Pancleus

PATIENT LEAFLET: INFORMATION FOR THE USER

PANCLEUS 20 mg gastro-resistant tablets

Pantoprazole
Equivalent medicine
Please read this leaflet carefully before taking this medicine.

• 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. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What PANCLEUS is and what it is used for
2. Before taking PANCLEUS
3. How to take PANCLEUS
4. Possible side effects
5. How to store PANCLEUS
6. Further information

1. WHAT PANCLEUS IS AND WHAT IT IS USED FOR

PANCLEUS 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 disorders of the stomach and intestine.
PANCLEUS is used for:
Adults and adolescents aged 12 years and older:
Treatment of symptoms (e.g. heartburn, acid regurgitation, painful swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.
Long-term treatment of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach) and prevention of its recurrence.
Adults:
Prevention of duodenal and gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in at-risk patients who require ongoing NSAID therapy.

2. BEFORE TAKING PANCLEUS

Do not take PANCLEUS
If you are allergic (hypersensitive) to pantoprazole or to any of the excipients in PANCLEUS
(see list in section 6).
If you are allergic to medicines containing other proton pump inhibitors.

Take special care with PANCLEUS
If you have severe liver problems. Inform your doctor if you have previously had liver issues.
Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are
taking PANCLEUS for long-term treatment. If your liver enzymes increase, treatment must be discontinued.
If you require ongoing treatment with NSAIDs and are taking PANCLEUS due to an increased risk of
developing gastric or intestinal complications. Any increased risk will be assessed based on your personal
risk factors such as age (65 years and older), history of gastric or duodenal ulcers, or 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.
If you are taking a medicine containing atazanavir (for the treatment of HIV infection), consult your doctor
for specific advice.
If you are taking a proton pump inhibitor such as PANCLEUS, 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 suffer from osteoporosis or are taking
corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
Taking a proton pump inhibitor such as PANCLEUS may interfere with the results of the urea breath test used
to detect Helicobacter pylori. Therefore, you must stop taking PANCLEUS two weeks before the test.

Inform your doctor immediately if you experience any of the following symptoms:
unintentional weight loss
repeated vomiting
difficulty swallowing
blood in vomit
pale appearance and feeling weak (anaemia)
blood in stools
severe and/or persistent diarrhoea, because PANCLEUS has been associated with a modest increase
in infectious diarrhoea.

Your doctor may decide that you need further tests to rule out malignancy, as pantoprazole may also relieve
symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations
should be considered.
If you take PANCLEUS 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 at every medical visit.

Taking other medicines
PANCLEUS 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 PANCLEUS 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).
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those
not requiring a prescription.

Pregnancy and breastfeeding
There are insufficient adequate data on the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported.
If you are pregnant, think you may be pregnant, or are breastfeeding, you should use this medicine only if your doctor considers the benefit to you to be greater than the potential risk to the fetus or infant.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
If you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.

3. HOW TO TAKE PANCLEUS

Always take PANCLEUS exactly as instructed by your doctor. If you have any doubts, you should
consult your doctor or pharmacist.
When and how should you take PANCLEUS?
Take the tablets 1 hour before a meal, without chewing or crushing them, swallowing them whole
with some water.
Unless otherwise instructed by your doctor, the usual 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 one tablet per day. This dose usually provides relief within 2–4 weeks, and at most
after a further 4 weeks. Your doctor will tell you 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 oesophagitis
The usual dose is one tablet per day. If symptoms recur, your doctor may double the dose; in this case,
you may instead use PANCLEUS 40 mg tablets, one tablet per day. After healing, the dose may be
reduced back to one 20 mg tablet per day.
Adults:
For the prevention of duodenal and gastric ulcers in patients requiring continuous treatment with NSAIDs
The usual dose is one tablet per day.
Particular patient groups:
If you have severe liver problems, you must not take more than one 20 mg tablet per day.
Children under 12 years: These tablets are not recommended for use in children under 12 years of age.
If you take more PANCLEUS than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take PANCLEUS
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 PANCLEUS
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any doubts about how to use PANCLEUS, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, PANCLEUS can cause adverse reactions, although not everyone experiences them.
The frequency of the possible adverse reactions listed below is defined using the following convention:
very common (affects more than 1 in 10 people)
common (affects 1 to 10 in 100 people)
uncommon (affects 1 to 10 in 1,000 people)
rare (affects 1 to 10 in 10,000 people)
very rare (affects less than 1 in 10,000 people)
not known (frequency cannot be estimated from the available data)

If you experience any of the following adverse reactions, stop treatment with these tablets and
contact your doctor immediately, or go to the nearest hospital emergency department:

Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating.

Serious skin disorders (frequency not known): appearance of skin blisters and rapid deterioration of your general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme) and photosensitivity.

Other serious disorders (frequency not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash, and kidney enlargement sometimes with pain during urination or lower back pain (severe kidney inflammation).

Other adverse reactions include:

Uncommon (affects 1 to 10 in 1,000 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.

If you take a proton pump inhibitor such as PANCLEUS, especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

Rare (affects 1 to 10 in 10,000 people)
visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities (peripheral oedema); allergic reactions; depression, breast enlargement in men.

Very rare (affects less than 1 in 10,000 people)
disorientation.

Not known (frequency cannot be estimated from the available data):
hallucinations, confusion (particularly in patients with prior experience of such symptoms);
decreased levels of sodium in the blood.

If you take PANCLEUS for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as tiredness, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor should decide whether periodic monitoring of blood magnesium levels is necessary.

Adverse reactions identified through blood tests:

Uncommon (affects 1 to 10 in 1,000 people)
increased liver enzymes.

Rare (affects 1 to 10 in 10,000 people)
increased bilirubin; increased blood lipids.

Very rare (affects less than 1 in 10,000 people)
reduction in platelet count, which may cause increased bleeding or bruising; reduction in white blood cell count, which may lead to more frequent infections.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you help provide more information on the safety of this medicine.

5. HOW TO STORE PANCLEUS

Keep PANCLEUS out of the sight and reach of children.
Do not use PANCLEUS after the expiry date which is stated on the carton and container after
Exp. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should 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. OTHER INFORMATION

What PANCLEUS contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of
pantoprazole (as sodium sesquihydrate).

• The excipients are:
  Tablet core: Mannitol, Anhydrous sodium carbonate, Sodium carboxymethyl starch (type A), Methacrylic acid – ethyl acrylate copolymer (Eudragit E PO), Calcium stearate, Opadry white OY-D-7233 (hypromellose, titanium dioxide E171, polyethylene glycol 400, sodium lauryl sulfate)

Coating: Kollicoat MAE 30 DP, light yellow colour (methacrylic acid – ethyl acrylate copolymer, propylene glycol, yellow iron oxide (E172), titanium dioxide (E171), talc, purified water)

Description of the appearance of PANCLEUS and contents of the pack
Light yellow, elliptical, biconvex gastro-resistant tablet.
Packs:
HDPE bottle and Al/Al blister
PANCLEUS is available in the following pack size:
Pack of 14 gastro-resistant tablets
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
S.F. Group S.r.l., Via Beniamino Segre 59, 00134 Rome, Italy

Manufacturer
Actavis Ltd., BLB016 Bulebel Industrial Estate, Zejtun ZTN 3000 - Malta
Actavis hf., Reykjavíkurvegur 78, IS-220 Hafnafjördur – Iceland
Balkanpharma – Dupnitsa AD, 3 Samokovsko Schosse Str., Dupnitsa 2600 - Bulgaria

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

This patient information leaflet was last approved on

PACKAGE LEAFLET: INFORMATION FOR THE USER

PANCLEUS 40 mg gastro-resistant tablets

Pantoprazole
Generic medicine
Read this leaflet carefully before taking this medicine.

• 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. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

7. What PANCLEUS is and what it is used for
8. Before taking PANCLEUS
9. How to take PANCLEUS
10. Possible side effects
11. How to store PANCLEUS
12. Further information

7. WHAT PANCLEUS IS AND WHAT IT IS USED FOR

PANCLEUS 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.
PANCLEUS is used for the treatment of:
Adults and adolescents aged 12 years and older:
Gastroesophageal reflux disease (GERD). Inflammation of the esophagus (the tube connecting the throat to the stomach) associated with regurgitation of gastric acid.
Adults:
Infection with a bacterium called Helicobacter pylori in patients with duodenal ulcer and gastric ulcer, in combination with two antibiotics (Eradication therapy). The aim is to eliminate the bacteria in order to reduce the risk of recurrence of these ulcers.
Stomach and duodenal ulcers.
Zollinger-Ellison syndrome and other conditions in which excessive acid is produced in the stomach.

8. BEFORE TAKING PANCLEUS

Do not take PANCLEUS
If you are allergic (hypersensitive) to pantoprazole or to any of the excipients of PANCLEUS
(see list in section 6).
If you are allergic to medicines containing other proton pump inhibitors.

Take special care with PANCLEUS
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 PANCLEUS for long-term treatment. If liver enzymes increase, treatment must 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.
If you are taking a medicine containing atazanavir (for the treatment of HIV infection) at the same
time as pantoprazole, please consult your doctor for specific advice.
If you are taking a proton pump inhibitor such as PANCLEUS, 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 suffer from
osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult
your doctor.
Taking a proton pump inhibitor such as PANCLEUS may interfere with the results of the urea breath
test used to detect Helicobacter pylori. Therefore, you must stop taking PANCLEUS at least two weeks
before the test.

Inform your doctor immediately if you experience any of the following symptoms:
unintentional weight loss
repeated vomiting
difficulty swallowing
blood in the vomit
you appear pale and feel weak (anaemia)
blood in the stools
severe and/or persistent diarrhoea, as PANCLEUS has been associated with a slight increase
in infectious diarrhoea.

Your doctor may decide that you need further tests to rule out malignant disease, as pantoprazole
relieves symptoms even in cases of cancer and could therefore delay diagnosis. If your symptoms
persist despite treatment, further investigations should be considered.
If you are taking PANCLEUS 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 at every medical visit.

Taking with other medicines
PANCLEUS 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 PANCLEUS may prevent these and other medicines from
working properly.
Warfarin and fenprocoumon, which affect blood clotting. You may need additional monitoring.
Atazanavir (used to treat HIV infection).
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including
those without a prescription.

Pregnancy and breastfeeding
There are insufficient data on the use of pantoprazole in pregnant women. Excretion in human breast milk
has been reported. If you are pregnant, think you may be pregnant, or are breastfeeding, you should use
this medicine only if your doctor considers the benefit to you greater than the potential risk to the fetus or
breastfed infant.

Ask your doctor or pharmacist for advice before taking any medicine.

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

9. HOW TO TAKE PANCLEUS

Always take PANCLEUS exactly as instructed by your doctor. If you have any doubts, you must consult your doctor or pharmacist.
When and how should you take PANCLEUS?
Take the tablets 1 hour before a meal without chewing or crushing them, swallowing them whole with some water.
Unless otherwise instructed by your doctor, the usual dose is:
Adults and adolescents aged 12 years and older:
For the treatment of reflux esophagitis
The usual dose is one tablet daily. Your doctor may instruct you to increase the dose to two tablets daily. The treatment period for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will tell you how long to take the medicine.
Adults:
For the treatment of an infection with a bacterium called Helicobacter pylori in patients with
duodenal ulcer and gastric ulcer, in combination with two antibiotics (Eradication therapy).
One tablet twice daily plus two tablets of an antibiotic—amoxicillin, clarithromycin, or metronidazole (or tinidazole)—each taken twice daily together with the pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before the evening meal. Follow your doctor's instructions and make sure to read the package leaflet for these antibiotics. The usual treatment duration is one or two weeks.
For the treatment of gastric and duodenal ulcers.
The usual dose is one tablet daily. After consulting your doctor, the dose may be doubled.
Your doctor will tell you how long to take the medicine. The treatment period for gastric ulcers is generally between 4 and 8 weeks. The treatment period for duodenal ulcers is generally between 2 and 4 weeks.
For long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much stomach acid is produced.
The recommended initial dose is usually two tablets daily.
Take both tablets 1 hour before a meal. Your doctor may subsequently adjust the dosage depending on the amount of gastric acid produced. If more than two tablets daily are prescribed, the tablets should be taken 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.
Special patient groups:
If you have moderate or severe kidney problems, you must not take PANCLEUS for Helicobacter pylori eradication.
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).
Children under 12 years: These tablets are not recommended for use in children under 12 years of age.
If you take more PANCLEUS than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take PANCLEUS
Do not take a double dose to make up for the forgotten dose. Take your next dose at the usual scheduled time.
If you stop taking PANCLEUS
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any doubts about how to use PANCLEUS, consult your doctor or pharmacist.

10. POSSIBLE ADVERSE REACTIONS

Like all medicines, PANCLEUS may cause adverse reactions, although not everyone experiences them.
The frequency of the possible adverse reactions listed below is defined using the following convention:
very common (affects more than 1 in 10 people)
common (affects 1 to 10 in 100 people)
uncommon (affects 1 to 10 in 1,000 people)
rare (affects 1 to 10 in 10,000 people)
very rare (affects less than 1 in 10,000 people)
not known (frequency cannot be estimated from the available data)

If you experience any of the following adverse reactions, stop treatment with these tablets
and consult your doctor immediately, or contact the nearest hospital emergency department:

Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, urticaria, breathing difficulties, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating.

Severe skin disorders (frequency not known): appearance of skin blisters and rapid deterioration of your general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson Syndrome, Lyell's Syndrome, Erythema Multiforme), and photosensitivity.

Other severe disorders (frequency not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, skin rash, and kidney enlargement sometimes accompanied by painful urination and lower back pain (severe kidney inflammation).

Other adverse reactions include:

Uncommon (affects 1 to 10 in 1,000 people)
headache; dizziness; diarrhoea; nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash, exanthema, eruption; pruritus; feeling of weakness, fatigue or general malaise; sleep disturbances.

If you take a proton pump inhibitor such as PANCLEUS, especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

Rare (affects 1 to 10 in 10,000 people)
vision disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities (peripheral oedema); allergic reactions; gynaecomastia (breast enlargement in males).

Very rare (affects less than 1 in 10,000 people)
disorientation.

Not known (frequency cannot be estimated from the available data)
hallucinations, confusion (particularly in patients with a history of these symptoms); decreased blood sodium levels.

If you take PANCLEUS 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, contact your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether periodic monitoring of magnesium levels in the blood is necessary.

Adverse reactions identified through blood tests:

Uncommon (affects 1 to 10 in 1,000 people)
increased liver enzymes.

Rare (affects 1 to 10 in 10,000 people)
increased bilirubin; increased blood lipids.

Very rare (affects less than 1 in 10,000 people)
reduced platelet count, which may lead to increased bleeding or bruising; reduced white blood cell count, which may result in more frequent infections.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

11. HOW TO STORE PANCLEUS

Keep PANCLEUS out of the sight and reach of children.
Do not use PANCLEUS after the expiry date stated on the carton and container after Exp. The expiry date refers to the last day of the month.
This medicinal product does not require any special storage conditions.
Medicines should 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.

12. OTHER INFORMATION

What PANCLEUS contains

• The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).
• The excipients are:
  Tablet core: Mannitol, Anhydrous sodium carbonate, Sodium carboxymethylcellulose (type A), Methacrylic acid – ethyl acrylate copolymer (Eudragit E PO), Calcium stearate, Opadry white OY-D-7233 (hypromellose, titanium dioxide E171, polyethylene glycol 400, sodium lauryl sulfate)

Coating: Kollicoat MAE 30 DP, yellow (methacrylic acid – ethyl acrylate copolymer,
propylene glycol, yellow iron oxide (E172), titanium dioxide (E171), talc, purified water).

Description of the appearance of PANCLEUS and packaging contents
Yellowish-brown, elliptical, biconvex gastro-resistant tablet.
Packaging: HDPE bottle and Al/Al blister
PANCLEUS is available in the following pack size:
Pack containing 14 gastro-resistant tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
S.F. Group S.r.l., Via Beniamino Segre 59, 00134 Rome, Italy

Manufacturer
Actavis Ltd., BLB016 Bulebel Industrial Estate, Zejtun ZTN 3000 - Malta
Actavis hf., Reykjavíkurvegur 78, IS-220 Hafnafjördur – Iceland
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:

This patient information leaflet was last approved on