PANTOPRAZOLO 20 mg Enteric-Coated Tablet

Содержание инструкции

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

Pantoprazolo Sandoz 20 mg gastro-resistant tablets

Generic medicine

Read this leaflet carefully before you start to take 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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Pantoprazolo Sandoz contains the active ingredient pantoprazole.
Pantoprazole is a “selective proton pump inhibitor”, a medicine that reduces the amount of acid
produced by the stomach. It is used to treat stomach and intestinal disorders related to acidity.
Pantoprazolo Sandoz is used in adults and adolescents starting from 12 years of age for:

• treatment of symptoms (such as heartburn, acid regurgitation, pain when swallowing) associated with gastroesophageal reflux, 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. Pantoprazolo Sandoz is used in adults for:
• prevention of gastric and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example ibuprofen) in patients at risk who require continued therapy with NSAIDs.

2. What you need to know before taking Pantoprazolo Sandoz

Do not take Pantoprazolo Sandoz

• if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to other medicines that are proton pump inhibitors.

Warnings and precautions
Tell your doctor, pharmacist or nurse before taking Pantoprazolo Sandoz:

• if you suffer from severe liver problems. If you have had liver problems in the past, tell your doctor; they will check your liver enzymes more frequently, especially while you are taking Pantoprazolo Sandoz for long-term treatment. If the liver enzymes increase, treatment must be stopped
• if you need to take medicines called NSAIDs continuously and you need to take Pantoprazolo Sandoz because you have an increased risk of developing gastric and intestinal complications. Any increase in the risk will be assessed based on individual risk factors, such as age (65 years or older) or a history of gastric or duodenal ulcer or gastrointestinal bleeding.
• if you have low levels of vitamin B12 or risk factors for a reduction in vitamin B12 and are receiving long-term treatment with pantoprazole. As with all antacids, pantoprazole can cause a reduction in the absorption of vitamin B12.
• if you are taking an HIV protease inhibitor such as atazanavir (used to treat HIV infections) together with pantoprazole, consult your doctor for specific advice.
• if you are taking a proton pump inhibitor such as pantoprazole, especially for a period longer than a year, may slightly increase the 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 take Pantoprazolo Sandoz for more than three months, the levels of magnesium in the blood may decrease. Low levels of magnesium can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, tell your doctor immediately. Low levels of magnesium can lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels
• if you are going to undergo a specific blood test (Chromogranin A)
• if you have ever had a skin reaction after treatment with a medicine similar to Pantoprazolo Sandoz that reduces gastric 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 therapy with Pantoprazolo Sandoz. Remember to also
report any other unwanted effects such as joint pain.

Immediately inform your doctor,before or after taking this medicine, if you notice the onset of
any of the following symptoms, which may be a sign of a more serious illness:

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

The doctor may decide to prescribe you some tests to rule out a malignant disorder, because
pantoprazole also relieves the symptoms of cancer and may delay diagnosis. If your symptoms
continue despite treatment, further investigations will be necessary.
If you take Pantoprazolo Sandoz as part of long-term therapy (over a year), your doctor will probably
keep you under regular surveillance. On each visit, report to your doctor the onset of
any new or abnormal symptom.

Children and adolescents
Pantoprazolo Sandoz is not recommended for use in children because there is no evidence of efficacy in
children up to 12 years of age.

Other medicines and Pantoprazolo Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
This is because pantoprazole can affect the effectiveness of other medicines, in this case tell
your doctor if you are taking:

• medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer) because Pantoprazolo Sandoz can interrupt the effectiveness of these and other medicines
• warfarin and phenprocoumon, which affect circulation and blood thinning. You may need further analysis
• medicines used to treat HIV infections, such as atazanavir
• methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer) - if you are taking methotrexate, your doctor may temporarily interrupt treatment with Pantoprazolo Sandoz, because pantoprazole can increase methotrexate levels in the blood
• fluvoxamine (used to treat depression and other psychiatric conditions - 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).

Pregnancy and breastfeeding
There is no adequate data for the use of pantoprazole in pregnant women. Excretion
has been reported in human breast milk.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
You should only use this medicine if your doctor believes that the benefit to the mother is greater than
the potential risk to the fetus or the baby.

Driving and operating machinery
Pantoprazolo Sandoz has no or minimal influence on the ability to drive and use machines.
If you experience side effects such as dizziness or visual disturbances, you should not drive or operate
machinery.

Pantoprazolo Sandoz contains the dye Ponceau 4R aluminium lake (E 124)
This may cause allergic reactions.

3. How to take Pantoprazolo Sandoz

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Taking this medicine
Take the tablets one hour before a meal, without chewing or breaking them, and swallow them whole, with
water.
The recommended dose is:

Adults and adolescents aged 12 years and over

• To treat symptoms (such as heartburn, acid regurgitation, pain when swallowing)associated with gastroesophageal refluxThe usual dose is one tablet a day. With this dosage, relief of symptoms is generally obtained within 2-4 weeks, or at worst after another 4 weeks. Your doctor will tell you how long to continue taking the medicine. After this period, any recurring symptoms can be controlled by taking one tablet a day, when necessary.
• For long-term management and prevention of relapse of reflux esophagitisThe usual dose is one tablet a day. If the disease recurs, your doctor may double the dose, in which case you can switch to the Pantoprazolo Sandoz 40 mg formulation (one tablet a day). After healing, you can reduce the dose again to one 20 mg tablet a day.

Adults

• For the prevention of duodenal and gastric ulcers in patients who require continued therapy with NSAIDsThe usual dose is one tablet a day.

Hepatic insufficiency
If you suffer from severe liver disorders, you should not take more than one 20 mg tablet a day

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

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

If you forget to take Pantoprazolo Sandoz
Do not take a double dose to make up for a missed dose. Take the next dose at the usual
time.

If you stop taking Pantoprazolo Sandoz
Do not stop taking these tablets without first consulting your doctor, pharmacist or
nurse.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

If you experience any of the following side effects, tell your doctor immediately or
contact the emergency room of the nearest hospital:

• severe allergic reactions( rare frequency: may affect up to 1 in 1000 people ): swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic facial swelling (angioedema/Quincke's edema), severe dizziness with a very fast heartbeat and profuse sweating
• severe skin disorders( 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, multiforme erythema) and light sensitivity
• other serious disorders( frequency not known: frequency cannot be estimated based on available data): yellowing of the skin or whites of the eyes (serious liver cell damage, jaundice) or fever, skin rashes and enlargement of the kidneys, sometimes with painful urination and back pain (severe kidney inflammation), which can lead to kidney failure.

Other side effects:
Common(may affect up to 1 in 10 people)

• Benign polyps in the stomach

Notcommon(may affect up to 1 in 100)

• headache, dizziness, diarrhea, feeling unwell, vomiting, bloating and flatulence, constipation, dry mouth, abdominal pain and discomfort, skin rashes, rash, eruption, itching, feeling of weakness, fatigue or general malaise, sleep disorders, hip, wrist or spine fractures. Rare(may affect up to 1 in 1000)
• distortion or loss of taste, visual disturbances, such as blurred vision, hives, joint pain, muscle pain, weight changes, increased body temperature, high fever, swelling of the extremities (peripheral edema), allergic reactions, depression, enlargement of the breasts in males Veryrare(may affect up to 1 in 10,000)
• disorientation Frequencynotknown(frequency cannot be estimated based on available data)
• hallucinations, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), tingling, itching, paresthesia, burning or numbness, erythema, possible joint pain.

Side effects identified through blood tests:
Notcommon(may affect up to 1 in 100)

• increased liver enzymes Rare(may affect up to 1 in 1000)
• increased bilirubin, increased lipid levels in the blood, sharp decrease in circulating granular white blood cells, associated with high fever. Veryrare(may affect up to 1 in 10,000)
• reduction in platelet count, which may cause a greater tendency to bleeding and bruising than usual; reduction in white blood cell count, which may increase the frequency of infections; abnormal reduction in the number of white blood cells and red blood cells, as well as platelets.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through
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 Pantoprazolo Sandoz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the blister or the bottle after the wording
EXP. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not use Pantoprazolo Sandoz after 6 months from opening the HDPE bottle.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Pantoprazolo Sandoz contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients are: Tablet core: calcium stearate, microcrystalline cellulose, crospovidone (type A), hydroxypropylcellulose (type EXF), anhydrous sodium carbonate, colloidal anhydrous silica.

Coating:
hypromellose, yellow iron oxide (E172), macrogol 400, methacrylic acid-ethyl acrylate copolymer
(1:1), polysorbate 80, ponceau 4R aluminium lake (E124), quinoline yellow aluminium lake (E104),
sodium lauryl sulfate, titanium dioxide (E171), triethyl citrate.

Description of the appearance of Pantoprazolo Sandoz and contents of the pack
Gastro-resistant tablets
Pantoprazolo Sandoz gastro-resistant tablets are yellow, oval-shaped tablets (coated with a special
coating), approximately 8.9 x 4.6 mm in size and available in
Blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 56x1, 60, 84, 90, 98, 100, 100x1, 140 tablets
Containers of 14, 28, 56, 98, 100, 250, 500 tablets
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz S.p.A. Largo U. Boccioni, 1 21040 Origgio (VA) Italy

Manufacturer
Salutas Pharma GmbH - Otto-von-Guericke-Allee 1 - 39179 Barleben (Germany)
Lek Spolka Akcyjna – Ul Domaniewska, 50C – 02-672 Warsaw (Poland)
Lek Pharmaceuticals d.d. – Verovskova 57 – 1000 Ljubljana (Slovenia )
LEK Pharmaceuticals d.d., Trimlini 2 D, 9220 Lendava (Slovenia)
Sandoz S.r.l Str. Livezeni nr. 7A 540472 Targu Mures (Romania)

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Austria: PANTOPRAZOL SANDOZ 20 MG - MAGENSAFTRESISTENTE TABLETTEN
Belgium: PANTOPRAZOL SANDOZ 20 MG MAAGSAPRESISTENTE TABLETTEN
Germany: PANTOPRAZOL SANDOZ 20 MG MAGENSAFTRESISTENTE TABLETTEN
Denmark: PANTOPRAZOL SANDOZ
Spain: PANTOPRAZOL SANDOZ 20 MG COMPRIMIDOS
GASTRORESISTENTESEFG
Finland: PANTOPRAZOL SANDOZ 20 MG ENTEROTABLETTI
France: PANTOPRAZOLE SANDOZ 20 MG, COMPRIMÉ GASTRO-RÉSISTANT
United Kingdom: PANTOPRAZOLE 20 MG GASTRO-RESISTANT TABLETS
Greece: OZEPRAN
Italy: PANTOPRAZOLO SANDOZ 20 MG COMPRESSE GASTRORESISTENTI
Netherlands: PANTOPRAZOL SANDOZ 20 MG, MAAGSAPRESISTENTE TABLETTEN
Norway: PANTOPRAZOL SANDOZ 20 MG ENTEROTABLETTER
Poland: IPP 20
Portugal: PANTOPRAZOL SANDOZ, COMPRIMIDOS GASTRORRESISTENTES A 20
MG
Sweden: PANTOPRAZOL SANDOZ 20 MG ENTEROTABLETTER
Slovenia: ACIPAN 20 MG GASTROREZISTENTNE TABLETE
Slovakia: PANTOPRAZOL SANDOZ 20 MG GASTROREZISTENTNÉ TABLETY

Pantoprazolo Sandoz 40 mg gastro-resistant tablets

Generic medicine

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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Pantoprazolo Sandoz contains the active ingredient pantoprazole.
Pantoprazole is a “selective proton pump inhibitor”, a medicine that reduces the amount of acid
produced by the stomach. It is used to treat stomach and intestinal disorders related to acidity.
Pantoprazolo Sandoz is used to treat adults and adolescents starting from 12 years of age for:

• reflux esophagitis: An inflammation of the esophagus (the tube that connects the throat to the stomach) accompanied by acid reflux from the stomach.

Pantoprazolo Sandoz is used to treat adults for:

• an infection by a bacterium called Helicobacter pyloriin patients with duodenal and gastric ulcers in combination with two antibiotics (eradication therapy). The goal is to eliminate the bacteria and therefore reduce the likelihood of these ulcers occurring again.
• Gastric and duodenal ulcers
• Zollinger-Ellison syndrome and other conditions that produce too much acid in the stomach

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

Do not take Pantoprazolo Sandoz

• if you are allergic to Pantoprazolo Sandoz or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to other medicines that are proton pump inhibitors.

Warnings and precautions
Tell your doctor, pharmacist or nurse before taking Pantoprazolo Sandoz:

• if you suffer from severe liver disorders. If you have had liver problems in the past, tell your doctor; they will check your liver enzymes more frequently, especially while you are taking Pantoprazolo

Sandoz as long-term treatment. If liver enzymes increase, the treatment
must be stopped

• if you have low levels of vitamin B12 or risk factors for a reduction in vitamin B12 and are receiving long-term treatment with pantoprazole. As with all antacids, pantoprazole can cause a reduction in the absorption of vitamin B12
• if you are taking an HIV protease inhibitor such as atazanavir (used to treat HIV infections) in combination with pantoprazole, consult your doctor for specific advice
• if you are taking a proton pump inhibitor such as pantoprazole, especially for a period longer than one year, may slightly increase the 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 take Pantoprazolo Sandoz for more than three months, the levels of magnesium in your blood may decrease. Low levels of magnesium can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, tell your doctor immediately. Low levels of magnesium can 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 are to undergo a specific blood test (Chromogranin A)
• consult your doctor if you have ever had a skin reaction after treatment with a medicine similar to Pantoprazolo Sandoz that reduces stomach acid.

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor
as soon as possible, as you may need to stop therapy with Pantoprazolo Sandoz. Remember to also report any other unwanted effects such as joint pain.

Tell your doctor immediately,before and after taking this medicine, if you notice the onset of any
of the following symptoms, which may be a sign of a more serious illness:

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

The doctor may decide to prescribe you some tests to rule out a malignant disorder, because
pantoprazole also relieves the symptoms of cancer and may delay diagnosis. If your symptoms
continue despite treatment, further investigations will be necessary.
If you take Pantoprazolo Sandoz as part of long-term therapy (over one year), your doctor will likely
monitor you regularly. On each visit, report to your doctor the onset of
any new or abnormal symptom.

Children and adolescents
Pantoprazolo Sandoz is not recommended for use in children because there is no evidence of efficacy in
children up to 12 years of age.

Other medicines and Pantoprazolo Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
This is because pantoprazole can affect the effectiveness of other medicines, in which case tell
your doctor if you are taking

• medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer) because Pantoprazolo Sandoz can interrupt the effectiveness of these and other medicines
• warfarin and phenprocoumon, which affect circulation and blood thinning. You may need further analysis
• medicines used to treat HIV infections, such as atazanavir
• methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer) - if you are taking methotrexate, your doctor may temporarily interrupt treatment with Pantoprazolo Sandoz, because pantoprazole can increase levels of methotrexate 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).

Pregnancy and breastfeeding
There is no adequate data for the use of pantoprazole in pregnant women. Excretion
into human breast milk has been reported.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You should only use this medicine if the doctor believes that the benefit to the mother outweighs the
potential risk to the fetus or infant.

Driving and using machines
Pantoprazolo Sandoz has no or minimal influence on the ability to drive and use machines.
If you experience side effects such as dizziness or vision disturbances, you should not drive or operate
machinery.

Pantoprazolo Sandoz contains the colouring agent Ponceau 4R aluminium lake (E 124)
This may cause allergic reactions.

3. How to take Pantoprazolo Sandoz

Take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.

Taking this medicine
Take the tablets one hour before a meal, without chewing or breaking them, and swallow them whole, with
water.
The recommended dose is:

Adults and adolescents aged 12 years and over

• To treat reflux esophagitisThe usual dose is one tablet a day. Your doctor may tell you to increase the dose to 2 tablets a day. The treatment period for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will tell you how long to continue taking the medicine.

Adults

• For the treatment of an infection caused by a bacterium called Helicobacter pylori in patients withduodenal ulcers and gastric ulcers in combination with two antibiotics (eradication therapy).

One tablet, twice a day and two antibiotic tablets of amoxicillin, clarithromycin or
metronidazole (or tinidazole), each to be taken twice a day with the pantoprazole tablet.
Take the first pantoprazole tablet 1 hour before breakfast and the second tablet of
these antibiotics. The usual treatment period is 1-2 weeks.

• For the treatment of gastric and duodenal ulcers.The usual dose is one tablet a day. After consulting your doctor, the dose may be doubled. Your doctor will tell you how long to take the medicine. The treatment period for gastric ulcers is usually between 4 and 8 weeks. The treatment period for duodenal ulcers is usually between 2 and 4 weeks.
• For the long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much acid isproduced in the stomach.The recommended starting dose is two tablets a day. Take two tablets 1 hour before a meal. The doctor may then adjust the dose, depending on the amount of acid in the stomach that is produced. If you have been prescribed more than two tablets a day, the tablets must be taken twice a day. If the doctor prescribes a daily dose of more than four tablets a day, you will be told exactly when to stop taking the medicine.

Renal impairment
If you have kidney problems, you should not take Pantoprazolo Sandoz for the eradication of Helicobacter

pylori.

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

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

If you take more Pantoprazolo Sandoz than you should
Tell your doctor or pharmacist. No known symptoms of overdose exist.

If you forget to take Pantoprazolo Sandoz
Do not take a double dose to make up for a missed dose. Take the next dose at the usual
time.

If you stop taking Pantoprazolo Sandoz
Do not stop taking these tablets without first consulting your doctor, pharmacist or
nurse.
If you have any questions about using this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

If you experience any of the following side effects, tell your doctor immediately or
contact the emergency room of the nearest hospital:

• severe allergic reactions( rare frequency: may affect up to 1 in 1000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the

face (angioedema/Quincke's edema), severe dizziness with a very fast heartbeat and profuse sweating
sweating

• severe skin disorders( frequency not known:the frequency cannot be defined 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, multiforme erythema) and light sensitivity
• other serious disorders( frequency not known:the frequency cannot be defined based on available data): yellowing of the skin or whites of the eyes (serious damage to liver cells, jaundice) or fever, skin rashes and enlargement of the kidneys, sometimes with painful urination and back pain (severe kidney inflammation), which can lead to kidney failure.

Other side effects:
Common (may affect up to 1 in 10 people)

• Benign polyps in the stomach

Notcommon(may affect up to 1 in 100 people)

• headache, dizziness, diarrhea, feeling unwell, vomiting, bloating and flatulence, constipation, dry mouth, pain and abdominal discomfort, skin rashes, rash, eruption, itching, feeling of weakness, fatigue or general malaise, sleep disturbances, hip, wrist or spine fractures. Rare(may affect up to 1 in 1000 people)
• distortion or loss of taste, visual disturbances, such as blurred vision, hives, joint pain, muscle pain, weight changes, increased body temperature, high fever, swelling of the extremities (peripheral edema), allergic reactions, depression, breast enlargement in males Veryrare(may affect up to 1 in 10,000 people)
• disorientation Frequencynotknown(the frequency cannot be defined based on available data)
• hallucinations, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), tingling, itching, paresthesia, burning or numbness, erythema, possible joint pain.

Side effects identified through blood tests:
Notcommon(may affect up to 1 in 100 people)

• increased liver enzymes Rare(may affect up to 1 in 1000 people)
• increased bilirubin, increased lipid levels in the blood, sharp decrease in circulating granular white blood cells, associated with high fever. Veryrare(may affect up to 1 in 10,000 people)
• reduction in platelet count, which may cause a greater tendency to bleeding and bruising than usual; reduction in white blood cell count, which may increase the frequency of infections; abnormal reduction in the number of red blood cells and white blood cells, as well as platelets.

Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. You can also report side effects directly through 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 Pantoprazolo Sandoz

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 blister or the bottle after the wording
EXP. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not use Pantoprazolo Sandoz after 6 months from opening the HDPE bottle.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Pantoprazolo Sandoz contains

• The active ingredient is Pantoprazolo. Each gastro-resistant tablet contains 40 mg of Pantoprazolo (as pantoprazolo sodium sesquihydrate).
• The other ingredients are: Tablet core: calcium stearate, microcrystalline cellulose, crospovidone (type A), hydroxypropylcellulose (type EXF), anhydrous sodium carbonate, anhydrous colloidal silicon dioxide

Coating:
hypromellose, yellow iron oxide (E172), macrogol 400, methacrylic acid-ethyl
acrylate copolymer (1:1), polysorbate 80, Ponceau 4R aluminium lake (E124), quinoline yellow aluminium lake
(E104), sodium lauryl sulfate, titanium dioxide (E171), triethyl citrate.

Description of the appearance of Pantoprazolo Sandoz and package contents
Gastro-resistant tablets
Pantoprazolo Sandoz gastro-resistant tablets are yellow, oval-shaped tablets (coated with a special
coating layer), approximately 11.7 x 6.0 mm in size and available in
Blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 56x1, 60, 84, 90, 98, 100, 100x1, 140 tablets
Containers of 14, 28, 56, 98, 100, 250, 500 tablets
Not all pack sizes may be marketed

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Sandoz S.p.A Largo U. Boccioni, 1 21040 Origgio (VA) Italy

Manufacturer
Salutas Pharma GmbH - Otto-von-Guericke-Allee 1 - 39179 Barleben (Germany)
Lek Spolka Akcyjna – Ul Domaniewska, 50C – 02-672 Warsaw (Poland)
Lek Pharmaceuticals d.d. – Verovskova 57 – 1000 Ljubljana (Slovenia )
LEK Pharmaceuticals d.d., Trimlini 2 D, 9220 Lendava, Slovenia
Sandoz S.r.l Str. Livezeni nr. 7A 540472 Targu Mures - Romania

This medicinal product is authorised in the member states of the European Economic Area with the following
names:
Austria: PANTOPRAZOL SANDOZ 40 MG - MAGENSAFTRESISTENTE
TABLETTEN
Belgium: PANTOPRAZOL 40 MG MAAGSAPRESISTENTE TABLETTEN
Germany: PANTOPRAZOL SANDOZ 40 MG MAGENSAFTRESISTENTE
TABLETTEN
Denmark: PANTOPRAZOL SANDOZ
Spain: PANTOPRAZOL SANDOZ 40 MG COMPRIMIDOS
GASTRORESISTENTES EFG
Finland: PANTOPRAZOL SANDOZ 40 MG ENTEROTABLETTI
France: PANTOPRAZOLE SANDOZ 40 MG, COMPRIMÉ GASTRO-
RÉSISTANT
United Kingdom: PANTOPRAZOLE 40 MG GASTRO-RESISTANT TABLETS
Greece: OZEPRAN
Italy: PANTOPRAZOLO SANDOZ 40 MG COMPRESSE
GASTRORESISTENTI
Netherlands: PANTOPRAZOL SANDOZ 40 MG, MAAGSAPRESISTENTE
TABLETTEN
Norway: PANTOPRAZOL SANDOZ 40 MG ENTEROTABLETTER
Poland: IPP 40
Portugal: PANTOPRAZOL SANDOZ, COMPRIMIDOS GASTRORRESISTENTES
A 40 MG
Sweden: PANTOPRAZOL SANDOZ 40 MG ENTEROTABLETTER
Slovenia: ACIPAN 40 MG GASTROREZISTENTNE TABLETE
Slovakia: PANTOPRAZOL SANDOZ 40 MG GASTROREZISTENTNÉ TABLETY