Pantecta

Package leaflet: Information for the user

Pantecta 20 mg gastro-resistant tablets

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

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

Contents of this leaflet:

1. What 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

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 to treat acid-related diseases of the stomach and intestine.
Pantecta is used for the treatment of adults and adolescents aged 12 years and older for:

• Symptoms (e.g. heartburn, acid regurgitation, pain on 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 gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in at-risk patients who require ongoing NSAID treatment.

2. What you should 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. Inform 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 treatment. If liver enzymes increase, treatment must be discontinued.
• If you require ongoing treatment with medicines called NSAIDs and are taking Pantecta because you are at 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 older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
• If you have low body reserves or risk factors for vitamin B12 deficiency and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12.
• If you are concurrently taking HIV protease inhibitors such as atazanavir (for treatment of HIV infection), please seek specific advice from your doctor.
• Taking a proton pump inhibitor such as pantoprazole, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• If you have been taking Pantecta for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced 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, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantecta. Remember to also report any other adverse effects such as joint pain.
• If you are scheduled for a specific blood test (Chromogranin A).

Inform your doctor immediately before or after taking this medicine if you notice any of the following symptoms, which may be signs of a more serious underlying condition:

• unintentional weight loss
• vomiting, particularly if repeated
• presence of blood in vomit; this may appear as dark coffee-ground-like material in the vomit
• appearance of blood in stools, which may appear dark or tarry
• difficulty swallowing or pain when swallowing
• paleness and weakness (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a slight increase in infectious diarrhea.

Your doctor may decide that you need certain tests to rule out a more serious illness, since pantoprazole can relieve symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you are taking Pantecta for long-term treatment (longer than 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances each time you see your doctor.

Children and adolescents
The use of Pantecta is not recommended in children, as 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 may affect the effectiveness of other medicines, so inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Pantecta may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily discontinue treatment with Pantecta because pantoprazole can increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders) – if you are taking fluvoxamine, your doctor may reduce your dose.
• Rifampicin (used to treat infections).
• St. John’s wort (Hypericum perforatum) (used to treat mild depression).

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

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

3. How to take Pantecta

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Method of administration
Take the tablets 1 hour before meals. Do not chew or crush them; swallow the tablets whole with a
little water.
The recommended dose is:
Adults and adolescents aged 12 years and older

• For the treatment of symptoms associated with gastroesophageal reflux disease (e.g. heartburn, acid regurgitation, pain when swallowing) The usual dose is one tablet daily. This dose usually provides relief within 2–4 weeks,
  and at most within a further 4 weeks. Your doctor will advise you on how long to continue taking the medicine. After this, any recurrence of symptoms can be managed by taking one tablet daily as needed.
• For long-term treatment and prevention of recurrence of reflux esophagitis The usual dose is one tablet daily. If the condition recurs, your doctor may double the dose; in this case, Pantecta 40 mg tablets, one tablet daily, may be used instead. After healing, the dose may be reduced back to one 20 mg tablet daily.

Adults

• For prevention of duodenal and gastric ulcers in patients requiring ongoing treatment with NSAIDs The usual dose is one tablet daily.

Patients with liver problems
If you have severe liver impairment, you must not take more than one 20 mg tablet daily.
Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.
If you take more Pantecta than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantecta
Do not take a double dose to make up for the missed dose. Take the next dose at the usual scheduled time.
If you stop taking Pantecta
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any questions about the use of this medicine, 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 department:

• Severe allergic reactions (rare frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the face (Quincke's edema / angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Serious skin disorders (frequency not known: frequency cannot be estimated from the available data): appearance of skin blisters and rapid deterioration of your general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson Syndrome, Lyell's Syndrome, Erythema multiforme), and sensitivity to light.
• Other serious disorders (frequency not known: frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash, and kidney enlargement sometimes with pain on urination, and pain in the lower back (severe kidney inflammation), which may 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; diarrhoea; nausea, vomiting; bloating and flatulence (gas); constipation;
  dry mouth; abdominal pain and feeling unwell; skin rash, exanthema, eruption; itching; feeling of weakness, fatigue or general malaise; sleep disorders; fractures of the hip, wrist or spine.

• Rare (may affect up to 1 in 1,000 people): altered or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of extremities (peripheral oedema); allergic reactions; depression, breast enlargement in men.

• Very rare (may affect up to 1 in 10,000 people): disorientation.

• Not known (frequency cannot be estimated from the available data): hallucinations, confusion (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 people): increased liver enzymes.
• Rare (may affect up to 1 in 1,000 people): increased bilirubin; increased levels of blood lipids; drastic decrease in circulating granulocytes, associated with high fever.
• Very rare (may affect up to 1 in 10,000 people): reduction in platelet count, which may cause bleeding or bruising more than normal; reduction in white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red and white blood cells as well as platelets.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at the website
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 stated on the carton and container after
Exp.
The expiry date refers to the last day of that month.
For bottles: do not use the tablets more than 120 days after first opening the bottle.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pantecta contains

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
• The other components are:
  Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate.
  Coating: hypromellose, povidone K25, titanium dioxide (E171), 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 oxides (E172), concentrated ammonia solution.

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

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

Manufacturer
Takeda GmbH, Oranienburg facility
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 about this medicinal product is available on the website of the Italian Medicines Agency (www.aifa.gov.it).

Package leaflet: information for the user

Pantecta 40 mg gastro-resistant tablets

Pantoprazole
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult 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 taking Pantecta
3. How to take Pantecta
4. Possible side effects
5. How to store Pantecta
6. Package contents 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 intestine.

Pantecta is used for the treatment of adults and adolescents aged 12 years and above for:

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

Pantecta is used for the treatment of adults for:

• Helicobacter pylori infection in patients with duodenal ulcer and gastric ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacteria in order to reduce the likelihood of these ulcers recurring.
• Gastric and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which excessive 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. Inform your doctor if you have ever had liver problems in the past. Your doctor may arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantecta for long-term treatment. If your liver enzymes increase, treatment should be discontinued.
• If you have low body stores or risk factors for vitamin B12 deficiency and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12.
• If you are taking protease inhibitors for HIV, such as atazanavir (for the treatment of HIV infection), consult your doctor for specific advice.
• Taking a proton pump inhibitor such as pantoprazole, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• If you have been taking Pantecta for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to 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 discontinue treatment with Pantecta. Remember to also report any other adverse effects such as joint pain.
• If you need to undergo a specific blood test (Chromogranin A). Inform your doctor immediately before or after taking this medicine if you notice any of the following symptoms, which may indicate a more serious underlying condition:
• unintentional weight loss
• vomiting, especially if recurrent
• presence of blood in vomit; this may appear as dark coffee-ground material in the vomit
• appearance of blood in stools, which may appear dark or tarry
• difficulty swallowing or pain when swallowing
• looking pale and feeling weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a slight increase in infectious diarrhea.

Your doctor may decide that you need certain tests to rule out malignancy, as pantoprazole can relieve symptoms of cancer and may delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you are taking Pantecta for long-term treatment (more than 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances at every medical visit.
Children and adolescents
The use of Pantecta is not recommended in children, as efficacy has not been demonstrated in children under 12 years of age.
Other medicines and Pantecta
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.
Pantecta may affect the effectiveness of other medicines, so inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Pantecta may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood clotting or thinning. You may need additional monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, or cancer) – if you are taking methotrexate, your doctor may temporarily discontinue treatment with Pantecta because pantoprazole can increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders) – if you are taking fluvoxamine, your doctor may reduce the dose.
• Rifampicin (used to treat infections).
• St. John’s wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy and breastfeeding
There are insufficient data on the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should use this medicine only if your doctor considers the benefit to you greater than the potential risk to the fetus or infant.
Driving and using machines
Pantecta does not alter or alters only negligibly the ability to drive vehicles and use machines.
If you experience adverse effects such as dizziness or visual disturbances, you must not drive or use machinery.

3. How to take Pantecta

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Method of administration
Take the tablets 1 hour before meals. Do not chew or crush them; swallow them whole with a
little water.
Adults and adolescents aged 12 years and older

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

Adults

• For the treatment of infection with a bacterium called Helicobacter pylori in patients with duodenal ulcer and gastric ulcer, in combination with two antibiotics (Eradication therapy). One tablet twice daily, plus two tablets of an antibiotic—among amoxicillin, clarithromycin, and metronidazole (or tinidazole)—each taken twice daily together with the pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before the evening meal. Follow your doctor's instructions and be sure to read the package leaflet for these antibiotics. The usual treatment duration is one or two weeks.
• For the treatment of gastric and duodenal ulcers. The usual dose is one tablet daily. After consulting your doctor, the dose may be doubled.

Your doctor will tell you how long to take the medicine. The treatment period for gastric ulcers is
generally between 4 and 8 weeks. The treatment period for duodenal ulcers is generally between 2 and
4 weeks.

• For long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much stomach acid is produced. The recommended starting dose is usually two tablets daily. Take both tablets 1 hour before a meal. Your doctor may subsequently adjust the dosage depending on the amount of gastric acid produced. If more than two tablets daily are prescribed, the tablets should be taken in two divided doses.
  If your doctor prescribes a daily dose of more than four tablets, you will be given specific instructions on when to stop taking the medicine.
  Patients with kidney problems
  If you have renal impairment, you must not take Pantecta for Helicobacter pylori eradication.
  Patients with liver problems
  If you have severe liver disease, you must not take more than one 20 mg pantoprazole tablet per day (tablets containing 20 mg of pantoprazole are available for this purpose).
  If you have severe or moderate liver disease, you must not take Pantecta for Helicobacter pylori eradication.
  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. Symptoms of overdose are not known.
  If you forget to take Pantecta
  Do not take a double dose to make up for the forgotten dose. Take your next dose at the usual 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 questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience any of the following side effects, consult your doctor immediately or contact the
nearest hospital emergency department:

• Severe allergic reactions (rare frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's edema / angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Severe skin disorders (frequency not known: frequency cannot be determined from available data): development of skin blisters and rapid deterioration of your general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson Syndrome, Lyell's Syndrome, Erythema Multiforme), and sensitivity to light.
• Other severe disorders (frequency not known: frequency cannot be determined from available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash, and kidney enlargement sometimes with painful urination and lower back pain (severe kidney inflammation), which may lead to possible kidney failure.

Other side effects include:

• Common (may affect up to 1 in 10 people): benign gastric polyps.
• Uncommon (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash; exanthema, eruption; itching; feeling of weakness, fatigue or general malaise; sleep disturbances; fractures of the hip, wrist or spine.
• Rare (may affect up to 1 in 1,000 people): altered or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of extremities (peripheral oedema); allergic reactions; depression; breast enlargement in men.
• Very rare (may affect up to 1 in 10,000 people): disorientation.
• Not known (frequency cannot be determined from available data): hallucinations, confusion (especially in patients with a history of these symptoms); decreased blood sodium levels, decreased blood magnesium levels (see section 2), tingling sensation, pins and needles, burning or numbness; erythema; possible joint pain; inflammation of the large intestine causing persistent watery diarrhoea.

Side effects identified through blood tests:

• Uncommon (may affect up to 1 in 100 people): increased liver enzymes.
• Rare (may affect up to 1 in 1,000 people): increased bilirubin; increased blood lipid levels; drastic reduction in circulating granulocytes, associated with high fever.
• Very rare (may affect up to 1 in 10,000 people): reduced platelet count, which may cause bleeding or bruising more than normal; reduced white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red blood cells, white blood cells, and platelets.

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

5. How to store 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 box and container after
Exp.
The expiry date refers to the last day of that month.
For bottles, do not use the tablets more than 100 days after first opening the bottle.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Pantecta contains

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

Description of the appearance of Pantecta and contents of the pack
Yellow, oval, biconvex gastro-resistant tablet (tablet) marked “P 40” on one side.
Packaging: bottles (containers made of high-density polyethylene with low-density polyethylene screw caps) and blisters (ALU/ALU blisters) without cardboard sleeve or with cardboard sleeve (wallet blister).
Pantecta is available in the following pack sizes:
7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100, 112, 168 gastro-resistant tablets.
Hospital packs: 50, 90, 100, 140, 140 (10x14), 150 (10x15), 700 (5x140) gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Takeda Italia SpA, Via Elio Vittorini 129, 00144 Roma, Italy

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

This medicinal product is authorized 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).