Pantoprazole Alter

Package leaflet: Information for the patient

Pantoprazole Alter 20 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, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, please tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Pantoprazolo Alter and what is it used for?

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

• Symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.
• Long-term treatment of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation) and prevention of its recurrence.
  Pantoprazolo Alter is used for the treatment of adults for:
• Prevention of duodenal and gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in at-risk patients who require ongoing NSAID therapy.

2. What you need to know before taking Pantoprazole Alter

Do not take Pantoprazole Alter

• 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 Alter. In particular:

• If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor may arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazole Alter 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 Alter because you are at increased risk of developing gastric or intestinal complications. Any increased risk will be assessed based on your individual risk factors such as age (65 years or older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
• If you have low body reserves or risk factors for low vitamin B12 levels and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12. Contact 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 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 (reduced bone density) or are at risk of osteoporosis (e.g., if you are taking steroids).
• If you have been taking Pantoprazole Alter for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or 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 Alter that reduces stomach acid.
• If you develop 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 Alter. 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 taking pantoprazole and contact your doctor immediately if you notice any symptoms related to these serious skin reactions, described in section 4.
• If you need to undergo 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 may indicate a more serious underlying condition:

• Unintentional weight loss
• Vomiting, especially if repeated
• Blood in vomit; this may appear as dark, coffee-ground-like material in the vomit
• 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 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 malignant disease, as pantoprazole can relieve symptoms of cancer and may delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you are taking Pantoprazole Alter for long-term treatment (more than 1 year), your doctor will likely monitor you regularly. You should report any new or unusual symptoms or circumstances each time you see your doctor.

Children and adolescents
The use of Pantoprazole Alter is not recommended in children, as efficacy and safety have not been established in children under 12 years of age.

Other medicines and Pantoprazole Alter
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.
Pantoprazole Alter 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 Pantoprazole Alter 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 Alter, 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 need to undergo 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 to be greater than the potential risk to the fetus or infant.

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

Pantoprazole Alter contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Pantoprazolo Alter

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Method of administration:
Take the tablets 1 hour before meals, without chewing or crushing them, swallowing them whole with a little water.

Recommended dose:
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 daily. This dose usually provides relief within 2–4 weeks, and at most within a further 4 weeks. Your doctor will advise you on how long to continue taking the medicine. After this treatment, any recurrence of symptoms may be managed by taking one tablet daily, as needed.

For long-term treatment and prevention of recurrence of reflux esophagitis
The usual dose is one tablet daily. If the disease recurs, your doctor may double the dose; in this case, you may use Pantoprazolo Alter 40 mg tablets, one tablet daily. After healing, the dose may be reduced again to one 20 mg tablet daily.

Adults:
For prevention of duodenal and gastric ulcers in patients requiring continuous treatment with NSAIDs
The usual dose is one tablet daily.

Patients with liver problems
If you have severe liver problems, you must not take more than one 20 mg tablet daily.

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

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

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

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

If you have any further 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 will experience them.
If you experience any of the following side effects, stop treatment with these tablets immediately and consult your doctor or contact 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 available data). You may notice one or more of the following symptoms: 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/sunlight. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arm), and blood tests may show abnormalities in white blood cell count or liver enzymes.
• Reddish, flat, circular or target-shaped rashes on the trunk, often with blisters in the centre, 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 (frequency not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin 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 available data):
  Hallucinations, confusion (particularly in patients with a history of such symptoms), tingling sensation, 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 levels of blood lipids, marked decrease in granulocytes (a type of white blood cells), associated with high fever.
• Very rare (may affect up to 1 in 10,000 people): Decrease in platelet count (which may cause increased bleeding or bruising), decrease in 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, tell 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 Alter

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

6. Contents of the pack and other information

What Pantoprazolo Alter contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of
pantoprazole (as sesquihydrate sodium).
The other components are:
Tablet core: sodium carbonate, mannitol (E421), crospovidone, pregelatinized maize,
calcium stearate.
Intermediate film coating: hypromellose, triacetin, titanium dioxide (E171).
Gastro-resistant film coating: methacrylic acid-ethyl acrylate copolymer 1:1, sodium lauryl sulfate,
polysorbate 80, triethyl citrate, talc, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
Description of the appearance of Pantoprazolo Alter 20 mg gastro-resistant tablets and pack contents
Pantoprazolo Alter 20 mg tablets are film-coated, light yellow, gastro-resistant coated, round, biconvex tablets.
Pantoprazolo Alter 20 mg is available in the following pack sizes:
Blister packs made of Polyamide/Alu/PVC with an aluminum foil lid containing 14, 15, 28 and 30 gastro-resistant tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
LABORATORI ALTER S.r.l.
Via Egadi 7
20144 - Milano
Manufacturer:
Laboratorios Alter, S.A.
Calle de Mateo Inurria, 30
28036 Madrid - Spain

PATIENT INFORMATION LEAFLET

Pantoprazole Alter 40 mg gastro-resistant tablets

Generic 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, 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, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Pantoprazole Alter contains the active substance pantoprazole. Pantoprazole Alter 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 Alter is used for:
The treatment of adults and adolescents aged 12 years and above for:

• Gastroesophageal reflux disease (reflux oesophagitis). An inflammation of the oesophagus (the tube connecting the throat to the stomach) associated with regurgitation of gastric acid.

Pantoprazole Alter 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 risk of recurrence of these ulcers.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before taking Pantoprazole Alter

Do not take Pantoprazole Alter

• 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 Alter.

• If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazole Alter for long-term treatment. If your liver enzymes increase, treatment must be stopped.
• If you have low body stores or risk factors for vitamin B12 deficiency and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12. Talk to 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 protease inhibitors for HIV, such as atazanavir (for the treatment of HIV infection), 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 fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or are at risk of osteoporosis (e.g., if you are taking steroids).
• If you have been taking Pantoprazole Alter 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 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 Alter that reduces gastric acidity.
• 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 stop treatment with Pantoprazole Alter. 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 of the symptoms related to these serious skin reactions described in section 4.
• If you are scheduled to undergo 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 repeated
• Blood in vomit, which may appear as dark coffee-ground-like material
• 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 certain tests to rule out a malignant disease, as pantoprazole can relieve symptoms of cancer and may delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you are taking Pantoprazole Alter 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 each time you see your doctor.

Children and adolescents
The use of Pantoprazole Alter is not recommended in children, as efficacy and safety have not been established in children under 12 years of age.

Other medicines and Pantoprazole Alter
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.
Pantoprazole Alter 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 Alter may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood clotting or thinning. You may need additional monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, or cancer). If you are taking methotrexate, your doctor may temporarily discontinue treatment with Pantoprazole Alter because pantoprazole may increase methotrexate levels in the blood.
• 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). Consult your doctor before taking pantoprazole if you are scheduled to undergo 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, 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 Alter does not affect or has negligible effect on the ability to drive or operate machinery.
However, if you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.

Pantoprazole Alter 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 Alter

Take this medicine exactly as directed by your doctor or
pharmacist. 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.
Recommended dose:
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 2
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 tablets of an antibiotic among 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 in which excess stomach acid is produced.
The recommended initial dose is usually two tablets daily.
Take both tablets 1 hour before a meal. Your doctor may subsequently adjust the dosage depending on the amount of gastric acid produced. If more than two tablets daily are prescribed, the tablets should be taken twice daily.
If your doctor prescribes a daily dosage of more than four tablets, you will be specifically instructed when to stop taking the medicine.
Patients with kidney problems:
If you have renal impairment, you must not take Pantoprazole Alter for the eradication
of Helicobacter pylori.
Patients with liver problems:
If you have severe liver impairment, you must not take more than one 20 mg pantoprazole tablet daily (tablets containing 20 mg of pantoprazole are available for this purpose).
If you have severe or moderate liver impairment, you must not take Pantoprazole Alter for the eradication of Helicobacter pylori.
Use in children and adolescents:
These tablets are not recommended for use in children under 12 years of age.
If you take more Pantoprazole Alter than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantoprazole Alter
Do not take a double dose to make up for the missed dose. Take your next dose at the scheduled time.
If you stop taking Pantoprazole Alter
Do not stop treatment with these tablets without first consulting your doctor or
pharmacist.
If you have any doubts about how to use this medicine, consult 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 this medicine immediately,
contact your doctor straight away, or go to the nearest hospital emergency department:

• Severe allergic reactions (uncommon frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's edema / angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Severe skin disorders (frequency not known: frequency cannot be estimated from available data): you may notice one or more of the following symptoms:
  • 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.
• red, flat, circular or target-shaped 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 fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other serious conditions (frequency not known): 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, rash, 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 available data): hallucinations, confusion (particularly in patients with a history of such symptoms), tingling sensation, 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, marked decrease in granulocytes (a type of white blood cell), 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 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, please inform 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 Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and container after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of 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 Alter contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of
pantoprazole (as sodium sesquihydrate).
The other components are:
Tablet core: sodium carbonate, mannitol (E421), crospovidone, pregelatinized maize starch, calcium stearate.
Intermediate film coating: hypromellose, triacetin, titanium dioxide (E171).
Gastro-resistant film coating: methacrylic acid-ethyl acrylate copolymer 1:1, sodium lauryl sulfate, polysorbate 80, triethyl citrate, talc, titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172).
Description of the appearance of Pantoprazolo Alter 40 mg gastro-resistant tablets and
packaging contents
Pantoprazolo Alter 40 mg tablets are film-coated, dark pink, gastro-resistant, round, biconvex tablets.
Pantoprazolo Alter 40 mg is available in packs of 14 and 28 gastro-resistant tablets in blisters made of Polyamide/Alu/PVC with an aluminum foil sheet.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
LABORATORI ALTER S.r.l.
Via Egadi 7, 20144
Milan, Italy
Manufacturer:
Laboratorios Alter, S.A.
Calle de Mateo Inurria, 30
28036 Madrid - Spain