Lansoprazole Aurobindo

Package leaflet: Information for the user

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

Generic medicine
Please read all of this leaflet carefully before you take 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The active substance of Lansoprazolo Aurobindo is lansoprazole, which is a proton pump inhibitor.
Proton pump inhibitors reduce the amount of acid produced in your stomach.
Your doctor may prescribe Lansoprazolo Aurobindo 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 ongoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs, used for pain or inflammation);
• Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Lansoprazolo Aurobindo for a different indication or at a dosage different from
that stated in this leaflet. Follow your doctor's instructions on how to take the medicine.
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 Aurobindo

Do not take Lansoprazole Aurobindo:

• 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 perform or may have already performed a further examination called endoscopy to diagnose your condition and/or rule out malignant disease.
If you develop diarrhoea during treatment with Lansoprazole Aurobindo, contact your doctor immediately, as Lansoprazole Aurobindo has been associated with a slightly increased risk of infectious diarrhoea.
If your doctor has prescribed Lansoprazole Aurobindo in combination with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatic diseases: read carefully the package leaflet of these medicines as well.
Taking a proton pump inhibitor such as Lansoprazole Aurobindo, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
If you take Lansoprazole Aurobindo long-term (for more than 1 year), your doctor will likely monitor you regularly. You must report any new and unusual symptoms or circumstances 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), consult your doctor for specific advice (see section Other medicines and Lansoprazole Aurobindo);
• 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 need to undergo a specific blood test (chromogranin A);
• if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole Aurobindo that reduces stomach acid.

If you notice the appearance of a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Lansoprazole Aurobindo.
Remember also to mention any other adverse effects such as joint pain.
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, skin rash, and joint stiffness. These signs must be reported to your doctor.

Other medicines and Lansoprazole Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
In particular, tell your doctor or pharmacist if you are taking medicines containing any of the following active substances, as Lansoprazole Aurobindo may affect how these medicines work:

• HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV infection) (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 disorders);
• antacids (used to treat heartburn or acid regurgitation);
• sucralfate (used to heal ulcers);
• St. John’s wort (Hypericum perforatum) (used to treat mild depression).

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice 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 Aurobindo. If you experience such adverse effects, you should be cautious, as your reaction ability may be reduced.
You are solely responsible for deciding whether you are fit to drive a motor vehicle or perform other tasks requiring high concentration. The use of medicines is one of the factors that may reduce your 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 in this leaflet as a guide.
If you are unsure about anything, discuss it with your doctor or pharmacist.

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

3. How to take Lansoprazole Aurobindo

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
suggest an alternative way of taking the medicine. Do not crush or chew these capsules or the contents of emptied
capsules, as the medicine will not work properly.

• If you take Lansoprazole Aurobindo once daily, try to take it at the same time each day. You may achieve better results if you take Lansoprazole Aurobindo first thing in the morning.
• If you take Lansoprazole Aurobindo twice daily, you should take the first dose in the morning and the second dose in the evening.

The dose of Lansoprazole Aurobindo depends on your condition. The usual doses of Lansoprazole
Aurobindo 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 persist, inform your doctor. If symptoms are not relieved 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 is usually given daily for 7 days.
The recommended antibiotic combinations are:

• Lansoprazole Aurobindo 30 mg together with 250–500 mg clarithromycin and 1,000 mg amoxicillin.
• Lansoprazole Aurobindo 30 mg 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 never miss a dose.

Treatment of duodenal or gastric ulcer in patients requiring ongoing treatment with NSAIDs: one 30 mg capsule daily for 4 weeks.
Prevention of duodenal or gastric ulcer in patients requiring ongoing treatment with NSAIDs: one 15 mg capsule daily; your doctor may adjust the dose up to one 30 mg capsule daily.
Zollinger-Ellison syndrome: the usual initial dose is two 30 mg capsules daily; then, depending on your
response to Lansoprazole Aurobindo, your doctor will decide the most appropriate dose for you.
Use in children
Lansoprazole Aurobindo must not be given to children.
If you take more Lansoprazole Aurobindo than you should
If you take more Lansoprazole Aurobindo than prescribed, seek immediate advice from your doctor.
If you forget to take Lansoprazole Aurobindo
If you forget to take a dose, take it as soon as you remember, unless it is almost time for the next dose.
If this is the case, do not take the missed dose and take the remaining capsules as usual. Do not take a double
dose to make up for a forgotten capsule.
If you stop taking Lansoprazole Aurobindo
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
treatment period.
If you have any doubts about how to use 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.

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

• headache, dizziness;
• diarrhoea, constipation, stomach pain, feeling unwell, intestinal gas (flatulence), dry or sore mouth or throat;
• skin rash, itching;
• changes in liver function tests;
• tiredness;
• 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 cell counts;
• fractures of the hip, wrist or spine.

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

• fever;
• restlessness, drowsiness, confusion, hallucinations, insomnia, vision disorders, dizziness;
• altered taste sensation, loss of appetite, inflammation of the tongue (glossitis);
• skin reactions such as burning or prickling sensation under the skin, bruising, redness and excessive sweating;
• sensitivity to light;
• 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 swelling in men, impotence;
• candidiasis (fungal infection, may 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 pharynx, difficulty swallowing, hives, or 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 low 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 skin loss (Stevens-Johnson syndrome and toxic epidermal necrolysis);
• very rarely, Lansoprazolo Aurobindo may cause a reduction in the number of white blood cells, and therefore resistance to infections may decrease. 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, you must immediately see a doctor. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis).

Frequency of the following side effects is unknown (frequency cannot be estimated from the available data):

• if you take Lansoprazolo Aurobindo for more than three months, magnesium levels in the blood 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 levels of potassium or calcium in the blood. Your doctor should decide whether periodic monitoring of blood magnesium levels is necessary;
• erythema, possibly 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, pharmacist or nurse. You can also report side effects directly via 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 Lansoprazole Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, on the bottle label and on the carton.
The expiry date refers to the last day of the month.
HDPE bottle: Use within 6 months after opening.
Blister:
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
Vial:
Do not store above 30°C.
Keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of any medicine 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 Aurobindo contains

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

Description of the appearance of Lansoprazolo Aurobindo and package contents

• Lansoprazolo Aurobindo 15 mg: yellow opaque hard capsules containing white or almost white spherical microgranules.
• Lansoprazolo Aurobindo 30 mg: white opaque hard capsules containing white or almost white spherical microgranules.

Pack sizes:
Capsules are supplied in OPA-Al-PVC/Al blisters containing 14 or 28 capsules, and in HDPE bottles containing 14 or 28 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 - Saronno (VA), Italy

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

This medicinal product is authorized in the European Economic Area Member States under the following trade names:
Italy: Lansoprazolo Aurobindo