Pantoprazole Teva Italia

Package leaflet: Information for the patient

Pantoprazole Teva Italia 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Pantoprazolo Teva Italia contains the active substance pantoprazole.
Pantoprazolo Teva Italia is a selective "proton pump inhibitor," i.e. a medicine that reduces the
amount of acid produced in the stomach. It is used for the treatment of stomach and
intestinal diseases related to acid.
Pantoprazolo Teva Italia is used for the treatment of adults and adolescents aged 12 years and older
for:

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

Pantoprazolo Teva Italia is used for the treatment of adults for:

• Prevention of duodenal and gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in at-risk patients who need to take NSAIDs continuously.

2. What you need to know before taking Pantoprazole Teva Italia

Do not take Pantoprazole Teva 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 or pharmacist before taking Pantoprazole Teva Italia

• If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor liver enzymes more frequently, especially if you are undergoing long-term treatment with Pantoprazole Teva Italia. If liver enzymes increase, treatment must be discontinued.
• If you are taking non-steroidal anti-inflammatory drugs (NSAIDs) regularly and are prescribed Pantoprazole Teva Italia because you have an increased risk of developing gastrointestinal complications. The potential increase in risk will be assessed based on your individual risk factors, such as age (65 years or older), history of gastric or duodenal ulcers, or previous gastrointestinal bleeding.
• If you have low vitamin B12 levels or risk factors that reduce its absorption and are undergoing long-term treatment with pantoprazole. Like all medicines that reduce gastric acid secretion, pantoprazole may reduce the absorption of vitamin B12.
• If you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) together with pantoprazole, seek specific advice from your doctor.
• Taking a proton pump inhibitor such as Pantoprazole Teva Italia, particularly for more than one year, may cause a slight increase in the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• If you need to undergo a specific blood test (Chromogranin A).
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Teva Italia that reduces gastric acidity.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazole Teva Italia. Remember to also report any other adverse effects such as joint pain.

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 underlying condition:

• unintentional weight loss
• vomiting, especially if repeated
• blood in vomit; this may appear as dark, coffee-ground-like particles in the vomit
• blood in stools; stools may appear black or tarry
• difficulty swallowing or pain when swallowing
• paleness and feeling weak (anaemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhoea, as Pantoprazole Teva Italia has been associated with a slight increase in the risk of infectious diarrhoea.

Your doctor may decide to carry out certain tests to rule out the presence of a tumour, since pantoprazole can relieve symptoms of cancer and thus delay diagnosis. If symptoms persist despite treatment, further investigations will be considered.
If you have been taking Pantoprazole Teva Italia for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor promptly. Low magnesium levels can 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 take Pantoprazole Teva Italia for a long period (more than one year), your doctor will likely need to carry out periodic check-ups. You must report any new or unusual symptoms or circumstances each time you see your doctor.

• 2 -

Children and adolescents
Pantoprazole Teva Italia is not recommended for use in children, as efficacy has not been demonstrated in patients under 12 years of age.

Other medicines and Pantoprazole Teva Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
This is because Pantoprazole Teva Italia may affect the effectiveness of other medicines, so it is important that you inform your doctor if you are taking:

• medicines such as ketoconazole, itraconazole, posaconazole (used to treat fungal infections), or erlotinib (used for certain types of cancer), since Pantoprazole Teva Italia may prevent these and other medicines from working properly;
• warfarin and phenprocoumon, which affect blood clotting. Additional monitoring may be required;
• medicines used to treat HIV infection, such as atazanavir;
• methotrexate (used to treat rheumatoid arthritis, psoriasis, or cancer) – if you are taking methotrexate, your doctor may temporarily discontinue treatment with pantoprazole, 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).

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

Driving and using machines
Pantoprazole Teva Italia does not affect or affects only slightly the ability to drive or operate machinery.
However, if you experience adverse effects such as dizziness or visual disturbances, avoid driving or operating machinery.

3. How to take Pantoprazole Teva Italia

Take this medicine exactly as your doctor or pharmacist has told you. If you are
unsure, consult your doctor or pharmacist.
Method of administration
Take the tablets one hour before a meal, swallowing them whole without chewing or crushing them, with a
glass of water.
The recommended dose is:
Adults and adolescents aged 12 years and older
For the treatment of symptoms (e.g., heartburn, acid regurgitation, and painful swallowing)
associated with gastroesophageal reflux disease

• 3 -

The recommended dose is one tablet daily. This dose usually provides symptom relief
within 2–4 weeks, or within a maximum of 4 additional weeks. Your doctor will advise you on how long you should continue
taking the medicine. After treatment, any recurring symptoms may be managed by taking one tablet daily as needed.
For long-term management and prevention of recurrence of reflux esophagitis
The recommended dose is one tablet daily. If symptoms recur, your doctor may double the
dose. In this case, you may use Pantoprazole Teva Italia 40 mg tablets, one tablet daily. After healing, the dose may be reduced to one Pantoprazole Teva Italia 20 mg tablet daily.
Adults:
For prevention of duodenal and gastric ulcers in patients who must take NSAIDs
long-term
The recommended dose is one tablet daily.
Patients with liver problems:
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 children under 12 years of age.
If you take more Pantoprazole Teva Italia than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantoprazole Teva Italia
Do not take a double dose to make up for the missed dose. Simply take the next dose at the usual scheduled time.
If you stop taking Pantoprazole Teva Italia
Do not stop taking these tablets without first consulting your doctor or pharmacist.
If you have any doubts about how to use this medicine, ask 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 taking these tablets immediately and contact your doctor or go to the nearest emergency room:

• Severe allergic reactions (rare 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 a rapid heartbeat and intense sweating.
• Severe skin conditions (frequency not known: frequency cannot be estimated based on available data): blistering of the skin and rapid deterioration in general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and light sensitivity.
• Other serious conditions (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 associated with painful urination and lower back pain (severe kidney inflammation), which may progress to kidney failure.

Other side effects are listed below.

• Common: may affect up to 1 in 10 people – benign gastric polyps
• Uncommon: may affect up to 1 in 100 people – headache; dizziness; diarrhoea; feeling unwell, vomiting; bloating and flatulence (meteorism); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption, itching; feeling of weakness, exhaustion or general malaise; sleep disorders; fractures of the hip, wrist or spine.
• Rare: may affect up to 1 in 1,000 people – altered or complete loss of taste sensation; 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.
• Frequency not known: frequency cannot be estimated based on available data – hallucinations, confusion (especially in patients with a history of these symptoms); decreased sodium levels in the blood; decreased magnesium levels in the blood (see section 2); decreased calcium levels in the blood (associated with reduced magnesium levels); decreased potassium levels; muscle spasms as a consequence of electrolyte imbalance; tingling sensation, tingling, prickling, burning sensation or numbness; skin rash, possible joint pain.

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; marked decrease in circulating granulocytes, associated with high fever.
• Very rare: may affect up to 1 in 10,000 people – decreased platelet count, which may lead to increased bleeding or bruising; decreased white blood cell count, which may lead to more frequent infections; concomitant and abnormal decrease in red blood cells, white blood cells and platelets.

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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pantoprazolo Teva Italia

• 5 -

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, on the HDPE bottle, or on the
carton after “EXP.” The expiry date refers to the last day of that month.
Store below 30°C.
HDPE bottle:
After first opening the container, use Pantoprazolo Teva Italia tablets within 100 days.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Pantoprazolo Teva Italia contains

• The active substance is pantoprazole.
• Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
• The other components are: Tablet core: dibasic sodium phosphate, mannitol, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose, sodium carboxymethylstarch. Coating: methacrylic acid-ethyl acrylate copolymer, yellow iron oxide, triethyl citrate.

Description of the appearance of Pantoprazolo Teva and package contents:
The 20 mg gastro-resistant tablets of Pantoprazolo Teva Italia are oval-shaped and yellow, and are available in aluminum blisters containing 7, 14, 15, 28, 30, 50x1, 56, 90, 98, 100 and 120 tablets, or in HDPE containers with child-resistant closure containing 14, 28 and 100 tablets*.
*Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 – Milan
Italy

Manufacturer
Teva Pharma S.L.U.,
Poligono Industrial Malpica,
calle C, Number 4, 50016
ZARAGOZA, Spain
Tel.: 00 34 976 57 17 84
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen
Hungary
Tel.: 00 36 52 515 130
TEVA UK Ltd
Bramptom Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Tel.: 0044 1323 501 111
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem
The Netherlands
Tel.: 0031 235 147 147

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

• 7 -

Patient information leaflet

Pantoprazole Teva 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, consult your doctor or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet:

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

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

Pantoprazolo Teva Italia contains the active substance pantoprazole.
Pantoprazolo Teva Italia is a selective "proton pump inhibitor", i.e. a medicine that reduces the amount of acid produced in the stomach. It is used to treat stomach and intestinal diseases related to acid.
Pantoprazolo Teva Italia is used for the treatment of adults and adolescents aged 12 years and older for:

• Gastroesophageal reflux disease (oesophagitis). Inflammation of the oesophagus (the tube connecting the throat to the stomach), accompanied by the backflow of stomach acid. Pantoprazolo Teva Italia is used for the maintenance treatment of adults for:
• Infection caused by a bacterium called Helicobacter pylori in patients with duodenal ulcers and gastric ulcers, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacteria and reduce the likelihood of ulcers recurring.
• Gastric and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions associated with excessive production of acid in the stomach.

4. What you need to know before taking Pantoprazole Teva Italia

Do not take Pantoprazole Teva 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 or pharmacist before taking Pantoprazole Teva Italia.

• 8 -
• If you have severe liver problems. Inform your doctor if you have had liver problems. Your doctor will monitor liver enzymes more frequently, especially if you are undergoing long-term treatment with Pantoprazole Teva Italia. If liver enzymes increase, treatment should be discontinued.
• If you have low levels of vitamin B12 or risk factors that reduce its absorption and are undergoing long-term treatment with pantoprazole. Like all medicines that reduce acid secretion, pantoprazole may reduce absorption of vitamin B12.
• If you are taking HIV protease inhibitors such as atazanavir (for treatment of HIV infection) together with pantoprazole, ask your doctor for specific advice.
• Taking a proton pump inhibitor such as Pantoprazole Teva Italia, particularly for more than one year, may cause a slight increase in the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• If you need to undergo a specific blood test (Chromogranin A).
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Teva Italia that reduces gastric acidity.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazole Teva Italia. Remember to also report any other adverse effects such as joint pain.

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, especially if repeated
• presence of blood in vomit; this may appear as dark, coffee-ground-like particles in the vomit
• notice blood in your stools; these may appear black or tarry
• difficulty swallowing or pain when swallowing
• paleness and feeling weak (anaemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhoea, as Pantoprazole Teva Italia has been associated with a slight increase in infectious diarrhoea.

Your doctor may decide to carry out certain tests to rule out the presence of a tumour, since
pantoprazole can relieve symptoms of cancer and may delay diagnosis. If symptoms persist
despite treatment, further investigations will be considered.
If you have been taking Pantoprazole Teva Italia for more than three 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, inform your doctor promptly. Low magnesium levels can 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 are taking Pantoprazole Teva Italia for a long period (more than one year), your doctor will likely need to perform periodic check-ups. You must report any new or unusual symptoms or circumstances each
time you see your doctor.

Children and adolescents
Pantoprazole Teva Italia is not recommended for use in children, as efficacy has not been demonstrated in children under 12 years of age.

• 9 -

Other medicines and Pantoprazole Teva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
This is because Pantoprazole Teva Italia may affect the effectiveness of other medicines, so it is important that you 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), since Pantoprazole Teva Italia may prevent these and other medicines from working properly;
• warfarin and fenprocoumon, which affect blood clotting. Additional monitoring may be required;
• medicines used to treat HIV infection, such as atazanavir;
• methotrexate (used to treat rheumatoid arthritis, psoriasis or cancer) – if you are taking methotrexate, your doctor may temporarily discontinue treatment with pantoprazole, 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).

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

Driving and using machines
Pantoprazole Teva Italia does not affect or has negligible effect on the ability to drive or use machines.
However, if you experience adverse effects such as dizziness or visual disturbances, avoid driving or using machines.

5. How to take Pantoprazolo Teva Italia

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 one hour before a meal, swallowing them whole without chewing or crushing, with a
glass of water.
The recommended dose is:
Adults and adolescents aged 12 years and older:
For the treatment of reflux esophagitis
The recommended dose is one tablet per day. Your doctor may instruct you to increase the dose to 2
tablets per day. The treatment period for reflux esophagitis is generally between 4 and 8
weeks. Your doctor will advise you on how long you should take the medicine.
Adults:

• 10 -

For the treatment of an infection caused by a bacterium called Helicobacter pylori in patients with duodenal
and gastric ulcers, in combination with two antibiotics (eradication therapy)
One tablet twice daily, together with two antibiotic tablets of amoxicillin, clarithromycin, and
metronidazole (or tinidazole), each to be taken twice daily along with the pantoprazole tablet. Take the first
pantoprazole tablet one hour before breakfast and the second pantoprazole tablet one hour before dinner. Follow your doctor's instructions and read the package leaflets of the antibiotics. The treatment period is usually one to two weeks.
For the treatment of gastric and duodenal ulcers
The recommended dose is one tablet per day. After consultation with your doctor, the dose may be
doubled.
Your doctor will advise you on 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 associated with excessive
stomach acid production
The usual starting dose is generally two tablets per day.
Take both tablets one hour before a meal. Your doctor may adjust the dose according to the amount of acid produced in your stomach. If more than two tablets per day are prescribed, the tablets should be taken twice daily.
If your doctor prescribes a daily dose exceeding four tablets, they will inform you exactly when you should stop taking the medicine.
Patients with kidney problems:

• If you have renal impairment, you must not take Pantoprazolo Teva Italia for the eradication of Helicobacter pylori.

Patients with liver problems:

• If you have severe liver problems, you must not take more than one 20 mg pantoprazole tablet per day (for this purpose, tablets containing 20 mg of pantoprazole are available).

If you have moderate or severe liver problems, you must not take Pantoprazolo Teva Italia for
the eradication of Helicobacter pylori.
Use in children and adolescents:
These tablets are not recommended for children under 12 years of age.
If you take more Pantoprazolo Teva Italia than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Pantoprazolo Teva Italia
Do not take a double dose to make up for the missed dose. Simply take the next dose at the usual scheduled time.
If you stop taking Pantoprazolo Teva Italia
Do not stop taking 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 may cause side effects, although not everyone experiences them.

• 11 -

If you experience any of the following side effects, stop taking these tablets immediately and contact your doctor or go to the nearest emergency room:

• Severe allergic reactions (rare 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 rapid heartbeat and intense sweating.
• Severe skin conditions (frequency not known: frequency cannot be estimated based on available data): blistering of the skin and rapid deterioration in general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and light sensitivity.
• Other serious conditions (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 associated with painful urination and lower back pain (severe kidney inflammation), which may progress to 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; feeling unwell; vomiting; bloating and flatulence (meteorism); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption, itching; feeling of weakness, fatigue or general malaise; sleep disturbances; fractures of the hip, wrist or spine.
• Rare: may affect up to 1 in 1,000 people – altered or complete loss of taste; visual disturbances such as blurred vision; urticaria, joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of extremities (peripheral oedema); allergic reactions; depression; breast enlargement in men.
• Very rare: may affect up to 1 in 10,000 people – disorientation
• Frequency not known (frequency cannot be estimated based on available data): hallucinations, confusion (especially in patients with a history of these symptoms); decreased sodium levels in blood; decreased magnesium levels in blood (see section 2); decreased calcium levels in blood (associated with reduced magnesium levels); decreased potassium levels; muscle spasms as a consequence of electrolyte imbalance; tingling sensation, pins and needles, prickling, burning sensation or numbness; skin rash, possible joint pain.

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 –
• 12 -

increased bilirubin; increased blood lipids; severe drop in circulating granulocytes, associated with high fever.

• Very rare: may affect up to 1 in 10,000 people – reduced platelet count, which may lead to increased bleeding or bruising; reduced white blood cell count, which may lead to more frequent infections; concomitant and abnormal reduction in red blood cells, white blood cells and platelets.

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

5. How to store Pantoprazole Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, as indicated on the blister, on the
HDPE bottle or on the box after “EXP.”. The expiry date refers to the last day of that month.
Store below 30°C.
HDPE bottle:
After first opening of the container, use within 60 days.
Medicines must not be disposed of 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 Teva Italia contains

• The active substance is pantoprazole.
• Each gastro-resistant tablet contains 40 mg of pantoprazole (as sesquihydrate sodium).
• The other components are: Tablet core: dibasic sodium phosphate, mannitol, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose, sodium carboxymethyl starch. Coating: methacrylic acid-ethyl acrylate copolymer, yellow iron oxide, triethyl citrate.

Description of the appearance of Pantoprazolo Teva Italia and package contents:
The 40 mg gastro-resistant tablets of Pantoprazolo Teva Italia are oval-shaped and yellow, and are available in aluminum blisters containing 7, 14, 15, 28, 30, 50x1, 56, 90, 98, 100 and 120 tablets, or in HDPE containers with child-resistant closure containing 28, 50, 56 and 100 (50x2) tablets*.
*Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 – Milan
Italy

• 13 -

Manufacturers
Teva Pharma S.L.U.,
Poligono Industrial Malpica,
Calle C, Number 4, 50016
Zaragoza, Spain
Tel.: 00 34 976 57 17 84
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen
Hungary
Tel.: 00 36 52 515 130
TEVA UK Ltd
Bramptom Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Tel.: 0044 1323 501 111
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem
The Netherlands
Tel.: 0031 235 147 147

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

• 14 -