Pantoprazole Krka: detailed information

Package leaflet: Information for the patient

Pantoprazolo Krka 20 mg gastro-resistant tablets

Pantoprazole
Generic medicine
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 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 side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Pantoprazolo Krka is and what it is used for

Pantoprazolo Krka is a selective "proton pump inhibitor," i.e. 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.
Pantoprazolo Krka is used for:
Adults and adolescents aged 12 years and older

Treatment of symptoms (e.g., heartburn, acid regurgitation, painful swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.
Long-term management of reflux esophagitis (inflammation of the esophagus accompanied by gastric acid regurgitation) 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 need to take NSAIDs continuously.

2. What you should know before taking Pantoprazole Krka

Do not take Pantoprazole Krka

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

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

If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor liver enzymes more frequently, especially if you are undergoing long-term treatment with Pantoprazole Krka. If liver enzymes increase, treatment must be discontinued.
If you are regularly taking medicines called NSAIDs and are being given Pantoprazole Krka because you have an increased risk of developing intestinal or stomach complications. The potential risk increase will be assessed based on your individual risk factors, such as age (65 years or older), history of previous gastric or duodenal ulcers, or previous stomach or intestinal bleeding.
If you have low vitamin B12 levels or risk factors that reduce its absorption and are undergoing long-term treatment with pantoprazole. Like all medicines that reduce acid secretion, pantoprazole may reduce the absorption of vitamin B12.
If you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) together with pantoprazole, consult your doctor for specific advice.
If you are taking a proton pump inhibitor such as pantoprazole, particularly for longer than 1 year, your risk of fracture of the hip, wrist, or spine may be slightly increased. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
If you have been taking Pantoprazole Krka for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause symptoms such as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. 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 Pantoprazole Krka that reduces gastric acidity.
If you develop 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 Krka. 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 if you notice any of the following symptoms:

Unintentional weight loss
Vomiting, especially if recurrent, or presence of blood in vomit; this may appear as dark, coffee-ground-like material in the vomit
Blood in stools; stools may be black or tarry
Difficulty swallowing or pain when swallowing
Pallor and feeling of weakness (anaemia)
Abdominal pain
Stomach pain
Severe and/or persistent diarrhoea, as Pantoprazole Krka has been associated with a slight increase in infectious diarrhoea.

Your doctor may decide to carry out some tests to rule out the presence of a tumour,
since pantoprazole can relieve cancer symptoms and may delay diagnosis. If symptoms
persist despite treatment, further investigations will be considered.
If you are taking Pantoprazole Krka for a long time (more than one year), your doctor will likely
need to perform periodic check-ups. You must report any new or unusual symptoms or circumstances
each time you see your doctor.
Children and adolescents
These tablets are not recommended for use in children under 12 years of age.
Other medicines and Pantoprazole Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Pantoprazole Krka may reduce the effectiveness of other medicines, so it is important that you
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 Pantoprazole Krka may prevent these and other medicines from working properly.
Warfarin and fenprocoumon, which affect blood clotting. Additional monitoring may be required.
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 decide to temporarily discontinue treatment with Pantoprazole Krka, as pantoprazole may increase methotrexate blood levels.
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).

Pantoprazole Krka with food and drinks
Take the tablets 1 hour before meals, without chewing or breaking them, and swallow them whole with water.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
There are insufficient data on the use of pantoprazole in pregnant women. Excretion in breast milk has been reported. You should take 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
Pantoprazole Krka does not affect or has a negligible effect on the ability to drive or use machines.
If you experience adverse effects such as dizziness or visual disturbances, avoid driving or using machines.
Pantoprazole Krka contains sorbitol
If you know you have an intolerance to certain sugars, consult your doctor before taking this
medicine.

3. How to take Pantoprazole Krka

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
When and how to take Pantoprazole Krka
Take the tablets one hour before a meal. Swallow them whole, without chewing or crushing, with a little water.
Unless otherwise directed by your doctor, the recommended dose is as follows.
Adults and adolescents aged 12 years and older
For the treatment of symptoms (e.g., heartburn, acid regurgitation, and painful swallowing) associated with gastroesophageal reflux disease
The recommended dose is one tablet daily. This dose usually relieves symptoms within 2–4 weeks, or at most after another 4 weeks. Your doctor will tell you how long you should continue taking the medicine. After treatment, any recurring symptoms can be managed by taking one tablet daily as needed.
For long-term management and prevention of recurrence of reflux esophagitis
The recommended dose is one tablet daily. If symptoms recur, your doctor may double the dose. In this case, you may use Pantoprazole Krka 40 mg tablets, one tablet daily. After healing, the dose may be reduced to one 20 mg tablet daily.
Adults
For prevention of duodenal and gastric ulcers in patients who must take NSAIDs continuously
The recommended dose is one tablet daily.
Special patient groups
If you have severe liver problems, you must not take more than one 20 mg tablet daily.
Use in children and adolescents
Children under 12 years of age
These tablets are not recommended for children under 12 years of age.
If you take more Pantoprazole Krka than you should
Inform your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantoprazole Krka
Do not take a double dose to make up for the missed dose. Simply take your next dose at the scheduled time.
If you stop taking Pantoprazole Krka
Do not stop taking these tablets without first consulting your doctor or pharmacist.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

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, stop taking these tablets immediately
and contact your doctor or go to the nearest emergency room.

Severe allergic reactions (frequency: rare (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 rapid heartbeat and intense sweating.

Severe skin conditions (frequency not known (the frequency cannot be determined from the available data)):

blistering of the skin and rapid deterioration in 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 conditions (frequency not known (the frequency cannot be determined from the available data)):

yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or
fever,
skin rash, and
kidney enlargement, sometimes associated with painful urination and lower back pain (severe kidney inflammation, potentially worsening into kidney failure).

If you take pantoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause 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 levels of potassium or calcium in the blood. Your doctor should decide whether regular monitoring of blood magnesium levels is necessary.

Rare (may affect up to 1 in 1,000 people)

Severe reduction in white blood cell count, increasing the risk of infections. Report any signs of sudden fever, sore throat, or extreme fatigue, which may indicate infection.

Very rare (may affect up to 1 in 10,000 people)

Reduction in the number of platelets in the blood, which may cause increased bleeding or bruising. Inform your doctor of any unexplained bruising or bleeding.

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;
malaise, vomiting;
bloating and flatulence;
constipation;
dry mouth;
abdominal pain and discomfort;
skin irritation,
rash, eruption;
itching;
fractures of the hip, wrist, or spine;
exhaustion, fatigue, or general malaise;
sleep disturbances.

Rare (may affect up to 1 in 1,000 people)

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;
breast enlargement in males;
taste disturbances.

Very rare (may affect up to 1 in 10,000 people)

disorientation.

Not known (frequency cannot be determined from the available data)

hallucinations, confusion (especially in patients who have previously experienced these symptoms);
decreased sodium levels in the blood;
decreased calcium levels in the blood;
decreased potassium levels in the blood;
tingling or numbness in the hands or feet;
muscle spasms;
erythema, possible joint pains.

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 lipids.

Very rare (may affect up to 1 in 10,000 people)

reduction in white blood cells, which may lead to more frequent infections;
severe reduction in blood cells, which may cause weakness, bruising, and increased susceptibility to infections.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pantoprazole Krka

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, packaging, and blister after the abbreviation EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions regarding temperature.
Blister pack: store in the original packaging to protect the medicine from moisture.
Bottle: keep the container tightly closed to protect it from moisture.
After first opening the bottle, the medicine should be used within 3 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Pantoprazolo Krka contains

The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
The excipients are: mannitol, crospovidone (type B), anhydrous sodium carbonate, sorbitol (E420), calcium stearate in the tablet core; and in the film coating: hypromellose, povidone (K25), titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, macrogol 6000 and talc.

Description of the appearance of Pantoprazolo Krka 20 mg gastro-resistant tablets and pack sizes

The 20 mg gastro-resistant tablets are oval, slightly biconvex, light yellowish-brown tablets.
Pack sizes: 7, 14, 15, 28, 30, 56, 60, 84, 98, 100, 100 x 1, 112 and 140 gastro-resistant tablets in blisters.
One plastic bottle containing 250 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative in Italy
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano, Italy

Manufacturer responsible for batch release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, D - 27472 Cuxhaven, Heinz-Lohmann-Straße 5, Germany

This medicinal product is authorized in other European Economic Area (EEA) Member States under the following names:

Member State Name	Medicinal Product Name
Denmark, Norway, Sweden, Finland, Portugal	PANTOPRAZOL KRKA
France	PANTOPRAZOLE TEVA
Germany	PANTOPRAZOL TAD
Ireland	ZOLEPANT
Italy	PANTOPRAZOLO KRKA
United Kingdom	PANTOPRAZOLE
Estonia, Latvia, Lithuania, Poland, Czech Republic, Czech Republic	NOLPAZA

Patient Information Leaflet

Pantoprazolo Krka 40 mg gastro-resistant tablets

Generic medicine
Pantoprazole
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are similar to yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Pantoprazolo Krka is and what it is used for

Pantoprazolo Krka is a selective "proton pump inhibitor", i.e. 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.
Pantoprazolo Krka is used for:
Adults and adolescents aged 12 years and older

Gastroesophageal reflux disease (oesophagitis). An inflammation of the oesophagus (the tube connecting the throat to the stomach) associated with acid regurgitation from the stomach.

Adults

Infection caused by a bacterium called Helicobacter pylori in patients with duodenal ulcers and gastric ulcers, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacteria and reduce the likelihood of ulcers recurring.
Gastric and duodenal ulcers.
Zollinger-Ellison syndrome and other conditions associated with excessive acid production in the stomach.

2. What you need to know before taking Pantoprazole Krka

Do not take Pantoprazole Krka

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

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

If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor liver enzymes more frequently, especially if you are undergoing long-term treatment with Pantoprazole Krka. If liver enzymes increase, treatment must be discontinued.
If you have low vitamin B12 levels or risk factors that reduce its absorption and are undergoing long-term treatment with pantoprazole. Like all medicines that reduce acid secretion, pantoprazole may lead to reduced absorption of vitamin B12.
If you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) together with pantoprazole, seek specific advice from your doctor.
If you are taking a proton pump inhibitor such as pantoprazole, particularly for longer than 1 year, your risk of fracture of the hip, wrist, or spine may be slightly increased. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
If you have been taking Pantoprazole Krka for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause symptoms such as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or increased heart rate.

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 magnesium levels.

If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Krka that reduces gastric acidity.
If you develop 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 Krka. 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 if you notice any of the following symptoms:

Unintentional weight loss
Vomiting, especially if repeated
Blood in vomit; this may appear as dark, coffee-ground-like material in the vomit
Blood in stools; stools may be black or appear tarry
Difficulty swallowing or pain when swallowing
Abdominal pain
Stomach pain
- Paleness and feeling weak (anemia)
Severe and/or persistent diarrhea, as Pantoprazole Krka has been associated with a slight increase in infectious diarrhea

Your doctor may decide to perform certain tests to rule out the presence of a tumor, since pantoprazole can also relieve symptoms of cancer and may delay diagnosis. If symptoms persist despite treatment, further investigations will be considered.
If you are taking Pantoprazole Krka for a long time (more than one year), your doctor will likely need to perform periodic check-ups. You must report any new or unusual symptoms or circumstances each time you see your doctor.
Children and adolescents
These tablets are not recommended for use in children under 12 years of age.
Other medicines and Pantoprazole Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pantoprazole Krka may affect the effectiveness of other medicines, so it is important that you 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 Pantoprazole Krka may prevent these and other medicines from working properly;
Warfarin and fenprocoumon, which affect blood clotting. Additional monitoring may be required;
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 decide to temporarily discontinue treatment with Pantoprazole Krka, as pantoprazole may 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).

Pantoprazole Krka with food and drink
Take the tablets 1 hour before meals, without chewing or breaking them, and swallow whole with water.
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.
There are insufficient data on the use of pantoprazole in pregnant women. Excretion in breast milk has been reported. You should take this medicine only if your doctor considers that the benefit to you outweighs the potential risk to the fetus or infant.
Driving and using machines
Pantoprazole Krka does not affect or affects only slightly the ability to drive or use machines.
If you experience adverse effects such as dizziness or visual disturbances, avoid driving or operating machinery.
Pantoprazole Krka contains sorbitol
If you know you are intolerant to certain sugars, consult your doctor before taking this medicine.

3. How to take Pantoprazolo Krka

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
When and how to take Pantoprazolo Krka
Take the tablets one hour before a meal, swallowing them whole without chewing or
crushing, with a little water.
Unless otherwise directed by your doctor, the recommended dose is as follows.
Adults and adolescents aged 12 years and older
For the treatment of reflux esophagitis
The recommended dose is one tablet per day. Your doctor may instruct you to increase the dose
to two tablets per day. The treatment period for reflux esophagitis is generally
between 4 and 8 weeks. Your doctor will advise you on how long you should take the medicine.
Adults
For the treatment of an infection caused by a bacterium called Helicobacter pylori in patients
with duodenal ulcers and gastric ulcers, in combination with two antibiotics (eradication therapy)
One tablet twice daily, together with two antibiotic tablets of amoxicillin,
clarithromycin, and metronidazole (or tinidazole), each to be taken twice daily along with the
pantoprazole tablet. Take the first pantoprazole tablet one hour before breakfast and the second pantoprazole tablet one hour before dinner. Follow your doctor's instructions and read the package leaflets of the antibiotics. The treatment period is usually one to two weeks.
For the treatment of gastric and duodenal ulcers
The recommended dose is one tablet per day. After consultation with your doctor, the dose may
be doubled.
Your doctor will advise you on how long you should 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
associated with excessive acid production in the stomach
The usual initial dose is generally two tablets per day.
Take both tablets one hour before a meal. Your doctor may subsequently adjust the dose according to the amount of acid produced in your stomach. If more than two tablets per day are prescribed, the tablets should be taken in two divided doses.
If your doctor prescribes a daily dose exceeding four tablets, they will inform you exactly when you should stop taking the medicine.
Special patient groups

If you have kidney problems or moderate to severe liver problems, you must not take Pantoprazolo Krka for Helicobacter pylori eradication.
If you have severe liver problems, you must not take more than one 20 mg pantoprazole tablet per day (20 mg pantoprazole tablets are available for this purpose).

Use in children and adolescents
Children under 12 years of age.
These tablets are not recommended for children under 12 years of age.
If you take more Pantoprazolo Krka than you should
Inform your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantoprazolo Krka
Do not take a double dose to make up for the missed dose. Simply take the next dose at the usual time.
If you stop taking Pantoprazolo Krka
Do not stop taking these tablets without first consulting your doctor or pharmacist.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

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, stop taking these tablets immediately
and contact your doctor or go to the nearest emergency room.

Severe allergic reactions (uncommon 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 a very rapid heartbeat and intense sweating.

Severe skin conditions (frequency not known (the frequency cannot be determined from the available data)):

blistering of the skin and rapid deterioration in general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and
sensitivity to light.

Other serious conditions (frequency not known (the frequency cannot be determined from the available data)):

yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or
fever,
skin rash and kidney enlargement, sometimes associated with painful urination and pain in the lower back (severe kidney inflammation, possibly worsening to kidney failure).

If you take pantoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause 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.

Rare (may affect up to 1 in 1,000 people)

Severe reduction in white blood cell count, increasing the risk of infections. Report any sudden fever, sore throat, or extreme tiredness, which may be signs of infection.

Very rare (may affect up to 1 in 10,000 people)

Reduction in the number of platelets in the blood, which may lead to increased bleeding or bruising. Inform your doctor of any unexplained bruising or bleeding.

Other side effects are listed below.

Common (may affect up to 1 in 10 people)

benign stomach polyps.

Uncommon (may affect up to 1 in 100 people)

headache;
dizziness;
diarrhoea;
malaise, vomiting;
bloating and flatulence;
constipation; dry mouth;
abdominal pain and discomfort;
skin irritation, rash, eruption;
itching;
fractures of the hip, wrist, or spine;
weakness, fatigue, or general malaise;
sleep disturbances.

Rare (may affect up to 1 in 1,000 people)

Vision disorders such as blurred vision;
hives;
joint pain;
muscle pain;
weight changes;
increased body temperature;
swelling of the extremities (peripheral oedema);
allergic reactions;
depression;
breast enlargement in males;
taste disturbances.

Very rare (may affect up to 1 in 10,000 people)

Disorientation.

Not known (frequency cannot be determined from the available data)

Hallucinations, confusion (especially in patients who have previously experienced these symptoms).
Decreased sodium levels in the blood.
Decreased calcium levels in the blood.
Decreased potassium levels in the blood.
Tingling or numbness in the hands or feet.
Muscle spasms;
Erythema, possible joint pains.

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 fats.

Very rare (may affect up to 1 in 10,000 people)

Reduction in white blood cells, which may lead to more frequent infections;
severe reduction in blood cells, which may cause weakness, bruising, or increased risk of infections.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pantoprazole Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, packaging, and blister after the word EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions regarding temperature.
Blister pack: store in the original packaging to protect the medicine from moisture.
Bottle: keep the bottle tightly closed to protect the medicine from moisture.
After first opening of the bottle, the medicine must be used within 3 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Pantoprazolo Krka contains

The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
The excipients are: mannitol, crospovidone (type B), anhydrous sodium carbonate, sorbitol (E420), calcium stearate in the tablet core; and in the film coating: hypromellose, povidone (K25), titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, macrogol 6000 and talc.

Description of the appearance of Pantoprazolo Krka and package contents
The 40 mg gastro-resistant tablets are slightly biconvex oval tablets of light yellowish-brown colour.
Pack sizes of 7, 14, 15, 28, 30, 56, 60, 84, 98, 100, 100 x 1, 112 and 140 gastro-resistant tablets in blisters.
A plastic bottle containing 250 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative for Italy
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano, Italy

Manufacturer responsible for batch release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicinal product is authorised in other European Economic Area countries under the following names:

Member State Name	Medicinal Product Name
Denmark, Norway, Sweden, Finland, Portugal	PANTOPRAZOL KRKA
France	PANTOPRAZOLE TEVA
Germany	PANTOPRAZOL TAD
Ireland	ZOLEPANT
Italy	PANTOPRAZOLO KRKA
United Kingdom	PANTOPRAZOLE
Estonia, Latvia, Lithuania, Poland, Czech Republic, Czech Republic	NOLPAZA