KROVANEG 15 мг Капсулы твердые

Содержание инструкции

1. Krovaneg 15 mg hard gastro-resistant capsules, 30 mg hard gastro-resistant capsules
   1. What is Krovaneg and what is it used for
   2. What you need to know before taking Krovaneg
   3. How to take Krovaneg
   4. Possible side effects
   5. How to store Krovaneg
   6. Contents of the pack and other information

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

Lansoprazole
Generic medicine

Read this leaflet carefully before you start to take 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 you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Krovaneg and what is it used for

The active ingredient of Krovaneg is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach produces.
Your doctor may prescribe Krovaneg 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 regurgitation
• 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 Krovaneg for another indication or with a different dosage than the one
Please consult your doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before taking Krovaneg

Do not take Krovaneg:

• 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.
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 diarrhoea during treatment with Krovaneg, contact your doctor immediately, as
Krovaneg has been associated with a small increase in infectious diarrhoea.
If your doctor has prescribed Krovaneg in addition to other medicines for the treatment of

Helicobacter pylori(antibiotics) or together with anti-inflammatory medicines to treat pain or diseases
If you are taking a proton pump inhibitor such as Krovaneg, 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 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 Krovaneg for a long time (for more than 1 year) your doctor will probably keep you under regular
observation. You should report any new and unusual symptom and circumstance whenever you see your
doctor.
Consult 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 acid-reducing agents, 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 gastric acidity.
• 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 unwanted effects such as joint pain.
• Severe skin reactions [Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS)] have been reported in association with treatment with lansoprazole. Stop using Krovaneg and consult your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in paragraph
• 4.
• During the intake of lansoprazole, 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 Krovaneg
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, even those available without a prescription.
In particular, tell your doctor or pharmacist if you are taking medicines containing any of the following
active ingredients, as Krovaneg 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).

Krovaneg with food and drink
To obtain the best results, you should take Krovaneg with a glass of water at least 30 minutes before
taking food.

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

Driving and operating machinery
Undesirable effects such as dizziness, vertigo, fatigue and visual disturbances sometimes occur in
patients taking Krovaneg.
If you experience effects such as 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 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 paragraphs.
Read all the information contained in this leaflet as a guide.
If you are not sure about something, discuss it with your doctor or pharmacist.

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

Krovaneg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e. essentially
“sodium-free”.

3. How to take Krovaneg

Take this medicine following exactly the instructions of your doctor. 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 hard capsules, your
doctor may advise an alternative way to take the medicine. Do not crush or chew these
hard capsules or the contents of the emptied hard capsules, because the medicine would not work
correctly.
If you take Krovaneg once a day, try to take it at the same time each day. You may get better
results if you take Krovaneg first thing in the morning.
If you take Krovaneg twice a day, you must take the first dose in the morning and the second dose in the
evening.
The dose of Krovaneg depends on your condition. The usual doses of Krovaneg for adults are reported
below. Your doctor may sometimes prescribe a different dose and will tell you how long the
treatment should last.

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

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

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

Treatment of esophageal inflammation (reflux esophagitis):one 30 mg capsule every
day for 4 weeks.

Long-term prevention of reflux esophagitis:one 15 mg capsule every day, your doctor
may adjust the dose up to one 30 mg capsule every 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 every day for 7 days.
The recommended antibiotic combinations are:

• 30 mg of Krovaneg together with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin;
• 30 mg of Krovaneg 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 30 mg capsule every day for 4 weeks.

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

Zollinger-Ellison syndrome:the usual initial dose is two 30 mg hard capsules every day, then
based on your response to Krovaneg, your doctor will decide the most suitable dose for you.

Use in children
Krovaneg should not be given to children.

If you take more Krovaneg than you should
If you take more Krovaneg than you have been told, ask your doctor for advice immediately.

If you forget to take Krovaneg
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 hard capsules
normally. Do not take a double dose to make up for the forgotten capsule
forgotten.

If you stop taking Krovaneg
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 period
of treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist .

4. Possible side effects

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

Stop using Krovaneg and consult your doctor immediately if you notice any of the following
symptoms

• reddish-purple blotches that are not raised, which look like targets or are circular on the trunk, often with blisters in the centre, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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

• headache, dizziness
• diarrhoea, constipation, stomach pain, feeling unwell, flatulence, dry or inflamed mouth or throat
• skin rash, 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
• fluid retention or swelling
• changes in red blood cell count.

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

• fever
• restlessness, drowsiness, confusion, hallucination, insomnia, vision disturbances, vertigo
• altered 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
• anaemia (paleness)
• kidney problems
• pancreatitis
• inflammation of the liver (can be seen as yellowing of the skin or eyes)
• breast enlargement in men, impotence
• candidiasis (fungal infection, can affect the skin or mucous membranes)
• angioedema; you must go to the doctor immediately if you experience symptoms of angioedema such as swelling of the face, throat, tongue or pharynx, difficulty swallowing, hives 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
• very rarely Krovaneg can cause a reduction in the number of white blood cells and resistance to infections may therefore decrease. If you develop an infection with symptoms such as fever and a serious deterioration in your general condition, or fever with symptoms of local infection such as an 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 (the frequency cannot be estimated from the available data):

• if you take Krovaneg for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels 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 magnesium levels can also lead to a reduction in blood potassium or calcium levels. The doctor should decide whether to regularly check magnesium levels in the blood
• low sodium levels in the blood. Common symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, muscle weakness or spasms, irritability, seizures, coma
• erythema, possibly associated with joint pain
• visual hallucinations.

Reporting of side effects
If you get any side effects, even 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.

5. How to store Krovaneg

Do not store at a temperature above 25°C. Store in the original packaging.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is reported on the blister and on the carton. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Krovaneg contains

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

Description of the appearance of Krovaneg and contents of the pack
Krovaneg capsules are hard capsules containing gastro-resistant granules.
Krovaneg is available in packs of 14 or 28 gastro-resistant hard capsules containing 15 mg or 30 mg in
blisters.

Marketing Authorisation Holder
Italchimici S.p.A. - Via Matteo Civitali, 1 - 20148 Milano.

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