Nolpaza

PACKAGE LEAFLET: INFORMATION FOR THE USER

NOLPAZA 40 mg gastro-resistant tablets

Pantoprazole
Generic medicine
Please read all of this leaflet carefully before you start 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 appear to be the same as yours, because it may be harmful.
• If you experience any side effect, inform your doctor or pharmacist. This includes any side effect not listed in this leaflet. See section 4.4

Contents of this leaflet:

1. What NOLPAZA 40 mg is and what it is used for
2. What you need to know before taking NOLPAZA 40 mg
3. How to take NOLPAZA 40 mg
4. Possible side effects
5. How to store NOLPAZA 40 mg
6. Contents of the pack and other information

1. What NOLPAZA 40 mg is and what it is used for

NOLPAZA 40 mg is a selective "proton pump inhibitor" that reduces the amount of acid produced by your stomach. It is used to treat conditions of the stomach and intestine caused by acidity.

NOLPAZA 40 mg is used to treat:

Adults and adolescents aged 12 years and above:

• Gastroesophageal reflux disease (GERD). An inflammation of the oesophagus (the tube connecting the throat to the stomach), associated with regurgitation of acidic stomach contents.

Adults:

• Infection caused by a bacterium called Helicobacter pylori in patients with duodenal or gastric ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacteria in order to reduce the likelihood of recurrence of these ulcers.
• Duodenal and gastric ulcers.
• Zollinger-Ellison syndrome and other conditions characterized by excessive acid secretion in the stomach.

2. What you need to know before taking NOLPAZA 40 mg

Do not take NOLPAZA 40 mg

• 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
Consult your doctor or pharmacist before taking NOLPAZA 40 mg

• If you have severe liver problems. If you have had liver disease, consult your doctor, who will arrange for more frequent monitoring of liver enzymes, especially if you are taking NOLPAZA 40 mg long-term. If liver enzymes increase, treatment should be discontinued.
• If your body’s vitamin B12 stores are limited or if you have risk factors for reduced vitamin B12 levels and are taking pantoprazole long-term. Like all anti-acid agents, pantoprazole may reduce the absorption of vitamin B12.
• If you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV) together with pantoprazole, consult your doctor.
• Taking a proton pump inhibitor such as pantoprazole, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• If you have been taking Nolpaza 40 mg for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Nolpaza 40 mg that reduces gastric acidity.
• If you develop a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as treatment with Nolpaza may need to be discontinued. Remember to also report any other adverse effects such as joint pain.
• If you are scheduled for a specific blood test (Chromogranin A).

Contact your doctor immediately if you notice any of the following symptoms:

• Unintentional weight loss
• Vomiting, particularly if repeated
• Presence of blood in vomit; this may appear as dark, coffee-ground-like material in the vomit
• Appearance of blood in stools, which may appear dark or tarry
• Difficulty swallowing or pain when swallowing
• If you are pale and feel weak (anemia)
• Chest pain
• Stomach pain
• Severe and/or persistent diarrhea, as NOLPAZA 40 mg has been associated with a slight increase in infectious diarrhea episodes.
• If you have ever had a skin reaction after treatment with a medicine similar to Nolpaza that reduces gastric acidity.

Your doctor will decide whether further tests are needed to rule out malignancy, since pantoprazole relieves symptoms of cancer and may therefore delay its diagnosis. If symptoms persist despite appropriate treatment, further investigations should be considered.
If you take NOLPAZA 40 mg long-term (for more than one year), your doctor will likely perform regular check-ups. You must inform your doctor of any new or unusual symptoms or circumstances.

Children and adolescents
The use of these tablets is not recommended in children under 12 years of age.
Other medicines and Nolpaza 40 mg
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
NOLPAZA 40 mg may reduce the effectiveness of other medicines; therefore, inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used for fungal infections) or erlotinib (used in certain types of cancer), as NOLPAZA 40 mg may reduce the effectiveness of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting. Additional monitoring may be required.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer) – if you are taking Nolpaza 40 mg, your doctor may temporarily discontinue treatment with Nolpaza 40 mg because 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).

NOLPAZA 40 mg with food and drink
Take the tablets one hour before a meal, without chewing or breaking them, swallowing them whole with some water.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you think you may be pregnant, or if you are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
There are insufficient adequate data on the use of pantoprazole in pregnant women. Excretion into human milk has been observed. Take this medicine only if your doctor considers the benefit to you greater than the potential risk to the fetus or infant.
Driving and using machines
Nolpaza does not affect or affects negligibly the ability to drive and use machines.
If you experience side effects such as dizziness or visual disturbances, you must not drive or use machinery.
NOLPAZA 40 mg contains sorbitol. If your doctor has informed you that you have an intolerance to certain sugars, inform him or her before taking this medicine.

3. How to take NOLPAZA 40 mg

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
When and how to take NOLPAZA 40 mg?
Take the tablets one hour before a meal, without chewing or breaking them, swallowing them whole with
some water.
Unless otherwise prescribed by your doctor, the recommended dose is:
Adults and adolescents from 12 years of age onwards:

For the treatment of reflux esophagitis
The recommended dose is one tablet daily. Your doctor may decide to increase the dose to two tablets daily. Normally, the treatment period for reflux esophagitis lasts from 4 to 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 called Helicobacter pylori in patients with duodenal ulcer and gastric ulcer, in combination with two antibiotics (eradication therapy).
One tablet twice daily, plus two antibiotic tablets—amoxicillin or clarithromycin and metronidazole (or tinidazole)—each to be taken twice daily together with the pantoprazole tablet. Take the first pantoprazole tablet in the morning, one hour before breakfast, and the second one hour before dinner. Follow your doctor's instructions and read the package leaflet of these antibiotics. Normally, the treatment period is one or two weeks.
For the treatment of duodenal and gastric ulcers.
The recommended dose is one tablet daily. On your doctor’s advice, the dose may be doubled.
Your doctor will tell you how long you should take the medicine. Normally, the treatment period for gastric ulcer lasts from 4 to 8 weeks; the treatment period for duodenal ulcer lasts from 2 to 4 weeks.
For long-term treatment of Zollinger-Ellison syndrome and other conditions with excessive acid secretion in the stomach.
Normally, the recommended initial dose is two tablets daily.
Take both tablets one hour before a meal. Subsequently, your doctor may adjust the dose depending on the amount of acid produced by your stomach. If your doctor prescribes more than two tablets daily, the tablets should be taken twice daily.
If your doctor prescribes a daily dose exceeding four tablets, he or she will inform you exactly when to stop taking the medicine.

Special patient groups:

• If you have moderate or severe kidney or liver problems, you must not take NOLPAZA 40 mg for the eradication of Helicobacter pylori.
• If you have severe liver problems, you must not take more than one 20 mg pantoprazole tablet daily (20 mg pantoprazole tablets are available).

Use in children and adolescents
Children under 12 years of age.
The use of these tablets is not recommended in children under 12 years of age.
If you take more NOLPAZA 40 mg than you should
Inform your doctor or pharmacist. There are no known symptoms of overdose.
If you forget to take NOLPAZA 40 mg
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.
If you stop taking NOLPAZA 40 mg
Do not stop taking the medicine without first talking to your doctor or pharmacist.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you experience any of the following adverse reactions, stop taking the medicine and contact your doctor or go to the nearest emergency room immediately:

• Severe allergic reactions (rare frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic facial swelling (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin conditions (frequency not known: cannot be estimated based on available data): appearance of blisters and rapid worsening of general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), and photosensitivity reactions.
• Other serious conditions (frequency not known: cannot be estimated based on available data): yellowing of the skin or the 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), which may lead to kidney failure.

Other possible adverse reactions are:

• 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, abdominal distension and flatulence, constipation, dry mouth, abdominal pain and discomfort, skin rashes, exanthema, pruritus, weakness, fatigue, exhaustion or general malaise, sleep disorders.
• Rare (may affect up to 1 in 1,000 people): visual disturbances such as blurred vision; urticaria, joint pain, muscle pain, weight changes, increased body temperature, swelling of limbs (peripheral oedema), allergic reactions, breast enlargement in men, taste disturbances.
• Very rare (may affect up to 1 in 10,000 people): disorientation.
• Not known (frequency cannot be estimated from available data): hallucinations, confusion (especially in patients who previously experienced such symptoms); decreased sodium levels in blood, decreased calcium levels in blood; decreased potassium levels in blood; tremor or numbness of hands or feet; muscle spasms.

Adverse reactions 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; severe reduction in white blood cell count leading to increased frequency of infections.
• Very rare (may affect up to 1 in 10,000 people): reduced platelet count leading to increased bleeding or bruising, reduced white blood cell count leading to increased frequency of infections; severe reduction in blood cells which may cause weakness, bruising or make infections more likely.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report adverse reactions directly via the website http://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 NOLPAZA 40 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of the month.
Blister packs: Store in the original packaging to protect from moisture.
Container: Keep the container tightly closed to protect from moisture.
After first opening the container, the product 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 required. This will help protect the environment.

6. Contents of the package and other information

What NOLPAZA 40 mg contains

• 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 hypromellose, povidone (K 25), titanium dioxide (E 171), yellow iron oxide (E 172), propylene glycol, methacrylic acid copolymer ethyl acrylate, sodium lauryl sulfate, polysorbate 80, macrogol 6000 and talc in the tablet coating.

Description of the appearance of NOLPAZA 40 mg and pack contents
The 40 mg gastro-resistant tablets are yellowish-brown, oval, slightly biconvex tablets.
Pack sizes:
Blister packs containing 7, 14, 15, 28, 30, 56, 60, 84, 100, 100 x 1, 112 and 140 gastro-resistant tablets.
Plastic container with 250 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
I.B.N. SAVIO S.r.l. - Via del Mare n. 36 – Pomezia (RM)

Responsible manufacturer for batch release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, Novo mesto, 8501 Slovenia

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

This leaflet was last reviewed on:

INSTRUCTION LEAFLET: INFORMATION FOR THE USER

NOLPAZA 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, contact your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. See section 4.4

Contents of this leaflet:

1. What NOLPAZA 20 mg is and what it is used for
2. What you need to know before taking NOLPAZA 20 mg
3. How to take NOLPAZA 20 mg
4. Possible side effects
5. How to store NOLPAZA 20 mg
6. Contents of the pack and other information

1. What NOLPAZA 20 mg is and what it is used for

NOLPAZA 20 mg is a selective "proton pump inhibitor" that reduces the amount of
acid produced by your stomach. It is used to treat conditions of the stomach and intestine
caused by acidity.
NOLPAZA 20 mg is used for:
Adults and adolescents aged 12 years and older:

• Treatment of symptoms (such as heartburn, acid regurgitation, painful 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 regurgitation of acidic stomach contents) and prevention of relapses.

Adults:

• Prevention of gastric and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen) in at-risk patients who require ongoing NSAID treatment.

2. What you should know before taking NOLPAZA 20 mg

Do not take NOLPAZA 20 mg

• 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 Nolpaza 20 mg

• If you have severe liver problems. If you have previously had liver problems, consult your doctor, who may recommend more frequent monitoring of liver enzymes, especially if you are taking NOLPAZA 20 mg long-term. If liver enzymes increase, treatment should be discontinued.
• If you need to take medicines known as NSAIDs continuously and you are taking NOLPAZA 20 mg to reduce your risk of developing stomach or intestinal complications. Any increased risk will be assessed based on your individual risk factors, such as age (65 years and older), history of duodenal or gastric ulcers, or gastrointestinal bleeding.
• If your body stores of vitamin B12 are limited or if you have risk factors for reduced vitamin B12 levels and you are taking pantoprazole long-term. Like all acid-reducing agents, pantoprazole may lead to reduced absorption of vitamin B12.
• If you are taking HIV protease inhibitors such as atazanavir (for treatment of HIV) together with pantoprazole, consult your doctor.
• Taking a proton pump inhibitor such as pantoprazole, particularly for over a year, may slightly increase the risk of fractures of the hip, wrist or spine.
• Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• If you have been taking Nolpaza 20 mg for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Nolpaza 20 mg that reduces stomach acidity.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as treatment with Nolpaza may need to be discontinued. Remember to report any other adverse effects such as joint pain.
• If you are due to undergo a specific blood test (chromogranin A)

Contact your doctor immediately if you notice any of the following symptoms:

• unexplained weight loss
• vomiting, particularly if repeated
• blood in vomit; this may appear as dark, coffee-ground-like material in the vomit
• appearance of blood in stools, which may appear dark or tarry
• difficulty swallowing or pain when swallowing
• if you are pale and feel weak (anaemia)
• chest pain

• stomach pain
• severe and/or persistent diarrhoea, as NOLPAZA 20 mg has been associated with a slight increase in episodes of infectious diarrhoea.

Your doctor will decide whether you need further tests to exclude malignant disease, since pantoprazole relieves the symptoms of cancer and may therefore delay its diagnosis.
If symptoms persist despite appropriate treatment, further investigations should be considered.
If you take NOLPAZA 20 mg long-term (for more than one year), your doctor will likely carry out regular check-ups. You must inform your doctor about any new or unusual symptoms or circumstances.
Children and adolescents
The use of these tablets is not recommended in children under 12 years of age.
Other medicines and NOLPAZA 20 mg
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
NOLPAZA 20 mg may reduce the effectiveness of other medicines, so inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used for fungal infections) or erlotinib (used in certain types of cancer), since NOLPAZA 20 mg may reduce the effectiveness of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting. Additional monitoring may be required.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer) – if you are taking Nolpaza 20 mg, your doctor may temporarily discontinue treatment with Nolpaza 20 mg because 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).

NOLPAZA 20 mg with food and drink
Take the tablets one hour before a meal, without chewing or breaking them, swallowing them whole with some water.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There are insufficient adequate data on the use of pantoprazole in pregnant women. Excretion into human milk has been observed. Take this medicine only if your doctor considers the benefit to you greater than the potential risk to the fetus or infant.
Driving and using machines

Nolpaza does not alter or alters only negligibly the ability to drive vehicles and use
machinery.
If you experience side effects such as dizziness or visual disturbances, you must not drive or
operate machinery.
NOLPAZA 20 mg contains sorbitol. If your doctor has informed you that you have an intolerance to
certain sugars, please inform them before taking this medicine.

3. How to take NOLPAZA 20 mg

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
When and how to take NOLPAZA 20 mg?
Take the tablets one hour before a meal. Do not chew or break the tablets; swallow them whole with some water.
Unless otherwise prescribed by your doctor, the recommended dose is:
Adults and adolescents from 12 years of age:
For the treatment of symptoms (heartburn, acid regurgitation, painful swallowing)
associated with gastroesophageal reflux disease
The recommended dose is 1 tablet (20 mg) daily.
This dose usually provides symptom relief within 2–4 weeks – at most within a further 4 weeks. Your doctor will advise you on how long to continue taking the medicine.
Thereafter, any recurring symptoms can be managed by taking one tablet daily as needed.
For long-term treatment and prevention of relapse of reflux esophagitis:
The recommended dose is one tablet daily. In case of relapse, your doctor may double the dose, in which case you may take NOLPAZA 40 mg tablets once daily. After healing, you may return to taking one 20 mg tablet daily.
Adults:
Prevention of gastric and duodenal ulcers in patients who need to take anti-inflammatory
medicines (NSAIDs) continuously:
The recommended dose is 1 tablet daily.
Special patient groups

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

Use in children and adolescents
Children under 12 years of age.
The use of these tablets is not recommended in children under 12 years of age.

If you take more NOLPAZA 20 mg than you should
Inform your doctor or pharmacist. There are no known symptoms of overdose.
If you forget to take NOLPAZA 20 mg
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.
If you stop taking NOLPAZA 20 mg
Do not stop taking this medicine without first talking to 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 the medicine and
contact your doctor or go to the nearest emergency room immediately:

• Severe allergic reactions (rare: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (angioedema/Quincke's edema), severe dizziness with rapid heartbeat and persistent sweating.
• Severe skin conditions (frequency not known: cannot be estimated from the available data): appearance of blisters 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 photosensitivity reactions.
• Other serious conditions (frequency not known: cannot be estimated from the available data): yellowing of the skin or the 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), which may lead to kidney failure.

Other possible 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, abdominal bloating and flatulence, constipation, dry mouth, abdominal pain and discomfort, skin rashes, exanthema, itching, weakness, fatigue, exhaustion or general malaise, sleep disorders.
• Rare (may affect up to 1 in 1,000 people): visual disturbances such as blurred vision; urticaria, joint pain, muscle pain, weight changes, increased body temperature, swelling of the limbs (peripheral oedema), allergic reactions, breast enlargement in men, taste disturbances.
• Very rare (may affect up to 1 in 10,000 people):

Disorientation

• Not available (frequency cannot be determined from the available data): Hallucinations, confusion (especially in patients who had previously shown such symptoms); decreased levels of sodium in the blood, decreased levels of calcium in the blood; decreased levels of potassium in the blood; tremor or numbness of hands or feet; muscle spasms.

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; severe reduction in white blood cell count leading to increased frequency of infections.
• Very rare (may affect up to 1 in 10,000 people): Reduced platelet count leading to increased bleeding or bruising; reduced white blood cell count leading to increased frequency of infections; severe reduction in blood cells which may cause weakness, bruising, or make infections more likely.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions via:
http://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 NOLPAZA 20 mg

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 packaging after
Exp. The expiry date refers to the last day of the month.
Blister: Store in the original packaging to protect it from moisture.
Container: Keep the container tightly closed to protect it from moisture.
After first opening the container, the product 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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NOLPAZA 20 mg contains

• Each gastro-resistant tablet contains 20 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 hypromellose, povidone (K 25), titanium dioxide (E 171), yellow iron oxide (E 172), propylene glycol, methacrylic acid-

ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, macrogol 6000 and talc in
the tablet coating.
Description of the appearance of NOLPAZA 20 mg and pack contents
The 20 mg gastro-resistant tablets are yellowish to light brown, oval, slightly biconvex.
Pack sizes:
Boxes containing 7, 14, 15, 28, 30, 56, 60, 84, 100, 100 x 1, 112 and 140 gastro-resistant tablets in
blister packs.
Plastic container with 250 gastro-resistant tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
I.B.N. SAVIO S.r.l. - Via del Mare n. 36 – Pomezia (RM)
Responsible for batch release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, Novo mesto, 8501 Slovenia
TAD Pharma GmbH, D – 27472 Cuxhaven, Heinz, Lohmann, Straße 5, Germany
This medicinal product is authorized in the European Economic Area Member States
under the following names:

This leaflet was last reviewed on