IBIMEZOLO 20 mg Kapsułka Twarda Powlekana

Treść ulotki

1. Ibimezolo 20 mg hard gastro-resistant capsules
   1. What is Ibimezolo and what is it used for
   2. What you need to know before taking Ibimezolo
   3. How to take Ibimezolo
   4. Possible side effects
   5. How to store Ibimezolo
   6. Contents of the pack and other information

Ibimezolo 20 mg hard gastro-resistant capsules

Omeprazole
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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What Ibimezolo is and what it is used for
• 2. What you need to know before you take Ibimezolo
• 3. How to take Ibimezolo
• 4. Possible side effects
• 5. How to store Ibimezolo
• 6. Contents of the pack and other information

1. What is Ibimezolo and what is it used for

Ibimezolo contains the active ingredient omeprazole and belongs to a group of medicines called “proton pump inhibitors”, which reduce the amount of acid produced by the stomach.
Ibimezolo is used for the treatment of the following diseases:

In adults:

• gastro-oesophageal reflux disease (GERD). This disease occurs when acid leaks from the stomach and passes into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn;
• ulcers (lesions) in the upper part of the intestine (duodenal ulcer) or of the stomach (gastric ulcer);
• ulcers infected by a bacterium called “ Helicobacter pylori”. If you suffer from this disease, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal;
• ulcers caused by medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Ibimezolo can also be used to prevent the formation of ulcers if you are taking NSAIDs (non-steroidal anti-inflammatory drugs);
• excessive acid in the stomach caused by an increase in tissue in the pancreas (Zollinger-Ellison syndrome).

In children:
Children over 1 year of age and weighing 10 kg or more

• gastro-oesophageal reflux disease (GERD). This disease occurs when acid leaks from the stomach and passes into the oesophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn. In children, the symptoms of this disease also include the return of stomach contents into the mouth (regurgitation), discomfort (vomiting) and poor weight gain.

Children over 4 years of age and adolescents

• Ulcers infected by a bacterium called “Helicobacter pylori”.If the child suffers from this disease, the

doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal
.

2. What you need to know before taking Ibimezolo

Do not take Ibimezolo

• if you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to medicines that, like Ibimezolo, contain other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole);
• if you are taking a medicine containing nelfinavir (used for HIV infections) (see “Other medicines and Ibimezolo”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ibimezolo.

• if you have ever had a skin reaction after treatment with a medicine similar to Ibimezolo that reduces stomach acid.
• if you are going 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 you may need to stop treatment with Ibimezolo. Remember to
also report any other undesirable effects such as joint pain.
Ibimezolo can mask the symptoms of other diseases. Therefore, if you experience the symptoms described below
before taking Ibimezolo or while taking it, contact your doctor immediately:

• unexplained weight loss and difficulty swallowing;
• stomach pain or indigestion;
• vomiting of food or blood;
• dark-colored stools (presence of blood in the stool);
• severe or persistent diarrhea, because omeprazole has been associated with a slight increase in infectious diarrhea;
• serious liver problems.

If you take Ibimezolo for a long time (more than 1 year) your doctor will prescribe regular check-ups. Tell your
doctor if you notice the appearance of new and particular symptoms.
If you are taking a proton pump inhibitor such as Ibimezolo, 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 reduced bone mass (osteoporosis) or are taking corticosteroids (medicines
that can increase the risk of osteoporosis) consult your doctor (see “Possible
side effects”).

Other medicines and Ibimezolo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
This is important because Ibimezolo can affect how some medicines work and,
vice versa, some medicines can have effects on the action of Ibimezolo.
Do not take Ibimezolo if you are taking a medicine containing nelfinavir (used for the treatment
of HIV infections).
Tell your doctor or pharmacist if you are taking one or more of the following medicines:

• ketoconazole, itraconazole or voriconazole (used to treat fungal infections);
• digoxin (used for the treatment of heart problems);
• diazepam (used for the treatment of anxiety, to relax muscles or for epilepsy);
• phenytoin (used for epilepsy). If you are taking phenytoin, your doctor will monitor you at the beginning and end of treatment with Ibimezolo;
• medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor will monitor you at the beginning and end of treatment with Ibimezolo;
• rifampicin (used for the treatment of tuberculosis);
• atazanavir (used for the treatment of HIV infection);
• tacrolimus (used in organ transplantation);
• St. John's wort ( Hypericum perforatum) (used for the treatment of mild depression);
• cilostazol (used for the treatment of intermittent claudication, i.e. pain in a leg when you exert yourself);
• saquinavir (used for the treatment of HIV infection);
• clopidogrel (used to prevent blood clots (thrombi);
• erlotinib (used for the treatment of cancer);
• methotrexate (used for the treatment of some tumors and rheumatoid arthritis).

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin together with Ibimezolo for the
treatment of ulcers caused by Helicobacter pyloriinfections, it is very important that you inform them if you are
taking any other medicines.

Ibimezolo with food and drink
The capsules can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It is unlikely that Ibimezolo will affect your ability to drive vehicles or operate tools or
machinery. Adverse reactions to the medicine such as dizziness and visual disturbances may occur (see
“Possible side effects”). If you experience them, do not drive vehicles and do not use machinery.

Ibimezolo containsless than 1 mmol (23 mg) of sodiumper capsule, i.e. essentially ‘sodium-free’.

3. How to take Ibimezolo

Take this medicine exactly as your doctor or pharmacist has instructed. If you have any doubts, consult your doctor or pharmacist.
Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and
your age.
The recommended dosesare listed below.

Adults:
For the treatment of symptoms of gastro-esophageal reflux disease (GERD), such as heartburn and
acid regurgitation :

• If your doctor has told you that a part of the digestive tract (esophagus) is slightly damaged, the usual dose is 20 mg once a day for 4-8 weeks. The doctor may increase the dose to 40 mg for another 8 weeks if the esophagus is not yet fully healed.
• The usual dose once the esophagus has healed is 10 mg once a day.
• If the esophagus is not damaged, the usual dose is 10 mg once a day.

For the treatment of ulcers in the upper part of the intestine (duodenal ulcer):

• The usual dose is 20 mg once a day for 2 weeks. The doctor may extend the intake of this dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer has not completely healed, the dose may be increased to 40 mg once a day

for 4 weeks.
For the treatment of stomach ulcers (gastric ulcer):

• The usual dose is 20 mg once a day for 4 weeks. The doctor may extend the intake of this dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer has not completely healed, the dose may be increased to 40 mg once a day for 8 weeks.

To prevent the recurrence of duodenal and gastric ulcers:

• The usual dose is 10 mg or 20 mg once a day. The doctor may increase the dose to 40 mg once a day.

For the treatment of duodenal and gastric ulcers caused by taking NSAIDs (non-steroidal anti-inflammatory drugs):

• The usual dose is 20 mg once a day for 4-8 weeks.

To prevent the formation of duodenal and gastric ulcers if you are using NSAIDs (non-steroidal anti-inflammatory drugs):

• The usual dose is 20 mg once a day.

For the treatment of ulcers caused by infection with Helicobacter pyloriand prevention of their
recurrence:

• The usual dose is 20 mg of Ibimezolo twice a day for one week.
• The doctor will tell you to also take two antibiotics from amoxicillin, clarithromycin and metronidazole.

For the treatment of excessive acid in the stomach caused by an increase in tissue in the
pancreas (Zollinger-Ellison syndrome):

• The usual dose is 60 mg per day.
• The doctor will adjust the dose according to your needs and also decide how long you should take the medicine.

Use in children and adolescents:
For the treatment of symptoms of gastro-esophageal reflux disease (GERD), such as heartburn and
acid regurgitation:

• Ibimezolo can be taken by children over 1 year of age and weighing more than 10 kg. The dose for children is based on the child's weight and the exact dose will be decided by the doctor.

For the treatment and prevention of the recurrence of ulcers caused by infection with Helicobacter pylori:

• Ibimezolo can be taken by children over 4 years of age. The dose for children is based on the child's weight and the exact dose will be decided by the doctor.
• The doctor will also prescribe two antibiotics called amoxicillin and clarithromycin to your child.

Taking this medicine

• Take the capsules in the morning.
• The capsules can be taken with food or on an empty stomach.
• The capsules should be swallowed whole with half a glass of water. The capsules must not be chewed or crushed, as they contain granules coated in such a way as to prevent the medicine from being broken down by the acid in the stomach. It is important not to damage the granules.

What to do if you or the child has difficulty swallowing the capsules

• If you or the child has difficulty swallowing the capsules:
• Open the capsules and swallow the contents directly with half a glass of water or pour the contents into a glass of water (non-carbonated), acidic fruit juice (e.g. apple, orange or pineapple) or applesauce.
• Always shake the contents before drinking (the mixture will not be clear), then drink the preparation immediately or within 30 minutes.
• To be sure you have taken all the medicine, rinse the glass thoroughly with half a glass of water and drink the contents. The solid particles contain the medicine - do not chew or crush them.

If you take more Ibimezolo than you should
If you take an amount of Ibimezolo greater than that prescribed by your doctor, contact your
doctor or pharmacist immediately.

If you forget to take Ibimezolo
If you forget to take a dose, take it as soon as you remember. However, if it is almost time to
take the next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you notice any of the following rare but serious side effects, stop taking Ibimezolo and
contact your doctor immediately:

• sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulty swallowing (severe allergic reaction);
• redness of the skin with the appearance of blisters or peeling. A severe formation of blisters with bleeding of the lips, eyes, mouth, nose and genitals may also appear (this could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”);
• yellowing of the skin, dark urine and fatigue may be symptoms of liver problems.

Other side effects include:

Common(may affect up to 1 in 10 people)

• headache;
• effects on the stomach or intestines such as: diarrhea, stomach pain, constipation, passing gas from the anus (flatulence);
• feeling unwell (nausea) or feeling sick (vomiting);
• Benign polyps in the stomach

Uncommon(may affect up to 1 in 100 people)

• swelling of the feet and ankles;
• disturbed sleep (insomnia);
• dizziness, tingling, feeling sleepy;
• feeling of spinning (vertigo);
• changes in blood tests related to liver function;
• rash, rash with swelling of the skin (urticaria) and itching on the skin;
• general feeling of unwellness and lack of energy.

If you take a proton pump inhibitor (medicine that reduces stomach acid) such as
Ibimezolo, 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 reduced bone mass
(osteoporosis) or are taking corticosteroids (anti-inflammatory medicines that can increase the risk
of osteoporosis) consult your doctor.

Rare(may affect up to 1 in 1,000 people)

• changes in blood composition, such as a decrease in the number of white blood cells or platelets. This can cause weakness and easy bruising, or may make you more likely to develop infections;
• allergic reactions, sometimes very serious, including swelling of the lips, tongue and throat, fever, shortness of breath;
• low levels of sodium in the blood. This can cause weakness, feeling unwell (vomiting) and cramps;
• feeling agitated, confused or depressed;
• changes in taste;
• problems with vision, such as blurred vision;
• sudden wheezing or shortness of breath (bronchospasm);
• dry mouth;
• inflammation inside the mouth;
• infection called “candidiasis” that can affect the intestines and is caused by a fungus;
• liver problems, including jaundice, which can cause yellowing of the skin, dark urine and fatigue;
• hair loss (alopecia);
• rash during exposure to the sun;
• joint pain (arthralgia) or muscle pain (myalgia);
• serious kidney problems (interstitial nephritis);
• increased sweating. Very rare(may affect up to 1 in 10,000 people)
• changes in the number of blood cells, including agranulocytosis (lack of white blood cells);
• aggressiveness;
• seeing, feeling or hearing events that are not real (hallucinations);
• serious liver problems up to liver failure and brain inflammation;
• sudden appearance of a severe rash or blisters and peeling of the skin, which may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• muscle weakness;
• breast enlargement in men.

In very rare cases Ibimezolo can affect white blood cells leading to a weakening of the immune system
(immuno-deficiency). If you should experience an infection with symptoms such as fever with a serious
worsening of general health or fever with symptoms of local infection such as sore throat, sore throat or mouth or difficulty urinating, consult your doctor as soon as possible, in order to rule out
a lack of white blood cells (agranulocytosis) by performing a blood test. It is important that in
this case you inform the doctor about the medicine you are taking.
Do not worry about the list of possible side effects as they may not occur.

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

• Erythema, possible joint pains
• inflammation of the colon (microscopic colitis);
• decreased levels of magnesium in the blood. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, seizures, dizziness and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to a decrease in potassium or calcium levels in the blood. The doctor should decide whether to regularly check magnesium levels in the blood.

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 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 Ibimezolo

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 packaging. The expiry date refers to
the last day of that month.
Store the medicine at a temperature not exceeding 30°C and in the original packaging to protect it
from humidity.
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 Ibimezolo contains

• The active ingredient is omeprazole. Each capsule contains 20 mg of omeprazole.
• The other ingredients are: microcrystalline cellulose, low-substituted hydroxypropylcellulose, mannitol, sodium croscarmellose, polysorbate 80, povidone K-30, arginine, sodium lauryl sulfate, glycine, light magnesium carbonate. Coating: hypromellose, ethyl acrylate-methacrylic acid copolymer, triethyl citrate, sodium hydroxide, titanium dioxide, talc. Capsule: indigo carmine (E-132), titanium dioxide, gelatin, water.

Description of the appearance of Ibimezolo and contents of the pack
Ibimezolo is presented as gastro-resistant hard capsules.
The pack contains 14 capsules in blisters

Marketing Authorisation Holder
I.B.N. Savio S.r.l. – Via del Mare, 36 – Pomezia (RM)

Manufacturer
Tedec-Meiji Farma, S.A. - Carretera M-300 Km 30,500 - 28802 Alcalà de Henares - Madrid (Spain)
Special Product’s Line Spa – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)