you stop taking Pantecta
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 everyone will experience them.

If you experience any of the following side effects, 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 swelling of the face (angioedema / Quincke's edema), severe dizziness with a very fast heartbeat and profuse sweating.
• Severe skin conditions (frequency not known: frequency cannot be estimated based on available data ):appearance of skin blisters and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, Multiforme erythema), and sensitivity to light.
• Othersevere conditions (frequency not known: frequency cannot be estimated based on available data ):yellowing of the skin or the whites of the eyes (severe damage to liver cells, jaundice) or fever, rash, and enlargement of the kidneys sometimes with pain when urinating, and lower back pain (severe kidney inflammation) that 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)

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

• Rare(may affect up to 1 in 1,000) Alteration or complete loss of taste; visual disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the extremities (peripheral edema); allergic reactions; depression, increase in breast volume in men.
• Very Rare(may affect up to 1 in 10,000) Disorientation.
• Not known(frequency cannot be estimated based on available data) Hallucinations, confusion (especially in patients with a history of these symptoms); decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), , , , erythema, possible joint pain,

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100) an increase in liver enzymes.
• Rare(may affect up to 1 in 1,000) 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) a reduction in the number of platelets, which can cause bleeding or bruising more than usual; 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.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
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 Pantecta

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 special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pantecta contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
• 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 Pantecta and contents of the pack
Gastro-resistant tablet (tablet) yellow, oval, biconvex marked “P20” on one side.
Packs: 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).
Pantecta is available in the following packs:
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, 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 SpA, Via Elio Vittorini 129, 00144 Roma

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 with the
following names:
More detailed information on this medicine is available on the website of the Italian Medicines Agency (www.aifa.gov.it ).

Pantecta 40 mg gastro-resistant tablets

Pantoprazole

Read this leaflet carefully before you start to take 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 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 Pantecta is and what it is used for
• 2. What you need to know before you take Pantecta
• 3. How to take Pantecta
• 4. Possible side effects
• 5. How to store Pantecta
• 6. Contents of the pack and other information

1. What Pantecta is and what it is used for

Pantecta contains the active substance pantoprazole. Pantecta 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.
Pantecta 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.

Pantecta is used for the treatment of adults for

• An infection with a bacterium called Helicobacter pyloriin 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 Pantecta

Do not take Pantecta

• 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 Pantecta

• If you have severe liver problems. Tell 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 Pantecta for long-term therapy. If liver enzymes increase, treatment must be stopped.
• If you have reduced body reserves or risk factors for reduced vitamin B12 and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole can lead to reduced absorption of vitamin B12.
• If you are simultaneously taking 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 or are taking corticosteroids (which can increase the risk of osteoporosis).
• If you have been taking Pantecta 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. Inform 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 Pantecta that reduces gastric acid.
• 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 stop therapy with Pantecta. Remember to report any other undesirable effects such as joint pain.
• If you are to undergo a specific blood test (Chromogranin A). Inform 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 Pantecta 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 see your doctor.

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

Other medicines and Pantecta
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including over-the-counter medicines.
Pantecta 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) because Pantecta 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 stop treatment with Pantecta 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
There is 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 your doctor considers the benefit for you greater than the potential risk
to the fetus or the baby.

Driving and using machines
Pantecta 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.

3. How to take Pantecta

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

Adults and adolescents 12 years and over

• For the treatment of reflux esophagitisThe 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 withduodenal ulcer and gastric ulcer in combination with two antibiotics (Eradication therapy).One tablet, twice a day plus two tablets of an antibiotic among amoxicillin, clarithromycin and metronidazole (or tinidazole), each taken twice a day with the pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before the evening meal. Follow your doctor's instructions and make sure to

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 generally between 2 and 4
weeks.

• For the long-term treatment of Zollinger-Ellison syndrome and other conditions inwhich 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 per 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 Pantecta 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
per 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 Pantecta 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 Pantecta than you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take Pantecta
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 Pantecta
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, 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: frequency cannot be estimated based on available data ):appearance of skin blisters and rapid deterioration of your

general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals
(Stevens-Johnson Syndrome, Lyell's Syndrome, Multiforme Erythema), and light sensitivity.

• Other serious conditions (frequency not known: frequency cannot be estimated based on available data ):yellowing of the skin or the white part of the eyes (serious liver cell damage, jaundice) or fever, rash, and enlargement of the kidneys sometimes with pain when urinating, and lower back pain (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.
• NotCommon(may affect up to 1 in 100 people) Headache; dizziness; diarrhea; nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; rash; eruption, rash; itching; feeling weak, tired or 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 disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the extremities (peripheral edema); allergic reactions; depression; increased breast volume in men.
• Very Rare(may affect up to 1 in 10,000 people) Disorientation.
• Not known(frequency cannot be estimated based on available data) Hallucinations, confusion (especially in patients with a history of these symptoms); decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), tingling, prickling and pins and needles sensation, burning or numbness sensation, erythema, possible joint pain, inflammation of the large intestine, causing persistent watery diarrhea.

Side effects identified through blood tests:

• Not Common(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.

Reporting of side effects
If you get any side effects, talk to 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
about the safety of this medicine.

5. How to store Pantecta

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 100 days from the first opening of the bottle.
This medicine does not require any particular 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 Pantecta 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 Pantecta and package contents
Yellow, oval, biconvex gastro-resistant tablet (tablet) marked “P 40” on one side.
Packs: 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).
Pantecta is available in the following pack sizes:
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, 140 (10x14), 150 (10x15), 700 (5x140) gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Takeda Italia SpA, 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 denominations:

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