ОМЕПРАЗОЛО 10 MG Enteric-coated hard capsule

Содержание инструкции

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

OMEPRAZOLO ABC 10 mg gastro-resistant hard capsules, 20 mg gastro-resistant hard capsules

Omeprazolo

Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could 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 ABC is and what it is used for
• 2. What you need to know before you take Omeprazolo ABC
• 3. How to take Omeprazolo ABC
• 4. Possible side effects
• 5. How to store Omeprazolo ABC
• 6. Contents of the pack and other information

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

Omeprazolo ABC 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 ABC 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 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 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 ABC can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excess acid in the stomach caused by an overgrowth 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 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 ABC

Do not take Omeprazolo ABC

• 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).

Do not take Omeprazolo ABC if you fall into any of the above-mentioned cases. If you have any doubts, ask your doctor or
pharmacist before taking Omeprazolo ABC.

Warnings and precautions
Talk to your doctor or pharmacist before taking Omeprazolo ABC.
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms
(DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with omeprazole treatment. Stop using Omeprazolo ABC and
consult your doctor immediately if you notice any of the symptoms related to these severe skin reactions
described in section 4.
Omeprazolo ABC may mask the symptoms of other diseases. Therefore, if you should experience the symptoms described below before taking Omeprazolo ABC 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.
• Darkening of the stools (presence of blood in the stools).
• Severe or persistent diarrhoea, because omeprazole has been associated with a slight increase in infectious diarrhoea;
• Severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazolo ABC that reduces stomach acid.
• You need to undergo a specific blood test (Chromogranin A).

If you take Omeprazolo ABC for a long time (more than a year) your doctor will prescribe regular check-ups.
Tell your doctor if you notice the appearance of new and unusual symptoms.
If you are taking a proton pump inhibitor such as Omeprazolo ABC, 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.
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 treatment with Omeprazolo ABC. Remember
to report any other undesirable effects such as joint pain.
This medicine may affect the way your body absorbs vitamin B12, especially if you
need to take it for a long period. Contact your doctor if you notice any of the following symptoms, which
may indicate low levels of vitamin B12:

• Extreme fatigue or lack of energy
• Tingling (paresthesia)
• Sore or red tongue, mouth ulcers
• Muscle weakness
• Blurred vision
• Memory problems, confusion, depression

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.

Children
Some children with chronic illnesses may require long-term treatment, although this is not
recommended.
Do not give this medicine to children under 1 year of age or weighing less than 10 kg.

Other medicines and Omeprazolo ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. Including over-the-counter medicines. This is important because Omeprazolo
ABC can affect the way some medicines work and, in turn, some medicines can
affect the action of Omeprazolo ABC.
Do not take Omeprazolo ABC if you are taking a medicine containing nelfinavir(used for
the treatment of HIV infections).

• ketoconazole, itraconazole, posaconazole 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 ABC;
• medicines used to thin the blood, such as warfarin or other vitamin K blockers. Your doctor will monitor you at the beginning and end of treatment with Omeprazolo ABC;
• 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 Omeprazolo ABC.

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

Omeprazolo ABC with food and drink
See section 3.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Omeprazole is excreted in breast milk but it is unlikely that when used at therapeutic doses it will have
effect on the baby.
The doctor will decide whether you can take Omeprazolo ABC during breastfeeding.

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

Omeprazolo ABC contains sucrose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.

Omeprazolo ABC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Omeprazolo ABC

Take this medicine following exactly the instructions of 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 dose is reported below:
Use in adults
For the treatment of symptoms of GERD such as heartburn and acid regurgitation:

• If your doctor has told you that your esophagus (the channel through which food passes) is slightly damaged, the recommended 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 recommended 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 recommended 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 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 recommended 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 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 recommended 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 recommended dose is 20 mg once a day for 4-8 weeks.

To prevent the formation ofduodenal and gastric ulcersif you are using NSAIDs:

• The recommended dose is 20 mg once a day.

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

• The recommended dose is 20 mg of Omeprazolo ABC twice a day for one week.
• Your doctor will tell you to also 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 recommended dose is 60 mg per day.
• Your doctor will adjust the dose according to your needs and also decide how long you should take the medicine.

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

• Omeprazolo ABC 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 Helicobacter
pyloriinfection:

• Omeprazolo ABC 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.
• 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 must 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 present 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. Solid particles contain the medicine - do not chew or crush them.

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

If you forget to take Omeprazolo ABC
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
forgotten dose.

If you stop taking Omeprazolo ABC
Do not stop taking Omeprazolo ABC without first talking to your doctor or pharmacist.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

If you notice any of the following rare (may affect up to 1 in 1,000) or very rare (may affect up to 1 in 10,000) but serious side effects, stop taking Omeprazolo
ABC 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) (rare)
• Reddening of the skin with the formation of blisters or peeling. Severe blistering with bleeding of the lips, eyes, mouth, nose and genitals may also appear. This may be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis” (very rare)
• Widespread skin rash, high temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (rare)
• A widespread red and scaly skin rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) (rare)
• Yellowing of the skin, dark urine and fatigue can 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) and 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, feeling sleepy.
• Feeling giddy (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 1,000)

• Changes in blood cell counts, 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.
• 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. 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)

• 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.
• Erythema multiforme.
• Muscle weakness.
• Enlargement of the breasts in men.

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

• Inflammation of the bowel (resulting in diarrhea).
• If you take Omeprazolo ABC for more than three months, your blood magnesium levels may decrease. Low magnesium levels can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low magnesium levels can also lead to a decrease in blood potassium or calcium levels. Your doctor should decide whether to check your blood magnesium levels periodically.
• Erythema, possible joint pain.

In very rare cases Omeprazolo ABC can affect white blood cells leading to immunodeficiency. If
you should develop an infection with symptoms such as fever with a severedeterioration of general health
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 as to exclude a lack of
white blood cells (agranulocytosis) by performing a blood test. It is important in this case to inform the
doctor about the medication you are taking.
Do not be worried by this list of possible side effects. You may not experience any of them.

Reporting of suspected adverse reactions
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 Omeprazolo ABC

Keep this medicine out of the reach and sight of children.
For the bottle:
Do not use this medicine after the expiry date which is stated on the packaging after Scad and after 28
days from the first opening of the bottle. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
The shelf life after first opening the bottle is 28 days (record the date of first opening
in the designated space on the packaging).
For the PVC-PVDC/Al blister:
do not store at a temperature above 25 °C.
Close the bottle tightly after use.
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 ABC contains
The active ingredient is omeprazole. Each capsule (gastro-resistant capsule) contains 10 mg or 20 mg of
omeprazole.

Omeprazolo ABC 10 mg gastro-resistant hard capsules contains 10 mg of omeprazole
The other ingredients are:
capsule content: hypromellose, talc, titanium dioxide (E171), ethyl acrylate copolymer of methacrylic acid,
triethyl citrate, sucrose spheres, disodium phosphate dihydrate.
Capsule shell: titanium dioxide (E171), purified water, gelatin, black ink.

Omeprazolo ABC 20 mg gastro-resistant hard capsules contains 20 mg of omeprazole
The other ingredients are:
capsule content: hypromellose, talc, titanium dioxide (E171), ethyl acrylate copolymer of methacrylic acid,
triethyl citrate, sucrose spheres, disodium phosphate dihydrate.
Capsule shell: titanium dioxide (E171), purified water, gelatin, black ink.

Description of the appearance of Omeprazolo ABC and contents of the pack
Gastro-resistant hard capsules
Omeprazolo ABC 10 mg: a bottle contains 14 gastro-resistant hard capsules of 10 mg
Omeprazolo ABC 20 mg: a bottle contains 14 gastro-resistant hard capsules of 20 mg
Omeprazolo ABC 10 mg: PVC-PVDC/Al blisters packs of 14 and 28 gastro-resistant hard capsules of 10
mg
Omeprazolo ABC 20 mg: PVC-PVDC/Al blisters packs of 14 and 28 gastro-resistant hard capsules of 20
mg

Marketing Authorisation Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Torino

Manufacturer
Towa Pharmaceutical Europe S.l. – C. de Sant Martì 75-97, 08107 Martorelles – Barcelona (Spain)