LANSOPRAZOLO 15 mg Tabletki Orodispersyjne

Treść ulotki

1. Lansoprazolo SUN Pharma 15 mg orodispersible tablets
   1. What is Lansoprazolo SUN Pharma and what is it used for
   2. What you need to know before you take Lansoprazolo SUN Pharma
   3. How to take Lansoprazolo SUN Pharma
   4. Possible side effects
   5. How to store Lansoprazolo SUN Pharma
   6. Package contents and other information

Lansoprazolo SUN Pharma 15 mg orodispersible tablets

Lansoprazolo SUN Pharma 30 mg orodispersible tablets
Lansoprazolo
Generic medicine
Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Lansoprazolo SUN Pharma and what is it used for

The active ingredient of Lansoprazolo SUN Pharma is lansoprazole, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by the stomach.
The doctor may prescribe Lansoprazolo SUN Pharma for the following indications:

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

The doctor may have prescribed Lansoprazolo SUN Pharma for another indication or with a different dosage
Consult your doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before you take Lansoprazolo SUN Pharma

Do not take Lansoprazolo SUN Pharma:

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

Warnings and precautions
Tell your doctor if you have a serious liver disease. Your doctor may need to adjust the dosage of the
medicine.
Your doctor may have performed or may perform a further examination called an endoscopy to diagnose
your condition and/or exclude a malignant disease.
If you experience severe or persistent diarrhea while taking Lansoprazolo SUN Pharma, contact
your doctor immediately, as Lansoprazolo SUN Pharma has been associated with a small increase in
infectious diarrhea.
If your doctor has prescribed Lansoprazolo SUN Pharma in addition to other medicines for the treatment
of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain
If you take Lansoprazolo SUN Pharma for more than three months, the levels of magnesium in your blood
may decrease. Low levels of magnesium manifest with fatigue, involuntary muscle contractions,
disorientation, convulsions, dizziness and increased heart rate. If you experience any of
these symptoms, tell your doctor immediately. Low levels of magnesium can also lead to a
reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests
to monitor magnesium levels.
If you are taking a proton pump inhibitor such as Lansoprazolo SUN Pharma, especially for a period
longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist or
spine. Tell your doctor if you have osteoporosis (reduced bone density) or if your
doctor has informed you that you may be at risk of developing osteoporosis (e.g. if you are
taking steroids).
This medicine can affect the way your body absorbs vitamin B12, especially if you
need to take it for a long period. Contact your doctor if you notice any of the following symptoms, which
may indicate low levels of vitamin B12:

• Extreme fatigue or lack of energy
• Tingling
• Sore or red tongue, mouth ulcers
• Muscle weakness
• Blurred vision
• Memory problems, confusion, depression

If you take Lansoprazolo SUN Pharma for a long time (for more than 1 year) your doctor will probably keep you
under regular observation. On each visit, report to your doctor any new or unusual symptoms or
circumstances.
Talk to your doctor before taking Lansoprazolo SUN Pharma:

• if you need to undergo a specific blood test (Chromogranin A).
• if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazolo SUN Pharma that reduces stomach acid.

Serious skin reactions including Stevens-Johnsons syndrome, toxic epidermal necrolysis, drug reaction
with eosinophilia and systemic symptoms (DRESS) have been reported in association with treatment with
lansoprazole. Stop using Lansoprazolo SUN Pharma and contact your doctor immediately if
you notice any of the symptoms described in section 4.
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor
as soon as possible, as you may need to stop therapy with Lansoprazolo SUN Pharma.
Remember to also report any other unwanted effects such as joint pain.
Inflammation of the kidneys may occur during the intake of lansoprazole. Signs and symptoms may
include a decrease in urine volume or blood in the urine and/or hypersensitivity reactions such as
fever, rash and joint stiffness. You should report these signs to your treating physician.

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

• HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV)
• methotrexate (used to treat autoimmune diseases and tumors)
• 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 illnesses)
• antacids (used to treat heartburn or acid reflux)
• sucralfate (used to heal ulcers)
• St. John's wort (Hypericum perforatum, used to treat mild depression)

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Side effects such as dizziness, vertigo, fatigue and visual disturbances sometimes occur in
patients taking Lansoprazolo SUN Pharma. If you experience side effects like these
you should be careful because it may cause a decrease in your ability to react.
You alone are responsible for deciding whether you are fit to drive a motor vehicle or perform other
tasks that require increased concentration. The use of medicines is one of the factors that
can reduce the ability to perform these actions safely due to their effects or side effects.
Descriptions of these effects can be found in other sections.
Read all the information contained in this leaflet as a guide.
If you have any doubts, discuss them with your doctor or pharmacist.

Lansoprazolo SUN Pharma contains aspartame
Each tablet of Lansoprazolo SUN Pharma 15 mg contains 4.5 mg of aspartame
Each tablet of Lansoprazolo SUN Pharma 30 mg contains 9.0 mg of aspartame
Aspartame is a source of phenylalanine. Phenylalanine may be harmful to you if you have phenylketonuria
(PKU), a rare genetic disorder that causes a buildup of phenylalanine because the body cannot
process it properly.

3. How to take Lansoprazolo SUN Pharma

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

Treatment of heartburn and acid reflux:one orodispersible tablet of 15
mg or 30 mg each day for 4 weeks. If symptoms are not relieved within 4 weeks, contact your doctor.

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

Treatment of stomach ulcer:one orodispersible tablet of 30 mg each day for 4 weeks.

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

Long-term prevention of reflux esophagitis:one orodispersible tablet of 15 mg each
day; your doctor may adjust the dosage up to one orodispersible tablet of 30 mg each day.

Treatment ofHelicobacter pyloriinfection: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. The treatment will be taken every day for 7 days.
The recommended antibiotic combinations are:

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

If you are treating your infection because you have an ulcer, it is likely that the ulcer will not recur if
the infection is successfully treated. To get the best results from this therapy, take the medicine
at the scheduled times and never miss a dose.

Treatment of duodenal or stomach ulcer in patients requiring continuous treatment
with NSAIDs:one orodispersible tablet of 30 mg each day for 4 weeks.

Prevention of duodenal or stomach ulcer in patients requiring continuous treatment
with NSAIDs:one orodispersible tablet of 15 mg each day; your doctor may adjust the dosage up to
one orodispersible tablet of 30 mg each day.

Zollinger-Ellison syndrome:the usual initial dose is two orodispersible tablets of 30 mg each day,
subsequently, based on your response to Lansoprazolo SUN Pharma, the doctor will decide the most suitable
dose for you.

Use in children
Lansoprazolo SUN Pharma should not be given to children.

How to take it

• 1- Hold the blister strip by the edges and separate one blister cell from the rest of the strip by gently pulling along the perforated separation line.
• 2- Carefully remove the backing
• 3- Gently push the tablet out.
• 4- Place the tablet in your mouth. This will dissolve directly in your mouth, so that it can be swallowed easily.

In case of difficulty swallowing
Your doctor may also instruct you to take the dissolved tablet with a syringe in your mouth, if you have serious
difficulty swallowing.
If you are taking the medicine through a syringe, you must follow these instructions:
It is important that the suitability of the chosen syringe is carefully tested.

• 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 body of 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 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 any remaining contents in the mouth.

If you are 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 the 15 mg tablet and a 50 mL syringe for the 30 mg tablet).
• Place the tablet into the barrel of the syringe.
• Replace the plunger onto 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 an additional 5 mL of air.
• Gently shake the syringe for 10-20 seconds until the tablet is dispersed.
• Connect the syringe to the tube and empty the contents of the syringe into the nasogastric tube.
• For the 15 mg tablet: fill the syringe with 10 mL of tap water and empty the contents of the syringe into the tube.
• For the 30 mg tablet: fill the syringe with 25 mL of tap water and empty the contents of the syringe into the tube.

If you take more Lansoprazolo SUN Pharma than you should
If you take more Lansoprazolo SUN Pharma than you have been told, seek advice from your doctor immediately.

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

If you stop taking Lansoprazolo SUN Pharma
Do not stop taking the treatment prematurely if your symptoms have improved. Your condition
may not be completely healed and may recur if you do not complete the treatment period.
If you have any doubts about the use of Lansoprazolo SUN Pharma, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you think you may have any of the following serious side effects, stop taking
this medicine and contact your doctor or go immediately to the emergency room of the nearest hospital.

• Very rarely Lansoprazolo SUN Pharma can cause serious hypersensitivity (allergic) reactions. Symptoms of a hypersensitivity reaction can include fever, skin rash, swollen face, enlarged lymph nodes, swollen tongue or throat, difficulty swallowing, hives, difficulty breathing and sometimes a drop in blood pressure.
• Very rarely, serious skin reactions have been reported with Lansoprazolo SUN Pharma that can be life-threatening. Symptoms include red patches on the trunk, which appear as circular patches or target-shaped macules, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)].
• Widespread rash, high body temperature and enlarged lymph nodes [drug reaction with eosinophilia and systemic symptoms (DRESS, frequency not known)].
• If you take Lansoprazolo SUN Pharma for more than three months, the levels of magnesium in your blood may decrease. Low levels of magnesium manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, tell your doctor immediately. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
• Very rarely Lansoprazolo SUN Pharma can cause a reduction in the number of white blood cells (agranulocytosis) and its resistance to infections may be reduced; or the abnormal reduction in the number of red blood cells, white blood cells, and platelets (pancytopenia). If you develop an infection with symptoms such as fever and a severe worsening of your general condition, or fever with symptoms of a local infection such as sore throat/pharynx/mouth or urinary problems, or experience fatigue, pale skin with bruising or unexplained bleeding for longer than usual, you should consult your doctor immediately. A blood test will be performed to check for a possible reduction in blood cells.
• Rarely Lansoprazolo SUN Pharma can cause inflammation of the pancreas (pancreatitis) and its symptoms include sudden, severe pain in the center of the upper abdomen that may radiate to the back, which can lead to nausea and vomiting.
• If you experience severe or persistent diarrhea during treatment with Lansoprazolo SUN Pharma, contact your doctor immediately, as Lansoprazolo SUN Pharma has been associated with a small increase in infectious diarrhea.

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

• headache, dizziness
• constipation, stomach pain, feeling unwell, intestinal gas (flatulence), dry or inflamed 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 and muscle pain
• water retention or swelling
• changes in red blood cell count
• risk of fracture of the hip, wrist and spine

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

• fever
• restlessness, drowsiness, confusion, hallucination, insomnia, vision disturbances, dizziness
• alteration of the sense of taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as a burning or tingling sensation under the skin, bruising, redness and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation on the skin (paresthesia), tremor
• anemia (paleness)
• inflammation of the kidneys (tubulo-interstitial nephritis), possible symptoms include changes in the amount of urine, blood in the urine
• inflammation of the liver (possible appearance of yellow skin or eyes)
• breast enlargement in men, impotence
• candidiasis (fungal infection, can affect the mucous membrane of the esophagus)

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 levels of sodium in the blood, symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, weakness or muscle spasms, irritability, convulsions, coma. Your doctor may decide to perform regular blood tests to monitor sodium levels.

Frequency not known: the frequency cannot be estimated on the basis of available data

• skin manifestations related to lupus or a lupus-like erythema.
• rash, possible joint pain.
• visual hallucinations

Reporting of side effects
talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system
at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects,
you can contribute to providing more information on the safety of this medicine.

5. How to store Lansoprazolo SUN Pharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiry date
refers to the last day of the month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water 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 SUN Pharma contains

• The active ingredient is lansoprazole. Each orodispersible tablet of Lansoprazolo SUN Pharma 15 mg contains 15 mg of lansoprazole. Each orodispersible tablet of Lansoprazolo SUN Pharma 30 mg contains 30 mg of

lansoprazole.

• The other ingredients are: microcrystalline cellulose, magnesium carbonate, low substituted hydroxypropylcellulose, hydroxypropylcellulose, talc, mannitol, corn starch, methacrylic acid-ethyl acrylate copolymer, macrogol, glyceryl monostearate, polysorbate 80, citric acid, triethyl citrate, hypromellose, red iron oxide (E172) and yellow iron oxide (E172), crospovidone, aspartame (E951), strawberry flavour, anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Lansoprazolo SUN Pharma and package contents
Lansoprazolo SUN Pharma 15 mg are round tablets of white to off-white colour, 9 mm in
diameter with dots from orange to dark brown imprinted with '15' on one side and smooth on the other side.
Lansoprazolo SUN Pharma 30 mg are round tablets of white to off-white colour, 12 mm in
diameter with dots from orange to dark brown imprinted with '30' on one side and smooth on the other side
The 15 mg oro-dispersible tablets of Lansoprazolo SUN Pharma are packaged in perforated blisters
per unit dose (AL/HDPE/PE with desiccant (attached to the film) calcium oxide in film
OPA/AL/HDPE/PE), in packs containing 14x1, 28x1, 56x1, 98x1 tablets of oro-
dispersible tablets.
The 30 mg oro-dispersible tablets of Lansoprazolo SUN Pharma are packaged in perforated blisters
per unit dose (AL/HDPE/PE with desiccant (attached to the film) calcium oxide in film
OPA/AL/HDPE/PE), in packs containing 14x1, 28x1, 56x1, 98x1 tablets of oro-
dispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132JH, Hoofddorp, Netherlands

Local Representative:
Sun Pharma Italia Srl - Viale Giulio Richard, 3 - 20143 Milan

Manufacturers
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp – Netherlands
Terapia S.A.
124 Fabricii Str.
400 635 Cluj-Napoca – Romania

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Sweden Lansoprazole SUN Pharma 15 mg mouth-disintegrating tablet
Lansoprazole SUN Pharma 30 mg mouth-disintegrating tablet
Spain Lansoprazol SUN 15 mg bucodispersable tablets EFG
Lansoprazol SUN 30 mg bucodispersable tablets EFG
France Lansoprazol SUN 15 mg orodispersible tablet
Lansoprazol SUN 30 mg orodispersible tablet
Italy Lansoprazolo SUN Pharma