Pantoprazole Mylan

Package leaflet: Information for the user

Pantoprazole Mylan 20 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 other people, 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Pantoprazolo Mylan is a selective proton pump inhibitor, a medicine that reduces the amount of acid produced in your stomach. It is used to treat conditions caused by acidic secretion in the stomach and intestine.

It can be used for:
Adults and adolescents from 12 years of age:

• Treatment of symptoms (heartburn, acid regurgitation, and pain on 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 regurgitation of stomach acid) and prevention of relapses.

Adults:

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

2. What you need to know before taking Pantoprazole Mylan

Do not take Pantoprazole Mylan:

• if you are allergic (hypersensitive) 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 Mylan

• if you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor will monitor your liver enzymes more frequently, especially if you are taking Pantoprazole Mylan as long-term treatment. If liver enzymes increase, treatment should be discontinued.
• if you need to take medicines called NSAIDs continuously and are taking Pantoprazole Mylan because you have an increased risk of developing stomach and intestinal complications. Any increased risk will be assessed according to your individual risk factors and age (65 years or older), as well as history of duodenal or gastric ulcers or gastrointestinal bleeding.
• if you have reduced body reserves or risk factors for reduced vitamin B__ absorption and are receiving long-term treatment with pantoprazole. Like all agents that reduce gastric acid secretion, pantoprazole may cause reduced absorption of vitamin B__. Contact your doctor if you notice any of the following symptoms, which could indicate low vitamin B__ levels:
• extreme tiredness or lack of energy
• pins and needles sensation
• sore or red tongue, mouth ulcers
• muscle weakness
• vision disturbances
• memory problems, confusion, depression
• if you are taking a medicine containing atazanavir (for the treatment of HIV infection) at the same time as pantoprazole, seek specific advice from your doctor.
• taking a proton pump inhibitor such as pantoprazole, particularly for more than one year, may slightly increase the risk of wrist, hip, or spine fracture. Inform your doctor if you have osteoporosis (reduced bone density) or have been told 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 may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor promptly. 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 gastric acidity.
• serious skin reactions have been reported in association with pantoprazole treatment, including 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).

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.
Contact your doctor immediately if you notice any of the following symptoms:

• unintentional weight loss
• recurrent vomiting
• difficulty swallowing
• vomiting blood
• looking pale and unwell (anemia)
• noticing blood in your stools
• severe and/or persistent diarrhoea, as pantoprazole is associated with a slight increase in infectious diarrhoea.

Your doctor may carry out further tests to rule out malignant tumour, because pantoprazole relieves the symptoms of cancer and could 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 keep you under regular review. Each time you see your doctor, report any new or unusual symptoms or circumstances.
Other medicines and Pantoprazole Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as Pantoprazole Mylan may affect the effectiveness of other medicines.

• Medicines such as ketoconazole, itraconazole, or posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because pantoprazole may interfere with the proper functioning of these and other similar drugs.
• Warfarin and phenprocoumon, which affect blood thickness and fluidity. You may need additional monitoring.
• Atazanavir (used to treat HIV infection) (see section 2 “Warnings and precautions”).
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer).
• Fluvoxamine (used to treat depression and other psychiatric conditions). If you are taking fluvoxamine, your doctor may reduce the dose.
• Rifampicin (used to treat infections).
• St John’s wort (Hypericum perforatum) (used to treat mild depression).

Talk to your doctor if you need to undergo a specific urine test (for THC; tetrahydrocannabinol) before taking pantoprazole.
Pregnancy, breastfeeding, and fertility
There are inadequate data on the use of pantoprazole in pregnant women. Excretion of pantoprazole in breast milk has been observed. If you are pregnant, breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
You should take this medicine only if your doctor considers the benefits to outweigh the potential risks to the fetus or newborn.
Driving and using machines
If you experience adverse effects such as dizziness or visual disturbances, do not drive or operate machinery.
Pantoprazole Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Pantoprazole Mylan

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
When and how should you take Pantoprazole Mylan?
Take the tablets 1 hour before meals, without chewing or breaking them, swallowing them whole with some
water.
Unless otherwise directed by your doctor, the usual dose is:
Adults and adolescents from 12 years of age:
Treatment of symptoms (e.g. heartburn, acid regurgitation, and pain on swallowing) associated with
gastro-oesophageal reflux disease
The recommended dose is one tablet daily. This dose usually provides relief within 2–4 weeks—sometimes up to 4 additional 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 daily, as needed.
For long-term treatment and prevention of relapse of reflux oesophagitis
The recommended dose is one tablet daily. If symptoms return, your doctor may double the dose; in this case, pantoprazole 40 mg, one tablet daily, may be used instead. After healing, the dose may be reduced again to 20 mg, one tablet daily.
Adults:
For prevention of gastric and duodenal ulcers in patients requiring continuous treatment with anti-inflammatory drugs (NSAIDs)
The usual dose is one tablet daily.
Special patient groups:

• If you suffer from severe liver problems, you must not take more than one 20 mg tablet per day.
• Children under 12 years of age: These tablets are not recommended for children under 12 years of age.

If you take more Pantoprazole Mylan than you should
Contact your doctor or pharmacist. There are no known symptoms of overdose.
If you forget to take Pantoprazole Mylan
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.
If you stop taking Pantoprazole Mylan
Do not stop taking these tablets without first 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 contact your
doctor or go to the nearest hospital emergency department straight away:
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), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with rapid and heavy heartbeat and excessive sweating.
• a reduction in the number of white or red blood cells and/or platelets, which may be seen in blood tests. You may also notice more frequent infections, or increased bruising or bleeding.

Not known (frequency cannot be established from available data)

• Severe skin conditions: you may notice one or more of the following symptoms – blistering of the skin and rapid deterioration in general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals, 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.

• non-elevated red spots, circular or target-shaped, 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 skin rash, high fever 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, swollen kidneys sometimes with painful urination and lower back pain (severe kidney inflammation 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 weakness, fatigue or general malaise, sleep disturbances, hip, wrist or spine fractures.
• Rare (may affect up to 1 in 1,000 people) Changes or complete loss of taste, visual disturbances such as blurred vision, hives, joint pain, muscle pain, weight changes, increased body temperature, swelling of the extremities (peripheral oedema), depression; breast enlargement in males.
• Not known (frequency cannot be estimated from available data) Hallucinations, confusion (particularly in patients with a history of these symptoms); tingling sensation, prickling, pins and needles, burning or numbness, 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.
• 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 Italian Medicines Agency (Agenzia Italiana del Farmaco) 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

Keep this medicine 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 the month.
Blister pack: This medicine does not require any special storage conditions.
PVC/PE/PVdC blister pack: Do not store above 25 °C.
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 contains
The active substance is pantoprazole sodium sesquihydrate, equivalent to 20 mg of pantoprazole.
The other components are anhydrous sodium carbonate, mannitol, crospovidone, povidone and calcium stearate. The coating contains methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion, sodium lauryl sulfate, polysorbate 80, triethyl citrate, hypromellose, titanium dioxide, macrogol 400 and yellow iron oxide.

Description of the appearance of Pantoprazolo Mylan and package contents
Pantoprazole tablets are dark yellow, oval, biconvex, film-coated tablets without any imprint on either side. They are available in blisters.
Blister packaging consists of aluminum blisters with or without a desiccant layer, packed in cardboard cartons containing 14 or 28 tablets.
PVC/PE/PVdC blisters with aluminum foil lid, packed in boxes containing 14 or 28 tablets.
Not all pack sizes may be marketed.

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

Manufacturers
Mc Dermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, 13 Dublin
Ireland
Mylan Hungary Kft
H-2900 Komarom
Mylan utca 1
Hungary

This medicinal product is authorized in the European Economic Area Member States under the following names:
Malta: PantoMylan 20 mg Gastroresistant tablets
Italy: Pantoprazolo Mylan 20 mg gastro-resistant tablets

Package leaflet: information for the user

Pantoprazolo Mylan 40 mg gastro-resistant tablets

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

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

Contents of this leaflet:

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

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

Pantoprazolo Mylan is a selective proton pump inhibitor, a medicine that reduces the amount of acid produced in your stomach. It is used to treat conditions caused by excess acid secretion in the stomach and intestine.
Pantoprazolo Mylan is used for the treatment of:
Adults and adolescents aged 12 years and older:

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

Adults:

• 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 thereby reduce the likelihood of these ulcers recurring.
• Gastric and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions causing excessive acid production in the stomach.

2. What you need to know before taking Pantoprazole Mylan

Do not take Pantoprazole Mylan:

• 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 Mylan

• if you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor will check your liver enzymes more frequently, especially if you are taking pantoprazole as long-term treatment. If liver enzymes increase, treatment must be stopped.
• if you have reduced body reserves or risk factors for reduced vitamin B__ absorption and are receiving long-term treatment with pantoprazole. Like all agents that reduce gastric acid secretion, pantoprazole may cause reduced absorption of vitamin B__. Contact your doctor if you notice any of the following symptoms, which could indicate low vitamin B__ levels:
• extreme tiredness or lack of energy
• pins and needles sensation
• sore or red tongue, mouth ulcers
• muscle weakness
• vision disturbances
• memory problems, confusion, depression
• if you are taking a medicine containing atazanavir (for the treatment of HIV infection) at the same time as pantoprazole, ask 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 fracture of the wrist, hip, 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 are taking pantoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, inform your doctor promptly. 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 gastric acidity.
• serious skin reactions have been reported in association with pantoprazole treatment, including 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).

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 pantoprazole therapy. Remember to also report any other adverse effects such as joint pain.
Inform your doctor immediately if you notice any of the following symptoms:

• unintentional weight loss
• recurrent vomiting
• difficulty swallowing
• vomiting blood
• you appear pale and unwell (anemia)
• you notice blood in your stools
• severe and/or persistent diarrhoea, as pantoprazole is associated with a slight increase in infectious diarrhoea.

Your doctor may carry out further tests to rule out malignant tumours, because pantoprazole relieves symptoms of cancer and could 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. Each time you see your doctor, report any new or unusual symptoms or circumstances.
Other medicines and Pantoprazole Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as Pantoprazole Mylan may affect the effectiveness of these medicines.

• Medicines such as ketoconazole, itraconazole or posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because pantoprazole may interfere with the proper functioning of these and similar drugs.
• Warfarin and phenprocoumon, which affect blood thickness and fluidity. You may need additional monitoring.
• Atazanavir (used to treat HIV infections) (see section 2 “Warnings and precautions”).
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer).
• 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).

Talk to your doctor if you are scheduled for a specific urine test (for THC; tetrahydrocannabinol) before taking pantoprazole.
Pregnancy, breastfeeding and fertility
There are insufficient data on the use of pantoprazole in pregnant women. Excretion of pantoprazole in breast milk has been observed. If you are pregnant, breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
You should take this medicine only if your doctor considers the benefits to outweigh the potential risks to the fetus or newborn.
Driving and using machines
If you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.
Pantoprazole Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Pantoprazole Mylan

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
When and how should you take Pantoprazole Mylan?
Take the tablets 1 hour before meals, without chewing or breaking them, swallowing them whole with a little
water.
Unless otherwise directed by your doctor, the usual dose is:
Adults and adolescents from 12 years of age:
Treatment of reflux esophagitis
The recommended dose is 1 tablet per day. Your doctor may increase the dose to 2 tablets per
day. The treatment period for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will
tell you how long to continue taking the medicine.
Adults:
For the treatment of infection with a bacterium called Helicobacter pylori in patients with
duodenal ulcers and gastric ulcers, in combination with two antibiotics (eradication therapy)
One tablet twice daily, plus two tablets of 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 you read the package leaflet of these antibiotics. The usual treatment duration is 1 to 2 weeks.
For the treatment of gastric and duodenal ulcers.
The recommended 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.
For long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much
stomach acid is produced.
The usual recommended initial dose is two tablets per day.
Take both tablets 1 hour before a meal. Then your doctor may adjust the dose depending on the amount
of stomach acid produced. If more than two tablets per day are prescribed, the tablets should be
taken twice daily.
If your doctor prescribes you a daily dose of more than four tablets per day, you will be told exactly
when to stop taking the medicine.
Particular patient groups:

• If you have kidney problems, or moderate to severe liver problems, you must not take pantoprazole for the eradication of Helicobacter pylori.
• 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).
• Children under 12 years of age. These tablets are not recommended for use in children under 12 years of age.

If you take more Pantoprazole Mylan than you should
Contact your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantoprazole Mylan
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.
If you stop taking Pantoprazole Mylan
Do not stop taking these tablets without first consulting your doctor or pharmacist.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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.
• A reduction in the number of white or red blood cells and/or platelets, which may be seen in blood tests. You may also notice more frequent infections, or increased bruising or bleeding.

Not known (frequency cannot be estimated from available data)

• Severe skin conditions: you may notice one or more of the following - blistering of the skin and rapid deterioration in general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals, 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-elevated, circular or target-shaped reddish 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 fever 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 kidney inflammation 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 discomfort, skin rashes, exanthema, rash, itching, feeling of weakness, fatigue or general malaise, sleep disorders, wrist, hip or spine fracture.
• Rare (may affect up to 1 in 1,000 people): altered or complete loss of taste, vision disorders such as blurred vision, hives, joint pain, muscle pain, weight changes, increased body temperature, swelling of the extremities (peripheral oedema), allergic reactions, depression; breast enlargement in males.
• Not known (frequency cannot be estimated from available data): hallucinations, confusion (especially in patients with a history of these symptoms); tingling, prickling, pins and needles sensation, burning or numbness, 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.
• 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 Italian Medicines Agency (Agenzia Italiana del Farmaco) 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

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 the month.
Blister pack: This medicine does not require any special storage conditions.
PVC/PE/PVdC blister pack: Do not store above 25 °C.
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 contains
The active substance is sodium pantoprazole sesquihydrate, equivalent to 40 mg of pantoprazole.
The other ingredients are anhydrous sodium carbonate, mannitol, crospovidone, povidone, and calcium stearate. The coating contains methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion, sodium lauryl sulfate, polysorbate 80, triethyl citrate, hypromellose, titanium dioxide, macrogol 400, and yellow iron oxide.

Description of the appearance of Pantoprazolo Mylan and package contents
Pantoprazole tablets are yellow banana-colored, oval, biconvex, film-coated tablets, without any markings on either side. They are available in blisters.
Packaging in blisters consisting of aluminum blisters with or without a desiccant layer, packed in cardboard cartons containing 14 or 28 tablets.
PVC/PE/PVdC blisters with aluminum foil lid, packed in boxes containing 14 or 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
Italy

Manufacturers
Mc Dermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, 13 Dublin
Ireland
Mylan Hungary Kft
H-2900 Komarom
Mylan utca 1
Hungary

This medicinal product is authorized in the European Economic Area countries under the following names:
Malta: PantoMylan 40 mg Gastroresistant tablets
Italy: Pantoprazolo Mylan 40 mg gastro-resistant tablets