Package leaflet: Information for the patient

GASTROLOC 20 mg gastro-resistant tablets

pantoprazole
Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Gastroloc is and what it is used for
What you need to know before taking Gastroloc
How to take Gastroloc
Possible side effects
How to store Gastroloc
Contents of the pack and other information

1. What Gastroloc is and what it is used for

Gastroloc contains the active substance pantoprazole. Pantoprazole 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 is used for the treatment of adults and adolescents aged 12 years and older for:

Symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with gastro-oesophageal reflux disease caused by acid reflux from the stomach.
Long-term treatment of reflux oesophagitis (inflammation of the oesophagus accompanied by acid regurgitation from the stomach) and prevention of its recurrence.

Gastroloc is used for the treatment of adults for:

Prevention of duodenal and gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in at-risk patients who require continuous treatment with NSAIDs.

2. What you need to know before taking Gastroloc

Do not take Gastroloc

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Gastroloc:

If you have severe liver problems. Inform your doctor if you have previously had liver problems. Your doctor may arrange for more frequent monitoring of your liver enzymes, especially if you are taking Gastroloc for long-term treatment. If your liver enzymes increase, treatment should be discontinued.
If you require ongoing treatment with NSAIDs and are taking Gastroloc because you are at 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. Consult your doctor if you experience any of the following symptoms, which may indicate low vitamin B12 levels:
extreme tiredness or lack of energy
tingling or prickling sensations
red or sore tongue, mouth ulcers
muscle weakness
vision disturbances
memory problems, confusion, depression
If you are simultaneously taking a proton pump inhibitor such as pantoprazole and a protease inhibitor for HIV, such as atazanavir (for treatment of HIV infection), ask your doctor for specific advice.
Patients taking a proton pump inhibitor such as pantoprazole, particularly for more than one year, may have a slightly increased risk of fractures of the hip, wrist, or spine. Speak to your doctor if you have osteoporosis (reduced bone density) or if your doctor tells you that you are at risk of osteoporosis (for example, if you are taking steroids).
If you have been taking Gastroloc for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or increased heart rate. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may also lead to reduced serum levels of calcium or potassium. Your doctor may decide to perform regular tests to monitor your magnesium levels.
If you need to undergo a specific blood test (Chromogranin A).
If you have ever had a skin reaction after treatment with a medicine similar to Gastroloc that reduces gastric acidity. If you notice the appearance of a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Gastroloc. Remember to also report any other adverse effects such as joint pain.

Contact your doctor immediately before or after taking this medicine
if you experience any of the following symptoms, which may be signs of another, more serious condition:

unexplained weight loss
vomiting, especially if repeated
presence of blood in vomit; this may appear as dark coffee-ground-like material in the vomit
appearance of blood in stools, which may appear dark or tarry
difficulty swallowing or pain when swallowing
looking pale and feeling weak (anaemia)
chest pain
stomach pain
severe and/or persistent diarrhoea, as this medicine has been associated with a slight increase in infectious diarrhoea.
Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme have been reported in association with pantoprazole treatment. Stop using pantoprazole and contact your doctor immediately if you notice any symptoms related to these serious skin reactions, described in section 4.

Your doctor may decide that you need certain tests to rule out malignancy,
as pantoprazole can also relieve symptoms of cancer and may delay diagnosis. If your
symptoms persist despite treatment, further investigations should be considered.
If you take Gastroloc 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
each time you see your doctor.

Children and adolescents
Gastroloc is not recommended in children, as it has not been shown to be effective in children under 12 years of age.

Other medicines and Gastroloc
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.
This is because Gastroloc may affect the effectiveness of other medicines, so 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 Gastroloc may prevent these and other medicines from working properly.
Warfarin and phenprocoumon, which affect blood clotting or thinning. You may need additional monitoring.
Medicines used to treat HIV infection, such as atazanavir.
Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily discontinue treatment with Gastroloc, as pantoprazole may increase methotrexate levels in the blood.
Fluvoxamine (used to treat depression and other psychiatric disorders) – if you are taking fluvoxamine, your doctor should reduce your dose.
Rifampicin (used to treat infections).
St. John’s wort (Hypericum perforatum) (used to treat mild depression).

Talk to your doctor before taking Gastroloc if you need to undergo a specific urine test (for THC, tetrahydrocannabinol).

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

Driving and using machines
Gastroloc has no effect or a negligible effect on the ability to drive and use machines.
If you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.

Gastroloc contains a colouring agent and sodium
This medicine contains the azo colouring agent Ponceau 4R aluminium lake (E124), which may cause allergic reactions.
This medicine contains less than 1 mmol of sodium (23 mg) per gastro-resistant tablet, i.e. essentially ‘sodium-free’.

3. How to take Gastroloc

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Method of administration
Take the tablets 1 hour before a meal. Do not chew or crush them; swallow the tablets whole with
a little water.
The recommended 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 daily. This dose usually provides relief within 2–4 weeks,
and in most cases within a further 4 weeks. Your doctor will advise you on how long to continue taking the medicine. Thereafter, any recurrence of symptoms can be managed by taking one tablet daily as needed.
For long-term treatment and prevention of recurrence of reflux oesophagitis The usual dose is one tablet daily. If symptoms return, your doctor may double the dose; in this case, you may instead use Gastroloc 40 mg tablets, one tablet daily. After healing, the dose may be reduced back to one 20 mg tablet daily.

Adults

For the prevention of duodenal and gastric ulcers in patients requiring continuous treatment with NSAIDs The usual dose is one tablet daily.

Hepatic impairment
If you suffer from severe liver problems, you must not take more than one 20 mg tablet daily.
Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.
If you take more Gastroloc than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Gastroloc
Do not take a double dose to make up for the missed dose. Take the next dose at the scheduled time.
If you stop taking Gastroloc
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop treatment with these tablets immediately
and consult your doctor immediately, or contact the emergency department of the nearest hospital:

Severe allergic reactions (uncommon frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
Severe skin disorders (frequency not known: frequency cannot be estimated from the available data): you may notice one or more of the following symptoms:
appearance of skin blisters and rapid worsening of your general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arm), and blood tests may show changes in certain types of white blood cells or liver enzymes.
Reddish, flat, circular or target-shaped rashes on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Other serious conditions (frequency not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, rash, and kidney enlargement sometimes with pain when urinating or lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other side effects include:

Common (may affect up to 1 in 10 people): benign gastric polyps.
Uncommon (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; feeling unwell, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash, exanthema, eruption; pruritus; feeling of weakness, fatigue or general malaise; sleep disorders, hip, wrist or spinal fracture.
Rare (may affect up to 1 in 1,000 people): altered or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of extremities (peripheral oedema); allergic reactions; depression; breast enlargement in men.
Very rare (may affect up to 1 in 10,000 people): disorientation.
Not known (frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients with prior experience of these symptoms), tingling sensation, itching, pins and needles, burning or numbness; erythema; possible joint pain; inflammation of the large intestine causing persistent watery diarrhoea.

Side effects identified through blood tests:

Uncommon (may affect up to 1 in 100 people): increased liver enzymes.
Rare (may affect up to 1 in 1,000 people): increased bilirubin; increased levels of blood lipids; marked decrease in circulating granulocytes, associated with high fever.
Very rare (may affect up to 1 in 10,000 people): reduced platelet count, which may cause increased bleeding or bruising; reduced white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red blood cells, white blood cells, and platelets.
Not known (frequency cannot be estimated from the available data): decreased levels of sodium, magnesium, calcium, or potassium in the blood (see section 2).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via 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 Gastroloc

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 blister pack, carton or HDPE bottle after "EXP.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use Gastroloc beyond 6 months after first opening the HDPE bottle.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Gastroloc contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole
(as sodium sesquihydrate).
The other components are:
Tablet core: calcium stearate, microcrystalline cellulose, crospovidone (type A),
hydroxypropylcellulose (type EXF), anhydrous sodium carbonate, anhydrous colloidal silica.
Coating: hypromellose, yellow iron oxide (E172), macrogol 400, methacrylic acid-ethyl acrylate 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 and the contents of the pack
Gastroloc gastro-resistant tablets are yellow, oval tablets (coated with a special coating layer), approximately 8.9 x 4.6 mm, available in:
Blister packs containing: 7, 10, 14, 15, 20, 28, 30, 50, 56, 56x1, 60, 84, 90, 98, 100, 100x1, 140 tablets;
Bottles containing: 14, 28, 98, 100, 250, 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milano
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)
Lek S.A. - ul. Podlipie 16 - 95-010 Strykow (Poland)
This medicinal product has been authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following names:
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 1A Pharma 20 MG MAAGSAPRESISTENTE TABLETTEN
This summary of product characteristics was last approved on

Patient Information Leaflet

GASTROLOC 40 mg gastro-resistant tablets

pantoprazole
Generic Medicine
Please read this leaflet carefully before using 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Gastroloc is and what it is used for
What you need to know before taking Gastroloc
How to take Gastroloc
Possible side effects
How to store Gastroloc
Contents of the pack and other information

1. What Gastroloc is and what it is used for

Gastroloc contains the active substance pantoprazole. Pantoprazole 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 is used for the treatment of adults and adolescents aged 12 years and older for:

Reflux esophagitis. An inflammation of the esophagus (the tube connecting the throat to the stomach) associated with regurgitation of gastric acid.

Gastroloc is used for the treatment of adults for:

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 likelihood of these ulcers recurring.
Stomach and duodenal ulcers.
Zollinger-Ellison syndrome and other conditions in which excessive acid is produced in the stomach.

2. What you need to know before taking Gastroloc

Do not take Gastroloc

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Gastroloc:

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 Gastroloc for long-term treatment. If your liver enzymes increase, treatment should be discontinued.
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. Consult your doctor if
you notice any of the following symptoms, which may indicate low vitamin B12 levels:

extreme tiredness or lack of energy
tingling or prickling sensations
red or sore tongue, mouth ulcers
muscle weakness
vision disturbances
memory problems, confusion, depression
If you are simultaneously taking a protease inhibitor for HIV, such as atazanavir (for treatment of HIV infection), ask your doctor for specific advice.
Patients taking a proton pump inhibitor such as pantoprazole, particularly for more than one year, may have a slightly increased risk of fractures of the hip, wrist, or spine. Consult your doctor if you have osteoporosis (reduced bone density) or if your doctor tells you that you are at risk of osteoporosis (e.g., if you are taking steroids).
If you have been taking Gastroloc for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced serum calcium or potassium levels. Your doctor may decide to perform regular tests to monitor your magnesium levels.
If you need to undergo a specific blood test (Chromogranin A).
If you have ever had a skin reaction after treatment with a medicine similar to Gastroloc that reduces gastric acidity.

If you develop a skin rash, especially in areas exposed to sunlight, consult your
doctor as soon as possible, as it may be necessary to discontinue treatment with Gastroloc. Remember to also report any other adverse effects such as joint pain.
Inform your doctor immediately before or after taking this medicine
if you notice any of the following symptoms, which may indicate a different, more serious condition:

unintentional weight loss
vomiting, particularly if repeated
presence of blood in vomit; this may appear as dark coffee-ground material in vomit
appearance of blood in stools, which may appear dark or tarry
difficulty swallowing or pain when swallowing
looking pale and feeling weak (anaemia)
chest pain
stomach pain
severe and/or persistent diarrhoea, as this medicine has been associated with a slight increase in infectious diarrhoea.
Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme have been reported in association with pantoprazole treatment. Stop using pantoprazole and contact your doctor immediately if you notice any symptoms related to these serious skin reactions, described in section 4.

Your doctor may decide that you need certain tests to rule out malignancy,
as pantoprazole relieves symptoms of cancer and may delay diagnosis. If your
symptoms persist despite treatment, further investigations should be considered.
If you take Gastroloc for long-term treatment (over 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances each time you see your doctor.
Children and adolescents
Gastroloc is not recommended in children, as its effectiveness has not been demonstrated in children under 12 years of age.
Other medicines and Gastroloc
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.
This is because Gastroloc may affect the effectiveness of other medicines, so 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 Gastroloc may prevent these and other medicines from working properly.
Warfarin and phenprocoumon, which affect blood clotting or thinning. You may need additional monitoring.
Medicines used to treat HIV infection, such as atazanavir.
Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily discontinue treatment with Gastroloc, as pantoprazole may increase methotrexate levels in the blood.
Fluvoxamine (used to treat depression and other psychiatric disorders) – if you are taking fluvoxamine, your doctor should reduce your dose.
Rifampicin (used to treat infections).
St. John’s wort (Hypericum perforatum) (used to treat mild depression).

Talk to your doctor before taking Gastroloc if you are due to undergo a specific urine test
(for THC, tetrahydrocannabinol).
Pregnancy, breastfeeding, and fertility
There are insufficient data on the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported.
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
You should use this medicine only if your doctor considers the benefit to you greater than the potential risk to the fetus or infant.
Driving and using machines
Gastroloc does not affect, or has a negligible effect on, the ability to drive and use machines.
If you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.
Gastroloc contains a colouring agent and sodium
This medicine contains the azo colouring agent Ponceau 4R aluminium lake (E 124), which may cause allergic reactions.
This medicine contains less than 1 mmol of sodium (23 mg) per gastro-resistant tablet, i.e., essentially ‘sodium-free’.

3. How to take Gastroloc

Take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, consult your doctor or pharmacist.
Method of administration
Take the tablets 1 hour before a meal, without chewing or crushing them, swallowing them whole with
a little water.
The recommended dose is:
Adults and adolescents aged 12 years and older:

For the treatment of reflux esophagitis The usual dose is one tablet per day. Your doctor may instruct you to increase the dose to two tablets per 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 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—either 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 per 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 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 per day. Take the two tablets 1 hour before a meal. Your doctor may later adjust the dose depending on the amount of gastric acid produced. If more than two tablets per day are prescribed, the tablets should be taken twice daily. If your doctor prescribes a daily dosage of more than four tablets per day, you will be given specific instructions on when to stop taking the medicine.

Renal impairment
If you have kidney problems, you must not take Gastroloc for the eradication of Helicobacter pylori.
Hepatic impairment
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).
If you have moderate to severe liver problems, you must not take Gastroloc for the eradication of Helicobacter pylori.
Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.
If you take more Gastroloc than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Gastroloc
Do not take a double dose to make up for the forgotten dose. Take your next dose at the usual time.
If you stop taking Gastroloc
Do not stop treatment with these tablets without first consulting your doctor or pharmacist.
If you have any doubts about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects, stop taking this medicine immediately and consult your doctor immediately, or contact the emergency department of the nearest hospital:

Severe allergic reactions (rare frequency: may affect up to 1 in 1,000 patients): swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the face (Quincke's oedema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
Severe skin disorders (frequency not known: frequency cannot be estimated from available data): you may notice one or more of the following symptoms: appearance of skin blisters and rapid worsening of your general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arm), and blood tests may show changes in certain types of white blood cells or liver enzymes.
Flat, non-elevated red spots, circular or target-shaped, on the trunk, often with blisters in the centre, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other serious conditions (frequency not known) yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash, and swollen kidneys sometimes with pain on urination or back pain (severe kidney inflammation), which may lead to kidney failure.
Other side effects include:

Common (may affect up to 1 in 10 people): benign stomach polyps.
Uncommon (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; feeling unwell, vomiting; bloating 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, hip, wrist or spinal fracture.
Rare (may affect up to 1 in 1,000 people): altered or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the extremities (peripheral oedema); allergic reactions; depression, breast enlargement in men.
Very rare (may affect up to 1 in 10,000 people): disorientation.
Frequency not known (frequency cannot be estimated from available data): hallucinations, confusion (especially in patients with prior experience of these symptoms), tingling sensation, itching, pins and needles, burning or numbness sensation, erythema, possible joint pain; inflammation of the large intestine causing persistent watery diarrhoea.

Side effects identified through blood tests:

Uncommon (may affect up to 1 in 100 people): increased liver enzymes.
Rare (may affect up to 1 in 1,000 people): increased bilirubin; increased levels of fats in the blood; marked decrease in circulating granulocytes, associated with high fever.
Very rare (may affect up to 1 in 10,000 people): reduced platelet count, which may cause bleeding or bruising more than normal; reduced white blood cell count, which may lead to more frequent infections; concurrent abnormal reduction in red blood cells, white blood cells, and platelets.
Frequency not known (frequency cannot be estimated from available data): decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via 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 Gastroloc

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 blister, packaging or bottle after "EXP.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use Gastroloc beyond 6 months after first opening the HDPE bottle.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Gastroloc contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole
(as sodium sesquihydrate).
The other components are:
Tablet core: calcium stearate, microcrystalline cellulose, crospovidone (type A),
hydroxypropylcellulose (type EXF), anhydrous sodium carbonate, anhydrous colloidal silica.
Coating: hypromellose, yellow iron oxide (E 172), macrogol 400, methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80, Ponceau 4R aluminium lake (E 124), quinoline yellow aluminium lake (E 104), sodium lauryl sulfate, titanium dioxide (E 171), triethyl citrate.
Description of the appearance of Gastroloc and pack contents
Gastroloc gastro-resistant tablets are yellow, oval tablets (coated with a special coating layer), approximately 11.7 x 6.0 mm in size, available in:
Blister packs containing: 7, 10, 14, 15, 20, 28, 30, 50, 56, 56x1, 60, 84, 90, 98, 100, 100x1, 140 tablets.
Bottles containing: 14, 28, 98, 100, 250, 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milano
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)
Lek S.A. - ul. Podlipie 16 - 95-010 Strykow (Poland)
This medicinal product has been authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
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 COMPRESSE GASTRORESISTENTI
Luxembourg: PANTOPRAZOL HEXAL 40 MG MAGENSAFTRESISTENTE TABLETTEN
Netherlands: PANTOPRAZOL 1A Pharma 40 MG, MAAGSAPRESISTENTE TABLETTEN
This patient information leaflet was last approved on