Lansoprazole Krka: detailed information

Package leaflet: Information for the patient

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

lansoprazole
Generic medicine
Please read this leaflet carefully before using 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

The active substance in Lansoprazole Krka is lansoprazole, a proton pump inhibitor.
Proton pump inhibitors reduce the amount of acid produced by the stomach.
Your doctor may prescribe Lansoprazole Krka 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 used in combination with antibiotic therapy.
Prevention or treatment of duodenal or gastric ulcers in patients requiring long-term treatment with NSAIDs (non-steroidal anti-inflammatory drugs) (NSAID therapy is used to treat pain or inflammation).
Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Lansoprazole Krka for an indication or dosage different from that stated in this leaflet. Take the medicine according to your doctor's instructions.
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 Lansoprazole Krka

Do not take Lansoprazole Krka

if you are allergic (hypersensitive) to lansoprazole or to any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions
Talk to your doctor or pharmacist before taking Lansoprazole Krka.
Inform your doctor if you have severe liver disease. Your doctor may decide to adjust the dose.
Your doctor may perform or refer you for an additional test called endoscopy in order to diagnose your condition and/or rule out malignant disease.
If you experience episodes of diarrhoea during treatment with Lansoprazole Krka, contact your doctor immediately, as Lansoprazole Krka has been associated with a slight increase in diarrhoeal infections.
If your doctor has prescribed Lansoprazole Krka in addition to other medicines used to treat Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatic disease: read carefully the package leaflets of these medicines as well.
If you need to take Lansoprazole Krka for a long time (more than 1 year), your doctor will likely schedule regular check-ups. You must always inform your doctor of any new or unusual symptoms or circumstances.
If you take a proton pump inhibitor such as Lansoprazole Krka, especially for more 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 have osteoporosis (reduced bone density) or are at risk of osteoporosis (e.g. if you are taking steroids).
While taking 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.
Talk to your doctor before taking lansoprazole:

if you have low levels of vitamin B12 or are at risk of low vitamin B12 levels and are undergoing 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 Krka that reduces stomach acidity, consult your doctor before taking Lansoprazole Krka.
if you develop a skin rash, especially in sun-exposed areas, inform your doctor as soon as possible, as it may be necessary to discontinue treatment with Lansoprazole Krka. Remember to mention other adverse effects such as joint pain.

Other medicines and Lansoprazole 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 substances, as Lansoprazole Krka may affect how 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 to treat infections),
digoxin (used to treat heart disorders),
warfarin (used to treat blood clots),
theophylline (used to treat asthma),
tacrolimus (used to prevent transplant rejection),
fluvoxamine (used as antidepressant therapy and for other psychiatric disorders),
antacids (used to treat heartburn and acid reflux),
sucralfate (used to treat ulcers),
St John's wort (Hypericum perforatum) (used to treat mild depression).

Lansoprazole Krka with food, drinks and alcohol
For best results, take Lansoprazole Krka at least 30 minutes before a meal with a glass of water.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are 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 Lansoprazole Krka. If you experience such adverse effects, you should be cautious, as your reaction ability may be reduced.
Only you can decide whether your condition allows you to drive a motor vehicle or perform other activities requiring concentration. Due to the effects or side effects, taking medicines may reduce your ability to perform these activities safely.
Other sections provide descriptions of such effects.
Read all the information in this leaflet as a guide.
If in doubt, consult your doctor, nurse or pharmacist.
Lansoprazole Krka contains sucrose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her 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 Lansoprazole Krka

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water. If you have difficulty swallowing the capsules, your doctor may advise you on alternative ways to take the medicine. Do not break or chew the capsules or their contents, as this would interfere with the proper mechanism of action.
If you take Lansoprazole Krka once daily, try to take it at the same time every day. You may achieve better results if you take Lansoprazole Krka first thing in the morning.
If you take Lansoprazole Krka twice daily, take the first dose in the morning and the second in the evening.
The dose of Lansoprazole Krka depends on your condition. The usual doses of Lansoprazole Krka for adults are listed below. Your doctor may sometimes prescribe a different dose and will inform you of the duration of treatment.

Heartburn and acid regurgitation
One 15 mg or 30 mg capsule daily for 4 weeks. If symptoms do not resolve 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 to one 30 mg capsule daily.

Treatment of Helicobacter pylori infection
The usual dose is one 30 mg capsule taken in the morning together with two different antibiotics and one 30 mg capsule taken in the evening together with two different antibiotics. Treatment is normally for 7 days.
The recommended antibiotic combinations are:

30 mg Lansoprazole Krka together with 250–500 mg clarithromycin and 1000 mg amoxicillin;
30 mg Lansoprazole Krka 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 ensure the medicine works properly, take it at the correct time and do not miss any doses.

Treatment of duodenal or gastric ulcer in patients requiring continuous NSAID therapy
One 30 mg capsule daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous NSAID therapy
One 15 mg capsule daily. Your doctor may adjust the dose to one 30 mg capsule daily.

Zollinger-Ellison syndrome
The usual starting dose is two 30 mg capsules daily. Depending on your response to Lansoprazole Krka, your doctor will determine the most appropriate dose for you.

Use in children
Lansoprazole Krka must not be given to children.

If you take more Lansoprazole Krka than you should
If you take more Lansoprazole Krka than prescribed, contact your doctor immediately.

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

If you stop taking Lansoprazole Krka
Do not stop treatment prematurely even if your symptoms improve.
Your condition may not have completely resolved and could recur if you do not complete the full course of treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lansoprazole Krka can cause side effects, although not everybody gets them.

The following side effects are common (occur in more than 1 in 100 patients):

headache, dizziness;
malaise, diarrhoea, stomach pain, constipation, flatulence, dryness or pain in the mouth or throat, benign polyps in the stomach;
changes in liver function test results;
skin rash, itching;
fatigue.

The following side effects are uncommon (may affect less than 1 in 100 patients):

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

The following side effects are rare (may affect less than 1 in 1,000 patients):

anaemia (pallor);
insomnia, hallucinations, confusion;
restlessness, dizziness, tingling sensation on the skin (paraesthesia), drowsiness, tremor;
visual disturbances;
inflammation of the tongue (glossitis), candidiasis (fungal infection, may affect skin or mucous membranes), pancreatitis, changes in taste;
inflammation of the liver (manifested by yellowing of the skin or eyes);
skin reactions such as burning or tingling under the skin, bruising, redness, hair loss, light sensitivity;
kidney problems;
breast enlargement in men;
fever, excessive sweating, angioedema, loss of appetite, impotence; you must immediately contact your doctor if you experience symptoms of angioedema such as swelling of the face, tongue or pharynx, difficulty swallowing, hives, or breathing difficulties.

The following side effects are very rare (may affect less than 1 in 10,000 patients):

Lansoprazole Krka may very rarely cause a reduction in the number of white blood cells, thereby decreasing resistance to infections. If you develop an infection with symptoms such as fever and severe worsening of your general condition, or fever accompanied by symptoms of local infection such as sore throat/pharynx/mouth or urinary problems, you must immediately contact your doctor. A blood test will be performed 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, blistering, severe inflammation and skin loss;
severe hypersensitivity reactions, including shock. Symptoms of a hypersensitivity reaction may include fever, skin rash, swelling and sometimes low blood pressure;
changes in certain laboratory test values, such as levels of sodium, cholesterol and triglycerides.

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 may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness and increased heart rate. If you experience any of these symptoms, contact 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.
visual hallucinations.
rash, possibly with joint pain.

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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lansoprazole Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
Blister:
Do not store above 25°C. Keep in the original packaging.
Containers:
Do not store above 25°C. Keep 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 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 Lansoprazolo Krka contains

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

Description of the appearance of Lansoprazolo Krka and package contents
15 mg capsules: white/brownish-red gelatin capsule containing enteric-coated granules ranging in colour from white to light brown or slightly pinkish.
30 mg capsules: white gelatin capsule containing enteric-coated granules ranging in colour from white to light brown or slightly pinkish.
Pack sizes:
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 pack 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