LANSOPRAZOLO 30 mg Tabletka Orodispersyjna

Treść ulotki

1. LANSOPRAZOLO EUROGENERICI 15 mg orodispersible tablets
   1. What is Lansoprazolo Eurogenerici and what is it used for
   2. What you need to know before taking Lansoprazolo Eurogenerici
   3. How to take Lansoprazolo Eurogenerici
   4. Possible side effects
   5. How to store Lansoprazolo Eurogenerici
   6. Contents of the pack and other information
2. Lansoprazole 15 mg orodispersible tablets are uncoated tablets colored from
3. LANSOPRAZOLO EUROGENERICI 30 mg orodispersible tablets
   1. What is LANSOPRAZOLO EUROGENERICI and what is it used for
4. lansoprazole which is a proton pump inhibitor. Proton pump inhibitors
   1. What you need to know before taking LANSOPRAZOLO EUROGENERICI
   2. How to take LANSOPRAZOLO EUROGENERICI
   3. Possible side effects
   4. How to store LANSOPRAZOLO EUROGENERICI
   5. Package Contents and Other Information

LANSOPRAZOLO EUROGENERICI 15 mg orodispersible tablets

Generic medicine

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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Lansoprazolo Eurogenerici and what is it used for

The active substance of Lansoprazolo Eurogenerici 15 mg orodispersible tablets is lansoprazole,
a proton pump inhibitor. Proton pump inhibitors reduce the amount of
acid produced by the stomach.
Lansoprazolo Eurogenerici is used for the treatment of adults.
The doctor may prescribe Lansoprazolo Eurogenerici for the following indications:

• Treatment of duodenal and stomach ulcers.
• Treatment of inflammation of the esophagus (reflux esophagitis).
• Prevention of reflux esophagitis.
• Treatment of heartburn and acid regurgitation.
• Treatment of infections caused by the bacterium Helicobacter pyloriwhen administered in combination with antibiotic therapy.
• Treatment or prevention of duodenal or stomach ulcers in patients who require continuous treatment with NSAIDs (NSAIDs used against pain or inflammation).
• Treatment of Zollinger-Ellison syndrome.

The doctor may have prescribed Lansoprazolo Eurogenerici for another indication or with a
to take the medicine.

2. What you need to know before taking Lansoprazolo Eurogenerici

DO NOT take Lansoprazolo Eurogenerici

• if you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6);
• if you are taking a medicine containing the active substance atazanavir (used in the treatment of HIV).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lansoprazolo Eurogenerici

• if you suffer from severe liver problems. Your doctor may need to adjust the dosage;
• if you have ever experienced a skin reaction following treatment with a medicine similar to Lansoprazolo Eurogenerici for reducing stomach acid. If a skin rash develops, especially in areas exposed to the sun, tell your doctor as soon as possible because you may need to stop taking Lansoprazolo Eurogenerici. Remember to report any other undesirable effects such as joint pain.
• If you are to undergo a specific blood test (Chromogranin A).

The doctor may have performed or may perform a further examination called endoscopy
in order to diagnose your illness and/or exclude any malignant nature of the same.
If you experience diarrhoea during treatment with Lansoprazolo Eurogenerici, contact
your doctor immediately, as Lansoprazolo Eurogenerici has been associated with a small
increase in infectious diarrhoea.
If your doctor has prescribed Lansoprazolo Eurogenerici in addition to other medicines for the
treatment of Helicobacter pyloriinfection (antibiotics) or at the same time as
anti-inflammatory drugs for the treatment of pain or rheumatic disease, read
the package leaflets of these medicines carefully.
If you take a proton pump inhibitor such as Lansoprazolo Eurogenerici, especially
for a period longer than one year, there may be a slight increase in the risk of
fractures of the hip, wrist or spine. If you suffer from osteoporosis or are
taking corticosteroids (which can increase the risk of osteoporosis) consult your
doctor.
If you take Lansoprazolo Eurogenerici for a long time (for more than one year), your doctor
will probably keep you under regular observation. You should inform him/her whenever you see
him/her about any symptom or circumstance that is new and exceptional.

Other medicines and Lansoprazolo Eurogenerici
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor if you are taking medicines containing any of the following
active substances, as Lansoprazolo Eurogenerici may affect their mode of action:

• Ketoconazole, itraconazole, rifampicin (medicines for the treatment of infections).
• Digoxin (used to treat heart conditions).
• Theophylline (used to treat asthma).
• Tacrolimus (used to prevent transplant rejection).
• Fluvoxamine (used to treat depression and other psychiatric illnesses).
• Antacids (used to treat heartburn and acid reflux).
• Sucralfate (used to heal ulcers).
• St John's Wort (Hypericum perforatum) (used to treat mild depression).

Lansoprazolo Eurogenerici with food and drink
To get the best results, you should take Lansoprazolo Eurogenerici at least 30 minutes
before taking food.

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

Driving and using machines
Undesirable effects such as dizziness, vertigo, fatigue and visual disturbances sometimes
occur in patients treated with Lansoprazolo Eurogenerici. If you experience effects
like these, you should be careful because your reaction ability may
decrease.
Only you are able to decide if you are fit to drive a motor vehicle
or cope with tasks that require high concentration. Due to their
mode of action or their undesirable effects, one of the factors that can reduce your
ability to do these things safely is the use of medicines.
You can find descriptions of these effects in other sections.
Read all the information contained in this leaflet.
If you have any doubts, contact your doctor, nurse or pharmacist.

Lansoprazolo Eurogenerici contains aspartame
This medicine contains 5.25 mg of aspartame in each orally disintegrating tablet.
Aspartame is a source of phenylalanine. It may be harmful if you suffer from phenylketonuria
(PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot
remove it properly.

3. How to take Lansoprazolo Eurogenerici

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
Place the tablet on your tongue and suck it slowly. The tablet dissolves rapidly
in your mouth, releasing the microgranules which must be swallowed without being chewed. You can
also swallow the tablets whole with a glass of water.
If you take Lansoprazolo Eurogenerici once a day, try to take it always every
day at the same time. You may achieve better results if you take Lansoprazolo Eurogenerici for
first thing in the morning.
If you take Lansoprazolo Eurogenerici twice a day, take the first dose in the morning and the
second in the evening.
The dose of Lansoprazolo Eurogenerici depends on your condition. The usual doses of
Lansoprazolo Eurogenerici for adults are reported below. Your doctor may sometimes prescribe a
different dose and tell you how long the treatment should last.

Treatment of heartburn and acid reflux:one or two orodispersible tablets of 15 mg every day for 4 weeks. If the symptoms persist, you should inform your
doctor. If the symptoms do not improve within 4 weeks, consult your doctor.

Treatment of duodenal ulcer:two orodispersible tablets of 15 mg every day for 2
weeks.

Treatment of gastric ulcer:two orodispersible tablets of 15 mg every day for 4
weeks.

Treatment of esophageal inflammation (reflux esophagitis):two orodispersible tablets
of 15 mg every day for 4 weeks.

Long-term prevention of reflux esophagitis:one orodispersible tablet of 15
mg every day; your doctor may adjust the dosage up to two orodispersible tablets
of 15 mg every day.

Treatment ofHelicobacter pyloriinfection:the usual dose is two orodispersible tablets
of 15 mg in association with two different antibiotics in the morning and two orodispersible tablets
of 15 mg in association with two different antibiotics in the evening. The treatment will be
every day for 7 days.
The recommended antibiotic combinations are:

• 30 mg of Lansoprazolo Eurogenerici together with 250-500 mg of clarithromycin and 1000 mg of amoxicillin.
• 30 mg of Lansoprazolo Eurogenerici together with 250 mg of clarithromycin and 400-500 mg of metronidazole.

If you are treating your infection because you have an ulcer, it is unlikely that the ulcer will recur,
if the infection is successfully treated. To allow the medicine to work best, take it at the scheduled times and do not forget a dose.
Treatment of duodenal or gastric ulcer in patients who need continuous treatment with NSAIDs:two orodispersible tablets of 15 mg every day for 4 weeks.

Prevention of duodenal or gastric ulcer in patients who need continuous treatment
with NSAIDs:one orodispersible tablet of 15 mg every day; your doctor
may adjust the dosage up to two orodispersible tablets of 15 mg every day.

Zollinger-Ellison syndrome:the usual dose corresponds to four orodispersible tablets
of 15 mg every day as initial treatment; subsequently your doctor will establish the best dose
for you based on your response to Lansoprazolo Eurogenerici.

Use in children and adolescents
Lansoprazolo Eurogenerici should not be given to children.

If you take more Lansoprazolo Eurogenerici than you should
If you take more Lansoprazolo Eurogenerici than you have been told, contact your doctor quickly.

If you forget to take Lansoprazolo Eurogenerici
If you forget to take a dose, take it as soon as you remember, unless it is already
time to take the next dose. If this happens do not take the forgotten dose and
take the rest of the orodispersible tablets normally. Do not take a double dose to
make up for the forgotten orodispersible tablet.

If you stop taking Lansoprazolo Eurogenerici
Do not stop the treatment prematurely, because your symptoms have improved. Your
condition may not be completely healed and may recur if you do not
complete your treatment cycle.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience diarrhoea during treatment with lansoprazole, contact your doctor immediately, as lansoprazole has been associated with a small increase in infectious diarrhoea.

The following side effects are common(may affect up to 1 in 10 people):

• headache, dizziness;
• diarrhoea, constipation, stomach pain, feeling unwell, flatulence, dry or inflamed mouth or throat;
• skin rash, itching;
• abnormal liver function tests;
• fatigue;
• benign polyps in the stomach.

The following side effects are uncommon(may affect up to 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 up to 1 in 1,000 people):

• fever;
• restlessness, drowsiness, confusion, hallucinations, insomnia, vision disturbances, vertigo;
• altered sense of taste, loss of appetite, inflammation of the tongue (glossitis);
• skin reactions such as burning or tingling under the skin, bruising, redness and excessive sweating;
• sensitivity to light;
• hair loss;
• tingling sensation on the skin (paresthesia), tremor;
• anaemia (pallor);
• kidney problems;
• pancreatitis;
• inflammation of the liver (can be detected by jaundice of the skin or eyes);
• breast enlargement in men, impotence;
• candidiasis (fungal infection affecting skin or mucous membranes);
• angioedema. Contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing.

The following side effects are very rare(may affect up to 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 mouth (stomatitis);
• colitis (inflammation of the colon);
• altered laboratory values such as sodium, cholesterol and triglyceride levels;
• very severe skin reactions with redness, blistering, severe inflammation and loss of skin;
• very rarely lansoprazole may cause a reduction in the number of white blood cells with possible reduction in its resistance to infections;
• contact your doctor immediately if you develop an infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as sore throat/pharyngitis/ulcerations in the oral cavity or problems with the urinary tract. A blood test is useful to verify the possible reduction of white blood cells (agranulocytosis).

The following side effects have a frequency not known(frequency cannot be estimated from the available data):

• if you take lansoprazole for more than three months, it is possible that blood levels of magnesium may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low
  levels of magnesium can also lead to a reduction in blood levels of potassium or
  calcium. Your doctor may decide to check magnesium levels in your
  blood regularly;
• skin rash, possibly associated with joint pain (subacute cutaneous lupus erythematosus);
• visual hallucinations.

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

5. How to store Lansoprazolo Eurogenerici

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 or on the
blister after the wording “EXP”. The expiry date refers to the last day of that month.
Store at a temperature below 25°C. Keep the medicine in the original packaging
to protect it from humidity.
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 Eurogenerici contains

• The active ingredient is lansoprazole. One (1) orally disintegrating tablet contains 15 mg of lansoprazole.
• The other ingredients are: Tablet core: microcrystalline cellulose, light magnesium carbonate, low substituted hydroxypropylcellulose, hydroxypropylcellulose (E463).

Coating: hypromellose 3 cps (E464), low substituted hydroxypropylcellulose, talc
(E553b), titanium dioxide (E171), mannitol (E421), methacrylic acid – ethyl acrylate copolymer
(1:1) dispersion, polyacrylate dispersion, glycerol monostearate, polyethylene glycol 6000,
triethyl citrate, polysorbate 80, anhydrous citric acid (E330), yellow iron oxide (E172), iron oxide
red (E172), talc (E553b), F-melt type C (Mannitol, Xylitol, Microcrystalline Cellulose,
Crospovidone, Dibasic Calcium Phosphate Anhydrous), crospovidone, microcrystalline cellulose,
aspartame (E951), strawberry aroma (flavoring, corn maltodextrin, propylene glycol
(E1520)), magnesium stearate (of vegetable origin) (E470b).

Description of the appearance of Lansoprazolo Eurogenerici and contents of the pack

Lansoprazole 15 mg orodispersible tablets are uncoated tablets colored from

white to off-white with spots of color varying from orange to dark brown. The
orodispersible tablets of lansoprazole 15 mg have “15” imprinted on one side. Each
15 mg lansoprazole orodispersible tablet has a strawberry aroma.
Lansoprazole 15 mg orodispersible tablets are available in packs of 7, 14, 28, 30 and 56
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6 - 20136 Milan

Manufacturer
STADA Arzneimittel AG, Stadastrasse 2 – 18 Bad Vilbel 61118, Germany

LANSOPRAZOLO EUROGENERICI 30 mg orodispersible tablets

Generic medicine

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 they have the same symptoms as you, 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 EUROGENERICI is and what it is used for
• 2. What you need to know before you take LANSOPRAZOLO EUROGENERICI
• 3. How to take LANSOPRAZOLO EUROGENERICI
• 4. Possible side effects
• 5. How to store LANSOPRAZOLO EUROGENERICI
• 6. Contents of the pack and other information

1. What is LANSOPRAZOLO EUROGENERICI and what is it used for

The active ingredient of LANSOPRAZOLO EUROGENERICI 30 mg orodispersible tablets is

lansoprazole which is a proton pump inhibitor. Proton pump inhibitors

reduce the amount of acid produced by your stomach.
LANSOPRAZOLO EUROGENERICI is used in adults.
Your doctor may prescribe LANSOPRAZOLO EUROGENERICI for the following indications:

• Treatment of duodenal and gastric ulcers.
• Treatment of inflammation of the esophagus (reflux esophagitis).
• Prevention of reflux esophagitis.
• Treatment of heartburn and acid regurgitation.
• Treatment of infections caused by the bacterium Helicobacter pyloriwhen administered in combination with antibiotic therapy.
• Treatment or prevention of duodenal or stomach ulcers in patients who require continuous treatment with NSAIDs (NSAIDs are used against pain or inflammation).
• Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed LANSOPRAZOLO EUROGENERICI for another indication or with
doctor to take the medicine.

2. What you need to know before taking LANSOPRAZOLO EUROGENERICI

DO NOT take LANSOPRAZOLO EUROGENERICI

• If you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are taking a medicine containing the active substance atazanavir (used in the treatment of HIV).

Warnings and precautions
Talk to your doctor or pharmacist before taking LANSOPRAZOLO EUROGENERICI:

• if you suffer from severe liver problems. Your doctor may need to adjust the dose;
• if you have experienced a skin reaction following treatment with a medicine similar to LANSOPRAZOLO EUROGENERICI that reduces stomach acid. If a rash appears, especially in areas exposed to the sun, tell your doctor as soon as possible, as you may need to stop taking LANSOPRAZOLO EUROGENERICI. Also remember to mention any other negative effects such as joint pain;
• if you are going to undergo a specific blood test (Chromogranin A).

The doctor may have performed or may perform a further examination called
endoscopy in order to diagnose your illness and/or exclude the possible malignant
nature of the same.
If you experience diarrhea during treatment with LANSOPRAZOLO EUROGENERICI contact
your doctor immediately, as LANSOPRAZOLO EUROGENERICI has been associated with a
small increase in infectious diarrhea.
If your doctor has prescribed LANSOPRAZOLO EUROGENERICI in addition to other medicines for
the treatment of Helicobacter pyloriinfection (antibiotics) or at the same time as
anti-inflammatory medicines for the treatment of pain or rheumatic disease: please
read the package leaflets of these medicines carefully.
Taking a proton pump inhibitor such as LANSOPRAZOLO EUROGENERICI,
especially for a long time (for more than 1 year) may cause a slight increase in the risk of
fracture of the hip, wrist and spine. Tell your doctor if you have osteoporosis or
if you are taking corticosteroids (which can increase the risk of osteoporosis).
If you take LANSOPRAZOLO EUROGENERICI for a long time (for more than a year) your doctor
will probably keep you under regular observation. You must notify him whenever you
see any symptom or circumstance that is new and exceptional.

Other medicines and LANSOPRAZOLO EUROGENERICI
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor if you are taking medicines containing any of the
following active substances, as LANSOPRAZOLO EUROGENERICI may affect how they
work:

• ketoconazole, itraconazole, rifampicin (medicines for the treatment of infections);
• digoxin (used to treat heart disease);
• theophylline (used to treat asthma);
• tacrolimus (used to prevent transplant rejection);
• fluvoxamine (used to treat depression and other psychiatric illnesses);
• antacids (used to treat heartburn and acid reflux);
• sucralfate (used to heal ulcers);
• St John's wort (Hypericum perforatum) (used to treat mild depression).

LANSOPRAZOLO EUROGENERICI with food and drink
To get the best results you should take LANSOPRAZOLO EUROGENERICI at least 30
minutes before taking food.

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

Driving and operating machinery
Undesirable effects such as dizziness, vertigo, fatigue and visual disturbances occur
sometimes in patients taking LANSOPRAZOLO EUROGENERICI. If you experience
undesirable effects such as these, you must be careful because your reaction ability may decrease.
Only you are able to decide whether you are fit to drive a vehicle or
perform tasks that require high concentration. Among the factors that can reduce your ability to do these things safely, their effects or
undesirable effects are the use of medicines.
Descriptions of these effects can be found in other paragraphs.
In case of any doubt, contact your doctor, nurse or pharmacist.

LANSOPRAZOLO EUROGENERICI contains aspartame
This medicine contains a source of phenylalanine. It may be harmful if you have
phenylketonuria.

3. How to take LANSOPRAZOLO EUROGENERICI

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
Place the tablet on your tongue and suck it slowly. The tablet dissolves rapidly
in your mouth, releasing the microgranules which must be swallowed without being chewed. You can
also swallow the tablets whole with a glass of water.
If you take LANSOPRAZOLO EUROGENERICI once a day, try to take it always at the
same time. You may obtain better results if you take LANSOPRAZOLO EUROGENERICI first
thing in the morning.
If you take LANSOPRAZOLO EUROGENERICI twice a day, you must take the first dose in the
morning and the second dose in the evening.
The dose of LANSOPRAZOLO EUROGENERICI depends on your condition. The usual doses of
LANSOPRAZOLO EUROGENERICI for adults are reported below. Your doctor may sometimes prescribe
a different dose and will tell you how long the treatment should last.

Treatment of heartburn and acid reflux:one orodispersible tablet of 15 mg (for this dosage appropriate strengths
are available) or one orodispersible tablet of 30 mg daily for 4 weeks. If the
symptoms persist you should tell your doctor. If the symptoms do not improve within 4 weeks
consult 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 tablet
orodispersible of 30 mg daily for 4 weeks.

Long-term prevention of reflux esophagitis:one orodispersible tablet of 15
mg (for this dosage appropriate strengths are available) daily, the doctor may adjust the dose up to one orodispersible tablet of 30 mg daily.

Treatment of infection byHelicobacter pylori:the usual dose is one tablet
orodispersible 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 will be daily for 7 days.
The recommended antibiotic combinations are:

• 30 mg of LANSOPRAZOLO EUROGENERICI together with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin;
• 30 mg of LANSOPRAZOLO EUROGENERICI together with 250 mg of clarithromycin and 400-500 mg of metronidazole.

If you are treating your infection because you have an ulcer, it is likely that the ulcer will no longer appear
if the infection is successfully treated. To get the best results from this
therapy, take the medicine at the scheduled times and never forget a dose.

Treatment of duodenal or gastric ulcer in patients who need continued treatment
with NSAIDs:one orodispersible tablet of 30 mg daily for 4
weeks.

Prevention of duodenal or gastric ulcer in patients who need continued treatment
with NSAIDs:one orodispersible tablet of 15 mg (for this dosage
appropriate strengths are available) daily, the 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, then based on your response to LANSOPRAZOLO EUROGENERICI the doctor will decide
the most suitable dose for you.

Use in children and adolescents
LANSOPRAZOLO EUROGENERICI should not be given to children.

If you take more LANSOPRAZOLO EUROGENERICI than you should
If you take more LANSOPRAZOLO EUROGENERICI than you have been told, ask your doctor for advice immediately.

If you forget to take LANSOPRAZOLO EUROGENERICI
If you forget to take a dose, take it as soon as you remember, unless it is already
time to take the next dose. If this happens do not take the forgotten dose and
take the remaining orodispersible tablets as usual. Do not take a double dose to make up for the forgotten tablet.

If you stop taking LANSOPRAZOLO EUROGENERICI
Do not stop the treatment prematurely if your symptoms have improved. Your
condition may not be completely healed and may recur if you do not
complete your treatment cycle.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience diarrhoea during treatment with lansoprazole, contact your doctor immediately, as lansoprazole has been associated with a small increase in infectious diarrhoea.

Common side effects(may affect up to 1 in 10 people):

• headache, dizziness;
• diarrhoea, constipation, stomach pain, feeling unwell, flatulence, dry or inflamed mouth or throat;
• skin rash, itching;
• changes in liver function tests;
• fatigue;
• benign polyps in the stomach.

Uncommon side effects(may affect up to 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.

Rare side effects(may affect up to 1 in 1,000 people):

• fever;
• restlessness, drowsiness, confusion, hallucinations, insomnia, vision disturbances, vertigo;
• change in sense of taste, loss of appetite, inflammation of the tongue (glossitis);
• skin reactions such as burning or tingling under the skin, bruising, redness and excessive sweating;
• sensitivity to light;
• hair loss;
• tingling sensation on the skin (paresthesia), tremor;
• anaemia (paleness);
• kidney problems;
• pancreatitis;
• inflammation of the liver (may be manifested by yellowing of the skin or eyes);
• enlargement of the breasts in men, impotence;
• candidiasis (fungal infection affecting skin or mucous membranes);
• angioedema. Contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing.

Very rare side effects(may affect up to 1 in 10,000 people):

• 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 mouth (stomatitis);
• colitis (inflammation of the colon);
• changes in laboratory values such as sodium, cholesterol and triglyceride levels;
• very serious skin reactions with redness, blisters, severe inflammation and loss of skin;
• very rarely lansoprazole may cause a reduction in the number of white blood cells and its resistance to infections may also decrease;
• contact your doctor immediately if you develop an infection with symptoms such as fever and a serious deterioration in your general condition, or fever with symptoms of local infection, sore throat/pharyngitis/ulcerations in the oral cavity or urinary tract problems. A blood test may be useful to check for a possible reduction in white blood cells (agranulocytosis).

Side effects with frequency not known (frequency cannot be estimated from the available data):

• if you are taking lansoprazole for more than three months, it is possible that you may experience a reduction in blood magnesium levels. Low magnesium levels in the blood can result in fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience these symptoms, contact your doctor immediately. Low magnesium levels can also cause a reduction in potassium or calcium levels in the blood. Your doctor may decide to prescribe you regular blood tests to monitor your magnesium levels;
• skin rash, possibly associated with joint pain (subacute cutaneous lupus erythematosus);
• 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
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 EUROGENERICI

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 and on the
blister. The expiry date refers to the last day of that month.
Store at a temperature below 25°C. Keep the medicine in the original packaging
to protect it from moisture.
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. Package Contents and Other Information

What LANSOPRAZOLO EUROGENERICI contains

• The active ingredient is lansoprazole. 1 orally disintegrating tablet of 30 mg contains 30 mg of lansoprazole.
• The other ingredients are:

Tablet core: microcrystalline cellulose, light magnesium carbonate,
low substituted hydroxypropylcellulose, hydroxypropylcellulose (E463).
Coating: hypromellose 3 cps (E464), low substituted hydroxypropylcellulose, talc
(E553b), titanium dioxide (E171), mannitol (E421), ethyl acrylate-methacrylic acid
copolymer (1:1) dispersion, polyacrylate dispersion, glycerol monostearate, polyethylene
glycol 6000, triethyl citrate, polysorbate 80, anhydrous citric acid (E330), yellow iron oxide
(E172), red iron oxide (E172), talc (E553b), F-melt type C (mannitol, xylitol,
microcrystalline cellulose, crospovidone, dibasic calcium phosphate anhydrous), crospovidone,
microcrystalline cellulose, aspartame (E951), strawberry aroma (flavoring, corn
maltodextrin, propylene glycol (E1520)), magnesium stearate (of vegetable origin) (E470b).

Description of the appearance of LANSOPRAZOLO EUROGENERICI and package contents
Lansoprazole 30 mg orally disintegrating tablets are available as uncoated
tablets, from white to off-white in color with speckles from orange to dark brown.
Lansoprazole 30 mg orally disintegrating tablets have "30" imprinted on one
side. Each Lansoprazole 30 mg orally disintegrating tablet has a strawberry flavor.
Lansoprazole 30 mg orally disintegrating tablets are available in packs of 7, 14, 28, 30 and 56
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6, 20136 Milan

Manufacturers
STADA Arzneimittel AG, Stadastrasse 2 – 18 61118 Bad Vilbel - Germany
STADA Arzneimittel GmbH, Muthgasse 36 1190 Vienna - Austria

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy LANSOPRAZOLO EUROGENERICI 30 mg orally disintegrating tablets
Portugal Lansoprazol Ciclum
Spain Lansoprazol Flas STADA 30 mg bucodispersable tablets EFG