Pantoprazole Mylan Italia: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Pantoprazole Mylan Italia 20 mg Gastro-resistant Tablets

pantoprazole
Equivalent medicine
Please 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 give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
What Pantoprazole Mylan Italia is and what it is used for
What you need to know before taking Pantoprazole Mylan Italia
How to take Pantoprazole Mylan Italia
Possible side effects
How to store Pantoprazole Mylan Italia
Contents of the pack and other information

1. What Pantoprazolo Mylan Italia is and what it is used for

Pantoprazolo Mylan Italia contains the active substance pantoprazolo. Pantoprazolo Mylan Italia is a
selective "proton pump inhibitor," a medicine that reduces the amount of acid produced by the
stomach. It is used to treat conditions caused by acidic secretion from the stomach and intestine.
Pantoprazolo Mylan Italia is used to treat adults and adolescents from the age of 12 for:
:
Symptoms (heartburn, acid regurgitation, and pain on swallowing) associated with gastroesophageal
reflux disease caused by the backflow of acid from the stomach.
long-term treatment and prevention of relapse of reflux oesophagitis (inflammation of the oesophagus accompanied by regurgitation of stomach acid).
Pantoprazolo is used to treat adults for:
prevention of gastric and duodenal ulcers caused by non-steroidal anti-inflammatory drugs
(NSAIDs, e.g. ibuprofen) in at-risk patients who require ongoing NSAID treatment.

2. What you need to know before taking Pantoprazole Mylan Italia

Do not take Pantoprazole Mylan Italia
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
Tell your doctor or pharmacist before taking Pantoprazole Mylan Italia:
if you have severe liver problems. Inform your doctor if you have ever had liver problems in the past.
Your doctor should check liver enzymes more frequently, especially if you are taking Pantoprazole Mylan Italia for a long time. If liver enzymes increase, treatment should be discontinued.
if your doctor has prescribed Pantoprazole Mylan Italia together with medicines called NSAIDs, as there is an increased risk of developing stomach and intestinal complications. This increased risk will be assessed according to your individual risk factors and age (65 years or older), a history of duodenal or gastric ulcers, or gastrointestinal bleeding.
if you have a reduced ability or are at risk for reduced absorption of vitamin B12 and are taking Pantoprazole Mylan Italia long-term. Like all agents that reduce acid secretion, pantoprazole may lead to reduced absorption of vitamin B12. Consult your doctor if you notice any of the following symptoms, which may indicate low vitamin B12 levels:

Extreme tiredness or lack of energy
Tingling and numbness
Red or sore tongue, mouth ulcers
Muscle weakness
Vision disturbances
Memory problems, confusion, depression

if you are taking HIV protease inhibitors such as atazanavir (used to treat HIV infection) together with pantoprazole, please consult your doctor for specific advice.
taking a proton pump inhibitor such as pantoprazole, 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 (reduced bone density) or if your doctor tells you that you are at risk of osteoporosis (e.g., if you are taking steroids).
if you have been taking pantoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
if you have ever had a skin reaction after treatment with a medicine similar to pantoprazole that reduces stomach acidity.
if you notice the appearance of a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue pantoprazole therapy. Remember to also report any other adverse effects such as joint pain.
serious skin reactions have been reported in association with pantoprazole treatment, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop using pantoprazole and contact your doctor immediately if you notice any symptoms related to these serious skin reactions, described in section 4.
if you are scheduled for 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:
unintentional weight loss
vomiting, especially if repeated
difficulty swallowing or pain when swallowing
blood in vomit; this may appear as dark, coffee-ground-like material in the vomit
pale and unwell appearance (anemia)
chest pain
stomach pain
blood in stools; stools may appear dark or tarry
severe and/or persistent diarrhoea, as pantoprazole is associated with a slight increase in diarrhoea-causing infections.

Your doctor may perform further tests to rule out malignant tumours, as pantoprazole relieves symptoms of cancer and may delay diagnosis. If symptoms persist despite treatment, further investigations will be considered.
If you are taking pantoprazole for long-term treatment (more than 1 year), your doctor will monitor you regularly. At each visit, inform your doctor of any new or unusual symptoms or circumstances.

Children and adolescents
The use of Pantoprazole Mylan Italia is not recommended in children, as efficacy has not been demonstrated in children under 12 years of age.

Other medicines and Pantoprazole Mylan Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines.
This is because Pantoprazole Mylan Italia 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 in certain types of cancer), because pantoprazole may affect how these and similar medicines work.
warfarin and phenprocoumon, which affect blood clotting. Additional monitoring may be required.
medicines used to treat HIV infection, such as atazanavir.
methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily discontinue treatment with Pantoprazole Mylan Italia, 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).
Consult your doctor before taking pantoprazole if you are scheduled for a specific urine test (for THC: tetrahydrocannabinol).

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 a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should not use this medicine during pregnancy or breastfeeding unless your doctor considers the benefits to outweigh the potential risks to the fetus or newborn.

Driving and using machines
Pantoprazole Mylan Italia does not affect or has a negligible effect on the ability to drive vehicles and use machinery. However, if you experience side effects such as dizziness or visual disturbances, you should not drive or operate machinery.

Pantoprazole Mylan Italia contains lactose and sodium.
Pantoprazole Mylan Italia contains lactose. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take Pantoprazole Mylan Italia

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

When and how to take Pantoprazole Mylan Italia
Take the tablets 1 hour before meals, without chewing or crushing them, swallowing them whole with some water.
Unless otherwise directed by your doctor, the recommended dose is:

Adults and adolescents aged 12 years and older:
Treatment of symptoms (e.g., heartburn, acid regurgitation, and pain on swallowing) associated with gastroesophageal reflux disease (GERD)
The usual dose is one tablet per day. This dose usually provides relief within 2–4 weeks – at most after an additional 4 weeks. Your doctor will advise you on how long to continue taking the medicine.
After this, any recurring symptoms can be managed by taking one tablet per day as needed.

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 this case, pantoprazole 40 mg tablets once daily may be used instead. After healing, the dose may be reduced again to 20 mg (one tablet per day).

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

Patients with liver problems
If you have severe liver problems, do not exceed a daily dose of 20 mg.

Use in children and adolescents
These tablets are not recommended for children under 12 years of age.

If you take more Pantoprazole Mylan Italia than you should
Contact your doctor or pharmacist. There are no known symptoms of overdose.

If you forget to take Pantoprazole Mylan Italia
Do not take a double dose to make up for the missed dose. Take the next dose at your usual time.

If you stop taking Pantoprazole Mylan Italia
Do not stop taking these tablets without consulting your doctor or pharmacist.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following side effects, stop taking these tablets immediately and inform your
doctor, or contact the Emergency Department of the nearest hospital:

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

Severe allergic reactions: swelling of the tongue and/or throat, difficulty swallowing, hives (skin rash), breathing difficulties, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating.

Not known (frequency cannot be estimated from available data)

Severe skin conditions:
blistering of the skin and rapid deterioration of general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arm), and blood tests may show changes in white blood cell count or liver enzymes.
non-elevated red, target-shaped or circular spots on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Other serious conditions:
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 inflammation of the kidneys which may lead to 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 (gas); constipation; dry mouth; abdominal pain and malaise; skin rashes, exanthema, rash; itching; feeling of fatigue or general malaise; sleep disorders, fracture of the pelvis, wrist or spine.

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

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

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

Disorientation.

Not known (frequency cannot be estimated from available data)

Hallucinations, confusion (especially in patients with a history of these symptoms); tingling sensation, pricking, pins and needles; burning or numbness sensation, 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 lipids, drastic decrease in circulating granulocytes associated with high fever.

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

reduced platelet count, which may cause increased bleeding or bruising; reduced white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red blood cells, white blood cells, and platelets.

Not known (frequency cannot be estimated from available data)

decreased 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Pantoprazole Mylan Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
For blister packs, do not store above 30°C. Store in the original packaging.
When packed in bottles, this medicine does not require any special storage temperature. Store in the original packaging.
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 Mylan Italia contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole
(as sodium sesquihydrate).
The other components are:
microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, anhydrous colloidal silica and
magnesium stearate. The coating contains sodium lauryl sulfate, polysorbate 80, methacrylic acid-ethyl acrylate copolymer, triethyl citrate, polyvinyl alcohol, macrogol 3350, titanium dioxide, talc, yellow iron oxide and aluminium lake of quinoline yellow. (See section 2 “Pantoprazolo Mylan Italia contains lactose and sodium”)
Description of the appearance of Pantoprazolo Mylan Italia and package contents
The tablets are yellow to ochre in colour and oblong in shape.
Pantoprazolo Mylan Italia is available in plastic bottles and blister packs.
Pantoprazolo Mylan Italia is available in the following pack sizes: packs of 7, 14, 15, 28, 30, 50, 56,
60, 100 and 250 tablets.
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Mylan S.p.A., Via Vittor Pisani, 20, 20124 Milano, Italy
Responsible Manufacturers for Batch Release
TOWA Pharmaceutical Europe, S.L.
C/ de Sant Marti, 75-97 Martorelles, 08107 Barcelona,
Spain.

Patient Information Leaflet

Pantoprazolo Mylan Italia 40 mg Gastro-resistant Tablets

pantoprazole
Equivalent 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Pantoprazolo Mylan Italia and what is it used for?

Pantoprazolo Mylan Italia contains the active substance pantoprazole. Pantoprazolo Mylan Italia is a
selective "proton pump inhibitor", a medicine that reduces the amount of acid produced by the
stomach. It is used to treat conditions caused by acidic secretions from the stomach and intestine.
Pantoprazolo Mylan Italia is used for treatment in adults and adolescents from 12 years of age for:

Reflux esophagitis. An inflammation of the esophagus (the tube connecting the throat to the stomach) associated with stomach acid regurgitation.

Pantoprazolo Mylan Italia is used in adults for:

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

2. What you need to know before taking Pantoprazole Mylan Italia

Do not take Pantoprazole Mylan Italia:

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
Tell your doctor or pharmacist before taking Pantoprazole Mylan Italia:

if you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor will need to monitor liver enzymes more frequently, especially if you are taking Pantoprazole Mylan Italia long-term. If liver enzymes increase, treatment should be discontinued.
if you have impaired ability or a risk factor for reduced vitamin B12 absorption and are taking Pantoprazole Mylan Italia long-term. Like all acid-reducing agents, pantoprazole may lead to reduced absorption of vitamin B12. Consult your doctor if you experience any of the following symptoms, which may indicate low vitamin B12 levels:
- Extreme tiredness or lack of energy
- Tingling and numbness
- Red or sore tongue, mouth ulcers
- Muscle weakness
- Vision disturbances
- Memory problems, confusion, depression
if you are taking HIV protease inhibitors such as atazanavir (used to treat HIV infection) together with pantoprazole, ask your doctor for specific advice.
Taking a proton pump inhibitor such as pantoprazole, 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 (reduced bone density) or have been told you are at risk of osteoporosis (for example, if you are taking steroids).
If you have been taking pantoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels can also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
if you have ever had a skin reaction after treatment with a medicine similar to pantoprazole that reduces stomach acidity.
if you develop a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as treatment with pantoprazole may need to be stopped. Remember to also report any other adverse effects such as joint pain.
serious skin reactions have been reported in association with pantoprazole treatment, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop using pantoprazole and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
if you are due to have 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
vomiting, especially if recurrent
difficulty swallowing or pain when swallowing
presence of blood in vomit; this may appear as dark coffee-ground-like material in vomit
pale and unwell appearance (anaemia)
chest pain
stomach pain
blood in stools; stools may appear dark or tarry
severe and/or persistent diarrhoea, as Pantoprazole has been associated with a slight increase in diarrhoea-causing infections

Your doctor may carry out further tests to rule out malignancy, as pantoprazole relieves symptoms of cancer and may delay diagnosis. If symptoms persist despite treatment, further investigations will be considered.
If you are taking pantoprazole long-term (more than 1 year), your doctor will monitor you regularly. At every visit, inform your doctor of any new or unusual symptoms or circumstances.

Children and adolescents
The use of Pantoprazole Mylan Italia is not recommended in children, as efficacy has not been demonstrated in children under 12 years of age.

Other medicines and Pantoprazole Mylan Italia
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 Pantoprazole Mylan Italia may affect the effectiveness of other medicines, so inform your doctor if you are taking:

Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because pantoprazole may affect how these and similar medicines work.
Warfarin and fenprocoumon, which affect blood clotting or thinning. Additional monitoring may be required.
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 discontinue treatment with pantoprazole, 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).

Consult your doctor before taking pantoprazole if you are due to undergo a specific urine test (for THC: tetrahydrocannabinol).

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
There are insufficient data on the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported.
You should not take this medicine during pregnancy or while breastfeeding unless your doctor considers the benefits to outweigh the potential risks to the fetus or newborn.

Driving and using machines
Pantoprazole Mylan Italia does not affect or has a negligible effect on the ability to drive vehicles or operate machinery. However, if you experience adverse effects such as dizziness or visual disturbances, you should not drive or operate machinery.

Pantoprazole Mylan Italia contains lactose and sodium
Pantoprazole Mylan Italia contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Pantoprazolo Mylan Italia

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, you should consult your doctor or pharmacist.
When and how to take Pantoprazolo Mylan Italia
Take the tablets 1 hour before meals, without chewing or crushing them, swallowing them whole with a little
water.
Unless otherwise directed by your doctor, the recommended dose is:
Adults and adolescents from 12 years of age:
Treatment of reflux esophagitis
The usual dose is 1 tablet per day. Your doctor may increase the dose to 2 tablets per
day. Treatment periods for reflux esophagitis are usually between 4 and 8 weeks. Your doctor
will tell you how long to continue taking the medicine.
Adults:
Treatment of infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and gastric ulcers, in combination with two antibiotics (eradication therapy)
One tablet twice daily, plus two tablets of the antibiotic amoxicillin or clarithromycin and
metronidazole (or tinidazole), each to be 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 make sure to read the package leaflet of these antibiotics. The usual treatment duration is 1–2 weeks.
Treatment of gastric and duodenal ulcers
The usual dose is one tablet per day. After consultation with your doctor, the dose may be
doubled. Your doctor will tell you how long to take the medicine. The treatment period for
gastric ulcers is usually between 4 and 8 weeks. The treatment period for duodenal ulcers is usually between 2 and 4 weeks.
Long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much stomach acid is produced
The recommended initial dose is two tablets per day.
Take both tablets 1 hour before a meal. Your doctor may then adjust the dose depending on the amount of stomach acid produced. If you have been prescribed more than two tablets per day, the tablets should be taken twice daily.
If your doctor prescribes a daily dose of more than four tablets per day, you will be given specific instructions on when to stop taking the medicine.
Patients with kidney problems

If you have kidney problems, you must not take Pantoprazolo for the eradication of Helicobacter pylori.

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 impairment, you must not take Pantoprazolo Mylan Italia 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 Mylan Italia than you should
Contact your doctor or pharmacist. There are no known symptoms of overdose.
If you forget to take Pantoprazolo Mylan Italia
Do not take a double dose to make up for the missed dose. Take the next dose at your usual time.
If you stop taking Pantoprazolo Mylan Italia
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 everyone gets them.
If you experience any of the following side effects, stop taking these tablets and contact your doctor immediately or go to the nearest hospital Emergency Department:

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

Severe allergic reactions: swelling of the tongue and/or throat, difficulty swallowing, hives (skin rash), breathing difficulties, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and heavy sweating.

Not known (frequency cannot be estimated from the available data)

Severe skin conditions: blistering of the skin and rapid deterioration in general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arm), and blood tests may show changes in white blood cell count or liver enzymes.
flat, non-raised red spots, target-shaped or circular rashes on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Other serious conditions: 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 that may lead to 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 (gas); constipation; dry mouth; abdominal pain and malaise; skin rashes, exanthema, rash; pruritus (itching); feeling of fatigue or general malaise; sleep disorders, pelvic, wrist or spinal fractures.

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 males.

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); sensations of tingling, pricking, 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 lipids, a drastic decrease in circulating granulocytes 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 the number of white blood cells, which may lead to more frequent infections; concurrent abnormal reduction in the number of red and white blood cells as well as platelets.

Not known (frequency cannot be estimated from the available data)

Decreased 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, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pantoprazole Mylan Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
For blister packs, do not store above 30°C. Store in the original packaging.
When supplied in bottles, this medicine does not require any special storage temperature conditions. Store in the original packaging.
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 Mylan Italia Contains

The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).
The other ingredients are: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, anhydrous colloidal silicon dioxide, and magnesium stearate. The coating contains sodium lauryl sulfate, polysorbate 80, methacrylic acid-ethyl acrylate copolymer, triethyl citrate, polyvinyl alcohol, macrogol 3350, titanium dioxide, talc, and yellow iron oxide. (See section ‘Pantoprazolo Mylan Italia contains lactose and sodium’)

Description of the Appearance of Pantoprazolo Mylan Italia and Package Contents
The tablets are slightly yellow to ochre in colour and oblong in shape.
Packaging: plastic bottles and blister packs.
Pantoprazolo Mylan Italia is available in the following pack sizes: packs containing 7, 14, 15, 28, 30, 50, 56, 60, 100 and 250 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy

Responsible Person for Batch Release
TOWA Pharmaceutical Europe, S.L. C/ de Sant Marti,
75-97 Martorelles,
08107 Barcelona, Spain