Pantoprazole Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

PANTOPRAZOLE DOC 20 mg gastro-resistant tablets

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

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

Contents of this leaflet
What PANTOPRAZOLE DOC 20 mg is and what it is used for
What you need to know before taking PANTOPRAZOLE DOC 20 mg
How to take PANTOPRAZOLE DOC 20 mg
Possible side effects
How to store PANTOPRAZOLE DOC 20 mg
Contents of the pack and other information

1. WHAT PANTOPRAZOLE DOC 20 MG IS AND WHAT IT IS USED FOR

PANTOPRAZOLE DOC 20 mg is a selective "proton pump inhibitor", a medicine that reduces the production of acid in the stomach (selective proton pump inhibitor). It is used for the treatment of acid-related diseases of the stomach and intestine.
PANTOPRAZOLE DOC 20 mg is used for the treatment of:
Adults and adolescents 12 years of age and older:

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING PANTOPRAZOLE DOC 20 MG

Do not take PANTOPRAZOLE DOC 20 mg
If you are allergic to pantoprazole, soybean lecithin, or 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 or pharmacist before taking PANTOPRAZOLE DOC:

• if you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor may decide to monitor your liver enzymes more frequently, especially if you are taking PANTOPRAZOLE DOC for long-term treatment. If your liver enzymes increase, treatment should be discontinued.

• if you require ongoing treatment with medicines called NSAIDs and are taking PANTOPRAZOLE DOC because you are at increased risk of developing gastric or intestinal complications. Any increased risk will be assessed based on your personal risk factors such as
  age (65 years and older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.

• if you have low body reserves or risk factors for vitamin B12 deficiency and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12.

• if you are concurrently taking protease inhibitors for HIV, such as atazanavir (for the treatment of HIV infection), consult your doctor for specific advice.

• taking a proton pump inhibitor such as pantoprazole, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of osteoporosis (e.g., if you are taking steroids).

• if you have been taking PANTOPRAZOLE DOC for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.

• if you have ever had a skin reaction after treatment with a medicine similar to PANTOPRAZOLE DOC 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 discontinue treatment with PANTOPRAZOLE DOC. Remember to also report any other adverse effects such as joint pain.

• if you need to undergo a specific blood test (Chromogranin A)

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

• unintentional weight loss;
• vomiting, especially if repeated;
• presence of blood in vomit: this may appear as dark, coffee-ground-like material in the vomit;
• appearance of blood in stools, which may appear dark or tarry;
• difficulty swallowing or pain when swallowing;
• paleness and weakness (anemia);
• chest pain;
• stomach pain;
• severe and/or persistent diarrhea, because PANTOPRAZOLE DOC 20 mg has been associated with a slight increase in infectious diarrhea.

Your doctor may decide that you need further tests to rule out a malignant disease, as pantoprazole may relieve symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you are taking PANTOPRAZOLE DOC 20 mg for long-term treatment (more than 1 year), your doctor will likely monitor you regularly. You should report any new or unusual symptoms or circumstances at every medical visit.

Children and adolescents
The use of PANTOPRAZOLE DOC 20 mg is not recommended in children, as efficacy has not been demonstrated in children under 12 years of age.

Other medicines and PANTOPRAZOLE DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
PANTOPRAZOLE DOC 20 mg may affect the effectiveness of other medicines, so inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as PANTOPRAZOLE DOC 20 mg may prevent these and other medicines from working properly.
• Warfarin and fenprocoumon, which affect blood clotting. You may need additional monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, certain types of cancer, or psoriasis). If you are taking methotrexate, your doctor may temporarily discontinue treatment with PANTOPRAZOLE DOC 20 mg, as it may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders). If you are taking fluvoxamine, your doctor may reduce the dose.
• Rifampicin (used to treat infections).
• St John's wort (Hypericum perforatum) (used to treat mild depression).

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

Driving and using machines
PANTOPRAZOLE DOC 20 mg does not alter or alters negligibly the ability to drive or use machines. If you experience adverse effects such as dizziness or visual disturbances, do not drive or operate machinery.

Important information about some ingredients of PANTOPRAZOLE DOC 20 mg
If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
PANTOPRAZOLE DOC 20 mg contains soybean lecithin. If you are allergic to peanuts or soy, do not use this medicine.

3. HOW TO TAKE PANTOPRAZOLO DOC 20 MG

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Method of administration Take the tablets one hour before a meal. Do not chew or crush them;
swallow the tablets whole with some water.
The recommended dose is:
Adults and adolescents 12 years of age and older
For the treatment of symptoms associated with gastroesophageal reflux disease (e.g. heartburn, acid
regurgitation, pain when swallowing)
The usual dose is one tablet per day. This dose usually provides relief within 2–4 weeks – at most after a further 4 weeks. Your doctor will advise you on how long to continue taking the medicine.
Afterwards, any recurrence of symptoms can be managed by taking one tablet per day , as needed.
For long-term treatment and prevention of recurrence of reflux esophagitis
The usual dose is one tablet per day. If the disease recurs, your doctor may double the dose; in this case, you may instead use PANTOPRAZOLO DOC 40 mg gastro-resistant tablets, one per day.
After healing, the dose may be reduced back to one 20 mg tablet per day.
Adults
For prevention of duodenal and gastric ulcers in patients requiring continuous treatment with NSAIDs
The usual dose is one tablet per day.
Special patient groups:

• If you have severe liver problems, you must not take more than one 20 mg tablet per day.
• Use in children under 12 years: These tablets are not recommended for use in children under 12 years of age.

If you take more PANTOPRAZOLO DOC 20 mg than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take PANTOPRAZOLO DOC 20 mg
Do not take a double dose to make up for the forgotten dose. Take the next dose at the usual scheduled time.
If you stop taking PANTOPRAZOLO DOC 20 mg
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of the possible adverse reactions listed below is defined using the following convention:
very common (may affect more than 1 in 10 people)
common (may affect up to 1 in 10 people)
uncommon (may affect up to 1 in 100 people)
rare (may affect up to 1 in 1,000 people)
very rare (may affect up to 1 in 10,000 people)
not known (frequency cannot be estimated from the available data)

If you experience any of the following adverse reactions, stop treatment with these tablets immediately and
contact your doctor or go to the nearest hospital emergency department:

• Severe allergic reactions (frequency: rare) – may affect up to 1 in 1,000 people: swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Severe skin disorders (frequency: not known) – frequency cannot be estimated from the available data: you may notice one or more of the following: appearance of skin blisters and rapid deterioration of your general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arm), and blood tests may show changes in white blood cell count or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).
• Other serious conditions (frequency: not known) – frequency cannot be estimated from the available data: yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, rash, and kidney enlargement sometimes with pain during urination and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions include:

• Common (may affect up to 1 in 10 people): benign gastric polyps.
• Uncommon (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash, exanthema, eruption; itching; feeling of weakness, fatigue or general malaise; sleep disturbances, fractures of the hip, wrist or spine.
• Rare (may affect up to 1 in 1,000 people): altered or complete loss of taste, visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature, high fever; swelling of extremities (peripheral oedema); allergic reactions; depression; breast enlargement in men.
• Very rare (may affect up to 1 in 10,000 people): disorientation.
• Not known (frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients with prior experience of these symptoms); tingling sensation, pins and needles, burning sensation or numbness; erythema; possible joint pain; inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions identified through blood tests:

• Uncommon (may affect up to 1 in 100 people): increased liver enzymes.
• Rare (may affect up to 1 in 1,000 people): increased bilirubin; increased blood lipids; a drastic decrease in circulating granulocytes associated with high fever.
• Very rare (may affect up to 1 in 10,000 people): reduced platelet count, which may cause bleeding or bruising more than normal; reduced white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red blood cells, white blood cells, and platelets.
• Not known (frequency cannot be estimated from the available data): decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PANTOPRAZOLE DOC 20 mg

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

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What PANTOPRAZOLO DOC 20 mg contains
The active substance is: pantoprazole.
Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
The other components are:
Tablet core
Maltitol (E 965), crospovidone type B, carmellose sodium, anhydrous sodium carbonate (E 500), calcium stearate
Tablet coating
Polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), macrogol 3350, soy lecithin, yellow iron oxide (E 172), anhydrous sodium carbonate (E 500), methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E 1505)

Description of the appearance of PANTOPRAZOLO DOC 20 mg and pack contents
PANTOPRAZOLO DOC 20 mg gastro-resistant tablets are oval and yellow. PANTOPRAZOLO DOC 20 mg is available in blister packs containing 14, 28 or 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy

Responsible manufacturers for batch release
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A. - Via Grignano, 43 - 24041 Brembate (BG) - Italy
Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino - S.S. 16 Zona Industriale - 73010 Zollino (LE) - Italy

This leaflet was last updated on

PACKAGE LEAFLET: INFORMATION FOR THE USER

PANTOPRAZOLE DOC 40 mg gastro-resistant tablets

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet
What PANTOPRAZOLE DOC 40 mg is and what it is used for
What you need to know before taking PANTOPRAZOLE DOC 40 mg
How to take PANTOPRAZOLE DOC 40 mg
Possible side effects
How to store PANTOPRAZOLE DOC 40 mg
Package contents and other information

1. WHAT PANTOPRAZOLE DOC 40 mg IS AND WHAT IT IS USED FOR

PANTOPRAZOLE DOC 40 mg is a selective "proton pump inhibitor", a medicine that reduces acid production in the stomach (selective proton pump inhibitor). It is used for the treatment of acid-related diseases of the stomach and intestine.
PANTOPRAZOLE DOC 40 mg is used for the treatment of:
Adults and adolescents aged 12 years and older:

• Reflux esophagitis. Inflammation of the esophagus (the tube connecting the throat to the stomach) associated with gastric acid reflux.
  Adults:
• Infection with a bacterium called Helicobacter pylori in patients with duodenal ulcer and gastric ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacterium in order to reduce the likelihood of recurrence of these ulcers.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which excessive stomach acid is produced.

2. WHAT YOU SHOULD KNOW BEFORE TAKING PANTOPRAZOLE DOC 40 mg

Do not take PANTOPRAZOLE DOC 40 mg
If you are allergic to pantoprazole, soybean lecithin, or 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 or pharmacist before taking PANTOPRAZOLE DOC:

• 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 PANTOPRAZOLE DOC for long-term treatment. If your liver enzymes increase, treatment should be stopped.
• if you require ongoing treatment with NSAIDs and are taking PANTOPRAZOLE DOC due to an increased risk of developing gastric and intestinal complications. Any increased risk will be assessed based on your individual risk factors such as age (65 years and older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
• if you have low body reserves or risk factors for vitamin B12 deficiency and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12.
• if you are taking protease inhibitors for HIV, such as atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
• if you are taking a proton pump inhibitor such as PANTOPRAZOLE DOC, particularly for more 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.
• if you have been taking PANTOPRAZOLE DOC for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced 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 PANTOPRAZOLE DOC 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 discontinue treatment with PANTOPRAZOLE DOC. Remember to also report any other adverse effects such as joint pain.
• if you need to undergo a specific blood test (Chromogranin A).

Inform your doctor immediately if you experience any of the following symptoms:

• unintentional weight loss;
• vomiting, especially if repeated;
• presence of blood in vomit: this may appear as dark, coffee-ground-like material in the vomit;
• presence of blood in stools, which may appear dark or tarry;
• difficulty swallowing or pain when swallowing;
• paleness and weakness (anaemia);
• chest pain;
• stomach pain;
• severe and/or persistent diarrhoea, as PANTOPRAZOLE DOC 40 mg has been associated with a slight increase in infectious diarrhoea.

Your doctor may decide that you need further tests to rule out malignancy, as pantoprazole can relieve symptoms of cancer and may delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you are taking PANTOPRAZOLE DOC 40 mg for long-term treatment (over 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances at every medical visit.

Children and adolescents
The use of PANTOPRAZOLE DOC 40 mg is not recommended in children, as efficacy has not been demonstrated in children under 12 years of age.

Other medicines and PANTOPRAZOLE DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
PANTOPRAZOLE DOC 40 mg may affect the effectiveness of other medicines, so inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as PANTOPRAZOLE DOC 40 mg may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, certain types of cancer, or psoriasis). If you are taking methotrexate, your doctor may temporarily discontinue treatment with PANTOPRAZOLE DOC 40 mg, as it may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders). If you are taking fluvoxamine, your doctor may reduce the dose.
• Rifampicin (used to treat infections).
• St John's wort (Hypericum perforatum) (used to treat mild depression).

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

Driving and using machines
PANTOPRAZOLE DOC 40 mg does not affect or has negligible effect on the ability to drive or use machinery.
However, if you experience adverse effects such as dizziness or visual disturbances, you should not drive or operate machinery.

Important information about some ingredients of PANTOPRAZOLE DOC 40 mg
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
PANTOPRAZOLE DOC 40 mg contains soybean lecithin. If you are allergic to peanuts or soy, do not use this medicine.

3. HOW TO TAKE PANTOPRAZOLO DOC 40 mg

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Method of administration
Take the tablets one hour before a meal, without chewing or crushing them, swallowing them whole with some water.

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

Adults
For the treatment of infection caused by a bacterium called Helicobacter pylori in patients with
duodenal ulcer and gastric ulcer, in combination with two antibiotics (eradication therapy)
One tablet twice daily, plus two antibiotic tablets (selected from amoxicillin, clarithromycin, and metronidazole (or tinidazole)), each taken twice daily together with the pantoprazole tablet.
Take the first pantoprazole tablet one hour before breakfast and the second pantoprazole tablet one hour before the evening meal. Follow your doctor's instructions and make sure to read the package leaflet for the antibiotics. The usual treatment duration is one or two weeks.

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

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach
The usual recommended initial dose is two tablets per day.
Take both tablets one hour before a meal. Your doctor may subsequently 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 twice daily.
If your doctor prescribes a daily dosage of more than four tablets, you will be specifically instructed when to stop taking the medicine.

Patients with kidney problems
If you have kidney problems, you must not take PANTOPRAZOLO DOC 40 mg for the eradication of Helicobacter pylori.

Patients with liver problems
If you have severe liver problems, you must not take more than one 20 mg pantoprazole tablet per day (tablets containing 20 mg of pantoprazole are available for this purpose).
If you have severe or moderate liver problems, you must not take PANTOPRAZOLO DOC 40 mg for the eradication of Helicobacter pylori.

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

If you take more PANTOPRAZOLO DOC 40 mg than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.

If you forget to take PANTOPRAZOLO DOC 40 mg
Do not take a double dose to make up for the missed dose. Take your next dose at the scheduled time.

If you stop taking PANTOPRAZOLO DOC 40 mg
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of the possible adverse reactions listed below is defined using the following convention:
very common (may affect more than 1 in 10 people)
common (may affect up to 1 in 10 people)
uncommon (may affect up to 1 in 100 people)
rare (may affect up to 1 in 1,000 people)
very rare (may affect up to 1 in 10,000 people)
not known (frequency cannot be estimated from the available data)

If you experience any of the following adverse reactions, stop treatment with these tablets immediately and
contact your doctor or go to the nearest hospital emergency department:

• Severe allergic reactions (frequency: rare – may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Serious skin disorders (frequency: not known – frequency cannot be estimated from the available data): development of skin blisters and rapid deterioration of general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g., under the arm), and blood tests may show abnormalities in white blood cell count or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).
• Other serious conditions (frequency: not known – frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, rash, and kidney enlargement sometimes with pain during urination or in the lower back (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions include:

• Common (may affect up to 1 in 10 people): Benign gastric polyps.
• Uncommon (may affect up to 1 in 100 people): Headache; dizziness; diarrhoea; nausea, vomiting; 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, hip, wrist or spinal fractures.
• Rare (may affect up to 1 in 1,000 people): Altered or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever, swelling of extremities (peripheral oedema); allergic reactions; depression, breast enlargement in men.
• Very rare (may affect up to 1 in 10,000 people): Disorientation.
• Not known (frequency cannot be estimated from the available data):
  Hallucinations, confusion (especially in patients with prior history of such symptoms), tingling, burning or numbness sensations, pins and needles, erythema, possible joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions identified through blood tests:

• Uncommon (may affect up to 1 in 100 people): Increased liver enzymes.
• Rare (may affect up to 1 in 1,000 people): Increased bilirubin; increased blood lipid levels; a drastic reduction in circulating granulocytes, associated with high fever.
• Very rare (may affect up to 1 in 10,000 people): Decrease in platelet count, which may cause increased bleeding or bruising; decrease in white blood cell count, which may lead to more frequent infections; concurrent abnormal reduction in red blood cells, white blood cells, and platelets.

Not known (frequency cannot be estimated from the available data)
Decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, tell your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PANTOPRAZOLE DOC 40 MG

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

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What PANTOPRAZOLO DOC 40 mg contains
The active substance is: pantoprazole.
Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium pantoprazole
sesquihydrate).
The other components are:
Tablet core
Maltitol (E 965), crospovidone type B, sodium carmellose, anhydrous sodium carbonate (E 500), calcium stearate
Tablet coating
Polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), macrogol 3350, soybean lecithin, yellow iron oxide
(E 172), anhydrous sodium carbonate (E 500), methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E
1505)
Description of the appearance of PANTOPRAZOLO DOC 40 mg and contents of the pack:
The gastro-resistant tablets of PANTOPRAZOLO DOC 40 mg are oval and yellow. PANTOPRAZOLO
DOC 40 mg is available in packs of 14, 28 or 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy
Responsible manufacturers for batch release
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A. - Via Grignano, 43 - 24041 Brembate (BG) - Italy
Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino - S.S. 16 Zona Industriale - 73010 Zollino
(LE) - Italy
This leaflet was last updated in January