Pantoprazole Almus

Patient Information Leaflet

PANTOPRAZOLE ALMUS 20 mg gastro-resistant tablets

Generic medicine
Please read all of 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 give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

PANTOPRAZOLO ALMUS contains the active substance 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 intestine.
PANTOPRAZOLO ALMUS is used to treat adults and adolescents aged 12 years 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 to treat 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 ongoing NSAID treatment.

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. Inform your doctor if you have ever had liver disease. Your doctor may arrange for more frequent monitoring of your liver enzymes, especially if you are taking PANTOPRAZOLO ALMUS for long-term treatment. If liver enzymes increase, treatment should be discontinued.
• If you require ongoing treatment with medicines called NSAIDs and are taking PANTOPRAZOLO ALMUS because you are at 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 older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
• If you have low body reserves or risk factors for low vitamin B12 levels and are undergoing long-term treatment with pantoprazole. As with all agents that reduce acidity, pantoprazole may lead to reduced absorption of vitamin B12.
• If you are taking protease inhibitors for HIV, such as atazanavir (for treatment of HIV infection), consult your doctor for specific advice.
• Taking a proton pump inhibitor such as pantoprazole, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Inform 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, it may lead to decreased magnesium levels in the blood. Low magnesium levels may present as fatigue, involuntary muscle contractions, confusion, seizures, dizziness or rapid heartbeat. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to decreased 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 develop a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as treatment with PANTOPRAZOLO ALMUS may need to be stopped. Remember to also report any other adverse effects such as joint pain.
• If you need to undergo a specific blood test (chromogranin A).

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

• Unintentional weight loss
• Vomiting, particularly if repeated
• Blood in vomit; this may appear as dark coffee-ground 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.

Your doctor may decide that you need further tests to rule out a malignant disease, as pantoprazole may relieve symptoms of cancer and could therefore delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you are taking PANTOPRAZOLO ALMUS for long-term treatment (over 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances at every medical visit.

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

Other medicines and PANTOPRAZOLO ALMUS
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines without a prescription.
PANTOPRAZOLO ALMUS 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 PANTOPRAZOLO ALMUS may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood clotting. 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 PANTOPRAZOLO ALMUS because pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders) – 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 insufficient data on the use of pantoprazole in pregnant women. Excretion into human breast milk has been reported.
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should use this medicine only if your doctor considers the benefit to you to be greater than the potential risk to the foetus or infant.

Driving and using machines
PANTOPRAZOLO ALMUS does not affect or affects negligibly the ability to drive and use machines.
However, if you experience adverse effects such as dizziness or visual disturbances, you must not drive or use machines.

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

3. How to take PANTOPRAZOLE ALMUS

Take this medicine exactly as instructed by 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, swallowing them whole with a little
water.
The recommended dose is:
Adults and adolescents aged 12 years and above

• For the treatment of symptoms associated with gastroesophageal reflux disease (e.g. heartburn, acid regurgitation, painful swallowing) The usual dose is one tablet daily. This dose normally provides relief within 2–4 weeks, and at most after a further 4 weeks. Your doctor will advise you on how long to continue taking the medicine. After this, any recurrence of symptoms can be managed by taking one tablet daily as needed.
• For long-term treatment and prevention of recurrence of reflux esophagitis The usual dose is one tablet daily. If the disease recurs, your doctor may double the dose; in this case, you may instead use PANTOPRAZOLE ALMUS 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.

Patients with liver problems
If you have severe liver impairment, you must not take more than one 20 mg tablet per day.
Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.
If you take more PANTOPRAZOLE ALMUS than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take PANTOPRAZOLE ALMUS
Do not take a double dose to make up for the missed dose. Take the next dose at the usual scheduled time.
If you stop taking PANTOPRAZOLE ALMUS
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, 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 this medicine immediately and
contact your doctor or go to the nearest hospital emergency department:

• Severe allergic reactions (rare 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.
• Serious skin disorders (frequency not known: frequency cannot be estimated from the 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, Erythema multiforme), and light sensitivity.
• Other serious disorders (frequency not known: frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash and kidney enlargement sometimes with painful urination, and pain in the lower back (severe kidney inflammation) which may lead to possible kidney failure.

Other side effects are:

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

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

Rare (may affect up to 1 in 1,000 people)
Altered or complete loss of taste; vision disorders 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 a history of these symptoms); decrease in blood sodium levels, decrease in blood magnesium levels (see section 2), sensations of tingling, pricking, 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 blood lipid levels; a drastic 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; concomitant abnormal reduction in red blood cells, white blood cells, and platelets.

Reporting of side effects
If you experience any side effect, 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 the website
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.
Bottle packaging
Do not use this medicine more than twenty-eight days after first opening the bottle.
Blister packaging
Store below 30°C.
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 PANTOPRAZOLO ALMUS contains

• The active substance is pantoprazole. Each tablet contains 20 mg of pantoprazole (as sodium sesquihydrate 22.55 mg).
• The other components are:
  • tablet core: microcrystalline cellulose (E460i), lactose monohydrate, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate (vegetable origin);
  • tablet coating: methacrylic acid-ethyl acrylate copolymer 1:1, sodium lauryl sulfate, polysorbate 80, triethyl citrate (E1505), talc (E553b), Colourant (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 package contents
PANTOPRAZOLO ALMUS tablets are gastro-resistant film-coated, yellow to ochre in colour, oval-shaped, biconvex tablets.
Bottle containing 14 gastro-resistant tablets.
Carton pack containing 14 and 28 gastro-resistant tablets in blister packs.
Not all pack sizes may be marketed.

Marketing Authorization 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

Patient Information Leaflet

PANTOPRAZOLE ALMUS 40 mg gastro-resistant tablets

Equivalent medicine
Please 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 give it to others, even if their symptoms are the same as yours, because 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:

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

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

PANTOPRAZOLE ALMUS contains the active substance pantoprazole. PANTOPRAZOLE 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 intestine.
PANTOPRAZOLE ALMUS is used in the treatment of adults and adolescents aged 12 years and older for:

• Gastroesophageal reflux disease (GORD). Inflammation of the oesophagus (the tube connecting the throat to the stomach) associated with regurgitation of gastric acid.

PANTOPRAZOLE ALMUS is used in 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 risk of recurrence of these ulcers.
• 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 PANTOPRAZOLE ALMUS

Do not take PANTOPRAZOLE 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 PANTOPRAZOLE ALMUS:

• If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor may arrange for more frequent monitoring of your liver enzymes, especially if you are taking PANTOPRAZOLE ALMUS for long-term treatment. If your liver enzymes increase, treatment should be discontinued.
• If you have low body stores 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.
• If you are concurrently taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection), consult your doctor for specific advice.
• Taking a proton pump inhibitor such as pantoprazole, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• If you take pantoprazole for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, confusion, seizures, dizziness or rapid heartbeat. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced levels of potassium or calcium 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 PANTOPRAZOLE ALMUS 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 PANTOPRAZOLE ALMUS. Remember to also report any other adverse effects such as joint pain.
• If you are scheduled for a specific blood test (chromogranin A).

Inform your doctor immediately before or after taking this medicine if you notice any of the following symptoms, which may be signs of a more serious underlying condition:

• Unintentional weight loss
• Vomiting, especially if repeated
• Blood in vomit; this may appear as dark, coffee-ground-like material in the vomit
• Presence 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.

Your doctor may decide that you need certain tests to rule out malignancy, as pantoprazole can relieve symptoms of cancer and might delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you take PANTOPRAZOLE ALMUS 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 whenever you see your doctor.
Children and adolescents
The use of PANTOPRAZOLE ALMUS is not recommended in children, as efficacy has not been demonstrated in children under 12 years of age.
Other medicines and PANTOPRAZOLE ALMUS
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines without a prescription.
PANTOPRAZOLE ALMUS may affect the effectiveness of other medicines; therefore, 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 PANTOPRAZOLE ALMUS may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood clotting. You may need additional 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 discontinue treatment with PANTOPRAZOLE ALMUS because pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders) – 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 insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been reported to be excreted in human breast milk.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should use this medicine only if your doctor considers the benefit to you to outweigh the potential risk to the foetus or infant.
Driving and using machines
PANTOPRAZOLE ALMUS does not affect or affects negligibly the ability to drive and use machines. However, if you experience adverse effects such as dizziness or visual disturbances, you should not drive or operate machinery.
PANTOPRAZOLE ALMUS contains lactose monohydrate and sodium
This medicine contains lactose monohydrate, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take PANTOPRAZOLE ALMUS

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 meals. Do not chew or crush the tablets; swallow them whole with a little
water.
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 antibiotics selected from amoxicillin, clarithromycin, and 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 both tablets 1 hour before a meal. Your doctor may subsequently adjust the dosage depending on the amount of gastric acid produced. If more than two tablets per day are prescribed, the tablets should be taken twice daily. If your doctor prescribes a daily dose of more than four tablets per day, you will be given specific instructions on when to stop taking the medicine.

Patients with kidney problems
If you have renal impairment, you must not take PANTOPRAZOLE ALMUS for Helicobacter pylori
eradication.
Patients with liver problems
If you have severe liver problems, you must not take more than one 20 mg pantoprazole tablet per day
(for this purpose, tablets containing 20 mg of pantoprazole are available).
If you have severe or moderate liver impairment, you must not take PANTOPRAZOLE ALMUS for
Helicobacter pylori eradication.
Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.
If you take more PANTOPRAZOLE ALMUS than you should
Consult your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take PANTOPRAZOLE ALMUS
Do not take a double dose to make up for a forgotten dose. Take your next dose at the scheduled time.
If you stop taking PANTOPRAZOLE ALMUS
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, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

• 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 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): 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, Erythema multiforme), and sensitivity to light.
• Other severe disorders (frequency not known: frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash, and kidney enlargement sometimes with painful urination, and pain in the lower back (severe kidney inflammation) which may lead to possible 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; nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth;
abdominal pain and feeling unwell; skin rash; exanthema, eruption; itching; feeling of weakness, tiredness or general malaise; sleep disorders; fractures of the hip, wrist or spine.
Rare (may affect up to 1 in 1,000 people)
Altered or complete loss 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 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 a history of these symptoms); decreased blood sodium levels; decreased blood magnesium levels (see section 2), sensations of tingling, pricking, 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 blood lipid levels; a drastic 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 abnormal bleeding or bruising; reduced white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red 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 inform your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store PANTOPRAZOLE ALMUS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Bottle packaging
Do not use this medicine more than twenty-eight days after first opening the bottle.
Blister packaging
Store below 25°C.
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 PANTOPRAZOLO ALMUS contains

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

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

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

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