PANTOREX 20 mg Enteric-Coated Tablets

Содержание инструкции

1. PANTOREX 20 mg gastro-resistant tablets
   1. What PANTOREX is and what it is used for
   2. What you need to know before taking PANTOREX
   3. How to take PANTOREX
   4. Possible side effects
   5. How to store PANTOREX
   6. Package Contents and Other Information
2. PANTOREX 40mg gastro-resistant tablets
   1. What PANTOREX is and what it is used for
   2. What you need to know before taking PANTOREX
   3. How to take PANTOREX
   4. Possible side effects
   5. How to store PANTOREX
   6. Contents of the pack and other information

PANTOREX 20 mg gastro-resistant tablets

Pantoprazole
Generic medicine

Read this leaflet carefully before you start to take this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PANTOREX is and what it is used for

PANTOREX 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.

PANTOREX 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. What you need to know before taking PANTOREX

Do not take PANTOREX

• if you are allergic to pantoprazole or 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 PANTOREX.

• 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 PANTOREX for long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you need continuous treatment with NSAIDs and are taking PANTOREX 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 a medicine containing atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
• Taking a proton pump inhibitor such as PANTOREX, especially for a period longer than one year, may slightly increase your risk of fracture of the hip, wrist or spine. Tell your doctor if you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
• If you have been taking Pantorex for more than three months, the levels of magnesium in your blood may decrease. Low levels of magnesium can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. Tell your doctor immediately if you experience any of these symptoms. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.

Tell your doctor immediatelyif you notice any of the following symptoms:

• an involuntary weight loss
• recurrent vomiting
• difficulty swallowing
• presence of blood in the vomit
• you are pale and feel weak (anemia) chest pain
• stomach pain
• presence of blood in the stools
• severe and/or persistent diarrhea, as PANTOREX has been associated with a modest increase in episodes of infectious diarrhea.
• fatigue, rambling, involuntary muscle contractions, convulsions, dizziness and increased heart rate.

Your doctor may decide that you need to undergo some tests to rule out malignancy,
as pantoprazole also relieves the symptoms of cancer and can cause a delay in diagnosis. If your
symptoms persist, despite treatment, further investigations should be considered.
If you take PANTOREX for long-term treatment (longer than 1 year), your doctor will probably
subject you to regular monitoring. You should report any new or unusual symptom
whenever you see your doctor.

Children and adolescents
The use of Pantorex is not recommended in children, given that its efficacy has not been demonstrated in children
under 12 years of age.

Other medicines and PANTOREX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. This is particularly important if you are taking any of the following
medicines:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer), as PANTOREX may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect the thickening or thinning of the blood. You may need further checks.
• Atazanavir (used to treat HIV infection).
• Methotrexate (used for the treatment of rheumatoid arthritis, psoriasis and cancer) - if you are taking methotrexate, your doctor may temporarily suspend treatment with PANTOREX. Fluvoxamine (used to treat depression and other psychiatric illnesses) - 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 no adequate data regarding the use of pantoprazole in pregnant women.
Excretion in human breast milk has been reported.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, 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. If
you experience side effects such as dizziness or visual disturbances, you should not drive or operate
machinery

3. How to take PANTOREX

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

When and how should you take PANTOREX?
Take the tablets one 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 1 tablet a day. This dose usually 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, each 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 disease returns, your doctor may double the dose,
in which case you can take PANTOREX 40 mg tablets, one a day. After healing, you can
reduce the dose back to one 20mg tablet a day.

Adults:

Prevention of duodenal and gastric ulcers in patients requiring continuous treatment with NSAIDs
The usual dose is 1 tablet a day.

Special patient groups

• If you suffer from severe liver problems, you should not take more than one 20mg tablet a day.
• Children under 12 years of age. These tablets are not recommended for use in children under 12 years of age.

If you take more PANTOREX than you should
Inform your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take PANTOREX
Do not take a double dose to make up for a missed dose. Take the next normal dose
at the scheduled time.

If you stop taking PANTOREX
Do not stop treatment with these tablets without first consulting your doctor or
pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

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

• Serious allergic reactions (rare; affects 1 in 10,000 users):swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the face (angioedema/Quincke's edema), severe dizziness with a 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 mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, Multiforme erythema) and light sensitivity.
• Other serious conditions (frequency not known):yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash and enlargement of the kidneys sometimes painful with pain when urinating and back pain (severe kidney inflammation). can
• lead to possible kidney failure.

Other possible side effects are:

• Common: Benign polyps in the stomach
• Uncommon(affects 1 to 10 users out of 1,000): headache; dizziness; diarrhea; feeling of nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rashes, rash, eruption, itching; feeling of weakness, fatigue or general malaise; sleep disturbances; hip, wrist and spine fracture.
• Rare(affects 1 to 10 users out of 10,000): distortion or complete loss of taste; visual disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities (peripheral edema); allergic reactions; depression; enlargement of the breasts in men.
• Very rare(affects less than 1 in 10,000 users): disorientation.
• 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), tingling, pins and needles, burning or numbness, erythema, possible joint pain

Inflammation of the large intestine, causing persistent watery diarrhea

Side effects identified through blood tests:

• Uncommon(affects 1 to 10 users out of 1,000): an increase in liver enzymes.
• Rare(affects 1 to 10 users out of 10,000): an increase in bilirubin; increased fats in the blood; a sudden drop in circulating granular white blood cells associated with high fever.
• Very rare(affects less than 1 in 10,000 users): a reduction in the number of platelets which may cause more bleeding or bruising than normal; a reduction in white blood cells which may lead to more frequent infections; concurrent abnormal reduction in the number of red blood cells, white blood cells, and platelets.

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
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store PANTOREX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, on the carton and on the blister
after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 PANTOREX contains

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

Description of the appearance of PANTOREX and package contents
Gastro-resistant tablet, light yellow in colour, elliptical in shape, biconvex.
Package:
Blisters: 14 tablets.
Blisters: 28 tablets.

Marketing Authorisation Holder
Dymalife Pharmaceutical
Via Bagnulo 95
80063 Piano di Sorrento (Na)
Italy

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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy PANTOREX

This leaflet was last updated on:

PANTOREX 40mg gastro-resistant tablets

Pantoprazole
Generic medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PANTOREX is and what it is used for

PANTOREX 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.

PANTOREX is used for:

Adults and adolescents 12 years and over:

• Reflux esophagitis. An inflammation of the esophagus (the tube connecting the throat to the stomach), accompanied by acid regurgitation.

Adults:

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

2. What you need to know before taking PANTOREX

Do not take PANTOREX

• if you are allergic to pantoprazole or 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 PANTOREX.

• 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 PANTOREX 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 can lead to reduced absorption of vitamin B12.
• If you are simultaneously taking a medicine containing atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
• Taking a proton pump inhibitor such as PANTOREX, particularly for a period of more than one year, may slightly increase your risk of fracture of the hip, wrist or spine. Tell your doctor if you suffer from osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you are taking Pantorex for more than three months, the levels of magnesium in your blood
may decrease. Low levels of magnesium can cause fatigue, involuntary
muscle contractions, disorientation, convulsions, dizziness, increased heart rate. Tell
your doctor immediately if you experience any of these symptoms. Low levels of magnesium can
also lead to a reduction in potassium or calcium levels in the blood. The doctor may decide
to perform regular blood tests to monitor your magnesium levels.

• if

Tell your doctor immediatelyif you notice any of the following symptoms:

• an unintentional weight loss
• recurrent vomiting
• difficulty swallowing
• blood in your vomit
• you are pale and feel weak (anemia)
• blood in your stools
• severe and/or persistent diarrhea, as PANTOREX has been associated with a modest increase in episodes of infectious diarrhea. chest pain
• stomach pain
• fatigue, rambling, involuntary muscle contractions, convulsions, dizziness and increased heart rate.

Your 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 can cause a delay in diagnosis. If your
symptoms persist despite treatment, further investigations should be considered.
If you take PANTOREX for long-term treatment (longer than 1 year), your doctor will probably
subject you to a regular check-up. You should report any new or exceptional symptom and
circumstance whenever you see your doctor.

Children and adolescents
The use of Pantorex is not recommended in children, given that efficacy has not been demonstrated in
children under 12 years of age

Other medicines and PANTOREX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. This is particularly important if you are taking any of the following
medicines:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer), as PANTOREX may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect the thickening or thinning of the blood. You may need further checks.
• Atazanavir (used to treat HIV infection).
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer) - if you are taking methotrexate, your doctor may temporarily suspend treatment with PANTOREX. Fluvoxamine (used to treat depression and other psychiatric illnesses) - 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 no adequate data regarding the use of pantoprazole in pregnant women.
Excretion in human breast milk has been reported.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, you should only use this medicine if your doctor considers the benefit to you 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 side effects such as dizziness or visual disturbances, you should not drive or use machines.

3. How to take PANTOREX

Always take this medicine exactly as your doctor has told you. If you have any doubts, ask your
doctor or pharmacist.

When and how should you take PANTOREX?
Take the tablets one 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 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 caused by 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 antibiotic tablets, i.e. amoxicillin or clarithromycin and
metronidazole (or tinidazole), each to be taken twice a day with the pantoprazole tablet.
Take the first pantoprazole tablet in the morning, 1 hour before breakfast and the second one hour
before the evening meal, or 1 hour before taking these antibiotics. The usual treatment period is one or 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 between 4 and
8 weeks. The period for the treatment of duodenal ulcers is typically 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 two tablets 1 hour before a meal. Afterwards, your doctor may adjust the
dosage, depending on the amount of gastric acid produced. If more than two tablets a day are prescribed, the tablets must be taken twice a day.
If your doctor prescribes a daily dose of more than four tablets a day, they will tell you exactly
when to stop taking the medicine.

Special groups of patients

• If you have kidney problems, moderate or severe liver problems, you should not take PANTOREX for the eradication of Helicobacter pylori.
• If you suffer from severe liver problems, you should not take more than one 20 mg pantoprazole tablet a 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 PANTOREX than you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take PANTOREX
Do not take a double dose to make up for a missed dose. Take the next normal dose
at the scheduled time.

If you stop taking PANTOREX
Do not stop treatment with these tablets without first consulting your doctor or
pharmacist.
If you have any doubts about the use of PANTOREX, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

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:

• Serious allergic reactions (rare; affects 1 in 10,000 users):swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the face (angioedema/Quincke's edema), severe dizziness with a 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 mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, Multiforme erythema) and light sensitivity.
• Other serious conditions (frequency not known):yellowing of the skin or whites of the eyes (severe damage to liver cells, jaundice) or fever, rash and enlargement of the kidneys sometimes painful with pain when urinating and back pain (severe kidney inflammation). Which can lead to possible kidney failure.

Other possible side effects are:

• Common: Benign polyps in the stomach
• Uncommon(affects 1 to 10 users out of 1,000) headache; dizziness; diarrhea; feeling of nausea, vomiting; abdominal distension and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rashes, exanthema, eruption, itching; feeling of weakness, fatigue or general malaise; sleep disturbances; hip, wrist or spine fracture.
• Rare(affects 1 to 10 users out of 10,000) distortion or complete loss of taste; visual disturbances such as blurred vision; hives; 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(frequency cannot be defined based on available data) hallucinations, confusion (especially in patients with a history of these symptoms); decreased levels of sodium in the blood. decreased level of magnesium in the blood (see paragraph 2), sensation of tingling, pins and needles, burning or numbness, erythema, possible joint pain.

Inflammation of the large intestine, causing persistent watery diarrhea

Side effects identified through blood tests:

• Uncommon(affects 1 to 10 users out of 1,000) An increase in liver enzymes.
• Rare(affects 1 to 10 users out of 10,000) An increase in bilirubin; increased fats in the blood; sudden decrease in circulating granular white blood cells associated with high fever.
• Very rare(affects less than 1 in 10,000) a reduction in the number of platelets which can cause more bleeding or bruising than normal; a reduction in white blood cells which can lead to more frequent infections; simultaneous abnormal reduction in the number of red blood cells, white blood cells, and platelets.

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

5. How to store PANTOREX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp. The expiry date
refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What PANTOREX contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients are: Tablet core: mannitol, anhydrous sodium carbonate, sodium starch glycolate (type A), basic butylated methacrylate copolymer (Eudragit E PO), calcium stearate. Coating: Opadry white OY-D-7233 (hypromellose, titanium dioxide E171, talc, macrogol 400, sodium lauryl sulfate). Enteric coating: Kollicoat MAE 30 DP, yellow (methacrylic acid - ethyl acrylate copolymer dispersion, propylene glycol, yellow iron oxide (E172), titanium dioxide E171, talc).

Description of the appearance of PANTOREX and contents of the pack
Gastro-resistant tablet, dark yellow in colour, elliptical in shape, biconvex.
Pack:
Blisters: 14 tablets
Blisters: 28 tablets.

Marketing Authorisation Holder
Dymalife Pharmaceutical
Via Bagnulo 95
80063 Piano di Sorrento (Na)
Italy

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

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

This leaflet was last updated on