Package Leaflet: Information for the User

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

Lansoprazole
Generic medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What LANSODOR is and what it is used for
What you need to know before taking LANSODOR
How to take LANSODOR
Possible side effects
How to store LANSODOR
Contents of the pack and other information

1. What LANSODOR is and what it is used for

The active substance in LANSODOR is lansoprazole, a proton pump inhibitor.
Proton pump inhibitors reduce the amount of acid produced in your stomach.
Your doctor may prescribe LANSODOR for the following conditions:

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 given 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 LANSODOR for a different indication or at a dosage different from that stated in this leaflet. Follow your doctor's instructions when taking this 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 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 before taking LANSODOR:

if you have ever had a skin reaction after treatment with a medicine similar to LANSODOR 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 stop treatment with LANSODOR. Remember to also report any other adverse effects such as joint pain.
Inform your doctor if you have severe liver disease. Your doctor may need to adjust the dose.
Your doctor may perform or may have already performed an additional examination called endoscopy to diagnose your condition and/or rule out malignant disease.
If you develop diarrhoea during treatment with LANSODOR, contact your doctor immediately, as LANSODOR has been associated with a small increased risk of infectious diarrhoea.
If your doctor has prescribed LANSODOR 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: please read carefully the package leaflets of these medicines as well.
If you take LANSODOR 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.

Other medicines and LANSODOR
Inform 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 any of the following active substances, as LANSODOR 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 regurgitation)
sucralfate (used to heal ulcers)
St. John’s wort (Hypericum perforatum) (used to treat mild depression)

LANSODOR with food and drinks
To achieve the best results, you must take LANSODOR at least 30 minutes before eating.

Pregnancy, 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 inadequate experience regarding the use of lansoprazole in pregnant women.
There is insufficient experience regarding the use of lansoprazole during breastfeeding. Based on results from animal studies, lansoprazole is considered to pass into breast milk.
When deciding whether to continue or discontinue breastfeeding or treatment with LANSODOR, your doctor will consider the benefits of breastfeeding for the child and the benefits of treatment with LANSODOR for you.

Driving and using machines
Adverse effects such as dizziness, vertigo, fatigue and visual disturbances may occasionally occur in patients taking LANSODOR. If you experience such adverse effects, you should be cautious, as your ability to concentrate may be reduced.
Only you are responsible for deciding whether you are fit to drive a motor vehicle or perform other tasks requiring increased concentration. The use of medicines represents one of the factors that may reduce your ability to perform these activities 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 unsure about anything, 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 certain 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 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 LANSODOR once daily, try to take it at the same time every day. You may achieve
better results if you take LANSODOR first thing in the morning.
If you take LANSODOR twice daily, you should 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 listed below. Your doctor may sometimes prescribe a different dose and will inform you how long the treatment should last.
Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg hard 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 hard capsule daily for 2 weeks.
Treatment of gastric ulcer: one 30 mg hard capsule daily for 4 weeks.
Treatment of inflammation of the oesophagus (reflux oesophagitis): one 30 mg hard capsule daily for 4 weeks.
Long-term prevention of reflux oesophagitis: one 15 mg hard capsule daily; your doctor may adjust the dose up to one 30 mg hard capsule daily.
Treatment of Helicobacter pylori infection: 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. Treatment is usually given daily for 7 days.
The recommended antibiotic combinations are:

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

If you are treating the infection due to a peptic 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 never miss a dose.
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Treatment of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: one 30 mg hard capsule daily for 4 weeks.
Prevention of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: one 15 mg hard capsule daily; your doctor may adjust the dose up to one 30 mg hard capsule daily.
Zollinger-Ellison syndrome: the usual starting dose is two 30 mg hard capsules daily; thereafter, the dose will depend on your response to LANSODOR, as determined by your doctor.
LANSODOR must not be given to children.
Always take LANSODOR exactly as your doctor has instructed 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 prescribed, 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 almost time for the next dose. In that case, do not take the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.
If you stop taking LANSODOR
Do not stop treatment prematurely, even if your symptoms have improved. Your condition may not be completely healed and may recur if you do not complete the full course of treatment.
If you have any questions about the use of this medicine, consult your doctor.

4. Possible side effects

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

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

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

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

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

fever
restlessness, drowsiness, confusion, hallucinations, insomnia, visual 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 difficulty breathing.

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

severe hypersensitivity reactions including shock. Symptoms of hypersensitivity reactions 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, increased levels of cholesterol and triglycerides in the blood
very severe skin reactions with redness, blistering, serious inflammation and skin loss
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 a 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). 6/8

If you are taking a proton pump inhibitor such as LANSODOR, 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 have osteoporosis or are taking
corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
Frequency not known:

erythema, possible joint pain, visual hallucinations.

If you take LANSODOR for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor should decide whether regular monitoring of blood magnesium levels is necessary.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
talk to your doctor or pharmacist. 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.
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5. How to store LANSODOR

Do not store above 25 °C.
Keep in the original packaging 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 must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What LANSODOR contains

The active substance is lansoprazole.
The other components are:

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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 (1:1) dispersion 30%
Capsule shell: gelatin, titanium dioxide (E171)
The 15 mg capsule shell additionally contains: quinoline yellow (E104)
Description of the appearance of LANSODOR and package contents
Gastro-resistant hard capsules are available in blisters of 7, 14, 28, 56 or 98 capsules.
Marketing Authorization 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 authorized in the Member States of the European Economic Area
under the following names:
LANSODOR, 15/30 mg gastro-resistant hard capsules
This Patient Information Leaflet was last updated on
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