LANSOCEL 15 mg Enteric-Coated Hard Capsules

Зміст інструкції

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

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

Generic medicine

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

1. What is LANSOCEL and what is it used for

The active ingredient of LANSOCEL is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid your stomach produces.
Your doctor may prescribe LANSOCEL 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 prescribed LANSOCEL for another indication or with a different dosage than
medicinal product.

2. What you need to know before taking LANSOCEL

Do not take LANSOCEL:

• 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
Tell your doctor before taking LANSOCEL:
If you have ever had a skin reaction after treatment with a medicine similar to LANSOCEL
that reduces stomach acid.
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact
your doctor as soon as possible, as you may need to stop treatment with
LANSOCEL. Remember to also report any other undesirable effects such as joint pain.
Tell your doctor if you have a serious liver disease. Your doctor may need to adjust the dosage.
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 LANSOCEL, contact your doctor immediately,
as LANSOCEL has been associated with a small increase in infectious diarrhea.
If your doctor has prescribed LANSOCEL in addition to other medicines for the treatment
of Helycobacter pyloriinfection (antibiotics) or together with anti-inflammatory medicines for
these medicines.
If you take LANSOCEL for a long time (for more than 1 year) your doctor will probably keep you under
regular observation. You should report any new and exceptional symptom and circumstance each
time you see your doctor.
If you are taking a proton pump inhibitor such as LANSOCEL, 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 are to undergo a specific blood test (Chromogranin A).
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 LANSOCEL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor if you are taking medicines containing any of the following active substances,
as LANSOCEL can affect their mechanism of action:

• 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)

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant 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 occur
sometimes in patients taking LANSOCEL.
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, nurse or pharmacist.

Important information about some of the excipients of LANSOCEL
LANSOCEL contains sucrose. If your doctor has told you that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

3. How to take LANSOCEL

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 the capsules, your
doctor may advise an alternative way to take the medicine. Do not crush or chew
these capsules or the contents of the emptied capsules, because the medicine would not work
correctly.
If you take LANSOCEL once a day, try to take it always at the same time. You may obtain
better results if you take LANSOCEL first thing in the morning.
If you take LANSOCEL twice a day, you must take the first dose in the morning and the second
dose in the evening.
The dose of LANSOCEL depends on your condition. The usual doses of LANSOCEL for adults
are reported below. The doctor may sometimes prescribe a different dose and will tell you for 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 the symptoms persist you should tell your doctor. If the symptoms do not
improve within 4 weeks, contact your doctor.

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

Treatment of stomach 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 ofHelycobacter 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 LANSOCEL together with 250-500 mg of clarithromycin and 1,000 g of amoxicillin
30 mg of LANSOCEL 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 stomach ulcer in patients requiring continuous treatment with NSAIDs:one 30 mg capsule every day for 4 weeks.

Prevention of duodenal or stomach 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 capsules every day, then based on your response to LANSOCEL the doctor will decide the most suitable dose for you.

Use in children
The use of LANSOCEL is not recommended in children as clinical data are limited. Treatment of children under one year of age should be avoided as the available data have not
demonstrated benefit in the treatment of gastroesophageal reflux disease.
Take the medicine exactly as your doctor has told you. If you have doubts about how to take the
medicine you should consult your doctor.

If you take more LANSOCEL than you should
In case of accidental ingestion/intake of an excessive dose of LANSOCEL, immediately notify
your doctor or go to the nearest hospital.

If you forget to take LANSOCEL
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 normally. Do not take a double dose to make up for the forgotten capsule.

If you stop taking LANSOCEL
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, please consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are common (may affect more than 1 in 100 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

The following side effects are uncommon (may affect up to 1 in 100 people)

• depression
• joint and muscle pain
• fluid retention or swelling
• changes in red blood cell count
• fractures of the hip, wrist or spine (see section 2. BEFORE TAKING LANSOCEL).

The following side effects are rare (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
• tingling sensation on the skin (paresthesia), tremor
• anaemia (paleness)
• kidney problems
• pancreatitis
• inflammation of the liver (may be manifested 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.

The following side effects are very rare (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 LANSOCEL 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 severe deterioration of your general condition, or fever with symptoms of local infection such as an 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).

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

• low levels of magnesium in the blood
• visual hallucinations If you take LANSOCEL for more than three months, blood magnesium levels may decrease. Low magnesium levels can manifest with fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low magnesium levels can also lead to reduced blood levels of potassium or calcium. The doctor should decide whether to check magnesium levels in the blood periodically.
• erythema, possible joint pain

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 LANSOCEL

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. The
expiry date refers to the last day of that 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 LANSOCEL contains

• The active ingredient is lansoprazole
• The other ingredients are: Gastro-resistant granules: hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), acrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate (E-1505), sugar spheres, purified water. Capsule: gelatin, titanium dioxide (E171), black ink.

Description of the appearance of LANSOCEL and contents of the pack
Gastro-resistant hard capsules.
LANSOCEL 15 mg: white opaque hard capsule containing spherical microgranules of colour from
white to off-white.
LANSOCEL 30 mg: white opaque hard capsule containing spherical microgranules of colour from
white to off-white.
The capsules are packaged in blisters of 14, 28 and 56 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
TOWA PHARMACEUTICAL EUROPE S.L.
CALLE SANT MARTI’, 75-97, 08107 MARTORELLES, BARCELONA, SPAIN

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