Lansoprazole Doc Generici: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Equivalent medicinal product
Please read 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The active substance 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 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 gastric or duodenal 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 LANSOPRAZOLO DOC for another indication or at a dosage different from that stated in this patient information leaflet. Always follow your doctor's instructions for taking this medicine.

2. WHAT YOU SHOULD KNOW BEFORE TAKING LANSOPRAZOLE DOC

Do not take LANSOPRAZOLE 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 LANSOPRAZOLE DOC
Inform your doctor if you suffer from severe liver disease. Your doctor may need to
adjust the dosage.
Your doctor may have performed or may perform another examination called endoscopy to diagnose
your condition and/or exclude malignant tumours.
Contact your doctor immediately if you develop diarrhoea during treatment with
LANSOPRAZOLE DOC, as LANSOPRAZOLE DOC has been associated with a slight
increase in infectious diarrhoea.
If your doctor has prescribed LANSOPRAZOLE DOC in combination with other medicines
for the treatment of Helicobacter pylori infection (antibiotics) or together with
anti-inflammatory medicines for pain or rheumatic diseases: read carefully the package leaflet of these medicines as well.
If you take lansoprazole long-term (more than 1 year), your doctor will likely ask to see you regularly
for monitoring. You must report any new or unusual symptoms or circumstances at each visit.
Talk to your doctor or pharmacist before taking LANSOPRAZOLE DOC:

if you have ever had a skin reaction after treatment with a medicine similar to LANSOPRAZOLE DOC 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 discontinue
treatment with LANSOPRAZOLE DOC. Remember to also report any other adverse
reactions such as joint pain.
Other medicines and LANSOPRAZOLE DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking medicines containing any of the following
active substances, as LANSOPRAZOLE DOC may alter how these medicines work:

ketoconazole, itraconazole and 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 for heartburn or acid regurgitation)
sucralfate (used to heal ulcers)
St John's wort (Hypericum perforatum) (used to treat mild depression)

LANSOPRAZOLE DOC with food, drinks and alcohol
To achieve the best results with this medicine, take LANSOPRAZOLE DOC
at least 30 minutes before meals.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
The use of LANSOPRAZOLE DOC is not recommended during pregnancy
due to inadequate experience with lansoprazole use in pregnancy.
Experience with lansoprazole use during breastfeeding is insufficient. Based on
animal studies, lansoprazole is believed to pass into breast milk.
When deciding whether to continue or discontinue breastfeeding or treatment with
LANSOPRAZOLE DOC, your doctor will consider the benefits of breastfeeding for the child and the benefits of treatment with
LANSOPRAZOLE DOC for you.
Driving and using machines
Adverse effects such as dizziness, vertigo, fatigue, and visual disturbances may
occasionally occur in patients taking LANSOPRAZOLE DOC. If you experience
such adverse effects, you should be cautious, as your reaction ability may be impaired.
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 is 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 guidance.
If you have any doubts, consult your doctor, nurse, or pharmacist.
Important information about some excipients in LANSOPRAZOLE DOC
This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain 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 LANSOPRAZOLE DOC

Peelable blisters open as described, following the instructions for opening
the aluminum foil.

Remove one blister by breaking along the perforation line.
Carefully peel back the rear corner of the aluminum foil to reveal the capsule.

(THE CAPSULE CANNOT BE PUSHED THROUGH THE ALUMINUM
FOIL)

Two hands carefully opening a package or plastic wrapper to remove the internal contents

Non-peelable blisters are opened by pushing the capsule through the aluminum foil.
Swallow the capsules whole with a glass of water. Do not crush or chew the capsules or the contents of a capsule, as this would compromise their effectiveness.
If you take LANSOPRAZOLE DOC once daily, try to take it at the same time every day. You may achieve better results if you take LANSOPRAZOLE DOC first thing in the morning.
If you take LANSOPRAZOLE DOC twice daily, take the first dose in the morning and the second dose in the evening.

The dose of LANSOPRAZOLE DOC depends on your condition. The usual doses of LANSOPRAZOLE DOC for adults are listed below. Your doctor may sometimes prescribe a different dose and will inform you of the duration of treatment.

Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg capsule for 4 weeks. If symptoms persist, inform your doctor. If symptoms have not improved within 4 weeks, contact your doctor.
Treatment of duodenal ulcer: one 30 mg capsule daily for 2 weeks
Treatment of gastric ulcer: one 30 mg capsule daily for 4 weeks
Treatment of inflammation in the esophagus (reflux esophagitis): one 30 mg capsule daily for 4 weeks
Long-term prevention of reflux esophagitis: one 15 mg capsule daily; your doctor may adjust the dose up to one 30 mg capsule daily.
Treatment of Helicobacter pylori infection: 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. Treatment is usually given daily for 7 days.
The recommended antibiotic combinations are:

30 mg of LANSOPRAZOLE DOC with 250–500 mg clarithromycin and 1,000 mg amoxicillin
30 mg of LANSOPRAZOLE DOC with 250–500 mg clarithromycin and 400–500 mg metronidazole

If you are treating your infection due to an 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.
Treatment of duodenal or gastric ulcers in patients requiring continued NSAID therapy: one 30 mg capsule daily for 4 weeks.
Prevention of duodenal or gastric ulcers in patients requiring continued NSAID therapy: one 15 mg capsule daily; your doctor may adjust the dose to one 30 mg capsule daily.
Zollinger-Ellison syndrome: The usual starting dose is two 30 mg capsules daily. Your doctor may subsequently adjust the dose according to what he or she considers most appropriate based on your response to LANSOPRAZOLE DOC.

LANSOPRAZOLE DOC must not be administered to children.
Take this medicine exactly as directed by your doctor. If you have any doubts about how to take this medicine, consult your doctor.

If you take more LANSOPRAZOLE DOC than you should
If you take more LANSOPRAZOLE DOC than prescribed, contact your doctor immediately or contact a National Toxicology Information Center immediately.

If you forget to take LANSOPRAZOLE DOC
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten capsule.

If you stop taking LANSOPRAZOLE DOC
Do not stop treatment prematurely because your symptoms have improved. Your condition may not be fully 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 or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, LANSOPRAZOLE DOC may cause adverse effects,
although not everyone experiences them.

The following adverse 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 liver function test results
fatigue
benign gastric polyps

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

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

The following adverse effects are rare (may affect up to 1 in 1,000 people):

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
sensitivity to light
hair loss
tingling (paraesthesia), tremor
anaemia (pallor)
kidney problems
pancreatitis
liver inflammation (may present as yellowing of the skin or whites of the eyes)
breast enlargement in males, impotence
candidiasis (fungal infection, may affect the skin or mucous membranes)
angioedema; you must see a doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue or throat, difficulty swallowing, hives, or breathing difficulties.
taking a proton pump inhibitor such as LANSOPRAZOLE DOC, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

The following adverse effects are very rare (may affect up to 1 in 10,000 people):

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)
changes in blood levels of sodium, cholesterol and triglycerides
severe skin reactions with redness, blistering, severe inflammation and skin loss
very rarely, LANSOPRAZOLE DOC may cause a reduction in the number of white blood cells, leading to decreased resistance to infections. If you develop an infection with symptoms such as fever and severe worsening of your general health, or fever with signs of local infection such as sore throat/pharynx/mouth or urinary problems, you must see a doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis).

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

If you have been treated with LANSOPRAZOLE DOC 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, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
Erythema, possible joint pain
Visual hallucinations

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this
leaflet, consult your doctor or pharmacist. You can also report adverse effects
directly via the national reporting system at the following address:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-
avversa.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LANSOPRAZOLE DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the
carton. The expiry date refers to the last day of that month.
Peelable and non-peelable blisters OPA-Al-PVC/Alu
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help
protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What LANSOPRAZOLO DOC contains

The active substance 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 components are:
Capsule contents: Sugar granules (sucrose and maize 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 the contents of the pack
Lansoprazole 15 mg gastro-resistant hard capsules are available in blister packs containing 14 capsules (peelable or non-peelable OPA-Al-PVC/Alu)
Lansoprazole 30 mg gastro-resistant hard capsules are available in blister packs containing 14 capsules (peelable or non-peelable OPA-Al-PVC/Alu)

Marketing Authorization Holder and Manufacturer
The Marketing Authorization 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 authorized in the Member States of the European
Economic Area under the following names:
Denmark: Lansoprazol DOC
Italy: LANSOPRAZOLO DOC