Zolonib

Package leaflet: Information for the user

ZOLONIB 20 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 other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4. 1. Contents of this leaflet:
  1. What ZOLONIB is and what it is used for
  2. What you need to know before taking ZOLONIB
  3. How to take ZOLONIB
  4. Possible side effects
  5. How to store ZOLONIB
  6. Contents of the pack and other information

1. What ZOLONIB is and what it is used for

ZOLONIB contains the active substance pantoprazole. Pantoprazole is a selective "proton pump inhibitor," a medicine that reduces the amount of acid produced in the stomach. It is used for the treatment of acid-related diseases of the stomach and intestine.
ZOLONIB is used to treat adults and adolescents above 12 years of age for

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

ZOLONIB is used to treat adults for

• Prevention of duodenal and gastric 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 should know before taking ZOLONIB

Do not take ZOLONIB

• 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 ZOLONIB.
Inform your doctor before taking this medicine:

• 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 ZOLONIB for long-term treatment. If your liver enzymes increase, treatment should be discontinued.
• If you require ongoing treatment with medicines called NSAIDs and are taking ZOLONIB 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 stores 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. Consult your doctor if you notice 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 concurrently taking HIV protease inhibitors such as atazanavir (for treatment of HIV infection), ask your doctor for specific advice.
• If you are taking a proton pump inhibitor such as pantoprazole, 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 (reduced bone density) or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
• If you have been taking ZOLONIB for more than three months, your blood magnesium levels may decrease. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. 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 had a skin reaction after treatment with a medicine similar to ZOLONIB that reduces gastric acidity.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with ZOLONIB. 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.
• If you are scheduled to undergo a specific blood test (Chromogranin A).

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
• Vomiting, particularly if recurrent
• Blood in vomit; this may appear as dark coffee-ground material in vomit
• Blood in stools, which may appear dark or tarry
• Difficulty swallowing or pain when swallowing
• Looking pale and feeling weak (anemia)
• Chest pain
• Stomach pain
• Severe and/or persistent diarrhea, as this medicine has been associated with a slight increase in infectious diarrhea.

Your doctor may decide that you need certain tests to rule out malignancy, as pantoprazole may relieve symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you are taking ZOLONIB for long-term treatment (more 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.

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

Other medicines and ZOLONIB
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.
ZOLONIB may affect the effectiveness of other medicines, so inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as ZOLONIB may prevent these and other medicines from working properly.
• Warfarin and fenprocoumon, which affect blood clotting or thinning. You may need additional monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily discontinue treatment with ZOLONIB 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 the 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 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 fetus or infant.

Driving and using machines
ZOLONIB does not affect or affects negligibly the ability to drive or operate machinery. However, if you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.

ZOLONIB contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take ZOLONIB

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Method of administration
Take the tablets 1 hour before meals without chewing or crushing them, swallowing them whole with some
water.
The recommended dose is:
Adults and adolescents over 12 years of age

• For the treatment of symptoms associated with gastroesophageal reflux disease (e.g. heartburn, acid regurgitation, pain when swallowing) . The usual dose is one tablet per day. This dose normally provides relief within 2-4 weeks, and at most after 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 one tablet per day , as needed.
• For long-term treatment and prevention of recurrence of reflux esophagitis The usual dose is one tablet per day. If the disease recurs, your doctor may double the dose; in this case, you may instead use ZOLONIB 40 mg tablets, one per day. After healing, the dose may be reduced back to one 20 mg tablet per day.

Adults

• For prevention of duodenal and gastric ulcers in patients requiring ongoing treatment with NSAIDs The usual dose is one tablet per day.

Patients with liver problems
If you have severe liver problems, you must not take more than one 20 mg tablet per day.
Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.
If you take more ZOLONIB than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take ZOLONIB
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 ZOLONIB
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 everybody gets 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: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, urticaria, breathing difficulties, allergic swelling of the face (Quincke's oedema / angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Severe 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.
• Reddish, flat, circular or target-shaped rashes on the trunk, often with blisters in the centre, 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). 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 the whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash, and kidney enlargement sometimes with pain on urination and lower back pain (severe kidney inflammation), which may lead to possible kidney failure.

Other 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; 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; fractures of the hip, wrist or spine.
• Rare (may affect up to 1 in 1,000 people): Altered or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the extremities (peripheral oedema); allergic reactions; 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); tingling sensation, pins and needles, burning sensation or numbness; skin rash, 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 lipid levels; drastic reduction in white blood cells, associated with high fever.
• Very rare (may affect up to 1 in 10,000 people): Decreased platelet count, which may cause increased bleeding or bruising; decreased white blood cell count, which may lead to more frequent infections; abnormal concurrent decrease in red blood cells, white blood cells, and platelets.
• Not known (frequency cannot be estimated from the available data): Decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Store below 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 ZOLONIB contains
The active substance is pantoprazole. Each tablet contains 20 mg of pantoprazole (equivalent to 22.56 mg of
pantoprazole sodium sesquihydrate).
The other components are:
Core:
Mannitol, microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate (Type A), anhydrous sodium carbonate, calcium stearate.
Isolating coating:
Hypromellose, propylene glycol, titanium dioxide (E171), yellow iron oxide (E172).
Enteric coating:
Methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, triethyl citrate.
Description of the appearance of ZOLONIB and contents of the pack
ZOLONIB is presented as gastro-resistant tablets. The tablets have a dosage of 20 mg. The tablets are pale yellow to ochre in colour, oblong-shaped and convex.
ZOLONIB is available in packs of 14, 28, 56 and 60 tablets in PVC/PCTFE/PVC/Aluminum blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Epifarma S.r.l - Via San Rocco, 6 - 85033 Episcopia (PZ) Italy
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal

Package leaflet: Information for the user

ZOLONIB 40 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What ZOLONIB is and what it is used for

ZOLONIB contains the active substance pantoprazole. Pantoprazole is a selective "proton pump inhibitor," a medicine that reduces the amount of acid produced in the stomach. It is used for the treatment of acid-related diseases of the stomach and intestine.

ZOLONIB is used in adults and adolescents above 12 years of age for:

• Reflux esophagitis. An inflammation of the esophagus (the tube connecting the throat to the stomach) associated with regurgitation of gastric acid.

ZOLONIB is used in adults for:

• 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 risk of recurrence of these ulcers.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which excessive stomach acid is produced.

2. What you should know before taking ZOLONIB

Do not take ZOLONIB

• 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 ZOLONIB.
Inform your doctor before taking this medicine:

• 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 ZOLONIB for long-term treatment. If your liver enzymes increase, treatment should be discontinued.
• If you have low body stores 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. Contact your doctor if you notice 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 simultaneously taking HIV protease inhibitors such as atazanavir (for treatment of HIV infection), consult your doctor for specific advice.
• If you take a proton pump inhibitor such as pantoprazole, 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 (reduced bone density) or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
• If you have been taking ZOLONIB for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. 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 had a skin reaction after treatment with a medicine similar to ZOLONIB that reduces gastric acidity.
• If you develop 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 ZOLONIB. 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.
• If you are scheduled for a specific blood test (Chromogranin A).

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

• Unintentional weight loss
• Vomiting, particularly if repeated
• Blood in vomit; this may appear as dark coffee-ground-like material in the vomit
• Presence of blood in stools, which may appear dark or tarry
• Difficulty swallowing or pain when swallowing
• Looking pale and feeling weak (anemia)
• Chest pain
• Stomach pain
• 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 a malignant disease, as pantoprazole may relieve symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you are taking ZOLONIB for long-term treatment (more 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.
Children and adolescents
The use of ZOLONIB is not recommended in children, as efficacy has not been demonstrated in children under 12 years of age.
Other medicines and ZOLONIB
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
ZOLONIB may affect the effectiveness of other medicines; therefore, inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as ZOLONIB may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood clotting or thinning. You may require additional monitoring.
• Medicines used to treat HIV infection such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily discontinue treatment with ZOLONIB because pantoprazole can 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).

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 inadequate data on the use of pantoprazole in pregnant women. Excretion into 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.
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 using machines
ZOLONIB does not affect or has a negligible effect on the ability to drive vehicles and use machines. However, if you experience adverse effects such as dizziness or vision disturbances, you should not drive or operate machinery.
ZOLONIB contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take ZOLONIB

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Method of administration
Take the tablets 1 hour before meals. Do not chew or crush them; swallow them whole with a little water.
The recommended dose is:
Adults and adolescents over 12 years of age

• For the treatment of reflux esophagitis: The usual dose is one tablet per day. Your doctor may instruct you to increase the dose to two tablets per day. The treatment period for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will tell you how long you should 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 per day. After consulting your doctor, the dose may be doubled. Your doctor will tell you how long you should 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 stomach acid is produced: The usual recommended starting dose is two tablets per day. 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 per day are prescribed, the tablets should be taken twice daily. If your doctor prescribes a daily dosage of more than four tablets per day, you will be given specific instructions on when to stop taking the medicine.

Patients with kidney problems
If you have kidney problems, you must not take ZOLONIB for Helicobacter pylori eradication.
Patients with liver problems
If you have severe liver problems, you must not take more than one 20 mg pantoprazole tablet per day (tablets containing 20 mg of pantoprazole are available for this purpose).
If you have severe or moderate liver problems, you must not take ZOLONIB 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 ZOLONIB than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take ZOLONIB
Do not take a double dose to make up for the missed dose. Take your next dose at the usual scheduled time.
If you stop taking ZOLONIB
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any doubts about using this medicine, consult 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 taking this medicine immediately and 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, facial swelling due to allergy (Quincke's edema / angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Serious skin disorders (frequency not known: frequency cannot be estimated from the available data): development of skin blisters and rapid deterioration in 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.
• Reddish, flat 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).
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other serious conditions (frequency not known: frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, rash, and kidney enlargement sometimes with painful urination and lower back pain (severe kidney inflammation), which may lead to possible kidney failure.

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; fractures of the hip, wrist or spine.

• Rare (may affect up to 1 in 1,000 people) Altered or complete loss of taste; vision disorders 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); tingling sensation, pins and needles, burning sensation or numbness; skin rash, 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 levels of blood fats; a drastic reduction in white blood cells, associated with high fever.
• Very rare (may affect up to 1 in 10,000 people) reduced platelet count, which may cause bleeding or bruising more than normal; reduced white blood cell count, which may lead to more frequent infections; abnormal concurrent reduction in red blood cells, white blood cells and platelets.
• Not known (frequency cannot be estimated from the available data) decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ZOLONIB

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.
Store below 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 ZOLONIB contains
The active substance is pantoprazole. Each tablet contains 40 mg of pantoprazole (equivalent to 45.11 mg of
pantoprazole sodium sesquihydrate).
The other components are:
Core:
Mannitol, microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate (Type A), sodium
carbonate anhydrous, calcium stearate.
Isolating coating:
Hypromellose, propylene glycol, titanium dioxide (E171), yellow iron oxide (E172).
Enteric coating:
Methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, triethyl citrate.
Description of the appearance of ZOLONIB and package contents
ZOLONIB is presented as gastro-resistant tablets. The tablets have a dosage of 40 mg. The tablets are pale yellow to ochre in colour, oblong and convex in shape.
ZOLONIB is available in packs of 14, 28, 56 and 60 tablets in PVC/PCTFE/PVC/Aluminum blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Epifarma S.r.l - Via San Rocco, 6 - 85033 Episcopia (PZ) Italy
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal