Lansoprazole Laboratori Alter: detailed information

Package leaflet: Information for the patient

Lansoprazole Laboratori Alter 15 mg orodispersible tablets

Lansoprazole
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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The active substance in Lansoprazole Laboratori Alter is lansoprazole, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by the stomach.
Your doctor may have prescribed Lansoprazole Laboratori Alter for the following indications:

Treatment of duodenal or gastric ulcer;
Treatment of oesophageal inflammation (reflux oesophagitis);
Prevention of reflux oesophagitis;
Treatment of stomach acidity and gastro-oesophageal reflux;
Treatment of infections caused by the bacterium Helicobacter pylori, when administered in combination with antibiotic therapy;
Treatment or prevention of duodenal or gastric ulcers in patients requiring long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), commonly used as painkillers or anti-inflammatory agents;
Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Lansoprazole Laboratori Alter for an indication or at a dosage different from that stated in this leaflet. Follow your doctor's instructions regarding administration of the medicine.
Consult your doctor if you do not feel better or if you feel worse after 14 days.

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

Do not take Lansoprazole Laboratori Alter:

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

Warnings and precautions
Inform your doctor if you have severe liver disease. Your doctor may need to adjust the dose.
Your doctor may decide to perform, or may have already performed, an additional test called endoscopy to confirm your condition and/or to rule out the presence of malignant disease.
If you develop diarrhoea during treatment with Lansoprazole Laboratori Alter, contact your doctor immediately, as Lansoprazole Laboratori Alter has been associated with a slight increase in infectious diarrhoea.
If your doctor has prescribed Lansoprazole Laboratori Alter in combination with other medicines for the treatment of Helicobacter pylori infection (antibiotics), or in combination with anti-inflammatory drugs to relieve pain or rheumatic diseases, carefully read the package leaflet of those medicines as well.
Taking a proton pump inhibitor such as Lansoprazole Laboratori Alter, particularly if taken for more than one year, may slightly increase the risk of fracture of the hip, wrist, or spine. Speak to your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
If you take Lansoprazole Laboratori Alter for a prolonged period (longer than one year), your doctor will likely decide to monitor your health regularly. Report any new or unusual symptoms and circumstances whenever you see your doctor.
Talk to your doctor before taking Lansoprazole Laboratori Alter:

if you have low levels of vitamin B12 or are at risk of low vitamin B12 levels and are receiving long-term treatment with Lansoprazole Laboratori Alter. As with all agents that reduce acid, Lansoprazole Laboratori Alter may lead to reduced absorption of vitamin B12
if you need to undergo a specific blood test (chromogranin A)
if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole 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 discontinue treatment with Lansoprazole Laboratori Alter. Remember to also report any other adverse effects such as joint pain.

Other medicines and Lansoprazole Laboratori Alter
Inform your doctor if you are taking or have recently taken any other medicines, including those without a prescription.
Specifically, inform your doctor if you are taking medicines containing any of the following active substances, as Lansoprazole 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).

Lansoprazole Laboratori Alter with food and drinks
Take Lansoprazole Laboratori Alter at least 30 minutes before meals to obtain the maximum benefit from the medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
Driving and using machines
Patients taking Lansoprazole Laboratori Alter may experience adverse effects such as dizziness, vertigo, fatigue, and visual disturbances. If you experience any of the above effects, you should take precautions, as your reaction ability may be reduced.
It is solely up to you to decide whether you are fit to drive a motor vehicle or perform other activities requiring concentration. Taking medicines is one of the factors that may reduce your ability to safely perform such activities 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.
Lansoprazole 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 Lansoprazole Laboratori Alter

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
Place the tablet on your tongue and start gently sucking it. The tablet will dissolve rapidly in the mouth, releasing microgranules which you must swallow without chewing, together with a glass of water.

If you have severe difficulty swallowing, your doctor may give you instructions for taking the tablet using an oral syringe.
In case of administration via oral syringe, follow the instructions below:
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 required at least for the 15 mg tablets and a 10 ml syringe for the 30 mg tablets);
Insert the tablet into the barrel of the syringe;
Replace the plunger into 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 draw in an additional 1 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 flush any residual contents into the oral cavity;
Repeat the previous step if necessary.

If you take Lansoprazole Laboratori Alter once daily, try to take it at the same time every day. The greatest benefits are obtained when Lansoprazole Laboratori Alter is taken in the morning.
If you take Lansoprazole Laboratori Alter twice daily, take the first dose in the morning and the second in the evening.
The dose of Lansoprazole Laboratori Alter varies depending on the condition being treated.
The usual doses of Lansoprazole Laboratori Alter in adults are listed below. Your doctor may sometimes prescribe a different dose and inform you about the duration of treatment.

Treatment of stomach acidity and gastroesophageal reflux: one orodispersible tablet of 15 or 30 mg daily 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 daily for 2 weeks.
Treatment of gastric ulcer: one orodispersible tablet of 30 mg daily for 4 weeks.
Treatment of esophageal inflammation (reflux esophagitis): one orodispersible tablet of 30 mg daily for 4 weeks.
Long-term prevention of reflux esophagitis: one orodispersible tablet of 15 mg daily; your doctor may decide to adjust the dose to one orodispersible tablet of 30 mg daily.
Treatment of Helicobacter pylori infection: 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. Treatment is usually taken daily for 7 days.
The recommended antibiotic combinations are:

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

If you are undergoing treatment for an infection because you have an ulcer, it is unlikely that the ulcer will recur if the infection has been successfully treated. To obtain the maximum benefit, take the medicine at the scheduled time and do not miss any doses.
Treatment of duodenal or gastric ulcer in patients requiring chronic NSAID therapy: one orodispersible tablet of 30 mg daily for 4 weeks.
Prevention of duodenal or gastric ulcer in patients requiring chronic NSAID therapy: one orodispersible tablet of 15 mg daily; your doctor may adjust the dose up to one orodispersible tablet of 30 mg daily.
Zollinger-Ellison syndrome: the usual initial dose is two orodispersible tablets of 30 mg daily; subsequently, depending on your response to Lansoprazole Laboratori Alter, your doctor will prescribe the dose most suitable for you.

Use in children
Lansoprazole Laboratori Alter must not be administered to children.

If you take more Lansoprazole Laboratori Alter than you should
If you take more Lansoprazole Laboratori Alter than prescribed, contact a doctor immediately.

If you forget to take Lansoprazole 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 that case, do not take the missed dose but continue taking the remaining tablets as scheduled. Do not take a double dose to make up for a forgotten orodispersible tablet.

If you stop taking Lansoprazole Laboratori Alter
Do not stop treatment prematurely just because symptoms have improved. Your condition may not have fully resolved and may recur if you do not complete the treatment.
If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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 test values;
fatigue;
benign stomach polyps.

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 1,000 people):

fever;
restlessness, drowsiness, confusion, hallucinations, insomnia, vision disturbances, dizziness;
changes in taste sensation, 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 (paraesthesia), tremor;
anaemia (pallor);
kidney problems;
pancreatitis;
liver inflammation (may present 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 pharynx, difficulty swallowing, hives and breathing difficulties, seek immediate medical attention;

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

severe hypersensitivity reactions, including shock. Symptoms of hypersensitivity may include fever, rash, swelling and sometimes low blood pressure;
inflammation of the mouth (stomatitis);
colitis (inflammation of the intestine);
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 white blood cell count and consequently to a decreased resistance to infections. If you experience symptoms indicating infection such as fever and severe deterioration in health, or fever with signs of local infection such as sore throat/pharynx/mouth or urinary problems, seek immediate medical attention. A blood test will be performed to check whether you are experiencing a reduction in white blood cells (agranulocytosis).

The following side effect has unknown frequency (frequency cannot be estimated from the 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, contact your doctor immediately. Low magnesium levels may in turn lead to reduced calcium or potassium levels in the blood. Your doctor may decide to perform 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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
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 Lansoprazole Laboratori Alter

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP.) stated on the blister and
on the carton. The expiry date refers to the last day of that month.
Do not store above 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 Lansoprazolo Laboratori Alter contains

The active substance is lansoprazole;
The other components are sugar spheres (sucrose and maize starch), magnesium carbonate, hypromellose, polysorbate 80, macrogol 6000, triethyl citrate, talc, methacrylic acid-ethyl acrylate copolymer, methyl methacrylate 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 package contents
Lansoprazolo Laboratori Alter 15 mg are white, round, flat orodispersible tablets, speckled with microgranules.
Lansoprazolo Laboratori Alter 15 mg is available in packages containing 14, 28, 56 or 98 tablets.

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

Responsible manufacturers for batch release
Laboratorios Salvat, S.A.
C/Gall 30-36
08950 Esplugues de Llobregat
Barcelona – Spain
Basics GmbH
Hemmerlrather Weg 201
51377 Leverkusen
Germany

This medicinal product is authorized in the European Economic Area Member States under the following names:
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

Patient information leaflet

Lansoprazole Laboratori Alter 30 mg orodispersible tablets

Lansoprazole
Please read this entire 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Lansoprazole Laboratori Alter and what is it used for?

The active substance in Lansoprazole Laboratori Alter is lansoprazole, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by the stomach. Your doctor may have prescribed Lansoprazole Laboratori Alter for the following indications:

Treatment of duodenal or gastric ulcer;
Treatment of oesophageal inflammation (reflux oesophagitis);
Prevention of reflux oesophagitis;
Treatment of stomach acidity and gastro-oesophageal reflux;
Treatment of infections caused by the bacterium Helicobacter pylori, when administered in combination with antibiotic therapy;
Treatment or prevention of duodenal or gastric ulcers in patients requiring long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), commonly used as painkillers or anti-inflammatory agents;
Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Lansoprazole Laboratori Alter for an indication or dosage different from that described in this leaflet. Always follow your doctor's instructions regarding administration of the medicine.
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 Lansoprazole Laboratori Alter

Do not take Lansoprazole Laboratori Alter:

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

Warnings and precautions
Inform your doctor if you suffer from severe liver disease. Your doctor may need to
adjust the dose.
Your doctor may decide to perform, or may have already performed, an additional test called
endoscopy to confirm your condition and/or to rule out the presence of a malignant
disease.
If you develop diarrhoea during treatment with Lansoprazole Laboratori Alter, contact
your doctor immediately, as Lansoprazole Laboratori Alter has been associated with a
slight increase in infectious diarrhoea.
If your doctor has prescribed Lansoprazole Laboratori Alter in combination with
other medicines for the treatment of a Helicobacter pylori infection (antibiotics), or in
combination with anti-inflammatory drugs to relieve pain or rheumatic diseases,
please read carefully the package leaflet of those medicines as well.
Taking a proton pump inhibitor such as Lansoprazole Laboratori Alter,
especially if taken for more than one year, may slightly increase the risk of
fracture of the hip, wrist, or spine. Consult your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of
osteoporosis).
If you take Lansoprazole Laboratori Alter for a prolonged period (longer than one
year), your doctor will likely decide to monitor your health regularly.
Report any new or unusual symptoms and circumstances each time you see your
doctor.
Consult your doctor before taking Lansoprazole Laboratori Alter:

if you have low levels of vitamin B12 or are at risk of low vitamin B12 levels and are receiving long-term treatment with Lansoprazole Laboratori Alter. As with all agents that reduce acid, Lansoprazole Laboratori Alter may lead to reduced absorption of vitamin B12
if you need to undergo a specific blood test (chromogranin A)
if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole 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 discontinue treatment with Lansoprazole Laboratori Alter. Remember to also report any other adverse effects such as joint pain.

Other medicines and Lansoprazole Laboratori Alter
Inform your doctor if you are taking, have recently taken, or might take any other medicines,
including those without a prescription.
Specifically, inform your doctor if you are taking medicines containing any of the
following active substances, as Lansoprazole 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).

Lansoprazole Laboratori Alter with food and drink
Take Lansoprazole Laboratori Alter at least 30 minutes before meals to obtain the
maximum benefit from the medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Driving and using machines
Patients taking Lansoprazole Laboratori Alter may experience adverse effects such as
dizziness, vertigo, fatigue, and visual disturbances. If you experience any of the above effects, you should take precautions, as your reaction ability may be reduced.
It is solely up to you to decide whether you are fit to drive a motor vehicle or perform other activities requiring concentration. Taking medicines is one of the factors that may impair 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.
Lansoprazole Laboratori Alter contains sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Lansoprazolo Laboratori Alter

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.
Place the tablet on your tongue and start gently sucking it. The tablet will dissolve rapidly in the mouth, releasing microgranules which you must swallow without chewing, together with a glass of water.

If you have severe difficulty swallowing, your doctor may give you instructions for taking the tablet using an oral syringe.

In case of administration using an oral syringe, follow the instructions below:
It is essential that the oral syringe is carefully tested to ensure its suitability.

Remove the plunger from the syringe (a 5 ml syringe is required at least for the 15 mg tablets and a 10 ml syringe for the 30 mg tablets);
Insert the tablet into the cylindrical barrel of the syringe;
Reinsert the plunger into 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 draw in an additional 1 ml of air;
Gently shake the syringe for 10–20 seconds until the tablet dissolves;
The contents can be directly poured into the oral cavity;
Refill the syringe with 2–5 ml of water to flush any remaining contents into the oral cavity;
Repeat the previous step, if necessary.

If you take Lansoprazolo Laboratori Alter once daily, try to take it at the same time every day. The greatest benefits are obtained when Lansoprazolo Laboratori Alter is taken in the morning.
If you take Lansoprazolo Laboratori Alter twice daily, take the first dose in the morning and the second in the evening.

The dose of Lansoprazolo Laboratori Alter varies depending on the condition being treated.
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 treatment.

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

Treatment of gastric ulcer: one orodispersible tablet of 30 mg daily for 4 weeks.

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

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

Treatment of Helicobacter pylori infection: 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. This treatment is usually taken daily for 7 days.

The recommended antibiotic combinations are:

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

Treatment of duodenal or gastric ulcer in patients requiring chronic NSAID therapy: one orodispersible tablet of 30 mg daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring chronic NSAID therapy: one orodispersible tablet of 15 mg daily; your doctor may adjust the dose up to one orodispersible tablet of 30 mg daily.

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

Use in children
Lansoprazolo Laboratori Alter must 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, contact 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 your next dose. In this case, do not take the missed dose but continue with the remaining tablets as scheduled. Do not take a double dose to make up for a forgotten orodispersible tablet.

If you stop Lansoprazolo Laboratori Alter treatment
Do not stop treatment prematurely just because your symptoms have improved. Your condition may not have been fully resolved, and it could recur if you do not complete the treatment.

If you have any questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 test results;
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 1,000 people):

fever;
restlessness, drowsiness, confusion, hallucinations, insomnia, vision disturbances, dizziness;
taste disturbances, loss of appetite, inflammation of the tongue (glossitis);
skin reactions such as burning or itching sensation, bruising, redness and excessive sweating;
light sensitivity;
hair loss;
tingling sensation (paraesthesia), tremor;
anaemia (pallor);
kidney problems;
pancreatitis;
liver inflammation (may present 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 breathing difficulties, contact your doctor immediately;

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

severe hypersensitivity reactions, including shock. Symptoms of hypersensitivity may include fever, skin 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 white blood cell count and consequently to a decreased resistance to infections. If you experience symptoms indicating infection such as fever and severe deterioration in health, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems, contact your doctor immediately. A blood test will be performed to check whether white blood cell count is decreasing (agranulocytosis).

The following side effect has unknown frequency (frequency cannot be estimated from the 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, contact your doctor immediately. Low magnesium levels may in turn cause reduced levels of calcium or potassium in the blood. Your doctor may decide to perform 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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lansoprazole Laboratori Alter

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP.) stated on the blister and on the carton. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Do not dispose of medicines 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 Lansoprazolo Laboratori Alter contains

The active substance is lansoprazole;
The other components are sugar spheres (sucrose and maize starch), magnesium carbonate, hypromellose, polysorbate 80, macrogol 6000, triethyl citrate, talc, methacrylic acid-ethyl acrylate copolymer, methyl methacrylate 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 the contents of the pack
Lansoprazolo Laboratori Alter 30 mg are white, round, flat orodispersible tablets, speckled with microgranules.
Lansoprazolo Laboratori Alter 30 mg is available in packs containing 14, 28, 56 or 98 tablets.

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

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 Leverkusen
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
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