MARICRIO 20 mg Enteric-Coated Hard Capsule

Зміст інструкції

1. MARICRIO 20 mg hard gastro-resistant capsules
   1. WHAT MARICRIO IS AND WHAT IT IS USED FOR
   2. What you need to know BEFORE taking MARICRIO
   3. HOW TO TAKE MARICRIO
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE MARICRIO
   6. Contents of the pack and OTHER INFORMATION

MARICRIO 20 mg hard gastro-resistant capsules

Omeprazole
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. Contents of this leaflet:
• 1. What MARICRIO is and what it is used for
• 2. What you need to know before you take MARICRIO
• 3. How to take MARICRIO
• 4. Possible side effects
• 5. How to store MARICRIO
• 6. Contents of the pack and other information

1. WHAT MARICRIO IS AND WHAT IT IS USED FOR

MARICRIO contains the active substance omeprazole. It belongs to a group of medicines
called ‘proton pump inhibitors’, which work by reducing the amount of acid produced
by the stomach.
MARICRIO is used for the treatment of the following conditions:
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 in the upper part of the intestine (duodenal ulcer) or of the stomach (gastric ulcer).
• Ulcers infected by a bacterium called ‘ Helycobacter 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). MARICRIO can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive acid in the stomach caused by an increase of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and with a body weight of 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 ‘ Helycobacter 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 MARICRIO

Do not take MARICRIO

• 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 containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medicine containing nelfinavir (used for HIV infections).

If you have any doubts, ask your doctor or pharmacist before taking MARICRIO.

Pay particular attention with MARICRIO
MARICRIO can mask the symptoms of other diseases. Therefore, if you experience the
symptoms described below before taking MARICRIO or while you are taking it, contact your
doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Dark coloured stools (presence of blood in the stools).
• Severe or persistent diarrhoea, because omeprazole has been associated with a slight increase in infectious diarrhoea.
• Serious liver problems.
• The use of proton pump inhibitors may cause alteration of the results of the urea breath test for the detection of Helycobacter pylori. Therefore, the administration of omeprazole must be stopped 2 weeks before the test. If you take MARICRIO for a long time (more than 1 year) your doctor will prescribe regular check-ups. Inform your doctor if you notice the appearance of new and particular symptoms.

If you are taking a proton pump inhibitor such as MARICRIO, especially for a period
longer than one year, there may be a slight increase in the risk of fractures of the hip, the
wrist or the spine. If you suffer from osteoporosis or are taking corticosteroids (which
can increase the risk of osteoporosis) consult your doctor.
Consult your doctor before taking Maricrio:

• if you have ever had a skin reaction after treatment with a medicine similar to Maricrio 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, consult your
doctor as soon as possible, as it may be necessary to stop treatment
with Maricrio. Remember to also report any other undesirable effects such as joint pain.

Taking MARICRIO with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription. This is important because MARICRIO
can affect the way some medicines work and, in turn, some medicines can
affect the action of MARICRIO.
Do not take MARICRIO if you are taking a medicine containing nelfinavir(used for the
treatment of HIV infections).
Tell your doctor or pharmacist if you are taking any 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 MARICRIO.
• 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 MARICRIO.
• 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).
• Saquinavir (used for the treatment of HIV infection).
• Clopidogrel (used to prevent blood clots (thrombi).
• Erlotinib (used for the treatment of cancer).
• Methotrexate (a chemotherapeutic medicine used in high doses for the treatment of cancer) - if you are taking methotrexate in high doses, your doctor may temporarily interrupt your treatment with MARICRIO. If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin together with MARICRIO for the treatment of ulcers caused by Helycobacter pyloriinfections, it is very important that you inform them if you are taking any other medicines. Taking MARICRIO with food and drinkThe capsules can be taken with or without food. Pregnancy and breastfeedingAsk your doctor or pharmacist for advice before taking any medicine. Before taking MARICRIO tell your doctor if you are pregnant or if you are planning to become pregnant. The doctor will decide if you can take MARICRIO during this period.

The doctor will decide if you can take MARICRIO during breastfeeding.

Driving and using machines
It is unlikely that MARICRIO can affect your ability to drive or operate tools or
machinery.
Adverse reactions to the medicine such as dizziness and visual disturbances may occur (see section
4). If you suffer from these, do not drive vehicles or use machinery.
MARICRIO contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule
gastroresistant, i.e. it is essentially ‘sodium-free’.

3. HOW TO TAKE MARICRIO

Always take MARICRIO exactly as your doctor has instructed. If you have any doubts, ask 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 usual doses are listed below.

Adults
For the treatment of symptoms of GERD, such as heartburn and acid reflux:

• If your doctor has told you that your esophagus is slightly damaged, the usual dose is 20 mg once a day for 4-8 weeks. Your 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 is not fully 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 is not fully healed, the dose may be increased to 40 mg once a day for 8 weeks. To preventthe 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 ulcersif you are taking NSAIDs:

• The usual dose is 20 mg once a day.

For the treatment of ulcers causedby infection withHelicobacter pyloriand prevention
of their recurrence :

• The usual dose is 20 mg of MARICRIO twice a day for one week.
• Your doctor will also tell you to take two antibiotics, such as amoxicillin, clarithromycin and metronidazole. For the treatment of excessive acid in the stomach caused by an increasein 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 will need to take the medicine.

Children
For the treatment of symptoms of GERD, such as heartburn and acid reflux:

• MARICRIO 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 causedby infection withHelicobacter pylori:
• MARICRIO 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
• It is recommended to 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 should 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 very well 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 MARICRIO than you shouldIf you take an amount of MARICRIO higher than prescribed by the doctor, contact your doctor or pharmacist immediately. If you forget to take MARICRIOIf 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 the missed dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, MARICRIO can cause side effects, although not everybody gets them.

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

• Sudden wheezing, swelling of the lips, tongue and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Redness of the skin with the appearance of blisters or peeling. A severe blistering may also appear 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 may be symptoms of liver problems. Side effects can occur with a certain frequency, as defined below:

Other side effects include:

Common side effects

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, passing gas (flatulence).
• Feeling unwell (nausea) or feeling sick (vomiting)
• Benign polyps in the stomach.

Uncommon side effects

• 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.
• Skin rash, skin rash with swelling of the skin (urticaria) and itching on the skin.
• General feeling of unwellness and lack of energy.

Rare side effects

• 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 get infections.
• Allergic reactions, sometimes very serious, including swelling of the lips, tongue and throat, fever, wheezing.
• Low levels of sodium in the blood. This can cause weakness, feeling unwell (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• An 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).

• Skin rash during exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Serious liver problems up to liver failure and brain inflammation.
• Sudden onset of a severe rash or blisters and peeling of the skin. These effects may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlargement of the breasts in men.

In very rare cases MARICRIO can affect white blood cells leading to an immuno-deficiency.
If you should develop an infection with symptoms such as fever with a severedeterioration
of your general condition or fever with symptoms of a local infection such as sore throat,
sore throat or mouth or difficulty urinating, you should consult your doctor as soon as possible,
so that a lack of white blood cells (agranulocytosis) can be ruled out by performing a blood test.
It is important that in this case you inform the doctor about the medicine you are taking.

Frequency not known
Inflammation of the intestine (with resulting diarrhea).
Alteration of the urea breath test (see section 2).
If you take MARICRIO for more than three months, your blood levels of magnesium
may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, 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 blood levels of potassium or calcium. The
doctor should decide whether to check magnesium levels in the blood regularly.
Erythema, possible joint pains.
Do not worry about the list of possible side effects. You may not experience any of them.

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:
https://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 MARICRIO

• Keep MARICRIO out of the sight and reach of children.
• Do not use MARICRIO after the expiry date stated on the packaging after Scad. The expiry date refers to the last day of the month.
• Do not store at a temperature above 30°C.
• Store in the original packaging, to protect the medicine from moisture.
• Medicines should not be disposed of via 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 MARICRIO contains

• The active substance is omeprazole. MARICRIO gastro-resistant hard capsules contain 20 mg of omeprazole.
• The excipients are: Core: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:gelatin, indigo carmine (E-132), titanium dioxide, water. PHARMACEUTICAL FORM AND CONTENTGastro-resistant hard capsules. 14 gastro-resistant hard capsules containing 20 mg. MARKETING AUTHORISATION HOLDERNEOPHARMED GENTILI S.p.A. Via S.G. Cottolengo, 15 - 20143 Milano MANUFACTURERSpecial Product’s Line S.p.A. Via Fratta Rotonda Vado Largo, 1 03012 Anagni (FR)