ОМЕПРАЗОЛО 10 мг Энтеросолидные капсулы

Содержание инструкции

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

OMEPRAZOLO ALMUS PHARMA 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 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 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. See section 4.

Contents of this leaflet:

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

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

OMEPRAZOLO ALMUS 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 ALMUS 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 ‘ 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). OMEPRAZOLO ALMUS PHARMA can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive 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 weighing 10 kg or more
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• ‘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 OMEPRAZOLO ALMUS PHARMA

Do not take OMEPRAZOLO ALMUS PHARMA

• 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 ALMUS PHARMA if you fall into any of the above-mentioned cases. If you have
any doubts, ask your doctor or pharmacist before taking OMEPRAZOLO ALMUS
PHARMA.

Warnings and precautions
Talk to your doctor or pharmacist before taking OMEPRAZOLO ALMUS PHARMA:

• If you have ever had a skin reaction after treatment with a medicine similar to OMEPRAZOLO ALMUS PHARMA that reduces stomach acid.
• 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 ALMUS PHARMA. Remember to report any other unwanted effects such as joint pain.
• If you are going to undergo a specific blood test (Chromogranin A).

OMEPRAZOLO ALMUS PHARMA can mask the symptoms of other diseases. Therefore, if
you experience the symptoms described below before taking OMEPRAZOLO ALMUS
PHARMA or while 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.
• Severe liver problems.

If you take OMEPRAZOLO ALMUS 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.
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If you take a proton pump inhibitor such as OMEPRAZOLO ALMUS PHARMA,
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.

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 ALMUS PHARMA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is important because OMEPRAZOLO ALMUS PHARMA can
affect how some medicines work and, in turn, some medicines can have
effects on the action of OMEPRAZOLO ALMUS PHARMA.
Do not take OMEPRAZOLO ALMUS PHARMA if you are taking a medicine containing

nelfinavir(used to treat HIV infections).
Tell your doctor or pharmacist if you are taking one or more of the following medicines:

• Ketoconazole, itraconazole, posaconazole 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 at the beginning and end of treatment with OMEPRAZOLO ALMUS 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 ALMUS PHARMA.
• 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 medicine used in high doses to treat cancer) - if you are taking methotrexate in high doses, your doctor may temporarily interrupt treatment with OMEPRAZOLO ALMUS PHARMA.

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin together with OMEPRAZOLO
ALMUS PHARMA for the treatment of ulcers caused by Helycobacter pyloriinfections, it is
very important that you tell your doctor if you are taking any other medicines.
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OMEPRAZOLO ALMUS PHARMA with food and drink
The capsules can be taken with food or on an empty stomach.

Pregnancy and breastfeeding
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 ALMUS PHARMA during this period.
Omeprazole is excreted in breast milk but it is unlikely that when used at therapeutic doses
it will have an effect on the baby. The doctor will decide whether you can take OMEPRAZOLO ALMUS
PHARMA during breastfeeding.

Driving and operating machinery
It is unlikely that OMEPRAZOLO ALMUS PHARMA will affect your ability to drive
vehicles or 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, you should not drive vehicles or operate
machinery.

OMEPRAZOLO ALMUS PHARMA containssucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.

OMEPRAZOLO ALMUS PHARMA containssodium.
This medicine contains less than 1 mmol (23 mg) of sodium per hard gastro-resistant capsule,
which is essentially ‘sodium-free’.

3. How to take OMEPRAZOLO ALMUS PHARMA

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist. The 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 recommended dose is 20 mg once a day for 4-8 weeks. The doctor may increase the dose to 40 mg for another 8 weeks if the esophagus is not yet completely 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. 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 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 recommended 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.

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To preventthe recurrence of duodenal and gastric ulcers:

• The recommended 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 recommended 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 recommended dose is 20 mg once a day.

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

• The recommended dose is 20 mg of OMEPRAZOLO ALMUS PHARMA twice a day for one week.
• The 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.
• The 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 reflux:

• OMEPRAZOLO ALMUS PHARMA can be taken by children over one 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
Helycobacter pylori:

• OMEPRAZOLO ALMUS PHARMA 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: 5/10
• 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 OMEPRAZOLO ALMUS PHARMA than you should
If you take an amount of OMEPRAZOLO ALMUS PHARMA greater than that prescribed by
your doctor, seek immediate medical attention or contact your pharmacist.

If you forget to take OMEPRAZOLO ALMUS PHARMA
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 dose.

If you stop taking OMEPRAZOLO ALMUS PHARMA
Do not stop taking OMEPRAZOLO ALMUS PHARMA 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 but serious side effects, stop taking
OMEPRAZOLO ALMUS PHARMA and contact your doctor immediately:

• Sudden difficulty breathing, 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. Severe blistering 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:
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Other side effects include:

Common side effects

• Headache.
• Effects on the stomach or intestines: diarrhoea, 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 discomfort and lack of energy.
• If you take a proton pump inhibitor such as OMEPRAZOLO ALMUS PHARMA, 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.

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.
• Problems with vision, such as blurred vision.
• Sudden difficulty breathing 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.

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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 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.
• Breast enlargement in men.

Frequency not known

• Inflammation of the intestine (resulting in diarrhoea). If you take OMEPRAZOLO ALMUS PHARMA for more than three months, the levels of magnesium in your blood may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness and increased heart rate. If you have 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. Your doctor should decide whether to periodically check the levels of magnesium in the blood.
• Reduction of calcium levels in the blood (hypocalcemia). The reduction of calcium levels in the blood may result from very low levels of magnesium.
• Reduction of potassium levels in the blood (hypokalaemia).
• Erythema, possible joint pains.

In very rare cases OMEPRAZOLO ALMUS PHARMA may affect white blood cells leading to
an immune deficiency. If you should develop an infection with symptoms such as fever with a

severedeterioration of the general state of 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, 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 be worried by 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
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 OMEPRAZOLO ALMUS PHARMA

Keep this medicine out of the sight and reach of children
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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 package, 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 ALMUS PHARMA contains

• The active ingredient is omeprazole. Each capsule contains 10 mg, 20 mg or 40 mg of omeprazole as gastro-resistant granules.
• Other ingredients are: Capsule core:sugar spheres (sucrose and corn starch), sodium carboxymethylcellulose (Type A), sodium lauryl sulfate, povidone, trisodium phosphate dodecahydrate, hypromellose, ethyl acrylate-methacrylic acid copolymer (1:1), triethyl citrate, titanium dioxide (E171), talc, sodium hydroxide. Capsule cap:red iron oxide (E172) (only 10 mg), erythrosine (E127), indigotine (E132) (only 20 mg and 40 mg) titanium dioxide (E171), water, gelatin. Capsule body:Quinoline Yellow (E104), erythrosine (E127), titanium dioxide (E171), water, gelatin. Printing ink:shellac, povidone, propylene glycol, sodium hydroxide, titanium dioxide (E171).

Description of the appearance of OMEPRAZOLO ALMUS PHARMA and contents of the pack
OMEPRAZOLO ALMUS PHARMA 10 mg:
Size 3 hard gelatin capsules with an opaque red cap and an opaque orange body.
The letter “O” has been printed on the cap and the number “10” on the body with white ink.
The capsules are filled with white to beige-colored pelletized microgranules.
Blister packs containing 14 and 28 capsules.
OMEPRAZOLO ALMUS PHARMA 20 mg:
Size 2 hard gelatin capsules with an opaque blue cap and an opaque orange body.
The letter “O” has been printed on the cap and the number “20” on the body with white ink.
The capsules are filled with white to beige-colored pelletized microgranules.
Blister packs containing 14 and 28 capsules.
OMEPRAZOLO ALMUS PHARMA 40 mg:
Size 0 hard gelatin capsules with an opaque blue cap and an opaque orange body.
The letter “O” has been printed on the cap and the number “40” on the body with white ink.
The capsules are filled with white to beige-colored pelletized microgranules.
Blister packs containing 14 capsules.
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Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmacare S.r.l.
Via Marghera, 29
20149 Milan
Italy

Manufacturer
TEVA Pharma S.L.U.
Poligono Industrial Malpica, calle C., number 4
50016 Zaragoza Spain
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