LANSOPRAZOLO 15 mg Tabletki Orodispersyjne

Treść ulotki

1. Lansoprazolo Laboratori Alter 15 mg orodispersible tablets
   1. What is Lansoprazolo Laboratori Alter and what is it used for
   2. What you need to know before you take Lansoprazolo Laboratori Alter
   3. How to take Lansoprazolo Laboratori Alter
   4. Possible side effects
   5. How to store Lansoprazolo Laboratori Alter
   6. Contents of the pack and other information
2. Lansoprazolo Laboratori Alter 30 mg orodispersible tablets
   1. What is Lansoprazolo Laboratori Alter and what is it used for
   2. What you need to know before taking Lansoprazolo Laboratori Alter
   3. How to take Lansoprazolo Laboratori Alter
   4. Possible side effects
   5. How to store Lansoprazolo Laboratori Alter
   6. Contents of the pack and other information

Lansoprazolo Laboratori Alter 15 mg orodispersible tablets

Lansoprazolo

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

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

Contents of this leaflet:

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

1. What is Lansoprazolo Laboratori Alter and what is it used for

The active ingredient of Lansoprazolo Laboratori Alter is lansoprazole, a proton pump inhibitor. The proton pump inhibitor reduces the amount of acid produced by the stomach.
Your doctor may prescribe Lansoprazolo Laboratori Alter for the following indications:

• Treatment of duodenal or stomach ulcers;
• Treatment of esophageal inflammation (reflux esophagitis);
• Prevention of reflux esophagitis;
• Treatment of stomach acidity and gastroesophageal reflux;
• Treatment of infections caused by the bacterium Helicobacter pylori, if administered in association with antibiotic therapy;
• Treatment or prevention of duodenal or stomach ulcers in patients who require chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs), usually used as painkillers or anti-inflammatory drugs;
• Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Lansoprazolo Laboratori Alter for an indication or with
the assumption of the medicine, follow your doctor's instructions.
Contact your doctor if you do not feel better or feel worse after 14 days.

2. What you need to know before you take Lansoprazolo Laboratori Alter

Do not take Lansoprazolo Laboratori Alter:

• if you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Tell your doctor if you suffer from severe liver disease. Your doctor may need to
adjust the dose.
Your doctor may decide to perform, or have already performed, a further examination called
endoscopy in order to ascertain your condition and/or to exclude the presence of a
malignant disease.
If you experience diarrhoea during treatment with Lansoprazolo Laboratori Alter, contact
your doctor immediately, as Lansoprazolo Laboratori Alter has been associated with a
slight increase in infectious diarrhoea.
If your doctor has prescribed Lansoprazolo Laboratori Alter in combination
with other medicines for the treatment of an Helicobacter pyloriinfection (antibiotics), or in
combination with anti-inflammatory drugs to relieve pain or rheumatic diseases,
Taking a proton pump inhibitor such as Lansoprazolo Laboratori Alter,
especially if taken for more than one year, may slightly increase the risk of a
fracture of the hip, wrist or spine. Contact your doctor if you suffer from
osteoporosis or if you are taking corticosteroids (which may increase the risk of
osteoporosis).
If you take Lansoprazolo Laboratori Alter for a prolonged period of time (more than one
year), your doctor is likely to decide to monitor your health regularly.
Report any new and unusual symptoms and circumstances whenever you see your
doctor.
Talk to your doctor before taking Lansoprazolo Laboratori Alter:

• if you have low levels of vitamin B12 or have risk factors for low levels of vitamin B12 and are receiving long-term treatment with Lansoprazolo Laboratori Alter. As with all agents that reduce acid, Lansoprazolo Laboratori Alter can lead to reduced absorption of vitamin B12
• if you are to undergo a specific blood test (Chromogranin A)
• if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazolo Laboratori Alter that reduces gastric acidity
• if you notice the appearance of a skin rash, especially in areas of skin exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to stop therapy with Lansoprazolo Laboratori Alter. Remember to also report any other side effects such as joint pain.

Other medicines and Lansoprazolo Laboratori Alter
Tell your doctor if you are taking or have recently taken any other medicines,
including those available without a prescription.
Specifically, tell your doctor if you are taking medicines that contain one of the
following active ingredients, as Lansoprazolo Laboratori Alter may interfere with their
mode of action:

• HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV);
• methotrexate (used to treat autoimmune diseases and cancer);
• ketoconazole, itraconazole, rifampicin (for the treatment of infections);
• digoxin (for the treatment of heart problems);
• warfarin (used to treat blood clots);
• theophylline (for the treatment of asthma);
• tacrolimus (to prevent transplant rejection);
• fluvoxamine (for the treatment of depression and other psychiatric disorders);
• antacids (for the treatment of stomach acidity or gastroesophageal reflux);
• sucralfate (for the treatment of ulcers);
• St. John's wort (Hypericum perforatum) (for the treatment of mild depression).

Lansoprazolo Laboratori Alter with food and drink
Take Lansoprazolo Laboratori Alter at least 30 minutes before meals to get the
maximum benefit from the medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor for advice before taking this medicine.

Driving and operating machinery
Patients taking Lansoprazolo Laboratori Alter may experience side effects such as
dizziness, vertigo, fatigue and visual disturbances. If you experience any of the
aforementioned effects, you should take precautions as your reaction ability may be reduced.
It is solely your responsibility to decide whether you are fit to drive a motor vehicle or
perform other activities that require greater concentration. Taking medicines
represents one of the factors that can reduce your ability to perform such activities safely due to their effects or side effects.
Descriptions of these effects can be found in other sections.
Read all the information contained in this leaflet as a guide. If you have any doubts, ask your
doctor, nurse or pharmacist.

Lansoprazolo Laboratori Alter contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before
taking this medicine.

3. How to take Lansoprazolo Laboratori Alter

Take this medicine exactly as your doctor has instructed. If you have any doubts
consult your doctor.
Place the tablet on your tongue and gently start to suck it. The tablet will
dissolve rapidly in your mouth, releasing microgranules that you should swallow without
chewing, with the help of a glass of water.
If you have severe difficulty swallowing, your doctor may give you instructions for
taking the tablet with the help of a syringe.
In case of administration via oral syringe, follow these instructions:
It is essential that the oral syringe is carefully tested to verify its
suitability.

• Remove the plunger from the syringe (a 5 ml syringe is needed for 15 mg tablets and a 10 ml syringe for 30 mg tablets);
• Insert the tablet into the cylindrical body of the syringe;
• Reposition the plunger on the syringe;
• For 15 mg tablets: fill the syringe with 4 ml of water.
• For 30 mg tablets: fill the syringe with 10 ml of water.
• Turn the syringe upside down and aspirate 1 additional ml of air;
• Gently shake the syringe for 10-20 seconds until the tablet dissolves;
• The contents can be poured directly into the oral cavity;
• Refill the syringe with 2-5 ml of water to pour the remaining contents into the oral cavity;
• Repeat the previous step, if necessary.

If you take Lansoprazolo Laboratori Alter once a day, try to take it at the same
time each day. The greatest benefits are obtained by taking Lansoprazolo Laboratori Alter in the
morning.
If you take Lansoprazolo Laboratori Alter twice a day, take the first dose in the morning
and the second in the evening.
The dose of Lansoprazolo Laboratori Alter varies depending on the condition you suffer from.
The usual doses of Lansoprazolo Laboratori Alter in adults are listed below. Your
doctor may sometimes prescribe a different dose and inform you about the duration of
such treatment.

Treatment of stomach acidity and gastroesophageal reflux:one 15 or 30 mg
orodispersible tablet every day for 4 weeks. If symptoms persist, consult
your doctor. If symptoms do not improve within 4 weeks, contact your doctor.

Treatment of duodenal ulcer:one 30 mg orodispersible tablet every day
for 2 weeks.

Treatment of stomach ulcer:one 30 mg orodispersible tablet every
day for 4 weeks.

Treatment of esophageal inflammation (reflux esophagitis):one 30 mg
orodispersible tablet every day for 4 weeks.

Long-term prevention of reflux esophagitis:one 15 mg orodispersible tablet every day; the doctor may decide to adjust the dose to one 30 mg orodispersible tablet every day.

Treatment ofHelicobacter pyloriinfection:the usual dose is one 30 mg
orodispersible tablet in combination with two different antibiotics in the morning and one
30 mg orodispersible tablet in combination with two different antibiotics in the evening. The
treatment is usually taken daily for 7 days.
The recommended antibiotic combinations are:

• 30 mg Lansoprazolo Laboratori Alter together with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin;
• 30 mg Lansoprazolo Laboratori Alter together with 250 mg of clarithromycin and 400-500 mg of metronidazole.

If you are undergoing treatment for an infection because you have an ulcer, it is unlikely that
it will recur if the infection has been successfully treated. To obtain the greatest
benefits, take the medicine at the scheduled time and do not miss any dose.

Treatment of duodenal or stomach ulcer in patients requiring
chronic treatment with NSAIDs:one 30 mg orodispersible tablet every day for 4
weeks.

Prevention of duodenal or stomach ulcer in patients requiring
chronic treatment with NSAIDs:one 15 mg orodispersible tablet every day; the
doctor may adjust the dose up to one 30 mg orodispersible tablet every day.

Zollinger-Ellison syndrome:the usual initial dose is two 30 mg orodispersible
tablets every day; subsequently, depending on the response to Lansoprazolo Laboratori
Alter, the doctor will prescribe the most suitable dose for you.

Use in children
Lansoprazolo Laboratori Alter should not be administered to children.

If you take more Lansoprazolo Laboratori Alter than you should
If you take more Lansoprazolo Laboratori Alter than you should, consult a
doctor immediately.

If you forget to take Lansoprazolo Laboratori Alter
If you forget to take a dose, take it as soon as you remember unless it is almost
time for the next dose. In this case, do not take the forgotten dose but
take the remaining orodispersible tablets as prescribed. Do not take a double dose to
make up for the forgotten orodispersible tablet.

If you stop taking Lansoprazolo Laboratori Alter
Do not stop treatment prematurely just because your symptoms have improved. Your
condition may not be completely resolved and may also recur if you do not
complete the treatment.
If you have any doubts about using this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects are common (may affect more than 1 in 100 people):

• headache, dizziness;
• diarrhoea, constipation, stomach pain, feeling of nausea, flatulence, dryness or pain in the mouth or throat;
• skin rash, itching;
• changes in liver function values;
• fatigue;
• benign polyps in the stomach.

The following side effects are uncommon (may affect less than 1 in 100 people):

• depression;
• joint or muscle pain;
• fluid retention or swelling;
• changes in blood cell counts;
• risk of fracture of the hip, wrist or spine.

The following side effects are rare (may affect less than 1 in 1000 people):

• fever;
• restlessness, drowsiness, confusion, hallucinations, insomnia, vision disturbances, vertigo;
• changes in taste, loss of appetite, inflammation of the tongue (glossitis);
• skin reactions such as burning or itching, bruising, redness and excessive sweating;
• sensitivity to light;
• hair loss;
• tingling sensation (paresthesia), tremor;
• anaemia (paleness);
• kidney disorders;
• pancreatitis;
• liver inflammation (may manifest as yellowing of the skin or eyes);
• breast enlargement in men, impotence;
• candidiasis (fungal infection, may affect the skin or mucous membranes);
• angioedema: if you experience symptoms of angioedema, such as swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing, seek medical attention immediately;

The following side effects are very rare (may affect less than 1 in 10,000):

• • severe hypersensitivity reactions, including shock. Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes low blood pressure;
  • inflammation of the mouth (stomatitis);
  • colitis (intestinal inflammation);
  • changes in blood test values for sodium, cholesterol and triglycerides;
  • very severe skin reactions including redness, blistering, severe inflammation and peeling;
  • in very rare cases, Lansoprazolo Laboratori Alter may lead to a reduction in the number of white blood cells and, consequently, to a lower resistance to infections. If you experience symptoms indicative of infection such as fever and severe deterioration of your health, or fever with symptoms of local infection such as sore throat/pharynx/mouth or urinary problems, seek medical attention immediately. A blood test will be performed to check if there is a reduction in white blood cells (agranulocytosis).

The following side effect has an unknown frequency (frequency cannot be estimated based on available data):

• if you take Lansoprazolo Laboratori Alter for more than three months, your blood magnesium levels may decrease. This decrease may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, seek medical attention immediately. Low magnesium levels may in turn cause a decrease in calcium or potassium levels in the blood. Your doctor may decide to have your blood tested at regular intervals to monitor your magnesium levels;
• erythema, possible joint pain;
• visual hallucinations.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at:
ttps://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 Lansoprazolo Laboratori Alter

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP.) which is reported on the blister and
on the packaging. The expiry date refers to the last day of that month.
Do not store at temperatures above 30º C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lansoprazolo Laboratori Alter contains

• The active ingredient is lansoprazole;
• The other components are sugar spheres (sucrose and corn starch), magnesium carbonate, hypromellose, polysorbate 80, macrogol 6000, triethyl citrate, talc, methacrylic acid-ethyl acrylate copolymer, methyl acrylate copolymer, methyl methacrylate and methacrylic acid copolymer, microcrystalline cellulose, hydroxypropylcellulose, sodium saccharin, mannitol (E-421), tropical flavour, malic acid and magnesium stearate.

Description of the appearance of Lansoprazolo Laboratori Alter and contents of the pack
Lansoprazolo Laboratori Alter 15 mg are round and flat orodispersible tablets, of
whitish colour, speckled with microgranules.
Lansoprazolo Laboratori Alter 15 mg is available in packs of 14, 28, 56 or 98
tablets.

Marketing Authorisation Holder
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milano

Manufacturers responsible for batch release
Laboratorios Salvat, S.A.
C / Gall 30-36
08950 Esplugues de Llobregat
Barcelona – Spain
Basics GmbH
Hemmerlrather Weg 201
51377 Leverkunsen
Germany
This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Lansoprazole Flas Salvat 15 mg comprimidos
bucodispersables
Spain
Lansoprazole Salvat 15 mg comprimés orodispersibles France
Lansoprazole 15 mg orodispersible tablets United Kingdom
Lansoprazol SUN 15 mg munsönderfallande tablett Sweden

Lansoprazolo Laboratori Alter 30 mg orodispersible tablets

Lansoprazolo

Read this leaflet carefully before taking this medicine as it contains important information for you.

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

Contents of this leaflet:

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

1. What is Lansoprazolo Laboratori Alter and what is it used for

The active ingredient of Lansoprazolo Laboratori Alter is lansoprazole, a proton pump inhibitor. The proton pump inhibitor reduces the amount of acid produced by the stomach.
Your doctor may prescribe Lansoprazolo Laboratori Alter for the following indications:

• Treatment of duodenal or stomach ulcers;
• Treatment of esophageal inflammation (reflux esophagitis);
• Prevention of reflux esophagitis;
• Treatment of stomach acidity and gastroesophageal reflux;
• Treatment of infections caused by the bacterium Helicobacter pylori, if administered in association with antibiotic therapy;
• Treatment or prevention of duodenal or stomach ulcers in patients who require chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs), usually used as painkillers or anti-inflammatory drugs;
• Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Lansoprazolo Laboratori Alter for an indication or with
the assumption of the medicine, follow your doctor's instructions.
Contact your doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before taking Lansoprazolo Laboratori Alter

Do not take Lansoprazolo Laboratori Alter:

• if you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Tell your doctor if you suffer from severe liver disease. Your doctor may need to
adjust the dose.
Your doctor may decide to perform, or have already performed, a further examination called
endoscopy in order to ascertain your condition and/or to exclude the presence of a malignant
disease.
If you experience diarrhoea during treatment with Lansoprazolo Laboratori Alter, contact
your doctor immediately, as Lansoprazolo Laboratori Alter has been associated with a
slight increase in infectious diarrhoea.
If your doctor has prescribed Lansoprazolo Laboratori Alter in combination
with other medicines for the treatment of an Helicobacter pyloriinfection (antibiotics), or in
combination with anti-inflammatory drugs to relieve pain or rheumatic diseases,
Taking a proton pump inhibitor such as Lansoprazolo Laboratori Alter,
especially if taken for more than one year, may slightly increase the risk of a
fracture of the hip, wrist or spine. Contact your doctor if you suffer from
osteoporosis or are taking corticosteroids (which may increase the risk of
osteoporosis).
If you take Lansoprazolo Laboratori Alter for a prolonged period of time (more than one
year), your doctor is likely to decide to monitor your health regularly.
Report any new and unusual symptoms and circumstances whenever you see your
doctor.
Contact your doctor before taking Lansoprazolo Laboratori Alter:

• if you have low levels of vitamin B12 or have risk factors for low levels of vitamin B12 and are receiving long-term treatment with Lansoprazolo Laboratori Alter. As with all agents that reduce acid, Lansoprazolo Laboratori Alter may lead to reduced absorption of vitamin B12
• if you are to undergo a specific blood test (Chromogranin A)
• if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazolo Laboratori Alter that reduces gastric acidity
• if you notice the appearance of a skin rash, especially in areas of skin exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to stop therapy with Lansoprazolo Laboratori Alter. Remember to also report any other unwanted effects such as joint pain.

Other medicines and Lansoprazolo Laboratori Alter
Tell your doctor if you are taking or have recently taken any other medicines,
including those available without a prescription.
Specifically, tell your doctor if you are taking medicines that contain one of the
following active ingredients, as Lansoprazolo Laboratori Alter may interfere with their
mode of action:

• HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV);
• methotrexate (used to treat autoimmune diseases and cancer);
• ketoconazole, itraconazole, rifampicin (for the treatment of infections);
• digoxin (for the treatment of heart problems);
• warfarin (used to treat blood clots)
• theophylline (for the treatment of asthma);
• tacrolimus (to prevent transplant rejection);
• fluvoxamine (for the treatment of depression and other psychiatric disorders);
• antacids (for the treatment of stomach acidity or gastroesophageal reflux);
• sucralfate (for the treatment of ulcers);
• St. John's wort (Hypericum perforatum) (for the treatment of mild forms of depression).

Lansoprazolo Laboratori Alter with food and drink
Take Lansoprazolo Laboratori Alter at least 30 minutes before meals to get the
maximum benefit from the medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are
breastfeeding, ask your doctor for advice before taking this medicine.

Driving and operating machinery
Patients taking Lansoprazolo Laboratori Alter may experience side
effects such as dizziness, vertigo, fatigue and visual disturbances. If you should
experience any of the above effects, you will need to take precautions as your
reaction ability may be reduced.
It is solely your responsibility to decide whether you are fit to drive a motor vehicle or
perform other activities that require greater concentration. Taking medicines
represents one of the factors that can reduce your ability to perform such activities safely due to their effects or side effects.
Descriptions of these effects can be found in other sections.
Read all the information contained in this leaflet as a guide. If you have any doubts, consult
your doctor, nurse or pharmacist.

Lansoprazolo Laboratori Alter contains sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine.

3. How to take Lansoprazolo Laboratori Alter

Take this medicine exactly as your doctor has instructed. If you have any doubts
consult your doctor.
Place the tablet on your tongue and start to suck it gently. The tablet will
dissolve rapidly in your mouth, releasing microgranules that you should swallow without
chewing them with the help of a glass of water.
If you have severe difficulty swallowing, your doctor may give you instructions for
taking the tablet with the help of a syringe.
In case of administration via oral syringe, follow these instructions:
It is essential that the oral syringe is carefully tested to verify its
suitability.

• Remove the plunger from the syringe (you will need a 5 ml syringe at least for 15 mg tablets and a 10 ml syringe for 30 mg tablets);
• Insert the tablet into the cylindrical body of the syringe;
• Reposition the plunger on the syringe;
• For 15 mg tablets: fill the syringe with 4 ml of water.
• For 30 mg tablets: fill the syringe with 10 ml of water.
• Turn the syringe upside down and aspirate 1 additional ml of air;
• Gently shake the syringe for 10-20 seconds until the tablet dissolves;
• The contents can be poured directly into the oral cavity;
• Refill the syringe with 2-5 ml of water to pour the remaining contents into the oral cavity;
• Repeat the previous step, if necessary.

If you take Lansoprazolo Laboratori Alter once a day, try to take it at the
same time each day. The greatest benefits are obtained by taking Lansoprazolo Laboratori Alter in the
morning.
If you take Lansoprazolo Laboratori Alter twice a day, take the first dose in the morning
and the second in the evening.
The dose of Lansoprazolo Laboratori Alter varies depending on the condition you suffer from.
The usual doses of Lansoprazolo Laboratori Alter in adults are listed below. Your
doctor may sometimes prescribe a different dose and inform you about the duration of
such treatment.

Treatment of stomach acidity and gastroesophageal reflux:one orodispersible tablet of 15 or 30 mg every day for 4 weeks. If symptoms persist, consult
your doctor. If symptoms do not improve within 4 weeks, contact your doctor.

Treatment of duodenal ulcer:one orodispersible tablet of 30 mg every day
for 2 weeks.

Treatment of stomach ulcer:one orodispersible tablet of 30 mg every
day for 4 weeks.

Treatment of esophageal inflammation (reflux esophagitis):one orodispersible tablet of 30 mg every day for 4 weeks.

Long-term prevention of reflux esophagitis:one orodispersible tablet of
15 mg every day; your doctor may decide to adjust the dose to one orodispersible tablet of 30 mg every day.

Treatment ofHelicobacter pyloriinfection:the usual dose is one orodispersible tablet of 30 mg in combination with two different antibiotics in the morning and one
orodispersible tablet of 30 mg in combination with two different antibiotics in the evening. The
treatment is usually taken daily for 7 days.
The recommended antibiotic combinations are:

• 30 mg Lansoprazolo Laboratori Alter together with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin;
• 30 mg Lansoprazolo Laboratori Alter together with 250 mg of clarithromycin and 400-500 mg of metronidazole.

If you are undergoing treatment for an infection because you have an ulcer, it is unlikely that
it will recur if the infection has been successfully treated. To obtain the greatest
benefits, take the medicine at the scheduled time and do not miss any dose.

Treatment of duodenal or stomach ulcer in patients requiring
chronic treatment with NSAIDs:one orodispersible tablet of 30 mg every day for 4
weeks.

Prevention of duodenal or stomach ulcer in patients requiring
chronic treatment with NSAIDs:one orodispersible tablet of 15 mg every day; the
doctor may adjust the dose up to one orodispersible tablet of 30 mg every day.

Zollinger-Ellison syndrome:the usual initial dose is two orodispersible tablets
of 30 mg every day; subsequently, depending on the response to Lansoprazolo Laboratori
Alter, your doctor will prescribe the most suitable dose for you.

Use in children
Lansoprazolo Laboratori Alter should not be given to children.

If you take more Lansoprazolo Laboratori Alter than you should
If you take more Lansoprazolo Laboratori Alter than you should, consult a
doctor immediately.

If you forget to take Lansoprazolo Laboratori Alter
If you forget to take a dose, take it as soon as you remember unless it is almost
time for the next dose. In this case, do not take the forgotten dose but
take the remaining orodispersible tablets as prescribed. Do not take a double dose to
make up for the forgotten orodispersible tablet.

If you stop taking Lansoprazolo Laboratori Alter
Do not stop treatment prematurely just because your symptoms have improved. Your
condition may not be completely resolved and may also recur if you do not
complete the treatment.
If you have any doubts about using this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects are common (may affect more than 1 in 100 people):

• headache, dizziness;
• diarrhea, constipation, stomach pain, feeling of nausea, flatulence, dryness or pain in the mouth or throat;
• skin rash, itching;
• changes in liver function values;
• fatigue;
• benign polyps in the stomach.

The following side effects are uncommon (may affect less than 1 in 100 people):

• depression;
• joint or muscle pain;
• fluid retention or swelling;
• changes in blood cell counts;
• risk of fracture of the hip, wrist or spine.

The following side effects are rare (may affect less than 1 in 1000 people):

• fever;
• restlessness, drowsiness, confusion, hallucinations, insomnia, vision disturbances, vertigo;
• changes in taste, loss of appetite, inflammation of the tongue (glossitis);
• skin reactions such as burning or itching sensation, bruising, redness and excessive sweating;
• sensitivity to light;
• hair loss;
• tingling sensation (paresthesia), tremor;
• anemia (pallor);
• kidney disorders;
• pancreatitis;
• liver inflammation (may manifest as yellowing of the skin or eyes);
• enlargement of the breast in men, impotence;
• candidiasis (fungal infection, may have an effect on the skin or mucous membranes);
• angioedema: if you experience symptoms of angioedema, such as swelling of the face, tongue or pharynx, difficulty swallowing, hives and difficulty breathing, seek medical attention immediately;

The following side effects are very rare (may affect less than 1 in 10,000):

• severe hypersensitivity reactions, including shock. Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a drop in blood pressure;
• inflammation of the oral cavity (stomatitis);
• colitis (intestinal inflammation);
• changes in laboratory analysis values of sodium, cholesterol and triglycerides;
• very severe skin reactions including redness, blistering, severe inflammation and peeling;
• in very rare cases, Lansoprazolo Laboratori Alter may lead to a decrease in the number of white blood cells and, consequently, to a lower resistance to infections. If you experience symptoms indicative of infection such as fever and severe deterioration of your health, or fever with symptoms of local infection such as sore throat/pharynx/mouth or urinary problems, seek medical attention immediately. A blood test will be performed to check if there is a decrease in white blood cells (agranulocytosis).

The following side effect has an unknown frequency (frequency cannot be estimated based on available data):

• if you take Lansoprazolo Laboratori Alter for more than three months, your blood magnesium levels may decrease. This decrease may manifest as symptoms such as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness and increased heart rate. If you experience any of these symptoms, seek medical attention immediately. Lowering of magnesium values may in turn cause a reduction in calcium or potassium levels in the blood. Your doctor may decide to subject you to regular blood tests to monitor your magnesium levels;
• erythema, possible joint pain;
• visual hallucinations.

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

5. How to store Lansoprazolo Laboratori Alter

Keep out of sight and reach of children.
Do not use this medicine after the expiry date (EXP.) which is stated on the blister and
on the packaging. The expiry date refers to the last day of that month.
Do not store at temperatures above 30 ºC.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lansoprazolo Laboratori Alter contains

• The active ingredient is lansoprazole;
• The other ingredients are sugar spheres (sucrose and corn starch), magnesium carbonate, hypromellose, polysorbate 80, macrogol 6000, triethyl citrate, talc, methacrylic acid-ethyl acrylate copolymer, methyl acrylate copolymer, methyl methacrylate and methacrylic acid copolymer, microcrystalline cellulose, hydroxypropylcellulose, sodium saccharin, mannitol (E-421), tropical flavour, malic acid and magnesium stearate.

Description of the appearance of Lansoprazolo Laboratori Alter and contents of the pack
Lansoprazolo Laboratori Alter 30 mg are round and flat, orally disintegrating tablets of
whitish colour, speckled with microgranules.
Lansoprazolo Laboratori Alter 30 mg is available in packs of 14, 28, 56 or 98
tablets.

Marketing Authorisation Holder
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milan

Manufacturer responsible for batch release
Laboratorios Salvat, S.A.
C / Gall 30-36
08950 Esplugues de Llobregat
Barcelona – Spain
Basics GmbH
Hemmerlrather Weg 201
51377 Leverkunsen
Germany
This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Lansoprazole Flas Salvat 30 mg comprimidos
bucodispersables
Spain
Lansoprazole Salvat 30 mg comprimés orodispersibles France
Lansoprazole 30 mg orodispersible tablets United Kingdom
Lansoprazol SUN 30 mg munsönderfallande tablett Sweden