LANSOPRAZOLO 15 mg Enteric-Coated Hard Capsules

Зміст інструкції

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

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

1. What is Lansoprazolo ABC and what it is used for

The active ingredient of Lansoprazolo ABC is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach produces.
Your doctor may prescribe Lansoprazolo ABC 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 NSAIDs (non-steroidal anti-inflammatory drugs used against pain and inflammation)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed Lansoprazolo ABC for another indication or with a different dosage than
See your doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before taking Lansoprazolo ABC

Do not take Lansoprazolo ABC
If you are allergic to lansoprazole or to any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Tell your doctor if you have a severe liver disease. Your doctor may need to adjust the dosage.
Your doctor may have performed or will perform a further examination called an endoscopy to diagnose your
condition and/or exclude a malignant disease.
If you experience diarrhea during treatment with Lansoprazolo ABC, contact your doctor immediately,
because Lansoprazolo ABC has been associated with a small increase in infectious diarrhea.
If your doctor has prescribed Lansoprazolo ABC in addition to other medicines for the treatment of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory medicines to treat pain or diseases
If you are taking a proton pump inhibitor such as Lansoprazolo ABC, 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. Consult your doctor if you suffer from osteoporosis (reduced bone density) or if your doctor tells you that you are at
risk of osteoporosis (for example if you are taking corticosteroids).
If you take Lansoprazolo ABC 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.
Talk to 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. Like all acid-reducing agents, lansoprazole can 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, contact your doctor as soon as possible, as it may be necessary to stop therapy with Lansoprazolo ABC. Remember to report any other unwanted effects such as joint pain.

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 treating physician.

Other medicines and Lansoprazolo ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
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 ABC can 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 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 ABC with food and drink
To obtain the best results, you should take Lansoprazolo ABC with a glass of water at least 30 minutes
before taking food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are 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 sometimes occur in
patients taking Lansoprazolo ABC.
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 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 ABC 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 ABC

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask 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 capsules or the
contents of emptied capsules, because the medicine would not work correctly.
If you take Lansoprazolo ABC once a day, try to take it at the same time each day. You may get
better results if you take Lansoprazolo ABC first thing in the morning.
If you take Lansoprazolo ABC twice a day, you must take the first dose in the morning and the second dose
in the evening.
The dose of Lansoprazolo ABC depends on your condition. The usual doses of Lansoprazolo ABC for
adults are reported 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 capsule every
day for 4 weeks. If 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, your 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 ABC together with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin
30 mg of Lansoprazolo ABC 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 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 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, your doctor may adjust the dosage up to one
30 mg capsule every day.

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

Use in children
Lansoprazolo ABC should not be given to children.

If you take more Lansoprazolo ABC than you should
If you take more Lansoprazolo ABC than you have been told, ask for advice from your doctor immediately.

If you forget to take Lansoprazolo ABC
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 ABC
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, intestinal gas (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 blood cell counts
• Rare side effects (may affect up to 1 in 1,000 people):
• fever
• restlessness, drowsiness, confusion, hallucinations, 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 occur with yellowing of the skin or eyes)
• breast enlargement 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 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 skin loss
• very rarely Lansoprazolo ABC may 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 ABC 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, seizures, dizziness and increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to a decrease in blood levels of potassium or calcium. The doctor should decide whether to periodically 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
• skin rash, 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 ABC

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 blister and the outer packaging after “Exp.”.
The expiry date refers to the last day of the month.
Do not store at a temperature above 25 °C.
Store in the original packaging.
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 ABC contains
Lansoprazolo ABC 15 mg gastro-resistant hard capsules
The active ingredient is lansoprazole. Each hard capsule contains 15 mg of lansoprazole.
The other ingredients are:

Gastro-resistant granules: hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), copolymer
of methacrylic acid-ethyl acrylate (1:1) dispersion 30%, triethyl citrate (E-1505), sucrose and corn
starch spheres, purified water.

Capsule: gelatin, titanium dioxide (E-171), black ink.
Lansoprazolo ABC 30 mg gastro-resistant hard capsules
The active ingredient is lansoprazole. Each hard capsule contains 30 mg of lansoprazole.
The other ingredients are:

Gastro-resistant granules: hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), copolymer
of methacrylic acid-ethyl acrylate (1:1) dispersion 30%, triethyl citrate (E-1505), sucrose and corn
starch spheres, purified water.

Capsule: gelatin, titanium dioxide (E-171), black ink.

Description of the appearance of Lansoprazolo ABC and contents of the pack
Hard capsules containing gastro-resistant granules.
Packs of 14 and 28 hard capsules of 15 mg and 30 mg in blisters.
Packs of 14 and 28 hard capsules of 15 mg and 30 mg in a container.

Marketing Authorisation Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Torino (Italy)

Manufacturer
Towa Pharmaceutical Europe, S.L.
C/de San Martì, 75-97, Martorelles, 08107
Barcelona, Spain