Lansoprazole Mylan Generics: detailed information

PACKAGE LEAFLET
VERSION FOR PULL-THROUGH BLISTER

Package leaflet: information for the patient

Lansoprazole Mylan Generics 15 mg gastro-resistant hard capsules, 30 mg gastro-resistant hard capsules

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor 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 effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Lansoprazole Mylan Generics and what is it used for

The active substance of this medicine is lansoprazole, which is a "proton pump inhibitor".
Proton pump inhibitors reduce the amount of acid produced by the stomach.
Lansoprazole Mylan Generics is used in the treatment of adults.
Your doctor may prescribe Lansoprazole Mylan Generics for the following conditions:

treatment of ulcers in the upper gastrointestinal tract (duodenal ulcer) or stomach (gastric ulcer)
treatment of inflammation of the oesophagus (reflux oesophagitis)
prevention of reflux oesophagitis
treatment of gastro-oesophageal reflux disease causing heartburn and acid regurgitation
treatment of infections caused by the bacterium Helicobacter pylori, when given in combination with antibiotic therapy
treatment or prevention of ulcers in the upper gastrointestinal tract (duodenal ulcer) or stomach (gastric ulcer) in patients requiring continuous treatment with NSAIDs (NSAID treatment is used for pain or inflammation)
treatment of Zollinger-Ellison syndrome (a tumour of the pancreas causing increased gastric acid secretion).

2. What you need to know before taking Lansoprazole Mylan Generics

Do not take Lansoprazole Mylan Generics:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Lansoprazole Mylan Generics if:

you have moderate or severe liver problems. Your doctor may need to adjust your dose
you have ever had a skin reaction after treatment with a medicine similar to lansoprazole that reduces stomach acid
you need to undergo a specific blood test (chromogranin A)
you have low levels of vitamin B12 or are at risk of low vitamin B12 levels and are receiving long-term treatment with lansoprazole. As with all agents that reduce acid, lansoprazole may lead to reduced absorption of vitamin B12
serious skin reactions have been reported [Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)] in association with lansoprazole treatment. Stop using lansoprazole and consult your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4
during treatment with lansoprazole, inflammation of the kidneys may occur. Signs and symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You must report such symptoms to your doctor.

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue lansoprazole therapy. Remember to also report any other adverse effects such as joint pain.
Your doctor may have performed or may need to perform an additional examination called endoscopy to diagnose your condition and/or rule out malignant disease.
If your doctor has prescribed lansoprazole in combination with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatic diseases, it is recommended that you read the package leaflet of these medicines carefully.
During treatment with lansoprazole, kidney inflammation may occur. Signs and symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. These signs must be reported to your doctor.
Taking a proton pump inhibitor such as lansoprazole, particularly for more than one year, may slightly increase the risk of fracture of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
During treatment
If you develop diarrhoea while taking lansoprazole, contact your doctor immediately, as lansoprazole has been associated with a small increased risk of infectious diarrhoea.
If you take Lansoprazole Mylan Generics for long periods (for more than one year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances at every visit to your doctor.

Children and adolescents
Lansoprazole Mylan Generics must not be used in children and adolescents.

Other medicines and Lansoprazole Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking medicines containing any of the following active substances, as lansoprazole may affect how these medicines work:

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of lansoprazole is not recommended during pregnancy.
Breastfeeding
Your doctor will decide whether you can take lansoprazole while breastfeeding. It is not known whether lansoprazole is excreted in breast milk.

Driving and using machines
Adverse effects such as dizziness, vertigo, somnolence, and visual disturbances may occasionally occur in patients taking lansoprazole. If such adverse effects occur, you should exercise caution, as your ability to react may be impaired. If you experience these adverse effects, do not drive or operate machinery.

Lansoprazole Mylan Generics contains sucrose and sodium
If you have been told by your doctor that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially ‘sodium-free’.

3. How to take Lansoprazole Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dose of Lansoprazole Mylan Generics depends on your condition. The recommended dose of
Lansoprazole Mylan Generics in adults is described below. Sometimes your doctor may prescribe a
different dose and will inform you how long the treatment should last.
Treatment of gastro-oesophageal reflux disease causing heartburn and acid regurgitation:
The recommended dose is 15 mg or 30 mg once daily for 4 weeks. If symptoms persist, you must
inform your doctor. If symptoms are not relieved within 4 weeks, contact your doctor.
Treatment of ulcers in the upper part of the intestine (duodenal ulcer):
The recommended dose is 30 mg once daily for 2 weeks. If the ulcer has not completely healed within this
time, your doctor may instruct you to continue taking the same dose for a further 2 weeks.
Treatment of stomach ulcer (gastric ulcer):
The recommended dose is 30 mg once daily for 4 weeks. If the ulcer has not completely healed within this
time, your doctor may instruct you to continue taking the same dose for a further 4 weeks.
Treatment of inflammation of the oesophagus (reflux oesophagitis):
The recommended dose is 30 mg once daily for 4 weeks. If healing is not complete within this time, your
doctor may instruct you to continue taking the same dose for a further 4 weeks.
Long-term prevention of reflux oesophagitis:
The recommended dose is 15 mg once daily. Your doctor may adjust the dose to 30 mg once daily, if
necessary.
Treatment of Helicobacter pylori infection:
The recommended dose is 30 mg in combination with two different antibiotics in the morning and 30 mg in
combination with two different antibiotics in the evening. Usually, treatment should be taken once daily for
7 days.
The recommended antibiotic combinations are:

30 mg lansoprazole together with 250–500 mg clarithromycin and 1000 mg amoxicillin twice daily
30 mg lansoprazole together with 250 mg clarithromycin and 400–500 mg metronidazole twice daily.

If you are being treated for an infection due to an ulcer, it is unlikely that the ulcer will recur if the infection
is successfully treated. To give the medicine the best chance to work, take it at the right time and do not miss a dose.
Treatment of ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer) in patients requiring continuous treatment with NSAIDs:
The recommended dose is 30 mg once daily for 4 weeks. If the ulcer has not completely healed, your doctor may instruct you to continue taking the same dose for a further 4 weeks.
If the ulcer still does not heal, your doctor may decide on a longer treatment and/or increase the dose.
Prevention of ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer) in patients requiring continuous treatment with NSAIDs:
The recommended dose is 15 mg once daily. Your doctor may increase the dose to 30 mg once daily.
Treatment of Zollinger-Ellison syndrome:
The recommended dose is 60 mg once daily. Depending on your response to lansoprazole, your doctor will determine the most appropriate dose for you. If your doctor recommends a dose greater than 120 mg daily, you should take half of the daily dose in the morning and half in the evening.
Patients with impaired liver function
If you suffer from moderate to severe liver disease, your doctor may recommend a lower dose of
lansoprazole and may carry out regular check-ups.
How to take the medicine
To remove Lansoprazole Mylan Generics from the blister pack:

Tear along the perforations of the aluminium foil to separate one unit
Pull the tab as indicated by the arrow to lift the foil from one blister
Push the capsule out from the back of the foil.

IMPORTANT: Do not attempt to push the capsule through the aluminium foil as with a common
capsule.
Swallow the capsule whole with a glass of water. If you find it difficult to swallow the capsule, your doctor may advise you on alternative ways to take this medicine. Do not break or chew the capsules or the contents of an emptied capsule, as this would prevent the medicine from working properly.
If you take Lansoprazole Mylan Generics once daily, try to take it at the same time every day. You may achieve the best results if you take Lansoprazole Mylan Generics first thing in the morning.
You must take the medicine at least 30 minutes before meals.
If you take Lansoprazole Mylan Generics twice daily, take the first dose in the morning and the second in the evening.
If you take more Lansoprazole Mylan Generics than you should
If you take more Lansoprazole Mylan Generics than prescribed, contact your doctor or pharmacist immediately.
If you forget to take Lansoprazole Mylan Generics
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed dose.
If you stop taking Lansoprazole Mylan Generics
Do not stop treatment earlier than planned just because your symptoms have improved. Your condition may not be completely healed, 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 or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking the medicine and contact your doctor immediately or go to the nearest hospital emergency department if you experience:
Uncommon: may affect up to 1 in 100 people

If an infection occurs with symptoms such as fever and severe deterioration in general condition, or fever with signs of local infection such as sore throat/pharynx/mouth or urinary problems, you must contact your doctor immediately. A blood test will be performed to check for a possible decrease in white blood cells (agranulocytosis or leukopenia).

Rare: may affect up to 1 in 1,000 people

Inflammation of the pancreas (pancreatitis), which may include symptoms such as severe abdominal pain, loss of appetite, nausea or vomiting, or a swollen abdomen.
Inflammation of the liver, which may present as yellowing of the skin or eyes (jaundice), pale stools, and dark urine.

Very rare: may affect up to 1 in 10,000 people

Severe skin reactions with redness of the skin accompanied by blisters or peeling, appearance of blisters and bleeding of the lips, eyes, mouth, nose, and genitals, severe inflammation and desquamation. These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis.
A reduction in the number of white or red blood cells or platelets, which may lead to fatigue, paleness, more frequent infections (e.g., mouth or throat ulcers), or increased tendency to bleeding or bruising (pancytopenia).
Severe hypersensitivity reactions including shock. Symptoms of hypersensitivity may include sudden signs of allergy such as fever, skin rash, itching or hives, swelling of the face, tongue or throat, difficulty breathing or swallowing, and sometimes a drop in blood pressure.

Not known (frequency cannot be estimated from available data)

Widespread skin rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms (DRESS)).

Other side effects
Tell your doctor if you have severe or prolonged diarrhoea. Your doctor may decide to change your
medication.
Common: may affect up to 1 in 10 people

Headache, dizziness
Diarrhoea, constipation, stomach pain, nausea or vomiting, bloating, dry mouth or throat
Skin rash, itching, hives
Changes in liver function test values
Fatigue
Benign polyps in the stomach

Uncommon: may affect up to 1 in 100 people

Depression
Joint or muscle pain
Fractures of the hip, wrist, or spine
Fluid retention or swelling
Reduced platelet count in the blood, leading to increased bleeding or bruising (thrombocytopenia)
Increase in certain types of white blood cells detectable in blood tests (eosinophilia).

Rare: may affect up to 1 in 1,000 people

Fever
Restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
Altered taste sensation, loss of appetite, inflammation of the tongue (glossitis)
Skin reactions such as burning or tingling sensation under the skin, bruising, redness, and excessive sweating
Light sensitivity
Hair loss
Skin tingling sensation (paresthesia), tremor
Anaemia (pallor and fatigue)
Decreased urine production or inability to urinate, blood or mucus in urine, lower back pain sometimes associated with skin rashes, fever, fatigue, and malaise. These may be signs of kidney disease
Fungal infection of the oesophagus
Breast enlargement in males, impotence.

Very rare: may affect up to 1 in 10,000 people

Inflammation of the mouth (stomatitis)
Colitis (inflammation of the intestine)
Decreased levels of sodium in the blood detectable in blood tests
Increased levels of fats in the blood detectable in blood tests.

Not known (frequency cannot be estimated from available data)

Erythema, possible joint pain
Visual hallucinations
If you have been taking lansoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as tiredness, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor promptly. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.

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 the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lansoprazole Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and on the carton after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25°C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lansoprazolo Mylan Generics contains
The active substance is lansoprazole. Each gastro-resistant capsule contains 15 mg or 30 mg of
lansoprazole.
The excipients are: gastro-resistant granules containing sugar spheres (maize starch and sucrose),
sodium lauryl sulfate, meglumine, mannitol, hypromellose, macrogol, talc, polysorbate 80, titanium dioxide
(E171), methacrylic acid-ethyl acrylate copolymer 1:1. The capsule shell contains: gelatin,
titanium dioxide (E171) and sodium lauryl sulfate.
Only in the 15 mg capsules: quinoline yellow (E104).
Description of the appearance of Lansoprazolo Mylan Generics and contents of the package
The 15 mg capsules are yellow, opaque, containing spherical microgranules white to off-white in colour.
The 30 mg capsules are white, opaque, containing microgranules white to off-white in colour.
The capsules are available in blisters in pack sizes of 7, 14, 15, 28, 30, 35, 56, 60 and 98 capsules.
Also available in calendar packs of 28 or 98 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Mylan S.p.a.
Via Vittor Pisani, 20
20124 Milano
Manufacturer
Laboratories Liconsa, S.A.
Avda. Miralcampo, N°7, Polígono Industrial de Miralcampo
19200 Azuqueca de Henares (Guadalajara) – Spain.
McDermott Laboratories t/a Gerard Laboratories
Baldoyle Industrial Estate, Grange Road – Dublin 13 – Ireland.
Doppel Farmaceutici S.r.l. – Via Volturno 48, 20089 Quinto de’ Stampi, Rozzano (MI) Italy.
Mylan Hungary Kft, Mylan utca 1, Komárom, H-2900 - Hungary
This medicinal product is authorised in the European Economic Area Member States under the
following names:
Denmark: Lansoprazol Viatris 15 mg, harde enterokapslar
Lansoprazol Viatris 30 mg, harde enterokapslar
Ireland: Razolager 15mg gastro-resistant capsules
Razolager 30mg gastro-resistant capsules
Italy: Lansoprazolo Mylan Generics
PACKAGE LEAFLET
VERSION FOR NON-PEEL BLISTER

Patient Information Leaflet

Lansoprazole Mylan Generics 15 mg gastro-resistant hard capsules, 30 mg gastro-resistant hard capsules

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor 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, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Lansoprazole Mylan Generics and what is it used for

The active substance of the medicine is lansoprazole, which is a "proton pump inhibitor".
Proton pump inhibitors reduce the amount of acid produced by the stomach.
Lansoprazole Mylan Generics is used in the treatment of adults.
Your doctor may prescribe Lansoprazole Mylan Generics for the following conditions:

treatment of ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer)
treatment of inflammation of the oesophagus (reflux oesophagitis)
prevention of reflux oesophagitis
treatment of gastro-oesophageal reflux disease causing heartburn and acid regurgitation
treatment of infections caused by the bacterium Helicobacter pylori, when given in combination with antibiotic therapy
treatment or prevention of ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer) in patients requiring continuous treatment with NSAIDs (NSAID treatment is used for pain or inflammation)
treatment of Zollinger-Ellison syndrome (a tumour in the pancreas causing increased secretion of gastric acid).

2. What you must know before taking Lansoprazole Mylan Generics.

Do not take Lansoprazole Mylan Generics:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Lansoprazole Mylan Generics if:

you have moderate or severe liver problems. Your doctor may need to adjust the dosage
you have ever had a skin reaction after treatment with a medicine similar to lansoprazole that reduces stomach acid
you need to undergo a specific blood test (chromogranin A)
you have low levels of vitamin B12 or have risk factors for low vitamin B12 levels and are receiving long-term treatment with lansoprazole. As with all agents that reduce acid, lansoprazole may lead to reduced absorption of vitamin B12
serious skin reactions [Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)] have been reported in association with lansoprazole treatment. Stop using lansoprazole and consult your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4
kidney inflammation may occur during lansoprazole treatment. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. These symptoms must be reported to your treating physician.

If you notice the appearance of a skin erythema, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue lansoprazole therapy. Remember to also report any other adverse effects such as joint pain.
Your doctor may have performed or may need to perform an additional examination called endoscopy, in order to diagnose your condition and/or rule out malignancy.
If your doctor has prescribed lansoprazole in combination with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatic diseases, it is recommended that you read the patient information leaflet of these medicines carefully.
During treatment
Kidney inflammation may occur during lansoprazole treatment. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. These signs must be reported to your treating physician.
Taking a proton pump inhibitor such as lansoprazole, especially for more than one year, may slightly increase the risk of fracture of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
During treatment
If diarrhoea occurs while taking lansoprazole, contact your doctor immediately, as lansoprazole has been associated with a small increased risk of infectious diarrhoea.
If you take Lansoprazole Mylan Generics for long periods (for more than one year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms or circumstances each time you see your doctor.
Children and adolescents
Lansoprazole Mylan Generics must not be used in children and adolescents.
Other medicines and Lansoprazole Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking medicines containing any of the following active substances, as lansoprazole may affect how these medicines work:

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of lansoprazole is not recommended during pregnancy.
Breastfeeding
Your doctor will decide whether you can take lansoprazole while breastfeeding. It is not known whether lansoprazole is excreted in breast milk.
Driving and using machines
Adverse effects such as dizziness, vertigo, somnolence, and visual disturbances may occasionally occur in patients taking lansoprazole. If such adverse effects occur, you should exercise caution, as your ability to react may be impaired. If these adverse effects occur, you must not drive or operate machinery.
Lansoprazole Mylan Generics contains sucrose and sodium
If you have been told by your doctor that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Lansoprazole Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dose of Lansoprazole Mylan Generics depends on your condition. The recommended dose of
Lansoprazole Mylan Generics in adults is described below. Sometimes your doctor may prescribe a
different dose and will inform you of how long the treatment should last.
Treatment of gastroesophageal reflux disease causing heartburn and acid regurgitation:
The recommended dose is 15 mg or 30 mg daily for 4 weeks. If symptoms persist, you must
inform your doctor. If symptoms are not relieved within 4 weeks, contact your doctor.
Treatment of ulcers in the upper part of the intestine (duodenal ulcer):
The recommended dose is 30 mg daily for 2 weeks. If the ulcer has not yet completely
healed within this time, your doctor may instruct you to continue taking the same dose for an additional 2 weeks.
Treatment of stomach ulcer (gastric ulcer):
The recommended dose is 30 mg daily for 4 weeks. If the ulcer has not yet completely
healed within this time, your doctor may instruct you to continue taking the same dose for an additional 4 weeks.
Treatment of inflammation of the oesophagus (reflux oesophagitis):
The recommended dose is 30 mg daily for 4 weeks. If healing is not yet complete within this time, your doctor may instruct you to continue taking the same dose for an additional 4 weeks.
Long-term prevention of reflux oesophagitis:
The recommended dose is 15 mg daily; your doctor may adjust the dose to 30 mg daily, if
necessary.
Treatment of Helicobacter pylori infection:
The recommended dose is 30 mg in combination with two different antibiotics in the morning and 30 mg in
combination with two different antibiotics in the evening. Usually, treatment should be taken daily for
7 days.
The recommended antibiotic combinations are:

30 mg of lansoprazole together with 250–500 mg of clarithromycin and 1000 mg of amoxicillin twice daily
30 mg of lansoprazole together with 250 mg of clarithromycin and 400–500 mg of metronidazole twice daily.

If you are being treated for an infection due to an ulcer, it is unlikely that the ulcer will recur if the
infection is successfully treated. To give the medicine the best chance of working, take it at the correct
time and do not miss a dose.
Treatment of ulcers in the upper part of the intestine (duodenal ulcer) or stomach
(gastric ulcer) in patients requiring ongoing NSAID treatment: The recommended dose is 30 mg daily for 4 weeks. If the ulcer has not yet completely healed, your doctor may instruct you to continue taking the same dose for an additional 4 weeks.
If the ulcer still does not heal, your doctor may decide on a longer treatment duration and/or increase the dose.
Prevention of ulcers in the upper part of the intestine (duodenal ulcer) or stomach
(gastric ulcer) in patients requiring ongoing NSAID treatment: The recommended dose is 15 mg daily; your doctor may increase the dose to 30 mg daily.
Treatment of Zollinger-Ellison syndrome:
The recommended dose is 60 mg daily. Subsequently, depending on your response to lansoprazole, your
doctor will determine the most appropriate dose for you.
If your doctor recommends taking more than 120 mg daily, you should take half of the daily dose in the morning and half in the evening.
Patients with impaired liver function
If you suffer from moderate to severe liver disease, your doctor may recommend a lower dose of
lansoprazole and may carry out regular check-ups.
How to take the medicine
Swallow the capsule whole with a glass of water. If you find it difficult to swallow the capsule, your
doctor may advise you on alternative ways to take this medicine. Do not break or chew the capsules or the contents of an emptied capsule, as this would prevent the medicine from working properly.
If you take Lansoprazole Mylan Generics once daily, try to take it at the same time every day. You may achieve the best results if you take Lansoprazole Mylan Generics first thing in the morning.
You must take the medicine at least 30 minutes before meals.
If you take Lansoprazole Mylan Generics twice daily, you should take the first dose in the morning and the second in the evening.
If you take more Lansoprazole Mylan Generics than you should
If you take more Lansoprazole Mylan Generics than prescribed, contact your doctor or pharmacist immediately.
If you forget to take Lansoprazole Mylan Generics
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed dose.
If you stop taking Lansoprazole Mylan Generics
Do not stop treatment earlier than planned, even if your symptoms have improved. Your condition may not be completely healed, and a relapse may occur if you do not complete your course of treatment.
If you have any questions 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 everyone will experience them.

Stop taking the medicine and contact your doctor immediately or go to the nearest hospital emergency department if you experience:

Uncommon: may affect up to 1 in 100 people

If an infection occurs with symptoms such as fever and severe deterioration in general condition, or fever with signs of local infection such as sore throat/pharynx/mouth or urinary problems, you must contact your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis or leukopenia).

Rare: may affect up to 1 in 1,000 people

Inflammation of the pancreas (pancreatitis), which may include symptoms such as severe abdominal pain, loss of appetite, nausea or vomiting, and bloated abdomen.
Inflammation of the liver, which may present as yellowing of the skin or eyes, pale stools, and dark urine.

Very rare: may affect up to 1 in 10,000 people

Severe skin reactions with redness of the skin, blistering or peeling, appearance of blisters and bleeding of the lips, eyes, mouth, nose, and genitals, severe inflammation and desquamation. These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis.
A reduction in the number of white blood cells, red blood cells, or platelets, which may lead to fatigue, paleness, more frequent infections (e.g., throat or mouth ulcers), or increased tendency to bleed or bruise easily (pancytopenia).
Severe hypersensitivity reactions, including shock. Symptoms of hypersensitivity may include sudden allergic reactions such as fever, skin rash, itching or hives, swelling of the face, tongue, or throat, difficulty breathing or swallowing, and sometimes a drop in blood pressure.

Not known (frequency cannot be estimated from available data)

Widespread rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms (DRESS)).

Other side effects
Inform your doctor if you experience severe or prolonged diarrhoea. Your doctor may decide to change your medicine.

Common: may affect up to 1 in 10 people

Headache, dizziness
Diarrhoea, constipation, stomach pain, nausea or vomiting, flatulence, dry mouth or throat
Skin rash, itching, hives
Changes in liver function test values
Fatigue
Benign polyps in the stomach.

Uncommon: may affect up to 1 in 100 people

Depression
Joint or muscle pain
Fractures of the hip, wrist, or spine
Fluid retention or swelling
Reduction in platelets in the blood, leading to increased bleeding or bruising (thrombocytopenia)
Increase in certain types of white blood cells detectable in blood tests (eosinophilia).

Rare: may affect up to 1 in 1,000 people

Fever
Restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
Altered sense of taste, loss of appetite, inflammation of the tongue (glossitis)
Skin reactions such as burning or tingling sensation under the skin, bruising, redness, and excessive sweating
Light sensitivity
Hair loss
Tingling sensation in the skin (paraesthesia), tremor
Anaemia (pallor and fatigue)
Decreased urine production or inability to urinate, blood or mucus in the urine, lower back pain sometimes associated with skin rashes, fever, fatigue, and malaise. These may be signs of kidney disease
Fungal infection of the oesophagus
Breast enlargement in males, impotence.

Very rare: may affect up to 1 in 10,000 people

Inflammation of the mouth (stomatitis)
Colitis (inflammation of the intestine)
Decreased levels of sodium in the blood detectable in blood tests
Increased levels of fats in the blood detectable in blood tests.

Not known (frequency cannot be estimated from available data)

Erythema, possible joint pain
Visual hallucinations
If you have been taking lansoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, inform your doctor promptly. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to prescribe regular blood tests to monitor your magnesium levels.

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 Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, on the carton, after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25°C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Lansoprazolo Mylan Generics contains
The active substance is lansoprazole. Each gastro-resistant capsule contains 15 mg or 30 mg of
lansoprazole.
The excipients are: gastro-resistant granules containing sugar spheres (corn starch and sucrose),
sodium lauryl sulfate, meglumine, mannitol, hypromellose, macrogol, talc, polysorbate 80, titanium dioxide
(E171), methacrylic acid-ethyl acrylate copolymer 1:1. The capsule shell contains: gelatin,
titanium dioxide (E171) and sodium lauryl sulfate. Yellow quinoline (E104) is present only in the 15 mg capsules.
Description of the appearance of Lansoprazolo Mylan Generics and contents of the pack
The 15 mg capsules are yellow, opaque, containing spherical microgranules of white to off-white colour.
The 30 mg capsules are white, opaque, containing microgranules of white to off-white colour.
The capsules are available in blisters in packs of 7, 14, 15, 28, 30, 35, 56, 60 and 98 capsules.
Calendar packs containing 28 or 98 capsules are also available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan S.p.a.
Via Vittor Pisani, 20
20124 Milan, Italy
Manufacturer:
Laboratories Liconsa, S.A.
Avenida Miralcampo 7, Poligono Industrials De Miralcampo,
19200 Azuqueca de Henares (Guadalajara) – Spain.
Doppel Farmaceutici S.r.l. – Via Volturno 48, 20089 Quinto de’ Stampi, Rozzano (MI) Italy.
Mylan Hungary Kft,
Mylan utca 1, Komárom,
H-2900, Hungary
This medicinal product is authorised in the European Economic Area Member States under the
following names:
Denmark: Lansoprazol Viatris 15 mg, harde enterokapslar
Lansoprazol Viatris 30 mg, harde enterokapslar
Ireland: Razolager 15mg gastro-resistant capsules
Razolager 30mg gastro-resistant capsules
Italy: Lansoprazolo Mylan Generics