Pantoprazole PensA: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazole Pensa 20 mg gastro-resistant tablets

Generic medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist.

Contents of this leaflet:

What Pantoprazole Pensa is and what it is used for
What you need to know before taking Pantoprazole Pensa
How to take Pantoprazole Pensa
Possible side effects
How to store Pantoprazole Pensa
Contents of the pack and other information

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

Pantoprazole 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.
Pantoprazole Pensa is used for:
Adults and adolescents aged 12 years and older:

Treatment of 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.

Adults:

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING PANTOPRAZOLE PENSA

Do not take Pantoprazole Pensa

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

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

If you have severe liver problems. Inform your doctor if you have previously had liver problems. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazole Pensa for long-term treatment. If liver enzymes increase, treatment must be discontinued.
If you require ongoing treatment with NSAIDs and are taking Pantoprazole Pensa 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 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, particularly 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 Pantoprazole Pensa that reduces gastric acidity.
If you need to undergo a specific blood test (chromogranin A).
If you take pantoprazole for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or 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 periodic blood tests to monitor magnesium levels.

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 Pantoprazole Pensa. Remember to report any other adverse effects such as joint pain.
Inform your doctor immediately if you experience any of the following symptoms:

Unintentional weight loss
Recurrent vomiting
Difficulty swallowing
Blood in vomit
Looking pale and feeling weak (anemia)
Blood in stools
Severe and/or persistent diarrhea, as Pantoprazole Pensa has been associated with a slight increase in infectious diarrhea
Fatigue, confusion, involuntary muscle contractions, seizures, dizziness, and increased heart rate.

Your doctor might decide that you need certain tests to rule out malignancy, as 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 Pantoprazole Pensa 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 whenever you see your doctor.
If you experience any alarm symptoms (e.g., significant unintentional weight loss, recurrent vomiting, dysphagia, hematemesis, anemia, or melena) and gastric ulcer is suspected or confirmed, malignancy must be ruled out, as treatment with pantoprazole may relieve symptoms and delay diagnosis.

Other medicines and Pantoprazole Pensa
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pantoprazole Pensa may affect the effectiveness of other medicines. Inform 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), as Pantoprazole Pensa may prevent these and other medicines from working properly.
Warfarin and phenprocoumon, which affect blood clotting or thinning. You may need additional monitoring.
Atazanavir (used to treat HIV infection)
High-dose methotrexate (used to treat cancer and psoriasis). Your doctor will consider discontinuing Pantoprazole Pensa.
Medicines such as fluvoxamine that inhibit CYP2C19 may increase systemic exposure to pantoprazole. Conversely, medicines such as rifampicin and St. John’s wort (Hypericum perforatum), which are enzyme inducers affecting CYP2C19 and CYP3A4, may reduce plasma concentrations of pantoprazole.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There are insufficient data on the use of pantoprazole in pregnant women. Pantoprazole Pensa should not be used during pregnancy unless clearly necessary.
Breastfeeding
Excretion into human breast milk has been reported. Pantoprazole Pensa should be used during breastfeeding only if your doctor considers the benefit to you to outweigh the potential risk to the breastfed infant.
Fertility
No evidence of impaired fertility has been observed following administration of pantoprazole in animal studies.

Driving and using machines
If you experience adverse effects such as dizziness or visual disturbances, do not drive or operate machinery.

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

Pantoprazole 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 PANTOPRAZOLE PENSA

Always take Pantoprazole Pensa exactly as instructed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist.
When and how should you take Pantoprazole Pensa?
Take the tablets 1 hour before a meal, without chewing or crushing them, swallowing them whole
with some water.
Unless otherwise instructed by your doctor, the recommended dose is:
Adults and adolescents aged 12 years and older:
For the treatment of symptoms associated with gastro-oesophageal reflux disorders (e.g. heartburn,
acid regurgitation, pain on swallowing)
The usual dose is one tablet daily. This dose usually provides relief within 2–4 weeks – at most within a further 4 weeks. Your doctor will tell you how long you should continue taking the medicine. After that, any recurrence of symptoms can be managed by
taking one tablet daily as needed.
For long-term treatment and prevention of recurrence of reflux oesophagitis
The usual dose is one tablet daily. If symptoms recur, your doctor may double the dose; in this case, you may instead use Pantoprazole Pensa 40 mg tablets, one tablet daily. After healing, the dose may be reduced back to one 20 mg tablet daily.
Adults:
For the prevention of duodenal and gastric ulcers in patients requiring continuous treatment with NSAIDs
The usual dose is one tablet daily.
Particular patient groups:

If you have severe liver problems, you must not take more than one 20 mg tablet daily.

Use in children
These tablets are not recommended for use in children under 12 years of age.
If you take more Pantoprazole Pensa than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantoprazole Pensa
Do not take a double dose to make up for the forgotten dose. Take the next dose at the usual scheduled time.
If you stop treatment with Pantoprazole Pensa
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any doubts about how to use Pantoprazole Pensa, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

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

If you experience any of the following adverse reactions, stop treatment with these tablets immediately and consult your doctor or contact the nearest hospital emergency department:

Serious allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, urticaria, breathing difficulties, allergic swelling of the face (Quincke's edema / angioedema), severe dizziness with rapid heartbeat and profuse sweating.
Serious skin disorders (frequency not known): appearance of skin blisters and rapid deterioration of general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), photosensitivity. Erythema, possible joint pain.
Other serious disorders (frequency not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash, and kidney enlargement sometimes accompanied by painful urination or back pain (severe kidney inflammation), potentially progressing to kidney failure.

Other adverse reactions include:

Common (affects 1 to 10 people in 100): benign gastric polyps
Uncommon (affects 1 to 10 people in 1,000): headache; dizziness; diarrhoea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and malaise; skin rash, exanthema; pruritus; feeling of weakness, fatigue or general malaise; sleep disturbances; hip, wrist or spine fracture.
Rare (affects 1 to 10 people in 10,000): distortion or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling of extremities (peripheral oedema); allergic reactions; depression, breast enlargement in men.
Very rare (affects less than 1 in 10,000): disorientation.
Not known (frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients with prior history of such symptoms); decreased sodium levels in blood; muscle spasms as a consequence of electrolyte disturbances; sensations of tingling, pricking, pins and needles, burning or numbness.
Not known (frequency cannot be estimated from the available data): inflammation of the large intestine, causing persistent watery diarrhoea.

Adverse reactions identified through blood tests:

Uncommon (affects 1 to 10 people in 1,000): increased liver enzymes.
Rare (affects 1 to 10 people in 10,000): increased bilirubin; increased blood lipids; reduced number of white blood cells in blood (agranulocytosis).
Very rare (affects less than 1 in 10,000): reduced platelet count, which may lead to bleeding or bruising more than normal; reduced white blood cell count, which may lead to more frequent infections; abnormally low levels of red and white blood cells and platelets (pancytopenia).
Not known: If you take Pantoprazole Pensa for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether regular monitoring of blood magnesium levels is necessary. Decreased levels of sodium and potassium.

If you take a proton pump inhibitor such as Pantoprazole Pensa, especially for 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 may increase the risk of osteoporosis), consult your doctor.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PANTOPRAZOLE PENSA

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 the month.
Packaging in Bottle
Do not use Pantoprazole Pensa more than 90 days after first opening the bottle.
This medicine does not require any special storage conditions.
Packaging in Blister
Store below 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Pantoprazolo Pensa contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of
pantoprazole (as sodium sesquihydrate).
The other components are:
Tablet core: microcrystalline cellulose (E460i), lactose monohydrate, sodium croscarmellose,
anhydrous colloidal silica, magnesium stearate (vegetable origin).
Film coating: methacrylic acid-ethyl acrylate copolymer 1:1, sodium lauryl sulfate, polysorbate
80, triethyl citrate (E1505), talc (E553b),
Colourant (Opadry II 85F32081 yellow): polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide (E171),
talc (E553b), yellow iron oxide (E172), quinoline yellow (E104)

Description of the appearance of Pantoprazolo Pensa 20 mg gastro-resistant tablets and pack contents
Pantoprazolo Pensa 20 mg tablets are film-coated, yellow to ochre in colour, with a gastro-resistant coating, oval-shaped, biconvex.

Pantoprazolo Pensa 20 mg is available in the following pack sizes:
Pack of 14, 28 and 56 gastro-resistant tablets in HDPE bottles with LDPE screw cap and tamper-evident seal (screw cap containing a desiccant capsule).
Pack of 14, 28 and 56 gastro-resistant tablets in blister packs contained in a printed cardboard carton.
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 Milano (MI) - Italy

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

PATIENT LEAFLET: INFORMATION FOR THE USER

Pantoprazole Pensa 40 mg gastro-resistant tablets

Generic medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

What Pantoprazole Pensa is and what it is used for
What you need to know before taking Pantoprazole Pensa
How to take Pantoprazole Pensa
Possible side effects
How to store Pantoprazole Pensa
Contents of the pack and other information

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

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

Adults:

Infection with a bacterium called Helicobacter pylori 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.
Stomach and duodenal ulcers.
Zollinger-Ellison syndrome and other conditions in which excessive acid is produced in the stomach.

2. WHAT YOU SHOULD KNOW BEFORE TAKING PANTOPRAZOLE PENSA

Do not take Pantoprazole Pensa

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

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

If you have severe liver problems. Inform your doctor if you have previously had liver issues. Your doctor may arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazole Pensa for long-term treatment. If liver enzymes increase, treatment should be discontinued.
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 simultaneously taking a medicine containing atazanavir (for the treatment of HIV infection), consult 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 Pantoprazole Pensa that reduces gastric acidity.
If you need to undergo a specific blood test (chromogranin A).
If you take pantoprazole for more than three months, it may lead to reduced magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or 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 periodic blood tests to monitor magnesium levels.

unintentional weight loss
recurrent vomiting
difficulty swallowing
presence of blood in vomit
looking pale and feeling weak (anemia)
presence of blood in stools
severe and/or persistent diarrhea, because Pantoprazole Pensa has been associated with a slight increase in infectious diarrhea, fatigue, confusion, involuntary muscle contractions, seizures, dizziness, and increased heart rate. Your doctor may decide that you need further tests to exclude 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 take Pantoprazole Pensa for long-term treatment (over 1 year), your doctor will likely monitor you regularly. You should report any new or unusual symptoms or circumstances whenever you see your doctor.
If you experience any alarming symptoms (e.g., significant unintentional weight loss, recurrent vomiting, dysphagia, hematemesis, anemia, or melena) and gastric ulcer is suspected or confirmed, malignancy must be ruled out, as treatment with pantoprazole may relieve symptoms and delay diagnosis.

Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazole Pensa may prevent these and other medicines from working properly.
Warfarin and phenprocoumon, which affect blood clotting or thinning. You may require additional monitoring.
Atazanavir (used to treat HIV infection)
High-dose methotrexate (used to treat cancer and psoriasis). Your doctor will consider discontinuing Pantoprazole Pensa.
Medicines such as fluvoxamine, which inhibit CYP2C19, may increase systemic exposure to pantoprazole. Conversely, medicines such as rifampicin and St. John’s wort (Hypericum perforatum), which are enzyme inducers affecting CYP2C19 and CYP3A4, may reduce plasma concentrations of pantoprazole.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There are insufficient data on the use of pantoprazole in pregnant women. Pantoprazole Pensa should not be used during pregnancy unless absolutely necessary.
Breastfeeding
Excretion in human breast milk has been reported. Pantoprazole Pensa should be used during breastfeeding only if your doctor considers the benefit to you to outweigh the potential risk to the breastfed infant.
Fertility
No evidence of impaired fertility has been observed following administration of pantoprazole in animal studies.

Driving and using machines
If you experience adverse effects such as dizziness or visual disturbances, do not drive or operate machinery.

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

Pantoprazole 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 PANTOPRAZOLE PENSA

Always take Pantoprazole Pensa exactly as directed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist.
When and how should you take Pantoprazole Pensa?
Take the tablets 1 hour before a meal, without chewing or crushing them, swallowing them whole
with some water.
Unless otherwise instructed by your doctor, the recommended dose is:
Adults and adolescents aged 12 years and older:
For the treatment of reflux esophagitis
The usual dose is one tablet per day. Your doctor may instruct you to increase the dose to 2
tablets per 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 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—amoxicillin, clarithromycin, or 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 make 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 per 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 excessive
stomach acid is produced.
The recommended initial dose is usually two tablets per day.
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 per day are prescribed, the tablets should be taken twice daily.
If your doctor prescribes a daily dosage of more than four tablets per day, you will be given specific instructions on when to stop taking the medicine.
Special patient groups:

If you have moderate or severe renal impairment, you must not take Pantoprazole Pensa for Helicobacter pylori eradication.
If you have severe hepatic impairment, you must not take more than one 20 mg pantoprazole tablet per day (for this purpose, tablets containing 20 mg of pantoprazole are available).

Use in children
These tablets are not recommended for use in children under 12 years of age.
If you take more Pantoprazole Pensa than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantoprazole Pensa
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 Pantoprazole Pensa
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any doubts about how to use Pantoprazole Pensa, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of the possible adverse reactions listed below is defined using the following convention:
very common (affects more than 1 in 10 people)
common (affects 1 to 10 in 100 people)
uncommon (affects 1 to 10 in 1,000 people)
rare (affects 1 to 10 in 10,000 people)
very rare (affects fewer than 1 in 10,000 people)
not known (frequency cannot be estimated from the available data)

If you experience any of the following adverse reactions, stop treatment with these tablets immediately and consult your doctor or contact the nearest hospital emergency department:

Serious allergic reactions (rare frequency): 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.
Serious skin disorders (frequency not known): appearance of skin blisters and rapid deterioration of general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson Syndrome, Lyell's Syndrome, Erythema multiforme), and photosensitivity. Erythema, possible joint pain.
Other serious disorders (frequency not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash, and kidney enlargement sometimes with pain on urination and lower back pain (severe kidney inflammation), possibly progressing to kidney failure.

Other adverse reactions include:

Common (affects 1 to 10 in 100 people): benign gastric polyps
Uncommon (affects 1 to 10 in 1,000 people): headache; dizziness; diarrhoea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash, exanthema; pruritus; feeling of weakness, fatigue or general malaise; sleep disorders; hip, wrist or spine fracture.
Rare (affects 1 to 10 in 10,000 people): distortion or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes;
increase in body temperature; swelling of extremities (peripheral oedema); allergic reactions; depression; breast enlargement in men.
Very rare (affects fewer than 1 in 10,000 people): disorientation.
Not known (frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients with prior experience of these symptoms); decreased sodium levels in the blood; muscle spasms as a consequence of electrolyte disturbances; sensations of tingling, prickling, pins and needles, burning or numbness.
Not known (frequency cannot be estimated from the available data): inflammation of the large intestine, causing persistent watery diarrhoea.

Adverse reactions identified through blood tests:

Uncommon (affects 1 to 10 in 1,000 people): increased liver enzymes.
Rare (affects 1 to 10 in 10,000 people): increased bilirubin; increased blood lipids; reduced number of white blood cells in the blood (agranulocytosis).
Very rare (affects fewer than 1 in 10,000 people): reduced platelet count, which may cause increased bleeding or bruising; reduced white blood cell count, which may lead to more frequent infections; abnormal reduction in red blood cells, white blood cells and platelets (pancytopenia).
Not known: if you take Pantoprazole Pensa for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PANTOPRAZOLE PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and container after "Exp."
The expiry date refers to the last day of the month.

Packaging in Bottle
Do not use Pantoprazole Pensa more than 90 days after first opening the bottle.

This medicine does not require any special storage conditions.

Packaging in Blister
Store at a temperature not exceeding 30°C.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Pantoprazolo Pensa contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of
pantoprazole (as sodium sesquihydrate).
The other components are:
Tablet core: microcrystalline cellulose (E460i), lactose monohydrate, sodium
croscarmellose, anhydrous colloidal silica, magnesium stearate (vegetable origin).
Film coating: methacrylic acid-ethyl acrylate copolymer 1:1, sodium lauryl sulfate, polysorbate
80, triethyl citrate (E1505), talc (E553b).
Colourant (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 pack contents
Pantoprazolo Pensa 40 mg tablets are film-coated, pale yellow to ochre in colour, with a gastro-resistant coating, 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 cap and tamper-evident seal (screw cap containing a desiccant capsule), and in packs of 14, 28 and 56 gastro-resistant tablets in blisters contained in a lithographed cardboard carton.
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