Pantoprazole Sun Pharmaceutical Industries Limited: detailed information

Package leaflet: Information for the patient

Pantoprazole Sun Pharmaceutical Industries Limited 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, pharmacist, or nurse.
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 adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Pantoprazolo Sun Pharmaceutical Industries Limited is and what it is used for

Pantoprazolo Sun Pharmaceutical Industries Limited contains the active substance pantoprazole.
Pantoprazole is a "selective proton pump inhibitor", a medicine that reduces the amount of acid produced in the stomach. It is used to treat stomach and intestinal diseases related to acidity.
Pantoprazolo Sun Pharmaceutical Industries Limited is used for the treatment of adults and
adolescents aged 12 years and older for

Symptoms (for example, heartburn, acid regurgitation, pain on swallowing) associated with gastro-oesophageal reflux caused by acid reflux from the stomach
Long-term treatment of reflux oesophagitis (inflammation of the oesophagus accompanied by regurgitation of stomach acid) and prevention of its recurrence. Pantoprazolo Sun Pharmaceutical Industries Limited is used for the treatment of adults for
Prevention of duodenal and gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example ibuprofen) in at-risk patients who require continuous treatment with anti-inflammatory medicines.

2. What you need to know before taking Pantoprazolo Sun Pharmaceutical Industries

Limited
Do not take Pantoprazolo Sun Pharmaceutical Industries Limited

If you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6).

it-pl-V59 1

If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Pantoprazolo Sun Pharmaceutical Industries Limited:

If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. In such cases, your doctor will monitor liver enzymes more frequently, especially if you are taking Pantoprazolo Sun Pharmaceutical Industries Limited as a long-term treatment. If liver enzymes increase, treatment should be discontinued.
If you regularly take medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) and are taking Pantoprazolo Sun Pharmaceutical Industries Limited due to an increased risk of gastrointestinal complications. This increased risk will be assessed based on your personal risk factors, such as age (65 years and older), history of gastric or duodenal ulcer, or gastrointestinal bleeding.
If you have low body reserves or risk factors for reduced vitamin B12 availability and are undergoing long-term treatment with pantoprazole, since, like all medicines that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12.
If you are taking a medicine containing atazanavir (for the treatment of 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, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you have osteoporosis (reduced bone density) or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
If you are taking Pantoprazolo Sun Pharmaceutical Industries Limited 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, consult your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether periodic monitoring of blood magnesium levels is necessary.
If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazolo Sun Pharmaceutical Industries Limited that reduces stomach acidity. If you notice the appearance of a skin rash, especially in sun-exposed areas, contact your doctor as soon as possible, as it may be necessary to discontinue therapy with Pantoprazolo Sun Pharmaceutical Industries Limited. 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 before or after taking this medicine if you notice any of the following symptoms, which could be signs of a more serious underlying condition:

Unintentional weight loss
Recurrent vomiting
Blood in vomit; this may appear as dark, coffee-ground-like material in the vomit
Blood in stools; stools may appear dark or tarry
Difficulty swallowing or pain when swallowing
Pale appearance and feeling weak (anaemia)
Chest pain
Stomach pain

it-pl-V59 2

Severe and/or persistent diarrhoea, as this medicine has been associated with a slight increase in infectious diarrhoea.

Your doctor may decide that you need certain tests to rule out the presence of malignant tumours, because pantoprazole can relieve cancer symptoms and thus delay diagnosis. If symptoms persist despite treatment, further investigations will be considered.
If you are taking Pantoprazolo Sun Pharmaceutical Industries Limited long-term (more than one year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances each time you see your doctor.

Children and adolescents
The use of Pantoprazolo Sun Pharmaceutical Industries Limited is not recommended in children, as efficacy has not been demonstrated in children under 12 years of age.

Other medicines and Pantoprazolo Sun Pharmaceutical Industries Limited
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.
This is because Pantoprazolo Sun Pharmaceutical Industries Limited can affect the effectiveness of other medicines. Therefore, inform your doctor if you are taking:

Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazolo Sun Pharmaceutical Industries Limited may prevent these and other medicines from working properly.
Warfarin and phenprocoumon, which affect blood thickness and clotting; in this case, you may need additional blood tests.
Medicines used to treat HIV infections, such as atazanavir.
Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking high doses of methotrexate, your doctor may temporarily discontinue treatment with Pantoprazolo Sun Pharmaceutical Industries Limited, as pantoprazole may increase methotrexate levels in the blood.
Fluvoxamine (used to treat depression and other psychiatric disorders) – if you are taking fluvoxamine, your doctor may reduce the dose.
Rifampicin (used to treat infections).
St John’s wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy, breastfeeding, and fertility
There are insufficient data on the use of pantoprazole in pregnant women. Excretion in breast milk has been reported.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should use this medicine only if your doctor considers the benefit to you to be greater than the potential risk to the foetus or newborn.

Driving and using machines
it-pl-V59 3
Pantoprazolo Sun Pharmaceutical Industries Limited does not affect, or has a negligible effect on, the ability to drive vehicles and use machines. However, if side effects such as dizziness or blurred vision occur, you must not drive or operate machinery.

Pantoprazolo Sun Pharmaceutical Industries Limited contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Pantoprazole Sun Pharmaceutical Industries Limited

Take this medicine exactly as your doctor has told you. If you are not sure,
consult your doctor or pharmacist.
Method of administration
Take the tablets 1 hour before a meal, without chewing or crushing them, swallowing them whole
with water.
The recommended dose is:
Adults and adolescents aged 12 years and older

For the treatment of symptoms (e.g. heartburn, acid regurgitation, and pain on swallowing) associated with gastro-oesophageal reflux The usual dose is one tablet daily. Relief is usually achieved within 2–4 weeks, or after a maximum of another 4 weeks. Your doctor will tell you how long you should continue taking the medicine. After this treatment, any relapse symptoms can be managed by taking one tablet daily as needed.
For long-term treatment and prevention of recurrence of reflux oesophagitis The usual dose is one tablet daily. If the disease recurs, your doctor may double the dose; in this case, you may take one tablet daily of Pantoprazole Sun Pharmaceutical Industries Limited 40 mg. After healing, the dose may again be reduced to one 20 mg tablet daily.

Adults

For prevention of gastric and duodenal ulcers in patients requiring continuous treatment with NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) The usual dose is one tablet daily.

Patients with liver problems
If you suffer from severe liver problems, you must not take more than one 20 mg tablet per
day.
Use in children and adolescents
These tablets are not recommended for children under 12 years of age.
If you take more Pantoprazole Sun Pharmaceutical Industries Limited than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
it-pl-V59 4
If you forget to take Pantoprazole Sun Pharmaceutical Industries Limited
Never take a double dose to make up for a forgotten dose. Take your next dose as usual at the regular time.
If you stop taking Pantoprazole Sun Pharmaceutical Industries Limited
Do not stop taking these tablets 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 will get them.
If you experience any of the following side effects, stop taking this medicine and speak to your doctor immediately or contact the emergency department of the nearest hospital:

Severe allergic reactions (uncommon 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 profuse sweating.
Severe skin disorders (frequency not known: frequency cannot be estimated from the available data): development of blisters on the skin and rapid worsening of general condition, erosions (with slight bleeding) of the mucous membranes of the eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and photosensitivity).
Other serious conditions (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, kidney enlargement, sometimes with painful urination and lower back pain (severe kidney inflammation), which may lead to possible kidney failure.

Other side effects include:

Common (may affect up to 1 in 10 people): Benign gastric polyps.
Uncommon (may affect up to 1 in 100 people): Headache; dizziness; diarrhoea; nausea, vomiting; flatulence and gas; constipation; dry mouth; abdominal pain and discomfort; skin rash; exanthema; itching; feeling of weakness, fatigue or general malaise; sleep disorders; fracture of the hip, wrist or spine.

it-pl-V59 5

Rare (may affect up to 1 in 1,000 people): Altered or complete loss of taste; visual disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of extremities (peripheral oedema); allergic reactions; depression; breast enlargement in men.
Very rare (may affect up to 1 in 10,000 people): Disorientation.
Not known (frequency cannot be estimated from the available data): Hallucinations, confusion (especially in patients with prior history of these symptoms); decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2); tingling sensation, pins and needles, burning or numbness, erythema, possible joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Side effects identified by 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 decrease in white blood cells in the blood associated with high fever.
Very rare (may affect up to 1 in 10,000 people): Reduced platelet count, which may cause bleeding or bruising more often than normal; reduced white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red and white blood cells as well as platelets.
Not known (frequency cannot be estimated from the available data): Low levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

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

5. How to store Pantoprazole Sun Pharmaceutical Industries Limited 20 mg

enteric-coated tablets

Keep this medicine out of the sight and reach of children.

it-pl-V59 6

Do not use this medicine after the expiry date stated on the carton and blister after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Bottle: Pantoprazole Sun Pharmaceutical Industries Limited must be used within 100 days after first opening the bottle.
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. Package contents and other information

What Pantoprazolo Sun Pharmaceutical Industries Limited 20 mg gastro-resistant tablets contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of
pantoprazole (as sodium pantoprazole sesquihydrate).
The other components are:
Core: anhydrous sodium carbonate, mannitol, crospovidone type A, hydroxypropylcellulose, microcrystalline cellulose, calcium stearate
Sub-coating: hypromellose, propylene glycol, povidone K30, titanium dioxide (E 171),
yellow iron oxide (E 172)
Gastro-resistant coating: methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, sodium lauryl sulfate, titanium dioxide (E 171), talc.

Description of the appearance of Pantoprazolo Sun Pharmaceutical Industries Limited 20 mg gastro-resistant tablets and package contents
White, gastro-resistant coated, oval, biconvex tablets with smooth surfaces on both sides.
Pantoprazolo Sun Pharmaceutical Industries Limited 20 mg is available in blister packs containing 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 and 500 gastro-resistant tablets, or in HDPE bottles with screw cap and desiccant containing 60 or 100 gastro-resistant tablets. DO NOT SWALLOW the desiccant.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands

Local representative:
Sun Pharma Italia Srl - Viale Giulio Richard, 3 - 20143 Milano

Manufacturers:
it-pl-V59 7
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp - The Netherlands
Terapia S.A.
Str. Fabricii, 124
400 632 Cluj-Napoca - Romania

This medicinal product is authorized in the European Economic Area Member States under the following names:
France: PANTOPRAZOLE CRISTERS PHARMA 20 mg, comprimé gastro-résistant
Germany: PANTOPRAZOL BASICS 20 mg magensaftresistente Tabletten
Italy: Pantoprazolo Sun Pharmaceutical Industries Limited
Poland: Ranloc
Spain: Pantoprazol SUN 20 mg comprimidos gastrorresistentes EFG
it-pl-V59 8

Patient information leaflet

Pantoprazole Sun Pharmaceutical Industries Limited 40 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, pharmacist, or nurse.
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 could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What is Pantoprazole Sun Pharmaceutical Industries Limited and what is it used for?

Pantoprazole Sun Pharmaceutical Industries Limited contains the active substance pantoprazole.
Pantoprazole is a "selective proton pump inhibitor", a medicine that reduces the amount of acid produced in the stomach. It is used to treat stomach and intestinal disorders related to acidity.
Pantoprazole Sun Pharmaceutical Industries Limited is used for the treatment of adults and adolescents aged 12 years and older for:

Gastro-oesophageal reflux disease (GORD), inflammation of the oesophagus (the tube connecting the throat to the stomach) associated with acid regurgitation from the stomach.

Pantoprazole Sun Pharmaceutical Industries Limited is used for the treatment of adults for:

Infection caused by a bacterium called Helicobacter pylori in patients with duodenal ulcer or gastric ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacterium and thereby reduce the likelihood of these ulcers recurring
Stomach and duodenal ulcers
Zollinger-Ellison syndrome and other conditions in which excessive acid is produced in the stomach.

2. What you should know before taking Pantoprazole Sun Pharmaceutical Industries

Limited
Do not take Pantoprazole Sun Pharmaceutical Industries Limited

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 medicines containing other proton pump inhibitors.

it-pl-V59 9
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Pantoprazole Sun
Pharmaceutical Industries Limited:

If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past; in this case, your doctor will check liver enzymes more frequently, especially if you are taking Pantoprazole Sun Pharmaceutical Industries Limited as a long-term treatment. If liver enzymes increase, treatment should be discontinued.
If you have low body stores or risk factors for reduced vitamin B12 availability and are being treated long-term with pantoprazole, since like all drugs that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12.
If you are taking HIV protease inhibitors such as atazanavir (for treatment of HIV infections) together with pantoprazole, consult your doctor for specific advice.
If you are taking a proton pump inhibitor such as pantoprazole, especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine. If you have osteoporosis (reduced bone density) or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
If you are taking Pantoprazole Sun Pharmaceutical Industries Limited for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether periodic monitoring of blood magnesium levels is necessary.
If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Sun Pharmaceutical Industries Limited that reduces gastric acidity. If you notice the appearance of a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as treatment with Pantoprazole Sun Pharmaceutical Industries Limited may need to be stopped. Remember to also report any other adverse effects such as joint pain.
If you need to undergo a specific blood test (Chromogranin A).

Inform your doctor immediately, before or after taking this medicine, if you notice any
of the following symptoms, which may indicate a more serious underlying condition:

Unintended weight loss
Recurrent vomiting
Blood in vomit; this may appear as dark coffee-ground-like material in the vomit
Appearance of blood in stools; stools may appear dark or tarry
Difficulty swallowing or pain when swallowing
Pale appearance and feeling weak (anaemia)
Chest pain
Stomach pain
Severe and/or persistent diarrhoea, as this medicine has been associated with a modest increase in infectious diarrhoea.

Your doctor may decide that you need further tests to exclude the presence of
malignant tumours, because pantoprazole relieves symptoms of cancer and may delay diagnosis. If
your symptoms persist despite treatment, further investigations should be considered.
it-pl-V59 10
If you are taking Pantoprazole Sun Pharmaceutical Industries Limited long-term (more than one year),
your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances each time you see your doctor.
Children and adolescents
The use of Pantoprazole Sun Pharmaceutical Industries Limited is not recommended in children,
as efficacy has not been demonstrated in children under 12 years of age.
Other medicines and Pantoprazole Sun Pharmaceutical Industries Limited
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including medicines without a prescription.
This is because Pantoprazole Sun Pharmaceutical Industries Limited can affect the efficacy of
other medicines; therefore, 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), since Pantoprazole Sun Pharmaceutical Industries Limited may prevent these and other medicines from working properly.
Warfarin and fenprocoumon, which affect blood clotting and density; in such cases, 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 Sun Pharmaceutical Industries Limited 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).

Pregnancy, breastfeeding and fertility
There are insufficient data on the use of pantoprazole in pregnant women. Excretion into breast milk has been reported.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
You should use this medicine only if your doctor considers the benefit to you to be greater than the potential risk to the foetus or newborn.
Driving and using machines
Pantoprazole Sun Pharmaceutical Industries Limited does not affect or has negligible effect on
the ability to drive vehicles and use machines.
If side effects such as dizziness or blurred vision occur, you must not drive or
use machinery.
Pantoprazole Sun Pharmaceutical Industries Limited contains sodium
it-pl-V59 11
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e.
essentially "sodium-free".

3. How to take Pantoprazole Sun Pharmaceutical Industries Limited

Take this medicine exactly as your doctor has told you. If you are unsure,
consult your doctor or pharmacist.
Method of administration
Take the tablets 1 hour before a meal, without chewing or crushing 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 two tablets per day. The usual duration of treatment for reflux esophagitis is 4–8 weeks. Your doctor will tell you how long to take the medicine.

Adults

For the treatment of infection caused by the bacterium Helicobacter pylori in patients with duodenal or gastric ulcers, in combination with two antibiotics (eradication therapy) One tablet twice daily, plus two antibiotic tablets: amoxicillin, clarithromycin, and metronidazole (or tinidazole), taken twice daily together with the pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before the evening meal. Follow your doctor’s instructions and read the package leaflets of these antibiotics. The duration of treatment is one or two weeks.
For the treatment of gastric or 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 usual duration of treatment for gastric ulcer is 4–8 weeks. The usual duration of treatment for duodenal ulcer is 2–4 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 usually two tablets per day. You must take both tablets 1 hour before a meal. Your doctor may adjust the dose depending on the amount of acid produced by your stomach. If you are prescribed more than two tablets per day, the dose should be divided into two daily administrations.

If your doctor prescribes you a daily dose of more than four tablets, they will tell you exactly
when to stop taking the medicine.
Patients with kidney problems
If you have kidney problems, you must not use Pantoprazole Sun Pharmaceutical Industries Limited
for the eradication of Helicobacter pylori.
it-pl-V59 12
Patients with liver problems
If you have severe liver problems, you must not take more than one 20 mg pantoprazole tablet per
day (tablets containing 20 mg of pantoprazole are available for this purpose).
If you have severe or moderate liver problems, you must not take Pantoprazole Sun
Pharmaceutical Industries Limited for the eradication of Helicobacter pylori.
Use in children and adolescents
These tablets are not recommended for children under 12 years of age.
If you take more Pantoprazole Sun Pharmaceutical Industries Limited than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantoprazole Sun Pharmaceutical Industries Limited
Never take a double dose to make up for a forgotten dose. Take your next normal dose at the usual time.
If you stop taking Pantoprazole Sun Pharmaceutical Industries Limited
Do not stop taking these tablets without first talking to your doctor or pharmacist.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can have side effects, although not everyone experiences them.
If you experience any of the following side effects, stop taking this medicine immediately and speak to your doctor or contact the emergency department of your nearest hospital:

Severe allergic reactions (uncommon frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, facial swelling due to allergy (Quincke's oedema/angioedema), severe dizziness with very rapid heartbeat and heavy sweating.
Severe skin disorders (frequency not known: frequency cannot be estimated from available data): blistering of the skin and rapid worsening of general condition, erosions (with slight bleeding) of the mucous membranes of the eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, especially in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and photosensitivity).
Other serious conditions (frequency not known: frequency cannot be estimated from available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, skin rashes, enlarged kidneys, sometimes with painful urination and lower back pain (severe kidney inflammation), which may lead to possible kidney failure.

Other side effects include:

Common (may affect up to 1 in 10 people): Benign gastric polyps.
Uncommon (may affect up to 1 in 100 people): Headache; dizziness, diarrhoea; nausea, vomiting, bloating and flatulence; constipation; dry mouth; abdominal pain and discomfort; skin rash; rash, itching; feeling of weakness, exhaustion or general malaise; sleep disturbances; fracture of the hip, wrist or spine.
Rare (may affect up to 1 in 1,000 people): Altered or complete loss of taste sensation; vision disorders 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 men.
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 with prior history of these symptoms); decreased sodium levels in blood, decreased magnesium levels in blood (see section 2), tingling sensation, pins and needles, burning or numbness, erythema, possible joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

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 white blood cells in the blood associated with high fever.
Very rare (may affect up to 1 in 10,000 people): Reduced platelet count, which may cause bleeding or bruising more easily than normal; reduced white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red and white blood cells as well as platelets.
Not known (frequency cannot be estimated from available data):
Low levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

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

5. How to store Pantoprazole Sun Pharmaceutical Industries Limited 40 mg

enteric-coated tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Bottle: Pantoprazole Sun Pharmaceutical Industries Limited should be used within 100 days after first opening the 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 Sun Pharmaceutical Industries Limited 40 mg gastro-resistant tablets contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of
pantoprazole (as sodium pantoprazole sesquihydrate).
The other components are:
Core: anhydrous sodium carbonate, mannitol, crospovidone type A, hydroxypropylcellulose, microcrystalline cellulose, calcium stearate
Sub-coating: hypromellose, propylene glycol, povidone K30, titanium dioxide (E 171),
yellow iron oxide (E 172)
Gastro-resistant coating: methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, sodium lauryl sulfate, titanium dioxide (E 171), talc, yellow iron oxide (E 172)

Description of the appearance of Pantoprazolo Sun Pharmaceutical Industries Limited 40 mg gastro-resistant tablets and package contents
it-pl-V59 15
Yellow gastro-resistant coated, oval, biconvex tablets, smooth on both sides.
Pantoprazolo Sun Pharmaceutical Industries Limited 40 mg is available in blister packs containing 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 and 500 gastro-resistant tablets, or in HDPE bottles with screw cap and desiccant containing 60 or 100 gastro-resistant tablets. DO NOT SWALLOW the desiccant.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands

Local representative:
Sun Pharma Italia Srl - Viale Giulio Richard, 3 - 20143 Milano, Italy

Manufacturers:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp - The Netherlands
Terapia S.A.
Str. Fabricii, 124
400 632 Cluj-Napoca - Romania

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: PANTOPRAZOL BASICS 40 mg magensaftresistente Tabletten
Italy: Pantoprazolo Sun Pharmaceutical Industries Limited
Poland: Ranloc
Spain: Pantoprazol SUN 40 mg comprimidos gastrorresistentes EFG
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