Pantoprazole Accord Healthcare: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazole Accord Healthcare 20 mg gastro-resistant tablets

Equivalent medicine
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

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

Contents of this leaflet:

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

1. What Pantoprazole Accord Healthcare is and what it is used for

Pantoprazole Accord Healthcare contains the active substance pantoprazole (as sodium sesquihydrate).
Pantoprazole Accord Healthcare is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in the stomach. It is used for the treatment of acid-related diseases of the stomach and intestine.

Pantoprazole Accord Healthcare 20 mg is used for the treatment of adults and adolescents aged 12 years and older for

Symptoms (e.g., heartburn, acid regurgitation, 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 acid regurgitation from the stomach) and prevention of its recurrence.

Pantoprazole Accord Healthcare 20 mg is used for the treatment of adults for

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

2. What you need to know before taking Pantoprazole Accord

Healthcare
Do not take Pantoprazole Accord Healthcare

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, pharmacist, or nurse before taking Pantoprazole Accord Healthcare

If you have severe liver problems. Inform your doctor if you have previously had liver issues. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazole Accord Healthcare for long-term treatment. If your liver enzymes increase, treatment should be discontinued.
If you require ongoing treatment with medicines called NSAIDs and are taking Pantoprazole Accord Healthcare 20 mg due to 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 older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
If you have low body reserves or risk factors for vitamin B12 deficiency and are undergoing long-term treatment with Pantoprazole Accord Healthcare. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12. Inform your doctor if you experience any of the following symptoms, which could indicate low vitamin B12 levels:
- extreme tiredness or lack of energy;
- tingling and numbness;
- sore or red tongue, mouth ulcers;
- muscle weakness;
- vision problems, memory problems, confusion, depression.
  If you are taking protease inhibitors for HIV (such as atazanavir) 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 or are taking corticosteroids (which can increase the risk of osteoporosis). If you take Pantoprazole Accord Healthcare for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat. 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 periodic blood tests to monitor your magnesium levels.
If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Accord Healthcare that reduces stomach acid.
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazole Accord Healthcare. Remember to also report any other adverse effects such as joint pain.
Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme have been reported in association with pantoprazole treatment. 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
presence of blood in vomit; this may appear as dark coffee-ground material in the vomit
appearance of blood in stools, which may appear dark or tarry
difficulty swallowing or pain when swallowing
looking pale and feeling weak (anemia)
chest pain
stomach pain
severe and/or persistent diarrhoea, as this medicine has been associated with a slight increase in infectious diarrhoea. Your doctor may decide that you need further testing to exclude malignant disease, as pantoprazole can also relieve symptoms of cancer and may delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.

If you take Pantoprazole Accord Healthcare for long-term treatment (more than 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances whenever you see your doctor.

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

Other medicines and Pantoprazole Accord Healthcare
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines.
Pantoprazole Accord Healthcare 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 for certain types of cancer), as Pantoprazole Accord Healthcare 20 mg may prevent these and other medicines from working properly.
Warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring.
Medicines used to treat HIV infection, such as atazanavir.
Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily discontinue treatment with Pantoprazole Accord Healthcare, 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).

Talk to your doctor before taking pantoprazole if you are scheduled for a specific urine test (for THC; tetrahydrocannabinol).

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

Driving and using machines
Pantoprazole Accord Healthcare does not affect or affects negligibly the ability to drive vehicles and use machines. However, if you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.

Important information about some excipients in Pantoprazole Accord Healthcare
Pantoprazole Accord Healthcare contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Pantoprazolo Accord Healthcare 20 mg

Always take Pantoprazolo Accord Healthcare exactly as your doctor has instructed you.
If you have any doubts, consult your doctor or pharmacist.
Method of administration
Take the tablets 1 hour before meals, without chewing or crushing them, swallowing them whole
with some water.
The recommended dose is:
Adults and adolescents aged 12 years and older

For the treatment of symptoms associated with gastroesophageal reflux disease (e.g. heartburn, acid regurgitation, pain when swallowing)

The usual dose is one tablet per day. This dose usually provides relief within 2–4 weeks – at most after another 4 weeks. Your doctor will tell you how long you should continue taking the medicine. After this, any recurrence of symptoms can be managed
by taking one tablet per day, as needed.

For long-term treatment and prevention of recurrence of reflux esophagitis The usual dose is one tablet per day. If the condition recurs, your doctor may double
the dose; in this case, you may instead use Pantoprazolo Accord Healthcare 40 mg tablets, one tablet per day. After healing, the dose may be reduced back to one 20 mg tablet per day.
Adults
For prevention of duodenal and gastric 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, you must not take more than one 20 mg tablet per day.
Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.
If you take more Pantoprazolo Accord Healthcare than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantoprazolo Accord Healthcare
Do not take a double dose to make up for the missed dose. Take your next dose at the usual scheduled time.
If you stop taking Pantoprazolo Accord Healthcare
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any questions about the use of this medicine, ask your doctor, pharmacist, or
nurse.

4. Possible side effects

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

Severe allergic reactions (rare frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's oedema / angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
Severe skin disorders (frequency not known: frequency cannot be estimated from the available data): appearance of skin blisters and rapid deterioration of your general condition, erosion (including mild bleeding) of 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.
Reddish, flat, circular or target-shaped spots on the trunk, often with blisters in the centre, 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 fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Other serious disorders (frequency not known: frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, rash, and kidney enlargement sometimes with pain when urinating and lower back pain (severe kidney inflammation), which may lead to possible kidney failure.

Other side effects include:

Common (may affect up to 1 in 10 people): Benign gastric polyps.
Uncommon (may affect up to 1 in 100 people): Headache; dizziness; diarrhoea; nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash, exanthema, eruption; itching; feeling of weakness, fatigue or general malaise; sleep disturbances; fractures of the hip, wrist, or spine.
Rare (may affect up to 1 in 1,000 people): Altered or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the extremities (peripheral oedema); allergic reactions; depression, breast enlargement in men.
Very rare (may affect up to 1 in 10,000 people): Disorientation.
Not known (frequency cannot be estimated from the available data): Hallucinations, confusion (especially in patients with a history of these symptoms); decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), tingling sensation, 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 lipid levels; a 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 abnormal bleeding or bruising; reduced white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red and white blood cells as well as platelets.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at http://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 Pantoprazolo Accord Healthcare

Keep Pantoprazolo Accord Healthcare out of the sight and reach of children.
Do not use Pantoprazolo Accord Healthcare after the expiry date which is stated on the carton and
on the container after "Exp".
The expiry date refers to the last day of that month.
Blister pack packaging
Store below 30°C.
Medicines should not be disposed of 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 Accord Healthcare contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of
pantoprazole (as sesquihydrate sodium).
The other components are:
Tablet core: microcrystalline cellulose (E460i), lactose monohydrate, sodium croscarmellose,
anhydrous colloidal silicon dioxide, magnesium stearate.
Coating: methacrylic acid-ethyl acrylate copolymer 1:1, sodium lauryl sulfate, polysorbate 80,
triethyl citrate (E1505), talc (E553b), Colourant (Opadry II 85F32081 yellow): polyvinyl alcohol,
macrogol 3350, titanium dioxide (E - 171), talc (E553b), yellow iron oxide (E-172), quinoline yellow aluminium lake (E - 104).
Description of the appearance of Pantoprazolo Accord Healthcare 20 mg gastro-resistant tablets and
pack contents
Pantoprazolo Accord Healthcare 20 mg tablets are yellow to ochre in colour, gastro-resistant coated, oval-shaped, biconvex tablets.
Pantoprazolo Accord Healthcare 20 mg is available in the following pack:
Pack of 14 and 28 gastro-resistant tablets in blister packs contained in a lithographed cardboard carton.
Marketing Authorisation Holder:
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona s/n,
Edifici Est, 6th floor,
Barcelona, 08039,
Spain
Manufacturer responsible for batch release:
TOWA Pharmaceutical Europe, S.L.
C/ de Sant Martí, 75-97, 08107 Martorelles
(Barcelona) - Spain

INSTRUCTION LEAFLET: INFORMATION FOR THE USER

Pantoprazole Accord Healthcare 40 mg gastro-resistant tablets

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
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 effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Pantoprazolo Accord Healthcare is and what it is used for

Pantoprazolo Accord Healthcare contains the active substance pantoprazole (as sodium sesquihydrate).
Pantoprazolo Accord Healthcare 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 Accord Healthcare 40 mg is used for the treatment of adults and adolescents aged 12 years and older for:
Reflux esophagitis, an inflammation of the esophagus (the tube connecting the throat to the stomach) associated with regurgitation of gastric acid.

Pantoprazolo Accord Healthcare 40 mg is used for the treatment of adults for:
Infection with a bacterium called Helicobacter pylori in patients with duodenal ulcer and gastric ulcer, in combination with two antibiotics (eradication therapy).
The aim is to eliminate the bacteria in order to reduce the likelihood of these ulcers recurring.

Gastric and duodenal ulcers.
Zollinger-Ellison syndrome and other conditions in which excessive stomach acid is produced.

2. What you need to know before taking Pantoprazolo Accord Healthcare

Do not take Pantoprazolo Accord Healthcare

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, pharmacist, or nurse before taking Pantoprazolo Accord Healthcare

If you have severe liver problems. Inform your doctor if you have previously had liver problems. Your doctor may arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazolo Accord Healthcare for long-term treatment. If your liver enzymes increase, treatment should be discontinued.
If you have low body reserves or risk factors for vitamin B12 deficiency and are undergoing long-term treatment with Pantoprazolo Accord Healthcare. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12. Inform your doctor if you experience any of the following symptoms, which could indicate low vitamin B12 levels:
- extreme tiredness or lack of energy;
- tingling or numbness
- sore or red tongue, mouth ulcers
- muscle weakness
- vision disturbances
- memory problems, confusion, depression
If you are taking protease inhibitors for HIV, such as atazanavir (for the treatment of HIV infection), consult your doctor for specific advice.
Taking a proton pump inhibitor such as pantoprazole, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
If you take Pantoprazolo Accord Healthcare for more than three months, you may experience reduced magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or rapid heartbeat. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels can also lead to reduced potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazolo Accord Healthcare 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 discontinue treatment with Pantoprazolo Accord Healthcare. Remember to report any other adverse effects such as joint pain. Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme have been reported with pantoprazole treatment. Discontinue use of 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 to undergo a specific blood test (Chromogranin A)

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

unintentional weight loss
vomiting, especially if repeated
presence of blood in vomit; this may appear as dark coffee-ground-like material in the vomit
passage of dark or tar-colored stools
difficulty swallowing or pain when swallowing
looking pale and feeling weak (anemia)
chest pain
stomach pain
severe and/or persistent diarrhea, as this medicine has been associated with a slight increase in infectious diarrhea.

Your doctor may decide that you need certain tests to rule out a malignant disease, as pantoprazole may relieve symptoms of cancer and could lead to a delayed diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you take Pantoprazolo Accord Healthcare for long-term treatment (over 1 year), your doctor will likely monitor you regularly. You should report any new or unusual symptoms or circumstances at every medical visit.
Children and adolescents
The use of Pantoprazolo Accord Healthcare is not recommended in children, as efficacy has not been demonstrated in children under 12 years of age.
Other medicines and Pantoprazolo Accord Healthcare
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.
Pantoprazolo Accord Healthcare can 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 for certain types of cancer), as Pantoprazolo Accord Healthcare may prevent these and other medicines from working properly.
Warfarin and fenprocoumon, which affect blood clotting. You may need additional monitoring.
Medicines used to treat HIV infection, such as atazanavir. Methotrexate (used to treat rheumatoid arthritis, psoriasis, or cancer) – if you are taking methotrexate, your doctor may temporarily discontinue treatment with Pantoprazolo Accord Healthcare because pantoprazole may increase methotrexate levels in the blood.
Fluvoxamine (used to treat depression and other psychiatric disorders) – if you are taking fluvoxamine, your doctor may reduce the dose.
Rifampicin (used to treat infections).
St. John’s wort (Hypericum perforatum) (used to treat mild depression).

Talk to your doctor before taking pantoprazole if you are scheduled for a specific urine test
(for THC; tetrahydrocannabinol).
Pregnancy, breastfeeding, and fertility
There are insufficient data on the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should use this medicine only if your doctor considers the benefit to you greater than the potential risk to the fetus or infant.
Driving and using machines
Pantoprazolo Accord Healthcare does not impair or impairs negligibly the ability to drive
vehicles and use machinery. However, if you experience adverse effects such as dizziness or vision disturbances, you should not drive or use machinery.
Important information about certain excipients in Pantoprazolo Accord Healthcare
Pantoprazolo Accord Healthcare contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Pantoprazolo Accord Healthcare

Always take Pantoprazolo Accord Healthcare exactly as instructed by your doctor.
If you have any doubts, consult your doctor or pharmacist.

Method of administration
Take the tablets 1 hour before meals. Do not chew or crush the tablets; swallow them whole with a glass of water.

Adults and adolescents aged 12 years and older
For the treatment of reflux esophagitis
The usual dose is one tablet daily. Your doctor may instruct you to increase the dose to two tablets daily. The treatment period for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will advise you on how long to take the medicine.

Adults
For the treatment of infection with a bacterium called Helicobacter pylori in patients with duodenal ulcer and gastric ulcer, in combination with two antibiotics (eradication therapy)
One tablet twice daily, plus two antibiotics selected from amoxicillin, clarithromycin, and metronidazole (or tinidazole), each 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 for these antibiotics. The usual treatment duration is one or two weeks.

For the treatment of gastric and duodenal ulcers
The usual dose is one tablet daily. After consulting your doctor, the dose may be doubled.
Your doctor will advise you on how long to take the medicine. The treatment period for gastric ulcers is generally between 4 and 8 weeks. The treatment period for duodenal ulcers is generally between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions with excessive stomach acid production
The recommended initial dose is usually two tablets daily.
Take both tablets 1 hour before a meal. Your doctor may adjust the dose depending on the amount of gastric acid produced. If more than two tablets per day are prescribed, the tablets should be taken twice daily.
If your doctor prescribes a daily dose of more than four tablets, you will be given specific instructions on when to stop taking the medicine.

Patients with kidney problems

If you have moderate or severe kidney impairment, you must not take Pantoprazolo Accord Healthcare for Helicobacter pylori eradication.

Patients with liver problems

If you have severe liver impairment, 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 Accord Healthcare for Helicobacter pylori eradication.

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

If you take more Pantoprazolo Accord Healthcare than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.

If you forget to take Pantoprazolo Accord Healthcare
Do not take a double dose to make up for the forgotten dose. Take your next dose at the scheduled time.

If you stop taking Pantoprazolo Accord Healthcare
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.

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

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:

Severe allergic reactions (uncommon frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's edema / angioedema), severe dizziness with rapid heartbeat and profuse sweating.
Severe skin disorders (frequency not known: frequency cannot be estimated from the available data): appearance of blisters on the skin and rapid deterioration of your 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, red, circular or target-shaped 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 (frequency not known: frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, rash, and kidney enlargement sometimes with pain during urination and lower back pain (severe kidney inflammation), which may lead to possible kidney failure.

Other side effects are:

Common (may affect up to 1 in 10 people): benign gastric polyps.
Uncommon (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash, exanthema, eruption; itching; feeling of weakness, fatigue or general malaise; sleep disturbances; fractures of the hip, wrist, or spine.
Rare (may affect up to 1 in 1,000 people): altered 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 edema); allergic reactions; depression; breast enlargement in men.
Very rare (affects less than 1 in 10,000 people): disorientation.
Not known (frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients with a history of these symptoms); decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), 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.
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.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at 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 Accord Healthcare

Keep Pantoprazole Accord Healthcare out of the sight and reach of children.
Do not use Pantoprazole Accord Healthcare after the expiry date, which is stated on the carton and
on the container after Exp.
The expiry date refers to the last day of that month.
Blister pack packaging
Store below 30°C.
Medicines should not be disposed of 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 Pantoprazole Accord Healthcare contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of
pantoprazole (as sodium sesquihydrate).
The excipients are:
Tablet core: microcrystalline cellulose (E460i), lactose monohydrate, sodium
croscarmellose, anhydrous colloidal silica, magnesium stearate.
Coating: methacrylic acid-ethyl acrylate copolymer 1:1, sodium lauryl sulfate, polysorbate 80,
triethyl citrate (E1505), talc (E553b),
Colourant (Opadry II 85F32029 yellow): polyvinyl alcohol, macrogol 3350, titanium dioxide (E-171),
talc (E553b), yellow iron oxide (E-172).
Description of the appearance of Pantoprazole Accord Healthcare 40 mg gastro-resistant tablets and
pack contents
Pantoprazole Accord Healthcare 40 mg tablets are pale yellow to ochre in colour, gastro-resistant coated, oval-shaped, biconvex tablets.
Pantoprazole Accord Healthcare 40 mg is available in the following pack: Pack of 14 and 28 gastro-resistant tablets in blisters contained in a printed cardboard carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona s/n,
Edifici Est, 6a planta,
Barcelona, 08039,
Spain
Manufacturer responsible for batch release:
TOWA Pharmaceutical Europe, S.L.
C/ de Sant Martí, 75 -97, 08107 Martorelles
(Barcelona) - Spain