PANTOPRAZOLO 20 mg Enteric-Coated Tablet

Зміст інструкції

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

Pantoprazolo Aurobindo 20 mg gastro-resistant tablets

Generic medicine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Pantoprazolo Aurobindo 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 intestines.
Pantoprazolo Aurobindo is used in the treatment of adults and adolescents 12 years of age 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.

Pantoprazolo Aurobindo is used in the treatment of adults for:

• the prevention of duodenal and stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who require continuous treatment with NSAIDs.

2. What you need to know before taking Pantoprazolo Aurobindo

Do not take Pantoprazolo 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 Pantoprazolo Aurobindo.

• If you have severe liver problems. Tell your doctor if you have had liver problems in the past. The doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazolo Aurobindo for long-term therapy. If liver enzymes increase, treatment must be discontinued.
• If you need continuous treatment with NSAIDs and are taking Pantoprazolo Aurobindo because you have an increased risk of developing gastric and intestinal complications. Any increased risk will be assessed based on your personal risk factors such as age (65 years and over), a history of gastric or duodenal ulcers or gastrointestinal bleeding.
• If you have reduced body stores of vitamin B12 or risk factors for reduced vitamin B12 and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole can lead to reduced absorption of vitamin B12.
• If you are simultaneously taking a protease inhibitor for HIV such as atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
• Taking a proton pump inhibitor such as Pantoprazolo Aurobindo, especially for a period longer than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Tell your doctor if you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
• If you have been treated with Pantoprazolo Aurobindo for more than three months, magnesium levels in the blood may decrease. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, tell your doctor immediately. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to periodically perform blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazolo Aurobindo that reduces stomach acid.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop therapy with Pantoprazolo Aurobindo. Also remember to report any other unwanted effects such as joint pain.
• If you are to undergo a specific blood test (Chromogranin A).

Tell your doctor immediately, before or after taking the medicine, if you notice any of the
following symptoms, which may be a sign of another, more serious, disorder:

• unintentional weight loss
• vomiting, especially if recurrent
• if you notice blood in your stools; which may appear black or tarry
• difficulty swallowing or pain when swallowing
• presence of blood in the vomit; this may appear dark like coffee grounds
• chest pain - stomach pain
• you are pale and feel weak (anemia)
• severe and/or persistent diarrhea, as this medicine has been associated with a modest increase in episodes of infectious diarrhea.

The doctor may decide that you need to undergo some tests to rule out a malignancy,
as pantoprazole also relieves the symptoms of cancer and may cause a delay in diagnosis. If your
symptoms persist despite treatment, further investigations should be considered.
If you take Pantoprazolo Aurobindo for long-term treatment (more than 1 year), the doctor will probably
keep you under regular control. You should report any new or unusual symptom or circumstance
whenever you see the doctor.

Children and adolescents
Pantoprazolo Aurobindo is not recommended for use in children because it has not been proven to work
in children under 12 years of age.

Other medicines and Pantoprazolo Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including medicines obtained without a prescription. This is because Pantoprazolo Aurobindo can
affect the effectiveness of other medicines, so tell your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer), as Pantoprazolo Aurobindo may prevent these and other medicines from working properly.
• Warfarin and phenprocoumone, which affect the thickening or dilution of the blood. You may need further checks.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used for the treatment of rheumatoid arthritis, psoriasis and cancer) - if you are taking methotrexate, your doctor may temporarily suspend treatment with Pantoprazolo Aurobindo, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used for the treatment of 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 no adequate data regarding the use of pantoprazole in pregnant women. Excretion
into human breast milk has been reported.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
You should only use this medicine if the doctor believes that the benefit of treatment for you is greater
than the potential risk to the unborn child or the newborn.

Driving and operating machinery
Pantoprazolo Aurobindo does not affect or has a negligible effect on the ability to drive vehicles or
operate machinery.
If you experience side effects such as dizziness or visual disturbances, you should not drive or operate machinery.

3. How to take Pantoprazolo Aurobindo

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

How to administer?
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 over:

For the treatment of symptoms associated with gastro-oesophageal reflux disease (e.g. heartburn, acid regurgitation,
pain when swallowing).
The usual dose is 1 tablet a day.
This dose usually provides relief in 2-4 weeks – at most after another 4 weeks. Your doctor will tell you
how long to continue taking the medicine. After that, if symptoms recur, they can be controlled by taking one tablet a day, as needed.

For long-term treatment and prevention of recurrent reflux oesophagitis
The usual dose is one tablet a day. If the symptom returns, your doctor may double the dose, in
which case you may take Pantoprazolo Aurobindo tablets 40 mg, one a day. After healing, you can reduce the dose back to one 20 mg tablet a day.

Adults:

Prevention of duodenal and gastric ulcers in patients who require continuous treatment with NSAIDs
The usual dose is 1 tablet a day.

Patients with liver problems
If you have severe liver problems, you should not take more than one 20 mg tablet a 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. No symptoms of overdose are known.

If you forget to take Pantoprazolo Aurobindo
Do not take a double dose to make up for a missed dose. Take the next usual dose
at the 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 questions about the use of Pantoprazolo Aurobindo, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, stop treatment with these tablets and
consult your doctor immediately, or contact the nearest hospital emergency room:

• Severe allergic reactions (rare frequency:can affect up to 1 in 1000 people ):swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic facial swelling (angioedema/Quincke's edema), severe dizziness with a very fast heartbeat and profuse sweating.
• Severe skin conditions (frequency not known:the frequency cannot be established based on available data ):appearance 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, Multiforme erythema) and light sensitivity.
• Other serious conditions (frequency not known:the frequency cannot be established based on available data ):yellowing of the skin or whites of the eyes (serious damage to liver cells, jaundice) or fever, rash and enlargement of the kidneys sometimes with pain when urinating and lower back pain (serious kidney inflammation), which can lead to kidney failure. Other possible side effects are:
• Common(may affect up to 1 in 10 people) Benign polyps in the stomach
• Uncommon(may affect up to 1 in 100 people) Headache; dizziness; diarrhea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; rash, exanthema, eruption, itching; feeling of weakness, fatigue or general malaise; sleep disorders; hip, wrist or spine fracture.
• Rare(may affect up to 1 in 1,000 people) Distortion or complete loss of the sense of taste; visual disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature

corporeal; high fever; swelling of the extremities (peripheral edema); allergic reactions; depression;
increase in breast volume in men.

• Very rare(may affect up to 1 in 10,000 people) Disorientation.
• Not known(the frequency cannot be defined based on available data) Hallucinations, confusion (especially in patients with a history of these symptoms); decreased levels of sodium in the blood, decreased levels of magnesium in the blood (see section 2), sensation of tingling, pins and needles, burning sensation or numbness, erythema, with possible joint pain.

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100 people) An increase in liver enzymes.
• Rare(may affect up to 1 in 1,000 people) An increase in bilirubin; increased fats in the blood; sudden decrease in circulating granular white blood cells associated with high fever.
• Very rare(may affect up to 1 in 10,000 people) A reduction in the number of platelets, which can cause more bleeding or bruising than normal; a reduction in white blood cells, which can lead to more frequent infections; concurrent abnormal reduction in the number of red blood cells and white blood cells, as well as platelets.

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

Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients are: Tablet Core: sodium carbonate (anhydrous), mannitol, crospovidone (type B), hydroxypropylcellulose, calcium stearate. Coating: hypromellose, yellow iron oxide (E 172), acrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, sodium lauryl sulfate, polysorbate 80, triethyl citrate

Description of the Appearance of Pantoprazolo Aurobindo and Package Contents
Gastro-resistant tablet.
Light yellow, oval, biconvex, smooth tablets on both sides, with enteric coating.
Blisters (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 opaque white HDPE container with an opaque white polypropylene closure.
HDPE container: 14, 100 and 500 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area with the following
names:
Bulgaria: Пaнтoпрaзoл Ауробиндо 20 mg стомашно-устойчиви таблетки
Cyprus: Pantoprazole Aurobindo 20 mg gastro-resistant tablets
Denmark: Pantoprazole “Aurobindo”
France: Pantoprazole Arrow Génériques 20 mg gastro-resistant tablet
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

Pantoprazolo Aurobindo 40 mg gastro-resistant tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Pantoprazolo Aurobindo contains the active ingredient 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 usedin the treatment of adults and adolescents 12 years of age and older for:

• Reflux esophagitis. An inflammation of the esophagus (the tube connecting the throat to the stomach), accompanied by acid regurgitation. Pantoprazolo Aurobindo is usedin the treatment of adults for:- An infection caused by a bacterium called Helicobacter pyloriin patients with duodenal ulcer and gastric ulcer in combination with two antibiotics (Eradication therapy). The purpose is to get rid of the bacteria in order to reduce the possibility that these ulcers will return.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before taking Pantoprazolo Aurobindo

Do not take Pantoprazolo Aurobindo

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

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

• If you have severe liver problems. Tell your doctor if you have had liver problems in the past. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazolo Aurobindo for long-term therapy. If liver enzymes increase, treatment must be discontinued.
• If you have reduced body stores of vitamin B12 or risk factors for reduced vitamin B12 and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole can lead to reduced absorption of vitamin B12.
• If you are simultaneously taking a HIV protease inhibitor such as atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
• Taking a proton pump inhibitor such as Pantoprazolo Aurobindo, especially for a period longer than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Tell your doctor if you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
• If you have been treated with Pantoprazolo Aurobindo for more than three months, it is possible that magnesium levels in the blood may decrease. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, tell your doctor immediately. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to periodically perform blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazolo Aurobindo that reduces stomach acid.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop therapy with Pantoprazolo Aurobindo. Remember to also report any other unwanted effects such as joint pain. - If you are to undergo a specific blood test (Chromogranin A).

Tell your doctor immediately, before or after taking the medicine, if you notice any of the following symptoms, which may be a sign of another, more serious, disorder:

• an involuntary weight loss
• vomiting, especially if recurrent
• if you notice blood in your stools; which may appear black or tarry
• difficulty swallowing or pain when swallowing
• presence of blood in the vomit; this may appear dark like coffee grounds
• chest pain
• stomach pain
• you are pale and feel weak (anemia)
• severe and/or persistent diarrhea, as this medicine has been associated with a modest increase in episodes of infectious diarrhea.

The doctor may decide that you need to undergo some tests to rule out a malignant disease, as pantoprazole also relieves the symptoms of cancer and may cause a delay in diagnosis. If your symptoms persist, despite treatment, further investigations must be considered. If you take Pantoprazolo Aurobindo for long-term treatment (longer than 1 year), the doctor will probably keep you under regular control. You should report any new or unusual symptom or circumstance whenever you see the doctor.

Children and adolescents
Pantoprazolo Aurobindo is not recommended for use in children because it has not been proven to work in children under 12 years of age.

Other medicines and Pantoprazolo Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is because Pantoprazolo Aurobindo can affect the effectiveness of other medicines, so tell your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer), as Pantoprazolo Aurobindo may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect the thickening or thinning of the blood. You may need further checks.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used for the treatment of rheumatoid arthritis, psoriasis and cancer) - if you are taking methotrexate, your doctor may temporarily suspend treatment with Pantoprazolo Aurobindo, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used for the treatment of 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 no adequate data regarding the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You should only use this medicine if the doctor believes that the benefit of treatment for you is greater than the potential risk to the unborn child or the newborn.

Driving and operating machinery
Pantoprazolo Aurobindo does not affect or has a negligible effect on the ability to drive vehicles or operate machinery.
If you experience side effects such as dizziness or visual disturbances, you should not drive or operate machinery.

3. How to take Pantoprazolo Aurobindo

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

Method of administrationTake 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 over:

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

Adults:

For the treatment of an infection caused by a bacterium calledHelicobacter pyloriin patients
with duodenal ulcer and gastric ulcer in combination with two antibiotics (Eradication therapy).
One tablet twice a day, plus two antibiotic tablets, namely amoxicillin or clarithromycin and
metronidazole (or tinidazole), each to be taken twice a day 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 with the antibiotics. The usual treatment period is one or two weeks.

For the treatment of gastric and duodenal ulcers.
The usual dose is one tablet a day. After consulting your doctor, the dose may be
doubled.
Your doctor will tell you how long to take the medicine. The treatment period for gastric ulcers ranges
from 4 to 8 weeks. The period for the treatment of duodenal ulcers is typically between 2 and 4
weeks.

For the long-term treatment of Zollinger-Ellison syndrome and other conditions in which
too much acid is produced in the stomach.
The recommended starting dose is usually two tablets a 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 are prescribed per day, the
tablets must be taken twice a day.
If your doctor prescribes a daily dose of more than four tablets a day, they will tell you exactly when
to stop taking the medicine.

Patients with kidney problems
If you have kidney problems, you should not take Pantoprazolo Aurobindo for the eradication of Helicobacter

pylori.

Patients with liver problems
If you suffer from severe liver problems, you should not take more than one 20 mg pantoprazole tablet a
day (tablets containing 20 mg of pantoprazole are available for this purpose).
If you suffer from moderate to severe liver problems, you should not take Pantoprazolo 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 Pantoprazolo Aurobindo than you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take Pantoprazolo Aurobindo
Do not take a double dose to make up for a missed dose. Take your normal next dose
at the scheduled time.

If you stop taking Pantoprazolo Aurobindo
Do not stop taking these tablets without first consulting your doctor or pharmacist.
If you have any questions about the use of Pantoprazolo Aurobindo, ask 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 these tablets and
consult a doctor immediately, or contact the nearest hospital emergency room:

• Severe allergic reactions (rare frequency:may affect up to 1 in 1000 people ):swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the face (angioedema/Quincke's edema), severe dizziness with a very fast heartbeat and profuse sweating.
• Severe skin conditions (frequency not known:frequency cannot be estimated from available data ):appearance 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, Multiforme erythema) and light sensitivity.
• 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, rash and enlargement of the kidneys sometimes with pain when urinating and lower back pain (severe kidney inflammation), which can lead to kidney failure.

Other possible side effects are:

• Common(may affect up to 1 in 10 people) Benign polyps in the stomach
• Uncommon(may affect up to 1 in 100 people) Headache; dizziness; diarrhea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; rash, exanthema, eruption, itching; feeling of weakness, fatigue or general malaise; sleep disorders; hip, wrist or spine fracture.
• Rare(may affect up to 1 in 1,000 people) Distortion 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 the extremities (peripheral edema); allergic reactions; depression; enlargement of the breast 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 a history of these symptoms); decreased levels of sodium in the blood, decreased levels of magnesium in the blood (see section 2), tingling, prickling and pins and needles sensation, burning or numbness sensation, erythema, with possible joint pain.

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100 people) An increase in liver enzymes.
• Rare(may affect up to 1 in 1,000 people) An increase in bilirubin; increased fats in the blood; sudden decrease in circulating granular white blood cells associated with high fever.
• Very rare(may affect up to 1 in 10,000 people) A reduction in the number of platelets which may cause bleeding or bruising more than normal; a reduction in white blood cells which may lead to more frequent infections; concurrent abnormal reduction in the number of red blood cells, white blood cells, and platelets.

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

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pantoprazolo Aurobindo contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients are: Tablet core: sodium carbonate (anhydrous), mannitol, crospovidone (type B), hydroxypropylcellulose, calcium stearate. Coating: hypromellose, yellow iron oxide (E 172), acrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, sodium lauryl sulfate, polysorbate 80, triethyl citrate.

Description of the appearance of Pantoprazolo Aurobindo and contents of the pack
Gastro-resistant tablet.
Yellow, oval, biconvex, film-coated tablets, smooth on both sides.
Blisters (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 opaque white HDPE container with an opaque white polypropylene closure.
HDPE container: 14, 100 and 500 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area with the following
names:
Bulgaria: Пaнтoпрaзoл Ауробиндо 40 mg стомашно-устойчиви таблетки
Cyprus: Pantoprazole Aurobindo 40 mg γαστροανθεκτικό δισκία
Denmark: Pantoprazole “Aurobindo”
France: Pantoprazole Arrow Génériques 40 mg comprimé gastro-resistant
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 updatedon