Prinzol

Package leaflet: Information for the patient

PRINZOL 20 mg gastro-resistant tablets

pantoprazole
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 other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PRINZOL is and what it is used for

PRINZOL 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.
PRINZOL is used for:
Adults and adolescents aged 12 years and older:

• Treatment of 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 oesophagus accompanied by acid regurgitation 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 treatment with NSAIDs.

2. What you need to know before taking PRINZOL

Do not take PRINZOL

• 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 PRINZOL.

• 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 PRINZOL for long-term treatment. If your liver enzymes increase, treatment must be discontinued.
• If you require ongoing treatment with NSAIDs and are taking PRINZOL because you are at increased risk of developing gastric or 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. Consult your doctor if you experience any of the following symptoms, which may indicate low vitamin B12 levels:
  • extreme tiredness or lack of energy
  • tingling and numbness
  • red or sore tongue, mouth ulcers
  • muscle weakness
  • vision disturbances
  • memory problems, confusion, depression.
• If you are taking a medicine containing atazanavir (for the treatment of HIV infection) at the same time as pantoprazole, ask your doctor for specific advice.
• Taking a proton pump inhibitor such as PRINZOL, particularly for more than one year, may slightly increase your risk of hip, wrist, or spine fracture. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• If you have been taking PRINZOL for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, 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 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 PRINZOL that reduces stomach acidity.
• If you need to undergo a specific blood test (Chromogranin A).
• 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 PRINZOL therapy. Remember to also report any other adverse effects such as joint pain.
• Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme have been reported in association with pantoprazole treatment. Stop using pantoprazole and contact your doctor immediately if you notice any symptoms related to these serious skin reactions, described in section 4.

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

• unintentional weight loss
• recurrent vomiting
• difficulty swallowing or painful swallowing
• presence of blood in vomit, which may appear as dark coffee-ground-like material
• you look pale and feel weak (anemia)
• chest pain
• stomach pain
• presence of blood in stools, which may appear dark or tarry
• severe and/or persistent diarrhea, as PRINZOL has been associated with a slight increase in infectious diarrhea episodes.

Your doctor may decide that you need certain tests to rule out malignancy, since pantoprazole may also relieve symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you are taking PRINZOL for long-term treatment (more than 1 year), your doctor will likely schedule regular check-ups. You must report any new or unusual symptoms or circumstances whenever you see your doctor.
Children and adolescents
The use of PRINZOL is not recommended in children, as its efficacy has not been demonstrated in children under 12 years of age.
Other medicines and PRINZOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription. This is particularly important if you are taking any of the following medicines:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as PRINZOL may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring.
• Atazanavir (used to treat HIV infection).
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily suspend treatment with PRINZOL because pantoprazole 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 its dose.
• Rifampicin (used to treat infections).
• St. John’s wort (Hypericum perforatum) (used to treat mild depression).

Talk to your doctor before taking pantoprazole if you are scheduled for a specific urine test (for THC; tetrahydrocannabinol).
Pregnancy, breastfeeding, and fertility
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, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, you should use this medicine only if your doctor considers the benefit to you greater than the potential risk to the fetus or child.
Driving and using machines
PRINZOL does not affect or has a negligible effect on the ability to drive and use machines. However, if you experience adverse effects such as dizziness or vision disturbances, you should not drive or operate machinery.
PRINZOL contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per gastroresistant tablet, i.e., essentially ‘sodium-free’.

3. How to take PRINZOL

Take this medicine exactly as instructed 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 a little water.
Unless otherwise instructed by your doctor, the recommended dose is:
Adults and adolescents aged 12 years and older:
For the treatment of symptoms associated with gastro-oesophageal reflux disease (e.g. heartburn,
acid regurgitation, pain when swallowing)
The usual dose is 1 tablet per day. This dose usually provides relief within 2–4 weeks – at most within a further 4 weeks. Your doctor will advise you on how long to continue taking the medicine. After that, any recurrence of symptoms can be managed by taking 1 tablet per day, as needed.
For long-term treatment and prevention of recurrence of reflux oesophagitis
The usual dose is 1 tablet per day. If the disease recurs, your doctor may double the dose, in which case you may take PRINZOL 40 mg tablets, one tablet per day. After healing, the dose may be reduced back to one 20 mg tablet per day.
Adults:
Prevention of duodenal and gastric ulcers in patients requiring continuous treatment with NSAIDs
The usual dose is 1 tablet per day.
Patients with liver problems
If you have severe liver problems, you must not take more than one 20 mg tablet per day.
Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.
If you take more PRINZOL than you should
Inform your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take PRINZOL
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 PRINZOL
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 or pharmacist.

4. Possible side effects

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

• Severe allergic reactions (uncommon frequency; 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): 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.
• Flat, non-elevated red spots, circular or target-shaped, on the trunk, often with blisters in the center, skin peeling, ulcers in mouth, throat, nose, genitals and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other serious disorders (frequency not known: frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash and kidney enlargement sometimes painful, with painful urination and back pain (severe kidney inflammation), which may lead to possible kidney failure.

Other possible side effects are:

• 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 disorders; fracture of the hip, wrist or spine
• Rare (may affect up to 1 in 1,000 people): distortion 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 the available data): hallucinations, confusion (especially in patients with prior experience of these symptoms); tingling sensation, pins and needles, burning or numbness, erythema, possible joint pain. Inflammation of the large intestine, causing persistent watery diarrhoea.

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 lipids; sudden drop in circulating granular white blood cells 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.
• Not known (frequency cannot be estimated from the available data): decreased sodium levels in the blood, decreased magnesium levels in the blood, decreased calcium levels in the blood, and decreased potassium levels in the blood (see section 2).

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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, 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. Package contents and other information

What PRINZOL contains

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other components are: Tablet core: mannitol, anhydrous sodium carbonate, sodium starch glycolate (type A), basic butyl methacrylate copolymer (Eudragit E PO), calcium stearate. Coating: Opadry white OY-D-7233 (hypromellose, titanium dioxide E171, talc, macrogol 400, sodium lauryl sulfate). Enteric coating: Kollicoat MAE 30 DP yellow (methacrylic acid-ethyl acrylate copolymer dispersion, propylene glycol, yellow iron oxide (E172), titanium dioxide E171, talc).

Description of the appearance of PRINZOL and packaging contents
Gastro-resistant tablet, light yellow in colour, elliptical, biconvex.
Packaging:
Blister: 14 tablets.
28 tablets

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. Group S.r.l.
Via Tiburtina, 1143
00156 Rome
Italy

Manufacturers
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Balkanpharma – Dupnitsa AD
3 Samokovsko Schosse Str.
Dupnitsa 2600
Bulgaria

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

Patient information leaflet

PRINZOL 40 mg gastro-resistant tablets

pantoprazole
Equivalent 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 their symptoms are the same as yours, as 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:

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

1. What PRINZOL is and what it is used for

PRINZOL 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.
PRINZOL is used for:
Adults and adolescents aged 12 years and older:

• Gastroesophageal reflux disease (GORD). Inflammation of the oesophagus (the tube connecting the throat to the stomach), accompanied by regurgitation of gastric acid.

Adults:

• Infection caused by a bacterium called Helicobacter pylori in patients with duodenal ulcer and gastric ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacteria in order to reduce the risk of recurrence of these ulcers.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before taking PRINZOL

Do not take PRINZOL

• 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 PRINZOL.

• If you have severe liver problems. Inform your doctor if you have previously had liver problems. Your doctor may arrange for more frequent monitoring of your liver enzymes, especially if you are taking PRINZOL for long-term treatment. If your liver enzymes increase, treatment should be stopped.
• 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. Consult your doctor if you experience any of the following symptoms, which may indicate low vitamin B12 levels:
• extreme tiredness or lack of energy
• tingling and numbness
• red or sore tongue, mouth ulcers
• muscle weakness
• vision disturbances
• memory problems, confusion, depression.
• If you are taking a medicine containing atazanavir (for the treatment of HIV infection) at the same time as pantoprazole, ask your doctor for specific advice.
• Taking a proton pump inhibitor such as PRINZOL, particularly for more than one year, may slightly increase your risk of fracture of the hip, wrist or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• If you need to undergo a specific blood test (chromogranin A).
• If you have been taking PRINZOL for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, 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 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 PRINZOL 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 PRINZOL therapy. Remember to also report any other adverse effects such as joint pain.
• Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme have been reported in association with pantoprazole treatment. Stop using pantoprazole and contact your doctor immediately if you notice any symptoms related to these serious skin reactions, described in section 4.

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

• unintentional weight loss
• recurrent vomiting
• difficulty swallowing or pain when swallowing
• presence of blood in vomit, which may appear as dark coffee-ground-like material
• paleness and weakness (anaemia)
• presence of blood in stools, which may appear dark or tarry
• severe and/or persistent diarrhoea, as PRINZOL has been associated with a slight increase in infectious diarrhoea episodes
• chest pain
• stomach pain

Your doctor may decide that you need certain tests to rule out malignancy, since pantoprazole can relieve symptoms of cancer and may delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you take PRINZOL for long-term treatment (more than 1 year), your doctor will likely schedule regular check-ups. You must report any new or unusual symptoms or circumstances whenever you see your doctor.
Children and adolescents
The use of PRINZOL is not recommended in children, as efficacy has not been demonstrated in children under 12 years of age.
Other medicines and PRINZOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription. This is particularly important if you are taking any of the following medicines:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as PRINZOL 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 (used to treat rheumatoid arthritis, psoriasis and cancer) – if you are taking methotrexate, your doctor may temporarily discontinue PRINZOL treatment, as pantoprazole 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).

Consult your doctor before taking pantoprazole if you are scheduled for a specific urine test (for THC; tetrahydrocannabinol).
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, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, you should use this medicine only if your doctor considers the benefit to you to outweigh the potential risk to the fetus or child.
Driving and using machines
PRINZOL does not affect or affects negligibly the ability to drive or use machines. However, if you experience adverse effects such as dizziness or vision disturbances, you should not drive or use machinery.
PRINZOL contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per gastro-resistant tablet, i.e. essentially ‘sodium-free’.

3. How to take PRINZOL

Always take this medicine exactly as your doctor has told you. If you are unsure, 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 a little water.
Unless otherwise instructed by your doctor, the recommended dose is:
Adults and adolescents aged 12 years and over:
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 an 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—amoxicillin or clarithromycin and metronidazole (or tinidazole)—each to be taken twice daily together with the pantoprazole tablet. Take the first pantoprazole tablet in the morning, one hour before breakfast, and the second one 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 ranges from 4 to 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
stomach acid is produced
The recommended initial dose is usually two tablets daily.
Take both tablets one hour before a meal. Subsequently, your doctor may adjust the dosage depending on the amount of gastric acid produced. If more than two tablets per day are prescribed, the tablets should be taken twice daily.
If your doctor prescribes a daily dosage of more than four tablets, you will be given specific instructions on when to stop taking the medicine.
Patients with kidney problems
If you have renal impairment, you must not take PRINZOL for Helicobacter pylori eradication.
Patients with liver problems
If you suffer from severe liver disease, 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 impairment, you must not take PRINZOL for Helicobacter pylori eradication.
Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.
If you take more PRINZOL than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take PRINZOL
Do not take a double dose to make up for the forgotten dose. Take the next dose at the scheduled time.
If you stop taking PRINZOL
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any doubts about how to use PRINZOL, contact your doctor or pharmacist.

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 this medicine immediately,
contact your doctor, or go to the nearest hospital emergency department:

• Severe allergic reactions (uncommon frequency: 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 based on available data): appearance of skin blisters and rapid worsening 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 changes in white blood cell count or liver enzymes.
• Flat, non-elevated reddish spots, circular or target-shaped, on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Or widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other serious disorders (frequency not known: frequency cannot be estimated based on available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, rash, and kidney enlargement sometimes painful, with pain on urination and lower back pain (severe kidney inflammation), which may lead to possible kidney failure.

Other possible 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; 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; fracture 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 edema); 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 based on available data): hallucinations, confusion (especially in patients with prior history of such symptoms); tingling sensation, pins and needles, burning sensation or numbness, erythema, possible joint pain. Inflammation of the large intestine causing persistent watery diarrhoea.

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 lipids; sudden drop 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 blood cells, white blood cells, and platelets
• Not known (frequency cannot be estimated based on available data): decreased sodium levels in the blood, decreased magnesium levels in the blood, decreased calcium levels in the blood, and decreased potassium levels in the blood (see section 2).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You may 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 PRINZOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
This medicine requires no 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. Package contents and other information

What PRINZOL 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: mannitol, anhydrous sodium carbonate, sodium starch glycolate (type A), basic butylated methacrylate copolymer (Eudragit E PO), calcium stearate. Coating: Opadry white OY-D-7233 (hypromellose, titanium dioxide E171, talc, macrogol 400, sodium lauryl sulfate). Enteric coating: Kollicoat MAE 30 DP, yellow (methacrylic acid copolymer - ethyl acrylate in dispersion, propylene glycol, iron oxide yellow (E172), titanium dioxide E171, talc).

Description of the appearance of PRINZOL and package contents
Gastro-resistant tablet, dark yellow in colour, elliptical, biconvex.
Packaging:
Blister: 14 tablets
28 tablets

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
S.F. Group S.r.l.
Via Tiburtina, 1143
00156 Rome
Italy

Manufacturers
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Balkanpharma – Dupnitsa AD
3 Samokovsko Schosse Str.
Dupnitsa 2600
Bulgaria

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