OMEPRAZEN - PACKAGE LEAFLET - LEAFLETS

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Omeprazen - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

Active ingredients: Omeprazole

OMEPRAZEN 10 mg gastro-resistant hard capsules
OMEPRAZEN 20 mg gastro-resistant hard capsules
OMEPRAZEN 40 mg gastro-resistant hard capsules

Why is Omeprazen used? What is it for?

OMEPRAZEN contains the active substance omeprazole. It belongs to a group of medicines called 'proton pump inhibitors' which work by reducing the amount of acid produced by the stomach.

OMEPRAZEN is used to treat the following conditions:

In adults:

"Gastro-oesophageal reflux disease" (GERD). This disease occurs when acid escapes from the stomach and passes into the esophagus (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 stomach (gastric ulcer).
Ulcers infected with a bacterium called "Helicobacter pylori". If you have 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). OMEPRAZEN can also be used to prevent ulcers from forming if you are taking NSAIDs.
Excessive stomach acid caused by tissue growth in the pancreas (Zollinger-Ellison syndrome).

In children:

Children older than 1 year and with a body weight greater than or equal to 10 kg

"Gastro-oesophageal reflux disease" (GERD). This disease occurs when acid escapes from the stomach and passes into the esophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn. In children, symptoms of this disease also include returning to the mouth of the stomach. stomach contents (regurgitation), being sick (vomiting) and low weight gain.

Children over 4 years of age and adolescents

Ulcers infected with a bacterium called "Helicobacter pylori". If the child has this disease, the doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Contraindications When Omeprazen should not be used

Do not take OMEPRAZEN

If you are allergic (hypersensitive) to omeprazole or any of the other ingredients of OMEPRAZEN.
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 are unsure, ask your doctor or pharmacist before taking OMEPRAZEN.

Precautions for use What you need to know before taking Omeprazen

OMEPRAZEN can hide the symptoms of other diseases. Therefore, if you experience the symptoms described below before taking OMEPRAZEN or while you are taking it, contact your doctor immediately:

Unmotivated weight loss and swallowing problems.
Stomach pain or indigestion.
Vomiting of food or blood.
Dark discoloration of the stool (presence of blood in the stool).
Severe or persistent diarrhea, because omeprazole has been associated with a slight increase in contagious diarrhea.
Severe liver problems.

If you have been taking OMEPRAZEN for a long time (more than 1 year) your doctor will prescribe regular checkups. Tell your doctor if you notice any new and unusual symptoms.

If you take a proton pump inhibitor such as OMEPRAZEN, especially for longer than one year, you may have a slightly increased risk of fracture of the hip, wrist or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis) consult your doctor.

Interactions Which drugs or foods may change the effect of Omeprazen

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.This is important because OMEPRAZEN can affect the way some medicines work and some medicines can affect the way OMEPRAZEN works.

Do not take OMEPRAZEN 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 or voriconazole (used to treat infections caused by fungi)
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 start and end of treatment with OMEPRAZEN.
Medicines used to thin the blood, such as warfarin or other vitamin K blockers. Your doctor will monitor you at the start and end of treatment with OMEPRAZEN.
Rifampicin (used to treat tuberculosis)
Atazanavir (used to treat HIV infection)
Tacrolimus (used in organ transplants)
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 for cancer treatment)
Methotrexate (a chemotherapy medicine used in high doses to treat cancer) - if you are taking methotrexate in high doses, your doctor may temporarily stop taking Omeprazen.

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

Taking OMEPRAZEN with food and drink

The capsules can be taken with food or on an empty stomach.

Warnings It is important to know that:

Pregnancy and breastfeeding

Before taking OMEPRAZEN tell your doctor if you are pregnant or want to become pregnant. Your doctor will decide whether you can take OMEPRAZEN during this time.

Your doctor will decide whether you can take OMEPRAZEN if you are breastfeeding.

Driving and using machines

OMEPRAZEN is unlikely to affect your ability to drive or use tools or machines. Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4). If you suffer from this, you should not drive or operate machinery.

Important information about some of the ingredients of OMEPRAZEN

OMEPRAZEN capsules contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Dose, Method and Time of Administration How to use Omeprazen: Posology

Always take OMEPRAZEN exactly as your doctor has told you. If in doubt, 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 given below.

Adults:

To treat symptoms of GERD, such as heartburn and acid regurgitation:

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 has 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 this dose for another 2 weeks if the ulcer has not yet healed.
If the ulcer does not fully heal, the dose can 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 a day for 4 weeks. Your doctor may extend this dose for another 4 weeks if the ulcer has not yet healed.
If the ulcer does not fully heal, the dose can be increased to 40 mg once daily for 8 weeks.

To prevent duodenal and stomach ulcers from returning:

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 duodenal and stomach ulcers from forming if you are using NSAIDs:

The usual dose is 20 mg once a day.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their reappearance:

The usual dose is 20 mg of OMEPRAZEN twice a day for one week.
Your doctor will tell you to also take two antibiotics including amoxicillin, clarithromycin and metronidazole.

To treat too much 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 will also decide how long you need to take the medicine.

Children:

To treat symptoms of GERD, such as heartburn and acid regurgitation:

OMEPRAZEN can be taken by children over 1 year of age and with a body weight of more than 10 kg. The dose for children is based on the child's weight and the doctor will decide the correct dose.

For the treatment and prevention of the recurrence of ulcers caused by Helicobacter pylori infection:

OMEPRAZEN can be taken by children over 4 years of age. The dose for children is based on the child's weight and the correct dose will be decided by the doctor.
Your doctor will also prescribe two antibiotics called weoxicillin and clarithromycin for 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 stomach acid. It is important not to damage the granules.

What to do if you or the child have trouble swallowing the capsules

If you or the child have trouble 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-sparkling), acidic fruit juice (e.g. apple, orange or pineapple) or apple puree.
Always shake the contents before drinking (the mixture will not be clear), then drink the preparation immediately or within 30 minutes.
To make sure that you have taken all of 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.

Overdose What to do if you have taken too much Omeprazen

If you take more OMEPRAZEN than you should

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

If you forget to take OMEPRAZEN

If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

Side Effects What are the side effects of Omeprazen

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

If you notice any of the following rare but serious side effects, stop taking OMEPRAZEN and contact your doctor immediately:

Sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulty in swallowing (severe allergic reaction).
Skin redness with blistering or peeling. Severe blistering may also appear with bleeding of the lips, eyes, mouth, nose and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
Yellow skin, dark urine and tiredness could be symptoms of liver problems.

Side effects can occur with a certain frequency, as defined below:

Very common: occur in more than 1 in 10 patients Common: it occurs in 1 to 10 patients in 100 Uncommon: affects 1 to 10 users in 1,000 Rare: affects 1 to 10 users in 10,000 Very rare: occur in less than 1 in 10,000 patients Not known: frequency cannot be estimated from the available data

The other side effects include:

Common side effects

Headache.
Effects on the stomach or intestines: diarrhea, stomach pain, constipation, wind (flatulence).
Feeling sick (nausea) or being sick (vomiting).

Uncommon side effects

Swelling of the feet and ankles.
Disturbed sleep (insomnia).
Dizziness, tingling, feeling sleepy.
Sensation of spinning (vertigo).
Changes in blood tests related to liver function.
Rash, rash with swelling of the skin (hives) and itching on the skin.
General feeling of being unwell and lack of energy.
If you take a proton pump inhibitor such as OMEPRAZEN, especially for longer than one year, you may have a slightly increased risk of fracture of the hip, wrist or spine. If you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis) consult your doctor.

Rare side effects

Changes in the composition of the blood, such as a reduction in the number of white blood cells or platelets. This can cause weakness and easy bruising, or it can make infections more likely.
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, being sick (vomiting) and cramps.
Feeling agitated, confused or depressed.
Changes in taste.
Problems with your eyesight, such as blurred vision.
Sudden wheezing or shortness of breath (bronchospasm).
Dry mouth
Inflammation inside the mouth.
An infection called "thrush" which can affect the gut and is caused by a fungus.
Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
Hair loss (alopecia).
Skin rash on exposure to the sun.
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 about unreal events (hallucinations).
Severe liver problems up to liver failure and inflammation of the brain.
Sudden onset of severe rash or blistering 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.
Chest enlargement in men.

Unknown side effects

Inflammation of the intestine (resulting in diarrhea)
If you take OMEPRAZEN for more than three months, your blood levels of magnesium may drop. Low magnesium levels can manifest themselves with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, please consult your doctor immediately. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor should decide whether to check your blood magnesium levels periodically.
Reduction in blood calcium levels (hypocalcaemia). The reduction in blood calcium levels can result from very low magnesium levels.

In very rare cases OMEPRAZEN can affect white blood cells leading to immune deficiency. If you develop an "infection with symptoms such as fever with a severe deterioration in general health or fever with symptoms of local infection such as pain in the neck, throat or mouth or difficulty urinating, you should see your doctor as soon as possible, in to rule out a lack of white blood cells (agranulocytosis) by carrying out a blood test It is important that in this case you tell your doctor what medicine you are taking.

Do not worry about the list of possible side effects. You may not get any. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national system of the Italian Medicines Agency (website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse). By reporting side effects you can help to provide more information on the safety of this medicine.

Expiry and Retention

Keep OMEPRAZEN out of the reach and sight of children.
Do not use OMEPRAZEN after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of the month.
Do not store above 30 ° C.
Keep the blister in the original package or keep the bottle tightly closed to protect the medicine from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Composition and pharmaceutical form

What OMEPRAZEN contains

The active ingredient is omeprazole. OMEPRAZEN gastro-resistant hard capsules contain 10 mg, 20 mg or 40 mg of omeprazole.
The other ingredients are disodium phosphate dihydrate, hydroxypropylcellulose, hypromellose, anhydrous lactose, magnesium stearate, mannitol, methacrylic acid - ethyl acrylate copolymer (1: 1) dispersion 30%, microcrystalline cellulose, macrogol (polyethylene glycol 400), sodium lauryl sulfate E172, titanium dioxide E171, gelatin, printing ink (contains shellac, ammonia, potassium hydroxide and black iron oxide E172), anhydrous colloidal silica and liquid paraffin.

Description of what OMEPRAZEN looks like and contents of the pack

OMEPRAZEN 10 mg capsules have a pink body, imprinted with "10", and a pink cap imprinted with "A / OS".
OMEPRAZEN 20 mg capsules have a pink body, imprinted with "20", and a reddish-brown cap imprinted with "A / OM".
OMEPRAZEN 40 mg capsules have a reddish-brown body, imprinted with "40" and a reddish-brown cap imprinted with "A / OL".

Packaging:

10 mg: Blisters containing 14, 28 and 35 capsules.
20 mg: Blister containing 14 capsules.
40mg: HDPE bottle containing 14 capsules;

Not all pack sizes may be marketed.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Omeprazen can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction 04.6 Pregnancy and lactation 04.7 Effects on ability to drive and use machines 04.8 Undesirable effects 04.9 Overdose 05.0 PHARMACOLOGICAL PROPERTIES 05.1 Pharmacodynamic properties 05.2 Pharmacokinetic properties 05.3 Preclinical safety data 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the primary packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER CIO 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

OMEPRAZEN HARD GASTRORESISTANT CAPSULES

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

10 mg: Each capsule contains 10 mg of omeprazole.

20 mg: Each capsule contains 20 mg of omeprazole.

40 mg: Each capsule contains 40 mg of omeprazole.

Excipients:

10 mg: Each capsule contains 4 mg of lactose.

20 mg: Each capsule contains 8 mg of lactose.

40 mg: Each capsule contains 9 mg of lactose.

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM

Hard gastro-resistant capsule.

10 mg: Hard gelatin capsules with opaque pink body, imprinted with "10" and opaque pink cap imprinted with "A / OS", containing gastro-resistant granules.

20 mg: Hard gelatin capsules with opaque pink body, imprinted with "20" and opaque reddish-brown cap imprinted with "A / OM", containing gastro-resistant granules.

40 mg: Hard gelatin capsules with reddish-brown body, imprinted "40" and opaque reddish-brown cap imprinted with A / OL, containing gastro-resistant granules.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

OMEPRAZEN capsules are indicated for:

Adults

• Treatment of duodenal ulcers

• Prevention of recurrence of duodenal ulcers

• Treatment of gastric ulcers

• Prevention of recurrence of gastric ulcers

• Eradication of Helicobacter pylori (H. pylori) in peptic ulcer, in association with appropriate antibiotic therapy

• Treatment of gastric and duodenal ulcers associated with the use of NSAIDs

• Prevention of gastric and duodenal ulcers associated with the use of NSAIDs in patients at risk

• Treatment of reflux esophagitis

• Long-term management of patients with healed reflux esophagitis

• Treatment of symptomatic gastroesophageal reflux disease

• Treatment of Zollinger-Ellison syndrome

Pediatric use

Children over 1 year of age and with a body weight ≥ 10 kg

• Treatment of reflux esophagitis

• Symptomatic treatment of heartburn and acid regurgitation in gastroesophageal reflux disease

Children and adolescents over 4 years of age

• Treatment of duodenal ulcer caused by H. pylori, in association with antibiotic therapy

04.2 Posology and method of administration

Dosage in adults

Treatment of duodenal ulcer

The recommended dose in patients with active duodenal ulcer is OMEPRAZEN 20 mg once daily. In most patients, ulcer healing is achieved within two weeks of starting treatment. In the case of ulcers that have not completely healed during the first course of treatment, healing is usually achieved during prolonged treatment for another two weeks. In patients with poorly responsive duodenal ulcer Omeprazen 40 mg once daily is recommended and healing is usually achieved within four weeks.

Prevention of relapse of duodenal ulcer

For the prevention of duodenal ulcer recurrence in negative patients H. pylori or when the eradication of H. pylori this is not possible, the recommended dose is OMEPRAZEN 20 mg once daily. In some patients a dose of 10 mg may be sufficient. In case of therapeutic failure, the dose can be increased to 40 mg.

Treatment of gastric ulcer

The recommended dose is OMEPRAZEN 20 mg once daily. In most patients, healing is achieved within four weeks of starting treatment. In the case of ulcers that have not completely healed after the first course of treatment, healing is usually achieved during prolonged treatment for another four weeks. In patients with ulcers. gastric poorly responsive, administration of OMEPRAZEN 40 mg once daily is recommended and healing is generally achieved within eight weeks.

Prevention of relapse in patients with gastric ulcer

For the prevention of relapse in patients with poorly responsive gastric ulcer, the recommended dose is OMEPRAZEN 20 mg once daily. If necessary, the dose can be increased to Omeprazen 40 mg once daily.

Eradication of H. pylori in peptic ulcer

For the "eradication of"H. pylori, Antibiotic selection should be based on the patient's individual drug tolerance and therapy should be undertaken according to local, regional, national resistance patterns and treatment guidelines.

• OMEPRAZEN 20 mg + clarithromycin 500 mg + amoxicillin 1,000 mg, each twice daily for one week, or

• OMEPRAZEN 20 mg + clarithromycin 250 mg (alternatively 500 mg) + metronidazole 400 mg (or 500 mg or tinidazole 500 mg), each twice daily for one week or

• OMEPRAZEN 40 mg once daily with amoxicillin 500 mg and metronidazole 400 mg (or 500 mg or tinidazole 500 mg), both three times a day for one week.

For each of the treatment regimens, should the patient still test positive for H. pylori therapy can be repeated.

Treatment of gastric and duodenal ulcers associated with the intake of NSAIDs

For the treatment of NSAID-associated gastric and duodenal ulcers, the recommended dose is OMEPRAZEN 20 mg once daily. In most patients, healing is achieved within four weeks of starting treatment. In patients not completely healed after the first course of treatment, healing is usually achieved by extending treatment for another four weeks.

Prevention of gastric and duodenal ulcers associated with the use of NSAIDs in patients at risk

For the prevention of gastric or duodenal ulcers associated with the use of NSAIDs in patients at risk (age> 60, history of gastric and duodenal ulcers, history of upper gastrointestinal bleeding) the recommended dose is OMEPRAZEN 20 mg once daily.

Treatment of reflux esophagitis

In patients with severe oesophagitis, OMEPRAZEN 40 mg once daily is recommended to achieve healing usually within eight weeks.

Long-term management of patients with healed reflux oesophagitis

For the long-term management of patients with healed reflux oesophagitis, the recommended dose is OMEPRAZEN 10 mg once daily. If necessary, the dose can be increased to Omeprazen 20-40 mg once daily.

Treatment of symptomatic gastroesophageal reflux disease

The recommended dose is OMEPRAZEN 20 mg per day. Patients can respond adequately to the 10 mg daily dose, therefore individual dose adjustment should be considered.

If symptomatic control is not achieved after four weeks of treatment with OMEPRAZEN 20 mg daily, further investigation is advised.

Treatment of Zollinger-Ellison syndrome

In patients with Zollinger-Ellison syndrome, dosage should be individually adjusted and treatment continued for as long as clinically indicated. The recommended starting dose is OMEPRAZEN 60 mg per day. All patients with severe disease who responded poorly to other therapies maintained effective control and control was maintained in more than 90% of patients with OMEPRAZEN doses between 20 mg and 120 mg / day. Daily dosages above 80 mg should be divided into two daily administrations.

Dosage in children

Children over 1 year of age and with a body weight ≥ 10 kg

Treatment of reflux esophagitis

Symptomatic treatment of heartburn and acid regurgitation in gastroesophageal reflux disease

The recommended doses are as follows:

Age Weight Dosage ≥1 year of age 10-20 kg 10 mg once a day. The dose can be increased to 20 mg once daily if needed ≥2 years of age > 20 kg 20 mg once a day. The dose can be increased to 40 mg once daily if needed

Reflux esophagitis: The treatment period is 4-8 weeks.

Symptomatic treatment of heartburn and acid regurgitation in gastroesophageal reflux disease:

The treatment lasts 2-4 weeks. If symptomatic control is not achieved after 2-4 weeks, the patient should be further investigated.

Children and adolescents over 4 years of age

Treatment of duodenal ulcer caused by H. pylori

Official local, regional and national guidelines regarding bacterial resistance, duration of treatment (most commonly 7 days, but sometimes up to 14 days) and appropriate use of antibiotics should be considered when selecting the appropriate combination therapy.

The treatment must be carried out under the supervision of a specialist.

The recommended posology is as follows:

Weight Dosage 15-30 kg Combination with two antibiotics: OMEPRAZEN 10 mg, amoxicillin 25 mg / kg body weight and clarithromycin 7.5 mg / kg body weight, all administered simultaneously twice daily for one week. 31-40 kg Combination with two antibiotics: OMEPRAZEN 20 mg, amoxicillin 750 mg and clarithromycin 7.5 mg / kg body weight are all administered twice daily for one week. > 40 kg Combination with two antibiotics: OMEPRAZEN 20 mg, amoxicillin 1 g and clarithromycin 500 mg, are all administered twice daily for one week.

Special populations

Impaired renal function

No dosage adjustment is required in patients with impaired renal function (see section 5.2).

Impaired liver function

In patients with impaired hepatic function, a daily dose of 10-20 mg may be sufficient (see section 5.2).

Elderly (> 65 years)

No dosage adjustment is required in elderly patients (see section 5.2).

Method of administration

It is recommended to take the OMEPRAZEN capsules in the morning, preferably on an empty stomach, swallowed whole with half a glass of water. The capsules should not be chewed or crushed.

For patients with swallowing difficulties and for children who can drink or swallow semi-solid foods

Patients can open the capsule and swallow the contents with half a glass of water, or mixed with slightly acidic liquids such as fruit juice or apple puree or still water. Patients should be advised that in these cases the dispersion should be swallowed immediately (or within 30 minutes) and that it should always be mixed just before drinking. Rinse the bottom with half a glass of water and drink the contents.

Alternatively, patients can dissolve the capsule in the mouth and swallow the contained granules with half a glass of water. The gastro-resistant granules should not be chewed.

04.3 Contraindications

Hypersensitivity to omeprazole, benzimidazole substitutes or to any of the excipients.

Omeprazole, like other proton pump inhibitors (PPIs), should not be administered concomitantly with nelfinavir (see section 4.5).

04.4 Special warnings and appropriate precautions for use

In the presence of certain alarm symptoms (eg significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when the presence of a gastric ulcer is suspected or confirmed, the malignant nature of the ulcer must be excluded as symptomatic response to therapy may delay a correct diagnosis.

Co-administration of atazanavir and proton pump inhibitors is not recommended (see section 4.5). If the combination of atazanavir and proton pump inhibitor is judged unavoidable, careful clinical monitoring (eg viral load) is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; the dose of omeprazole it must not exceed 20 mg.

Omeprazole, like all acid-suppressive medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be taken into consideration in patients with low reserves or risk factors for reduced vitamin absorption. B12 in case of long-term therapies.

Omeprazole is a CYP2C19 inhibitor. Potential interaction with drugs metabolised by CYP2C19 should be considered at the initiation or end of treatment with omeprazole. An interaction between clopidogrel and omeprazole is observed (see section 4.5). The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of clopidogrel and omeprazole should be discouraged (see section 4.5).

Interference with laboratory tests

The increased CgA level may interfere with investigations for neuroendocrine tumors. To avoid this interference, omeprazole treatment should be stopped at least five days before the start of CgA measurements (see section 5.1).

Proton pump inhibitors (PPIs) such as omeprazole have been shown to cause severe hypomagnesaemia in patients treated for at least three months and in many cases for one year. Serious symptoms of hypomagnesaemia include fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia. They can initially manifest insidiously and be neglected. Hypomagnesaemia in most patients improves after taking magnesium and discontinuing the proton pump inhibitor.

Healthcare professionals should consider measuring magnesium levels before initiating PPI treatment and periodically during treatment in patients on prolonged therapy or on therapy with digoxin or drugs that can cause hypomagnesaemia (eg diuretics). Severe hypomagnesaemia can produce hypocalcemia.

Proton pump inhibitors, especially when used in high doses and for prolonged periods (> 1 year), may cause a slightly increased risk of hip, wrist and spine fractures, especially in elderly patients or in the presence of other known risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10% to 40%. This increase may be partly due to other risk factors. Patients at risk of osteoporosis should receive treatment according to current clinical practice guidelines and must take an "adequate amount of vitamin D and calcium.

Some children with chronic conditions may need long-term treatment although it is not recommended.

OMEPRAZEN contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Treatment with proton pump inhibitors may cause a slightly increased risk of gastrointestinal infections such as those from Salmonella And Campylobacter (see section 5.1).

As with all long-term treatments, especially if the duration of treatment is greater than 1 year, patients should be monitored regularly.

04.5 Interactions with other medicinal products and other forms of interaction

Influence of omeprazole on the pharmacokinetics of other active substances

Active ingredients with pH-dependent absorption

Gastric pH-dependent absorption of active substances may be increased or decreased by decreased intragastric acidity during treatment with omeprazole.

Nelfinavir, atazanavir

Plasma levels of nelfinavir and atazanavir decrease when omeprazole is co-administered.

Concomitant administration of omeprazole and nelfinavir is contraindicated (see section 4.3). Co-administration of omeprazole (40 mg once daily) reduced the mean exposure of nelfinavir by approximately 40% and reduced the mean exposure of the pharmacologically active metabolite M8 by approximately 75-90%. The interaction may also involve inhibition of CYP2C19.

Concomitant administration of omeprazole and atazanavir is not recommended (see section 4.4). Co-administration of omeprazole (40 mg once daily) and atazanavir 300 mg / ritonavir 100 mg to healthy volunteers resulted in a 75% reduction in atazanavir exposure. The increase in atazanavir dose to 400 mg did not offset the impact of omeprazole on atazanavir exposure. Co-administration of omeprazole (20 mg once daily) and atazanavir 400 mg / ritonavir 100 mg to healthy volunteers resulted in an approximately 30% reduction in atazanavir exposure compared to atazanavir 300 mg / ritonavir 100 mg once. per day.

Digoxin

Concomitant treatment with omeprazole (20 mg / day) and digoxin in healthy subjects resulted in a 10% increase in the bioavailability of digoxin. Digoxin toxicity has rarely been reported. However, caution is advised in the use of high doses of omeprazole in elderly patients. Therapeutic monitoring of digoxin should therefore be increased.

Clopidogrel

Results from studies in healthy patients showed a "pharmacokinetic (PK) / pharmacodynamic (PD) interaction between clopidogrel (loading dose 300 mg / maintenance dose 75 mg per day) and omeprazole (80 mg po per day), resulting in a mean decrease of 46% in exposure to the active metabolite of clopidogrel and a mean decrease of 16% in maximal inhibition (ADP induced) of platelet aggregation.

Diverging data from observational and clinical studies have been reported on the clinical implications of a PK / PD interaction of omeprazole in terms of major cardiovascular events. As a precaution, concomitant use of omeprazole and clopidogrel should be discouraged (see section 4.4).

Other active ingredients

The absorption of posaconazole, erlotinib, ketoconazole and itraconazole is significantly reduced and therefore clinical efficacy may be compromised. Concomitant use of posaconazole and erlotinib should be avoided.

Active substances metabolised by CYP2C19

Omeprazole is a moderate inhibitor of its main metabolising enzyme, CYP2C19. Therefore, the metabolism of concomitant active substances also metabolised by CYP2C19 may be decreased and systemic exposure to these substances increased. Examples of such drugs are R-warfarin and other vitamin K antagonists, cilostazol, diazepam and phenytoin.

Cilostazol

Omeprazole, given at a dose of 40 mg to healthy volunteers in a cross-over study, increased the Cmax and AUC of cilostazol by 18% and 26% respectively and of one of its active metabolites by 29% and 69% respectively. .

Phenytoin

Monitoring of phenytoin plasma concentration is recommended during the first two weeks after starting omeprazole treatment and, if a phenytoin dose adjustment is required, monitoring and further dose adjustment is recommended when ending treatment. with omeprazole.

Mechanism unknown

Saquinavir

Concomitant administration of omeprazole and saquinavir / ritonavir resulted in increased plasma levels of saquinavir up to approximately 70% with good tolerability in HIV-positive patients.

Tacrolimus

Concomitant administration of omeprazole has been reported to increase the serum levels of tacrolimus. Monitoring of tacrolimus concentrations and renal function (creatinine clearance) should be increased and, if necessary, the tacrolimus dosage adjusted.

Methotrexate

When given together with proton pump inhibitors, an increase in methotrexate levels has been reported in some patients. When methotrexate is administered in high doses, a temporary withdrawal of omeprazole may need to be considered.

Influence of other active substances on the pharmacokinetics of omeprazole

CYP2C19 and / or CYP3A4 inhibitors

As omeprazole is metabolised by CYP2C19 and CYP3A4, the active substances inhibiting CYP2C19 or CYP3A4 (such as clarithromycin and voriconazole) may increase the serum levels of omeprazole, decreasing its rate of metabolism. Co-administration of voriconazole results in more than doubled exposure to omeprazole. Since the administration of high doses of omeprazole was well tolerated, no dose adjustment of omeprazole is generally necessary. However, dose adjustment should be made. considered in patients with severe hepatic impairment and in the case of long-term treatment.

Inducers of CYP2C19 and / or CYP3A4

Active substances inducing CYP2C19 or CYP3A4 or both (such as rifampicin and St. John's wort) may cause a decrease in the serum levels of omeprazole, increasing its metabolic rate.

04.6 Pregnancy and lactation

The results of three prospective epidemiological studies (more than 1000 exposed patient outcomes) indicate no undesirable effects of omeprazole on pregnancy or on the health of the fetus / newborn. Omeprazole can be used during pregnancy.

Omeprazole is excreted in breast milk but is unlikely to affect the infant when administered in therapeutic doses.

04.7 Effects on ability to drive and use machines

OMEPRAZEN is unlikely to affect the ability to drive or use machines. Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4.8). If they suffer from it, patients should not drive or operate machinery.

04.8 Undesirable effects

The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhea, flatulence, nausea / vomiting.

The following adverse reactions, identified or suspected, have been highlighted during clinical trials with omeprazole and post-marketing. In no case was a correlation with the administered drug dose established. Undesirable effects are classified according to frequency and Organ Classification System (SOC). Frequency categories are defined using the following convention: Very common (≥1 / 10), Common (≥1 / 100 to

SOC / frequency Side effects Disorders of the blood and lymphatic system Rare: Leukopenia, thrombocytopenia Very rare: Agranulocytosis, pancytopenia Disorders of the immune system Rare: Hypersensitivity reactions, e.g., fever, angioedema and anaphylactic reaction / shock Metabolism and nutrition disorders Rare: Hyponatremia Not known: Hypomagnesaemia (see section 4.4 Special warnings and precautions for use); hypocalcemia * Psychiatric disorders Uncommon: Insomnia Rare: Agitation, confusion, depression Very rare: Aggression, hallucinations Nervous system disorders Common: Headache Uncommon: Dizziness, paraesthesia, somnolence Rare: Changes in taste Eye disorders Rare: Blurred vision Ear and labyrinth disorders Uncommon: Dizziness Respiratory, thoracic and mediastinal disorders Rare: Bronchospasm Gastrointestinal disorders Common: Abdominal pain, constipation, diarrhea, flatulence, nausea / vomiting Rare: Dry mouth, stomatitis, gastrointestinal candidiasis Not known: Microscopic colitis Hepatobiliary disorders Uncommon: Elevation of liver enzyme values Rare: Hepatitis with or without jaundice Very rare: Hepatic failure, encephalopathy in patients with pre-existing liver disease Skin and subcutaneous tissue disorders Uncommon: Dermatitis, itching, rash, hives Rare: Alopecia, photosensitization Very rare: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN) Musculoskeletal and connective tissue disorders Uncommon: Fracture of the hip, wrist or spine (see section 4.4 Special warnings and precautions for use) Rare: Arthralgia, myalgia Very rare: Muscle weakness Renal and urinary disorders Rare: Interstitial nephritis Diseases of the reproductive system and breast Very rare: Gynecomastia General disorders and administration site conditions Uncommon: Malaise, peripheral edema Rare: Increased sweating

* hypocalcemia can result from severe hypomagnesaemia.

Pediatric population

The safety of omeprazole was evaluated in a total of 310 children aged 0 to 16 years with acid-related disease. Limited long-term data are available in 46 children who received omeprazole maintenance therapy for up to 749 days in a clinical study in severe erosive esophagitis. The adverse event profile was generally the same as in adults. in both short-term and long-term treatment There are no long-term data regarding the effects of omeprazole treatment on puberty and growth.

04.9 Overdose

Limited information is available regarding overdose with omeprazole in humans. Doses up to 560 mg have been reported in the literature and there have been occasional reports of single oral doses up to 2400 mg of omeprazole (120 times the usually recommended clinical dose).

Nausea, vomiting, dizziness, abdominal pain, diarrhea and headache have been reported. In individual cases, apathy, depression and confusion were also observed.

The symptoms described were transient and no serious consequences were reported. The rate of elimination did not change with increasing doses (first order kinetics). Treatment, if necessary, is symptomatic.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: Proton pump inhibitors, ATC code: A02BC01

Mechanism of action

Omeprazole, a racemic mixture of two active enantiomers, reduces gastric acid secretion by a highly specialized mechanism of action. Omeprazole is a specific inhibitor of proton pump at the level of the gastric parietal cells. It acts rapidly and promotes a reversible control of the inhibition of gastric acid secretion with a single daily administration.

Omeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the intracellular canaliculi within the parietal cells, where it inhibits the H + K + - ATPase - proton pump. This action on the last stage of the gastric acid formation process is dose-dependent and causes a highly effective inhibition of acid secretion, both of the basal and of the stimulated one, regardless of the stimulus used.

Pharmacodynamic effects

All observed pharmacodynamic effects are due to the activity of omeprazole on acid secretion.

Effects on gastric acid secretion

The oral administration of omeprazole once a day allows a rapid and effective inhibition of day and night gastric acid secretion, which reaches its maximum within the first 4 days of treatment.

In patients suffering from duodenal ulcer, the administration of 20 mg of omeprazole maintained an average reduction of 80% in intragastric acidity over 24 hours; 24 hours after the administration of omeprazole the peak of acid secretion, after stimulation with pentagastrin, is on average reduced by about 70%.

Oral administration of 20 mg of omeprazole maintains the intragastric pH at> 3 for a mean time of 17 hours out of 24 in patients with duodenal ulcer.

As a consequence of reduced acid secretion and intragastric acidity, omeprazole dose-dependently reduces / normalizes acid exposure of the esophagus in patients with gastroesophageal reflux disease.

Inhibition of acid secretion is related to the plasma concentration / time curve (AUC) of omeprazole and not to the actual plasma concentration at a given time.

No tachyphylaxis was observed during treatment with omeprazole.

Effects on H. pylori

H. pylori it is associated with peptic acid disease which includes duodenal ulcer disease and gastric ulcer disease. H. pylori it is considered the main culprit in the development of gastritis.

H. pylori together with gastric acid secretion they represent the most important factors for the development of peptic ulcer disease. H. pylori is the main factor in the development of atrophic gastritis which is associated with an increased risk of developing gastric tumors.

The "eradication of"H. pylori with omeprazole and antimicrobials it is associated with a "high rate of scarring and long-term remission of peptic ulcers.

The dual therapies studied showed less efficacy than the triple therapies. However, they can be taken into account if known hypersensitivity precludes the use of a triple combination.

Other effects related to acid inhibition

During long-term treatment, an increase in the frequency of appearance of gastric glandular cysts has been observed, which represent the physiological consequence of the pronounced inhibition of acid secretion. These formations are benign and reversible in nature.

Decreased gastric acidity of any origin, including that due to proton pump inhibitors, increases the gastric bacterial load normally present in the gastrointestinal tract. Treatment with acid-lowering drugs may cause a slightly increased risk of gastrointestinal infections such as for example from Salmonella And Campylobacter.

During treatment with antisecretory medicinal products, serum gastrin increases in response to decreased acid secretion. Chromogranin A (CgA) also increases due to decreased gastric acidity. The increased level of CgA may interfere with investigations for neuroendocrine tumors. Reports from the literature indicate that treatment with the proton pump inhibitor should be stopped at least five days before the start of CgA measurements. CgA and gastrin are not normalized after 5 days, measurements should be repeated 14 days after stopping omeprazole treatment.

An increase in the number of ECL cells, possibly related to an increase in serum gastrin levels, has been observed in some patients (both children and adults) during long-term treatment with omeprazole.

Pediatric use

In an uncontrolled study with children (1 to 16 years of age) with severe reflux oesophagitis, omeprazole, at doses of 0.7 to 1.4 mg / kg, improved the degree of esophagitis in 90% of cases. and significantly reduced reflux symptoms. In a single-blind study, children aged 0-24 months with clinically diagnosed reflux oesophagitis were treated with 0.5, 1.0 or 1.5 mg omeprazole / kg. The frequency of vomiting / regurgitation episodes decreased by 50% after 8 weeks of treatment, regardless of dose.

Eradication of H. pylori in children

A double-blind, randomized clinical trial (Héliot study) established that omeprazole in combination with two antibiotics (amoxicillin and clarithromycin) is effective and safe in the treatment of H. pylori in children aged 4 and over with gastritis: eradication rate of "H. pylori: 74.2% (23/31 patients) with omeprazole + amoxicillin + clarithromycin versus 9.4% (3/32 patients) with amoxicillin + clarithromycin. However, no clinical benefit has been shown with regard to dyspeptic symptoms. This study does not support information for children under the age of 4.

05.2 Pharmacokinetic properties

Absorption

Omeprazole and omeprazole magnesium are sensitive to the acid environment, and are therefore administered orally in the form of gastro-resistant granules contained in capsules or tablets.

Absorption of omeprazole is rapid, with maximum plasma levels visible approximately 1-2 hours after dosing. Absorption of omeprazole occurs in the small intestine and is generally completed within 3-6 hours. Concomitant food intake does not affect the bioavailability of the drug. Systemic availability (bioavailability) after a single oral dose of omeprazole is approximately 40%. After repeated daily administrations the bioavailability increases to about 60%.

Distribution

The apparent volume of distribution in healthy subjects is approximately 0.3 l / kg body weight. 97% of omeprazole is bound to plasma proteins.

Metabolism

Omeprazole is completely metabolised by the cytochrome P450 (CYP) system. Most of the metabolism of omeprazole is dependent on the specific polymorphically expressed CYP2C19 isoform responsible for the formation of hydroxyomeprazole which is the major metabolic in plasma. The remainder depends on another specific isoform, CYP3A4, responsible for the formation of omeprazole sulfone. As a consequence of omeprazole's high affinity for CYP2C19, there is a potential for competitive inhibition and drug-drug metabolic interaction between omeprazole and other substrates of CYP2C19. . However, due to its low affinity for CYP3A4, omeprazole does not have the ability to inhibit the metabolism of other CYP3A4 substrates. Furthermore, omeprazole has no inhibitory effect on major CYP enzymes.

Approximately 3% of the Caucasian population and 15-20% of the Asian population have a functional deficiency of the CYP2C19 enzyme, thus being defined as poor metabolisers. In these individuals, the metabolism of omeprazole is probably more catalysed by CYP3A4. After repeated administration. of 20 mg omeprazole once daily, the mean AUC was 5 to 10 times higher in poor metabolisers than in subjects with a functional CYP2C19 enzyme (extensive metabolisers). Maximum plasma concentrations were 3 to 5 times higher. These results have no implications for the posology of omeprazole.

Excretion

The plasma elimination half-life of omeprazole is usually less than one hour after both single and repeated oral once-daily dosing. Omeprazole is completely cleared from the plasma between doses, and therefore there is no tendency for accumulation during once daily administration. Approximately 80% of an oral dose of omeprazole is excreted in the urine as metabolites, the remainder in the faeces originating primarily from biliary secretion.

The AUC of omeprazole increases after repeated administration. This increase is dose-dependent and results in a non-linear dose-AUC relationship after repeated administration. The dependence on time and dose is due to a decrease in first pass metabolism and systemic clearance. probably caused by an inhibition of the CYP2C19 enzyme by omeprazole and / or its metabolites (eg sulphone).

No effect of the metabolites on gastric acid secretion was observed.

Special populations

Impaired liver function

In patients with hepatic dysfunction, the metabolism of omeprazole is impaired, resulting in an increase in AUC. There was no tendency to accumulate when omeprazole was administered once daily.

Impaired renal function

The pharmacokinetics of omeprazole, including systemic bioavailability and rate of elimination, are not altered in patients with impaired renal function.

Senior citizens

The rate of metabolism of omeprazole is slightly reduced in elderly subjects (75-79 years of age).

Pediatric patients

During the treatment of children from 1 year of age at recommended doses, plasma concentrations comparable to those in adults were observed. In children less than 6 months of age, omeprazole clearance was reduced due to omeprazole's poor metabolic capacity.

05.3 Preclinical safety data

Gastric ECL cell hyperplasia and carcinoids were detected in experiments in rats treated for life with omeprazole. These changes are the result of high hypergastrinemia secondary to acid inhibition. Similar observations were obtained following treatment with H2 antagonists, proton pump inhibitors and after partial fundus resection. These changes are therefore not attributable to a direct effect of any single active ingredient.