PANTOPRAZOLO 20 mg Enteric-Coated Tablet

Зміст інструкції

1. Pantoprazolo TecniGen Italia 20 mg gastro-resistant tablets
   1. What is Pantoprazolo TecniGen Italia and what is it used for
   2. What you need to know before taking Pantoprazolo TecniGen
2. Pantoprazolo TecniGen Italia because it presents an increased risk of developing
   1. How to take Pantoprazolo TecniGen Italia
   2. Possible side effects
   3. How to store Pantoprazolo TecniGen Italia
   4. Package Contents and Other Information
   5. What is Pantoprazolo TecniGen Italia and what it is used for
   6. What you need to know before taking Pantoprazolo TecniGen Italia
   7. How to take Pantoprazolo TecniGen Italia
   8. Possible side effects
   9. How to store Pantoprazolo TecniGen Italia
   10. Package Contents and Other Information

Pantoprazolo TecniGen Italia 20 mg gastro-resistant tablets

Generic medicine

Read this leaflet carefully before taking this medicine because it containsimportant information for you.

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

Contents of this leaflet:

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

1. What is Pantoprazolo TecniGen Italia and what is it used for

Pantoprazolo TecniGen Italia 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.

Adults and adolescents 12 years and over

• Symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.
• Long-term treatment of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach) and prevention of its recurrence.

Adults

• Prevention of duodenal and stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who require continuous treatment with NSAIDs.

2. What you need to know before taking Pantoprazolo TecniGen

Italy
Do not take Pantoprazolo TecniGen Italy

• If you are allergic to pantoprazole 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, pharmacist or nurse before taking Pantoprazolo TecniGen
Italy

• If you have severe liver problems. Tell your doctor if you have ever had liver problems. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking Pantoprazolo TecniGen Italy for long-term therapy. In case of

an increase in liver enzymes, treatment should be discontinued.

• If you need continuous treatment with medicines called NSAIDs and are taking

Pantoprazolo TecniGen Italia because it presents an increased risk of developing

gastric and intestinal complications. Every increased risk will be evaluated based on your personal risk factors such as age (65 years and over), a history 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 pantoprazolo. As with all agents that reduce acidity, pantoprazolo can lead to reduced absorption of vitamin B12.
• If you are simultaneously taking a medicine containing atazanavir (for the treatment of HIV infection) or methotrexate, ask your doctor for specific advice.
• If you have been taking pantoprazolo for more than 3 months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform blood tests regularly to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazolo TecniGen Italia that reduces gastric acidity.
• If you are to undergo a specific blood test (Chromogranin A).

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 interrupt therapy with Pantoprazolo TecniGen Italia. Remember to also report any other undesirable effects such as joint pain.

Immediately inform your doctorif you notice any of the following symptoms,

• unintentional weight loss
• vomiting, especially if repeated
• presence of blood in the vomit;
• appearance of blood in the stool
• difficulty swallowing
• you appear pale and feel weak (anemia)
• severe and/or persistent diarrhea, as this medicine has been associated with a modest increase in infectious diarrhea.

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

Other medicines and Pantoprazolo TecniGen Italia
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicine.

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer) because Pantoprazolo TecniGen Italia may prevent these and other medicines from working properly.
• Warfarin and phenprocoumone, which affect blood thickening or dilution. You may need further checks.
• Atazanavir (used to treat HIV infection)
• Methotrexate

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

Driving and using machines
If you experience undesirable effects such as dizziness or visual disturbances, you should not drive or use machinery.

3. How to take Pantoprazolo TecniGen Italia

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

Adults and adolescents 12 years and over

• For the treatment of symptoms associated with gastroesophageal reflux disease (e.g.heartburn, acid regurgitation, pain when swallowing)The usual dose is one tablet a day. This dose normally provides relief in 2 - 4 weeks
• at most after another 4 weeks. Your doctor will tell you how long to continue taking the medicine. After this, each recurrence of symptoms can be controlled by takingone tablet a day, as needed.
• For long-term treatment and for the prevention of recurrent reflux esophagitisThe recommended dose is one tablet a day. If the disease recurs, your doctor may double the dose, in which case you can instead use Pantoprazolo TecniGen Italia 40 mg tablets, one a day. After healing, the dose can be reduced back to one 20 mg tablet a day.

Adults

• For the prevention of duodenal and gastric ulcers in patients who requirecontinuous treatment with NSAIDsThe usual dose is one tablet a day.

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

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

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

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

If you forget to take Pantoprazolo TecniGen Italia
Do not take a double dose to make up for a missed dose. Take the normal
dose at the scheduled time.

If you stop taking Pantoprazolo TecniGen Italia
Do not stop treatment with these tablets without first consulting your doctor
or pharmacist.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

If you experience any of the following side effects, stop treatment with these
tablets andconsult your doctor immediately, or contact the nearest hospital emergency room:

• Severe allergic reactions (rare):swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic facial swelling (angioedema/Quincke's edema), severe dizziness with a very fast heartbeat and profuse sweating.
• Severe skin conditions (frequency not known):appearance of skin blisters and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, Multiforme erythema), and sensitivity to light.
• Other severe conditions (frequency not known):yellowing of the skin or the white part of the eyes (severe damage to liver cells, jaundice) or fever, rash, and enlargement of the kidneys sometimes with pain when urinating, and pain in the lower back (severe inflammation of the kidneys).

Other side effects are:

• Common(may affect up to 1 in 10 people) Benign polyps in the stomach.
• Uncommon(may affect up to 1 in 100 people) Headache; dizziness; diarrhea; nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; rash, exanthema, eruption; itching; feeling of weakness, fatigue or general malaise; sleep disturbances. If you are taking a proton pump inhibitor such as Pantoprazolo TecniGen Italia, especially for a period longer than one year, there may be a slight increase in the risk of hip, wrist or vertebral fractures. If you suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis) consult your doctor.
• Rare(may affect up to 1 in 1,000 people) Alteration 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, increased breast volume in

men.

• Very Rare(may affect up to 1 in 10,000) Disorientation.

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100 people) an increase in liver enzymes.
• Rare(may affect up to 1 in 1,000 people) an increase in bilirubin; increased levels of fats in the blood; drastic decrease in circulating granulocytes, associated with high fever.
• Very Rare(may affect up to 1 in 10,000 people) a reduction in the number of platelets, which may cause more bleeding or bruising than normal; a reduction in the number of white blood cells, which may lead to more frequent infections; concurrent abnormal reduction in the number of red blood cells, white blood cells, and platelets.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Pantoprazolo TecniGen Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the package and on the
container after Exp.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C
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. Package Contents and Other Information

informationWhat Pantoprazolo
TecniGen Italia contains
Pantoprazolo TecniGen Italia is available as gastro-resistant tablets.

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients are: Core: Anhydrous sodium carbonate, Mannitol, Microcrystalline cellulose, Pregelatinized maize starch, Sodium starch glycolate (Type A), Calcium stearate Coating: Hypromellose, Propylene glycol, Titanium dioxide (E171) Yellow iron oxide (E172) Gastro-resistant coating: Ethyl acrylate-methacrylic acid copolymer, Polysorbate 80 Sodium Lauryl Sulfate, Triethyl citrate

Description of the appearance of Pantoprazolo TecniGen Italia and contents of the pack
Pantoprazolo TecniGen Italia are gastro-resistant tablets. They are pale yellow to
yellowish, oblong and convex tablets.
Pantoprazolo TecniGen Italia is available in packs of 14 and 28 tablets.

Marketing Authorisation Holder

AIC Holder:
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)

Manufacturer:
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal

This medicinal product is authorised in the Member States of the European Economic Area with
thefollowing denominations:
Member State Name Medicinal Product Name
Italy Pantoprazolo TecniGen Italia
Portugal Pantoprazol Pentafarma Genéricos

Pantoprazolo TecniGen Italia 40 mg gastro-resistant tablets
Generic medicine

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

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

Contents of this leaflet:

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

1. What is Pantoprazolo TecniGen Italia and what it is used for

Pantoprazolo TecniGen Italia is a selective “proton pump inhibitor”, a medicine that
reduces the amount of acid produced in the stomach. It is used for the treatment of acid-related diseases
of the stomach and intestine.
Pantoprazolo TecniGen Italia is used for the treatment

Adults and adolescents 12 years and over

• Reflux esophagitis. Inflammation of the esophagus (the tube connecting the throat to the stomach) accompanied by acid regurgitation. Adults
• An infection with a bacterium called Helicobacter pyloriin patients with duodenal ulcer and gastric ulcer in combination with two antibiotics (eradication therapy). The purpose is to get rid of the bacteria in order to reduce the possibility 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 Pantoprazolo TecniGen Italia

Do not take Pantoprazolo TecniGen Italia

• If you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing other proton pump inhibitors. Warnings and precautionsTalk to your doctor, pharmacist or nurse before taking Pantoprazolo TecniGen Italia
• If you have severe liver problems. Tell your doctor if you have ever had liver problems in the past. The doctor will arrange for more frequent monitoring of your liver enzymes,

especially if you are taking Pantoprazolo TecniGen Italia for long-term therapy.
In case of increased liver enzymes, treatment should be discontinued.

• If you have reduced body stores or risk factors for reduced vitamin B12 and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole can lead to reduced absorption of vitamin B12.
• If you are taking atazanavir (for the treatment of HIV infection) or high-dose methotrexate at the same time as pantoprazole, ask your doctor for specific advice.
• If you have been taking pantoprazole for more than 3 months, it is possible that magnesium levels in the blood may decrease. Low levels of magnesium can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low levels of magnesium can also cause a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
• if you have ever had a skin reaction after treatment with a medicine similar to Pantoprazolo TecniGen Italia that reduces gastric acid
• If you are to undergo a specific blood test (Chromogranin A).

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, see your
doctor as soon as possible, as it may be necessary to stop therapy with Pantoprazolo
TecniGen Italia. Remember to also report any other undesirable effects such as joint pain.

Tell your doctor immediatelyif you notice any of the following symptoms

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

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

Other medicines and Pantoprazolo TecniGen Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicine

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because Pantoprazolo TecniGen Italia may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood clotting or thinning. You may need further checks
• Atazanavir (used to treat HIV infection)
• Methotrexate.

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

Driving and using machines
If you experience side effects such as dizziness or visual disturbances, you should not drive or use
machinery.

3. How to take Pantoprazolo TecniGen Italia

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Adults and adolescents 12 years and over

• For the treatment of reflux esophagitisThe 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 called Helicobacter pylori in patients with duodenal ulcer and gastric ulcer in combination with two antibiotics (Eradication therapy)One tablet, twice a day plus two tablets of an antibiotic between amoxicillin, clarithromycin and metronidazole (or tinidazole), each taken twice a day with the pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before the evening meal. Follow the

usual treatment period is one or two weeks.

• For the treatment of gastric and duodenal ulcersThe usual dose is one tablet a day. After consulting your doctor, the dose may be doubled. Your doctor will tell you how long to take the medicine. The treatment period for gastric ulcers is 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 stomachThe recommended initial dose is usually two tablets a day. Take the two tablets 1 hour before a meal. The doctor may subsequently adjust the dosage, depending on the amount of gastric acid produced. If more than two tablets are prescribed per day, the tablets must be taken twice a day. If the doctor prescribes a daily dosage of more than four tablets a day, you will be told exactly when to stop taking the medicine.

Special populations
If you have kidney problems, moderate to severe liver problems, you should not take Pantoprazolo
TecniGen Italia 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 (tablets containing 20 mg of
pantoprazole are available for this purpose).

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

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

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

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

If you stop taking Pantoprazolo TecniGen Italia
Do not stop treatment with these tablets without first consulting your doctor or
pharmacist.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop treatment with these
tablets andconsult your doctor immediately, or contact the nearest hospital emergency room:

• Severe allergic reactions (rare):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.
• Severe skin conditions (frequency not known):appearance of skin blisters and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson Syndrome, Lyell's Syndrome, Multiforme Erythema), and sensitivity to light.
• Other severe conditions (frequency not known):yellowing of the skin or the white part of the eyes (severe liver cell damage, jaundice) or fever, rash, and enlargement of the kidneys sometimes with pain when urinating, and lower back pain (severe kidney inflammation).

Other side effects are:

• Common(may affect up to 1 in 10 people) Benign polyps in the stomach.
• Uncommon(may affect up to 1 in 100 people) Headache; dizziness; diarrhea; nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; rash; eruption, rash; itching; feeling weak, tired or generally unwell; sleep disturbances. If you are taking a proton pump inhibitor such as Pantoprazole

TecniGen Italia, especially for a period longer than one year, a slight increase in the risk of hip, wrist or vertebral fractures may occur. If you suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis) consult your doctor.

• Rare(may affect up to 1 in 1,000 people) Alteration or complete loss of taste; vision 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; increased breast volume in men.
• Very Rare(may affect up to 1 in 10,000) Disorientation.

• Not known(frequency cannot be estimated from available data) Hallucinations, confusion (especially in patients with a history of these symptoms); decreased sodium levels in the blood; tingling, prickling, pins and needles, burning sensation or numbness; inflammation of the large intestine, causing persistent watery diarrhea; erythema, possible joint pain.

If you take Pantoprazolo TecniGen Italia 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, seizures, dizziness, increased
heart rate. If you have any of these symptoms, consult your doctor immediately. Low
levels of magnesium can also lead to a decrease in blood levels of potassium or calcium.
The doctor should decide whether to periodically check magnesium levels in the blood (see
paragraph 2).

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100) an increase in liver enzymes.
• Rare(may affect up to 1 in 1,000) an increase in bilirubin; increased levels of fats in the blood; drastic decrease in circulating granulocytes, associated with high fever.
• Very Rare(may affect up to 1 in 10,000) a reduction in the number of platelets, which may cause more bleeding or bruising than normal; a reduction in the number of white blood cells, which may lead to more frequent infections; coexisting abnormal reduction in the number of red blood cells and white blood cells, as well as platelets.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects
you can help provide more information on the safety of this medicine.

5. How to store Pantoprazolo TecniGen Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the package and on the container
after Exp.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C
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. Package Contents and Other Information

What Pantoprazolo TecniGen Italia contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients are:
• Core: Anhydrous sodium carbonate, Mannitol, Microcrystalline cellulose, Pregelatinized maize starch, Sodium starch glycolate (Type A), Calcium stearate
• Film coating: Hypromellose, Propylene glycol, Titanium dioxide (E171) Yellow iron oxide (E172)
• Gastro-resistant coating: Methacrylic acid - ethyl acrylate copolymer, Polysorbate 80
• Sodium Lauryl Sulfate, Triethyl citrate

Description of the appearance of Pantoprazolo TecniGen Italia and contents of the pack
Pantoprazolo TecniGen Italia are gastro-resistant tablets. They are pale yellow to
yellowish, oblong and convex tablets.
Pantoprazolo TecniGen Italia is available in packs of 14 and 28 tablets.

Marketing Authorisation Holder

AIC Holder:
Tecnigen S.r,l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)

Manufacturer:
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Member StateMedicinal Product Name
Italy Pantoprazolo TecniGen Italia
Portugal Pantoprazol Pentafarma Genéricos