LANSODOR 15 mg Enteric-Coated Hard Capsule

Зміст інструкції

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

LANSODOR 15 mg hard gastro-resistant capsules, 30 mg hard gastro-resistant capsules

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

1. What is LANSODOR and what is it used for

The active ingredient of LANSODOR is lansoprazole, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach produces.
Your doctor may prescribe LANSODOR for the following indications:

• 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 given you LANSODOR for another indication or with a different dosage than
the medicine.
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2. What you need to know before taking LANSODOR

Do not take LANSODOR:

• if you are allergic to lansoprazole or 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 before taking LANSODOR:

• if you have ever had a skin reaction after treatment with a medicine similar to LANSODOR that reduces stomach acid;
• if you are going 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 stop the therapy with LANSODOR. Remember to also report any other unwanted effects such as joint pain.
Tell your doctor if you have a severe liver disease. Your doctor may need to adjust the dose.
Your doctor may have performed or is performing a further examination called endoscopy to diagnose your condition and/or exclude a malignant disease.
If you experience diarrhea during treatment with LANSODOR, contact your doctor immediately, as LANSODOR has been associated with a small increase in infectious diarrhea.
If your doctor has given you LANSODOR in addition to other medicines for the treatment of Helycobacter pyloriinfection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatic diseases: please read the leaflet of these medicines carefully.
If you take LANSODOR 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 symptoms and circumstances whenever you see your doctor.

Other medicines and LANSODOR
Tell your doctor if you are taking or have recently taken any other medicines, including those without a prescription.
In particular, tell your doctor if you are taking medicines containing one of the following active substances, as LANSODOR can affect the way these medicines work:
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• 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).

LANSODOR with food and drink
To get the best results, you should take LANSODOR at least 30 minutes before eating food.

Pregnancy and breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
The use of LANSODOR is not recommended during pregnancy, as there is no adequate experience on the use of lansoprazole during pregnancy.
There is insufficient experience regarding the use of lansoprazole during breastfeeding. Based on studies in animals, it is believed that lansoprazole passes into breast milk.
When deciding whether to continue or stop breastfeeding or treatment with LANSODOR, the treating doctor will need to consider the benefits of breastfeeding for the child and the benefits of treatment with LANSODOR for you.

Driving and operating machinery
Undesirable effects such as dizziness, vertigo, fatigue and visual disturbances sometimes occur in patients taking LANSODOR. If you experience effects like these, you should be careful because your ability to concentrate may decrease.
You alone are responsible for deciding whether you are fit to drive a motor vehicle or perform other tasks that require increased concentration. The use of medicines is one of the factors that can reduce the ability to perform these actions safely, due to their effects or their side effects.
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.

Important information about some of the ingredients of LANSODOR
LANSODOR contains sucrose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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3. How to take LANSODOR

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 LANSODOR once a day, try to take it at the same time each day. You may
achieve better results if you take LANSODOR first thing in the morning.
If you take LANSODOR twice a day, you must take the first dose in the morning and the
second dose in the evening.
The dose of LANSODOR depends on your condition. The usual doses of LANSODOR for
adults are given 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 hard capsule for 4
weeks. If symptoms persist, you should tell your doctor. If
your symptoms are not relieved within 4 weeks, contact your doctor.

Treatment of duodenal ulcer: one 30 mg hard capsule per day for 2
weeks.

Treatment of stomach ulcer:one 30 mg hard capsule per day for 4
weeks.

Treatment of esophageal inflammation (reflux esophagitis):one 30 mg hard
capsule per day for 4 weeks.

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

Treatment ofHelicobacter pyloriinfection:the usual dose is one 30 mg hard
capsule in combination with two different antibiotics in the morning and one 30 mg hard
capsule in combination with two different antibiotics in the evening. The treatment will usually
take place every day for 7 days.
The recommended antibiotic combinations are:

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

If you are treating the infection because you have an ulcer, it is unlikely that the ulcer will 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.
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Treatment of duodenal or stomach ulcer in patients who require continuous treatment with NSAIDs:one 30 mg hard capsule per day for 4 weeks.

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

Zollinger-Ellison syndrome:the usual starting dose is two 30 mg hard capsules
per day, then it depends on your response to the dose of LANSODOR that your doctor decides
is most suitable for you.
LANSODOR should not be given to children.
Always take LANSODOR exactly as your doctor has told you. If you have any doubts
consult your doctor or pharmacist.

If you take more LANSODOR than you should
If you take more LANSODOR than you have been told, consult your doctor or go to the nearest
hospital as soon as possible.

If you forget to take LANSODOR
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 as normal. Do not take a double dose to make up for
the forgotten one.

If you stop taking LANSODOR
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 questions about using this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects are common (occur in more than 1 in 100 patients):

• headache, dizziness
• diarrhoea, constipation, stomach pain, feeling unwell, intestinal gas (flatulence), dry or inflamed mouth or throat
• skin rash, itching
• changes in liver function tests
• fatigue 5/8
• benign polyps in the stomach.

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

• depression
• joint or muscle pain
• water retention or swelling
• changes in red blood cell count

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

• 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
• tingling sensation on the skin (paresthesia), tremor
• anaemia (pallor)
• 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 should immediately see a doctor if you experience symptoms of angioedema such as swelling of the face, tongue or pharynx, difficulty swallowing, hives and difficulty breathing.

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

• 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, increased levels of cholesterol and triglycerides in the blood
• very severe skin reactions with redness, blisters, severe inflammation and loss of skin
• very rarely LANSODOR may 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, see your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). 6/8

If you take a proton pump inhibitor such as LANSODOR, 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.
Frequency not known:

• rash, possible joint pain, visual hallucinations.

If you take LANSODOR for more than three months, it is possible that your blood levels of magnesium may decrease. Low levels of magnesium can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, vertigo and increased heart rate. If you experience 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 regularly check magnesium levels in the blood.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your doctor or pharmacist. 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 LANSODOR

Do not store at a temperature above 25 ºC.
Store in the original package to protect from moisture.
Keep LANSODOR out of the sight and reach of children.
Do not use LANSODOR after the expiry date stated on the blister and the carton. The expiry
date refers to the last day of the month.
Medicines should not be disposed of via 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 LANSODOR contains

• The active ingredient is lansoprazole
• The other ingredients are:

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Capsule content:sugar spheres (sucrose and corn starch), sodium lauryl sulfate,
meglumine, mannitol (E421), hypromellose, macrogol, talc, polysorbate 80, titanium dioxide
(E171), acrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%

Capsule shell:gelatin, titanium dioxide (E171)

The 15 mg capsule shell also contains:quinoline yellow (E104)

Description of the appearance of LANSODOR and contents of the pack
The hard gastro-resistant capsules are available in blisters of 7, 14, 28, 56 or 98 capsules.

Marketing Authorisation Holder:
S.F. Group Srl
Via Tiburtina, 1143
00156 Rome –
Italy

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
under the following denominations:
LANSODOR, 15/30 mg hard gastro-resistant capsules
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