ERMES 15 mg Hard Capsule

Зміст інструкції

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

Ermes 15 mg hard capsules, 30 mg hard capsules

Lansoprazole

EQUIVALENT 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 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 Ermes is and what it is used for
• 2. What you need to know before you take Ermes
• 3. How to take Ermes
• 4. Possible side effects
• 5. How to store Ermes
• 6. Contents of the pack and other information

1. What Ermes is and what it is used for

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

2. What you need to know before taking Ermes

Do not take Ermes:

• if you are allergic (hypersensitive) 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
Talk to your doctor or pharmacist before taking Ermes:

• if you have ever had a skin reaction after treatment with a medicine similar to Ermes that reduces stomach acid.
• 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 Ermes.
Also remember to report any other unwanted 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 rule out a malignant disease.
If you experience diarrhea while taking Ermes, contact your doctor immediately, as
Ermes has been associated with a small increase in infectious diarrhea.
If your doctor has prescribed Ermes in addition to other medicines for the treatment of infection by

Helycobacter pylori(antibiotics) or together with anti-inflammatory medicines to treat pain or
If you take Ermes 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 each
time you see your doctor.
If you are taking a proton pump inhibitor such as ERMES, 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.
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. It is necessary
to report these signs to your treating doctor.

Other medicines and Ermes
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 if you are taking medicines containing one of the following active
substances, as Ermes 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)

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

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, suspect you are pregnant or are planning to become pregnant, 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 Ermes.
If you experience undesirable 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.

Ermes contains sucrose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take Ermes

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 emptied capsules, because the medicine would not work
correctly.
If you take Ermes once a day, try to take it at the same time each day. You may get
better results if you take Ermes first thing in the morning.
If you take Ermes twice a day, you must take the first dose in the morning and the second dose in the
evening.
The dose of Ermes depends on your condition. The usual doses of Ermes 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 each day for 4 weeks. If symptoms persist you should tell your doctor. If symptoms do not
improve within 4 weeks, contact your doctor

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

Treatment of stomach ulcer:one 30 mg capsule each day for 4 weeks

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

Long-term prevention of reflux esophagitis:one 15 mg capsule each day, the
doctor may adjust the dose up to one 30 mg capsule each 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 Ermes together with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin
30 mg of Ermes 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 no longer
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 each day for 4 weeks.

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

Zollinger-Ellison syndrome:the usual initial dose is two 30 mg capsules each day, then
based on your response to Ermes the doctor will decide the most appropriate dose for you.
Use in children:
The use of Ermes is not recommended in children because clinical data are limited.
Treatment of children under one year of age should be avoided as available data have not shown beneficial effects in the treatment of gastro-
esophageal reflux disease.

If you take more Ermes than you should
If you take more Ermes than you have been told, ask your doctor for advice immediately. In case of
accidental ingestion/intake of an excessive dose of Ermes, immediately notify
your doctor or go to the nearest hospital.

If you forget to take Ermes
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 Ermes
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 Ermes, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ermes 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, intestinal gas (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. If you take a proton pump inhibitor like Ermes, especially for a period longer than one year, there may be a slight increase in the risk of hip, wrist or spine fractures. If you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis) consult your doctor.

The following side effects are rare (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 (pallor)
• 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 should immediately go to the doctor if you experience symptoms of angioedema such as swelling of the face, tongue or pharynx, difficulty swallowing, urticaria 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 loss of skin
• very rarely Ermes 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 severe deterioration of your general condition, or fever with symptoms of local infection such as inflamed throat/pharynx/mouth or urinary problems, go to your doctor immediately. You will be given a blood test to check for a possible reduction in white blood cells (agranulocytosis).

Frequency not known:

• hypomagnesaemia If you take ERMES for more than three months, your blood magnesium levels may decrease. Low magnesium levels 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 magnesium levels can also lead to a decrease in blood potassium or calcium levels. The doctor should decide whether to periodically check magnesium levels in the blood.
• erythema, possible 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
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . Reporting side
effects helps to provide more information on the safety of this medicine.

5. How to store Ermes

Keep this medicine out of sight and reach of children.
Do not use Ermes after the expiry date which is reported on the blister and on the package. The expiry
date refers to the last day of the month.
Do not store at a temperature above 30°C.
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 Ermes contains

• The active ingredient is lansoprazole
• The excipients 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 Ermes and contents of the pack
Hard capsules containing gastro-resistant granules
Ermes 15 mg hard capsules: Packs of 14 and 28 capsules
Ermes 30 mg hard capsules: Packs of 14 and 28 capsules
Not all pack sizes may be marketed

Marketing Authorisation Holder
LANOVA FARMACEUTICI S.r.l.
Via Conca D’oro, 212 – 00141 Roma

The manufacturer is:
Laboratorios Salvat, S.A. – C/Gall 30-36 – Esplugues del Llobregat - Barcelona (Spain)
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR) (Italy)