Package leaflet: Information for the patient

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

Lansoprazole
Equivalent medicine
Please read all of this leaflet carefully before you start 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 may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Krovaneg is and what it is used for

The active substance of Krovaneg is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by your stomach.
Your doctor may prescribe Krovaneg for the following indications in adults:

Treatment of duodenal 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 administered in combination with antibiotic therapy
Treatment or prevention of duodenal or gastric ulcers in patients requiring continuous treatment with NSAIDs (non-steroidal anti-inflammatory drugs) (NSAIDs are used to treat pain or inflammation)
Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Krovaneg for another indication or at a different dosage than that stated in this leaflet. Always bring the medicine with you when visiting your doctor.
Contact 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Tell your doctor if you have severe liver disease. Your doctor may need to adjust your dose.
Your doctor may have performed or may perform an additional examination called endoscopy to diagnose
your condition and/or to exclude malignant disease.
If you develop diarrhoea during treatment with Krovaneg, contact your doctor immediately, as Krovaneg
has been associated with a small increased risk of infectious diarrhoea.
If your doctor has prescribed Krovaneg in addition to other medicines for the treatment of Helicobacter pylori
infection (antibiotics) or together with anti-inflammatory medicines to treat pain or inflammatory diseases:
please read carefully the package leaflet of these medicines as well.
If you take a proton pump inhibitor such as Krovaneg, especially for more than one year, there may be a
slight increase in the risk of fractures of the hip, wrist or spine. Inform your doctor if you have 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 long-term (for more than 1 year), your doctor will likely monitor you regularly. You must
report any new or unusual symptoms or circumstances each time 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 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.
If you are scheduled for 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, consult 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.
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 Krovaneg and contact 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 decreased 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.

Other medicines and Krovaneg
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
In particular, tell your doctor or pharmacist if you are taking medicines containing any of the following active substances, 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 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).

Krovaneg with food and drink
For best results, take Krovaneg with a glass of water at least 30 minutes before eating.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Adverse effects such as dizziness, vertigo, fatigue, and visual disturbances may occasionally occur in patients taking Krovaneg.
If you experience any of these adverse effects, you should be cautious, as your ability to concentrate may be reduced.
You alone are responsible for deciding whether you are fit to drive a motor vehicle or perform other tasks requiring increased concentration. The use of 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 contained in this leaflet for guidance.
If you are unsure about anything, discuss it with your doctor or pharmacist.

Krovaneg contains sucrose and lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her 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 exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Swallow the capsule whole with a glass of water. If you find it difficult to swallow the hard capsules,
your doctor may advise you on an alternative way to take the medicine. Do not crush or chew these
hard capsules or the contents of emptied hard capsules, as the medicine will not work properly.
If you take Krovaneg once daily, try to take it at the same time each day. You may achieve better
results if you take Krovaneg first thing in the morning.
If you take Krovaneg twice daily, you should 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 listed
below. Your doctor may sometimes prescribe a different dose and will tell you how long the treatment
should last.
Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg capsule daily for 4 weeks. If
symptoms have not improved within 4 weeks, contact your doctor.
Treatment of duodenal ulcer: one 30 mg capsule daily for 2 weeks.
Treatment of gastric ulcer: one 30 mg capsule daily for 4 weeks.
Treatment of inflammation of the oesophagus (reflux oesophagitis): one 30 mg capsule daily for 4
weeks.
Long-term prevention of reflux oesophagitis: one 15 mg capsule daily; your doctor may adjust the
dose up to one 30 mg capsule daily.
Treatment of Helicobacter pylori infection: 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. Treatment should be taken daily for 7 days.
The recommended antibiotic combinations are:

30 mg Krovaneg together with 250–500 mg clarithromycin and 1,000 mg amoxicillin;
30 mg Krovaneg 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
scheduled times and do not miss any doses.
Treatment of duodenal or gastric ulcer in patients requiring continuous NSAID treatment: one 30 mg
capsule daily for 4 weeks.
Prevention of duodenal or gastric ulcer in patients requiring continuous NSAID treatment: one 15 mg
capsule daily; your doctor may adjust the dose up to one 30 mg capsule daily.
Zollinger-Ellison syndrome: the usual starting dose is two 30 mg hard capsules daily; depending on
your response to Krovaneg, your doctor will decide the most appropriate dose for you.
Use in children
Krovaneg must not be given to children.
If you take more Krovaneg than you should
If you take more Krovaneg than prescribed, seek immediate advice from your doctor.
If you forget to take Krovaneg
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose.
In that case, do not take the missed dose and continue with your regular dosing schedule. Do not take a
double dose to make up for a forgotten capsule.
If you stop taking Krovaneg
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 using 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 Krovaneg and consult your doctor immediately if you notice any of the following
symptoms:

red, flat spots not raised, resembling a target or circular in shape, on the trunk, often with blisters in the centre, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
widespread rash, high body 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, intestinal gas (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, hallucinations, insomnia, vision disturbances, dizziness
altered sense of taste, loss of appetite, inflammation of the tongue (glossitis)
skin reactions such as burning or prickling sensation under the skin, bruising, redness, and excessive sweating
light sensitivity
hair loss
tingling sensation on the skin (paraesthesia), tremor
anaemia (pallor)
kidney problems
pancreatitis
liver inflammation (may present as yellowing of the skin or eyes)
breast enlargement in men, impotence
candidiasis (fungal infection, may affect skin or mucous membranes)
angioedema; you must immediately see a doctor if you experience symptoms of angioedema such as swelling of the face, throat, tongue or pharynx, difficulty swallowing, hives, or breathing difficulties.

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 low 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, blistering, severe inflammation, and skin loss
very rarely, Krovaneg may cause a reduction in white blood cell count, thereby reducing resistance to infections. If you develop an infection with symptoms such as fever and severe worsening of your general condition, or fever with signs of local infection such as inflamed throat/pharynx/mouth or urinary problems, seek immediate medical attention. You will
undergo 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 Krovaneg for more than three months, magnesium blood levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether regular monitoring of blood magnesium levels is necessary
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 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 Krovaneg

Do not store above 25°C. Keep in the original packaging.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Krovaneg contains

The active substance is lansoprazole. Each gastro-resistant hard capsule contains 15 mg of lansoprazole or 30 mg of lansoprazole.
The other components are: Capsule contents: sucrose and maize starch spheres, monohydrate lactose, 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 package contents
Krovaneg capsules are hard capsules containing gastro-resistant granules.
Krovaneg is available in packs of 14 or 28 gastro-resistant hard capsules of 15 mg or 30 mg in blister packs.
Marketing Authorization Holder
Italchimici S.p.A. - Via Matteo Civitali, 1 - 20148 Milan.
Manufacturer
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA).