LEVOGENIX 15 mg Hard Capsule

Зміст інструкції

1. Levogenix 15 mg hard gastro-resistant capsules, 30 mg hard gastro-resistant capsules

Levogenix 15 mg hard gastro-resistant capsules, 30 mg hard gastro-resistant capsules

Lansoprazole
Generic medicine
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 only for you. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:
What Levogenix is and what it is used for
What you need to know before you take Levogenix
How to take Levogenix
Possible side effects
How to store Levogenix
Contents of the pack and other information

What Levogenix is and what it is used for
The active ingredient of Levogenix is lansoprazole, which is a proton pump inhibitor. Proton
pump inhibitors reduce the amount of acid your stomach produces.
Your doctor may prescribe Levogenix for the following indications in adults:
Treatment of duodenal and stomach ulcers
Treatment of inflammation of the esophagus (reflux esophagitis)
Prevention of reflux esophagitis
Treatment of heartburn and acid reflux
Treatment of infections caused by the bacterium Helicobacter pyloriwhen
administered in combination with antibiotic therapy
Treatment or prevention of duodenal or stomach ulcers in patients who
require continuous treatment with NSAIDs (non-steroidal anti-inflammatory drugs)
(NSAIDs are used against pain or inflammation)
Treatment of Zollinger-Ellison syndrome
Your doctor may have prescribed Levogenix for another indication or with a different dosage than
described here.
See your doctor if you do not feel better or if you feel worse after 14 days

What you need to know before you take Levogenix
Do not take Levogenix:
if you are allergic to lansoprazole or any of the other ingredients of this
medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Levogenix.
If you have a severe liver disease. Your doctor may need to adjust the dosage. Your doctor may
have performed or will perform a further examination called an endoscopy to diagnose your
condition and/or exclude a malignant disease.
If you experience diarrhea while taking Levogenix, contact your doctor immediately,
because Levogenix has been associated with a small increase in infectious diarrhea.
If your doctor has prescribed Levogenix in addition to other medicines for the treatment
of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory medicines, read
the leaflets of these medicines.
If you take a proton pump inhibitor such as Levogenix, especially for a period
longer than one year, you may have a slight increase in the risk of fractures of the hip,
wrist or spine. Tell your doctor if you suffer from osteoporosis (reduced bone density) or if your doctor tells you that you are at risk of osteoporosis (for example, if you
are taking steroids).
If you take Levogenix for a long time (for more than 1 year) your doctor will probably keep you under
regular observation. You should report any new and exceptional symptom and circumstance whenever
you see your doctor.
Talk to your doctor before taking lansoprazole:
If you have low levels of vitamin B12 or have risk factors for low levels of vitamin B12
and are receiving long-term treatment with lansoprazole. As with all agents that
reduce acid, lansoprazole may lead to reduced absorption of vitamin B12
If you are to undergo a specific blood test (Chromogranin A)
If you have ever had a skin reaction after treatment with a medicine similar to
lansoprazole that reduces stomach acid.
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 stop therapy with lansoprazole. Remember to report any other
side effects such as joint pain.
During the intake of lansoprazole, an inflammation of the kidneys may occur. 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 Levogenix
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including over-the-counter medicines.
In particular, tell your doctor or pharmacist if you are taking medicines containing any of the
following active ingredients, as Levogenix 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 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 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)

Levogenix with food and drink
To get the best results you should take Levogenix with a glass of water at least 30
minutes before eating food.

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

Driving and operating machinery
Side effects such as dizziness, vertigo, fatigue and visual disturbances occur
sometimes in patients taking Levogenix.
If you experience side effects like these, you should be careful because your ability to
pay attention may decrease.
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
represents one of the factors that can reduce the ability to perform these actions safely,
because of 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 are not sure about anything, discuss it with your doctor or pharmacist.

Levogenix contains sucrose and lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.

Levogenix contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, which is
essentially “sodium-free”.

How to take Levogenix
Always take this medicine exactly as your doctor has told you. If you have doubts
consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water. If you find it difficult to swallow the capsules, your
doctor may advise you on an alternative way to take the medicine. Do not crush or
chew these capsules or the contents of the emptied capsules, because the medicine will not
work properly.
If you take Levogenix once a day, try to take it at the same time each day. You may
get better results if you take Levogenix first thing in the morning.
If you take Levogenix twice a day, you should take the first dose in the morning and the second
dose in the evening.
The dose of Levogenix depends on your condition. The usual doses of Levogenix for adults
are listed below. Your doctor may prescribe a different dose and tell you how long
the treatment should last.

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

Treatment of duodenal ulcer: one 30 mg capsule per day for 2 weeks

Treatment of stomach ulcer:one 30 mg capsule per day for 4 weeks

Treatment of inflammation of the esophagus (reflux esophagitis):one 30 mg
capsule per day for 4 weeks

Long-term prevention of reflux esophagitis:one 15 mg capsule per day, the
doctor may adjust the dose up to one 30 mg capsule per day

Treatment ofHelicobacter pyloriinfection:the usual dose is one 30 mg capsule in
combination with two different antibiotics in the morning and one 30 mg capsule in combination
with two different antibiotics in the evening. The treatment will be daily for 7 days.
The recommended antibiotic combinations are:
30 mg of Levogenix together with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin 30 mg
of Levogenix 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 do not miss a dose.
Treatment of duodenal or stomach ulcer in patients who require a
continuous treatment with NSAIDs:one 30 mg capsule per day for 4 weeks.

Prevention of duodenal or stomach ulcer in patients who require a
continuous treatment with NSAIDs:one 15 mg capsule per day, the doctor may adjust
the dosage up to one 30 mg capsule per day.

:the usual initial dose is two 30 mg capsules per day, then
based on your response to Levogenix, the doctor will decide the most suitable dose for you.

Use in children
Levogenix should not be given to children.

If you take too much Levogenix
If you take more Levogenix than you have been told, ask for advice from a doctor immediately.

If you forget to take Levogenix
If you forget to take a dose, take it as soon as you remember unless it is almost
time for your next dose. If this happens, do not take the missed dose and take the
rest of the capsules as normal. Do not take a double dose to make up for a forgotten capsule

If you stop taking Levogenix
Do not stop taking the treatment prematurely if your symptoms have improved. Your
condition may not be completely healed and may return if you do not complete the
treatment period.
If you have any questions about using this medicine, ask your doctor or pharmacist.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

Common side effects (may affect up to 1 in 10 people):
headache, dizziness
diarrhea, constipation, stomach pain, feeling unwell (nausea), vomiting, intestinal gas
(flatulence), dry or inflamed mouth or throat
skin rash, small itchy red spots on the skin (urticaria), itching
changes in liver function tests
fatigue
benign polyps in the stomach

Uncommon side effects (may affect up to 1 in 100 people):
depression
joint and muscle pain

• changes in the number of some blood cells (thrombocytopenia, eosinophilia, leucopenia)
• fractures of the hip, wrist, or spine (see also “Warnings and precautions”) fluid retention or swelling

Rare side effects (may affect up to 1 in 1,000):
fever
restlessness, drowsiness, confusion, hallucination, insomnia, vision problems, vertigo
change in taste, loss of appetite, inflammation of the tongue (glossitis)
skin reactions such as a burning or tingling sensation under the skin (erythema
multiforme), bruising, redness
excessive sweating
sensitivity to light
hair loss
tingling sensation on the skin (paresthesia), tremor
anemia (paleness)
kidney problems
pancreatitis
inflammation of the liver (may cause yellowing of the skin or eyes)
breast enlargement in men, impotence
candidiasis of the esophagus (fungal infection, can affect the skin or mucous membranes)
angioedema; you should go to the doctor immediately if you experience symptoms of angioedema
such as swelling of the face, tongue or throat, difficulty swallowing, urticaria and
difficulty breathing

Very rare side effects (may affect up to 1 in 10,000 people):
severe hypersensitivity reactions including shock. Symptoms of hypersensitivity reactions
may include fever, rash, swelling and sometimes a drop in blood pressure
inflammation of the mouth (stomatitis)
inflammation of the colon (colitis)
changes in laboratory values such as sodium, cholesterol and triglyceride levels
very severe skin reactions with redness, blisters, severe inflammation and loss of
skin (Stevens-Johnson Syndrome, toxic epidermal necrolysis)
reduction in the number of white blood cells (reduced resistance to infections) and decrease of
all blood cells (pancytopenia). If you develop an infection with symptoms such as
fever and a significant worsening of your general condition, or fever with symptoms of
local infection such as inflamed throat/pharynx/mouth or urinary problems, see your
doctor immediately. You will be given a blood test to check for a
possible reduction in white blood cells (agranulocytosis)

Frequency not known (frequency cannot be estimated from available data):
if you take Levogenix for more than three months, it is possible that your blood levels of magnesium
may decrease.
low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If
you have any of these symptoms, consult your doctor immediately. Low levels of
magnesium can also lead to a reduction in blood levels of potassium or calcium.
The doctor should decide whether to regularly check magnesium levels in the blood

• disease characterized by lesions and inflammation of the skin (cutaneous lupus erythematosus). Low levels of sodium in the blood. Common symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, muscle weakness or spasms, irritability, seizures, hallucinations

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

How to store Levogenix
Do not store above 25°C. Store in the original package.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and on
the box. The expiry date refers to the last day of that month.
Do not dispose of any medicine via water or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

Contents of the pack and other information
What Levogenix contains
The active ingredient is lansoprazole
Each gastro-resistant capsule contains 15 mg or 30 mg of lansoprazole.
The other ingredients are:
Capsule content: sucrose and corn starch spheres, disodium phosphate anhydrous lactose,
hypromellose, mannitol, hypromellose phthalate, diethyl phthalate, cetyl alcohol, talc, titanium dioxide
(E171), sodium lauryl sulfate.
Capsule shell: gelatin, titanium dioxide (E171)

Description of Levogenix and contents of the pack
Levogenix capsules are hard capsules containing gastro-resistant granules.
Levogenix is available in packs of 14 or 28 gastro-resistant hard capsules containing 15 mg and 30 mg
in PVC/PVDC/aluminium blisters.

Marketing Authorisation Holder
GENETIC S.p.A. - Via Della Monica, 26 - Castel S. Giorgio (SA)

Manufacturer:
Genetic S.p.A. Contrada Canfora – 84084 Fisciano (SA)