LANSOPRAZOLO 15 mg Капсулы Твердые

Содержание инструкции

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

Lansoprazolo Almus 15 mg hard capsules, 30 mg hard capsules

Generic medicine

Read this leaflet carefully before taking this medicine as 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 they have the same symptoms as you, as it may 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 Lansoprazolo Almus is and what it is used for
• 2. What you need to know before you take Lansoprazolo Almus
• 3. How to take Lansoprazolo Almus
• 4. Possible side effects
• 5. How to store Lansoprazolo Almus
• 6. Contents of the pack and other information

1. What is LANSOPRAZOLO ALMUS and what it is used for

The active substance of LANSOPRAZOLO ALMUS is lansoprazole, which is a proton pump inhibitor.
Proton pump inhibitors reduce the amount of acid your stomach produces.
Your doctor may prescribe LANSOPRAZOLO ALMUS for the following indications in adults:

• 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 Helicobacter pyloriwhen administered in combination with antibiotic therapy
• Treatment or prevention of duodenal or stomach ulcers in patients who require continuous treatment with drugs used against pain or inflammation (non-steroidal anti-inflammatory drugs - NSAIDs)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed LANSOPRAZOLO ALMUS for another indication or with a different dosage
than the one described in this leaflet.
Consult your doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before you take LANSOPRAZOLO ALMUS

Do not take LANSOPRAZOLO ALMUS:

• if you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
During the intake of lansoprazole, inflammation of the kidneys may occur. Signs and symptoms
may include a decrease in urine volume or blood in the urine and/or hypersensitivity reactions such as
fever, rash and joint stiffness. You should report these signs to your
doctor.
Tell your doctor if you have a severe liver disease. The doctor may need to adjust the dosage.
The doctor may perform or have performed a further examination called endoscopy to
diagnose your condition and/or exclude a malignant disease.
If you experience diarrhoea during treatment with LANSOPRAZOLO ALMUS, contact your
doctor immediately, as LANSOPRAZOLO ALMUS has been associated with a small increase in infectious
diarrhoea.
If your doctor has prescribed LANSOPRAZOLO ALMUS in addition to other medicines for the treatment
of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory medicines for
of these medicines.
If you take a proton pump inhibitor such as LANSOPRAZOLO ALMUS, 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. Tell your doctor if you suffer from osteoporosis (reduced
bone density) or if your doctor tells you that you are at risk of osteoporosis (e.g. if you are
taking steroids).
If you take LANSOPRAZOLO ALMUS 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.
Consult your doctor before taking lansoprazole:

• If you have low levels of vitamin B12 or have risk factors for low levels of vitamin B12 and are receiving long-term treatment with lansoprazole. As with all acid-reducing agents, lansoprazole may lead to reduced absorption of vitamin B12.
• If you are to undergo a specific blood test (Chromogranin A).
• If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole that reduces gastric acidity.

If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult
your doctor as soon as possible, as it may be necessary to stop therapy with
lansoprazole. Remember to also report any other undesirable effects such as joint pain.

Other medicines and LANSOPRAZOLO ALMUS
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, even those available without a prescription.
In particular, tell your doctor or pharmacist if you are taking medicines containing one of the
following active ingredients, as LANSOPRAZOLO ALMUS may affect their mechanism
of action:

• HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV)
• methotrexate (used to treat autoimmune diseases and cancer)
• ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• warfarin (used to treat blood clots)
• 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)

LANSOPRAZOLO ALMUS with food and drink
To get the best results you should take LANSOPRAZOLO ALMUS at least 30 minutes before
taking food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Undesirable effects such as dizziness, vertigo, fatigue and visual disturbances sometimes occur in
patients taking LANSOPRAZOLO ALMUS.
If you experience effects like these, you should be careful because your ability to
pay attention 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
represents one of the factors that can reduce the ability to perform these actions safely, due to
their effects or 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 or pharmacist.

LANSOPRAZOLO ALMUS contains sucrose and sodium
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed you with an
intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially
‘sodium-free’.

3. How to take LANSOPRAZOLO ALMUS

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water. If you find it difficult to swallow hard capsules, your
doctor may advise an alternative way to take the medicine. Do not crush or chew
these hard capsules or the contents of the emptied hard capsules, because the medicine will not
work correctly.
If you take LANSOPRAZOLO ALMUS once a day, try to take it at the same time each day.
You may get better results if you take LANSOPRAZOLO ALMUS first thing in the morning.
If you take LANSOPRAZOLO ALMUS twice a day, you must take the first dose in the morning and the
second dose in the evening.
The dose of LANSOPRAZOLO ALMUS depends on your condition. The usual doses of LANSOPRAZOLO
ALMUS for adults are reported below. Your doctor may sometimes prescribe a different dose and will
tell you how long the treatment should last.

Treatment of heartburn and acid reflux:one 15 mg or 30 mg capsule
for 4 weeks. If the symptoms are not relieved within 4 weeks, contact your doctor.

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

Treatment of gastric ulcer:one 30 mg capsule every day for 4 weeks.

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

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

Treatment ofHelicobacter pyloriinfection: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. The treatment will be every day for 7 days.
The recommended antibiotic combinations are:
30 mg of LANSOPRAZOLO ALMUS together with 250-500 mg of clarithromycin and 1,000 mg of
amoxicillin
30 mg of LANSOPRAZOLO ALMUS together with 250 mg of clarithromycin and 400-500 mg of
metronidazole
If you are treating your infection because you have an ulcer, it is likely that the ulcer will not recur
if the infection is treated successfully. To get 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 continuous treatment with NSAIDs:one 30 mg capsule every day for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs:one 15 mg capsule every day, the doctor may adjust the dosage up to
one 30 mg capsule every day.

Zollinger-Ellison syndrome:the usual initial dose is two 30 mg hard capsules every day, then
based on your response to LANSOPRAZOLO ALMUS the doctor will decide the most suitable dose for you.

Use in children
LANSOPRAZOLO ALMUS should not be given to children.

If you take more LANSOPRAZOLO ALMUS than you should
If you take more LANSOPRAZOLO ALMUS than you have been told, ask your doctor for advice immediately.

If you forget to take LANSOPRAZOLO ALMUS
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 hard capsules normally. Do not take a double dose to make up for the
forgotten capsule.

If you stop taking LANSOPRAZOLO ALMUS
Do not stop taking the treatment prematurely if your symptoms have improved. Your
condition may not be completely healed and may recur if you do not complete the
treatment period.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• headache, dizziness
• diarrhoea, constipation, stomach pain, feeling unwell, flatulence, dry or inflamed 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 and muscle pain
• fluid retention or swelling
• changes in red blood cell count

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

• fever
• restlessness, drowsiness, confusion, hallucination, insomnia, vision disturbances, vertigo
• change in 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 (paleness)
• kidney problems
• pancreatitis
• inflammation of the liver (may be indicated by yellowing of the skin or eyes)
• breast enlargement in men, impotence
• candidiasis (fungal infection, can 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 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)
• inflammation of the colon (colitis)
• 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 ALMUS can cause a reduction in the number of white blood cells and resistance to infections may therefore decrease. If you develop an infection with symptoms such as fever and a severe deterioration in your general condition, or fever with symptoms of local infection such as an inflamed throat/pharynx/mouth or urinary problems, see your 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 available data)

• if you take LANSOPRAZOLO ALMUS for more than three months, it is possible that blood levels of magnesium may decrease. Low levels of magnesium 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 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
• low levels of sodium in the blood. Common symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, muscle weakness or spasms, irritability, seizures, coma
• erythema, possibly associated with joint pain
• visual hallucinations

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system at https://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 ALMUS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LANSOPRAZOLO ALMUS contains
LANSOPRAZOLO ALMUS 15 mg hard capsules

• The active substance is lansoprazole. Each hard capsule contains 15 mg of lansoprazole.
• The other ingredients are sucrose and corn starch spheres, heavy magnesium carbonate, hypromellose, polysorbate 80, macrogol 6000, triethyl citrate, talc, titanium dioxide (E171), acrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (Eudragit L30 D-55), sodium hydroxide.
• Capsule components: gelatin, titanium dioxide (E171), erythrosine (E127), red iron oxide (E172).

LANSOPRAZOLO ALMUS 30 mg hard capsules

• The active substance is lansoprazole. Each hard capsule contains 30 mg of lansoprazole.
• The other ingredients are sucrose and corn starch spheres, heavy magnesium carbonate, hypromellose, polysorbate 80, macrogol 6000, triethyl citrate, talc, titanium dioxide (E171), acrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (Eudragit L30 D-55), sodium hydroxide.
• Capsule components: gelatin, titanium dioxide (E171), erythrosine (E127), red iron oxide (E172).

Description of the appearance of LANSOPRAZOLO ALMUS and contents of the pack
Blisters of 14 and 28 hard capsules.

Marketing Authorisation Holder
Almus S.r.l. – Via Cesarea, 11/10 – 16121 Genova – Italy

Manufacturer
Laboratorios Salvat, S.A. – C/Gall 30-36 Esplugues del Llobregat, Barcelona – Spain