Pantoprazole Tecnigen Italia: detailed information

Package leaflet: Information for the user

Pantoprazole TecniGen Italia 20 mg gastro-resistant tablets

Generic medicine
Read this entire 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, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Pantoprazole TecniGen Italia is and what it is used for
What you need to know before taking Pantoprazole TecniGen Italia
How to take Pantoprazole TecniGen Italia
Possible side effects
How to store Pantoprazole TecniGen Italia
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 intestine.
Adults and adolescents aged 12 years and older

Symptoms (e.g., heartburn, acid regurgitation, pain when swallowing) associated with gastroesophageal reflux disease caused by reflux of acid 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 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 to any of the other ingredients of this medicine (listed in section 6).
If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Pantoprazolo TecniGen Italy

If you have severe liver problems. Inform 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 treatment. If

liver enzymes increase, treatment must be discontinued.

If you require ongoing treatment with medicines called NSAIDs and are taking Pantoprazolo TecniGen Italy because you are at increased risk of developing gastric and intestinal complications. Any increased risk will be assessed based on your personal risk factors such as age (65 years and older), history of gastric or duodenal ulcers, or history of gastrointestinal bleeding.
If you have low body reserves or risk factors for low vitamin B12 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 at the same time a medicine containing atazanavir (for the treatment of HIV infection) or methotrexate, ask your doctor for specific advice.
If you have been taking pantoprazole for more than 3 months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also cause reduced levels of potassium or calcium 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 Italy that reduces gastric acidity.
If you are scheduled 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 discontinue treatment with
Pantoprazolo TecniGen Italy. Remember to also report any other adverse effects such as
joint pain.
Contact your doctor immediately if you notice any of the following symptoms:

unintentional weight loss
vomiting, particularly if repeated
presence of blood in vomit
appearance of blood in stools
difficulty swallowing
you appear pale and feel weak (anemia)
severe and/or persistent diarrhoea, as this medicine has been associated with a slight increase in infectious diarrhoea.

Your doctor may decide that you need certain tests to rule out malignancy, as pantoprazole can also relieve symptoms of cancer and could therefore delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you take Pantoprazolo TecniGen Italy for long-term treatment (over 1 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 Pantoprazolo TecniGen Italy
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

Pregnancy, breastfeeding, and fertility
There are inadequate 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, are planning a pregnancy, 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 greater than the potential risk to the fetus or infant.
Driving and use of machines
If you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.

3. How to take Pantoprazolo TecniGen Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents aged 12 years 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 daily. This dose usually provides relief within 2 - 4 weeks, and at most within a further 4 weeks. Your doctor will advise you on how long to continue taking the medicine. After this, any recurrence of symptoms can be managed by taking one tablet daily, as needed.
For long-term treatment and prevention of recurrence of reflux esophagitis The recommended dose is one tablet daily. If the disease recurs, your doctor may double the dose; in this case, you may instead use Pantoprazolo TecniGen Italia 40 mg tablets, one tablet daily. After healing, the dose may be reduced back to one 20 mg tablet daily.

Adults

For prevention of duodenal and gastric ulcers in patients requiring continuous treatment with NSAIDs The usual dose is one tablet daily.

Special populations
If you have severe liver problems, you must not take more than one 20 mg tablet daily.
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. Do not chew or crush the tablets; swallow them whole with some water.
If you take more Pantoprazolo TecniGen Italia than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantoprazolo TecniGen Italia
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 TecniGen Italia
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's oedema / angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
Serious skin disorders (frequency not known): development of skin blisters and rapid deterioration of your general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson Syndrome, Lyell's Syndrome, Erythema multiforme), and sensitivity to light.
Other serious disorders (frequency not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, skin rash, and kidney enlargement sometimes accompanied by painful urination and lower back pain (severe kidney inflammation).

Other side effects 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; 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 Pantoprazole TecniGen Italia, 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 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): 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 the 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 available data): hallucinations, confusion (especially in patients with a history of these symptoms); decreased blood sodium levels; sensations of tingling, pins and needles, burning, or numbness; inflammation of the large intestine causing persistent watery diarrhoea; erythema, possible joint pain. If you take Pantoprazole TecniGen Italia for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as tiredness, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to reduced blood potassium or calcium levels. Your doctor should decide whether to periodically monitor your blood magnesium levels (see section 2).

Side effects 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 sharp 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 increased bleeding or bruising; reduced white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red and white blood cells as well as platelets.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website:
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 Pantoprazole 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 box and container after Exp.
The expiry date refers to the last day of that month.
Do not store above 25 °C.
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. Package contents and other information

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

The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
The other components are:
Core: Anhydrous sodium carbonate, Mannitol, Microcrystalline cellulose, Pregelatinized maize starch, Sodium starch glycolate (Type A), Calcium stearate
Isolation film: Hypromellose, Propylene glycol, Titanium dioxide (E171), Iron oxide yellow (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 package
Pantoprazolo TecniGen Italia are gastro-resistant tablets. They are pale yellow to yellowish, oblong, convex tablets.
Pantoprazolo TecniGen Italia is available in packs containing 14 or 28 tablets.

Marketing Authorization Holder
Marketing Authorization Holder (A.I.C.):
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

| Member State | Name of the medicinal product | |--------------|-------------------------------| | Italy | Pantoprazolo TecniGen Italia | | Portugal | Pantoprazol Pentafarma Genéricos |

Package leaflet: Information for the user

Pantoprazole TecniGen Italia 40 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Pantoprazole TecniGen Italia is and what it is used for
What you need to know before taking Pantoprazole TecniGen Italia
How to take Pantoprazole TecniGen Italia
Possible side effects
How to store Pantoprazole TecniGen Italia
Contents of the pack and other information

1. What Pantoprazolo TecniGen Italia is 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 of
Adults and adolescents aged 12 years and older

Reflux esophagitis. An inflammation of the esophagus (the tube connecting the throat to the stomach) associated with regurgitation of gastric acid. 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 bacteria in order to reduce the likelihood of these ulcers recurring.
Stomach and duodenal ulcers.
Zollinger-Ellison syndrome and other conditions in which excessive 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 precautions Talk to your doctor, pharmacist, or nurse before taking Pantoprazolo TecniGen Italia
If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor will arrange for more frequent monitoring of your liver enzymes,

especially if you are taking Pantoprazolo TecniGen Italia for long-term
treatment. If your liver enzymes increase, treatment must be discontinued.

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 at the same time as pantoprazole a medicine containing atazanavir (for the treatment of HIV infection), or high-dose methotrexate, consult your doctor for specific advice.
If you have been taking pantoprazole for more than 3 months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also cause reduced levels of potassium or calcium 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 acidity
If you are scheduled for 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 discontinue treatment with Pantoprazolo
TecniGen Italia. Remember to also report any other adverse effects such as joint pain.
Contact your doctor immediately if you notice any of the following symptoms

unintentional weight loss
vomiting, particularly if repeated
presence of blood in vomit
appearance of blood in stools
difficulty swallowing
you appear pale and feel weak (anaemia)
severe and/or persistent diarrhoea, as this medicine has been associated with a slight increase in infectious diarrhoea.

Your doctor may decide that you need certain tests to rule out malignancy,
since pantoprazole can also relieve symptoms of cancer and could lead to 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 (longer than 1 year), your
doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances each time 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), since Pantoprazolo TecniGen Italia may prevent these and other medicines from working properly.
Warfarin and fenprocoumon, which affect blood clotting or thinning. You may need additional monitoring
Atazanavir (used to treat HIV infection)
Methotrexate.

Pregnancy, breastfeeding and fertility
There are insufficient data on the use of pantoprazole in pregnant women. Excretion into 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 greater than the potential risk to the foetus or 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 Pantoprazolo TecniGen Italia

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Adults and adolescents aged 12 years and older

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 twice daily, plus two tablets of an antibiotic—either amoxicillin, clarithromycin, or metronidazole (or tinidazole)—each taken twice daily together 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 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 in which too much acid is produced in the stomach
The recommended initial dose is usually two tablets daily. Take the two tablets 1 hour before a meal. Your doctor may subsequently adjust the dosage depending on the amount of gastric acid produced. If more than two tablets daily are prescribed, the tablets should be taken in two divided doses. If your doctor prescribes a daily dosage exceeding four tablets, you will be given specific instructions on when to stop taking the medicine.

Special populations
If you have renal problems or moderate to severe hepatic impairment, you must not take Pantoprazolo TecniGen Italia for Helicobacter pylori eradication.
If you have severe hepatic impairment, you must not take more than one 20 mg pantoprazole tablet per day (for this purpose, tablets containing 20 mg of pantoprazolo are available).

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, swallowing them whole with some water.

If you take more Pantoprazolo TecniGen Italia than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.

If you forget to take Pantoprazolo TecniGen Italia
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 treatment with Pantoprazolo TecniGen Italia
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, 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 taking this medicine immediately and
contact your doctor or go to the nearest hospital emergency department:

Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's oedema / angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
Serious skin disorders (frequency not known): appearance of skin blisters and rapid deterioration of your general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson Syndrome, Lyell's Syndrome, Erythema multiforme), and sensitivity to light.
Other serious disorders (frequency not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, skin rash, and swollen kidneys sometimes with pain on urination, and lower back pain (severe kidney inflammation).

Other side effects 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; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash; exanthema, eruption; itching; feeling of weakness, fatigue or general malaise; sleep disturbances. If you are taking a proton pump inhibitor such as Pantoprazole TecniGen Italia, especially 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.
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 a history of these symptoms); decreased blood sodium levels; sensations of tingling, pins and needles, burning or numbness; inflammation of the large intestine causing persistent watery diarrhoea; erythema, possible joint pain.

If you take Pantoprazole TecniGen Italia for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether to periodically monitor your blood magnesium levels (see section 2).

Side effects 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 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 increased bleeding or bruising; reduced white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red and white blood cells as well as platelets.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the website 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 Pantoprazole TecniGen Italia

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 container after Exp.
The expiry date refers to the last day of that month.
Do not store above 25 °C.
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 Pantoprazolo TecniGen Italia contains

The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
The other components are:
Core: Anhydrous sodium carbonate, Mannitol, Microcrystalline cellulose, Pregelatinized corn starch, Sodium starch glycolate (Type A), Calcium stearate
Isolation 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 pack contents
Pantoprazolo TecniGen Italia are gastro-resistant tablets. They are pale yellow to yellowish, oblong, convex tablets.
Pantoprazolo TecniGen Italia is available in packs of 14 and 28 tablets.
Marketing Authorization Holder
Marketing Authorization 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 authorized in the European Economic Area countries under the
following names:
Member State Medicinal product name
Italy Pantoprazolo TecniGen Italia
Portugal Pantoprazol Pentafarma Genéricos