LANSOPRAZOLO 15 mg Enteric-Coated Hard Capsules

Зміст інструкції

1. Lansoprazolo Krka 15 mg hard gastro-resistant capsules, 30 mg hard gastro-resistant capsules
   1. What is Lansoprazolo Krka and what is it used for
   2. What you need to know before taking Lansoprazolo Krka
   3. How to take Lansoprazolo Krka
   4. Possible side effects
   5. How to store Lansoprazolo Krka
   6. Package Contents and Other Information

Lansoprazolo Krka 15 mg hard gastro-resistant capsules, 30 mg hard gastro-resistant capsules

lansoprazole

Generic medicine

Read this leaflet carefully before you start to use 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, pharmacist or nurse.
• This medicine has been prescribed for you only. 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Lansoprazolo Krka and what is it used for

The active substance of Lansoprazolo Krka is lansoprazole, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by the stomach.
Your doctor may prescribe Lansoprazolo Krka 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 pylori, when combined with antibiotic therapy.
• Prevention or treatment of duodenal or stomach ulcers in patients who require continuous therapy with NSAIDs (non-steroidal anti-inflammatory drugs) (NSAID treatment is used against pain or inflammation).
• Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Lansoprazolo Krka with an indication or a dose different from
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 Lansoprazolo Krka

Do not take Lansoprazolo Krka

• if you are allergic (hypersensitive) 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 Lansoprazolo Krka.
Tell your doctor if you suffer from a severe liver disease. The doctor may decide to
adjust the dose.
Your doctor may perform or have performed an additional examination called an endoscopy in order to
diagnose your condition and/or exclude a malignant disease.
If you experience episodes of diarrhoea during treatment with Lansoprazolo Krka, contact your
doctor immediately, as Lansoprazolo Krka has been associated with a slight increase in
diarrheal infections.
If your doctor has prescribed Lansoprazolo Krka in addition to other medicines aimed at
treating Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory drugs for
treating pain or a rheumatic disease: read the package leaflets of these medicines carefully.
If you need to take Lansoprazolo Krka for a long time (over 1 year), your doctor will probably
subject you to regular check-ups. You should always inform your doctor of any new or unusual
symptoms or circumstances.
If you are taking a proton pump inhibitor such as Lansoprazolo Krka, 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. Consult your doctor if you suffer from osteoporosis (reduced bone density) or are at
risk of osteoporosis (e.g. if you are taking steroids).
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. It is necessary to report these signs to your
treating physician.
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 undergoing long-term treatment with lansoprazole. As with all acid-reducing agents, lansoprazole can 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 Lansoprazolo Krka that reduces stomach acid, contact your doctor before taking Lansoprazolo Krka.
• if you develop a rash, especially in areas exposed to the sun, inform your doctor as soon as possible, as it may be necessary to stop treatment with Lansoprazolo Krka. Remember to also mention other negative effects such as joint pain.

Other medicines and Lansoprazolo Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, inform your doctor or pharmacist if you are taking medicines containing any of the
following active ingredients, as Lansoprazolo Krka can affect the way these medicines work:

• HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV), methotrexate (used to treat autoimmune diseases and cancer),
• ketoconazole, itraconazole, rifampicin (used against infections),
• digoxin (used to treat heart disorders),
• warfarin (used for the treatment of blood clots)
• theophylline (used to treat asthma),
• tacrolimus (used to prevent transplant rejection),
• fluvoxamine (used as an antidepressant therapy and for other psychiatric illnesses),
• antacids (used to treat heartburn and acid reflux),
• sucralfate (used to treat ulcers),
• St John's wort (Hypericum perforatum) (used to treat mild depression).

Lansoprazolo Krka with food, beverages and alcohol
To get the best results, you should take Lansoprazolo Krka at least 30 minutes before a meal with
a glass of water.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast 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 occur sometimes in
patients taking Lansoprazolo Krka. If you experience such undesirable effects, you should be careful because your reaction ability may be reduced.
You alone can decide whether your condition allows you to drive a motor vehicle or perform other activities that require concentration. Given the effects or
undesirable effects, the use of medicines can reduce the ability to perform these activities safely.
The other paragraphs provide a description of these effects.
Read all the information in this leaflet as a guide.
If you have any doubts, consult your doctor, nurse or pharmacist.

Lansoprazolo Krka contains sucrose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially
"sodium-free".

3. How to take Lansoprazolo Krka

Take this medicine always following the instructions of your doctor or pharmacist. 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 other ways to take the medicine. Do not break or chew the capsules or
their contents because this would block its correct mechanism of action.
If you take Lansoprazolo Krka once a day, try to take it every day at the same time. You may
achieve better results if you take Lansoprazolo Krka first thing in the morning.
If you take Lansoprazolo Krka twice a day, you must take the first dose in the morning and the second
in the evening.
The dose of Lansoprazolo Krka depends on your condition. The usual dosages of Lansoprazolo Krka for
adults are reported below. Your doctor may sometimes prescribe a different dose and tell you for
how long the treatment should last.

Heartburn and acid reflux
One 15 mg or 30 mg capsule every day for 4 weeks. If these do not disappear 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 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. The doctor may adjust the dose to one 30 mg capsule every day.

Treatment ofHelicobacter pyloriinfection
The usual dose is one 30 mg capsule together with two different antibiotics in the morning and one capsule
of 30 mg together with two different antibiotics in the evening. The treatment will normally be every day for 7
days.
The recommended combinations of antibiotics are:

• 30 mg of Lansoprazolo Krka together with 250-500 mg of clarithromycin and 1000 mg of amoxicillin;
• 30 mg of Lansoprazolo Krka 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 no longer recur
if the infection is treated successfully. To allow the medicine to work best, take it
at the right time and do not miss any dose.
Treatments of duodenal or stomach ulcer in patients who need continuous therapy
based on NSAIDs
One 30 mg capsule every day for 4 weeks.

Prevention of duodenal or stomach ulcer in patients who need continuous therapy
based on NSAIDs
One 15 mg capsule every day. The doctor may adjust the dose to one 30 mg capsule every day.

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

Use in children
Lansoprazolo Krka should not be given to children.

If you take more Lansoprazolo Krka than you should
If you take more Lansoprazolo Krka than you have been told, consult your doctor immediately.

If you forget to take Lansoprazolo Krka
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, skip the forgotten dose and take the remaining capsules normally. Do not take a double dose to make up for the missed capsule.

If you stop taking Lansoprazolo Krka
Do not stop the treatment prematurely if the symptoms have improved.
Your condition may not have completely disappeared, and may recur if you do not complete the treatment period.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lansoprazolo Krka can cause side effects, although not everybody gets them.
The following side effects are common(may affect more than 1 in 10 people):

• headache, dizziness;
• feeling unwell or malaise, diarrhoea, stomach pain, constipation, flatulence, dryness or soreness of the mouth or throat, benign polyps in the stomach;
• changes in the values of tests for liver function;
• skin rashes, itching;
• tiredness.

The following side effects are uncommon(may affect up to 1 in 100 people):

• changes in blood cell counts;
• depression;
• muscle or joint pain;
• fluid retention or swelling.

The following side effects are rare(may affect up to 1 in 1,000 people):

• anaemia (paleness);
• insomnia, hallucinations, confusion;
• restlessness, vertigo, tingling sensation on the skin (paresthesia), drowsiness, tremor;
• vision disturbances;
• inflammation of the tongue (glossitis), candidiasis (fungal infection, can affect the skin or mucous membranes), pancreatitis, changes in the sense of taste;
• inflammation of the liver (manifests with yellowing of the skin or eyes);
• skin reactions such as burning or tingling under the skin, bruising, redness, hair loss, sensitivity to light;
• kidney problems;
• breast enlargement in men;
• fever, excessive sweating, angioedema, loss of appetite, impotence; you should immediately see a doctor if you experience symptoms of angioedema, such as swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing.

The following side effects are very rare(may affect up to 1 in 10,000 people):

• Lansoprazolo Krka can very rarely 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 worsening of your general condition, or fever accompanied by symptoms of local infection such as sore throat/pharynx/mouth or urinary problems, see your doctor immediately. You will be given a blood test to check for a possible decrease in white blood cells (agranulocytosis).
• inflammation of the intestine (colitis), inflammation of the mouth (stomatitis).
• very severe skin reactions with redness, blisters, severe inflammation and skin loss.
• serious hypersensitivity reactions, including shock. Symptoms of a hypersensitivity reaction may include fever, skin rashes, swelling and sometimes a drop in blood pressure.
• changes in some test values, such as sodium, cholesterol and triglyceride levels.

The frequency of the following side effects is not known (cannot be estimated from the available data):

• if you take lansoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels can also lead to a decrease 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.
• visual hallucinations.
• rash, possibly with joint pain.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 Lansoprazolo Krka

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
Blisters:
Do not store at a temperature above 25ºC. Store in the original packaging.
Containers:
Do not store at a temperature above 25ºC. Store in the original packaging.
Keep the container (bottle) tightly closed, to protect the medicine from moisture.
Use the contents within 4 months of opening the container.
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 Krka contains

• The active ingredient is lansoprazole. Each capsule contains 15 mg or 30 mg of lansoprazole.
• The capsules also contain sugar spheres (sucrose and corn starch), sucrose, corn starch, povidone, dibasic sodium phosphate dihydrate, sodium lauryl sulfate, ethyl acrylate-methacrylic acid copolymer (1:1) dispersion 30%, talc, macrogol 6000, titanium dioxide (E171), polysorbate 80. Capsule shell: gelatin, titanium dioxide (E171). 15 mg capsules also contain red iron oxide (E172). See section 2 Lansoprazolo Krka contains sucrose and sodium.

Description of the appearance of Lansoprazolo Krka and package contents
15 mg capsules: white/reddish-brown gelatin capsule, containing enteric-coated granules of
color from white to light brown or slightly pink.
30 mg capsules: white gelatin capsule, containing enteric-coated granules of color from white
to light brown or slightly pink.
Packages:
Plastic container with 14, 28, 56 and 98 capsules. The container for 14, 28 or 56 capsules contains a
desiccant. The container for 98 capsules contains 1 desiccant.
Boxes of 7 (30 mg), 14, 28, 49, 56 and 98 capsules in blisters.
Not all package sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local Representative for Italy
KRKA Farmaceutici Milano S.r.l. Viale Achille Papa 30, 20149 Milano, Italy

Manufacturer and batch release
KRKA, d.d. Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia