GASTROLOC 20 mg Enteric-Coated Tablet

Зміст інструкції

1. GASTROLOC 20 mg gastro-resistant tablets
   1. What is Gastroloc 20 mg and what is it used for
   2. What you need to know before taking Gastroloc 20 mg
   3. How to take Gastroloc 20 mg
   4. Possible side effects
   5. How to store Gastroloc 20 mg
   6. Package contents and other information
2. GASTROLOC 40 mg gastro-resistant tablets
   1. What Gastroloc 40 mg is and what it is used for
   2. What you need to know before taking Gastroloc 40 mg
   3. How to take Gastroloc 40 mg
   4. Possible side effects
   5. How to store Gastroloc 40 mg
   6. Package contents and other information

GASTROLOC 20 mg gastro-resistant tablets

Pantoprazolo
Read this leaflet carefully before you start to use 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 their symptoms are the same as yours, 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 Gastroloc 20 mg is and what it is used for
• 2. What you need to know before you take Gastroloc 20 mg
• 3. How to take Gastroloc 20 mg
• 4. Possible side effects
• 5. How to store Gastroloc 20 mg
• 6. Contents of the pack and other information

1. What is Gastroloc 20 mg and what is it used for

Gastroloc 20 mg 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 intestines.

Gastroloc 20 mg is used for:

Adults and adolescents 12 years and older:

• 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 Gastroloc 20 mg

Do not take Gastroloc 20 mg

• if you are allergic (hypersensitive) to pantoprazole or to any of the other ingredients of this medicine (see section 6).
• If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions
Talk to your doctor or pharmacist before taking Gastroloc 20 mg:

• 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 Gastroloc 20 mg for long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you need continuous treatment with NSAIDs and are taking Gastroloc 20 mg 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.
• If you have ever had a skin reaction after treatment with a medicine similar to Gastroloc 20 mg that reduces gastric acid.
• 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 stop therapy with Gastroloc 20 mg. Remember to also report any other unwanted effects such as joint pain.

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 Gastroloc 20 mg 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 in
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 Gastroloc 20 mg for long-term treatment (more than 1 year) your doctor will probably
keep you under regular control. You should report any new or unusual symptom
whenever you see your doctor.

Other medicines and Gastroloc 20 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including over-the-counter medicines.
Gastroloc 20 mg 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) because Gastroloc 20 mg 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 Gastroloc 20 mg.

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

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

Gastroloc 20 mg contains the coloring agent Ponceau 4R aluminum lake (E124):may
cause allergic reactions.

3. How to take Gastroloc 20 mg

Take this medicine following exactly the instructions of your doctor or pharmacist.

If you have doubts, consult your doctor or pharmacist.

When and how should you take Gastroloc 20 mg?
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 of 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 onetablet a day, as needed.

For long-term treatment and for the prevention of recurrent reflux esophagitis
The usual dose is one tablet a day. If the disorder returns, your doctor may double the dose,
in which case you may instead use Gastroloc 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.

Particular groups of patients:

• 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 Gastroloc 20 mg than you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take Gastroloc 20 mg
Do not take a double dose to make up for a missed dose. Take the normal dose
next at the scheduled time.

If you stop taking Gastroloc 20 mg
Do not stop treatment with these tablets without first consulting your doctor or
pharmacist.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicinecan cause side effects, although not everyone

will experience them.

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:

• Severe allergic reactions (may affect up to 1 in 1,000 patients): swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic facial swelling (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 worsening of your general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, Multiforme erythema) and sensitivity to light.
• Other severe 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 with pain when urinating or lower back pain (severe kidney inflammation). Other possible side effects are:
• Not Common(may affect up to 1 in 100 patients) headache; dizziness; diarrhea; feeling unwell, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; rash, exanthema, eruption; itching; feeling weak, tired or generally unwell; sleep disturbances. If you are taking a proton pump inhibitor such as Gastroloc 20 mg, 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(may affect up to 1 in 1,000 patients)

Alteration or complete loss of the sense 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(may affect up to 1 in 10,000 patients) disorientation.
• Not known(frequency cannot be estimated on the basis of available data): Hallucinations, confusion (especially in patients with a history of these symptoms); sensation of tingling (paresthesia); muscle spasm; decreased levels of sodium in the blood; erythema; possible joint pain. If you take Gastroloc 20 mg for more than three months, blood levels of magnesium may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, seizures, 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. Your doctor may decide to check magnesium levels in the blood periodically.

Side effects identified through blood tests:

• Not Common(may affect up to 1 in 100 patients) an increase in liver enzymes.
• Rare(may affect up to 1 in 1,000 patients) an increase in bilirubin; increased fats in the blood; a sharp decrease in circulating granulocytes, associated with high fever.
• Very Rare(may affect up to 1 in 10,000 patients) a reduction in the number of platelets, which can cause bleeding or bruising more than usual; a reduction in the number of white blood cells, which can lead to more frequent infections; concurrent abnormal reduction in the number of red blood cells and white blood cells, as well as platelets.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
consult your doctor or pharmacist. You can also report side effects directly through
the national reporting system at: http://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 Gastroloc 20 mg

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 package and blister or bottle
after Exp. The expiry date refers to the last day of the month.
This medicine does not require special storage conditions.

Do not throw away any medicine in the 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 GASTROLOC 20 mg contains

• The active ingredient ispantoprazole. Each gastro-resistant tablet contains pantoprazole 20 mg (as pantoprazole sodium sesquihydrate).
• The other ingredients are:Tablet core: calcium stearate, microcrystalline cellulose, crospovidone, hydroxypropylcellulose (type EXF), anhydrous sodium carbonate, anhydrous colloidal silica.

Coating:
hypromellose, yellow iron oxide (E172), macrogol 400, ethyl acrylate-methacrylic acid copolymer
(1:1), polysorbate 80, Ponceau 4R aluminium lake (E124), quinoline yellow aluminium lake
(E104), sodium lauryl sulfate, titanium dioxide (E171), triethyl citrate.

Description of the appearance of Gastroloc 20 mg and package contents
Gastroloc 20 mg gastro-resistant tablets are yellow, oval-shaped tablets (coated with a special
coating layer), available in
Blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 56x1, 60, 84, 90, 98, 100, 100x1, 140
tablets
Containers of 14, 28, 98, 100, 250, 500 tablets

Not all pack sizes may be marketed

Marketing Authorisation Holder
GLAXOSMITHKLINE CONSUMER HEALTHCARE S.P.A. - Via Zambeletti snc - 20021
Baranzate (MI)

Manufacturers responsible for batch release
Salutas Pharma GmbH - Otto-von-Guericke-Allee 1 - 39179 Barleben (Germany)
Lek Spolka Akcyjna – Ul Domaniewska, 50C – 02-672 Warszawa (Poland)
Lek Pharmaceuticals d.d. – Verovskova 57 – 1000 Ljubljana (Slovenia )
Lek Pharmaceuticals d.d. Trimlini 2 D – 9220 Lendava (Slovenia)
Sandoz S.r.l Str. Livezeni nr. 7ª – 540472 Targu Mures (Romania)

This medicinal product is authorised in the member states of the EEA under the following denominations:
Austria: GASTROLOC HEXAL 20 MG - MAGENSAFTRESISTENTE TABLETTEN
Germany: PANTOPRAZOL HEXAL® 20 MG MAGENSAFTRESISTENTE TABLETTEN
Spain: PANTOPRAZOL BEXAL 20 MG COMPRIMIDOS GASTRORESISTENTES EFG
Hungary: PANTOPRAZOL SANDOZ 20 MG GYOMORNEDV-ELLENÁLLÓ TABLETTA
Ireland: PANTOPRAZOLE ROWEX 20 MG GASTRO-RESISTANT TABLETS
Italy: GASTROLOC 20 MG COMPRESSE GASTRORESISTENTI
Luxembourg: PANTOPRAZOL HEXAL 20 MG MAGENSAFTRESISTENTE TABLETTEN
Netherlands: PANTOPRAZOL SANDOZ 20, MAAGSAPRESISTENTE TABLETTEN 20 MG

GASTROLOC 40 mg gastro-resistant tablets

Pantoprazolo
Read this leaflet carefully before you start to use 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 their symptoms are the same as yours, 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 Gastroloc 40 mg is and what it is used for
• 2. What you need to know before you take Gastroloc 40 mg
• 3. How to take Gastroloc 40 mg
• 4. Possible side effects
• 5. How to store Gastroloc 40 mg
• 6. Contents of the pack and other information

1. What Gastroloc 40 mg is and what it is used for

Gastroloc 40 mg 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.

Gastroloc 40 mg 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 pylori in patients with duodenal ulcer and gastric ulcer 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 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 Gastroloc 40 mg

Do not take Gastroloc 40 mg

• if you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of this medicine (see section 6).
• If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions
Talk to your doctor or pharmacist before taking Gastroloc 40 mg:

• If you have severe liver problems. Tell your doctor if you have had liver problems in the past. The doctor will order more frequent monitoring of your liver enzymes, especially if you are taking Gastroloc 40 mg 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.
• If you have ever had a skin reaction after treatment with a medicine similar to Gastroloc 40 mg 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 stop therapy with Gastroloc 40 mg. Remember to also report any other undesirable effects such as joint pain.

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, because Gastroloc 40 mg 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 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 Gastroloc 40 mg for long-term treatment (more than 1 year) your doctor will probably keep you
under regular control. You should report any new or unusual symptom or circumstance
whenever you see your doctor.

Other medicines and Gastroloc 40 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including medicines without a prescription.
Gastroloc 40 mg 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) because Gastroloc 40 mg 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 Gastroloc 40 mg.

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, or think you may be, or are
breastfeeding, you should use this medicine only if your doctor considers the benefit for you
greater than the potential risk to the fetus or infant.
If you are pregnant or breastfeeding, suspect or are planning a
pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

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

Gastroloc 40 mg contains the coloring agent Ponceau 4R aluminium lake (E124):it may
cause allergic reactions.

3. How to take Gastroloc 40 mg

Take this medicine following exactly the instructions of your doctor or pharmacist.

If you have any doubts, consult your doctor or pharmacist.

When and how should you take Gastroloc 40 mg?
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 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 called Helicobacter pylori in 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 tablet of
pantoprazole. 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 for
weeks.

For the treatment of gastric and duodenal ulcers.
The usual dose is one tablet a day. After consulting your doctor, the dose can 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 dose,
depending on the amount of gastric acid produced. If more than two tablets are prescribed per day,
the tablets should be taken twice a day.
If your doctor prescribes a daily dosage 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 Gastroloc 40 mg 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. These tablets are not recommended for use in children under 12 years of age.

If you take more Gastroloc 40 mg than you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take Gastroloc 40 mg
Do not take a double dose to make up for a missed dose. Take the normal dose
next at the scheduled time.

If you stop taking Gastroloc 40 mg
Do not stop treatment with these tablets without first consulting your doctor or
pharmacist.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicinecan cause side effects, although not everyone

will experience them.

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:

• Severe allergic reactions (may affect up to 1 in 1,000 patients): swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, swelling

allergic to 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 worsening of your general condition, erosion (including mild bleeding) of the 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 (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 possible side effects are:
• Not Common(may affect up to 1 in 100 patients) headache; dizziness; diarrhea; feeling unwell, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; rash, exanthema, eruption; itching; feeling weak, tired or generally unwell; sleep disturbances. If you are taking a proton pump inhibitor such as Gastroloc 40 mg, 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(may affect up to 1 in 1,000 patients) Alteration or complete loss of the sense of taste; vision disorders 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(may affect up to 1 in 10,000 patients) disorientation.
• Not known(frequency cannot be estimated based on available data): Hallucinations, confusion (especially in patients with a history of these symptoms); sensation of tingling (paresthesia); muscle spasm; decreased levels of sodium in the blood; erythema; possible joint pain. If you take Gastroloc 40 mg for more than three months, blood levels of magnesium may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to a decrease in blood levels of potassium or calcium. Your doctor may decide to check your magnesium levels in your blood periodically.

Side effects identified through blood tests:

• Not Common(may affect up to 1 in 100 patients) an increase in liver enzymes.
• Rare(may affect up to 1 in 1,000 patients) an increase in bilirubin; increased fats in the blood; sharp decrease in circulating granulocytes, associated with high fever.
• Very Rare(may affect up to 1 in 10,000 patients) a 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; coexisting abnormal reduction in the number of red blood cells and white blood cells, as well as platelets.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
consult your doctor or pharmacist. You can also report side effects directly through
the national reporting system at: http://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 Gastroloc 40 mg

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 package and on the blister or bottle
after Exp. The expiry date refers to the last day of the month.
Do not use Gastroloc after 6 months have passed from the first opening of the HDPE container.
This medicine does not require special 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. Package contents and other information

What GASTROLOC 40 mg contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients are:Tablet core: calcium stearate, microcrystalline cellulose, crospovidone, hydroxypropylcellulose (type EXF), anhydrous sodium carbonate, anhydrous colloidal silica Coating:hypromellose, yellow iron oxide (E172), macrogol 400, ethyl acrylate-methacrylic acid copolymer (1:1), polysorbate 80, Ponceau 4R aluminium lake (E124), quinoline yellow aluminium lake (E104), sodium lauryl sulfate, titanium dioxide (E171), triethyl citrate.

Description of the appearance of Gastroloc 40 mg and package contents
Gastroloc 40 mg gastro-resistant tablets are yellow, oval-shaped tablets (coated with a special
coating layer), available in
Blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 56x1, 60, 84, 90, 98, 100, 100x1, 140 tablets
Containers of 14, 28, 98, 100, 250, 500 tablets

Not all pack sizes may be marketed

Marketing Authorisation Holder
GLAXOSMITHKLINE CONSUMER HEALTHCARE S.P.A. - Via Zambeletti snc - 20021
Baranzate (MI)

Manufacturers responsible for batch release
Salutas Pharma GmbH - Otto-von-Guericke-Allee 1 - 39179 Barleben (Germany)
Lek Spolka Akcyjna – Ul Domaniewska, 50C – 02-672 Warszawa (Poland)
Lek Pharmaceuticals d.d. – Verovskova 57 – 1000 Ljubljana (Slovenia )
Lek Pharmaceuticals d.d. Trimlini 2 D – 9220 Lendava (Slovenia)
Sandoz S.r.l Str. Livezeni nr. 7A – 540472 Targu Mures (Romania)

This medicinal product is authorised in the member states of the EEA under the following denominations:
Austria: GASTROLOC HEXAL 40 MG - MAGENSAFTRESISTENTE TABLETTEN
Germany: PANTOPRAZOL HEXAL® 40 MG MAGENSAFTRESISTENTE TABLETTEN
Spain: PANTOPRAZOL BEXAL 40 MG COMPRIMIDOS GASTRORESISTENTES EFG
Hungary: PANTOPRAZOL SANDOZ 40 MG GYOMORNEDV-ELLENÁLLÓ TABLETTA
Ireland: PANTOPRAZOLE ROWEX 40 MG GASTRO-RESISTANT TABLETS
Italy: GASTROLOC 40 mg gastro-resistant tablets
Luxembourg: PANTOPRAZOL HEXAL 40 MG MAGENSAFTRESISTENTE TABLETTEN
Netherlands: PANTOPRAZOL SANDOZ 40, MAAGSAPRESISTENTE TABLETTEN 40 MG