OMEPRAZOLO 10 mg Kapsułki O Przedłużonym Uwalnianiu

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

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

Omeprazolo

Generic medicine

Read this leaflet carefully before you start to use 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What OMEPRAZOLO ARISTO PHARMA is and what it is used for

OMEPRAZOLO ARISTO PHARMA contains 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 ARISTO PHARMA 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 ‘ Helicobacter pylori’. If you suffer from 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). OMEPRAZOLO ARISTO PHARMA can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive acid production in the stomach caused by an overgrowth of tissue in the pancreas (Zollinger-Ellison syndrome).

Children aged over 1 year 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 condition, 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 PHARMA

Do not take OMEPRAZOLO ARISTO PHARMA

• If you are allergic to omeprazole or any of the excipients 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
PHARMA.

Warnings and precautions
OMEPRAZOLO ARISTO PHARMA can mask the symptoms of other diseases. Therefore, if
you experience any of the symptoms described below before taking
OMEPRAZOLO ARISTO PHARMA or while you are already taking it, contact your doctor
immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Darkening of the stools (presence of blood in the stools).
• Severe or persistent diarrhea, because omeprazole has been associated with a slight increase in infectious diarrhea.
• Serious liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to OMEPRAZOLO ARISTO PHARMA that reduces stomach acid.
• You must 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 it may be necessary to stop the
therapy with OMEPRAZOLO ARISTO PHARMA. Remember to report any other adverse
effects such as joint pain.
If you take OMEPRAZOLO ARISTO PHARMA 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.
Taking a proton pump inhibitor such as OMEPRAZOLO ARISTO PHARMA,
especially for a period longer than one year, may slightly increase the risk of
fracture of the hip, wrist or spine. Tell your doctor if you suffer from
osteoporosis or if you are taking corticosteroids (which can increase the risk of
osteoporosis).

Other medicines and OMEPRAZOLO ARISTO PHARMA
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
OMEPRAZOLO ARISTO PHARMA can affect the way some medicines work and, in turn, some medicines can have effects on the action of OMEPRAZOLO ARISTO PHARMA.
Do not take OMEPRAZOLO ARISTO PHARMA if you are using 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, posaconazole, 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 PHARMA
• 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 PHARMA
• 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 at high doses for the treatment of cancer) - if you are taking a high dose of methotrexate, your doctor may temporarily suspend your treatment with OMEPRAZOLO ARISTO PHARMA

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin together with
OMEPRAZOLO ARISTO PHARMA for the treatment of ulcers caused by infections from

Helicobacter pylori, it is very important that you tell if you are taking any other
medicines.

OMEPRAZOLO ARISTO PHARMA with food and drink
Take the capsules preferably on an empty stomach. The capsules MUST NOT be
chewed or crushed. They must be swallowed whole with a glass of water.

Pregnancy and breastfeeding
Before taking OMEPRAZOLO ARISTO PHARMA, tell your doctor if you are pregnant or if you wish to become pregnant. The doctor will decide if you can take
OMEPRAZOLO ARISTO PHARMA during this period.
The doctor will decide if you can take OMEPRAZOLO ARISTO PHARMA during
breastfeeding.

Driving and operating machinery
It is unlikely that OMEPRAZOLO ARISTO PHARMA can affect your ability to drive and
use 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.

OMEPRAZOLO ARISTO PHARMA contains sucrose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is
essentially ‘sodium-free’

3. How to take OMEPRAZOLO ARISTO PHARMA

Always take this medicine exactly as your doctor has told you. 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 recommended dose is:
For the treatment of GERD symptoms, 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 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 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. Your 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. Your 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 byHelicobacter pyloriinfectionand prevention
of their recurrence:

• The usual dose is 20 mg of OMEPRAZOLO ARISTO PHARMA 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 a

growth of tissue in the pancreas (Zollinger-Ellison syndrome):

• The usual dose is 60 mg per day.
• Your 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 GERD symptoms such as heartburn and acid reflux:

• OMEPRAZOLO ARISTO PHARMA 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 byHelicobacter pyloriinfection:

• OMEPRAZOLO ARISTO PHARMA can be used in 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.
• Your 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 your 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), an 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 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 OMEPRAZOLO ARISTO PHARMA than you should
If you use a quantity of OMEPRAZOLO ARISTO PHARMA greater than that prescribed by
your doctor, contact your doctor or pharmacist immediately.

If you forget to take OMEPRAZOLO ARISTO PHARMA
If you forget to take a dose, take it as soon as you remember. However, if it is already
almost time to take the 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, this medicine can cause side effects, although not everyone gets them.
Not everyone will experience them.

If you notice any of the following rare but serious side effects, stop taking
OMEPRAZOLO ARISTO PHARMA 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.

Other side effects include:

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

• 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 (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling sensations like “pins and needles”, 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.

Rare side effects (may affect up to 1 in 1000 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 get infections.
• Allergic reactions, sometimes very serious, including swelling of the lips, tongue and throat, fever and 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 (may affect up to 1 in 10,000 people)

• Changes in the count of blood cells, 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 appearance 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.

Not known (frequency cannot be estimated from the available data)

• Inflammation of the intestines (leading to diarrhea).
• If you are taking OMEPRAZOLO ARISTO PHARMA for more than three months, the levels of magnesium in your blood may decrease. Low levels of magnesium can be reported by fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you develop any of these symptoms, see your doctor immediately. Low levels of magnesium can also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to have you undergo regular blood tests to monitor magnesium levels.
• Skin rash, possible joint pain.

In very rare cases OMEPRAZOLO ARISTO PHARMA can affect white blood cells leading to
an immune deficiency. If you develop an infection with symptoms such as fever with
a serious deterioration of your 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, so that a lack of white blood cells
(agranulocytosis) can be ruled out 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.
If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your
doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
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 OMEPRAZOLO ARISTO PHARMA

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after Scad. The expiry date refers to the last day of the month.
• For Al/Al blisters: Store at a temperature below 30°C. Keep the blister in the original packaging to protect the medicine from moisture.
• For PCV-PVDC/Al blisters: Store at a temperature below 25°C. Keep the blister in the original packaging to protect the medicine from moisture.
• For bottles: This medicine does not require any particular storage temperature. Keep the bottle tightly closed 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 OMEPRAZOLO ARISTO PHARMA contains

• The active ingredient is omeprazole. OMEPRAZOLO ARISTO PHARMA 10 mg gastro-resistant hard capsules contain 10 mg of omeprazole. OMEPRAZOLO ARISTO PHARMA 20 mg gastro-resistant hard capsules contain 20 mg of omeprazole.
• The other ingredients are sugar spheres (sucrose and corn starch), hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), disodium phosphate dihydrate (E-339 ii), sodium lauryl sulfate, polysorbate 80, methacrylic acid-ethyl acrylate copolymer, triethyl citrate (E-1505). Capsule:gelatin, titanium dioxide (E-171), printing ink (black iron oxide (E-172), potassium hydroxide and shellac). See section 2 OMEPRAZOLO ARISTO PHARMA contains sucrose.

Description of the appearance of OMEPRAZOLO ARISTO PHARMA and contents of the pack
OMEPRAZOLO ARISTO PHARMA 10 mg capsules are hard gelatin capsules with an opaque white body printed with “OM 10”, containing granules.
OMEPRAZOLO ARISTO PHARMA 20 mg capsules are hard gelatin capsules with an opaque white body printed with “OM 20”, containing granules.
White HDPE bottles with a screw cap with a hermetic seal provided with a desiccant capsule:
14, 28, 90 and 100 capsules.
Al/Al blisters: 14 and 28 capsules.
PVC-PVDC/Al blisters: 14, 28, 30 and 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Esteve Pharmaceuticals, S.A.
Passeig de la Zona Franca, 109, 08038, Barcelona, Spain

Manufacturer responsible for batch release
TOWA Pharmaceutical Europe, S.L.
C/ de Sant Martí, 75-97, Martorelles, 08107 Barcelona, Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following denominations:
Belgium: Omeboix 10, 20, 40 mg gastro-resistant capsules
France: Omeprazole Alter 20 mg gastro-resistant capsule
Germany: Omeboix 10, 20, 40 mg acid-resistant hard capsules
Italy: Omeboix
Netherlands: Omecat 10, 20, 40 mg enteric coated capsules, hard
Poland: Omeboix
Portugal: Omeboix 20 & 40 mg gastroresistant capsule
Czech Republic: Omeboix
Romania: Omez 10, 20, 40 mg gastroresistant capsules
Spain: Omeprazol cinfa 40 mg hard gastroresistant capsule