PANCLEUS 20 mg Enteric-Coated Tablet

Зміст інструкції

1. PANCLEUS 20 mg gastro-resistant tablets
   1. WHAT IS PANCLEUS 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
2. PANCLEUS 40 mg gastro-resistant tablets
   1. WHAT IS PANCLEUS 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

PANCLEUS 20 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. Do not pass it on to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT IS PANCLEUS 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:

Adults and adolescents 12 years and over:
Treatment of symptoms (e.g. heartburn, acid regurgitation, pain when 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 stomach ulcers caused by non-steroidal
anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who require
continuous treatment with NSAIDs.

2. 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. Tell your doctor if you have had liver problems in the past. The
doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are
taking PANCLEUS for long-term therapy. If liver enzymes increase
treatment should be discontinued.
If you need continuous treatment with NSAIDs and are taking PANCLEUS because you have an
increased risk of developing gastric and intestinal complications. Any increased risk
will be assessed based on your personal risk factors such as age (65 years and over),
a history of gastric or duodenal ulcers or gastrointestinal bleeding.
If you have reduced body stores or risk factors for reduced vitamin B12 and are undergoing
long-term treatment with pantoprazole. As with all agents that reduce
acidity, pantoprazole can lead to reduced absorption of vitamin B12.
If you are simultaneously taking atazanavir
(for the treatment of HIV infection) with pantoprazole, ask your doctor for specific advice.
If you are taking a proton pump inhibitor such as PANCLEUS, especially for a period
longer than one year, there may be a slight increase in the risk of hip, wrist or vertebral fractures. If you suffer from osteoporosis or are taking corticosteroids
(which can increase the risk of osteoporosis) consult your doctor.
Taking a proton pump inhibitor such as PANCLEUS can cause
an alteration in the results of the urea breath test for the detection of Helycobacter
pylori. Therefore, you should stop taking PANCLEUS two weeks before the test.

Tell your doctor immediatelyif you notice any of the following symptoms:
unintentional weight loss
recurrent vomiting
difficulty swallowing
presence of blood in the vomit
appear pale and feel weak (anemia)
presence of blood in the stool
severe and/or persistent diarrhea, because PANCLEUS has been associated with a modest increase
of infectious diarrhea.
The doctor may decide that you need to undergo some tests to rule out a malignant disease
as pantoprazole also relieves the symptoms of cancer and may cause a delay
in 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 probably keep you
under regular control. You should report any new or
exceptional symptom or circumstance whenever you see your doctor.

Taking other medicines
PANCLEUS can affect the effectiveness of other medicines, so tell your doctor if you are taking
Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal
infections) or erlotinib (used for some types of cancer) as PANCLEUS may prevent these
and other medicines from working properly.
Warfarin and phenprocoumon, which affect blood clotting or thinning. You may
need further checks.
Atazanavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.

Pregnancy and breastfeeding
There are no adequate data regarding the use of pantoprazole in pregnant women. Excretion has been reported
in human breast milk. If you are pregnant, or think you may be, or are
breastfeeding, you should use this medicine only if the doctor considers the benefit for you
greater than the potential risk to the fetus or infant.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
If you experience side effects such as dizziness or visual disturbances, you should not drive or operate
machinery.

3. HOW TO TAKE PANCLEUS

Always take PANCLEUS exactly as your doctor has instructed. 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 and swallow them whole
with a little water.
Unless otherwise informed by your doctor, the usual dose is:

Adults and adolescents 12 years and over:

For the treatment of symptoms associated with gastro-esophageal reflux disease (e.g. heartburn, acid regurgitation,
pain when swallowing)
The usual dose is one tablet a day. This dose normally provides relief in 2 - 4
weeks - at most after another 4 weeks. Your doctor will tell you how long to continue
taking the medicine. After that, any recurrence of symptoms can be controlled

by taking one tablet a day,as needed.

For long-term treatment and prevention of recurrent reflux esophagitis
The usual dose is one tablet a day. If the symptom returns, your doctor may double the dose,
in which case you can instead use PANCLEUS 40 mg tablets, one a day. After healing, you
can reduce the dose back to one 20 mg tablet a day.

Adults:

For the prevention of duodenal and gastric ulcers in patients who require continuous treatment
with NSAIDs
The usual dose is one tablet a day.

Special patient groups:
If you suffer from severe liver problems, you should not take more than one 20 mg tablet a
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. No symptoms of overdose are known.

If you forget to take PANCLEUS
Do not take a double dose to make up for a missed dose. Take the normal dose
at the next 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 questions about the use of PANCLEUS, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

If you experience any of the following side effects, stop taking these tablets and
consult a doctor immediately, or contact the nearest hospital emergency room:
Serious allergic reactions (rare):swelling of the tongue and/or throat, difficulty in
swallowing, urticaria, difficulty breathing, allergic facial swelling (angioedema/Quincke's
edema), severe dizziness with very fast heartbeat and profuse sweating.

Severe skin conditions (frequency not known):appearance of skin blisters and rapid
deterioration of your general condition, erosion (including slight bleeding) of the eyes, nose,
mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, Multiforme erythema) and
sensitivity to light.

Other serious conditions (frequency not known):yellowing of the skin or whites of the eyes
(serious damage to liver cells, jaundice) or fever, rash, and enlargement of the kidneys
sometimes with pain when urinating or lower back pain (serious kidney inflammation).
Other side effects are:

Uncommon(affects 1 to 10 people in 1,000)
headache; dizziness; diarrhoea; nausea, vomiting; abdominal bloating and flatulence (air);
constipation; dry mouth; abdominal pain and feeling unwell; rash, exanthema,
eruption; itching; feeling of weakness, fatigue or general malaise; sleep disturbances.
If you take a proton pump inhibitor like PANCLEUS, especially for a period
longer than one year, there may be a slight increase in the risk of fractures of the hip,
wrist or spine. If you suffer from osteoporosis or are taking corticosteroids
(which can increase the risk of osteoporosis) consult your doctor.

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

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

Not known(the frequency cannot be estimated from the available data):
Hallucinations, confusion (especially in patients with a history of these symptoms);
decrease in blood sodium levels.
If you take PANCLEUS for more than three months, it is possible that blood levels of
magnesium may decrease. Low magnesium levels can manifest with fatigue, involuntary
muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have
any of these symptoms, consult your doctor immediately. Low levels
of magnesium can also lead to a reduction in blood levels of potassium or calcium. The
doctor should decide whether to periodically check magnesium levels in the blood.

Side effects identified through blood tests:
Uncommon(affects 1 to 10 people in 1,000)
increased liver enzymes.

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

Very Rare(affects less than 1 in 10,000)
reduction in the number of platelets, which can cause bleeding or bruising more than
normal; a reduction in the number of white blood cells, which can lead to more frequent infections.

Reportingofsideeffects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can 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 reported on the package and the container after
Exp. The expiry date refers to the last day of the month.
This medicine does not require any particular 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. FURTHER INFORMATION

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

• The excipientsare: Tablet core: Mannitol, Anhydrous sodium carbonate, Sodium carboxymethylcellulose (Type A), Acrylic acid - ethyl acrylate copolymer (Eudragit E PO), Calcium stearate, Opadry white OY-D-7233 (hypromellose, titanium dioxide E171, Macrogol 400, sodium lauryl sulfate)

Coating: Kollicoat MAE 30 DP, light yellow in colour (Acrylic acid – ethyl acrylate copolymer, Propylene glycol, Yellow iron oxide (E172), Titanium dioxide (E171), Talc,
Purified water

Description of PANCLEUS and contents of the pack
Elliptical, biconvex, light yellow gastro-resistant tablet.
Packs:
HDPE bottle and Al/Al blister
PANCLEUS is available in the following pack:
Pack of 14 gastro-resistant tablets
Not all pack sizes may be marketed

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

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 Member States of the European Economic Area with the
following denominations:

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. In fact, this medicine could be dangerous for other individuals, even if their symptoms are the same as yours.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 7. What is PANCLEUS 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 IS PANCLEUS 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 12 years and older:
Reflux esophagitis. An inflammation of the esophagus (the tube connecting the throat to the stomach)
accompanied by acid regurgitation.

Adults:
An infection with a bacterium called Helicobacter pyloriin patients with duodenal
ulcers and gastric ulcers in combination with two antibiotics (Eradication therapy). The purpose is to
get rid of the bacteria in order to reduce the possibility that these ulcers will return.
Ulcers of the stomach and duodenum.
Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the
stomach.

8. BEFORE TAKING PANCLEUS

Do not take PANCLEUS
If you are allergic (hypersensitive) to pantoprazole or 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. Tell your doctor if you have had liver problems in the past. The
doctor may order more frequent monitoring of your liver enzymes, especially if you are
taking PANCLEUS for long-term therapy. If liver enzymes increase
treatment should be discontinued.
If you have reduced body stores or risk factors for reduced vitamin B12 and are undergoing
long-term treatment with pantoprazole. As with all agents that reduce
acidity, pantoprazole may lead to reduced absorption of vitamin B12.
If you are simultaneously taking atazanavir
(for the treatment of HIV infection) with pantoprazole, ask your doctor for specific advice.
If you take a proton pump inhibitor such as PANCLEUS, especially for a period
longer than one year, there may be a slight increase in the risk of fractures of the hip,
wrist or spine. If you suffer from osteoporosis or are taking corticosteroids
(which can increase the risk of osteoporosis) consult your doctor.
Taking a proton pump inhibitor such as PANCLEUS may cause
an alteration of the results of the urea breath test for the detection of Helicobacter
pylori. Therefore, you must stop taking PANCLEUS two weeks before the test.

Immediately inform your doctorif you notice any of the following symptoms:
an involuntary weight loss
recurrent vomiting
difficulty swallowing
presence of blood in the vomit
appear pale and feel weak (anemia)
presence of blood in the stool
severe and/or persistent diarrhea, as PANCLEUS has been associated with a modest increase
in infectious diarrhea.
The doctor may decide that you need to undergo some tests to rule out a malignant
disease as pantoprazole also relieves the symptoms of cancer and may cause a delay
in 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
keep you under regular control. You should report any new or unusual symptom and
circumstance whenever you meet the doctor.

Taking with other medicines
PANCLEUS can affect the effectiveness of other medicines, so tell 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) because PANCLEUS may prevent these
and other medicines from working properly.
Warfarin and phenprocoumon, which affect blood clotting or thinning. You may
need further checks.
Atazanavir (used to treat HIV infection).

Pregnancy and breastfeeding
There are no adequate data regarding the use of pantoprazole in pregnant women. Excretion has been reported
in human breast milk. If you are pregnant, or think you may be, or
are breastfeeding, you should use this medicine only if the doctor considers the benefit for you
greater than the potential risk to the fetus or infant.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
If you experience side effects such as dizziness or visual disturbances, you should not drive or operate
machinery.

9. HOW TO TAKE PANCLEUS

Always take PANCLEUS exactly as your doctor has instructed. If you have any doubts, 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 and swallow them whole with some water.
Unless otherwise informed by your doctor, the usual dose is:

Adults and adolescents 12 years of age and over:

For the treatment of reflux esophagitis
The usual dose is one tablet a day. Your doctor may tell you to increase the dose to 2 tablets a day. 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 calledHelicobacter pyloriin patients with duodenal ulcer and gastric ulcer in combination with two antibiotics (Eradication Therapy).
One tablet, twice a day plus two tablets of an antibiotic between amoxicillin, clarithromycin and metronidazole (or tinidazole), each taken twice a day 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 for two weeks.

For the treatment of gastric and duodenal ulcers.
The usual dose is one tablet a day. 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 the long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.
The recommended starting dose is usually two tablets a 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 are prescribed per day, the tablets must be taken twice a day.
If your doctor prescribes a daily dose of more than four tablets a day, you will be told exactly when to stop taking the medicine.

Particular groups of patients:
If you have moderate or severe kidney problems, you should not take PANCLEUS for the eradication of Helicobacter pylori.
If you suffer from severe liver problems, you should not take more than one 20 mg tablet of pantoprazole per day (tablets containing 20 mg of pantoprazole are available for this purpose).
Children under 12 years of age. 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. No symptoms of overdose are known.

If you forget to take PANCLEUS
Do not take a double dose to make up for a missed dose. Take the normal next dose at the 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 the use of PANCLEUS, ask your doctor or pharmacist.

10. POSSIBLE SIDE EFFECTS

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

If you experience any of the following side effects, stop taking these tablets
and consult your doctor immediately, or contact the nearest hospital emergency room:
Severe allergic reactions (rare):swelling of the tongue and/or throat, difficulty in
swallowing, hives, difficulty breathing, allergic swelling of the face (angioedema/Quincke's
edema), severe dizziness with a very fast heartbeat and heavy sweating.

Serious skin conditions (frequency not known):appearance of skin blisters and rapid
deterioration of your general condition, erosion (including slight bleeding) of the eyes, nose,
mouth/lips or genitals (Stevens-Johnson Syndrome, Lyell's Syndrome, Multiforme Erythema) and
sensitivity to light.

Other serious conditions (frequency not known):yellowing of the skin or the whites of the eyes
(serious damage to the liver cells, jaundice) or fever, rash, and enlargement of the kidneys
sometimes with pain when urinating and lower back pain (serious kidney inflammation).
Other side effects are:

Uncommon(affects 1 to 10 people in 1,000)
headache; dizziness; diarrhea; feeling sick, vomiting; abdominal bloating and flatulence (gas);
constipation; dry mouth; abdominal pain and feeling unwell; rash, exanthema,
eruption; itching; feeling weak, tired or unwell; sleep disturbances.
If you take a proton pump inhibitor like PANCLEUS, especially for a period
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 can increase the risk of osteoporosis) consult your doctor.

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

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

Not known(the frequency cannot be estimated from the available data)
hallucinations, confusion (especially in patients with a history of these symptoms);
decrease in blood sodium levels.
If you take PANCLEUS for more than three months, it is possible that your blood magnesium
levels may decrease. Low magnesium levels can manifest with fatigue, involuntary muscle
contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of
these symptoms, consult your doctor immediately. Low
magnesium levels can also lead to a decrease in blood potassium or calcium levels. The
doctor should decide whether to check magnesium levels in the blood periodically.

Side effects identified through blood tests:
Uncommon(affects 1 to 10 people in 1,000)
increased liver enzymes.

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

Very Rare(affects less than 1 in 10,000)
reduction in the number of platelets, which can cause bleeding or bruising more than
normal; a reduction in the number of white blood cells, which can lead to more frequent
infections.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili”.
By reporting side effects you can help provide more information on the safety
of this medicine.

11. HOW TO STORE PANCLEUS

Keep PANCLEUS out of sight and reach of children.
Do not use PANCLEUS after the expiry date, which is stated on the package 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. FURTHER INFORMATION

What contains PANCLEUS

• The active substanceis pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sesquihydrate sodium).
• The excipientsare: Tablet core: Mannitol, Anhydrous sodium carbonate, Sodium carboxymethylamide (Type A), Acrylic acid - ethyl acrylate copolymer (Eudragit E PO), Calcium stearate, Opadry white OY-D-7233 (hypromellose, titanium dioxide E171, Macrogol 400, sodium lauryl sulfate)

Coating: Kollicoat MAE 30 DP, yellow in color (Acrylic 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
Elliptical, biconvex, dark yellow gastro-resistant tablet.
Packs: HDPE bottle and Al/Al blister
PANCLEUS is available in the following pack:
Pack of 14 gastro-resistant tablets
Not all pack sizes may be marketed.

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

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 Member States of the European Economic Area with the
following denominations: