PANTOPRAZOLO 20 mg Enteric-Coated Tablet

Зміст інструкції

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

Pantoprazolo Alter 20 mg gastro-resistant tablets

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

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

Contents of this leaflet:

• 1. What Pantoprazolo Alter is and what it is used for
• 2. What you need to know before you take Pantoprazolo Alter
• 3. How to take Pantoprazolo Alter
• 4. Possible side effects
• 5. How to store Pantoprazolo 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 ingredient pantoprazolo. Pantoprazolo 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.

Pantoprazolo Alteris used for:

the treatment of adults and adolescents 12 years of age and older for:

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

2. What you need to know before taking Pantoprazolo Alter

Do not take Pantoprazolo 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 Pantoprazolo Alter. In
particular:

• If you have severe liver problems. Tell your doctor if you have ever had liver problems in the past. The doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazolo Alter for long-term therapy. If liver enzymes increase, treatment should be discontinued;
• If you need continuous treatment with medicines called NSAIDs and are taking Pantoprazolo Alter because you have an increased risk of developing gastric and intestinal complications. Any increased risk will be assessed based on your personal risk factors such as age (65 years and over), a history of gastric or duodenal ulcers or gastrointestinal bleeding;
• If you have reduced body stores or risk factors for reduced vitamin B12 and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole can lead to reduced absorption of vitamin B12. Talk to your doctor if you notice any of the following symptoms, which may indicate low levels of vitamin B12:
• Extreme fatigue or lack of energy
• Tingling and prickling
• Red or sore tongue, mouth ulcers
• Muscle weakness
• Vision problems
• Memory problems, confusion, depression
• If you are simultaneously taking HIV protease inhibitors 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 a period longer than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Tell your doctor if you have osteoporosis (reduced bone density) or if you are at risk of osteoporosis (e.g. if you are taking steroids);
• If you have been taking Pantoprazolo Alter for more than three months, the levels of magnesium in your blood may decrease. Low levels of magnesium can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. Tell your doctor immediately if you experience any of these symptoms. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. The 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 Pantoprazolo 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 therapy with Pantoprazolo Alter. Remember to also report any other unwanted effects such as joint pain;
• Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and multiforme erythema have been reported in association with treatment with pantoprazole. Stop using pantoprazole and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions, described in section 4
• If you are to undergo a specific blood test (Chromogranin A)

Tell your doctor immediatelybefore or after taking this medicine, if you notice
any of the following symptoms, which may be a sign of a more serious illness:

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

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

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

Other medicines and Pantoprazolo Alter
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including over-the-counter medicines.
Pantoprazolo Alter can affect the effectiveness of other medicines, so tell your doctor if you are
taking:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer) as Pantoprazolo Alter may prevent these and other medicines from working properly;
• Warfarin and phenprocoumon, which affect blood thickening, or thinning. You may need further checks;
• Medicines used to treat HIV infection, such as atazanavir;
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer); if you are taking methotrexate, the doctor may temporarily suspend treatment with Pantoprazolo Alter because pantoprazole can increase methotrexate levels in the blood;
• Fluvoxamine (used to treat depression and other psychiatric illnesses) - if you are taking fluvoxamine the 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 to undergo a specific urine test (for the detection of THC; tetrahydrocannabinol).

Pregnancy and breastfeeding and fertility
There are no adequate data regarding the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
You should only use this medicine if the doctor considers the benefit to you greater than the potential risk
to the fetus or the baby.

Driving and operating machinery
Pantoprazolo Alter does not alter or negligibly alters the ability to drive vehicles and operate
machinery.
If you experience side effects such as dizziness or visual disturbances, you should not drive or operate
machinery.

Pantoprazolo 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 following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Method of administration:
Take the tablets 1 hour before meals without chewing or crushing them and swallow them whole
with a little water.
The recommended dose is:

Adults and adolescents of 12 years and over:

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

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

Adults:

For the prevention of duodenal and gastric ulcers in patients who require
continuous treatment with NSAIDs
The usual dose is one tablet a day.

Patients with liver problems
If you suffer from severe liver problems, you should not take more than one 20 mg tablet a day.

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

If you take more Pantoprazolo Alter than you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take Pantoprazolo Alter
Do not take a double dose to make up for a missed dose. Take the normal dose
at the next 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 on the use of this medicine, ask your doctor or pharmacist or
nurse.

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 treatment with these
tablets and consult your doctor immediately or contact the nearest hospital emergency room:

• Severe allergic reactions (rare frequency:can affect up to 1 in 1000 ):swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic facial swelling (angioedema / Quincke's edema), severe dizziness with a very fast heartbeat and profuse sweating.
• Severe skin conditions (frequency not known:the frequency cannot be defined based on available data ). You may notice one or more of the following manifestations: appearance of skin blisters and rapid deterioration of your general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals or sensitivity/rash, especially 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 armpit) and blood tests may show changes in white blood cell count or liver enzymes.
• reddish, non-raised, circular or target-shaped spots on the trunk, often with blisters in the center, skin peeling, ulcers on 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other serious conditions (frequency not known):yellowing of the skin or the whites of the eyes (serious damage to liver cells, jaundice) or fever, rash, and enlargement of the kidneys sometimes with pain when urinating and lower back pain (serious kidney inflammation) which may lead to possible kidney failure.

Other side effects are:

• Common(may affect up to 1 in 10 people): Benign polyps in the stomach.
• Uncommon(may affect up to 1 in 100 people): Headache, dizziness, diarrhea, nausea, vomiting, bloating (gas), constipation, dry mouth, abdominal pain and feeling unwell, skin rash, exanthema, eruption, itching, feeling of weakness, fatigue or general malaise, sleep disorders, hip, wrist or spine fractures.
• Rare(may affect up to 1 in 1,000 people): Alteration or complete loss of taste, vision disorders such as blurred vision, hives, joint pain, muscle pain, weight changes, increased body temperature, high fever, swelling of the extremities (peripheral edema), allergic reactions, depression, increased breast volume in men.
• Very Rare(may affect up to 1 in 10,000 people): Disorientation.
• Not Known(frequency cannot be estimated based on available data):

Hallucinations, confusion (especially in patients with a history of these symptoms,
tingling, prickling and pins and needles sensation, burning or numbness sensation,
erythema, possible joint pain, inflammation of the large intestine causing persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100 people): an increase in liver enzymes.
• Rare(may affect up to 1 in 1,000 people): an increase in bilirubin, increased levels of fats in the blood, drastic decrease in circulating granulocytes (some types of white blood cells), associated with high fever.
• Very Rare(may affect up to 1 in 10,000 people): a reduction in the number of platelets (which may cause more bleeding or bruising than normal), a reduction in the number of white blood cells (which may lead to more frequent infections), coexisting abnormal reduction in the number of red blood cells and white blood cells, as well as platelets.
• Not Known(frequency cannot be estimated from available data) Decrease in sodium, magnesium, calcium or potassium levels in the blood (see section 2).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor, pharmacist or nurse. You can also report side effects directly through 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 Pantoprazolo 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 package and on the container
after SCAD.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pantoprazolo Alter contains
The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of
pantoprazole (as sesquihydrate sodium).
The other ingredients are:
Tablet core: sodium carbonate, mannitol (E421), crospovidone, pregelatinized starch,
calcium stearate.
Intermediate coating film: hypromellose, triacetin, titanium dioxide (E171).
Gastro-resistant film: 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, with a gastro-resistant coating, round,
biconvex in shape.
Pantoprazolo Alter 20 mg is available in the following packs:
Blister packs Polyamide/Alu/PVC and an aluminum foil containing 14, 15, 28 and 30 gastro-resistant
tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
LABORATORI ALTER S.r.l.
Via Egadi 7

• 20144 - Milan

Manufacturer:
Laboratorios Alter, S.A.
Calle de Mateo Inurria, 30
28036 Madrid - Spain

Pantoprazolo Alter 40 mg gastro-resistant tablets

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

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

Contents of this leaflet:

• 1. What Pantoprazolo Alter is and what it is used for
• 2. What you need to know before you take Pantoprazolo Alter
• 3. How to take Pantoprazolo Alter
• 4. Possible side effects
• 5. How to store Pantoprazolo 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 ingredient pantoprazolo. Pantoprazolo 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.

Pantoprazolo Alteris used for:

The treatment of adults and adolescents 12 years of age and older for:

• Reflux esophagitis. An inflammation of the esophagus (the tube connecting the throat to the stomach) accompanied by acid reflux.

Pantoprazolo Alter is used for the treatment of adults for:

• An infection with a bacterium called Helicobacter pylori in patients with duodenal ulcer and gastric ulcer in combination with two antibiotics (eradication therapy). The purpose is to get rid of the bacteria in order to reduce the possibility that these ulcers will return.
• Ulcers of the stomach and duodenum.
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before you take Pantoprazolo Alter

Do not take Pantoprazolo 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 Pantoprazolo Alter.

• If you have severe liver problems. Tell 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 Pantoprazolo Alter for long-term therapy. If your liver enzymes increase, treatment should be discontinued;
• If you have reduced body stores or risk factors for reduced vitamin B12 and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole can lead to reduced absorption of vitamin B12. Talk to your doctor if you notice any of the following symptoms, which may indicate low levels of vitamin B12:
• Extreme fatigue or lack of energy
• Tingling and prickling
• Red or sore tongue, mouth ulcers
• Muscle weakness
• Vision problems
• Memory problems, confusion, depression
• If you are taking protease inhibitors of HIV such as 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 a period longer than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Tell your doctor if you have osteoporosis (reduced bone density) or if you are at risk of osteoporosis (for example, if you are taking steroids);
• If you have been taking Pantoprazolo Alter for more than three months, the levels of magnesium in your blood may decrease. Low levels of magnesium can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. Tell your doctor immediately if you experience any of these symptoms. Low levels of magnesium can also lead to a reduction in potassium or calcium levels 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 Pantoprazolo Alter that reduces gastric acidity;
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazolo 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 you may need to stop therapy with Pantoprazolo Alter. Remember to also report any other unwanted effects such as joint pain;
• Severe skin reactions such as Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and multiforme erythema have been reported in association with treatment with pantoprazole. Stop using pantoprazole and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions, described in section 4.
• If you are to undergo a specific blood test (Chromogranin A).

Tell your doctor immediatelybefore or after taking this medicine, if you notice
any of the following symptoms, which may be a sign of a more serious illness:

• unintentional weight loss
• vomiting, especially if repeated
• presence of blood in the vomit, which may appear as dark coffee grounds in the vomit
• appearance of blood in the stool which may appear dark or tarry
• difficulty swallowing or pain when swallowing
• appear pale and feel weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a modest increase in infectious diarrhea.

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

Children and adolescents
The use of Pantoprazolo Alter is not recommended in children, given that its efficacy and safety have not been demonstrated
in children under 12 years of age.

Other medicines and Pantoprazolo Alter
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including over-the-counter medicines.
Pantoprazolo Alter can affect the effectiveness of other medicines, so tell your doctor if you are
taking:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because Pantoprazolo Alter may prevent these and other medicines from working properly;
• Warfarin and phenprocoumone, which affect blood clotting or thinning. You may need further 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 suspend treatment with Pantoprazolo Alter because pantoprazole can increase methotrexate levels in the blood;
• Fluvoxamine (used to treat depression and other psychiatric illnesses) - 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 to undergo a specific urine test (for the detection of THC; tetrahydrocannabinol).

Pregnancy and breastfeeding and fertility
There are no adequate data regarding the use of pantoprazole in pregnant women. It has been
reported to be excreted in human breast milk.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this
medicine.
You should only use this medicine if your doctor considers the benefit for you greater than the
potential risk to the fetus or the baby.

Driving and using machines
Pantoprazolo Alter does not alter or alters negligibly the ability to drive vehicles and use
machines.
If you experience side effects such as dizziness or visual disturbances, you should not drive or use
machines.

Pantoprazolo 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 following exactly the instructions of 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 and swallow them whole
with a little water.
The recommended dose is:

Adults and adolescents of 12 years and over:

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

Adults:

For the treatment of an infection with a bacterium calledHelicobacter pyloriin
patients with duodenal ulcer and gastric ulcer in combination with two antibiotics
(Eradication therapy).
One tablet, twice a day plus two tablets of an antibiotic between amoxicillin,
clarithromycin and metronidazole (or tinidazole), each taken twice a day with the
Pantoprazolo tablet. Take the first Pantoprazolo tablet 1 hour before
breakfast and the second Pantoprazolo tablet 1 hour before the evening meal. Follow the
usual treatment duration is one or two weeks.

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

For the long-term treatment of Zollinger-Ellison syndrome and other
conditions in which too much acid is produced in the stomach.
The recommended starting dose is usually two tablets a day.
Take the two tablets 1 hour before a meal. The doctor may subsequently adjust the
dosage, depending on the amount of gastric acid produced. If more than two
tablets are prescribed per day, the tablets must be taken twice a day.
If the doctor prescribes a daily dose of more than four tablets a day, you will be
told exactly when to stop taking the medicine.

Patients with kidney problems:
If you have kidney problems, you should not take Pantoprazolo Alter for the eradication
of Helicobacter pylori.

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

If you forget to take Pantoprazolo Alter
Do not take a double dose to make up for a missed dose. Take the normal
next dose at the 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 doubts 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 these
tablets and consult your doctor immediately, or contact the nearest hospital emergency
room:

• Severe allergic reactions (rare frequency:can affect up to 1 in 1000 people ):swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic facial swelling (angioedema / Quincke's edema), severe dizziness with a very fast heartbeat and profuse sweating.
• Severe skin conditions (frequency not known:frequency cannot be defined based on available data ):you may notice one or more of the following manifestations
• 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, especially in areas of skin exposed to light/sun. You may also have joint pain or flu-like symptoms, fever, swollen glands (e.g. under the armpit) and

blood tests may show changes in the white blood cell count or liver enzymes.

• non-raised, reddish, circular or target-shaped spots on the trunk, often with blisters in the center, skin peeling, ulcers on 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 severe conditions (frequency not known):yellowing of the skin or the whites of the eyes (severe liver cell damage, jaundice) or fever, rash, and swelling of the kidneys sometimes with pain when urinating and lower back pain (severe kidney inflammation) which can lead to possible kidney failure.

Other side effects are:

• -Common(may affect up to 1 in 10 people): Benign polyps in the stomach.
• Uncommon(may affect up to 1 in 100 people): Headache, dizziness, diarrhea, nausea, vomiting, bloating (gas), constipation, dry mouth, abdominal pain and feeling unwell, skin rash, exanthema, eruption, itching, feeling weak, tired or generally unwell, sleep disturbances, hip, wrist or spine fractures.
• Rare(may affect up to 1 in 1,000 people): Alteration or complete loss of the sense of taste, vision disorders such as blurred vision, hives, joint pain, muscle pain, weight changes, increased body temperature, high fever, swelling of the extremities (peripheral edema), allergic reactions, depression, increased breast volume in men.
• Very Rare(may affect up to 1 in 10,000 people): Disorientation.
• Not Known(frequency cannot be estimated based on available data): Hallucinations, confusion (especially in patients with a history of these symptoms), tingling, pins and needles, burning or numbness, erythema, possible joint pain, inflammation of the large intestine causing persistent watery diarrhea

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100 people): an increase in liver enzymes.
• Rare(may affect up to 1 in 1,000 people): an increase in bilirubin, increased levels of fats in the blood, drastic decrease in circulating granulocytes (some types of white blood cells), associated with high fever.
• Very Rare(may affect up to 1 in 10,000 people): a reduction in the number of platelets (which can cause more bleeding or bruising than normal), a reduction in the number of white blood cells (which can lead to more frequent infections), coexisting abnormal reduction in the number of red blood cells and white blood cells, as well as platelets.
• Not Known(frequency cannot be estimated from available data) Decrease in sodium, magnesium, calcium or potassium levels in the blood (see section 2).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through 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 Pantoprazolo 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 package and on the
container after SCAD.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pantoprazolo Alter contains
The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 mg of
pantoprazole (as sesquihydrate sodium).
The other ingredients are:
Tablet core: sodium carbonate, mannitol (E421), crospovidone, pregelatinized starch, calcium
stearate.
Intermediate coating film: hypromellose, triacetin, titanium dioxide (E171).
Gastro-resistant film: 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 40 mg gastro-resistant tablets and
contents of the pack
Pantoprazolo Alter 40 mg tablets are film-coated, dark pink, with a gastro-resistant coating, round,
biconvex in shape.
Pantoprazolo Alter 40 mg is available in packs of 14 and 28 gastro-resistant tablets in
Polyamide/Alu/PVC blisters and an aluminum foil
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
LABORATORI ALTER S.r.l.
Via Egadi 7 20144
Milan

Manufacturer:
Laboratorios Alter, S.A.
Calle de Mateo Inurria, 30
28036 Madrid - Spain