PANTORC Powder for injectable solution

Зміст інструкції

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

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

1. What is Pantorc and what is it used for

Pantorc contains the active ingredient pantoprazole. Pantorc 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.
Pantorc 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.

Pantorc 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 continued treatment with NSAIDs.

2. What you need to know before taking Pantorc

Do not take Pantorc

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

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

• 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 Pantorc for long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you need continuous treatment with medicines called NSAIDs and are taking Pantorc 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. Talk to your doctor if you notice any of the following symptoms, which may indicate low levels of vitamin B12:
• Extreme fatigue or lack of energy
• Tingling and numbness
• Red or sore tongue, mouth ulcers
• Muscle weakness
• Vision problems
• Memory problems, confusion, depression
• 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 (e.g. if you are taking steroids).
• If you have been taking Pantorc 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 decrease 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 Pantorc that reduces stomach acid.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to stop treatment with Pantorc. Remember to also report any other unwanted effects such as joint pain.
• Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and multiforme erythema have been reported in association with treatment with pantoprazole. Stop using pantoprazole and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions, described in section 4.
• 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
• 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 a malignancy
because pantoprazole also relieves the symptoms of cancer and may cause a delay in diagnosis. If
your symptoms persist despite treatment, further investigations should be considered.
If you take Pantorc for long-term treatment (longer than 1 year), your doctor will probably
keep you under regular control. You should report any new or unusual symptom
whenever you meet your doctor.

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

Other medicines and Pantorc
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including over-the-counter medicines.
Pantorc 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 Pantorc 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 stop treatment with Pantorc 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).

Talk to your doctor before taking pantoprazole if you are to undergo a specific urine test
(for THC; tetrahydrocannabinol).

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 your doctor considers the benefit to you greater than the potential
risk to the fetus or the baby.

Driving and using machines
Pantorc 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.

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

3. How to take Pantorc

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, regurgitation

acid, 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 onetablet 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 Pantorc 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 Pantorc than you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take Pantorc
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 Pantorc
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 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 ):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.
• reddish, non-raised, circular or target-shaped spots on the trunk, often with blisters in the center, skin peeling, ulcers on mouth, throat, nose, genitals and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other severe conditions (frequency not known): yellowing of the skin or the whites of the eyes (severe damage to liver cells, jaundice) or fever, rash, and swelling 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; nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; rash, exanthema, eruption; itching; feeling weak, tired or generally unwell; sleep disorders; hip, wrist or spine fractures.
• Rare(may affect up to 1 in 1,000 people) Alteration or complete loss of the sense of taste; visual disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the extremities (peripheral edema); allergic reactions; depression, increased breast volume in men.
• Very Rare(may affect up to 1 in 10,000 people) Disorientation.
• Not Known(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 sodium, magnesium, calcium or potassium levels in the blood (see section 2).

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 on the safety of
this medicine.

5. How to store Pantorc

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 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 Pantorc contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
• 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 (E1 520), 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 Pantorc and contents of the pack
Gastro-resistant tablet (tablet) yellow, oval, biconvex marked “P20” on one side.
Packs: bottles (container made of high-density polyethylene with a low-density polyethylene screw cap) and blisters (ALU/ALU blisters) without a cardboard reinforcement or with a cardboard reinforcement (wallet blisters).
Pantorc 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 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 names:
More detailed information on this medicine is available on the website of the Italian Medicines Agency ( www.aifa.gov.it ).

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

1. What Pantorc is and what it is used for

Pantorc contains the active substance pantoprazole. Pantorc 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.
Pantorc 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.

Pantorc 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 of these ulcers returning.
• 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 Pantorc

Do not take Pantorc

• 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 Pantorc

• 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 Pantorc 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. Talk to your doctor if you notice any of the following symptoms, which may indicate low levels of vitamin B12:
• Extreme fatigue or lack of energy
• Tingling and prickling
• Red or sore tongue, mouth ulcers
• Muscle weakness
• Vision problems
• Memory problems, confusion, depression
• If you are taking protease inhibitors of HIV such as atazanavir (for the treatment of HIV infection) at the same time as pantoprazole, 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 Pantorc 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, seizures, 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 Pantorc 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 pantoprazole. Remember to also report any other unwanted effects such as joint pain.
• Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and multiforme erythema have been reported in association with treatment with pantoprazole. Stop using pantoprazole and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions, described in section 4.
• 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
• 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

The doctor may decide that you need to undergo some tests to rule out a 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 Pantorc for a 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 Pantorc is not recommended in children, as its effectiveness has not been demonstrated in
children under 12 years of age.

Other medicines and Pantorc
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including over-the-counter medicines.
Pantorc 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 Pantorc may prevent these and other medicines from working properly.
• Warfarin and phenprocoumone, 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 Pantorc 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).

Talk to your doctor before taking pantoprazole if you are to undergo a specific urine test
(for THC; tetrahydrocannabinol).

Pregnancy and breastfeeding and fertility
There are no adequate data regarding the use of pantoprazole in pregnant women. Excretion in human breast milk 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
Pantorc does not alter or negligibly alters the ability to drive vehicles and use machines.
If you experience side effects such as dizziness or vision disturbances, you should not drive or use
machinery.

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

3. How to take Pantorc

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.
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 starting dose is usually two tablets a day.
Take the two tablets 1 hour before a meal. The 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 the 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 Pantorc 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 Pantorc 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 Pantorc than you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take Pantorc
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 Pantorc
Do not stop taking 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, 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 estimated 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.
• reddish, non-raised, circular or target-shaped spots on the trunk, often with blisters in the center, skin peeling, ulcers on the mouth, throat, nose, genitals and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other serious conditions (frequency not known): yellowing of the skin or the whites of the eyes (serious damage to liver cells, jaundice) or fever, rash, and swelling 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.
• Uncommon(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; skin rash, exanthema,
rash; itching; feeling of weakness, fatigue or general malaise; sleep disorders;
hip, wrist or spine fractures.

• Rare(may affect up to 1 in 1,000 people) Alteration or complete loss of the sense of taste; visual disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the extremities (peripheral edema); allergic reactions; depression; increased breast volume in men.
• Very Rare(may affect up to 1 in 10,000 people) Disorientation.
• Not Known(frequency cannot be estimated on the basis of 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; concurrent 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, 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 on the safety of
this medicine.

5. How to store Pantorc

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 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 Pantorc contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 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 (E1 520), 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 Pantorc’s appearance and package contents
Gastro-resistant tablet (tablet) yellow, oval, biconvex marked “P40” on one side.
Packs: bottles (high-density polyethylene container with a low-density polyethylene screw cap) and blisters (ALU/ALU blisters) without a cardboard reinforcement or with a cardboard reinforcement (wallet blisters).
Pantorc 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 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 blister 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 Authorisation Holder
Takeda Italia SpA, via Elio Vittorini 129, 00144 Rome

Manufacturer
Takeda GmbH, Oranienburg Production Site
Lehnitzstraße 70 - 98
D-16515 Oranienburg
Germany
Delpharm Novara S.r.l.
Via Crosa 86
28065 Cerano (NO)
Italy

This medicinal product is authorised in the Member States of the European Economic Area 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 ).

Pantorc 40 mg powder for injectable solution

pantoprazole

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

1. What Pantorc is and what it is used for

Pantorc contains the active substance pantoprazole. Pantorc 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.
This preparation is injected into a vein and will only be administered to you if your doctor believes that injectable pantoprazole is currently more appropriate than pantoprazole tablets. The tablets will replace the injections as soon as your doctor deems it appropriate.

Pantorc is used for the treatment of adults with:

• Reflux esophagitis. Inflammation of the esophagus (the tube connecting the throat to the stomach) accompanied by acid reflux.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before using Pantorc

Do not take Pantorc

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Pantorc

• 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. If liver enzymes increase, treatment must be stopped.
• If you are taking protease inhibitors of HIV such as atazanavir (for the treatment of HIV infection) at the same time as pantoprazole, 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 Pantorc for more than three months, the levels of magnesium in your blood may decrease. Low levels of magnesium can cause fatigue, involuntary muscle contractions, confusion, 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 decrease 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 Pantorc 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 therapy with Pantorc. Also remember to report any other unwanted effects such as joint pain.
• Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and multiforme erythema have been reported in association with treatment with pantoprazole. Stop using pantoprazole and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions, described in section 4.
• 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, 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
• 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.

The doctor may decide that you need to undergo some tests to rule out a malignant disease
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.

Children and adolescents
The use of Pantorc is not recommended in children, given that its efficacy has not been demonstrated in
children under 18 years of age.

Other medicines and Pantorc
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including over-the-counter medicines.
Pantorc 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 Pantorc may prevent these and other medicines from working properly.
• Warfarin and phenprocoumone, 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 stop treatment with Pantorc 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).

Talk to your doctor before taking pantoprazole if you are to undergo a specific urine test
(for THC; tetrahydrocannabinol).

Pregnancy and breastfeeding and fertility
There are no adequate data regarding the use of pantoprazole in pregnant women. Excretion
into human breast milk 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 infant.

Driving and using machines
Pantorc 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 vehicles or use
machines.

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

3. How to take Pantorc

The nurse or doctor will administer the daily dose as an injection into a vein over a period of 2 - 15 minutes.
The recommended dose is:

Adults

For gastric ulcers, duodenal ulcers and reflux esophagitis.
One vial (40 mg of pantoprazole) per day.

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

too much acid is produced in the stomach.
Two vials (80 mg of pantoprazole) per day.
Following this, the doctor may adjust the dosage, based on the amount of your gastric acid secretion. If more than two vials (80 mg) per day are prescribed, the injections will be divided into
two equal administrations. The doctor may temporarily prescribe a dosage higher than four vials (160 mg) per day. If rapid control of gastric acidity is required,
an initial dose of 160 mg (four vials) will be sufficient to adequately reduce acid levels in the stomach.

Patients with liver problems
If you suffer from severe liver problems, the daily injection should only be 20 mg (half a vial).

Use in children and adolescents
These injections are not recommended for use in children and adolescents under 18 years of age.

If you take more Pantorc than you should
The dosages are carefully controlled by the nurse or doctor, so an overdose is very unlikely. No symptoms of overdose are known.
If you have any doubts about the use of Pantorc, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

If you experience any of the following side effects, 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.
• 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 slight 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.
• reddish, non-raised, circular or target-shaped spots on the trunk, often with blisters in the center, skin peeling, ulcers on mouth, throat, nose, genitals and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other serious conditions (frequency not known)yellowing of the skin or the whites of the eyes (serious damage to liver cells, jaundice) or fever, rash, and swelling of the kidneys sometimes with pain when urinating, and lower back pain (serious kidney inflammation) that can lead to possible kidney failure.

Other side effects are:

• Common(may affect up to 1 in 10 people) Inflammation of the vein wall and blood clotting (thrombophlebitis) at the injection site of the medicine; 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; skin rash, exanthem, eruption; itching; feeling of weakness, fatigue or general malaise; sleep disorders; hip, wrist or spine fractures.

• Rare(may affect up to 1 in 1000) Alteration or complete loss of the sense of taste; visual disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the extremities (peripheral edema); allergic reactions; depression; increased breast volume in men.
• Very Rare(may affect up to 1 in 10,000) Disorientation.
• Not Known(frequency cannot be estimated based on available data) Hallucinations, confusion (especially in patients with a history of these symptoms); tingling, pins and needles, burning sensation or numbness, erythema, possible joint pain, inflammation of the colon, causing persistent watery diarrhea.

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 1000) 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 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 Pantorc

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 the vial after
Exp.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Keep the vial in the outer packaging to protect it from light.
Use the reconstituted solution within 12 hours.
Use the reconstituted and diluted solution within 12 hours.
From a microbiological point of view, the product must be used immediately. If not used
immediately, the storage times and conditions before use are the responsibility
of the user and should normally not exceed 12 hours at no more than 25°C.
Do not use Pantorc if you notice an altered appearance (e.g. if turbidity or precipitate is observed).
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 Pantorc Contains

• The active ingredient is pantoprazole. Each vial contains 40 mg of pantoprazole (as pantoprazole sodium).
• The other ingredients are: disodium edetate and sodium hydroxide (for pH adjustment).

Description of the Appearance of Pantorc and Package Contents
Pantorc is a powder for injectable solution from white to almost white. It is presented in a
transparent glass vial of 10 mL closed with an aluminum capsule and a gray rubber stopper containing 40 mg
of powder for injectable solution.
Pantorc is available in the following pack sizes:
Pack of 1 vial.
Multipack of 5 (5 packs of 1) vials.
Hospital pack of 1 vial.
Hospital multipack of 5 (5 packs of 1) vials.
Hospital multipack of 10 (10 packs of 1) vials.
Hospital multipack of 20 (20 packs of 1) vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Takeda Italia SpA, via Elio Vittorini 129, 00144 Rome

Manufacturer
Takeda GmbH
Singen Site
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).
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The following information is intended exclusively for healthcare professionals or healthcare
operators:
The ready-to-use solution should be prepared by injecting 10 mL of sodium chloride 9 mg/mL (0.9%)
injection solution into the vial containing the powder. This solution can be administered
directly or after dilution with 100 mL of sodium chloride 9 mg/mL (0.9%) injection solution or
glucose 55 mg/mL (5%) injection solution. Glass or plastic containers should be used for
dilution.
Pantorc should not be reconstituted or diluted with solvents other than those indicated above.
After reconstitution, the solution must be used within 12 hours. From a
microbiological point of view, the product must be used immediately. If not used immediately, the
storage times and conditions before use are the responsibility of the user and
should not normally exceed 12 hours, at no more than 25°C.
The medicine must be administered intravenously in 2 - 15 minutes.
The contents of the vial are exclusively for a single intravenous administration. Any
product remaining in the container or with altered appearance (e.g. if turbidity or
precipitation is observed) must be discarded.