Lansoprazole Mylan Generics Italia

PACKAGE LEAFLET

Package leaflet: information for the patient

Lansoprazole Mylan Generics Italia 15 mg orodispersible tablets, 30 mg orodispersible tablets

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, as 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

1. What Lansoprazole Mylan Generics Italia is and what it is used for
2. What you need to know before taking Lansoprazole Mylan Generics Italia
3. How to take Lansoprazole Mylan Generics Italia
4. Possible side effects
5. How to store Lansoprazole Mylan Generics Italia
6. Contents of the pack and other information

1. What Lansoprazolo Mylan Generics Italia is and what it is used for

The active substance of Lansoprazolo Mylan Generics Italia is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by your stomach.
Your doctor may prescribe Lansoprazolo Mylan Generics Italia for the following:

• Treatment of duodenal (intestinal) and gastric ulcers
• Treatment of inflammation of the oesophagus (reflux oesophagitis)
• Prevention of reflux oesophagitis
• Treatment of heartburn and acid regurgitation
• Treatment of infections caused by the bacterium Helicobacter pylori, when given in combination with an antibiotic
• Treatment or prevention of duodenal (intestinal) or gastric ulcers in patients requiring continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Lansoprazolo Mylan Generics Italia to treat a different condition or at a different dosage than that stated in this leaflet. Take the medicine according to your doctor's instructions.

2. What you need to know before taking Lansoprazolo Mylan Generics Italia

Do not take Lansoprazolo Mylan Generics Italia:

• 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 Lansoprazolo Mylan Generics Italia:

• if you have liver problems. Your doctor may need to adjust your dose
• if you have ever had a skin reaction after treatment with a medicine similar to lansoprazole that reduces stomach acid
• if you are due to have a specific blood test (chromogranin A)
• if you have low levels of vitamin B12 or are at risk of low vitamin B12 levels and are receiving long-term treatment with these medicines. Like all acid-reducing agents, Lansoprazolo Mylan Generics Italia may lead to reduced absorption of vitamin B12.

This medicine can affect the way your body absorbs vitamin B12, especially if
you need to take it for a long time. Contact your doctor if you notice any of the following symptoms,
which could indicate low vitamin B12 levels:

• extreme tiredness or lack of energy
• tingling sensations
• sore or red tongue, mouth ulcers
• muscle weakness
• blurred vision
• memory problems, confusion, depression.

Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with lansoprazole treatment. Stop using Lansoprazolo Mylan Generics Italia and contact your doctor immediately if you notice any of the symptoms described in section 4.

If you develop 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.
Remember to also report any other adverse effects such as joint pain.
If your doctor has prescribed Lansoprazolo Mylan Generics Italia in combination with other medicines to treat
infection caused by the bacterium Helicobacter pylori (antibiotics) or together with other
anti-inflammatory medicines to treat pain or rheumatic diseases, please read carefully the package
leaflet of these medicines as well.
Your doctor may perform or may have already performed an additional examination called endoscopy to diagnose
your condition and/or exclude malignancy.
While taking Lansoprazolo Mylan Generics Italia, 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, skin rash and joint stiffness. These signs must be reported to your
doctor.
If you take Lansoprazolo Mylan Generics Italia for more than three months, your blood
magnesium levels may decrease. If you feel very tired, confused, dizzy, experience muscle cramps,
seizures (epileptic fits) or increased heart rate, contact your doctor immediately
as you may have low blood magnesium levels (see section 4 “Possible side effects”). A reduction in blood magnesium levels may also lead to decreased levels of calcium and potassium in the blood. Therefore, your doctor may periodically monitor your blood magnesium levels.
If you take a proton pump inhibitor such as Lansoprazolo Mylan Generics Italia, especially for
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 have been taking Lansoprazolo Mylan Generics Italia for a long time (for over 1 year), your doctor will likely monitor you regularly. You should report any new or unusual symptoms and circumstances each time you see your doctor.
During treatment
If you experience severe or persistent diarrhoea during treatment with Lansoprazolo Mylan Generics Italia,
contact your doctor immediately, as lansoprazole has been associated with a small increased risk of infectious diarrhoea.
Other medicines and Lansoprazolo Mylan Generics Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those not requiring a prescription.
In particular, inform your doctor if you are taking medicines containing any of the following:

• HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV)
• methotrexate (used to treat autoimmune diseases and cancer)
• ketoconazole (used to treat Cushing's syndrome - when the body produces excess cortisol)
• itraconazole (used to treat fungal infections)
• rifampicin (used to treat tuberculosis)
• 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 conditions)
• antacids (used to treat heartburn or acid reflux such as aluminium hydroxide or magnesium carbonate)
• sucralfate (used to heal ulcers)
• St John's wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy and breastfeeding
The use of Lansoprazolo Mylan Generics Italia during pregnancy is not recommended as there
are no available data.
It is not known whether lansoprazole is excreted in breast milk. Discuss with your doctor whether
it is better for you to continue taking the medicine or to breastfeed your
baby.
If you are pregnant, think you might be pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Side effects such as dizziness, vertigo (a sensation of spinning when sitting or standing still), drowsiness and visual disturbances may occasionally occur in patients taking lansoprazole. If you experience such side effects, you should be cautious, as your ability to concentrate may be reduced.
Only you are responsible for deciding whether you are fit to drive a motor vehicle or perform other tasks requiring increased concentration. Taking medicines is one of the factors that may impair your ability to perform these tasks safely due to their effects or side effects.
Descriptions of these effects can be found in other sections. Read all the information in this leaflet carefully. If you are unsure about anything, consult your doctor or pharmacist.
Lansoprazolo Mylan Generics Italia contains sucrose, aspartame and sodium
This medicine contains 5.97 mg of aspartame per tablet.
This medicine contains 11.93 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder causing phenylalanine to accumulate because the body cannot eliminate it properly.
This medicine contains sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Lansoprazole Mylan Generics Italia

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dose of Lansoprazole Mylan Generics Italia depends on your condition. The recommended doses of
Lansoprazole Mylan Generics Italia for adults are listed below. Your doctor may sometimes prescribe a different dose and will inform you of the duration of treatment.
Treatment of heartburn and acid regurgitation: one orodispersible tablet of 15 mg or
30 mg daily for 4 weeks. If symptoms persist, consult your doctor. If symptoms are not
relieved within 4 weeks, contact your doctor.
Treatment of duodenal ulcer (in the intestine): 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 inflammation of the food pipe (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 adjust the dose up to one orodispersible tablet of 30 mg daily.
Treatment of infection caused by Helicobacter pylori : the recommended dose is one orodispersible tablet of 30 mg in combination with two different antibiotics in the morning and one orodispersible tablet of 30 mg in combination with two different antibiotics in the evening. Treatment lasts for 7 days.
The recommended antibiotic combinations are:

• 30 mg Lansoprazole Mylan Generics Italia together with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg Lansoprazole Mylan Generics Italia together with 250 mg clarithromycin and 400–500 mg metronidazole.

If you are being treated for this infection because you have an ulcer, the ulcer is unlikely to recur if the infection is successfully treated. To achieve the best results from this therapy, take the medicine at the prescribed times and never miss a dose.
Treatment of duodenal ulcer (in the intestine) or gastric ulcer in patients requiring continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs): one orodispersible tablet of 30 mg daily for 4 weeks.
Prevention of duodenal ulcer (in the intestine) or gastric ulcer in patients requiring continuous treatment with NSAIDs: one orodispersible tablet of 15 mg daily; your doctor may adjust the dose up to one orodispersible tablet of 30 mg daily.
Zollinger-Ellison syndrome: the recommended initial dose is two orodispersible tablets of 30 mg
daily; thereafter, based on your response to Lansoprazole Mylan Generics Italia, your doctor will determine the most appropriate dose for you.
Use in patients with liver problems
If you have moderate or severe liver problems, your doctor may prescribe half the recommended dose.
Use in the elderly
Your doctor may prescribe a reduced dose if you are elderly. The maximum recommended dose for elderly patients is 30 mg daily.
Use in children:
Lansoprazole Mylan Generics Italia must not be given to children.
How to take it
To achieve the best results from your medicine, you must take Lansoprazole Mylan Generics Italia
at least 30 minutes before meals.
If you take Lansoprazole Mylan Generics Italia once daily, try to take it at the same time every day. You may achieve better results if you take Lansoprazole Mylan Generics Italia first thing in the morning.
If you take Lansoprazole Mylan Generics Italia twice daily, take the first dose in the morning and the second dose in the evening.
Lansoprazole Mylan Generics Italia tablets are easily broken, so handle them carefully. Do not touch the tablets with wet hands, as they may break.
Lansoprazole Mylan Generics Italia is available in blisters with a peelable or push-through film.

1. For blisters with peelable film only: hold the blister by the edges and gently separate one blister cavity from the rest of the strip by pulling along the perforations around it.
2. Carefully remove the foil. For non-perforated blisters, take care not to remove the foil from adjacent tablets.
3. Gently push the tablet out of the packaging.
4. Place the tablet in your mouth. It will dissolve directly in the mouth, allowing it to be swallowed easily.

You may also swallow the tablet whole with a glass of water.

Your doctor may also instruct you to take the tablet using an oral syringe if you have serious difficulty swallowing.
If using an oral syringe:

• Remove the plunger from the syringe (use at least a 5 ml syringe for a 15 mg tablet and a 10 ml syringe for a 30 mg tablet)
• Place the tablet into the syringe
• Replace the plunger into the syringe
• For the 15 mg tablet: draw 4 ml of tap water into the syringe
• For the 30 mg tablet: draw 10 ml of tap water into the syringe
• 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 is dissolved
• The contents can be emptied directly into the mouth
• Refill the syringe with 2–5 ml of tap water to completely empty the syringe into the mouth
• Repeat the last step if necessary.

If using a nasogastric tube:
It is important that the suitability of the selected tube is carefully tested. The recommended diameter of the nasogastric tube to be used is 3.3 mm (French size 10) or larger.

• Remove the plunger from the syringe (use at least a 25 ml syringe for a 15 mg tablet and a 50 ml syringe for a 30 mg tablet)
• Place the tablet into the syringe
• Replace the plunger into the syringe
• For the 15 mg tablet: draw 10 ml of tap water into the syringe
• For the 30 mg tablet: draw 25 ml of tap water into the syringe
• Turn the syringe upside down and draw in an additional 5 ml of air
• Gently shake the syringe for 10–20 seconds until the tablet is dissolved
• Connect the syringe to the tube and empty the syringe contents into the nasogastric tube
• For the 15 mg tablet: refill the syringe with 10 ml of tap water and completely empty the syringe into the tube
• For the 30 mg tablet: refill the syringe with 25 ml of tap water and completely empty the syringe into the tube

If you take more Lansoprazole Mylan Generics Italia than you should
If you take more Lansoprazole Mylan Generics Italia than prescribed, contact your doctor immediately.
If you forget to take Lansoprazole Mylan Generics Italia
If you forget to take a dose, take it as soon as you remember, unless it is close to the time for your next dose. In that case, do not take the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.
If you stop taking Lansoprazole Mylan Generics Italia
Do not stop treatment prematurely even if your symptoms have improved. Your condition may not be fully healed and symptoms may return if you do not complete the full 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 gets them.
If you think you are experiencing any of the following serious side effects, stop treatment immediately and contact your doctor or go to the nearest hospital emergency department.

• Very rarely, Lansoprazole Mylan Generics Italia may cause severe hypersensitivity (allergic) reactions. Symptoms of a hypersensitivity reaction may include fever, skin rash, facial swelling, swollen lymph nodes, swelling of the tongue or throat, difficulty swallowing, hives, breathing difficulties and sometimes a drop in blood pressure.
• Very rarely, severe skin reactions, which may be life-threatening, have been reported with Lansoprazole Mylan Generics Italia. Symptoms include red spots on the trunk, often appearing as circular patches or target-like macules, frequently with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)].
• Widespread rash, high body temperature and swollen lymph nodes [drug reaction with eosinophilia and systemic symptoms (DRESS), frequency not known)].
• If you take Lansoprazole Mylan Generics Italia for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• Very rarely, Lansoprazole Mylan Generics Italia may cause a reduction in white blood cells (agranulocytosis), reducing your resistance to infections; or abnormal reduction in red blood cells, white blood cells and platelets (pancytopenia). If you develop an infection with symptoms such as fever and severe worsening of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems, or if you experience fatigue, pale skin, unusual bruising or prolonged unexplained bleeding, you must consult your doctor immediately. A blood test will be performed to check for possible reduction in blood cells.
• Rarely, Lansoprazole Mylan Generics Italia may cause inflammation of the pancreas (pancreatitis). Symptoms include sudden, severe pain in the upper middle part of the abdomen that may radiate to the back, possibly leading to nausea and vomiting.
• If you develop severe or persistent diarrhoea during treatment with Lansoprazole Mylan Generics Italia, contact your doctor immediately, as Lansoprazole Mylan Generics Italia has been associated with a small increased risk of infectious diarrhoea.

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

• headache, dizziness
• diarrhoea, constipation, stomach pain, feeling unwell (nausea) or being unwell (vomiting), bloating, dry or sore mouth or throat
• skin rash, itching
• changes in liver function tests
• fatigue
• benign polyps in the stomach

Uncommon (may affect up to 1 in 100 people):

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

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

• fever
• restlessness, drowsiness
• confusion, sensing, seeing or feeling things that are not real (hallucinations), difficulty falling asleep (insomnia)
• vision disturbances
• a sensation of spinning while standing still (vertigo)
• altered 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
• skin tingling sensation (paresthesia), tremor
• anaemia (pallor)
• kidney inflammation (tubulo-interstitial nephritis); possible symptoms include changes in urine output, blood in urine
• liver inflammation (possible development of yellowing of the skin or eyes)
• breast swelling in men, impotence
• candidiasis (fungal infection, may affect the oesophageal mucosa)

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

• inflammation of the mouth (stomatitis)
• inflammation of the colon (colitis)
• increased laboratory values such as cholesterol and triglyceride levels
• low sodium levels in the blood; symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, muscle weakness or spasms, irritability, seizures, coma. Your doctor may decide to perform regular blood tests to monitor your sodium levels.

Frequency not known (frequency cannot be estimated from the available data):

• skin manifestations related to lupus or lupus erythematosus rash
• skin rash, possible joint pain
• visual hallucinations

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

5. How to store Lansoprazole Mylan Generics Italia

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from moisture.
Bottles: use within 100 days of opening. Keep the bottle tightly closed to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the blister, carton, and bottle after EXP. The expiry date refers to the last day of that month.
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 Mylan Generics Italia contains
The active substance is lansoprazole.
The excipients are: sugar spheres, light magnesium carbonate (E504), crospovidone (E1202),
hydroxypropylcellulose (E463), methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E1505),
sodium hydroxide (E524), talc (E553b), polysorbate (E433), macrogol, iron oxide red (E172),
iron oxide yellow (E172), mannitol (E421), microcrystalline cellulose (E460), sodium starch glycolate,
aspartame (E951), sodium lauryl sulfate, sodium bicarbonate (E500), citric acid monohydrate (E330),
strawberry flavouring and magnesium stearate (see section 2 “Lansoprazolo Mylan Generics Italia contains
sucrose, aspartame and sodium”).

Description of the appearance of Lansoprazolo Mylan Generics Italia and pack contents
This medicine is in the form of orodispersible tablets (solid oral formulation) that disperse to release gastro-resistant microgranules.
Lansoprazolo Mylan Generics Italia 15 mg orodispersible tablets are white to off-white tablets with orange to dark brown specks, round, flat-surfaced with bevelled edges, engraved with "LP1" on one side and "M" on the other.
Lansoprazolo Mylan Generics Italia 30 mg orodispersible tablets are white to off-white round tablets with orange to dark brown specks, flat-surfaced with bevelled edges, engraved with "LP2" on one side and "M" on the other.

Lansoprazolo Mylan Generics Italia 15 mg and 30 mg orodispersible tablets are available in:

• Blister packs (with peelable film) containing 7, 14, 28, 30, 56, 90 or 98 tablets;
• Single-dose blister packs (with peelable film) containing 28 x 1 tablets;
• Blister packs (with press-through opening) containing 7, 14, 28, 30, 56, 90 or 98 tablets;
• Single-dose blister packs (with press-through opening) containing 28 x 1 tablets;
• Single-dose blister packs (with press-through opening) containing 14 x 1 tablets;
• Plastic bottles with hydrophilic cotton and screw caps containing 30, 100 or 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milano, Italy

Manufacturer
Viatris UK Healthcare Limited
Building 20, Station Close, Potters Bar, EN6 1TL
United Kingdom
Generics [UK] Ltd.
Station Close, Potters Bar, Hertfordshire, EN6 1TL
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Hungary Kft
H-2900 Komarom, Mylan utca 1
Hungary

This medicinal product is authorized in the European Economic Area and the United Kingdom (Northern Ireland) under the following names: