LANSOPRAZOLO 15 mg Enteric-Coated Hard Capsule

Зміст інструкції

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

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

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 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 or pharmacist. See section 4.

Contents of this leaflet:

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

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

The active substance of Lansoprazolo Aurobindo is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach produces.
Your doctor may prescribe Lansoprazolo Aurobindo 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 Helycobacter pyloriwhen administered in combination with antibiotic therapy;
• Treatment or prevention of duodenal or stomach ulcers in patients who require continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs, used against pain or inflammation);
• Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Lansoprazolo Aurobindo for another indication or with a different dosage than
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 Aurobindo

Do not take Lansoprazolo Aurobindo:

• 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 dose.
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 while taking Lansoprazolo Aurobindo, contact your doctor immediately,
because Lansoprazolo Aurobindo has been associated with a small increase in infectious diarrhoea.
If your doctor has prescribed Lansoprazolo Aurobindo in addition to other medicines for the treatment
of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory medicines to treat
Taking a proton pump inhibitor such as Lansoprazolo Aurobindo, especially for a
period longer than one year, may slightly increase the risk of fractures of the hip, wrist and
spine. Tell your doctor if you suffer from osteoporosis or if you are taking corticosteroids (which
may increase the risk of osteoporosis).
If you take Lansoprazolo Aurobindo 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.
Talk to your doctor before taking lansoprazole:

• if you are taking a medicine containing atazanavir and nelfinavir (for the treatment of HIV infection) talk to your doctor for specific advice (see section Other medicines and Lansoprazolo Aurobindo);
• 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 Lansoprazolo Aurobindo that reduces acid in the stomach.

If you notice the appearance of a skin rash, especially in areas exposed to the sun, contact your doctor as
soon as possible, as it may be necessary to stop treatment with Lansoprazolo Aurobindo.
Also remember to mention any other negative effects such as joint pain.
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 doctor.

Other medicines and Lansoprazolo Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.
In particular, tell your doctor or pharmacist if you are taking medicines containing one of the following active
substances, as Lansoprazolo Aurobindo may affect how these medicines work:

• HIV protease inhibitors such as atazanavir and nelfinavir (used for the treatment of HIV) (see section Warnings and precautions);
• methotrexate (used to treat autoimmune diseases and cancer);
• ketoconazole, itraconazole, rifampicin (used to treat infections);
• digoxin (used to treat heart problems);
• theophylline (used to treat asthma);
• warfarin (used to treat blood clots);
• 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).

Lansoprazolo Aurobindo with food and drink
For best results, take Lansoprazolo Aurobindo at least 30 minutes before taking food.

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

Driving and using machines
Undesirable effects such as dizziness, vertigo, fatigue and visual disturbances sometimes occur in
patients taking Lansoprazolo Aurobindo. If you experience effects like these you must
be careful because your reaction ability may be reduced.
You alone are responsible for deciding whether you are fit to drive a motor vehicle or to
perform other tasks that require greater concentration. The use of medicines represents 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 sections.
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.

Lansoprazolo Aurobindo contains sucrose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor or pharmacist before
taking this medicine.

3. How to take Lansoprazolo Aurobindo

Take this medicine following exactly 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 an alternative way to take the medicine. Do not crush or chew these capsules or the
contents of emptied capsules, because the medicine would not work correctly.

• If you take Lansoprazolo Aurobindo once a day, try to take it at the same time each day. You may get better results if you take Lansoprazolo Aurobindo first thing in the morning.
• If you take Lansoprazolo Aurobindo twice a day, you must take the first dose in the morning and the second dose in the evening.

The dose of Lansoprazolo Aurobindo depends on your condition. The usual doses of Lansoprazolo
Aurobindo for adults are reported below. Your doctor may sometimes 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 daily for
4 weeks. If symptoms persist, you should tell your doctor. If 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 esophageal inflammation (reflux esophagitis):one 30 mg capsule daily
for 4 weeks.

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

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 generally be administered daily for 7 days.
The recommended antibiotic combinations are:

• Lansoprazolo Aurobindo 30 mg together with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin.
• Lansoprazolo Aurobindo 30 mg together with 250 mg of clarithromycin and 400-500 mg of metronidazole. If your infection is being treated because you have an ulcer, the ulcer is likely to no longer occur 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 per day for 4 weeks.

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

Zollinger-Ellison syndrome:the usual initial dose is two 30 mg capsules per day, then based on your
response to Lansoprazolo Aurobindo, your doctor will decide the most appropriate dose for you.

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

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

If you forget to take Lansoprazolo Aurobindo
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 capsules
normally. Do not take a double dose to make up for the missed capsule.

If you stop taking Lansoprazolo Aurobindo
Do not stop treatment prematurely if your symptoms have improved.
Your condition may not be completely healed and may recur if you do not complete the
treatment period.
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.
Common side effects (may affect up to 1 in 10 people):

• headache, dizziness;
• diarrhoea, constipation, stomach pain, feeling unwell, flatulence, dry or sore 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 or muscle pain;
• fluid retention or swelling;
• changes in blood counts;
• fractures of the hip, wrist and spine.

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

• fever;
• restlessness, drowsiness, confusion, hallucinations, 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 (may be manifested by yellowing of the skin or eyes);
• breast enlargement in men, impotence;
• candidiasis (fungal infection, can affect the skin or mucous membranes);
• angioedema; you must 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.

Very rare side effects (may affect up to 1 in 10,000 people):

• severe hypersensitivity reactions including shock. Symptoms of hypersensitivity reactions can include fever, rash, swelling and sometimes a drop in blood pressure;
• inflammation of the mouth (stomatitis);
• colitis (inflammation of the colon);
• 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 and toxic epidermal necrolysis);
• very rarely Lansoprazole Aurobindo may 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 severe deterioration of your general condition, or fever with symptoms of local infection such as an inflamed throat/pharynx/mouth or urinary problems, see your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis).

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

• if you take Lansoprazole Aurobindo for more than three months, it is possible that 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 check magnesium levels in the blood periodically;
• erythema, with possible joint pain;
• visual hallucinations.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lansoprazolo Aurobindo

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, the label of the bottle and
the carton.
The expiry date refers to the last day of the month.
HDPE bottle: Use within 6 months of opening.

Blister:
Do not store at a temperature above 30°C.
Store in the original package to protect the medicine from moisture.

Bottle:
Do not store at a temperature above 30°C.
Keep the bottle tightly closed to protect the medicine from moisture.
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 Lansoprazolo Aurobindo contains

• The active ingredient is lansoprazole. Lansoprazolo Aurobindo capsules contain 15 mg or 30 mg of lansoprazole.
• The other ingredients are: Capsule contents:sugar spheres (sucrose, corn starch), sodium lauryl sulfate, meglumine, mannitol (E421), hypromellose, macrogol, talc, polysorbate 80, titanium dioxide (E171), methacrylic acid-ethyl acrylate copolymer. Capsule shell:gelatin, titanium dioxide (E171). The shell of the 15 mg capsulealso contains: quinoline yellow (E104).

Description of the appearance of Lansoprazolo Aurobindo and contents of the pack

• Lansoprazolo Aurobindo 15 mg: capsules with an opaque yellow head and body containing spherical microgranules which are white or almost white in colour.
• Lansoprazolo Aurobindo 30 mg: capsules with an opaque white head and body containing spherical microgranules which are white or almost white in colour.

Packs:
The capsules are supplied in OPA-Al-PVC/Al blisters of 14 and 28 capsules and in HDPE bottles of 14 and 28 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102

• 21047 - Saronno (VA) Manufacturer: Laboratorios Liconsa, S.A. Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo, 19200 Azuqueca de Henares (Guadalajara), Spain

This medicinal product is authorised in the Member States of the European Economic Area with the
following trade names:
Italy: Lansoprazolo Aurobindo