Package leaflet: Information for the user

Pantoprazole Sandoz 20 mg gastro-resistant tablets

Equivalent medicine
Please read all of 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, pharmacist or nurse.
This medicine has been prescribed for you only. Never give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Pantoprazolo Sandoz contains the active substance 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 from the age of 12 years for:

treatment of symptoms (such as heartburn, acid regurgitation, pain on swallowing) associated with gastroesophageal reflux, caused by acid reflux from the stomach
long-term management of reflux esophagitis (inflammation of the esophagus accompanied by regurgitation of gastric acid) 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 at-risk patients who require ongoing NSAID therapy.

2. What you need to know before taking Pantoprazole Sandoz

Do not take Pantoprazole 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 proton pump inhibitor medicines.

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

if you have severe liver problems. If you have previously had liver problems, inform your doctor; they will check your liver enzymes more frequently, especially if you are taking Pantoprazole Sandoz as long-term treatment. If your liver enzymes increase, treatment should be stopped
if you need to take medicines called NSAIDs continuously and you are taking Pantoprazole Sandoz because you are at increased risk of developing gastric and intestinal complications. Any increased 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 reduced vitamin B12 and are receiving long-term treatment with pantoprazole. As with all antacids, pantoprazole may cause reduced 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 more than one year, you may have a slightly increased risk of fracture 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 take Pantoprazole Sandoz for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause symptoms such as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
if you need 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 Pantoprazole Sandoz 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 it may be necessary to discontinue treatment with Pantoprazole Sandoz. Remember to also report any other adverse effects such as joint pain.
Inform your doctor immediately, before or after taking this medicine, if you experience any of the following symptoms, which could be signs of a more serious illness:

unintentional weight loss
vomiting, particularly if repeated
presence of blood in vomit; this may appear as dark, coffee-ground-like material in your vomit
presence of blood in stools; which may appear black or tarry
difficulty swallowing or pain when swallowing
paleness and weakness (anaemia)
chest pain
stomach pain
severe and/or persistent diarrhoea, as this medicine has been associated with a slight increase in infectious diarrhoea.

Your doctor may decide to carry out certain tests to rule out a malignant condition, because pantoprazole also relieves symptoms of tumours and could delay diagnosis. If your symptoms persist despite treatment, further investigations will be needed.
If you take Pantoprazole Sandoz as long-term therapy (over one year), your doctor will likely monitor you regularly. At each visit, inform your doctor of any new or unusual symptoms.
Children and adolescents
Pantoprazole Sandoz is not recommended for use in children, as efficacy has not been demonstrated in children up to 12 years of age.
Other medicines and Pantoprazole Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
This is because pantoprazole may affect the effectiveness of other medicines. In particular, inform your doctor if you are taking:

medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), because Pantoprazole Sandoz may interfere with the effectiveness of these and other medicines
warfarin and phenprocoumon, which affect blood circulation and thinning. You may need additional tests
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 discontinue treatment with Pantoprazole Sandoz, as pantoprazole may 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 are insufficient data on the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You should use this medicine only if your doctor considers the benefit to the mother to outweigh the potential risk to the fetus or infant.
Driving and using machines
Pantoprazole Sandoz has no or negligible influence on the ability to drive and use machines.
If you experience adverse effects such as dizziness or visual disturbances, do not drive or operate machinery.
Pantoprazole 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 instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
How to take this medicine
Take the tablets one hour before a meal, without chewing or breaking them, swallowing them whole with
water.
The recommended dose is:
Adults and adolescents aged 12 years and older

To treat symptoms (such as heartburn, acid regurgitation, pain when swallowing) associated with gastro-oesophageal reflux The usual dose is one tablet per day. With this dosage, symptoms are generally relieved within 2–4 weeks, or in the worst case within a further 4 weeks. Your doctor will tell you how long you should continue taking the medicine. After this period, any recurring symptoms can be managed by taking one tablet per day as needed.
For long-term management and prevention of relapse of reflux oesophagitis The usual dose is one tablet per day. If the condition recurs, your doctor may double the dose, in which case you may switch to the Pantoprazolo Sandoz 40 mg formulation (one tablet per day). After healing, the dose may be reduced again to one 20 mg tablet per day.

Adults

For prevention of duodenal and gastric ulcers in patients requiring continuous treatment with NSAIDs The usual dose is one tablet per day.

Hepatic impairment
If you suffer from severe liver disorders, you must not take more than one 20 mg tablet per 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. There are no known symptoms of overdose.
If you forget to take Pantoprazolo Sandoz
Do not take a double dose to make up for the forgotten dose. Take the next dose at your 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 the use of this medicine, consult your doctor, pharmacist, or nurse.

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, tell your doctor immediately or
contact the emergency department of the nearest hospital:

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 swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating
severe skin disorders (frequency not known: frequency cannot be estimated from the available data): blistering of the skin and rapid deterioration in general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), and light sensitivity
other serious disorders (frequency not known: frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin rashes and kidney enlargement, sometimes with painful urination and lower back pain (severe kidney inflammation), which may lead to kidney failure.

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

Benign gastric polyps

Uncommon (may affect up to 1 in 100 people)

Headache, dizziness, diarrhoea, feeling unwell, vomiting, bloating and flatulence, constipation, dry mouth, abdominal pain and discomfort, skin rash, exanthema, eruption, pruritus, feeling of weakness, exhaustion or general malaise, sleep disorders, fractures of the hip, wrist or spine.
Rare (may affect up to 1 in 1,000 people)
Distortion or loss of taste sensation, visual disturbances such as blurred vision, urticaria, joint pain, muscle pain, weight changes, increased body temperature, high fever, swelling of the extremities (peripheral oedema), allergic reactions, depression, breast enlargement in males
Very rare (may affect up to 1 in 10,000 people)
Disorientation
Frequency not known (frequency cannot be estimated from the available data)
Hallucinations, confusion (especially in patients with a history of these symptoms), decreased blood sodium levels, decreased blood magnesium levels (see section 2), tingling sensation, pruritus, paresthesia, burning or numbness sensation, erythema, possible joint pain.

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 lipid levels, marked decrease in circulating granular white blood cells, associated with high fever.
Very rare (may affect up to 1 in 10,000 people)
Reduction in platelet count, which may cause increased tendency to bleeding and bruising; reduction in white blood cell count, which may increase the frequency of infections; abnormal decrease in the number of both white and red blood cells as well as platelets.

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

5. How to store Pantoprazolo Sandoz

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

6. Package contents and other information

What Pantoprazolo Sandoz contains

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

Gastro-resistant tablets
Pantoprazolo Sandoz gastro-resistant tablets are yellow, oval tablets (coated with a special enteric coating), approximately 8.9 x 4.6 mm in size, available in:

Blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 56x1, 60, 84, 90, 98, 100, 100x1, 140 tablets
Bottles containing 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

Manufacturers
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 European Economic Area member states under 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 GASTRORESISTENTES EFG
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

Patient Information Leaflet: Information for the User

Pantoprazolo Sandoz 40 mg gastro-resistant tablets

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, pharmacist or nurse.
This medicine has been prescribed for you only. Never give it to others, even if their symptoms are the same as yours, because it could be dangerous.
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Pantoprazolo Sandoz contains the active substance 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 from the age of 12 years for:

reflux esophagitis: Inflammation of the esophagus (the tube connecting the throat to the stomach) associated with acid regurgitation from the stomach.

Pantoprazolo Sandoz is used to treat adults for:

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

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 proton pump inhibitors.

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

if you have severe liver problems. If you have previously had liver problems, inform your doctor; they will check your liver enzymes more frequently, especially while you are taking Pantoprazolo Sandoz as long-term treatment. If your liver enzymes increase, treatment should be discontinued
if you have low levels of vitamin B12 or risk factors for reduced vitamin B12 and are receiving long-term treatment with pantoprazole. Like all antacids, pantoprazole may cause reduced absorption of vitamin B12
if you are taking a 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, particularly for longer than one year, you may have a slightly increased risk of fracture 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 take Pantoprazolo Sandoz for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause symptoms such as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to carry out regular blood tests to monitor your magnesium levels
if you need 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 gastric acidity.

If you develop a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazolo Sandoz. Remember to also report any other adverse effects such as joint pain.
Contact your doctor immediately, before and after taking this medicine, if you notice the onset of any of the following symptoms, which could be signs of another, more serious illness:

unintentional weight loss
vomiting, particularly if repeated
presence of blood in vomit; this may appear as dark, coffee-ground-like material in your vomit
presence of blood in stools; which may appear black or tarry
difficulty swallowing or pain when swallowing
paleness and weakness (anaemia)
chest pain
stomach pain
severe and/or persistent diarrhoea, as this medicine has been associated with a slight increase in infectious diarrhoea.

Your doctor may decide to prescribe certain tests to rule out a malignant condition, because pantoprazole can also relieve symptoms of cancer and could delay diagnosis. If your symptoms continue despite treatment, further investigations will be necessary.
If you take Pantoprazolo Sandoz as part of a long-term treatment (over one year), your doctor will likely monitor you regularly. At each visit, inform your doctor of any new or unusual symptoms.
Children and adolescents
Pantoprazolo Sandoz is not recommended for use in children, as efficacy has not been demonstrated 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 without a prescription.
This is because pantoprazole may affect the effectiveness of other medicines. In this case, inform your doctor if you are taking

medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), because Pantoprazolo Sandoz may interfere with the effectiveness of these and other medicines
warfarin and phenprocoumon, which affect blood circulation and thinning. You may need additional tests
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 discontinue treatment with Pantoprazolo Sandoz, as pantoprazole may 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 are insufficient data on the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You should use this medicine only if your doctor considers the benefit to the mother to outweigh the potential risk to the foetus or infant.
Driving and using machines
Pantoprazolo Sandoz has no or negligible influence on the ability to drive and use machines.
However, if you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.
Pantoprazolo Sandoz contains the colour Ponceau 4R aluminium lake (E 124)
This may cause allergic reactions.

3. How to take Pantoprazolo Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How to take this medicine
Take the tablets one hour before a meal, without chewing or breaking them, swallowing them whole with
water.
The recommended dose is:
Adults and adolescents aged 12 years and older

For the treatment of reflux esophagitis The usual dose is one tablet per day. Your doctor may instruct you to increase the dose to 2 tablets per day. The treatment period for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will tell you how long to continue taking the medicine.

Adults

For the treatment of infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and gastric ulcers, in combination with two antibiotics (eradication therapy).
One tablet twice daily, and two tablets of the antibiotic amoxicillin, clarithromycin or
metronidazole (or tinidazole), each to be taken twice daily 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 make sure to read the package leaflet
of these antibiotics. The usual treatment duration is 1–2 weeks.
For the treatment of gastric and duodenal ulcers. The usual dose is one tablet per day. After consulting your doctor, the dose may be doubled. Your doctor will tell you how long to take the medicine. The treatment period for gastric ulcers is usually between 4 and 8 weeks. The treatment period for duodenal ulcers is usually between 2 and 4 weeks.
For long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much stomach acid is produced. The recommended initial dose is two tablets per day. Take two tablets one hour before a meal. Your doctor may then adjust the dose depending on the amount of stomach acid produced. If you have been prescribed more than two tablets per day, the tablets should be taken twice daily. If your doctor prescribes a daily dose of more than four tablets per day, you will be given specific instructions on when to stop taking the medicine.

Renal impairment
If you have kidney problems, you must not take Pantoprazolo Sandoz for Helicobacter pylori
eradication.
Hepatic impairment
If you have severe liver disease, you must not take more than one 20 mg tablet per day (for this reason, tablets containing 20 mg of pantoprazole are available).
If you have moderate or severe liver problems, you must not take Pantoprazolo Sandoz for Helicobacter pylori eradication.
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. There are no known symptoms of overdose.
If you forget to take Pantoprazolo Sandoz
Do not take a double dose to make up for the forgotten dose. Take the next dose at your usual scheduled 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 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 will experience them.
If you experience any of the following side effects, tell your doctor immediately or
contact the nearest hospital emergency department:

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 swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating
Severe skin disorders (frequency not known: frequency cannot be estimated from the available data): blistering of the skin and rapid deterioration in general condition, erosion (including slight bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme) and light sensitivity
Other serious disorders (frequency not known: frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, skin rashes and kidney enlargement, sometimes with painful urination and lower back pain (severe kidney inflammation), which may lead to kidney failure.

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

Benign gastric polyps

Uncommon (may affect up to 1 in 100 people)

Headache, dizziness, diarrhoea, feeling unwell, vomiting, bloating and flatulence, constipation, dry mouth, abdominal pain and discomfort, skin rash, exanthema, eruption, itching, feeling of weakness, fatigue or general malaise, sleep disorders, fractures of the hip, wrist or spine.

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

Distortion or loss of taste sensation, visual disturbances such as blurred vision, hives, joint pain, muscle pain, weight changes, increased body temperature, high fever, swelling of the extremities (peripheral oedema), allergic reactions, depression, breast enlargement in males.

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

Disorientation.

Frequency not known (frequency cannot be estimated from the 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 sensation, itching, paresthesia, burning or numbness sensation, erythema, possible joint pain.

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 lipid levels, marked decrease in circulating granular white blood cells, associated with high fever.

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

Reduction in platelet count, which may cause an increased tendency to bleeding and bruising; reduction in white blood cell count, which may increase the frequency of infections; abnormally low numbers of red and white blood cells as well as platelets.

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

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

6. Package contents and other information

What Pantoprazolo Sandoz contains

The active substance is Pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
The other components are: Tablet core: calcium stearate, microcrystalline cellulose, crospovidone (type A), hydroxypropylcellulose (type EXF), anhydrous sodium carbonate, anhydrous colloidal 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 package contents
Gastro-resistant tablets
Pantoprazolo Sandoz gastro-resistant tablets are yellow, oval tablets (coated with a special coating layer), approximately 11.7 x 6.0 mm in size, and available in
Blister packs containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 56x1, 60, 84, 90, 98, 100, 100x1, 140 tablets
Bottles containing 14, 28, 56, 98, 100, 250, 500 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Manufacturers
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 authorized in the European Economic Area countries under 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
Slovak Republic: PANTOPRAZOL SANDOZ 40 MG GASTROREZISTENTNÉ TABLETY