PANTOPRAZOLO 20 mg Tabletka Powlekana

Treść ulotki

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

PANTOPRAZOLO ALMUS 20 mg gastro-resistant tablets

Generic medicine

Read this leaflet carefully before taking 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 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is PANTOPRAZOLO ALMUS and what it is used for

PANTOPRAZOLO ALMUS contains the active ingredient pantoprazole. PANTOPRAZOLO ALMUS is a
“proton pump inhibitor” selective, 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.
PANTOPRAZOLO ALMUS is used for the treatment of adults and adolescents 12 years of age and older for

• 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.

PANTOPRAZOLO ALMUS is used for the treatment of adults for

• 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 PANTOPRAZOLO ALMUS

Do not take PANTOPRAZOLO ALMUS

• 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 PANTOPRAZOLO ALMUS

• If you have severe liver problems. Tell your doctor if you have ever had liver problems. The doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking PANTOPRAZOLO ALMUS for long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you need continuous treatment with medicines called NSAIDs and are taking PANTOPRAZOLO ALMUS 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 HIV protease inhibitors such as atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
• Taking a proton pump inhibitor such as pantoprazole, especially for a period of more than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Tell your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
• If you take pantoprazole for more than three months, a reduction in blood magnesium levels may occur. A reduction in magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or 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 periodic blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to PANTOPRAZOLO ALMUS that reduces stomach 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 PANTOPRAZOLO ALMUS. Remember to also report any other unwanted effects such as joint pain.
• If you are to undergo a specific blood test (Chromogranin A).

Tell your doctor immediately, before or after taking this medicine, if you notice any of the
following symptoms, which may be a sign of a more serious illness:

• an unintentional weight loss
• vomiting, especially if repeated
• presence of blood in the vomit; this may appear as dark coffee grounds in the vomit
• appearance of blood in the stools which may appear dark or tarry
• difficulty swallowing or pain when swallowing
• appear pale and feel weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a modest increase in infectious diarrhea.

The doctor may decide that you need to undergo some tests to rule out a malignant disease as
pantoprazole also relieves the symptoms of cancer and may cause a delay in diagnosis. If your symptoms
persist despite treatment, further investigations should be considered.
If you take PANTOPRAZOLO ALMUS 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.

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

Other medicines and PANTOPRAZOLO ALMUS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including over-the-counter medicines.
PANTOPRAZOLO ALMUS can affect the effectiveness of other medicines, so tell your doctor if you are
taking:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer) as PANTOPRAZOLO ALMUS may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood clotting or thinning. You may need further checks.
• 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 suspend treatment with PANTOPRAZOLO ALMUS because pantoprazole may increase methotrexate levels in the blood.
• 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
into 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.
You should use this medicine only if the doctor considers the benefit for you greater than the potential risk
to the fetus or the baby.

Driving and using machines
PANTOPRAZOLO ALMUS does not alter or negligibly alters the ability to drive vehicles and use
machinery.
If you experience side effects such as dizziness or visual disturbances, you should not drive or use machinery.

PANTOPRAZOLO ALMUS contains lactose monohydrate and sodium
This medicine contains lactose monohydrate, a type of sugar. If your doctor has diagnosed you with
intolerance to some sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodiumper tablet, i.e. essentially ‘sodium-free’.

3. How to take PANTOPRAZOLO ALMUS

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

Method of administration
Take the tablets 1 hour before meals without chewing or crushing them and swallow them whole with a little
water.
The recommended dose is:

Adults and adolescents 12 years and over

• For the treatment of symptoms associated with gastroesophageal 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 this, any recurrence of symptoms can be controlled by taking one tablet a day, as needed.
• For long-term treatment and for the prevention of recurrent reflux esophagitisThe usual dose is one tablet a day. If the disease recurs, your doctor may double the dose, in which case you may instead use PANTOPRAZOLO ALMUS 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 NSAIDsThe usual dose is one tablet a day.

Patients with liver problems
If you suffer from severe liver problems, you should not take more than one 20 mg tablet a day.

Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.

If you take more PANTOPRAZOLO ALMUS than you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take PANTOPRAZOLO ALMUS
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 PANTOPRAZOLO ALMUS
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, 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 taking these tablets and
consult a doctor immediately, or contact the nearest hospital emergency room:

• Severe allergic reactions (rare frequency:may affect up to 1 in 1,000 people) :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:frequency cannot be estimated based on available data) :appearance of skin blisters and rapid deterioration of your general condition, erosion (including slight 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:frequency cannot be estimated based on available data) :yellowing of the skin or the white part of the eyes (serious damage to liver cells, jaundice) or fever, rash and enlargement of the kidneys sometimes with pain when urinating, and pain in the lower back (serious kidney inflammation) which can lead to possible kidney failure. Other side effects are:

Common(may affect up to 1 in 10 people)
Benign polyps in the stomach.

Uncommon(may affect up to 1 in 100 people)
Headache; dizziness; diarrhea; nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth;
abdominal pain and feeling unwell; rash, exanthema, eruption; itching; feeling
of weakness, fatigue or general malaise; sleep disturbances; hip, wrist or
spine fractures.

Rare(may affect up to 1 in 1,000 people)
Alteration or complete loss of taste; vision disorders such as blurred vision;
hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the extremities (peripheral edema); allergic reactions; depression,
increase in breast volume in men.

Very Rare(may affect up to 1 in 10,000 people)
Disorientation.

Not known(frequency cannot be estimated based on available data)
Hallucinations, confusion (especially in patients with a history of these symptoms); decreased
level of sodium in the blood, decreased level of magnesium in the blood (see section 2),
sensation of tingling, prickling, pinpricks, burning or numbness, erythema, possible joint pains; inflammation of the large intestine, causing persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100 people) An increase in liver enzymes.
• Rare(may affect up to 1 in 1,000 people) an increase in bilirubin; increased levels of fats in the blood; drastic decrease in circulating granulocytes, associated with high fever.
• Very Rare(may affect up to 1 in 10,000 people) a reduction in the number of platelets, which can cause more bleeding or bruising 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 get any side effects, talk to 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 PANTOPRAZOLO ALMUS

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.
Packaging in Bottle
Do not use this medicine more than twenty-eight days after first opening the bottle.
Packaging in Blister
Store at a temperature below 30° C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What PANTOPRAZOLO ALMUS contains

• The active ingredient is pantoprazole. Each tablet contains 20 mg of pantoprazole (as 22.55 mg pantoprazole sodium sesquihydrate).
• The other ingredients are:
• tablet core: microcrystalline cellulose (E460i), lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, vegetable magnesium stearate;
• tablet coating: methacrylic acid-ethyl acrylate copolymer 1:1, sodium lauryl sulfate, polysorbate 80, triethyl citrate (E1505), talc (E553b), Colouring agent (Opadry II 85F32081 yellow): polyvinyl alcohol, macrogol 3350, titanium dioxide (E-171), talc (E553b), yellow iron oxide (E-172), quinoline yellow (E-104).

Description of the appearance of PANTOPRAZOLO ALMUS and contents of the pack
PANTOPRAZOLO ALMUS tablets are film-coated, gastro-resistant, from yellow to
ochre in colour, oval in shape, and biconvex.
Bottle of 14 gastro-resistant tablets.
Pack of 14 and 28 gastro-resistant tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Almus S.r.l.
Via Cesarea, 11/10
16121 Genoa
Italy
E-mail: [email protected]

Manufacturer
Towa Pharmaceutical Europe S.L.
C/ de Sant Martí, 75-97
08107 Martorelles, Barcelona
Spain

PANTOPRAZOLO ALMUS 40 mg gastro-resistant tablets

Generic medicine

Read this leaflet carefully before taking 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 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is PANTOPRAZOLO ALMUS and what it is used for

PANTOPRAZOLO ALMUS contains the active ingredient pantoprazole. PANTOPRAZOLO ALMUS 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.
PANTOPRAZOLO ALMUS is used for the treatment of adults and adolescents 12 years of age and older for

• Reflux esophagitis. An inflammation of the esophagus (the tube connecting the throat to the stomach) accompanied by acid regurgitation. PANTOPRAZOLO ALMUS is used for the treatment of adults for
• An infection with 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 in order to reduce the possibility that these ulcers will return.
• Ulcers of the stomach and duodenum.
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before taking PANTOPRAZOLO ALMUS

Do not take PANTOPRAZOLO ALMUS

• If you are allergic (hypersensitive) 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 PANTOPRAZOLO ALMUS:

• If you have severe liver problems. Tell your doctor if you have ever had liver problems in the past. Your doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are taking PANTOPRAZOLO ALMUS for long-term therapy. If liver enzymes increase, treatment should be discontinued.
• If you have reduced body stores of vitamin B12 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 taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) at the same time as pantoprazole, ask your doctor for specific advice.
• Taking a proton pump inhibitor such as pantoprazole, especially for a period longer than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Tell your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
• If you take pantoprazole for more than three months, a reduction in magnesium levels in the blood may occur. A reduction in magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or 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 periodic blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to PANTOPRAZOLO ALMUS 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 PANTOPRAZOLO ALMUS. Also remember to report any other undesirable effects such as joint pain.
• If you are to undergo a specific blood test (Chromogranin A). Tell your doctor immediatelybefore or after taking this medicine, if you notice any of the following symptoms, which may be a sign of a more serious illness:
• unintentional weight loss
• vomiting, especially if repeated
• presence of blood in the vomit; this may appear as dark coffee grounds in the vomit
• appearance of blood in the stool which may appear dark or tarry
• difficulty swallowing or pain when swallowing
• appearing pale and feeling weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a modest increase in infectious diarrhea.

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 could cause a delay in diagnosis. If your symptoms
persist despite treatment, further investigations should be considered.
If you take PANTOPRAZOLO ALMUS for a long-term treatment (longer than 1 year) your doctor will probably
keep you under regular control. You must report any new or unusual symptom or circumstance
whenever you meet your doctor.

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

Other medicines and PANTOPRAZOLO ALMUS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including over-the-counter medicines.
PANTOPRAZOLO ALMUS can affect the effectiveness of other medicines, so tell your doctor if you are
taking:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) as PANTOPRAZOLO ALMUS may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood thickening or thinning. You may need further monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis or cancer) - if you are taking methotrexate, your doctor may temporarily suspend treatment with PANTOPRAZOLO ALMUS because pantoprazole can increase methotrexate levels in the blood.
• 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
into human breast milk has been reported.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or
pharmacist for advice before taking this medicine.
You should only use this medicine if your doctor considers the benefit to you greater than the potential risk
to the fetus or the baby.

Driving and using machines
PANTOPRAZOLO ALMUS does not alter or alters negligibly the ability to drive vehicles and use
machinery. If you experience side effects such as dizziness or visual disturbances, you should not drive or use
machinery.

PANTOPRAZOLO ALMUS contains lactose monohydrate and sodium
This medicine contains lactose monohydrate, a type of sugar. If your doctor has diagnosed you with
lactose intolerance, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodiumper tablet, i.e. essentially ‘sodium-free’.

3. How to take PANTOPRAZOLO ALMUS

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

Method of administration
Take the tablets 1 hour before meals without chewing or crushing them and swallow them whole with a little
water.

Adults and adolescents 12 years and older

• For the treatment of reflux esophagitisThe 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 withduodenal ulcer and gastric ulcer in combination with two antibiotics (Eradication therapy).One tablet, twice a day plus two tablets of an antibiotic among amoxicillin, clarithromycin and metronidazole (or tinidazole), each taken twice a day with the pantoprazole tablet. Take the

first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour
before dinner and the 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 typically between 4 and 8 weeks. The treatment period for duodenal ulcers is typically between 2 and 4 weeks.
• For the long-term treatment of Zollinger-Ellison syndrome and other conditions in whichtoo much acid is produced in the stomach.The recommended initial dose is usually two tablets a day. Take the two tablets 1 hour before a meal. The doctor may subsequently adjust the dosage, depending on the amount of gastric acid produced. If more than two tablets are prescribed per day, the tablets must be taken twice a day. If the doctor prescribes a daily dose of more than four tablets a day, you will be told exactly when to stop taking the medicine.

Patients with kidney problems
If you have kidney problems you should not take PANTOPRAZOLO ALMUS for the eradication of Helicobacter

pylori.

Patients with liver problems
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).
If you suffer from severe or moderate liver problems, you should not take PANTOPRAZOLO ALMUS 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 PANTOPRAZOLO ALMUS than you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take PANTOPRAZOLO ALMUS
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 PANTOPRAZOLO ALMUS
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, 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 and
consult your doctor immediately, or contact the nearest hospital emergency room:

• Severe allergic reactions (rare frequency:can affect up to 1 in 1,000 people) :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:the frequency cannot be defined based on available data) :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 sensitivity to light.
• Other serious conditions (frequency not known:the frequency cannot be defined based on available data) :yellowing of the skin or the whites of the eyes (serious damage to liver cells, jaundice) or fever, rash, and enlargement of the kidneys sometimes with pain when urinating, and pain in the lower back (serious kidney inflammation) which can lead to possible kidney failure.

Other side effects are:

Common(may affect up to 1 in 10 people)
Benign polyps in the stomach.

Uncommon(may affect up to 1 in 100 people)
Headache; dizziness; diarrhea; nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth;
abdominal pain and feeling unwell; rash; eruption, rash; itching; feeling
of weakness, fatigue or general malaise; sleep disturbances; hip, wrist or
spinal fractures.

Rare(may affect up to 1 in 1,000 people)
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;
high fever; swelling of the extremities (peripheral edema); allergic reactions; depression;
increase in breast volume in men.

Very Rare(may affect up to 1 in 10,000 people)
Disorientation.

Not known(the frequency cannot be defined based on available data)
Hallucinations, confusion (especially in patients with a history of these symptoms); decreased
level of sodium in the blood; decreased level of magnesium in the blood (see section 2),
sensation of tingling, prickling, pinpricks, burning or numbness, erythema, possible joint pains;
inflammation of the large intestine, causing persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon (may affect up to 1 in 100) an increase in liver enzymes.
• Rare (may affect up to 1 in 1,000) an increase in bilirubin; increased levels of fats in the blood; drastic decrease in circulating granulocytes, associated with high fever.
• Very Rare (may affect up to 1 in 10,000) 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; coexisting abnormal reduction in the number of red blood cells and white blood cells, as well as platelets.

Reporting of side effects
If you get any side effects, talk to 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 PANTOPRAZOLO ALMUS

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.
Packaging in a bottle
Do not use this medicine more than twenty-eight days after first opening the bottle.
Packaging in blisters
Store at a temperature below 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What PANTOPRAZOLO ALMUS contains

• The active ingredient is pantoprazole. Each tablet contains 40 mg of pantoprazole (as 45.10 mg pantoprazole sodium sesquihydrate).
• The other ingredients are:
• tablet core: microcrystalline cellulose (E460i), lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, vegetable magnesium stearate;
• tablet coating: methacrylic acid-ethyl acrylate copolymer 1:1, sodium lauryl sulfate, polysorbate 80, triethyl citrate (E1505), talc (E553b), Colorant (Opadry II 85F32029 yellow): polyvinyl alcohol, macrogol 3350, titanium dioxide (E-171), talc (E553b), yellow iron oxide (E-172).

Description of the appearance of PANTOPRAZOLO ALMUS and contents of the pack
PANTOPRAZOLO ALMUS tablets are film-coated, gastro-resistant, from yellow to
ochre in colour, oval in shape, and biconvex.
Bottle of 14 gastro-resistant tablets
Pack of 14 and 28 gastro-resistant tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Almus S.r.l.
Via Cesarea 11/10
16121 Genoa
Italy
E-mail: [email protected]

Manufacturer
Towa Pharmaceutical Europe S.L.
C/ de Sant Martí, 75-97
08107 Martorelles, Barcelona
Spain