PANTOPRAZOLO 20 mg Enteric-Coated Tablet

Зміст інструкції

1. Pantoprazolo Krka 20 mg gastro-resistant tablets
   1. What Pantoprazolo Krka is and what it is used for
   2. What you need to know before taking Pantoprazolo Krka
   3. How to take Pantoprazolo Krka
   4. Possible side effects
   5. How to store Pantoprazolo Krka
   6. Package contents and other information
2. Pantoprazolo Krka 40 mg gastro-resistant tablets
   1. What is Pantoprazolo Krka and what is it used for
   2. What you need to know before you take Pantoprazolo Krka
   3. How to take Pantoprazolo Krka
   4. Possible side effects
   5. How to store Pantoprazolo Krka
   6. Contents of the pack and other information

Pantoprazolo Krka 20 mg gastro-resistant tablets

Pantoprazolo

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor 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. See section 4.

Contents of this leaflet:

• 1. What Pantoprazolo Krka is and what it is used for
• 2. What you need to know before you take Pantoprazolo Krka
• 3. How to take Pantoprazolo Krka
• 4. Possible side effects
• 5. How to store Pantoprazolo Krka
• 6. 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", meaning a medicine that reduces
the amount of acid produced in the stomach. It is used for the treatment of stomach and intestinal diseases related to acid.

Pantoprazolo Krka is used for:

Adults and adolescents aged 12 years and over

• 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 acid regurgitation) and prevention of its recurrence.

Adults

• Prevention of duodenal and gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example ibuprofen) in patients at risk who need to take NSAIDs constantly.

2. What you need to know before taking Pantoprazolo Krka

Do not take Pantoprazolo 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 that contain other proton pump inhibitors.

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

• If you suffer from severe liver disorders. Tell your doctor if you have ever had liver problems. The doctor will check liver enzymes more frequently, especially in case of long-term treatment with Pantoprazolo Krka. If liver enzymes increase, treatment must be discontinued.
• If you need to constantly take medicines called NSAIDs and you are administered Pantoprazolo Krka because you have a higher risk of developing complications of the intestines and stomach. The possible increase in risk will be assessed based on your personal risk factors, such as age (65 years or older) and the development of previous gastric or duodenal ulcers or previous bleeding of the stomach or intestines.
• If you have reduced levels of vitamin B12 or risk factors that reduce its absorption and you are taking long-term treatment with pantoprazole. Like all medicines that reduce acid secretion, pantoprazole can determine a lower absorption of vitamin B12.
• If you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) together with pantoprazole, ask your doctor for specific advice.
• If you are taking a proton pump inhibitor such as pantoprazole, especially for a period of time longer than 1 year, it may slightly increase your risk of fracture of the hip, wrist or spine. Tell your doctor if you suffer from osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If you have been taking Pantoprazolo Krka for more than three months, the levels of magnesium in the blood may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you experience any of these symptoms, tell your doctor immediately. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazolo Krka that reduces stomach acidity
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as you may need to stop treatment with Pantoprazolo Krka. Remember to report any other unwanted effects such as joint pain.
• If you are to undergo a specific blood test (Chromogranin A).

Tell your doctor immediatelyif you notice the appearance of any of the following symptoms:

• unintentional weight loss
• vomiting, especially if repeated; presence of blood in the vomit; this may appear as dark coffee in the vomit
• presence of blood in the stool; which may be black or appear tarry
• difficulty swallowing or pain when swallowing
• paleness and feeling of weakness (anemia)
• abdominal pain
• stomach pain
• severe and/or persistent diarrhea, as Pantoprazolo Krka has been associated with a slight increase in infectious diarrhea.

The doctor may decide to subject you to some tests to exclude the presence of a tumor
because pantoprazole also relieves the symptoms of cancer and can delay diagnosis. If the symptoms
persist despite treatment, further
investigations will be considered.
If you take Pantoprazolo Krka for a long period (more than one year), the doctor will probably
need to subject you to periodic checks. You must report any new and unusual symptom or circumstance
every time you see your doctor.

Children and adolescents
These tablets are not recommended for use in children under the age of 12 years.

Other medicines and Pantoprazolo Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Pantoprazolo Krka can compromise the effectiveness of other medicines, so you need to
tell your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole and posaconazole (used for the treatment of fungal infections) or erlotinib (used for some types of tumors) because Pantoprazolo Krka may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood density. Further checks may be necessary.
• 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 interrupt treatment with Pantoprazolo Krka in as pantoprazole can increase the levels of methotrexate in the blood.
• Fluvoxamine (used to treat depression and other psychiatric illnesses) - if you are taking fluvoxamine your doctor may reduce the dose.
• Rifampicin (used to treat infections)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Pantoprazolo Krka with food and drink
Take the tablets 1 hour before meals without chewing or breaking the tablets, and swallow them
whole with water.

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.
There is insufficient data on the use of pantoprazole in pregnant women. Excretion has been reported
in breast milk. You should only take this medicine if your doctor believes that the
benefit to you is greater than the potential risk to the fetus or the infant.

Driving and operating machinery
Pantoprazolo Krka does not alter or alters negligibly the ability to drive vehicles or operate
machinery.
If you develop side effects such as dizziness or visual disturbances, avoid driving vehicles or
operating machinery.

Pantoprazolo 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 following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.

When and how to take Pantoprazolo Krka
Take the tablets one hour before a meal and swallow them whole, without chewing or
crushing, with a little water.
Unless your doctor provides different instructions, the recommended dose is as follows.

Adults and adolescents aged 12 years or over

For the treatment of symptoms (e.g., heartburn, acid regurgitation and painful swallowing
) associated with gastroesophageal reflux disease
The recommended dose is one tablet a day. Generally, this dose relieves symptoms
within 2-4 weeks or at most after another 4 weeks. Your doctor will tell you how long you should
continue to take the medicine. After treatment, any recurring symptoms can
be controlled by takingone tablet a dayas needed.

For the long-term management and prevention of the recurrence of reflux esophagitis
The recommended dose is one tablet a day. If the discomfort recurs, your doctor may
double the dose. In this case, you may use Pantoprazolo Krka 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 need to take NSAIDs
constantly
The recommended dose is one tablet a day.

Special patient groups
If you suffer from severe liver problems, you cannot take more than one 20 mg tablet a day.

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. No symptoms of overdose are known.

If you forget to take Pantoprazolo Krka
Do not take a double dose to make up for a missed dose. Simply
take the next normal dose at the scheduled 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 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 everybody gets them.

If you experience any of the following side effects, stop taking these tablets and immediately inform your doctor or go to the nearest emergency room.
Severe allergic reactions (rare frequency (may affect up to 1 in 1,000 people):

• swelling of the tongue and/or throat,
• difficulty swallowing,
• urticaria (hives),
• difficulty breathing,
• allergic swelling of the face (angioedema/Quincke's edema),
• severe dizziness with a very rapid heartbeat and profuse sweating.

Severe skin conditions (frequency not known (frequency cannot be estimated based on available data)):

• blistering of the skin and rapid deterioration of 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 (frequency cannot be estimated based on available data)):

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

If you take pantoprazolo for more than three months, your blood magnesium levels may decrease. Low magnesium levels can manifest with fatigue, involuntary muscle contractions, confusion, convulsions, dizziness and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels can also lead to a reduction in blood potassium or calcium levels. The doctor should decide whether to regularly check magnesium levels in the blood.

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

• Serious reduction in the number of white blood cells, which makes infections more likely. Report any signs of sudden fever, sore throat, extreme fatigue, 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 can cause bleeding or bruising more than normal. Report any bruises or unexplained bleeding to your doctor.

The other side effects are as follows.

Common (may affect up to 1 in 10 people)

• benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Headache;
• dizziness;
• diarrhea;
• feeling unwell, vomiting;
• meteorism and flatulence;
• constipation;
• dry mouth;
• abdominal pain and discomfort;
• skin irritation,
• rash, eruption;
• itching;
• fractures of the hip, wrist or spine;
• fatigue, tiredness or general feeling of unwellness;
• sleep disturbances.

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

• Vision disturbances such as blurred vision;
• urticaria (hives);
• joint pain;
• muscle pain;
• weight changes;
• increased body temperature;
• swelling of the extremities (peripheral edema);
• allergic reactions;
• depression;
• enlargement of the breasts in males;
• altered taste.

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

• Disorientation.

Not known (frequency cannot be estimated based on available data)

• Hallucinations, confusion (especially in patients who have previously suffered from these symptoms);
• Decreased level of sodium in the blood;
• Decreased level of calcium in the blood;
• Decreased levels of potassium 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 fats in the blood;

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

• Reduction of white blood cells, which can lead to more frequent infections;
• serious reduction of blood cells that can cause weakness, bruising and make infections more likely.

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
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . . Reporting
side effects helps provide more information on the safety of this medicine.

5. How to store Pantoprazolo Krka

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 carton label and
on the packaging and on the blister after the wording EXP. The expiry date refers to the last day
of that month.
This medicine does not require special storage conditions regarding
temperature.
Blister packaging: 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 of the bottle, the medicine must be used within 3 months.
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 Krka contains

• The active ingredient 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 hypromellose, povidone (K25), titanium dioxide (E171), Yellow iron oxide (E172), propylene glycol, methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, macrogol 6000 and talc in the film coating.

Description of the appearance of Pantoprazolo Krka 20 mg gastro-resistant tablets and package contents

The 20 mg gastro-resistant tablets are oval, slightly biconvex tablets of light yellowish-brown color.
Packs 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
TAD Pharma GmbH, D - 27472 Cuxhaven, Heinz - Lohmann - Straße 5, Germany

This medicinal product is authorised in the other Member States of the European Economic Area under the
following denominations:

Pantoprazolo Krka 40 mg gastro-resistant tablets

Generic medicine
Pantoprazolo

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Pantoprazolo Krka is a selective "proton pump inhibitor", meaning a medicine that reduces
the amount of acid produced in the stomach. It is used for the treatment of stomach and intestinal diseases related to acid.

Pantoprazolo Krka is used for:

Adults and adolescents aged 12 years and over

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

Adults

• An infection caused by a bacterium called Helicobacter pyloriin patients with duodenal ulcers and gastric ulcers in association with two antibiotics (eradication therapy). The goal is to eliminate the bacteria and reduce the likelihood of ulcers recurring.
• Gastric and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions associated with the production of an excessive amount of acid in the stomach.

2. What you need to know before you take Pantoprazolo Krka

Do not take Pantoprazolo 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 Pantoprazolo Krka:

• If you suffer from severe liver disorders. Tell your doctor if you have ever had liver problems. The doctor will check liver enzymes more frequently, especially in case of long-term treatment with Pantoprazolo Krka. If liver enzymes increase, treatment must be discontinued.
• If you have reduced levels of vitamin B12 or risk factors that reduce its absorption and are taking long-term treatment with pantoprazole. Like all medicines that reduce acid secretion, pantoprazole can cause reduced absorption of vitamin B12.
• If you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) together with pantoprazole, ask your doctor for specific advice.
• If you are taking a proton pump inhibitor such as pantoprazole, particularly for a period longer than 1 year, may slightly increase your risk of fracture of the hip, wrist or spine. Tell your doctor if you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
• If you have been taking Pantoprazolo Krka for more than three months, magnesium levels in the blood may decrease. Low levels of magnesium can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased

heartbeat. If you experience any of these symptoms, tell your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide whether to perform regular blood tests to monitor magnesium levels.

• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazolo Krka that reduces stomach acid.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as you may need to stop therapy with Pantoprazolo Krka. Remember to also report any other undesirable effects such as joint pain.
• If you are to undergo a specific blood test (Chromogranin A).

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

• unintentional weight loss
• vomiting, especially if repeated
• presence of blood in the vomit; this may appear as dark coffee in the vomit
• presence of blood in the stool; which may be black or tarry in appearance
• difficulty swallowing or pain when swallowing
• abdominal pain
• stomach pain
• - paleness and feeling of weakness (anemia)
• severe and/or persistent diarrhea, as Pantoprazolo Krka has been associated with a slight increase in infectious diarrhea

The doctor may decide to subject you to some tests to rule out the presence of a tumor
because pantoprazole also relieves the symptoms of cancer and can delay diagnosis. If symptoms
persist despite treatment, further investigations will be considered.
If you take Pantoprazolo Krka for a long period (more than a year), your doctor will probably
need to subject you to periodic checks. You should report any new and unusual symptom or circumstance
every 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 Pantoprazolo Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Pantoprazolo Krka can impair the effectiveness of other medicines, so you must
tell your doctor if you are taking:

• medicines such as ketoconazole, itraconazole and posaconazole (used for the treatment of fungal infections) or erlotinib (used for some types of cancer) because Pantoprazolo Krka may prevent these and other medicines from working properly;
• warfarin and phenprocoumon, which affect blood density. Further checks may be necessary;
• 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 interrupt treatment with Pantoprazolo Krka in as pantoprazole can increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric illnesses) - if you are taking fluvoxamine, your doctor may reduce the dose.
• Rifampicin (used to treat infections)
• St John's Wort ( Hypericum perforatum) (used to treat mild depression).

Pantoprazolo Krka with food and drink
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 are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
There is insufficient data on the use of pantoprazole in pregnant women. Excretion in breast milk has been reported. You should only take this medicine if your doctor believes that the
benefit to you is greater than the potential risk to the fetus or the baby.

Driving and using machines
Pantoprazolo Krka does not alter or negligibly alters the ability to drive vehicles or operate
machinery.
If you develop side effects such as dizziness or visual disturbances, avoid driving vehicles or
operating machinery.

Pantoprazolo 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 your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.

When and how to take Pantoprazolo Krka
Take the tablets one hour before a meal and swallow them whole, without chewing or
crushing, with a little water.
Unless your doctor provides different instructions, the recommended dose is as follows.

Adults and adolescents aged 12 years or over

For the treatment of reflux esophagitis
The recommended 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 generally
between 4 and 8 weeks. Your doctor will tell you how long you should take the medicine.

Adults

For the treatment of an infection caused by a bacterium calledHelicobacter pyloriin patients
with duodenal ulcers and gastric ulcers in association with two antibiotics (eradication therapy)
One tablet, twice a day, together with two tablets of amoxicillin antibiotics,
clarithromycin and metronidazole (or tinidazole), each to be taken twice a day together 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 a day. After consulting your doctor, the dose may
be doubled.
Your doctor will tell you 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 the production of an excessive amount of acid in the stomach
The recommended starting dose is generally two tablets a day.
Take the two tablets one hour before a meal. Your doctor may subsequently adjust the
dose based on the amount of acid produced in your stomach. If more than two
tablets are prescribed per day, the tablets should be taken twice a day.
If your doctor prescribes a daily dose of more than four tablets a day, they will tell you
exactly when you should stop taking the medicine.

Special patient groups

• If you have kidney problems or moderate or severe liver problems, you cannot take Pantoprazolo Krka for the eradication of Helicobacter pylori.
• If you suffer from severe liver problems, you cannot take more than one pantoprazole 20 mg tablet a day (tablets containing 20 mg of pantoprazole 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. No symptoms of overdose are known.

If you forget to take Pantoprazolo Krka
Do not take a double dose to make up for a missed dose. Simply
take the next dose at the scheduled time.

If you stop taking Pantoprazolo 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 everybody gets them.

If you experience any of the following side effects, stop taking these tablets and immediately inform your doctor or go to the nearest emergency room.
Severe allergic reactions (rare (may affect up to 1 in 1,000)):

• swelling of the tongue and/or throat,
• difficulty swallowing,
• urticaria (hives),
• difficulty breathing,
• allergic swelling of the face (angioedema/Quincke's edema),
• severe dizziness with a very rapid heartbeat and profuse sweating.

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

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

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

• yellowing of the skin or the whites of the eyes (serious damage to liver cells, jaundice) or
• fever,
• skin rash and swelling of the kidneys, sometimes associated with painful urination and lower back pain (serious inflammation of the kidneys, with possible progression to kidney failure).

If you take pantoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, confusion, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels can also lead to a decrease in blood potassium or calcium levels. The doctor should decide whether to regularly check magnesium levels in the blood.

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

• Serious reduction in the number of white blood cells, which makes infections more likely. Report any signs of sudden fever, sore throat, extreme fatigue, which may be signs of infection.

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

• Reduction in the number of platelets in the blood, which can cause bleeding or bruising more than usual. Report any bruises or unexplained bleeding to your doctor.

The other side effects are as follows.

Common (may affect up to 1 in 10 people)

• benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Headache;
• dizziness;
• diarrhea;
• feeling unwell, vomiting;
• meteorism and flatulence;
• constipation; dry mouth;
• abdominal pain and discomfort;
• skin irritation, rash, eruption;
• itching;
• fractures of the hip, wrist or spine;
• fatigue, tiredness or general feeling of unwellness;
• sleep disturbances.

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

• Visual disturbances such as blurred vision;
• urticaria (hives);
• joint pain;
• muscle pain;
• weight changes;
• increased body temperature;
• swelling of the extremities (peripheral edema);
• allergic reactions;
• depression;
• enlargement of the breasts in males;
• altered taste.

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

• Disorientation.

Not known (frequency cannot be estimated from available data)

• Hallucinations, confusion (especially in patients who have previously suffered from these symptoms).

• Decreased level of sodium in the blood.
• Decreased level of calcium in the blood.
• Decreased levels of potassium 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)

• Increased bilirubin;
• increased fats in the blood.

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

• Decreased white blood cells, which can lead to more frequent infections;
• serious reduction of blood cells that can cause weakness, bruising or make infections more likely.

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
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa Reporting side effects
helps to provide more information on the safety of this medicine.

5. How to store Pantoprazolo Krka

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 carton label and
on the packaging and on the blister pack after the wording EXP. The expiry date refers to the last day
of that month.
This medicine does not require 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 in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pantoprazolo Krka contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 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 hypromellose, povidone (K25), titanium dioxide (E171), Yellow iron oxide (E172), propylene glycol, methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, macrogol 6000 and talc in the film coating.

Description of the appearance of Pantoprazolo Krka and contents of the pack
The 40 mg gastro-resistant tablets are oval, slightly biconvex tablets of light yellowish-brown color.
Packs 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 the other Member States of the European Economic Area under the
following denominations: