PANTOPRAZOLO 20 mg Enteric-Coated Tablet

Зміст інструкції

1. Pantoprazolo Pensa 20 mg gastro-resistant tablets
   1. WHAT PANTOPRAZOLO PENSA IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANTOPRAZOLO PENSA
   3. HOW TO TAKE PANTOPRAZOLO PENSA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE PANTOPRAZOLO PENSA
   6. PACKAGE CONTENTS AND OTHER INFORMATION
2. Pantoprazolo Pensa 40 mg gastro-resistant tablets
   1. WHAT PANTOPRAZOLO PENSA IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANTOPRAZOLO PENSA
   3. HOW TO TAKE PANTOPRAZOLO PENSA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE PANTOPRAZOLO PENSA
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Pantoprazolo Pensa 20 mg gastro-resistant tablets

Generic medicine
Read this leaflet carefully before taking this medicine.

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

Contents of this leaflet:

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

1. WHAT PANTOPRAZOLO PENSA IS AND WHAT IT IS USED FOR

Pantoprazolo Pensa 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.

Pantoprazolo Pensais used for:

Adults and adolescents 12 years and older:

• Treatment of 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.

Adults:

• 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 YOU TAKE PANTOPRAZOLO PENSA

Do not take Pantoprazolo Pensa

• If you are allergic to pantoprazole, substituted benzimidazoles or to any of the excipients of this medicine (see section 6) or to the combined therapy.
• If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions
Talk to your doctor or pharmacist before taking Pantoprazolo Pensa

• If you have severe liver problems. Inform your doctor if you have had liver problems in the past. The doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazolo Pensa for long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you need continuous treatment with NSAIDs and are taking Pantoprazolo Pensa 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 a medicine containing atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
• If you are at risk of osteoporosis, are an elderly patient or in the presence of other risk factors, proton pump inhibitors, especially when used at high doses and for periods longer than 1 year, may increase the risk of fractures of the hip, wrist and spine.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazolo Pensa that reduces gastric acidity.
• If you are to undergo a specific blood test (Chromogranin A).
• If you take pantoprazole for more than three months, a reduction in blood magnesium levels may occur. A reduction in magnesium levels can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or 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 periodic blood tests to monitor magnesium levels.

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
Pantoprazolo Pensa. Remember to also report any other undesirable effects such as pain in the
joints.

Inform your doctor immediatelyif you notice any of the following symptoms:

• an involuntary weight loss
• recurrent vomiting
• difficulty swallowing
• presence of blood in the vomit
• appear pale and feel weak (anemia)
• presence of blood in the stool
• severe and/or persistent diarrhea, because Pantoprazolo Pensa has been associated with a modest increase in infectious diarrhea
• fatigue, rambling, involuntary muscle contractions, convulsions, dizziness and increased heart rate.

The doctor may decide that you need to undergo some tests to rule out a malignant
disease as pantoprazole also relieves the symptoms of cancer and may cause a delay
in diagnosis. If your symptoms persist despite treatment, further investigations must be considered.
If you take Pantoprazolo Pensa for long-term treatment (more than 1 year), your doctor will
probably keep you under regular control. You should report any new or
exceptional symptom or circumstance whenever you meet your doctor.
If you experience any alarming symptoms (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, hematemesis, anemia or melena) and when the
presence of a gastric ulcer is suspected or confirmed, malignancy must be ruled out as treatment with
pantoprazole can relieve symptoms and delay diagnosis.

Other medicines and Pantoprazolo Pensa
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Pantoprazolo Pensa can affect the effectiveness of other medicines, tell your doctor if you are
taking any of the following medicines:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer) because Pantoprazolo Pensa may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood thickening or dilution. You may need further checks.
• Atazanavir (used to treat HIV infection)
• High-dose methotrexate (used to treat cancer and psoriasis). The doctor will assess the suspension of Pantoprazolo Pensa.
• Medicines such as fluvoxamine that inhibit CYP2C19 may increase the systemic exposure of pantoprazole. Instead, medicines such as rifampicin and St. John's wort (Hypericum perforatum), which are enzymatic inducers that affect CYP2C19 and CYP3A4, may reduce plasma concentrations of pantoprazole.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are no adequate data regarding the use of pantoprazole in pregnant women. Pantoprazolo
Pensa should not be used during pregnancy unless absolutely necessary.
Breastfeeding
Excretion in human breast milk has been reported. Pantoprazolo Pensa should be used
during breastfeeding only if the doctor considers the benefit to you greater than the potential risk
to the infant.
Fertility
There has been no evidence of impaired fertility following the administration of pantoprazole in studies
on animals.

Driving and using machines
If you experience side effects such as dizziness or visual disturbances, you should not drive or use
machinery.

Pantoprazolo Pensa contains lactose monohydrate.
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

Pantoprazolo Pensa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. HOW TO TAKE PANTOPRAZOLO PENSA

Always take Pantoprazolo Pensa following exactly the instructions of your doctor. If you have any doubts,
you should consult your doctor or pharmacist.

When and how should you take Pantoprazolo Pensa?
Take the tablets 1 hour before a meal without chewing or crushing them and swallow them whole
with some water.
Unless otherwise informed by your doctor, the recommended dose is:

Adults and adolescents 12 years and over:

For the treatment of symptoms associated with gastro-esophageal reflux disease (e.g. heartburn,
acid regurgitation, pain when swallowing)
The usual dose is one tablet a day. This dose normally provides relief in 2 - 4
weeks - at most after another 4 weeks. Your doctor will tell you how long to continue
taking the medicine. After that, any recurrence of symptoms can be controlled

by taking one tablet a day, as needed.

For long-term treatment and for the prevention of recurrent reflux esophagitis
The usual dose is one tablet a day. If the symptom returns, your doctor may double the
dose, in which case you may instead use Pantoprazolo Pensa 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.

Particular groups of patients:

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

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

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

If you forget to take Pantoprazolo Pensa
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 Pantoprazolo Pensa
Do not stop treatment with these tablets without first consulting your doctor or
pharmacist.
If you have any further questions on the use of Pantoprazolo Pensa, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The frequency of the possible side effects listed below is defined using the following
convention:
very common (affects more than 1 in 10 patients)
common (affects 1 to 10 patients in 100)
uncommon (affects 1 to 10 patients in 1,000)
rare (affects 1 to 10 patients in 10,000)
very rare (affects less than 1 in 10,000)
not known (frequency cannot be estimated based on available data)

If you experience any of the following side effects, stop taking these
tablets and consult your doctor immediately, or contact the nearest hospital emergency room:

• Serious allergic reactions (rare):swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic facial swelling (angioedema / Quincke's edema), severe dizziness with a very fast heartbeat and profuse sweating.
• Serious skin conditions (frequency not known):appearance of skin blisters and rapid deterioration of your general condition, erosion (including slight bleeding) of the eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell's syndrome, Multiforme Erythema) and light sensitivity. Redness, possible joint pain.
• Other serious conditions (frequency not known):yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, skin rash, and enlargement of the kidneys sometimes with pain when urinating or lower back pain (severe kidney inflammation) with the possibility of progressing to kidney failure

Other side effects are:

• Common(affects 1 to 10 patients in 100) benign polyps in the stomach
• Uncommon(affects 1 to 10 patients in 1,000) headache; dizziness; diarrhea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash, exanthema; itching; feeling of weakness, fatigue or general malaise; sleep disturbances; hip, wrist or spine fracture.
• Rare(affects 1 to 10 patients in 10,000) distortion or complete loss of the sense of taste; visual disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities (peripheral edema); allergic reactions; depression, increased breast volume in men.
• Very Rare(affects less than 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 levels of sodium in the blood; muscle spasms as a result of electrolyte disorders; sensation of tingling, prickling, pinpricks, burning or numbness.
• Not known(frequency cannot be estimated based on available data) Inflammation of the large intestine, causing persistent watery diarrhea

Side effects identified through blood tests:

• Uncommon(affects 1 to 10 patients in 1,000) an increase in liver enzymes.
• Rare(affects 1 to 10 patients in 10,000) an increase in bilirubin; increased fats in the blood; reduction in the number of white blood cells in the blood (agranulocytosis).
• Very Rare(affects less than 1 in 10,000) a reduction in the number of platelets, which can cause bleeding or bruising more than normal; a reduction in the number of white blood cells, which can lead to more frequent infections; abnormal reduction in the number of red blood cells and white blood cells, and platelets (pancytopenia)
• Not known: If you take Pantoprazolo Pensa for more than three months, your blood magnesium levels may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels can also lead to decreased blood levels of potassium or calcium. Your doctor should decide whether to regularly check your magnesium levels in the blood. Decrease in sodium and potassium levels.

If you take a proton pump inhibitor such as Pantoprazolo Pensa, especially for
a period longer than one year, there may be a slight increase in the risk of fractures
of the hip, wrist or spine. If you suffer from osteoporosis or are taking
corticosteroids (which can increase the risk of osteoporosis) consult your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can contribute to providing more
information on the safety of this medicine.

5. HOW TO STORE PANTOPRAZOLO PENSA

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 pack and on the container
after Exp.
The expiry date refers to the last day of the month.

Pack in Bottle
Do not use Pantoprazolo Pensa for more than 90 days after first opening the bottle.
This medicine does not require any special storage conditions.

Pack in Blister
Store at a temperature not exceeding 30°C.
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 Pantoprazolo Pensa contains
The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of
pantoprazole (as sodium sesquihydrate).
The other ingredients are:
Tablet core: microcrystalline cellulose (E460i), lactose monohydrate, sodium croscarmellose,
anhydrous colloidal silica, vegetable magnesium stearate.
Film coating: methacrylic acid-ethyl acrylate copolymer 1:1, sodium lauryl sulfate, polysorbate
80, triethyl citrate (E1505), talc (E553b),
Colorant (Opadry II 85F32081 yellow): polyvinyl alcohol, macrogol 3350, titanium dioxide (E-171),
talc (E553b), yellow iron oxide (E-172), quinoline yellow (E-104)

Description of the appearance of Pantoprazolo Pensa 20 mg gastro-resistant tablets and package
contents
Pantoprazolo Pensa 20 mg tablets are film-coated, from yellow to ochre, with
gastro-resistant coating, oval in shape, and biconvex.
Pantoprazolo Pensa 20 mg is available in the following packs:
Pack of 14, 28 and 56 gastro-resistant tablets in an HDPE bottle with an LDPE screw cap and
tamper-evident ring (screw cap containing a desiccant capsule).
Pack of 14, 28 and 56 gastro-resistant tablets in blisters contained in a lithographed cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milan (MI) - Italy

Manufacturer
Towa Pharmaceutical Europe S.L.
c/ de Sant Martí, 75-97
08107 Martorelles (Barcelona) - Spain

Pantoprazolo Pensa 40 mg gastro-resistant tablets

Generic medicine
Read this leaflet carefully before taking this medicine.

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

Contents of this leaflet:

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

1. WHAT PANTOPRAZOLO PENSA IS AND WHAT IT IS USED FOR

Pantoprazolo Pensa 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.

Pantoprazolo Pensais used for:

Adults and adolescents 12 years and over:

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

Adults:

• An infection with a bacterium called Helicobacter pylori in patients with duodenal ulcer and gastric ulcer in combination with two antibiotics (Eradication therapy). The purpose is to get rid of the bacteria in order to reduce the possibility that these ulcers will return.
• 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 YOU TAKE PANTOPRAZOLO PENSA

Do not take Pantoprazolo Pensa

• if you are allergic to pantoprazole, to substituted benzimidazoles or to any of the excipients of this medicine (see list in section 6) or to the combined therapy.
• if you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions
Talk to your doctor or pharmacist before taking Pantoprazolo Pensa

• If you have severe liver problems. Tell your doctor if you have had liver problems in the past. The doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazolo Pensa for long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you have reduced body stores or risk factors for reduced vitamin B12 and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole can lead to reduced absorption of vitamin B12.
• If you are simultaneously taking a medicine containing atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
• If you are at risk of osteoporosis, are an elderly patient or have other risk factors, proton pump inhibitors, especially when used at high doses and for periods longer than 1 year, may increase the risk of fractures of the hip, wrist and spine.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazolo Pensa that reduces gastric acidity.
• If you are to undergo a specific blood test (Chromogranin A).
• If you take pantoprazole for more than three months, a reduction in blood magnesium levels may occur. A reduction in magnesium levels can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. Immediately inform your doctor if you experience any of these symptoms. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

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
Pantoprazolo Pensa. Remember to report any other side effects such as joint pain.

Immediately inform your doctorif you notice any of the following symptoms:

• an involuntary weight loss
• recurrent vomiting
• difficulty swallowing
• presence of blood in vomit
• appear pale and feel weak (anemia)
• presence of blood in the stool
• severe and/or persistent diarrhea, because Pantoprazolo Pensa has been associated with a modest increase in infectious diarrhea, fatigue, rambling, involuntary muscle contractions, convulsions, dizziness and increased heart rate. The doctor may decide that you need to undergo some tests to rule out a malignancy as 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 Pantoprazolo Pensa for long-term treatment (longer than 1 year), your doctor will
probably keep you under regular control. You must report any new or
exceptional symptom or circumstance whenever you meet the doctor.
If you experience any alarming symptoms (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, hematemesis, anemia or melena) and when the
presence of a gastric ulcer is suspected or confirmed, malignancy must be ruled out as treatment with
pantoprazole can relieve symptoms and delay diagnosis.

Other medicines and Pantoprazolo Pensa
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Pantoprazolo Pensa can affect the effectiveness of other medicines, tell your doctor if you are
taking any of the following medicines:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because Pantoprazolo Pensa may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood thickening or thinning. You may need further checks.
• Atazanavir (used to treat HIV infection)
• High-dose methotrexate (used to treat cancer and psoriasis). The doctor will assess the suspension of Pantoprazolo Pensa.
• Medicines such as fluvoxamine that inhibit CYP2C19 may increase the systemic exposure of pantoprazole. Instead, medicines such as rifampicin and St. John's wort (Hypericum perforatum), which are enzymatic inducers that affect CYP2C19 and CYP3A4, may reduce plasma concentrations of pantoprazole.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are no adequate data regarding the use of pantoprazole in pregnant women. Pantoprazolo
Pensa should not be used during pregnancy unless absolutely necessary
Breastfeeding
Excretion in human breast milk has been reported. Pantoprazolo Pensa should be used
during breastfeeding only if the doctor considers the benefit to you greater than the potential risk
to the infant.
Fertility
There has been no evidence of impaired fertility following the administration of pantoprazole in studies
on animals.

Driving and operating machinery
If you experience side effects such as dizziness or visual disturbances, you should not drive or operate
machinery.

Pantoprazolo Pensa contains lactose monohydrate.
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking
this medicine.

Pantoprazolo Pensa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. HOW TO TAKE PANTOPRAZOLO PENSA

Always take Pantoprazolo Pensa exactly as your doctor has instructed. If you have any doubts,
you should consult your doctor or pharmacist.

When and how should you take Pantoprazolo Pensa?
Take the tablets 1 hour before a meal without chewing or crushing them and swallow them whole
with some water.
Unless otherwise informed by your doctor, 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 calledHelicobacter pyloriin 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
or for two 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 long-term treatment of Zollinger-Ellison syndrome and other conditions in
which too much acid is produced in the stomach.
The recommended initial dose is usually two tablets a day.
Take the two tablets 1 hour before a meal. The 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 the doctor prescribes a daily dosage of more than four tablets a day, you will be told
exactly when to stop taking the medicine.

Particular groups of patients:

• If you have moderate or severe kidney problems, you should not take Pantoprazolo Pensa for the eradication of Helicobacter pylori.
• If you suffer from severe liver problems, you should not take more than one 20 mg pantoprazole tablet a day (tablets containing 20 mg of pantoprazole are available for this purpose).

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

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

If you forget to take Pantoprazolo Pensa
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 Pantoprazolo Pensa
Do not stop treatment with these tablets without first consulting your doctor or
pharmacist.
If you have any doubts about the use of Pantoprazolo Pensa, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following
convention:
very common (affects more than 1 in 10 patients)
common (affects 1 to 10 patients in 100)
uncommon (affects 1 to 10 patients in 1,000)
rare (affects 1 to 10 patients in 10,000)
very rare (affects less than 1 in 10,000)
not known (the frequency cannot be estimated from the available data)

If you experience any of the following side effects, stop taking these
tablets and consult your doctor immediately, or contact the nearest hospital emergency
room:

• Serious allergic reactions (rare):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):appearance of blisters on the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, Multiforme erythema) and light sensitivity. Redness, possible joint pain.
• Other serious conditions (frequency not known):yellowing of the skin or the whites of the eyes (severe liver damage, jaundice) or fever, rash, and enlargement of the kidneys sometimes with pain when urinating and lower back pain (severe kidney inflammation) with the possibility of progression to kidney failure

Other side effects are:

• Common(affects 1 to 10 patients in 100) benign polyps in the stomach
• Uncommon(affects 1 to 10 patients in 1,000) headache; dizziness; diarrhea; nausea, vomiting; abdominal bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; rash, exanthema; itching; feeling of weakness, fatigue or general malaise; sleep disturbances; hip, wrist or spine fracture.
• Rare(affects 1 to 10 patients in 10,000) distortion or complete loss of the sense of taste; visual disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes;

increased body temperature; swelling of the extremities (peripheral edema); allergic
reactions; depression; increase in breast volume in men.

• Very Rare(affects less than 1 in 10,000) disorientation.
• Not known(the frequency cannot be estimated from the available data) Hallucinations, confusion (especially in patients with a history of these symptoms); decreased levels of sodium in the blood; muscle spasms as a result of electrolyte disturbances; sensation of tingling, prickling, pinpricks, burning or numbness.
• Not known(the frequency cannot be estimated from the available data) Inflammation of the large intestine, causing persistent watery diarrhea

Side effects identified through blood tests:

• Uncommon(affects 1 to 10 patients in 1,000) an increase in liver enzymes.
• Rare(affects 1 to 10 patients in 10,000) an increase in bilirubin; increased fats in the blood; reduction in the number of white blood cells in the blood (agranulocytosis).
• Very Rare(affects less than 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; abnormal reduction in the number of red blood cells and white blood cells, and platelets (pancytopenia)
• Not known: if you take Pantoprazolo Pensa for more than three months, your blood magnesium levels may decrease. Low levels of magnesium can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness and increased heart rate.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through
the national reporting system at https://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 PANTOPRAZOLO PENSA

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 on the container
after Exp.
The expiry date refers to the last day of the month.

Pack in Bottle
Do not use Pantoprazolo Pensa for more than 90 days after first opening the bottle.
This medicine does not require any special storage conditions.

Pack in Blister
Store at a temperature not exceeding 30°C.
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 Pantoprazolo Pensa contains
The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 mg of
pantoprazole (as sesquihydrate sodium).
The other ingredients are:
Tablet core: microcrystalline cellulose (E460i), lactose monohydrate, sodium
croscarmellose, anhydrous colloidal silica, vegetable magnesium stearate.
Film coating: methacrylic acid-ethyl acrylate copolymer 1:1, sodium lauryl sulfate, polysorbate
80, triethyl citrate (E1505), talc (E553b),
Colorant (Opadry II 85F32029 yellow): polyvinyl alcohol, macrogol 3350, titanium dioxide (E-171),
talc (E553b), yellow iron oxide (E-172).

Description of the appearance of Pantoprazolo Pensa 40 mg gastro-resistant tablets and package
contents
Pantoprazolo Pensa 40 mg tablets are film-coated, pale yellow to ochre, gastro-resistant, oval-shaped, biconvex.
Pantoprazolo Pensa 40 mg is available in packs of 14, 28 and 56 gastro-resistant tablets in
HDPE bottles with LDPE screw caps and a tamper-evident seal (screw cap containing a capsule
with a desiccant effect) and in 14, 28 and 56 gastro-resistant tablets in blisters contained in
lithographed cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milan (MI) - Italy

Manufacturer
Towa Pharmaceutical Europe, S.L.
c/ de Sant Martí, 75-97
08107 Martorelles (Barcelona) - Spain