LANSOPRAZOLO 15 mg Enteric-Coated Hard Capsule

Зміст інструкції

1. LANSOPRAZOLO SANDOZ BV 15 mg gastro-resistant hard capsules, 30 mg gastro-resistant hard capsules
   1. What is LANSOPRAZOLO SANDOZ BV and what is it used for
   2. What you need to know before taking LANSOPRAZOLO SANDOZ BV
   3. How to take Lansoprazolo Sandoz BV
   4. POSSIBLE SIDE EFFECTS
   5. How to store Lansoprazolo Sandoz BV
   6. Contents of the pack and other information

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

Generic medicine

Read this leaflet carefully before you start 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.
• 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 SANDOZ BV is and what it is used for
• 2. What you need to know before you take LANSOPRAZOLO SANDOZ BV
• 3. How to take LANSOPRAZOLO SANDOZ BV
• 4. Possible side effects
• 5. How to store LANSOPRAZOLO SANDOZ BV
• 6. Contents of the pack and other information

1. What is LANSOPRAZOLO SANDOZ BV and what is it 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.
The doctor may prescribe Lansoprazolo Sandoz BV for the following indications:

• Treatment of duodenal and stomach ulcers
• Treatment of esophageal inflammation (reflux esophagitis)
• Prevention of reflux esophagitis
• Treatment of heartburn and acid regurgitation
• Treatment of infections caused by the bacterium Helicobacter 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 given you Lansoprazolo Sandoz BV for another indication or with a
doctor to take the medicine.

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

Do not take Lansoprazolo 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 Lansoprazolo Sandoz BV.

• 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 endoscopy to diagnose your condition and/or exclude a malignant disease.
• If you experience diarrheaduring treatment with Lansoprazolo Sandoz BV, contact your doctor immediately, as Lansoprazolo Sandoz BV has been associated with a small increase in infectious diarrhea.
• If your doctor has given you Lansoprazolo Sandoz BV in addition to other medicines for the treatment of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatic diseases: please read
• If you take Lansoprazolo Sandoz BV 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.
• If you are taking a proton pump inhibitor such as Lansoprazolo Sandoz BV, 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. If you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis) consult your doctor.
• If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazolo capsules that reduces stomach acid.
• If you are 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 interrupt the therapy with Lansoprazolo Sandoz BV. Remember to also report any other undesirable effects such as joint pain

Other medicines and Lansoprazolo Sandoz BV
Tell 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 Lansoprazolo Sandoz BV can 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 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 Sandoz BV with food, beverages and alcohol
To get the best results, you should take Lansoprazolo Sandoz BV at least 30 minutes before taking food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, 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 occur sometimes in patients taking Lansoprazolo Sandoz BV. If you experience these undesirable effects, you should be careful because your reaction ability may decrease.
You alone are responsible for deciding whether you are fit to drive a motor vehicle or to perform other tasks that require increased concentration. Due to their effects or their undesirable effects, the use of medicines represents one of the factors that can reduce the ability to perform these actions safely.
The descriptions of these effects can be found in other paragraphs.
Read all the information contained in this leaflet as a guide.
If you are not sure about something, discuss it with your doctor, nurse or pharmacist.

Lansoprazolo Sandoz BV contains sucrose
Lansoprazolo Sandoz BV contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Lansoprazolo Sandoz BV

Take this medicine following the instructions of your doctor exactly. If you have any
doubts, consult your doctor.

• Swallow the capsule whole with a glass of water. If you find it difficult to swallow 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 Sandoz BV once a day, try to take it at the same time each day. You may get better results if you take Lansoprazolo Sandoz BV first thing in the morning.
• If you take Lansoprazolo Sandoz BV twice a day, you must take the first dose in the morning and the second dose in the evening.

The dose of Lansoprazolo Sandoz BV depends on your condition. The usual doses of
Lansoprazolo Sandoz BV for adults are listed below. Your doctor may sometimes prescribe a
different dose and tell you how long the treatment should last.

Treatment of heartburn and acid reflux:the recommended dose is one
capsule of 15 mg or 30 mg 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: the recommended dose is one 30 mg capsule per
day for 2 weeks.

Treatment of stomach ulcer:the recommended dose is one 30 mg capsule per
day for 4 weeks.

Treatment of esophageal inflammation (reflux esophagitis):the dose
recommended is one 30 mg capsule per day for 4 weeks.

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

Treatment ofHelicobacter pyloriinfection:the recommended dose is one capsule
of 30 mg 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 usually
be given daily for 7 days.
The recommended antibiotic combinations are:

• 30 mg of Lansoprazolo Sandoz BV together with 250-500 mg of clarithromycin and 1,000 g of amoxicillin
• 30 mg of Lansoprazolo Sandoz BV together with 250 mg of clarithromycin and 400-500 mg of metronidazole

If you are treating the infection because you have an ulcer, the ulcer is unlikely to return 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:the recommended dose is one 30 mg capsule per day
for 4 weeks.

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

Zollinger-Ellison syndrome:the recommended dose is two 30 mg capsules per day,
afterwards, the doctor will decide the most suitable dose for you based on your response to the dose of
Lansoprazolo Sandoz BV

Use in children
Lansoprazolo Sandoz BV should not be given to children.
Always take the medicine following the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.

If you take more Lansoprazolo Sandoz BV than you should
If you take more Lansoprazolo Sandoz BV than you have been told, seek immediate
medical advice or go to the nearest hospital as soon as possible.

If you forget to take Lansoprazolo Sandoz BV
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 happens, do not take the missed dose and take the
rest of the capsules as normal. Do not take a double dose to make up for the
missed dose.

If you stop taking Lansoprazolo Sandoz BV
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 course of treatment.
If you have any doubts about the use of Lansoprazolo Sandoz BV, ask your doctor.

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, wind (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.

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

• fever
• restlessness, drowsiness, confusion, hallucination, 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
• pins and needles sensation on the skin (paresthesia), tremor
• anaemia (paleness)
• kidney problems
• pancreatitis
• inflammation of the liver (may manifest as yellow skin or yellow eyes)
• breast enlargement in men, impotence
• candidiasis (fungal infection, can affect the skin or mucous membranes)
• angioedema; you must go to the doctor immediatelyif 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 may 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
• very rarely Lansoprazolo Sandoz BV can cause a reduction in the number of white blood cells and resistance to infections may 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 inflamed throat/pharynx/mouth or urinary problems go to the doctor immediately. You will be given a blood test to check for a possible reduction in white blood cells (agranulocytosis).

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

• If you take Lansoprazolo Sandoz BV for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have 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 check your blood magnesium levels periodically
• rash, possible 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 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 Sandoz BV

Keep this medicine out of the sight and reach of children.
Do not use Lansoprazolo Sandoz BV after the expiry date stated on the blister and on the
pack. 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 ºC.
Store in the original package to protect from moisture.
Bottle:
Do not store at a temperature above 30 ºC.
Keep the bottle tightly closed to protect it 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 Sandoz BV contains

• The active ingredient is lansoprazole. Lansoprazolo Sandoz BV contains 15 mg or 30 mg of lansoprazole.
• Other ingredients are: Capsule content:sugar spheres (sucrose and 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 15 mg capsule shell also contains:quinoline yellow (E104)

Description of the appearance of Lansoprazolo Sandoz BV and contents of the pack

• Lansoprazolo Sandoz BV 15 mg: capsules with opaque yellow cap and body containing spherical microgranules from white to almost white in colour
• Lansoprazolo Sandoz BV 30 mg: capsules with opaque white cap and body containing spherical microgranules from white to almost white in colour.

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz BV, Veluwezoom 22, 1327 AH Almere, Netherlands

Representative for Italy: Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA)

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 authorised in the Member States of the European Economic Area
under the following designations:
Denmark: Lansoprazol Medical Valley, hard enterokapsler 15/30 mg
Italy: Lansoprazolo Sandoz BV gastro-resistant hard capsules 15/30 mg
Portugal: Lansoprazol Bluefish, 15/30 mg, Gastrorresistant capsule

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