Inipant

INIPANT 20 mg gastro-resistant tablets (pantoprazole)

Patient information leaflet: information for the patient

INIPANT 20 mg gastro-resistant tablets

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. It could be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform 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 taking INIPANT
3. How to take INIPANT
4. Possible side effects
5. How to store INIPANT
6. Package contents and other information

1. What INIPANT is and what it is used for

The active substance 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 intestine.
INIPANT is used for:
Adults and adolescents aged 12 years and older:

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

2. What you need to know before taking INIPANT

Do not take INIPANT:

• If you are allergic (hypersensitive) to pantoprazole, substituted benzimidazoles, or to any of the excipients of INIPANT (listed in section 6) or of combination 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. Inform your doctor if you have previously had liver problems. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking INIPANT

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

• If you require ongoing 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 your doctor based on your individual risk factors such as age (65 years and older), or history of gastric or duodenal ulcers or gastrointestinal bleeding.
• If you have low body reserves or risk factors for vitamin B12 deficiency and are undergoing long-term treatment with pantoprazole due to a condition 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 may 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 elderly, or have 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, or 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, particularly in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with INIPANT. Remember to report any other adverse effects such as joint pain.
• If you are scheduled to undergo a specific blood test (Chromogranin A).

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

• Unintentional weight loss
• Recurrent vomiting
• Difficulty swallowing
• Presence of blood in vomit
• Looking pale and feeling weak (anemia)
• Blood in stools
• Severe and/or persistent diarrhoea, as INIPANT has been associated with a slight increase in infectious diarrhoea.
• Fatigue, confusion, involuntary muscle contractions, seizures, dizziness, and increased heart rate.

Your doctor may decide that you need certain tests to rule out malignancy, as pantoprazole may relieve symptoms of cancer and could therefore delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you take INIPANT for long-term treatment (over one year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances 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 medicines.
INIPANT 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 INIPANT may prevent these and other medicines from working properly;
• Warfarin and fenprocoumon, which affect blood clotting. You may need additional monitoring;
• Atazanavir (used to treat HIV infection);

INIPANT 20mg gastro-resistant tablets (pantoprazole)

• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). Your doctor might temporarily discontinue treatment with INIPANT, as pantoprazole may increase methotrexate levels in the blood.
  Pregnancy and breastfeeding
  If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
  Pregnancy
  There are insufficient data on 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 your doctor considers the benefit to you to outweigh the potential risk to the breastfed infant.
Driving and using machines
If you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.

3. How to Take INIPANT:

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Unless otherwise instructed 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, painful swallowing): The usual dose is one tablet per day. This dose usually provides relief within 2–4 weeks, and at most after an additional 4 weeks. Your doctor will advise you on how long to continue taking the medicine. Afterwards, recurrence of symptoms can be managed by taking one tablet per day as needed. For long-term treatment and prevention of recurrence of reflux esophagitis: The recommended dose is usually one tablet per day. If symptoms return, your doctor may double the dose; in this case, you may use “INIPANT 40mg tablets”, one tablet per day. After healing, the dose can be reduced back to one 20 mg tablet per day.
• Adults: For the prevention of duodenal and gastric ulcers in patients requiring ongoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs): The usual dose is one tablet per day.

Patients with liver problems – If you have severe liver problems, you must not take more than one 20 mg tablet per day.
Use in children 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. Do not chew or crush the tablets; swallow them whole with some water.
If you take more INIPANT than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take INIPANT
Do not take a double dose to make up for the forgotten dose. Take your next dose at the usual scheduled time.
If you stop taking INIPANT
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
INIPANT 20mg gastro-resistant tablets (pantoprazolo)
If you have any doubts about how to use INIPANT, consult your doctor or pharmacist.

4. Possible Side Effects

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

Severe allergic reactions (rare frequency: affects up to 1 in 1,000 people):

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

Serious skin disorders (frequency not known: frequency cannot be estimated from the available data):

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

Other serious disorders (frequency not known: frequency cannot be estimated from the available data):

• yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice);
• fever;
• rash;
• kidney enlargement sometimes with pain on urination and lower back pain (severe kidney inflammation), possibly progressing to kidney failure.

Other side effects include:
Uncommon (affects up to 1 in 100 people):

• headache;
• dizziness;
• diarrhoea;
• 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 take a proton pump inhibitor such as INIPANT, especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
  Common (affects up to 1 in 10 people):
• benign gastric polyps
  Rare (affects up to 1 in 1,000 people):
• altered or complete loss of taste sensation;
• visual disturbances such as blurred vision;
• hives;

INIPANT 20mg gastro-resistant tablets (pantoprazole)

• joint pain;
• muscle pain;
• weight changes;
• increased body temperature;
• fever;
• swelling of the extremities (peripheral oedema); allergic reactions; depression;
• breast enlargement in males.
  Very rare (affects up to 1 in 10,000 people):
• disorientation.
  Not known (frequency cannot be estimated from the available data):
• hallucinations, confusion (especially in patients with prior experience of these symptoms);
• decreased sodium levels in the blood;
• tingling sensations (paraesthesia);
• muscle spasms as a consequence of electrolyte disturbances;
• erythema, possible joint pain;
• inflammation of the large intestine, causing persistent watery diarrhoea.

Side effects identified through blood tests:
Uncommon (affects 1 to 10 users in 1,000):

• increased liver enzymes;
  Rare (affects up to 1 in 1,000 people):
• increased bilirubin;
• increased blood lipid levels; decreased number of white blood cells in the blood (agranulocytosis)
  Very rare (affects 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;
• abnormally low numbers of red and white blood cells and platelets (pancytopenia).

If you take INIPANT for more than three months, blood magnesium levels may decrease. Low magnesium levels may present with:

• fatigue;
• involuntary muscle contractions;
• disorientation;
• seizures;
• dizziness and increased heart rate.

Low magnesium levels may also lead to reduced levels of calcium, sodium and potassium. If you experience any of these symptoms, contact your doctor immediately. Your doctor should decide whether to monitor your blood magnesium levels periodically.

Direct reporting of side effects:
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the 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 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 the month.
This medicine does not require any special storage conditions.
INIPANT 20mg gastro-resistant tablets (pantoprazole)
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What INIPANT contains

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (equivalent 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:
Yellowish, oval-shaped, biconvex gastro-resistant tablets.
Packaging: Aluminium/aluminium foil blisters (AL/AL).
One pack of INIPANT 20mg contains 14 or 28 gastro-resistant tablets in blisters.

Marketing Authorization 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
This summary of product characteristics was last approved on
INIPANT 40mg gastro-resistant tablets (pantoprazole)

Package leaflet: information for the patient

INIPANT 40 mg gastro-resistant tablets

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform 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 taking 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 substance 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 intestine, such as ulcers and esophagitis.
INIPANT is used for:
Adults and adolescents aged 12 years and above:

• Reflux esophagitis, inflammation of the esophagus (the tube connecting the throat to the stomach), associated with regurgitation of gastric acid.
  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 aim is to eliminate the bacteria in order to reduce the likelihood of these ulcers recurring.
• Gastric and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions characterized by excessive acid production 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 any of the excipients of this medicine (see list in section 6), or of combination therapy.
• if you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions
INIPANT 40mg gastro-resistant tablets (pantoprazole)

• Consult your doctor or pharmacist before taking INIPANT if you have severe liver problems. Inform your doctor if you have previously had liver problems. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking INIPANT for long-term treatment. If liver enzymes increase, treatment must be discontinued.
• if you require ongoing 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 your doctor based on your individual risk factors such as age (65 years and older), or history of gastric or duodenal ulcers or gastrointestinal bleeding.
• if you have low body reserves or risk factors for vitamin B12 deficiency and are undergoing long-term treatment with pantoprazole, especially if you have a condition 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 may 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 elderly, or have 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 sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with INIPANT. Remember to also report any other adverse effects such as joint pain.
• if you are scheduled for a specific blood test (Chromogranin A).

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

• Unintentional weight loss;
• Recurrent vomiting;
• Difficulty swallowing;
• Presence of blood in vomit;
• Pale appearance and feeling weak (anemia);
• Blood in stools;
• Severe and/or persistent diarrhea, as INIPANT has been associated with a slight increase in infectious diarrhea.
• Fatigue, confusion, involuntary muscle contractions, seizures, dizziness, and increased heart rate. Your doctor may decide that you need certain tests to rule out malignancy, as pantoprazole can relieve symptoms of cancer and may delay diagnosis. If symptoms persist despite treatment, further investigations should be considered. If you take INIPANT for long-term treatment (over one year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances whenever you see your doctor.

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

INIPANT 40mg gastro-resistant tablets (pantoprazole)

• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). Your doctor might temporarily discontinue treatment with INIPANT, as pantoprazole may increase methotrexate levels in the blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There are insufficient data on the use of pantoprazole in pregnant women. INIPANT must not be used during pregnancy unless clearly necessary.
Breastfeeding
Excretion in human milk has been reported. INIPANT should be used during breastfeeding only if your doctor considers the benefit to you greater than the potential risk to the breastfed infant.

Driving and using machines
If you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.

3. How to take INIPANT:

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist. Unless otherwise instructed 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 daily. Your doctor may instruct you to increase the dose to two tablets daily. The treatment period for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will tell you 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 of INIPANT together with two antibiotic tablets selected from amoxicillin, clarithromycin, and metronidazole (or tinidazole), taken twice daily. Take the first tablet of INIPANT 1 hour before breakfast and the second tablet of INIPANT 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 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 long-term treatment of Zollinger-Ellison syndrome and other conditions with excessive gastric acid production:
The usual starting dose is two tablets daily.
Take both tablets 1 hour before a meal. Your doctor may adjust the dosage depending on the amount of gastric acid produced. If more than two tablets per day are prescribed, the tablets should be taken in two divided doses.
If your doctor prescribes a daily dosage of more than four tablets, you will be given specific instructions on when to stop taking the medicine.

Patients with liver problems
INIPANT 40mg gastro-resistant tablets (pantoprazole)

• if you have moderate or severe kidney problems, you must not take INIPANT for Helicobacter pylori eradication;
• if you have severe liver problems, you must not take more than one 20 mg pantoprazole tablet 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 administration
Take the tablets 1 hour before a meal. Do not chew or crush the tablets. Swallow them whole with some water.

If you take more INIPANT than you should:
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take INIPANT:
Do not take a double dose to make up for the missed dose. Take your next dose at the usual scheduled time.
If you stop taking INIPANT:
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any doubts about how to use INIPANT, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, INIPANT may cause side effects, although not everyone experiences them.
If you experience any of the following side effects, stop treatment with these tablets and
contact your doctor immediately, or contact the emergency department of your nearest hospital:
Severe allergic reactions (rare frequency: up to 1 in 1,000 people):

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

Serious skin disorders (frequency not known: frequency cannot be estimated from the available data):

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

Other serious disorders (frequency not known: frequency cannot be estimated from the available data):

• yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice);
• fever;
• skin rash;
• kidney enlargement sometimes with pain during urination and lower back pain (severe kidney inflammation), possibly progressing to kidney failure.

Other side effects include:
Uncommon (affects up to 1 in 100 people):

• headache;
• dizziness;
• diarrhea;
• nausea, vomiting;
• abdominal distension and flatulence (gas), constipation;
• dry mouth;
• abdominal pain and feeling unwell;
• skin rash, exanthema, eruption;
• itching;
• feeling of weakness, fatigue or general malaise;
• sleep disturbances;

If you take a proton pump inhibitor such as INIPANT, especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine. If you have osteoporosis or are taking corticosteroids (which may 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 1,000 people):

• altered or complete loss of taste;
• visual disturbances 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;
• breast enlargement in men.

Very rare (affects up to 1 in 10,000 people):

• disorientation.

Not known (frequency cannot be estimated from the available data):

• hallucinations, confusion (especially in patients with prior history of these symptoms);
• decreased levels of sodium in the blood;
• tingling (paresthesia);
• muscle spasms as a consequence of electrolyte disturbances;
• erythema, possible joint pain;
• inflammation of the colon causing persistent watery diarrhea.

Side effects identified through blood tests:
Uncommon:

• increased liver enzymes;

Rare: increased bilirubin;

• increased levels of fats in the blood;
• reduction in the number of white blood cells (agranulocytosis).

Very rare (affects fewer than 1 in 10,000 patients):

• reduction in the number of platelets, which may cause abnormal bleeding or bruising;
• reduction in the number of white blood cells, which may lead to more frequent infections;
• abnormal reduction in the number of red and white blood cells and platelets (pancytopenia).

If you take INIPANT for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present with:

• fatigue;
• involuntary muscle contractions;
• disorientation;
• seizures;
• dizziness;
• increased heart rate.

INIPANT 40mg gastro-resistant tablets (pantoprazole)
Low magnesium levels may also lead to reduced levels of calcium and decreased levels of sodium and potassium.
If you experience any of these symptoms, contact your doctor immediately. Your doctor should decide whether to periodically monitor your blood magnesium levels.

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

Keep INIPANT 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 the month.
This medicine does not require any special storage conditions.
Do not dispose of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What INIPANT contains:

• The active substance is PANTOPRAZOLE. Each gastro-resistant tablet contains 40 mg of pantoprazole (equivalent 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, iron oxide yellow (E172), titanium dioxide (E171), talc.

Description of the appearance of INIPANT 40 mg and pack contents:
Dark yellow, oval-shaped, biconvex gastro-resistant tablets.
Packaging: Aluminium/aluminium foil blisters (AL/AL).
One pack of INIPANT 40 mg contains 14 or 28 gastro-resistant tablets in blisters.
Marketing Authorization 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
This leaflet was last approved on