Maricrio

PACKAGE LEAFLET: INFORMATION FOR THE USER

MARICRIO 20 mg gastro-resistant hard capsules

Omeprazole
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 others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 known as 'proton pump inhibitors', which work by reducing the amount of acid produced by the stomach.
MARICRIO 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 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). MARICRIO may also be used to prevent ulcers from forming if you are taking NSAIDs.
• Excess acid in the stomach caused by a growth of tissue in the pancreas (Zollinger-Ellison syndrome).

In children:
Children aged over 1 year and weighing more 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 aged over 4 years 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 MARICRIO

Do not take MARICRIO

• 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 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, consult your doctor or pharmacist before taking MARICRIO.
Take special care with MARICRIO
MARICRIO may mask symptoms of other diseases. Therefore, if you experience any of the
following symptoms before or while taking MARICRIO, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Black-coloured stools (indicating presence of blood in the stool).
• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in the risk of infectious diarrhoea.
• Severe liver problems.
• The use of proton pump inhibitors may alter the results of the urea breath test for detecting Helicobacter pylori. Therefore, omeprazole treatment should be discontinued at least 2 weeks before the test. If you have been taking 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 or unusual symptoms.

If you take a proton pump inhibitor such as MARICRIO, 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 have osteoporosis or are taking corticosteroids (which may 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 acidity.
• If you need to undergo a specific blood test (Chromogranin A).

If you develop a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Maricrio. Remember to also report any other adverse effects such as joint pain.
Taking MARICRIO with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. This is important because MARICRIO may affect how some medicines work, and conversely, some medicines may affect the action of MARICRIO.
Do not take MARICRIO 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 MARICRIO.
• 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 MARICRIO.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (used in organ transplantation).
• St. John’s wort (Hypericum perforatum) (used to treat mild depression).
• Cilostazol (used to treat intermittent claudication).
• Saquinavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots (thrombi)).
• Erlotinib (used to treat cancer).
• Methotrexate (a chemotherapeutic agent used in high doses for cancer treatment) – if you are taking high-dose methotrexate, your doctor may temporarily discontinue your treatment with MARICRIO. If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with MARICRIO 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. Taking MARICRIO with food and drinks The capsules can be taken with food or on an empty stomach. Pregnancy and breastfeeding Ask your doctor or pharmacist for advice before taking any medicine. Before taking MARICRIO, inform your doctor if you are pregnant or planning to become pregnant. Your doctor will decide whether you can take MARICRIO during this period.

Your doctor will decide whether you can take MARICRIO during breastfeeding.
Driving and using machines
It is unlikely that MARICRIO will affect your ability to drive or use tools or machinery.
However, adverse reactions such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or operate machinery.
MARICRIO contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per gastro-resistant hard capsule, i.e. it is essentially ‘sodium-free’.

3. HOW TO TAKE MARICRIO

Always take MARICRIO exactly as directed by your doctor. 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 usual doses are listed below.

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

• If your doctor has informed you that your esophagus 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 esophagus has not yet fully healed.
• The usual dose once the esophagus has healed is 10 mg once daily.
• If the esophagus 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 preventing 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 preventing the formation of duodenal and gastric ulcers when using NSAIDs:

• 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 MARICRIO twice daily for one week.
• Your doctor will also instruct you to take two antibiotics, chosen from amoxicillin, clarithromycin, and metronidazole.

For the treatment of excessive stomach acid caused by an overgrowth of tissue 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.

Children

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

• MARICRIO 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:

• MARICRIO 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

• It is recommended to 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. The capsules must not be chewed or crushed, 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 pour the contents into a glass of water (non-carbonated), into an acidic fruit juice (e.g., apple, orange, or pineapple juice), or into apple puree.
• Always shake the mixture before drinking (the mixture will not be clear), and drink the preparation immediately or within 30 minutes.
• To ensure the full dose is taken, rinse the glass thoroughly with half a glass of water and drink the rinse water. The solid particles contain the medicine—do not chew or crush them.

If you take more MARICRIO than you should
If you take more MARICRIO than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take MARICRIO
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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, MARICRIO may 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, throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin redness with blistering or peeling. Severe blistering with bleeding of the lips, eyes, mouth, nose and genitals may also occur. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• Yellowing of the skin, dark-coloured urine and fatigue could be symptoms of liver problems. Side effects may occur with a certain frequency as defined below:

Other undesirable effects include:
Common side effects

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach ache, constipation, passing wind (flatulence).
• Feeling unwell (nausea) or being unwell (vomiting).
• Benign stomach polyps.

Uncommon side effects

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling, drowsiness.
• Feeling of spinning (vertigo).
• Changes in blood tests relating to liver function.
• Skin rash, skin rash with swelling of the skin (urticaria), and itching of the skin.
• General feeling of being unwell and lack of energy.

Rare side effects

• Changes in blood composition, such as reduced number of white blood cells or platelets. This may cause weakness and easy bruising, or may make infections more likely.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.
• Low sodium levels in the blood. This may cause weakness, feeling unwell (vomiting), and cramps.
• Feeling restless, confused or depressed.
• 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 may affect the intestine and is caused by a fungus.
• Liver problems, including jaundice, which may cause yellowing of the skin, dark urine and tiredness.
• 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 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).
• Severe liver problems up to liver failure and brain inflammation.
• Sudden onset of severe skin 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.
• Breast enlargement in men.

In very rare cases, MARICRIO may affect white blood cells leading to immunodeficiency.
If you develop an infection with symptoms such as fever accompanied by severe deterioration
in your general health, or fever with signs of local infection such as neck, throat or mouth pain, or
difficulty urinating, you must 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.
Frequency not known
Inflammation of the intestine (resulting in diarrhoea).
Alteration of urea breath test (see section 2).
If you take MARICRIO 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, consult
your doctor immediately. Low magnesium levels may also lead to reduced blood levels of
potassium or calcium. Your doctor should decide whether regular monitoring of magnesium
levels in the blood is necessary.
Erythema, possible joint pain.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Following the instructions in the leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effects, 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 the
following website:
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 "Exp". The expiry date refers to the last day of the month.
• Do not store above 30°C.
• Store in the original packaging to protect the medicine from moisture.
• Medicines must 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. Package contents 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 hydroxypropyl cellulose, 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: gelatin, indigo carmine (E-132), titanium dioxide, water.

PHARMACEUTICAL FORM AND CONTENT
Gastro-resistant hard capsules. 14 gastro-resistant hard capsules of 20 mg.

MARKETING AUTHORISATION HOLDER
NEOPHARMED GENTILI S.p.A.
Via S.G. Cottolengo, 15 - 20143 Milan

MANUFACTURER
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)