Lansoprazole Tecnigen Italia: detailed information

Package leaflet: information for the patient

Lansoprazolo TecniGen Italia 15 mg orodispersible tablets

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor 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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT LANSOPRAZOLE TECNIGEN ITALIA IS AND WHAT IT IS USED FOR

The active substance of Lansoprazole TecniGen Italia is lansoprazolo, a proton pump inhibitor.
The proton pump inhibitor reduces the amount of acid produced by the stomach.
Your doctor may have prescribed Lansoprazole TecniGen Italia for the following indications:

Treatment of duodenal or gastric ulcer;
Treatment of oesophageal inflammation (reflux oesophagitis);
Prevention of reflux oesophagitis;
Treatment of gastric 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 TecniGen Italia for an indication or at a dosage different from that stated in this leaflet. For taking the medicine, follow your doctor's instructions.

2. WHAT YOU SHOULD KNOW BEFORE TAKING LANSOPRAZOLE TECNIGEN ITALIA

Do not take Lansoprazole TecniGen Italia:

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

Warnings and precautions
Talk to your doctor before taking Lansoprazole TecniGen Italia if:

you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole TecniGen Italia that reduces gastric acidity.
- you need to undergo a specific blood test (chromogranin A).

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to discontinue treatment with Lansoprazole TecniGen Italia. Remember to report any other adverse effects such as joint pain.
Inform your doctor if you suffer from severe liver disease. Your doctor may need to adjust your dose.
Your doctor may decide to perform, or may have already performed, an additional examination called endoscopy to diagnose your condition and/or to rule out the presence of malignant disease.
If you develop diarrhoea during treatment with Lansoprazole TecniGen Italia, contact your doctor immediately, as Lansoprazole TecniGen Italia has been associated with a slight increase in the rate of infectious diarrhoea.
If your doctor has prescribed Lansoprazole TecniGen Italia in combination with other medicines for the treatment of Helicobacter pylori infection (antibiotics), or in combination with anti-inflammatory medicines to relieve pain or rheumatic disease, please read carefully the package leaflet of those medicines as well.
Taking a proton pump inhibitor such as Lansoprazole TecniGen Italia, 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 TecniGen Italia 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 lead to reduced levels of calcium or potassium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
If you take Lansoprazole TecniGen Italia for a prolonged period (longer than one year), your doctor will likely decide to monitor your health status regularly. If any unusual symptoms or signs occur, discuss them with your doctor at the earliest opportunity.

Other medicines and Lansoprazole TecniGen Italia
Inform your doctor if you are currently taking, or have recently taken, any other medicines, including those not requiring a prescription.
Specifically, inform your doctor if you are taking medicines containing any of the following active substances, as Lansoprazole TecniGen Italia may interfere with their mode of action:

ketoconazole, itraconazole, rifampicin (for the treatment of infections);
digoxin (for the treatment of heart problems);
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);
diuretics (to increase frequency of urination);
St. John’s wort (Hypericum perforatum) (for the treatment of mild forms of depression).

Lansoprazole TecniGen Italia with food and drinks
Take Lansoprazole TecniGen Italia 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 breastfeeding, consult your doctor before taking this medicine.

Driving and using machines
Patients taking Lansoprazole TecniGen Italia may experience adverse effects such as dizziness, vertigo, fatigue, and visual disturbances. If you experience any of these effects, you should take precautions, as your reaction capability may be reduced.
It is solely your responsibility to decide whether you are fit to drive a motor vehicle or perform other activities requiring increased concentration. The use of medicines is one of the factors that may reduce your ability to safely carry out 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 TecniGen Italia 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 TECNIGEN ITALIA

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 a syringe.

Administration via syringe or nasogastric tube (with a diameter of 12F or 18F): Follow the instructions below:

Remove the plunger from the syringe (a 5 ml syringe is required at minimum for 15 mg tablets and a 10 ml syringe for 30 mg tablets);
Place the tablet into the 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 up an additional 1 ml of air;
Gently shake the syringe for 10–20 seconds until the tablet dissolves;
Attach the nasogastric tube to the syringe and administer the contents through the nasogastric tube;
Refill the syringe with 2–5 ml of water and flush the tube with this water.

Administration via 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 minimum for 15 mg tablets and a 10 ml syringe for 30 mg tablets);
Place the tablet into the 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 up an additional 1 ml of air;
Gently shake the syringe for 10–20 seconds until the tablet dissolves;
The contents can be administered directly into the oral cavity;
Refill the syringe with 2–5 ml of water and administer the remaining contents into the oral cavity;
Repeat the previous step, if necessary.

If you take Lansoprazole TecniGen Italia once daily, try to take it at the same time every day. The greatest benefit is obtained when Lansoprazole TecniGen Italia is taken in the morning.
If you take Lansoprazole TecniGen Italia twice daily, take the first dose in the morning and the second in the evening.

The dose of Lansoprazole TecniGen Italia varies depending on the condition being treated. The usual doses for adults are listed below. Your doctor may sometimes prescribe a different dose and will 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. This treatment is usually taken daily for 7 days.

The recommended antibiotic combinations are:

30 mg Lansoprazole TecniGen Italia together with 250–500 mg clarithromycin and 1,000 mg amoxicillin;
30 mg Lansoprazole TecniGen Italia together with 250 mg clarithromycin and 400–500 mg metronidazole.

If you are undergoing treatment for an infection causing an ulcer, it is unlikely that the ulcer will recur if the infection has been successfully treated. To achieve the best results, take the medicine at the prescribed time and do not miss any doses.

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

Prevention of duodenal or gastric ulcer in patients requiring chronic treatment with NSAIDs: one orodispersible tablet of 15 mg daily; your doctor may decide to increase 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; thereafter, depending on your response to Lansoprazole TecniGen Italia, your doctor will prescribe the most appropriate dose for you.

Use in children
Lansoprazole TecniGen Italia must not be administered to children.

If you take more Lansoprazole TecniGen Italia than you should
If you take more Lansoprazole TecniGen Italia than prescribed, contact a doctor immediately.

If you forget to take Lansoprazole TecniGen Italia
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Lansoprazole TecniGen Italia
Do not stop treatment prematurely just because your symptoms have improved. Your condition may not be fully resolved, and symptoms may return if you do not complete the full course of treatment.

If you have any doubts about how to use this medicine, consult your doctor.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, Lansoprazolo TecniGen Italia can cause adverse effects, although not all
people will experience them.
The following adverse effects are common (may affect more than 1 in 100 patients):

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 gastric polyps.

The following adverse effects are uncommon (may affect less than 1 in 100 patients):

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 adverse effects are rare (may affect less than 1 in 1,000 patients):

fever;
restlessness, drowsiness, confusion, hallucinations, insomnia, visual 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;
light sensitivity;
hair loss;
tingling sensation (paraesthesia), tremor;
anaemia (pallor);
kidney disorders;
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, urticaria, or breathing difficulties, seek immediate medical attention;

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

severe hypersensitivity reactions, including shock. Symptoms of hypersensitivity reactions may include fever, skin rash, swelling, and sometimes low blood pressure;
inflammation of the oral cavity (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 skin peeling;
in very rare cases, Lansoprazolo TecniGen Italia may lead to a reduction in the number of white blood cells and, consequently, to 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 for a reduction in white blood cells (agranulocytosis).

The following adverse effect has unknown frequency:

hypomagnesaemia;
erythema, possible joint pain;
visual hallucinations.

If you experience any adverse effect, including those not listed in this leaflet,
contact your doctor.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet,
contact your doctor or pharmacist. You may also report adverse effects directly
via the national reporting system at the website
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting adverse effects, you can help provide more information on the safety
of this medicine.

5. HOW TO STORE LANSOPRAZOLE TECNIGEN ITALIA

Keep out of the sight and reach of children.
Do not use Lansoprazole TecniGen Italia after the expiry date stated on the blister and on the
packaging. 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 no longer required. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Lansoprazolo TecniGen Italia contains

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

Description of the appearance of Lansoprazolo TecniGen Italia and pack contents
Lansoprazolo TecniGen Italia 15 mg are round, flat orodispersible tablets of whiteish colour, speckled with microgranules.
Lansoprazolo TecniGen Italia 15 mg is available in packs containing 14, 28 or 56 tablets.

Marketing Authorization Holder
TECNIGEN s.r.l.
Via Galileo Galilei, 40
20092 – Cinisello Balsamo (Milan) - Italy

Manufacturer
LABORATORIOS SALVAT, S.A.
Gall 30-36 – 08950
Esplugues de Llobregat
Barcelona - Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Lansoprazolo TecniGen Italia Italy
Duomate Flas 15 mg bucodispersable tablets Spain

Patient Information Leaflet

Lansoprazolo TecniGen Italia 30 mg orodispersible tablets

lansoprazole
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor 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 could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT LANSOPRAZOLE TECNIGEN ITALIA IS AND WHAT IT IS USED FOR

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

Treatment of duodenal or gastric ulcer;
Treatment of oesophageal inflammation (reflux oesophagitis);
Prevention of reflux oesophagitis;
Treatment of gastric 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 TecniGen Italia for an indication or dosage different from that stated in this leaflet. Always follow your doctor's instructions regarding the use of this medicine.

2. WHAT YOU SHOULD KNOW BEFORE TAKING LANSOPRAZOLE TECNIGEN ITALIA

Do not take Lansoprazole TecniGen Italia:

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

Warnings and precautions
Talk to your doctor before taking Lansoprazole TecniGen Italia if:

you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole TecniGen Italia that reduces gastric acidity.
you need to undergo a specific blood test (chromogranin A).

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to discontinue treatment with Lansoprazole TecniGen Italia. Remember to also report any other adverse effects such as joint pain.
Inform your doctor if you suffer from severe liver disease. Your doctor may need to adjust your dose.
Your doctor may decide to perform, or may have already performed, an additional examination called endoscopy to diagnose your condition and/or to rule out the presence of a malignant disease.
If you develop diarrhea during treatment with Lansoprazole TecniGen Italia, contact your doctor immediately, as Lansoprazole TecniGen Italia has been associated with a slight increase in the rate of infectious diarrhea.
If your doctor has prescribed Lansoprazole TecniGen Italia 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 disease, carefully read the package leaflet of those medicines as well.
Taking a proton pump inhibitor such as Lansoprazole TecniGen Italia, especially if taken for more than one year, may slightly increase the risk of fracture of the hip, wrist, or spine. Talk to your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
If you take Lansoprazole TecniGen Italia for more than three months, your blood magnesium levels may decrease. This decrease might 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 could in turn lead to reduced levels of calcium or potassium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
If you take Lansoprazole TecniGen Italia for a prolonged period (longer than one year), your doctor will likely decide to monitor your health status regularly. If any unusual symptoms or signs occur, discuss them with your doctor at the earliest opportunity.

Other medicines and Lansoprazole TecniGen Italia
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 TecniGen Italia may interfere with their mode of action:

ketoconazole, itraconazole, rifampicin (for the treatment of infections);
digoxin (for the treatment of heart problems);
theophylline (for the treatment of asthma);
tacrolimus (to prevent organ 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);
diuretics (to increase frequency of urination);
St. John's wort (Hypericum perforatum) (for the treatment of mild forms of depression).

Lansoprazole TecniGen Italia with food and drinks
Take Lansoprazole TecniGen Italia at least 30 minutes before meals to obtain the maximum benefit from the medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.

Driving and using machines
Patients taking Lansoprazole TecniGen Italia may experience adverse effects such as dizziness, vertigo, fatigue, and visual disturbances. If you experience any of these effects, you should take precautions, as your reaction capabilities 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 high concentration. The use of medicines is one of the factors that may reduce your ability to safely carry out 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 TecniGen Italia 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 TECNIGEN ITALIA

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 sucking it gently. 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 a syringe.

Administration via syringe or nasogastric tube (with a diameter of 12F or 18F):
Follow the instructions below:

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);
Place the tablet into the cylindrical body 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;
Attach the tube to the syringe and administer the contents through the nasogastric tube;
Refill the syringe with 2–5 ml of water and flush the tube with this water.

Administration via oral syringe:
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);
Place the tablet into the cylindrical body 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 solution can then be directly administered into the oral cavity;
Refill the syringe with 2–5 ml of water and administer the remaining solution into the oral cavity;
Repeat the previous step if necessary.

If you take Lansoprazole TecniGen Italia once daily, try to take it at the same time each day. The greatest benefit is obtained when Lansoprazole TecniGen Italia is taken in the morning.
If you take Lansoprazole TecniGen Italia twice daily, take the first dose in the morning and the second in the evening.

The dose of Lansoprazole TecniGen Italia varies depending on your condition. The usual doses for adults are listed below. Your doctor may sometimes prescribe a different dose and will 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 initial dose is one orodispersible tablet of 30 mg taken in the morning together with two different antibiotics, and one orodispersible tablet of 30 mg taken in the evening together with two different antibiotics. This treatment is usually taken daily for 7 days.

The recommended antibiotic combinations are:

30 mg Lansoprazole TecniGen Italia together with 250–500 mg clarithromycin and 1,000 mg amoxicillin;
30 mg Lansoprazole TecniGen Italia together with 250 mg clarithromycin and 400–500 mg metronidazole.

If you are undergoing treatment for an infection due to an ulcer, it is unlikely that the ulcer will recur if the infection has been successfully treated. To achieve the best results, take the medicine at the prescribed 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 decide to adjust the dose up to one orodispersible tablet of 30 mg daily.

Use in children
Lansoprazole TecniGen Italia must not be administered to children.

If you take more Lansoprazole TecniGen Italia than you should
If you take more Lansoprazole TecniGen Italia than prescribed, contact a doctor immediately.

If you forget to take Lansoprazole TecniGen Italia
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, do not take the missed dose but continue with your regular dosing schedule. Do not take a double dose to make up for the missed orodispersible tablet.

If you stop taking Lansoprazole TecniGen Italia
Do not stop treatment prematurely just because symptoms have improved. Your condition may not have fully resolved and symptoms may return if you do not complete the treatment.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Lansoprazolo TecniGen Italia may cause adverse reactions, although not all people experience them.

The following adverse reactions are common (may affect more than 1 in 100 patients):

headache, dizziness;
diarrhoea, constipation, stomach pain, nausea, flatulence, dryness or pain in the mouth or throat;
skin rash, itching;
changes in liver function test results;
fatigue.

The following adverse reactions are uncommon (may affect less than 1 in 100 patients):

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

The following adverse reactions are rare (may affect less than 1 in 1,000 patients):

fever;
restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo;
altered taste sensation, 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 disorders;
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, urticaria or breathing difficulties, seek immediate medical attention;

The following adverse reactions are very rare (may affect less than 1 in 10,000 patients):

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 TecniGen Italia may cause a reduction in white blood cell count and consequently decreased resistance to infections. If you experience symptoms suggestive of infection such as fever and severe deterioration in health, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems, seek immediate medical attention. A blood test will be performed to check for a reduction in white blood cells (agranulocytosis).

The following adverse reaction has unknown frequency:

hypomagnesaemia;
erythema, possible joint pain;
visual hallucinations.

If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the website
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LANSOPRAZOLE TECNIGEN ITALIA

Keep out of the sight and reach of children.
Do not use Lansoprazole TecniGen Italia after the expiry date stated on the blister and on the
packaging. 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. PACKAGING CONTENTS AND OTHER INFORMATION

What Lansoprazolo TecniGen Italia contains

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

Description of the appearance of Lansoprazolo TecniGen Italia and the contents of the pack
Lansoprazolo TecniGen Italia 30 mg are white, round, flat orodispersible tablets with a speckled appearance due to microgranules.
Lansoprazolo TecniGen Italia 30 mg is available in packs containing 14, 28 or 56 tablets.

Marketing Authorization Holder
TECNIGEN s.r.l.
Via Galileo Galilei, 40
20092 – Cinisello Balsamo (Milan) - Italy

Manufacturer
LABORATORIOS SALVAT, S.A.
Gall 30-36 – 08950
Esplugues de Llobregat
Barcelona - Spain

This medicinal product is authorized in the European Economic Area Member States under the following names:
Lansoprazolo TecniGen Italia Italy
Duomate Flas 30 mg comprimidos bucodispersables Spain