Ibimezolo

Package leaflet: Information for the user

Ibimezolo 20 mg gastro-resistant hard capsules

Omeprazole
Generic medicine
Please read all of this leaflet carefully before you start 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 others, even if they have the same symptoms as you, because it could 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 taking 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 Ibimezolo is and what it is used for

Ibimezolo contains the active substance 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 to treat the following conditions:

In adults:

• Gastro-oesophageal reflux disease (GERD). This condition occurs when acid leaks out of the stomach and passes into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn;
• Ulcers (sores) in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer);
• Ulcers infected with a bacterium called Helicobacter pylori. If you have this condition, 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 may also be used to prevent ulcers from forming if you are taking NSAIDs (non-steroidal anti-inflammatory drugs);
• Excessive production of stomach acid caused by a growth of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:
Children above 1 year of age and with body weight greater than or equal to 10 kg

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

Children above 4 years of age and adolescents

• Ulcers infected with a bacterium called Helicobacter pylori. If your child has this condition, the
  doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you should know before taking Ibimezolo

Do not take Ibimezolo

• if you are allergic to omeprazole or to 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 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 treatment with Ibimezolo may need to be discontinued. Remember to also report any other side effects such as joint pain.
Ibimezolo may mask symptoms of other diseases. Therefore, if you experience any of the following symptoms before or while taking Ibimezolo, 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 stools);
• severe or persistent diarrhoea, because omeprazole has been associated with a slight increase in the risk of infectious diarrhoea;
• severe liver problems.

If you have been taking Ibimezolo for a long time (more than 1 year), your doctor will prescribe regular check-ups. Inform your doctor if you notice any new or unusual symptoms.
If you take a proton pump inhibitor such as Ibimezolo, especially for more 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 may increase the risk of osteoporosis), consult your doctor (see "Possible side effects").

Other medicines and Ibimezolo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is important because Ibimezolo can affect how some medicines work and, conversely, some medicines can affect the action of Ibimezolo.
Do not take Ibimezolo if you are taking a medicine containing nelfinavir (used to treat HIV infections).
Inform 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 to treat heart problems);
• diazepam (used to treat anxiety, to relax muscles, or for epilepsy);
• phenytoin (used for epilepsy). If you are taking phenytoin, your doctor will monitor you closely 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 closely at the beginning and end of treatment with Ibimezolo;
• rifampicin (used to treat tuberculosis);
• atazanavir (used to treat HIV infection);
• tacrolimus (used in organ transplants);
• St. John’s wort (Hypericum perforatum) (used to treat mild depression);
• cilostazol (used to treat intermittent claudication, i.e. leg pain during physical exertion);
• saquinavir (used to treat HIV infection);
• clopidogrel (used to prevent blood clots (thrombi));
• erlotinib (used to treat cancer);
• methotrexate (used to treat certain cancers and rheumatoid arthritis).

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

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or 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 or use tools or machines. Adverse reactions such as dizziness and visual disturbances may occur (see "Possible side effects"). If you experience these, do not drive or operate machinery.

Ibimezolo contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially 'sodium-free'.

3. How to take Ibimezolo

Take this medicine exactly as directed by your doctor or pharmacist. 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 age.
The recommended doses are listed below.

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

• If your doctor has informed you that a part of the digestive tract (oesophagus) is slightly damaged, the usual dose is 20 mg once daily for 4–8 weeks. Your doctor may increase the dose to 40 mg for an additional 8 weeks if the oesophagus has not yet fully healed.
• Once the oesophagus has healed, the usual dose is 10 mg once daily.
• If the oesophagus is not damaged, the usual dose is 10 mg once daily.

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

• The usual dose is 20 mg once daily for 2 weeks. Your doctor may extend treatment with 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 daily for 4 weeks.

For the treatment of stomach ulcers (gastric ulcer):

• The usual dose is 20 mg once daily for 4 weeks. Your doctor may extend treatment with 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 daily for 8 weeks.

For the prevention of recurrence of duodenal and gastric ulcers:

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

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

• The usual dose is 20 mg once daily for 4–8 weeks.

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

• The usual dose is 20 mg once daily.

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

• The usual dose is 20 mg of Ibimezolo twice daily for one week.
• Your doctor will also instruct you to take two antibiotics among amoxicillin, clarithromycin, and metronidazole.

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

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

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

• Ibimezolo may be taken by children over 1 year of age and weighing more than 10 kg. The dose for children is based on body weight, and the exact dose will be determined by the doctor.

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

• Ibimezolo may be taken by children over 4 years of age. The dose for children is based on body weight, and the exact dose will be determined by the doctor.
• Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.

How to take this medicine

• Take the capsules in the morning.
• The capsules may be taken with food or on an empty stomach.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain coated granules designed to prevent the medicine from being broken down by stomach acid. 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 capsule and take the contents directly with half a glass of water, or mix the contents into a glass of water (non-carbonated), into an acidic fruit juice (e.g. apple, orange, or pineapple), or into apple puree.
• Always shake the mixture before drinking (the mixture will not be clear), and drink it immediately or within 30 minutes.
• To ensure you have taken the full dose, rinse the glass thoroughly with half a glass of water and drink the rinse. The solid particles contain the medicine—do not chew or crush them.

If you take more Ibimezolo than you should
If you take more Ibimezolo than 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 for your next dose, skip the missed dose.
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction);
• redness of the skin with blistering or peeling. There may also be severe blistering with bleeding of the lips, eyes, mouth, nose and genitals (this could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”);
• yellowing of the skin, dark urine and fatigue could be symptoms of liver problems.

Other side effects include:
Common (may affect up to 1 in 10 people)

• headache;
• stomach or intestinal problems such as: diarrhoea, stomach pain, constipation, passing wind (flatulence);
• feeling unwell (nausea) or being unwell (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, drowsiness;
• sensation of dizziness (vertigo);
• changes in blood tests related to liver function;
• skin rash, skin rash with swelling of the skin (urticaria) and itching;
• general feeling of being unwell and lack of energy.

If you take a proton pump inhibitor (a medicine that reduces the acidity of gastric juices) such as
Ibimezolo, especially for 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 reduced numbers of white blood cells or platelets. This may cause weakness and easy bruising, or make infections more likely;
• allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, shortness of breath;
• low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting) and cramps;
• restlessness, confusion or depression;
• changes in taste;
• vision problems, such as blurred vision;
• sudden wheezing or breathlessness (bronchospasm);
• dry mouth;
• inflammation inside the mouth;
• an infection called “candidiasis” which can affect the intestine and is caused by a fungus;
• liver problems, including jaundice, which can cause yellowing of the skin, dark urine and fatigue;
• hair loss (alopecia);
• skin rash during exposure to sunlight;
• joint pain (arthralgia) or muscle pain (myalgia);
• severe kidney problems (interstitial nephritis);
• increased sweating.

Very rare (may affect up to 1 in 10,000 people)

• changes in blood cell counts, including agranulocytosis (lack of white blood cells);
• aggression;
• seeing, feeling or hearing things that are not real (hallucinations);
• severe liver problems up to liver failure (hepatic failure) and inflammation of the brain;
• sudden onset of severe skin rash or blistering 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 may affect white blood cells, leading to weakening of the immune system
(immunodeficiency). If you develop an infection with symptoms such as fever with a severe worsening of your general health, or fever with signs of local infection such as neck, throat or mouth pain or difficulty urinating, consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) by means of a blood test. It is important that in this case you inform your doctor about the medicine you are taking.
Do not be alarmed by this list of possible side effects, as they may not occur.
Frequency not known (frequency cannot be estimated from the available data)

• Erythema, possible joint pain;
• inflammation of the colon (microscopic colitis);
• decrease in magnesium levels in the blood. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor should decide whether to monitor magnesium levels in your blood regularly.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 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 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. Package contents and other information

What Ibimezolo contains

• The active substance is omeprazole. Each capsule contains 20 mg of omeprazole.
• The other components are: microcrystalline cellulose, low-substituted hydroxypropylcellulose, mannitol, sodium croscarmellose, polysorbate 80, povidone K-30, arginine, sodium lauryl sulfate, glycine, light magnesium carbonate. Coating: hypromellose, methacrylic acid-ethyl acrylate copolymer, triethyl citrate, sodium hydroxide, titanium dioxide, talc. Capsule shell: 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.
Pack: 14 capsules in blisters.

Marketing Authorization 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)