Lansoprazole Sandoz BV

PACKAGE LEAFLET: INFORMATION FOR THE USER

LANSOPRAZOLE SANDOZ BV 15 mg gastro-resistant hard capsules, 30 mg gastro-resistant hard capsules

Generic medicine
Please 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LANSOPRAZOLO SANDOZ BV is and what it is used for

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

• 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 non-steroidal anti-inflammatory drugs (NSAIDs, used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

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

2. What you need to know before taking LANSOPRAZOLE SANDOZ BV

Do not take Lansoprazole Sandoz BV:

• if you are allergic (hypersensitive) to lansoprazole or to any of the other ingredients of this medicine (listed in section 6)
• if you are taking a medicine containing the active substance atazanavir (used in the treatment of HIV).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lansoprazole Sandoz BV.

• 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 an additional test called endoscopy to diagnose your condition and/or exclude malignant disease.
• If you develop diarrhea during treatment with Lansoprazole Sandoz BV, contact your doctor immediately, as Lansoprazole Sandoz BV has been associated with a slight increase in infectious diarrhea.
• If your doctor has prescribed Lansoprazole Sandoz BV in combination with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines for pain or rheumatic diseases: please read carefully the package leaflet of these medicines as well.
• If you take Lansoprazole Sandoz BV long-term (for more than 1 year), your doctor will likely monitor you regularly. You must report any new or unusual symptoms and circumstances each time you see your doctor.
• If you are taking a proton pump inhibitor such as Lansoprazole Sandoz BV, especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
• If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole capsules that reduces gastric acidity.
• If you need to undergo a specific blood test (chromogranin A).

If you notice the appearance of a skin rash, especially in areas exposed to sunlight,
contact your doctor as soon as possible, as it may be necessary to discontinue treatment
with Lansoprazole Sandoz BV. Remember to also report any other adverse effects such as
joint pain.
Other medicines and Lansoprazole Sandoz BV
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
In particular, tell your doctor if you are taking medicines containing any of the following
active substances, as Lansoprazole Sandoz BV may affect how these medicines work:

• ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• 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)

Lansoprazole Sandoz BV with food, drinks and alcohol
To achieve the best results, take Lansoprazole Sandoz BV at least 30 minutes before eating.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, 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 Sandoz BV. If you experience these adverse effects,
you should be cautious, as your reaction ability 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. Due to their effects or side effects,
the use of medicines represents one of the factors that may reduce your ability to perform
these activities safely.
Descriptions of these effects can be found in other sections.
Read all the information contained in this leaflet as a guide.
If you are unsure about anything, discuss it with your doctor, nurse, or pharmacist.
Lansoprazole Sandoz BV contains sucrose
Lansoprazole Sandoz BV contains sucrose. If your doctor has diagnosed you with an
intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Lansoprazole Sandoz BV

Take this medicine exactly as your doctor has told you. If you have
any doubts, consult your doctor.

• Swallow the capsule whole with a glass of water. If you have difficulty swallowing the capsules, your doctor may advise you on an alternative way to take 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 Sandoz BV once daily, try to take it at the same time each day. You may achieve better results if you take Lansoprazole Sandoz BV first thing in the morning.
• If you take Lansoprazole Sandoz BV twice daily, you should take the first dose in the morning and the second dose in the evening.

The dose of Lansoprazole Sandoz BV depends on your condition. The usual doses of
Lansoprazole Sandoz BV for adults are listed below. Your doctor may sometimes prescribe a different dose and will tell you how long your treatment should last.
Treatment of heartburn and acid regurgitation: the recommended dose is one
15 mg or 30 mg capsule for 4 weeks. If symptoms persist, inform your doctor.
If symptoms are not relieved within 4 weeks, contact your doctor.
Treatment of duodenal ulcer: the recommended dose is one 30 mg capsule daily for 2 weeks.
Treatment of gastric ulcer: the recommended dose is one 30 mg capsule daily for 4 weeks.
Treatment of inflammation of the oesophagus (reflux oesophagitis): the recommended dose is one 30 mg capsule daily for 4 weeks.
Long-term prevention of reflux oesophagitis: the recommended dose is one 15 mg capsule daily; your doctor may adjust the dose up to one 30 mg capsule daily.
Treatment of Helicobacter pylori infection: the recommended 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:

• 30 mg Lansoprazole Sandoz BV together with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg Lansoprazole Sandoz BV together with 250 mg clarithromycin and 400–500 mg metronidazole

If you are treating the infection because you have an ulcer, it is unlikely that the ulcer will 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 therapy: the recommended dose is one 30 mg capsule daily for 4 weeks.
Prevention of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: the recommended dose is one 15 mg capsule daily; your doctor may adjust the dose up to one 30 mg capsule daily.
Zollinger-Ellison syndrome: the recommended dose is two 30 mg capsules daily; thereafter, your doctor will determine the most appropriate dose for you based on your response to Lansoprazole Sandoz BV.
Use in children
Lansoprazole Sandoz BV must not be given to children.
Always take the medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
If you take more Lansoprazole Sandoz BV than you should
If you take more Lansoprazole Sandoz BV than prescribed, seek immediate medical advice or go to the nearest hospital as soon as possible.
If you forget to take Lansoprazole Sandoz BV
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. If this is the case, do not take the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Lansoprazole Sandoz BV
Do not stop treatment prematurely even if your symptoms improve. 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 the use of Lansoprazole Sandoz BV, consult your doctor.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Common adverse reactions (may affect up to 1 in 10 people):

• headache, dizziness
• diarrhoea, constipation, stomach pain, feeling unwell or nausea, gas (flatulence), dry or sore mouth or throat
• skin redness (erythema), itching
• changes in liver function tests
• fatigue
• benign polyps in the stomach

Uncommon adverse reactions (may affect up to 1 in 100 people):

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

Rare adverse reactions (may affect up to 1 in 1,000 people):

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, vision disturbances, 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
• 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 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 breathing difficulties.

Very rare adverse reactions (may affect up to 1 in 10,000 people):

• severe hypersensitivity reactions including shock. Symptoms of hypersensitivity may include fever, erythema, 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, blistering, severe inflammation and skin loss
• very rarely, Lansoprazolo Sandoz BV may cause a reduction in the number of white blood cells, leading to decreased 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. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis).

Frequency not known (frequency cannot be determined from the available data)

• If you take Lansoprazolo Sandoz BV for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or 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 periodic monitoring of blood magnesium levels is necessary.
• erythema, possible joint pain.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor. You can also report adverse reactions directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Lansoprazole Sandoz BV

Keep this medicine out of the sight and reach of children.
Do not use Lansoprazole Sandoz BV after the expiry date stated on the blister and on the
packaging. 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 from moisture.
Bottle:
Do not store above 30 °C.
Keep the bottle tightly closed to protect from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Package contents and other information

What Lansoprazolo Sandoz BV contains

• The active substance is lansoprazole. Lansoprazolo Sandoz BV contains 15 mg or 30 mg of lansoprazole.
• The other components are:
  Capsule contents: sugar spheres (sucrose and maize 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 15 mg capsule shell additionally contains: quinoline yellow (E104)

Description of the appearance of Lansoprazolo Sandoz BV and package contents

• Lansoprazolo Sandoz BV 15 mg: opaque yellow hard capsules containing spherical microgranules white to almost white in colour
• Lansoprazolo Sandoz BV 30 mg: opaque white hard capsules containing spherical microgranules white to almost white in colour.

Pack sizes:
Capsules are supplied in OPA-Al-PVC/Al blisters containing 14, 28, 30, 56 and 98 capsules, and in
HDPE bottles containing 14, 28, 56 and 98 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Sandoz BV, Veluwezoom 22, 1327 AH Almere, The Netherlands
Italian representative: Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturer responsible for batch release:
LABORATORIOS LICONSA, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo,
19200 Azuqueca de Henares (Guadalajara),
Spain
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

This medicinal product is authorized in the European Economic Area Member States
under the following names:
Denmark: Lansoprazol Medical Valley, harde enterokapsler 15/30 mg
Italy: Lansoprazolo Sandoz BV gastro-resistant hard capsules 15/30 mg
Portugal: Lansoprazol Bluefish, 15/30 mg, Cápsula gastorresistente

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