INIPANT 20 mg Enteric-Coated Tablet

Зміст інструкції

1. INIPANT 20 mg gastro-resistant tablets
   1. What INIPANT is and what it is used for
   2. What you need to know before taking INIPANT
   3. How to Take INIPANT:
   4. Possible Undesirable Effects
   5. How to Store INIPANT
   6. Contents of the pack and other information
2. INIPANT 40 mg gastro-resistant tablets
   1. What INIPANT is and what it is used for
   2. What you need to know before taking INIPANT:
   3. How to Take INIPANT:
   4. Possible Side Effects
   5. How to Store INIPANT
   6. Package Contents and Other Information

INIPANT 20mg gastro-resistant tablets (pantoprazole)

INIPANT 20 mg gastro-resistant tablets

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. In fact, this medicine may be dangerous for other individuals, even if their symptoms are the same as yours.
• If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What INIPANT is and what it is used for

The active ingredient of INIPANT is PANTOPRAZOLE.
INIPANT (pantoprazole) 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 intestines.

INIPANT is used for:

Adults and adolescents 12 years and over:

• Treatment of symptoms associated with gastroesophageal reflux disease, caused by the reflux of acid from the stomach (e.g. heartburn, regurgitation, acid, pain when swallowing).
• Long-term treatment of reflux esophagitis, inflammation of the esophagus (the tube connecting the throat to the stomach) accompanied by acid reflux, and prevention of recurrences, i.e. the possible return of these conditions. Adults
• Prevention of stomach and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example ibuprofen), in patients at risk because they require continuous treatment with these drugs.

2. What you need to know before taking INIPANT

Do not take INIPANT:

• If you are allergic (hypersensitive) to pantoprazole, substituted benzimidazoles or any of the excipients of INIPANT (listed in section 6) or the combined therapy;
• If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions
Talk to your doctor or pharmacist before taking INIPANT:

• If you have severe liver problems. Tell your doctor if you have had liver problems in the past. The doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking INIPANT Pag. 1to 6

INIPANT 20mg gastro-resistant tablets (pantoprazole)
for long-term therapy. If liver enzymes increase, treatment must be
stopped.

• If you need continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) because taking INIPANT increases the risk of developing gastric and intestinal complications. Any increased risk will be assessed by the doctor based on your personal risk factors such as age (65 years and over), or previous episodes of gastric or duodenal ulcers or gastrointestinal bleeding.
• If you have reduced body reserves or risk factors for reduced vitamin B12 and are undergoing long-term treatment with pantoprazole, as you suffer from a disease called Zollinger-Ellison syndrome or other diseases characterized by excessive production of hydrochloric acid in the stomach. As with all agents that reduce acidity, pantoprazole can lead to reduced absorption of vitamin B12.
• If you are simultaneously taking a medicine containing atazanavir (for the treatment of HIV infection) with pantoprazole, ask your doctor for specific advice.
• If you are at risk of osteoporosis, are an elderly patient or in the presence of other risk factors, proton pump inhibitors, especially when used at high doses and for periods longer than 1 year, may increase the risk of fractures of the hip, wrist and spine.
• If you have ever had a skin reaction after treatment with a medicine similar to INIPANT 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 you may need to stop treatment with INIPANT. Remember to also report any other undesirable effects such as joint pain.
• If you are to undergo a specific blood test (Chromogranin A)

Immediately inform your doctor if you notice any of the following symptoms:

• An involuntary weight loss
• Recurrent vomiting
• Difficulty swallowing
• Presence of blood in vomit
• You appear pale and feel weak (anemia)
• Presence of blood in the stool
• Severe and/or persistent diarrhea, as INIPANT has been associated with a modest increase in infectious diarrhea.
• Fatigue, dizziness, involuntary muscle contractions, convulsions, dizziness and increased heart rate.

The doctor may decide that you need to undergo some tests to rule out a malignancy
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 INIPANT for long-term treatment (more than one year) your doctor will probably
keep you under regular control. You should report any new or exceptional symptom or circumstance
whenever you see your doctor.

Other medicines and INIPANT
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
INIPANT 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 INIPANT may prevent these and other medicines from working properly;
• Warfarin and phenprocoumon, which affect the thickening, or dilution of the blood. You may need further checks;
• Atazanavir (used to treat HIV infection);

Pag. 2to 6
INIPANT 20mg gastro-resistant tablets (pantoprazole)

• Methotrexate (used for the treatment of rheumatoid arthritis, psoriasis and cancer). The doctor may temporarily suspend treatment with INIPANT as pantoprazole may increase methotrexate levels in the blood. Pregnancy and breastfeedingIf 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. Pregnancy There are no adequate data regarding the use of pantoprazole in pregnant women. INIPANT should not be used during pregnancy unless absolutely necessary.

Breastfeeding
Excretion in human breast milk has been reported. INIPANT should be used during breastfeeding
only if the doctor considers the benefit to you greater than the potential risk to the infant.

Driving and operating machinery
If you experience side effects such as dizziness or visual disturbances, you should not drive or operate machinery.

3. How to Take INIPANT:

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
.
Unless otherwise informed by your doctor, the usual dose is:

• Adults and adolescents over 12 years of age: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. Afterwards, the recurrence of symptoms can be controlled by taking one tablet a day, as needed. For long-term treatment and prevention of recurrent reflux esophagitis:The recommended dose is usually one tablet a day. If the symptom returns, your doctor may double the dose, in which case you can use “INIPANT 40mg tablets”, one tablet 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 non-steroidal anti-inflammatory drugs (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 under 12 years of age

• These tablets are not recommended for use in children under 12 years of age.

Method of administration
Take the tablets 1 hour before a meal without chewing or crushing them and swallow them whole with a
little water.

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

If you forget to take INIPANT
Do not take a double dose to make up for a missed dose. Take the normal dose
next scheduled time.

If you stop taking INIPANT
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
Page 3to 6
INIPANT 20mg gastro-resistant tablets (pantoprazole)
If you have any doubts about the use of INIPANT, ask your doctor or pharmacist.

4. Possible Undesirable Effects

Like all medicines, this medicine can cause undesirable effects, although not everyone will experience them.

If you experience any of the following undesirable effects, stop treatment with these tablets and
consult your doctor immediately, or contact the nearest hospital emergency room:
Severe allergic reactions (rare frequency:affects up to 1 in 1000 people ):

• swelling of the tongue and/or throat;
• difficulty swallowing;
• hives;
• difficulty breathing;
• allergic swelling of the face (angioedema/Quincke's edema);
• severe dizziness with a very fast heartbeat and profuse sweating.

Serious skin conditions (frequency not known:the frequency cannot be defined based on available data
):

• appearance of skin blisters and rapid deterioration of your general condition;
• erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson Syndrome, Lyell's Syndrome, Multiforme Erythema) and light sensitivity.

Other serious conditions (frequency not known:the frequency cannot be defined based on available data):

• yellowing of the skin or whites of the eyes (serious damage to liver cells, jaundice);
• fever;
• skin rash;
• enlargement of the kidneys, sometimes with pain when urinating and lower back pain (serious kidney inflammation) with the possibility of progressing to kidney failure.

Other undesirable effects are:
Not common(affects up to 1 in 100 people) :

• headache;
• dizziness;
• diarrhea;
• feeling of nausea, vomiting;
• abdominal 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;
• if you are taking a proton pump inhibitor such as INIPANT, especially for a period longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine. If you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis) consult your doctor. Common (affects up to 1 in 10 people):
• Benign polyps in the stomach Rare (affects up to 1 in 1000):
• alteration or complete loss of the sense of taste;
• visual disturbances such as blurred vision;
• hives;

Pag. 4to 6
INIPANT 20mg gastro-resistant tablets (pantoprazole)

• joint pain;
• muscle pain;
• weight changes;
• increased body temperature;
• fever
• swelling of the extremities (peripheral edema); allergic reactions; depression;
• increase in breast volume in men. Very rare(affects up to 1 in 10,000):
• disorientation. Not known(the frequency cannot be defined based on available data):
• hallucinations, confusion (especially in patients with a history of these symptoms);
• decrease in blood sodium levels;
• tingling (paresthesia).;
• muscle spasms as a result of electrolyte disturbances.
• erythema, possible joint pain
• Inflammation of the large intestine, causing persistent watery diarrhea.

Undesirable effects identified through blood tests:
Not common (affects 1 to 10 users out of 1,000):

• increased liver enzymes; Rare(affects up to 1 in 1000) :
• an increase in bilirubin;
• increased levels of fats in the blood; reduction in the number of white blood cells in the blood (agranulocytosis) Very rare(affects up to 1 in 10,000):
• a reduction in the number of platelets, which can cause bleeding or bruising more than usual;
• a reduction in the number of white blood cells, which can lead to more frequent infections;
• abnormal reduction in the number of red blood cells and white blood cells, and platelets (pancytopenia). If you take INIPANT for more than three months, it is possible that blood magnesium levels may decrease. Low levels of magnesium can manifest with:
• fatigue;
• involuntary muscle contractions;
• disorientation;
• convulsions;
• dizziness and increased heart rate; Low levels of magnesium can also lead to a reduction in calcium levels, decreased levels of sodium and potassium. If you experience any of these symptoms, consult your doctor immediately. The doctor should decide whether to periodically check magnesium levels in the blood.

Direct reporting of undesirable effects:
If you experience any undesirable effect, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report undesirable effects directly through the national reporting system
at the address: www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting undesirable effects you can contribute to providing more information on the safety of
this medicine.

5. How to Store INIPANT

Keep INIPANT out of sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the package and container after
“ Scad.”
The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Page 5to 6
INIPANT 20mg gastro-resistant tablets (pantoprazole)
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 INIPANT contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (corresponding to 22.58 mg of pantoprazole sodium sesquihydrate).
• The other components of the tablet are: Core: Mannitol (E421), anhydrous sodium carbonate, sodium starch glycolate, methacrylic acid copolymer, calcium stearate; Primary coating: hypromellose, titanium dioxide (E171), talc, macrogol (PEG 400), sodium lauryl sulfate; Secondary coating: methacrylic acid-ethyl acrylate copolymer dispersion 30%, propylene glycol, yellow iron oxide (E172), titanium dioxide (E171), talc.

Description of the appearance of INIPANT 20mg and contents of the pack:
Gastro-resistant tablets of light yellow color, oval shape, biconvex.
Pack: Aluminum / aluminum (AL/AL) blisters.
One pack of INIPANT 20mg contains 14 or 28 gastro-resistant tablets in blisters.

Marketing Authorisation Holder:
So.Se.PHARM S.r.l. - Via dei Castelli Romani, 22 - 00071 Pomezia (Rome) - Italy

Manufacturers:
Special Product’s Line S.p.A.- Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR), Italy
Pag. 6to 6
INIPANT 40mg gastro-resistant tablets (pantoprazole)

INIPANT 40 mg gastro-resistant tablets

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. In fact, this medicine may be dangerous for other individuals, even if their symptoms are the same as yours.
• If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What INIPANT is and what it is used for

The active ingredient of INIPANT is pantoprazole.
INIPANT (pantoprazole) 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 intestines, such as ulcers and
esophagitis.

INIPANT is used for:

Adults and adolescents 12 years and over:

• Esophagitis from reflux, the inflammation of the esophagus (the tube connecting the throat to the stomach) accompanied by acid regurgitation. Adults:
• Treatment of infection caused by a bacterium called Helicobacter Pylori in patients with duodenal ulcer and gastric ulcer, in combination with two antibiotics (eradication therapy). The purpose is to eliminate the bacteria in order to reduce the likelihood of these ulcers returning.
• 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 taking INIPANT:

Do not take INIPANT:

• if you are allergic to pantoprazole, substituted benzimidazoles or to any of the excipients of this medicine (see list in section 6), or to the combined therapy.
• If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions
Page. 1to 6
INIPANT 40mg gastro-resistant tablets (pantoprazole)

• Consult your doctor or pharmacist before taking INIPANTIf you have severe liver problems, i.e. of the liver. Tell your doctor if you have had liver problems in the past. The doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking INIPANT for long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you need continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) because taking INIPANT increases the risk of developing gastric and intestinal complications. Any increased risk will be assessed by the doctor based on your personal risk factors such as age (65 years and over), or previous episodes of gastric or duodenal ulcers or gastric or intestinal bleeding.
• If you have reduced body reserves or risk factors for reduced vitamin B12 and are undergoing long-term treatment with pantoprazole, as you are affected by a disease called Zollinger-Ellison syndrome or other diseases characterized by excessive production of hydrochloric acid in the stomach. As with all agents that reduce acidity, pantoprazole can lead to reduced absorption of vitamin B12.
• If you are simultaneously taking a medicine containing atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
• If you are at risk of osteoporosis, are an elderly patient or in the presence of other risk factors, proton pump inhibitors, especially when used at high doses and for periods longer than 1 year, may increase the risk of fractures of the hip, wrist and spine.
• If you have ever had a skin reaction after treatment with a medicine similar to INIPANT that reduces gastric acidity. 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 stop therapy with INIPANT. Remember to report any other unwanted effects such as joint pain.
• If you are to undergo a specific blood test (Chromogranin A)

Immediately inform your doctor if you notice any of the following symptoms:

• Unintentional weight loss;
• Recurrent vomiting;
• Difficulty swallowing;
• Presence of blood in vomit;
• Appear pale and feel weak (anemia);
• Presence of blood in the stool;
• Severe and/or persistent diarrhea, as INIPANT has been associated with a modest increase in infectious diarrhea.
• Fatigue, confusion, involuntary muscle contractions, convulsions, dizziness and increased heart rate. The doctor may decide that you need to undergo some tests to exclude a malignant disease as pantoprazole also relieves the symptoms of cancer and could cause a delay in diagnosis. If the symptoms persist despite treatment, further investigations should be considered. If you take INIPANT for long-term treatment (more than one year) your doctor will probably keep you under regular control. You must report any new or unusual symptom or circumstance whenever you meet the doctor.

Other medicines and INIPANT
Inform your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
INIPANT 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) as INIPANT may prevent these and other medicines from working properly;
• Warfarin and phenprocoumon, which affect blood clotting or dilution. You may need further checks;
• Atazanavir (used to treat HIV infection).

Page. 2to 6
INIPANT 40mg gastro-resistant tablets (pantoprazole)

• Methotrexate (used for the treatment of rheumatoid arthritis, psoriasis and cancer). The doctor may temporarily suspend treatment with INIPANT as pantoprazole can increase levels of methotrexate in the blood.
• Pregnancy and breastfeedingIf you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy There are no adequate data regarding the use of pantoprazole in pregnant women. INIPANT should not be used during pregnancy unless absolutely necessary. Breastfeeding Excretion in human milk has been reported. INIPANT should be used during breastfeeding only if the doctor considers the benefit to you greater than the potential risk to the infant.

Driving and operating machinery
If you experience side effects such as dizziness or visual disturbances, you should not drive or operate machinery.

3. How to Take INIPANT:

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. Unless otherwise informed by your doctor, the usual dose
is:

• Adults and adolescents over 12 years of age: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 withduodenal ulcer and gastric ulcer, in association with two antibiotics (eradication therapy):One tablet of INIPANT together with two tablets of antibiotic between amoxicillin, clarithromycin and metronidazole (or tinidazole), twice a day. Take the first INIPANT tablet 1 hour before breakfast and the second INIPANT tablet 1 hour before the evening meal.

Usual treatment 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 can be
doubled. Your doctor will tell you how long to take the medicine. The treatment period for
gastric ulcers is typically between 4 and 8 weeks. The treatment period for duodenal ulcers is
typically 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 initial dose is usually two tablets a day.
Take the two 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 are prescribed per
day, the tablets must be taken in two doses per day.
If your 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 liver problems
Page 3to 6
INIPANT 40mg gastro-resistant tablets (pantoprazole)

• if you have moderate or severe kidney problems, you should not take INIPANT for the eradication of Helicobacter Pylori;
• if you suffer from severe liver problems, you should not take more than one 20 mg tablet of pantoprazole per day (use “INIPANT 20mg tablets”). Use in children under 12 years of age
• These tablets are not recommended for use in children under 12 years of age. Method of administrationTake the tablets 1 hour before a meal without chewing or crushing them and swallow them whole with a little water.

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

If you forget to take INIPANT:
Do not take a double dose to make up for a missed dose. Take the normal dose
next time it is due.

If you stop taking INIPANT:
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any doubts about the use of INIPANT, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, INIPANT can cause side effects, although not everybody gets them.
manifest.

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 (very rare:affects up to 1 in 1000 ):

• swelling of the tongue and/or throat;
• difficulty swallowing;
• urticaria;
• difficulty breathing;
• allergic swelling of the face (angioedema/Quincke's edema);
• severe dizziness with a very fast heartbeat and heavy sweating. Serious skin conditions (frequency not known:the frequency cannot be determined based on available data ):
• appearance of skin blisters and rapid deterioration of your general condition;
• erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, Multiforme erythema) and light sensitivity. Other serious conditions (frequency not known:the frequency cannot be determined based on available data ):
• yellowing of the skin or whites of the eyes (serious damage to liver cells, jaundice);
• fever;
• skin rash;
• enlargement of the kidneys sometimes with pain when urinating and lower back pain (serious kidney inflammation) with the possibility of progression to kidney failure.

Other side effects are:

Uncommon(affects up to 1 in 100) :

• headache;
• dizziness;
• diarrhea;
• feeling of nausea, vomiting;

Page 4to 6
INIPANT 40mg gastro-resistant tablets (pantoprazole)

• abdominal 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;
• if you take a proton pump inhibitor such as INIPANT, especially for a period longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine. If you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis) consult your doctor. Common (affects up to 1 in 10):
• Benign polyps in the stomach Rare (affects up to 1 in 1000):
• alteration or complete loss of the sense 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;
• increase in breast volume in men. Very rare(affects up to 1 in 10,000):
• disorientation. Not known(the frequency cannot be defined based on available data):
• hallucinations, confusion (especially in patients with a history of these symptoms);
• decreased levels of sodium in the blood;
• tingling (paresthesia);
• muscle spasms as a result of electrolyte disturbances.
• erythema, possible joint pain
• Inflammation of the large intestine, causing persistent watery diarrhea.

Side effects identified through blood tests:
Uncommon:

• increased liver enzymes; Rare:an increase in bilirubin;
• increased levels of fats in the blood;
• reduction in the number of white blood cells (agranulocytosis). Very rare(affects less than 1 in 10,000):
• a reduction in the number of platelets which may cause bleeding or bruising more than normal;
• a reduction in the number of white blood cells, which can lead to more frequent infections;
• abnormal reduction in the number of red blood cells and white blood cells, and platelets (pancytopenia).

If you take INIPANT for more than three months, it is possible that blood levels of magnesium may decrease. Low levels
of magnesium can manifest with:

• fatigue;
• involuntary muscle contractions;
• disorientation;
• convulsions;
• dizziness;
• increased heart rate;

Page 5to 6
INIPANT 40mg gastro-resistant tablets (pantoprazole)
Low levels of magnesium can also lead to a reduction in calcium levels and a decrease in levels
of sodium and potassium.
If you experience any of these symptoms, consult your doctor immediately. The doctor should
decide whether to periodically check magnesium levels in the blood.

Direct reporting of side effects:
If you experience any side effect, including those not listed in this leaflet, please inform your
doctor or pharmacist.
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 INIPANT

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

6. Package Contents and Other Information

What INIPANT contains:

• The active ingredient is PANTOPRAZOLE. Each gastro-resistant tablet contains 40 mg of pantoprazole (corresponding to 45.16 mg of pantoprazole sodium sesquihydrate).
• The other components are: Core: Mannitol (E421), anhydrous sodium carbonate, sodium starch glycolate, methacrylic acid copolymer, calcium stearate; Primary coating: hypromellose, titanium dioxide (E171), talc, macrogol (PEG 400), sodium lauryl sulfate; Secondary coating: methacrylic acid-ethyl acrylate copolymer dispersion 30%, propylene glycol, yellow iron oxide (E172), titanium dioxide (E171), talc.

Description of the appearance of INIPANT 40 mg and package contents:
Gastro-resistant tablets of dark yellow color, oval shape, biconvex.
Packaging: Aluminum / aluminum (AL/AL) blisters.
One pack of INIPANT 40mg contains 14 or 28 gastro-resistant tablets in blisters.

Marketing Authorisation Holder:
So.Se.PHARM S.r.l. - Via dei Castelli Romani, 22 - 00071 Pomezia (Rome) - Italy

Manufacturers:
Special Product’s Line S.p.A.- Via Fratta Rotonda Vado Largo 1- 03012 Anagni (FR), Italy
Page 6of 6