LANSOPRAZOLO 15 mg Enteric-Coated Hard Capsule

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1. LANSOPRAZOLO DOC 15 mg hard gastro-resistant capsules, 30 mg hard gastro-resistant capsules
   1. WHAT IS LANSOPRAZOLO DOC AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING LANSOPRAZOLO DOC
   3. HOW TO TAKE LANSOPRAZOLO DOC
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE LANSOPRAZOLO DOC
   6. PACKAGE CONTENTS AND OTHER INFORMATION

LANSOPRAZOLO DOC 15 mg hard gastro-resistant capsules, 30 mg hard gastro-resistant capsules

Generic medicine

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

1. WHAT IS LANSOPRAZOLO DOC AND WHAT IS IT USED FOR

The active ingredient in LANSOPRAZOLO DOC is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by your stomach.
Your doctor may prescribe LANSOPRAZOLO DOC for the following indications:

• Treatment of ulcers in the stomach or duodenum
• Treatment of inflammation in the esophagus (reflux esophagitis)
• Prevention of reflux esophagitis
• Treatment of heartburn and acid regurgitation
• Treatment of infections caused by the bacterium Helicobacter pylori, when administered together with antibiotic therapy
• Treatment or prevention of stomach or duodenal 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 LANSOPRAZOLO DOC for another indication or with
consult your doctor to take the medicine.

2. WHAT YOU NEED TO KNOW BEFORE TAKING LANSOPRAZOLO DOC

Do not take LANSOPRAZOLO DOC:

• if you are allergic (hypersensitive) 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).

Take special care with LANSOPRAZOLO DOC
Tell your doctor if you suffer from a serious liver disease. Your doctor may need to
adjust the dosage.
Your doctor may have performed or is performing another examination called endoscopy to diagnose
your condition and/or exclude a malignant tumor.
Contact your doctor immediately if you experience diarrhoea during treatment with
LANSOPRAZOLO DOC as LANSOPRAZOLO DOC has been associated with a slight
increase in infectious diarrhoea.
If your doctor has prescribed LANSOPRAZOLO DOC in addition to other medicines
for the treatment of Helycobacter pyloriinfection (antibiotics) or together with
anti-inflammatory medicines to treat pain or rheumatic diseases: read
If you take lansoprazole for a long time (more than 1 year), your doctor will probably ask to see you regularly, so that they can monitor you. You should report any
new or unusual symptoms each time you see your doctor.
Ask your doctor or pharmacist before taking LANSOPRAZOLO DOC:

• if you have ever had a skin reaction after treatment with a medicine similar to LANSOPRAZOLO DOC that reduces stomach acid.
• if you are 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
therapy with LANSOPRAZOLO DOC. Remember to also report any other adverse effects such as joint pain.

Other medicines and LANSOPRAZOLO DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor if you are taking medicines containing any of the
following active substances, as LANSOPRAZOLO DOC may alter the way
these medicines work:

• ketoconazole, itraconazole and rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• theophylline (used for the treatment of asthma)
• tacrolimus (used to prevent transplant rejection)
• fluvoxamine (used to treat depression and other psychiatric disorders)
• antacids (used for heartburn or acid reflux)
• sucralfate (used to heal ulcers)
• St John's wort ( Hypericum perforatum) (used to treat mild depression)

LANSOPRAZOLO DOC with food, drinks and alcohol
To get the best results with this medicine you should take LANSOPRAZOLO
DOC at least 30 minutes before meals.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
The use of LANSOPRAZOLO DOC is not recommended during pregnancy
as there is inadequate experience regarding the use of lansoprazole during pregnancy.
Experience with the use of lansoprazole during breastfeeding is insufficient. Based on
results from animal studies, it is believed that lansoprazole passes into breast milk.
When deciding whether to continue or discontinue breastfeeding or therapy with
LANSOPRAZOLO DOC, the treating doctor will consider the benefits
of breastfeeding for the child and the benefits of therapy with
LANSOPRAZOLO DOC for you.

Driving and using machines
Adverse effects such as dizziness, vertigo, fatigue and visual disturbances can
sometimes occur in patients taking LANSOPRAZOLO DOC. If you experience
adverse effects like these, you should be careful as your reaction ability
may be reduced.
You alone are responsible for deciding whether you are fit to drive a motor vehicle or to 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 sections.
Read all the information contained in this leaflet as a guide.
If you have any doubts, consult your doctor, nurse or pharmacist.

Important information about some of the excipients of LANSOPRAZOLO DOC
This medicine contains sucrose. If you have been told by your doctor that you suffer from
intolerance to some sugars, consult your doctor 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 DOC

The peelable blisters are opened as described following the instructions for opening the aluminum packaging.

• Remove a blister by breaking along the perforation line.
• Carefully peel back the rear corner of the aluminum packaging to reveal the capsule.

(THE CAPSULE CANNOT BE PRESSED THROUGH THE ALUMINUM PACKAGING)

Non-peelable blisters are opened by pressing through the aluminum foil.
The capsules should be swallowed whole with a glass of water. Do not crush or
chew the capsules or their contents, as this would compromise their
effectiveness.
If you take LANSOPRAZOLO DOC once a day, try to take it at the
same time each day. You may get better results if you take LANSOPRAZOLO DOC first
thing in the morning.
If you take LANSOPRAZOLO DOC twice a day, you must take the first dose in the
morning and the second dose in the evening.
The dose of LANSOPRAZOLO DOC depends on your condition. The usual doses of
LANSOPRAZOLO DOC for adults are provided below. Sometimes your doctor
may 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 symptoms persist, you should inform your doctor. If your symptoms
have not improved within 4 weeks, contact your doctor.

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

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

Treatment of inflammation of the esophagus (reflux esophagitis):one capsule of
30 mg per 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 1 capsule of 30 mg in
combination with two different antibiotics in the evening. The treatment will usually
take place every day for 7 days.
The recommended combinations of antibiotics are:

• 30 mg of LANSOPRAZOLO DOC with 250-500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg of LANSOPRAZOLO DOC with 250-500 mg clarithromycin and 400-500 mg metronidazole

If you are treating your infection because you have an ulcer, it is unlikely that this ulcer will
recur if the infection is successfully treated. To get the best
results from this therapy, take the medicine at the scheduled times and never forget
a dose.
Treatment of duodenal or gastric ulcers in patients requiring
continued treatment with NSAIDs:one 30 mg capsule every day for 4 weeks.

Prevention of duodenal or gastric ulcers in patients requiring
continued treatment with NSAIDs:one 15 mg capsule every day, the doctor may
adjust the dose to one 30 mg capsule every day.

Zollinger-Ellison syndrome:The usual starting dose is 2 capsules of 30 mg per
day. The doctor may then adjust the dose to what they decide is most
suitable for you based on your response to LANSOPRAZOLO DOC.
LANSOPRAZOLO DOC should not be administered to children.
Take this medicine following the instructions of your doctor exactly. If you
have any doubts about how to take this medicine, consult your doctor.

If you take more LANSOPRAZOLO DOC than you should
If you take a quantity of LANSOPRAZOLO DOC greater than that which has been
prescribed to you, contact your doctor immediately or contact an immediate National
Toxicological Information Center.

If you forget to take LANSOPRAZOLO DOC
If you forget to take a dose, take it as soon as you remember, unless it
is time for the next dose. If this happens, skip the missed dose and continue to
take the remaining capsules as prescribed. Do not take a double dose to
make up for the forgotten capsule.

If you stop the treatment with LANSOPRAZOLO DOC
Do not stop the treatment prematurely because your symptoms have
improved. Your condition may not be fully cured 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, LANSOPRAZOLO DOC can cause side effects
although not everybody gets them.
The following side effects are common (may affect up to 1 in 10 people)

• headache, dizziness
• diarrhoea, constipation, stomach pain, nausea or vomiting, flatulence, dry or inflamed mouth or throat.
• skin rash, itching
• changes in the values of liver function tests
• tiredness
• benign polyps in the stomach.

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

• depression
• muscle or joint pain
• fluid retention or swelling
• changes in blood cell counts.

The following side effects are rare (may affect up to 1 in 1000)

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
• change in the sense of taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or tingling under the skin, bruising, redness and excessive sweating
• sensitivity to light
• hair loss
• tingling (paresthesia), tremor
• anaemia (pallor)
• kidney problems
• pancreatitis
• inflammation of the liver (may appear as yellowing of the skin or whites of the eyes)
• enlargement of the male breast, 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.
• taking a proton pump inhibitor such as LANSOPRAZOLO DOC, especially for a period of time longer than one year, may slightly increase the risk of fracture of the hip, wrist or spine. Tell your doctor if you suffer from osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

The following side effects are very rare (may affect up to 1 in

• 10,000)
• severe hypersensitivity reactions including shock. Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a drop in blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• alterations in the values of sodium, cholesterol and triglyceride levels
• severe skin reactions with redness, blistering, severe inflammation and loss of skin.
• very rarely LANSOPRAZOLO DOC may cause a reduction in the number of white blood cells leading to a decrease in resistance to infections. If an infection occurs with symptoms such as fever and a severe worsening of your general health condition, or fever with symptoms of local infection such as sore throat/pharynx/mouth or urinary problems, you should immediately see a doctor. You will be given a blood test to check for a possible reduction in white blood cells (agranulocytosis).

Frequency not known (frequency cannot be estimated on the basis of available data)

• If you are being treated with LANSOPRAZOLO DOC for more than three months, it is possible that the levels of magnesium in your blood may decrease. Low levels of magnesium can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness and increased heart rate. If you experience any of these symptoms, tell your doctor immediately. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to check magnesium levels.
• Erythema, possible joint pain
• Visual hallucinations

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 system at
http://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 LANSOPRAZOLO DOC

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 on the
cardboard box. The expiry date refers to the last day of that month.
Peelable and non-peelable OPA- Al-PVC/Alu blister
Do not store at a temperature above 30°C
Store in the original package to protect from humidity.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to eliminate medicines that you no longer use. This will help to protect
the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What LANSOPRAZOLO DOC contains

• The active ingredient is lansoprazole LANSOPRAZOLO DOC 15 mg gastro-resistant hard capsules are opaque capsules with yellow body and cap. Each capsule contains 15 mg of lansoprazole LANSOPRAZOLO DOC 30 mg gastro-resistant hard capsules are opaque capsules with white body and cap. Each capsule contains 30 mg of lansoprazole
• The other ingredients are: Capsule contents:Sugar granules (sucrose and corn starch), sodium lauryl sulfate, meglumine, mannitol (E421), hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide (E171), methacrylic acid - ethyl acrylate copolymer (1:1), 30% dispersion Capsule shell:Gelatin, titanium dioxide (E171) The 15 mg capsule shell also contains:Quinoline yellow (E104)

Description of the appearance of LANSOPRAZOLO DOC and package contents
Lansoprazole 15 mg gastro-resistant hard capsules are available in blister packs
containing 14 capsules (peelable or non-peelable OPA- Al-PVC/Alu blister)
Lansoprazole 30 mg gastro-resistant hard capsules are available in blister packs
containing 14 capsules (peelable or non-peelable OPA- Al-PVC/Alu blister)

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Doc Generici S.r.l.
Via Turati, 40
20121 Milan
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:
Denmark Lansoprazol DOC
Italy LANSOPRAZOLO DOC