OMEPRAZOLO 10 mg Enteric-Coated Hard Capsule

Зміст інструкції

1. OMEPRAZOLO ARISTO 10 mg hard gastro-resistant capsules, 20 mg hard gastro-resistant capsules, 40 mg hard gastro-resistant capsules
   1. What Omeprazolo Aristo is and what it is used for
   2. What you need to know before taking Omeprazolo Aristo
   3. How to take Omeprazolo Aristo
   4. Possible side effects
   5. How to store Omeprazolo Aristo
   6. Contents of the pack and other information

OMEPRAZOLO ARISTO 10 mg hard gastro-resistant capsules, 20 mg hard gastro-resistant capsules, 40 mg hard gastro-resistant capsules

Generic medicine

Read this leaflet carefully before you start 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. It may be harmful for people other than you, even if their symptoms are the same as yours.
• If you get any side effects, speak to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of this leaflet:

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

1. What Omeprazolo Aristo is and what it is used for

Omeprazolo Aristocontains the active ingredient omeprazole. It belongs to a group of medicines
called ‘proton pump inhibitors’, which work by reducing the amount of acid produced
by the stomach.

Omeprazolo Aristois 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 ‘ 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). Omeprazolo Aristocan 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 ‘ 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 Omeprazolo Aristo

Do not take Omeprazolo Aristo

• if you are allergic to the active ingredient 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, ask your doctor or pharmacist before taking Omeprazolo Aristo.

Warnings and precautions
Talk to your doctor or pharmacist before taking Omeprazolo Aristo:

• if you have ever had a skin reaction after treatment with a medicine similar to Omeprazolo Aristo 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 therapy with
Omeprazolo Aristo. Also remember to report any other undesirable effects such as joint pain.
Omeprazolo Aristo can mask the symptoms of other diseases. Therefore, if you experience the
symptoms described below before taking Omeprazolo Aristo 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 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 Omeprazolo Aristo 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 Omeprazolo Aristo, 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 treatment with omeprazole, inflammation of your kidneys may occur. Signs and
symptoms may include a reduced urine volume or the presence of blood in the urine
and/or hypersensitivity reactions such as fever, skin rashes and joint stiffness. Report these
signs to your doctor.

Other medicines and Omeprazolo Aristo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is important because Omeprazolo Aristo can affect the way
some medicines work and, in turn, some medicines can have effects on the action of
Omeprazolo Aristo.
Do not take Omeprazolo Aristo 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 Omeprazolo Aristo.
• 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 Omeprazolo Aristo.
• 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).

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

OMEPRAZOLO ARISTO with food and drink
The capsules can be taken with food or on an empty stomach.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. The doctor will decide
whether you can take Omeprazolo Aristo during this period.

Driving and operating machinery
It is unlikely that Omeprazolo Aristo will affect your ability to drive vehicles or use
tools or machinery. Adverse reactions to the drug such as dizziness and visual disturbances may occur (see section 4). If you suffer from these, do not drive vehicles or operate machinery.

OMEPRAZOLO ARISTO contains sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.

3. How to take Omeprazolo Aristo

Take this medicine exactly as your doctor has told you. 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:

• 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 completely 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. Your doctor may extend the intake of this dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer is 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 is not completely 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 using NSAIDs:

• The usual dose is 20 mg once a day.

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

• The usual dose is 20 mg of Omeprazolo Aristo twice a day for one week.
• Your doctor will also tell you to take two antibiotics among 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 will have to take the medicine.

Use in children
For the treatment of symptoms of GERD, such as heartburn and acid reflux:

• Omeprazolo Aristo 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 by
Helicobacter pylori:

• Omeprazolo Aristo 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 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 very well with half a glass of water and drink the contents. Do not chew or crush the solid particles, they contain the medicine.

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

If you forget to take Omeprazolo Aristo
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 the missed one.

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
Omeprazolo Aristo 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 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.

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).
• Benign polyps in the stomach.
• Feeling unwell (nausea) or feeling sick (vomiting).

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 discomfort and lack of energy.
• Fracture of the hip, wrist or spine (see section “Warnings and precautions for use”)

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 develop 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.
• Eye 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 the sun.
• 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 events that are not real (hallucinations).
• Serious liver problems up to liver failure and brain inflammation.
• Sudden onset of 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.
• Breast enlargement in men.

Frequency not known

• Hypomagnesemia.
• erythema, possible joint pain.

If you take Omeprazolo Aristo for more than three months, it is possible that blood levels of magnesium
may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate.
If you have any of these symptoms, consult your doctor immediately. The doctor should
decide whether to periodically check magnesium levels in the blood.
In very rare cases Omeprazolo Aristo may affect white blood cells leading to
immunodeficiency. If you should develop an infection with symptoms such as fever with a severe
deterioration of the general condition or fever with symptoms of local infection such as
sore throat, sore throat or mouth or difficulty urinating, you should consult a 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 in this case to inform the doctor about the medicine you are taking.
Do not worry about the list of possible side effects. You may not experience any of them.

Reporting 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
website: 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 Omeprazolo Aristo

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 pack after Exp. The expiry
date refers to the last day of that month.
Store at a temperature below 30°C.
Store in the original container to protect the medicine from moisture.
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 the medicine containsOmeprazolo Aristo

• The active ingredient is omeprazole. Each capsule contains 10 mg, 20 mg or 40 mg of omeprazole as gastro-resistant granules.
• The other ingredients are:

Capsule core:sugar spheres (sucrose and corn starch), sodium carboxymethylcellulose (Type A), sodium lauryl sulfate, povidone, trisodium phosphate dodecahydrate, hypromellose,
methacrylic acid–ethyl acrylate copolymer (1:1), triethyl citrate, titanium dioxide (E171), talc,
sodium hydroxide.

Capsule cap:red iron oxide (E172) (only 10 mg), erythrosine (E127),
indigo carmine (E132) (only 20 mg and 40 mg), titanium dioxide (E171), water, gelatin, quinoline yellow (E104).

Capsule body:Quinoline yellow (E104), erythrosine (E127), titanium dioxide (E171),
gelatin, water.

Printing ink:shellac, povidone, propylene glycol, sodium hydroxide, titanium
dioxide (E171).

Description ofOmeprazolo Aristoand contents of the pack
OMEPRAZOLO ARISTO 10 mg:
Hard gelatin capsules, size 3, with an opaque red cap and an opaque orange body. The letter “O” has been imprinted on the cap and the number “10” on the body with white ink. The
capsules are filled with white to beige-colored pelletized microgranules.
Pack containing a blister of 14 capsules.
Pack containing two blisters of 14 capsules.
OMEPRAZOLO ARISTO 20 mg:
Hard gelatin capsules, size 2, with an opaque blue cap and an opaque orange body. The letter “O” has been imprinted on the cap and the number “20” on the body with white ink. The capsules
are filled with white to beige-colored pelletized microgranules.
Pack containing a blister of 14 capsules.
Pack containing two blisters of 14 capsules.
OMEPRAZOLO ARISTO 40 mg:
Hard gelatin capsules, size 0, with an opaque blue cap and an opaque orange body. The letter “O” has been imprinted on the cap and the number “40” on the body with white ink. The capsules
are filled with white to beige-colored pelletized microgranules.
Pack containing a blister of 14 capsules.
Pack containing two blisters of 14 capsules.

Marketing authorisation holder
Aristo Pharma GmbH
Wallenroder Straße 8 - 10
13435 Berlin
Germany

Distributor:
Aristo Pharma Italy srl
info@aristo-pharma .it
Manufacturer
TEVA Pharma S.L.U.
Poligono Industrial Malpica, calle C., number 4, 50016 Zaragoza
Spain