Pantoprazole Aurobindo: detailed information

Package leaflet: Information for the user

Pantoprazole Aurobindo 20 mg gastro-resistant tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Never give it to others, even if they have the same symptoms as you, because it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Pantoprazole Aurobindo is and what it is used for

Pantoprazole Aurobindo contains the active substance pantoprazole. Pantoprazole Aurobindo is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in the stomach. It is used for the treatment of acid-related diseases of the stomach and intestine.
Pantoprazole Aurobindo is used in the treatment of adults and adolescents from the age of 12 years and older for:

Symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.
Long-term treatment of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach) and prevention of its recurrence.

Pantoprazole Aurobindo is used in the treatment of adults for:

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

2. What you need to know before taking Pantoprazole Aurobindo

Do not take Pantoprazole Aurobindo

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.

Warnings and precautions
Talk to your doctor or pharmacist before taking Pantoprazole Aurobindo.

If you have severe liver problems. Inform your doctor if you have previously had liver problems. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazole Aurobindo for long-term treatment. If your liver enzymes increase, treatment must be stopped.
If you require ongoing treatment with NSAIDs and are taking Pantoprazole Aurobindo because you are at increased risk of developing gastric or intestinal complications. Any increased risk will be assessed based on your personal risk factors such as age (65 years and older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
If you have low body reserves or risk factors for vitamin B12 deficiency and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12.
If you are simultaneously taking a protease inhibitor for HIV, such as atazanavir (for treatment of HIV infection), ask your doctor for specific advice.
Taking a proton pump inhibitor such as Pantoprazole Aurobindo, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
If you have been taking Pantoprazole Aurobindo 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 rapid heartbeat. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Aurobindo 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 Pantoprazole Aurobindo. Remember to also report any other adverse effects such as joint pain.
If you are scheduled for a specific blood test (Chromogranin A).

Inform your doctor immediately, before or after taking the medicine, if you notice any of the
following symptoms, which could be signs of another, more serious condition:

unintentional weight loss
vomiting, particularly if recurrent
if you notice blood in your stools; they may appear black or tarry
difficulty swallowing or pain when swallowing
presence of blood in vomit; this may appear dark, like ground coffee
chest pain – stomach pain
you are pale and feel weak (anaemia)
severe and/or persistent diarrhoea, as this medicine has been associated with a slight increase in infectious diarrhoea episodes.

Your doctor may decide that you need certain tests to rule out malignancy,
since pantoprazole also relieves symptoms of cancer and could cause a delay in diagnosis. If your
symptoms persist despite treatment, further investigations should be considered.
If you are taking Pantoprazole Aurobindo for long-term treatment (more than 1 year), your doctor will likely
monitor you regularly. You must report any new or unusual symptoms or circumstances whenever you see your doctor.
Children and adolescents
Pantoprazole Aurobindo is not recommended for use in children, as its efficacy has not been proven in children under 12 years of age.
Other medicines and Pantoprazole Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This is because Pantoprazole Aurobindo may 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), since Pantoprazole Aurobindo may prevent these and other medicines from working properly.
Warfarin and phenprocoumon, which affect blood clotting or thinning. You may need additional monitoring.
Medicines used to treat HIV infection, such as atazanavir.
Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily suspend treatment with Pantoprazole Aurobindo, 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 decide to 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 human breast milk has been reported.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should use this medicine only if your doctor considers the benefit of treatment for you to outweigh the potential risk to the unborn or newborn child.
Driving and using machines
Pantoprazole Aurobindo does not affect or has a negligible effect on the ability to drive or use machines.
However, if you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.

3. How to take Pantoprazolo Aurobindo

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Method of administration?
Take the tablets one hour before a meal, without chewing or crushing them, swallowing them whole with some
water.
The recommended dose is:
Adults and adolescents aged 12 years and older:
For the treatment of symptoms associated with gastro-oesophageal reflux disease (e.g. heartburn, acid
regurgitation, pain on swallowing).
The usual dose is 1 tablet per day.
This dose usually provides relief within 2–4 weeks – at most after another 4 weeks. Your doctor will advise you
on how long to continue taking the medicine. After that, any recurrence of symptoms can be managed by
taking one tablet per day as needed.
For long-term treatment and prevention of recurrence of reflux oesophagitis
The usual dose is one tablet per day. If symptoms return, your doctor may double the dose, in which case you
may take Pantoprazolo Aurobindo 40 mg tablets, one per day. After healing, the dose may be reduced to one 20 mg tablet per day.
Adults:
Prevention of duodenal and gastric ulcers in patients requiring continuous treatment with NSAIDs
The usual dose is 1 tablet per day.
Patients with liver problems
If you have 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 use in children under 12 years of age.
If you take more Pantoprazolo Aurobindo than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantoprazolo Aurobindo
Do not take a double dose to make up for the missed dose. Take the next dose at the usual scheduled time.
If you stop taking Pantoprazolo Aurobindo
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any doubts about how to use Pantoprazolo Aurobindo, consult your doctor or pharmacist.

4. Possible side effects

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

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.
Serious skin disorders (frequency not known: frequency cannot be estimated from the available data): development of skin blisters and rapid deterioration of your general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), and sensitivity to light.
Other serious 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, rash and kidney enlargement sometimes with painful urination and lower back pain (severe kidney inflammation), which may lead to kidney failure. Other possible side effects include:
Common (may affect up to 1 in 10 people): benign gastric polyps
Uncommon (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash, exanthema, eruption, itching; feeling of weakness, fatigue or general malaise; sleep disorders; hip, wrist or spinal fracture.
Rare (may affect up to 1 in 1,000 people): distortion or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increase in 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 experience of these symptoms); decreased levels of sodium in the blood, decreased levels of magnesium in the blood (see section 2), tingling sensation, pins and needles, burning sensation or numbness, erythema, possibly accompanied by 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 lipids; sudden drop 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 bleeding or bruising; reduction in white blood cells, which may lead to more frequent infections; concomitant abnormal reduction in red blood cells, white blood cells, and platelets.

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 Aurobindo

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. Pack contents and other information

What Pantoprazolo Aurobindo contains

The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
The other components are: Tablet core: sodium carbonate (anhydrous), mannitol, crospovidone (type B), hydroxypropylcellulose, calcium stearate. Coating: hypromellose, yellow iron oxide (E 172), methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion, sodium lauryl sulfate, polysorbate 80, triethyl citrate.

Description of the appearance of Pantoprazolo Aurobindo and pack contents
Gastro-resistant tablet.
Light yellow, oval, biconvex, smooth on both sides, enteric-coated tablets.
Blister (Polyamide/Aluminium/PVC-Aluminium) in a carton:
Blister packs: 7, 14, 15, 28, 30, 56, 60, 98, 100, and 500 gastro-resistant tablets.
HDPE container: white opaque round HDPE container with white opaque polypropylene cap.
HDPE container: 14, 100 and 500 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l. - Via San Giuseppe, 102 - 21047 Saronno (VA)

Responsible manufacturer for batch release
APL Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

This medicinal product is authorised in the European Economic Area Member States under the following names:
Bulgaria: Пaнтoпрaзoл Ауробиндо 20 mg стомашно-устойчиви таблетки
Cyprus: Pantoprazole Aurobindo 20 mg γαστροανθεκτικό δισκία
Denmark: Pantoprazole “Aurobindo”
France: Pantoprazole Arrow Génériques 20 mg comprimé gastro-resistant
Germany: Pantoprazol Aurobindo 20 mg magensaftresistente Tablette
Italy: Pantoprazolo Aurobindo
Malta: Pantoprazole 20 mg gastro-resistant tablets
Netherlands: Pantoprazol Aurobindo 20 mg maagsapresistente tabletten
Poland: Pantoprazol Vitama
Romania: Pantoprazol Aurobindo 20 mg comprimate gastrorezistente
Spain: Pantoprazole Aurobindo 20 mg comprimidos gastroresistentes EFG
Sweden: Pantoprazole Aurobindo 20 mg enterotabletter
United Kingdom: Pantoprazole 20 mg gastro-resistant tablets

This leaflet was last updated on

Package leaflet: Information for the user

Pantoprazole Aurobindo 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Pantoprazolo Aurobindo contains the active substance pantoprazole. Pantoprazolo Aurobindo is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in the stomach. It is used for the treatment of acid-related diseases of the stomach and intestine.
Pantoprazolo Aurobindo is used in the treatment of adults and adolescents from the age of 12 years and older for:

Gastro-oesophageal reflux disease (GORD). An inflammation of the oesophagus (the tube connecting the throat to the stomach), accompanied by regurgitation of gastric acid. Pantoprazolo Aurobindo is used in the treatment of adults for: - Infection caused by a bacterium called Helicobacter pylori in patients with duodenal ulcer and gastric ulcer, in combination with two antibiotics (Eradication therapy). The aim is to eliminate the bacteria in order to reduce the risk of recurrence of these ulcers.
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 Aurobindo

Do not take Pantoprazole Aurobindo

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.

Warnings and precautions
Talk to your doctor or pharmacist before taking Pantoprazole Aurobindo.

If you have severe liver problems. Inform your doctor if you have previously had liver problems. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazole Aurobindo for long-term treatment. If your liver enzymes increase, treatment must be stopped.
If you have low body reserves or risk factors for vitamin B12 deficiency and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12.
If you are concurrently taking a protease inhibitor for HIV, such as atazanavir (for the treatment of HIV infection), consult your doctor for specific advice.
Taking a proton pump inhibitor such as Pantoprazole Aurobindo, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
If you have been taking Pantoprazole Aurobindo for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or rapid heartbeat. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Aurobindo 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 Pantoprazole Aurobindo. 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 the medicine, if you notice any of the
following symptoms, which may be signs of another, more serious condition:

unintentional weight loss
vomiting, particularly if recurrent
if you notice blood in your stools; they may appear black or tarry
difficulty swallowing or pain when swallowing
presence of blood in vomit; this may appear dark, like ground coffee
chest pain
stomach pain
you are pale and feel weak (anaemia)
severe and/or persistent diarrhoea, as this medicine has been associated with a slight increase in episodes of infectious diarrhoea.

Your doctor may decide that you need further tests to exclude malignancy,
since pantoprazole also relieves symptoms of cancer and could cause a delay in diagnosis. If your
symptoms persist despite treatment, further investigations should be considered.
If you take Pantoprazole Aurobindo for long-term treatment (more than 1 year), your doctor will likely
monitor you regularly. You must report any new or unusual symptoms or circumstances whenever you see your doctor.
Children and adolescents
Pantoprazole Aurobindo is not recommended for use in children, as its efficacy has not been demonstrated
in children under 12 years of age.
Other medicines and Pantoprazole Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines, including those obtained without a prescription. This is because Pantoprazole Aurobindo 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 Pantoprazole Aurobindo may prevent these and other medicines from working properly.
Warfarin and fenprocoumon, which affect blood clotting or thinning. You may need additional monitoring.
Medicines used to treat HIV infection, such as atazanavir.
Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily suspend treatment with Pantoprazole Aurobindo, 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 decide to 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 inadequate data on the use of pantoprazole in pregnant women. Excretion into human breast milk has been reported.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should use this medicine only if your doctor considers the benefit of treatment to you to outweigh the potential risk to the unborn or newborn child.
Driving and using machines
Pantoprazole Aurobindo has no effect or a negligible effect on the ability to drive or use machines.
However, if you experience adverse effects such as dizziness or visual disturbances, you must not drive or use machines.

3. How to take Pantoprazole Aurobindo

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Method of administration Take the tablets one hour before a meal, without chewing or crushing them, and swallow them whole with a little 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 treatment period for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will tell you
how long to take the medicine.
Adults:
For the treatment of an infection caused by a bacterium called Helicobacter pylori in patients with
duodenal ulcer and gastric ulcer, in combination with two antibiotics (Eradication therapy) .
One tablet twice daily, plus two antibiotic tablets—amoxicillin or clarithromycin and metronidazole (or tinidazole)—each to be taken twice daily together with the pantoprazole tablet.
Take the first pantoprazole tablet in the morning, 1 hour before breakfast, and the second one hour
before the evening meal. Follow your doctor’s instructions and make sure to read the package leaflet for these
antibiotics. The usual treatment duration is one or two 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 ranges
between 4 and 8 weeks. The treatment period for duodenal ulcers is generally between 2 and 4
weeks.
For long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much
stomach acid is produced.
The recommended initial dose is usually two tablets per day.
Take both tablets 1 hour before a meal. Subsequently, your doctor may adjust the dose depending on the amount of gastric acid produced. If more than two tablets per day are prescribed, the tablets should be taken twice daily.
If your doctor prescribes a daily dose of more than four tablets, you will be given specific instructions on when to stop taking the medicine.
Patients with kidney problems
If you have kidney problems, you must not take Pantoprazole Aurobindo for the eradication of Helicobacter
pylori .
Patients with liver problems
If you suffer from severe liver problems, you must not take more than one 20 mg pantoprazole tablet per
day (20 mg pantoprazole tablets are available for this purpose).
If you have moderate to severe liver problems, you must not take Pantoprazole Aurobindo for the
eradication of Helicobacter pylori.
Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.
If you take more Pantoprazole Aurobindo than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantoprazole Aurobindo
Do not take a double dose to make up for a forgotten dose. Take your next dose at the usual scheduled time.
If you stop taking Pantoprazole Aurobindo
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any doubts about how to use Pantoprazole Aurobindo, consult your doctor or pharmacist.

4. Possible side effects

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

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 oedema/angioedema), severe dizziness with very rapid heartbeat and heavy sweating.
Serious skin disorders (frequency not known: frequency cannot be estimated from the available data): development of skin blisters and rapid deterioration in your general condition, erosion (including mild 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, rash and kidney enlargement sometimes accompanied by painful urination and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other possible side effects include:

Common (may affect up to 1 in 10 people): benign gastric polyps
Uncommon (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash, exanthema, eruption, itching; feeling of weakness, fatigue or general malaise; sleep disturbances; fracture of the hip, wrist or spine.
Rare (may affect up to 1 in 1,000 people): distortion or complete loss of taste; 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 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 a 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, possibly with 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 lipids; sudden drop in circulating granular white blood cells associated with high fever.
Very rare (may affect up to 1 in 10,000 people): reduced platelet count, which may cause abnormal bleeding or bruising; 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.

Reporting of side effects
If you get any side effects, including ones 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 Aurobindo

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Aurobindo 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: sodium carbonate (anhydrous), mannitol, crospovidone (type B), hydroxypropylcellulose, calcium stearate. Coating: hypromellose, yellow iron oxide (E 172), methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion, sodium lauryl sulfate, polysorbate 80, triethyl citrate.

Description of the appearance of Pantoprazolo Aurobindo and pack contents
Gastro-resistant tablet.
Yellow, oval, biconvex, enteric-coated tablets, smooth on both sides.
Blister (Polyamide/Aluminum/PVC-Aluminum) in a carton:
Blister packs: 7, 14, 15, 28, 30, 56, 60, 98, 100, and 500 gastro-resistant tablets.
HDPE container: round, white, opaque HDPE container with white, opaque polypropylene closure.
HDPE container: 14, 100 and 500 gastro-resistant tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l. - via San Giuseppe, 102 - 21047 Saronno (VA)
Manufacturer responsible for batch release
APL Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG
3000, Malta
Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD,
United Kingdom
This medicinal product is authorized in the European Economic Area countries under the following
names:
Bulgaria: Пaнтoпрaзoл Ауробиндо 40 mg стомашно-устойчиви таблетки
Cyprus: Pantoprazole Aurobindo 40 mg gastro-resistant tablets
Denmark: Pantoprazole “Aurobindo”
France: Pantoprazole Arrow Génériques 40 mg comprimé gastro-résistant
Germany: Pantoprazol Aurobindo 40 mg magensaftresistente Tablette
Italy: Pantoprazolo Aurobindo
Malta: Pantoprazole 40 mg gastro-resistant tablets
Netherlands: Pantoprazol Aurobindo 40 mg maagsapresistente tabletten
Poland: Pantoprazol Vitama
Romania: Pantoprazol Aurobindo 40 mg comprimate gastrorezistente
Spain: Pantoprazole Aurobindo 40 mg comprimidos gastroresistentes EFG
Sweden: Pantoprazole Aurobindo 40 mg enterotabletter
United Kingdom: Pantoprazole 40 mg gastro-resistant tablets
This leaflet was last updated in