Active ingredients: Omeprazole
Omeprazole 10 mg gastro-resistant hard capsules
Omeprazole 20 mg gastro-resistant hard capsules
Why is Omeprazole used - Generic Drug? What is it for?
Omeprazole DOC Generici contains the active substance omeprazole. It belongs to a group of medicines called 'proton pump inhibitors'. These work by reducing the amount of acid produced by the stomach.
Omeprazole 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 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). Omeprazole 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-Elliso 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.
- Symptoms of this disease in children may also include stomach contents returning to the mouth (regurgitation), being sick (vomiting) and poor weight gain.
Children over 4 years of age and adolescents
- Ulcers infected with 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.
Contraindications When Omeprazole - Generic Drug should not be used
Do not take Omeprazole
- if you are allergic to omeprazole or 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)
Precautions for use What you need to know before taking Omeprazole - Generic Drug
Talk to your doctor or pharmacist before taking Omeprazole.
Omeprazole DOC Generici may hide the symptoms of other diseases. Therefore, if you experience the symptoms described below before taking Omeprazole 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 take a proton pump inhibitor such as omeprazole, 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
If you have been taking Omeprazole 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.
Omeprazole may interfere with some tests (chromogranin A). To avoid this interference, Omeprazole must be temporarily discontinued five days before the test.
Interactions Which drugs or foods can modify the effect of Omeprazole - Generic Drug
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This is important because Omeprazole can affect the way some medicines work and some medicines can affect the way Omeprazole works.
Do not take Omeprazole 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 beginning and at the end of your treatment with Omeprazole.
- Medicines used to thin the blood, such as warfarin or other vitamin K blockers. Your doctor will monitor you at the beginning and at the end of your treatment with Omeprazole.
- Rifampicin (used to treat tuberculosis)
- Atazanavir (used to treat HIV infection)
- Tacrolimus (used in organ transplants)
- Erlotinib (used to treat cancer)
- Methotrexate (a chemotherapy medicine used in high doses to treat cancer). If you are taking a high dose of methotrexate, your doctor may temporarily stop your omeprazole treatment
- St. John's wort (Hypericum perforatum) (used to treat mild depression)
- Cilostazol (used to treat intermittent claudication)
- Saquinavir (used to treat HIV infections)
- Clopidogrel (used to prevent blood clots (thrombi))
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Omeprazole for the treatment of ulcers caused by Helicobacter pylori infections, it is very important that you tell if you are taking any other medicines.
Omeprazole DOC Generici 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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide whether you can take Omeprazole during this time.
Your doctor will decide whether you can take Omeprazole if you are breastfeeding.
Driving and using machines
Omeprazole 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.
Omeprazole DOC Generici contains sucrose.
If you have been told by your doctor that you have an "intolerance to some sugars, contact your doctor before taking this medicine
Dose, Method and Time of Administration How to use Omeprazole - Generic Drug: Posology
Always take this medicine 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 recommended dose is
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 to 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 Omeprazole 20 mg twice a day for one week.
- Your doctor will also tell you to 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 for.
Use in children
To treat symptoms of GERD, such as heartburn and acid regurgitation:
- Omeprazole DOC Generici 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 doctor will decide the correct dose.
For the treatment and prevention of the recurrence of ulcers caused by Helicobacter pylori infection:
- Omeprazole DOC Generici can be taken by children over 4 years of age. The dose for children is based on the child's weight and the doctor will decide the correct dose.
- Your doctor will also prescribe two antibiotics called amoxicillin 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 should 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:
- Break the capsule and dissolve it in a tablespoon 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 an overdose of Omeprazole - Generic Drug
If you take more Omeprazole than you should
If you take more Omeprazole than prescribed by your doctor, contact your doctor or pharmacist immediately.
If you forget to take Omeprazole
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
Side Effects What are the side effects of Omeprazole - Generic Drug
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 Omeprazole 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.
The 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, wind (flatulence).
- Feeling sick (nausea) or being sick (vomiting).
Uncommon side effects (may affect up to 1 in 100 people)
- 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 itchy skin.
- General feeling of being unwell and lack of energy
- Fracture of the wrist, hip or spine
Rare side effects (may affect up to 1 in 1000 people)
- 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 (may affect up to 1 in 10,000 people)
- 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.
In very rare cases Omeprazole DOC Generici can affect the white blood cells leading to an 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.
Not known (frequency cannot be estimated from the available data)
- Inflammation of the intestines (which can lead to diarrhea)
- If you take Omeprazole 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.
Don't worry about the list of possible side effects. You may not get any.
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 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.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "EXP:". The expiry date refers to the last day of that month.
Do not store above 25 ° C.
OPA-Al-PVC / Al blisters: Store in the original container to protect from moisture.
HDPE bottle: Keep the bottle tightly closed to protect the medicine from moisture.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Omeprazole Doc Generici contains:
- The active substance is omeprazole: Omeprazole DOC Generici contains 10 mg or 20 mg of omeprazole.
- The other ingredients are:
- Capsule contents: sugar spheres (consisting of corn starch and sucrose), sodium lauryl sulfate, anhydrous disodium phosphate, mannitol, hypromellose 6 cP, macrogol 6000, talc, polysorbate 80, titanium dioxide (E171) and methacrylic acid copolymer- ethyl acrylate (1: 1).
- Capsule components: gelatin. The 10 and 20 mg capsules also contain the coloring agents quinoline yellow and titanium dioxide.
What Omeprazole looks like and contents of the pack:
Omeprazole DOC Generici 10 mg: opaque yellow capsule containing whitish to cream-white spherical microgranules.
Omeprazole DOC Generici 20 mg: opaque yellow capsule containing whitish to cream-white spherical microgranules.
The capsules are packaged in blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 140, 280 and 500 capsules; and in HDPE bottles of 5, 7, 14, 15, 28, 30, 50, 56, 60, 90, 100 and 500 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.
01.0 NAME OF THE MEDICINAL PRODUCT
OMEPRAZOLE DOC GENERICI HARD GASTRORESISTANT CAPSULES
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Omeprazole DOC Generici 10 mg capsules: one capsule contains 10 mg of omeprazole.
Omeprazole DOC Generici 20 mg capsules: one capsule contains 20 mg of omeprazole.
Excipient with known effect:
Each omeprazole 10 mg capsule contains 51 to 58 mg of sucrose.
Each 20 mg capsule of omeprazole contains 102 to 116 mg of sucrose.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Hard gastro-resistant capsule
Omeprazole DOC Generici 10 mg capsules: opaque yellow capsules containing whitish to cream-white spherical microgranules.
Omeprazole DOC Generici 20 mg capsules: opaque yellow capsules containing whitish to cream-white spherical microgranules.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Omeprazole DOC Generici is indicated in:
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
Adults
Treatment of duodenal ulcer
The recommended dose in patients with active duodenal ulcer is Omeprazole 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 Omeprazole 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 Omeprazole 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 Omeprazole 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 Omeprazole 40 mg once a day is recommended, which generally results in healing 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 Omeprazole 20 mg once daily. If needed, the dose can be increased to Omeprazole 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.
• Omeprazole 20 mg + clarithromycin 500 mg + amoxicillin 1,000 mg, each twice daily for one week, or
• Omeprazole 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
• Omeprazole 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 Omeprazole 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 Omeprazole 20 mg once daily. day.
Treatment of reflux esophagitis
The recommended dose is Omeprazole 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 by prolonging treatment for another four weeks.
In patients with severe oesophagitis, omeprazole 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 Omeprazole 10 mg once daily. If needed, the dose can be increased to Omeprazole 20-40 mg once daily.
Treatment of symptomatic gastroesophageal reflux disease
The recommended dose is Omeprazole 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 Omeprazole 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 Omeprazole 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 Omeprazole tablets between 20 mg and 120 mg / day. Daily dosages above 80 mg should be divided into two daily administrations.
Pediatric population
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:
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:
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 Omeprazole DOC Generici 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 the active substance, to benzimidazole substitutes or to any of the excipients listed in section 6.1.
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 any alarm symptoms (eg significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, 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 has been 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.
Hypomagnesemia
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 improves in most patients 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).
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.
Interference with laboratory tests
Increased levels of Chromogranin A (CgA) can interfere with tests for neuroendocrine tumors. To avoid this interference, omeprazole treatment should be temporarily stopped at least 5 days before CgA measurement (see section 5.1).
Treatment with proton pump inhibitors may cause a slightly increased risk of gastrointestinal infections from Salmonella AndCampylobacter (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.
Some children with chronic conditions may need long-term treatment although it is not recommended.
This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.
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
In a cross-over clinical study, clopidogrel (300 mg loading dose followed by 75 mg / day) was administered for 5 days as monotherapy and with omeprazole (80 mg administered together with clopidogrel). Exposure to the active metabolite of clopidogrel decreased by 46% (day 1) and 42% (day 5) when clopidogrel and omeprazole were co-administered. When clopidogrel and omeprazole were co-administered there was a decrease in 47% (24 hours) and 30% (day 5) of the mean inhibition of platelet aggregation. In another study it was shown that administration of clopidogrel and omeprazole at different times does not prevent their interaction, which appears to be driven by "inhibitory action of omeprazole on CYP2C19. Inconsistent data from observational and clinical studies have been reported on the clinical implications of this pharmacokinetic / pharmacodynamic interaction in terms of increased major cardiovascular events.
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. increased monitoring of tacrolimus concentrations and renal function (creatinine clearance) is required and, if necessary, the tacrolimus dosage should be adjusted.
Methotrexate
When given with proton pump inhibitors, methotrexate levels have been reported to increase in some patients. In case of administration of high doses of methotrexate, a temporary discontinuation of omeprazole may be considered.
Influence of other active substances on the pharmacokinetics of omeprazole
CYP2C19 and / or CYP3A4 inhibitors
Since omeprazole is metabolised by CYP2C19 and CYP3A4, 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
Pregnancy
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.
Feeding time
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
Omeprazole 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). Patients should not drive or operate machines if they suffer from these.
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
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.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/responsabili.
04.9 Overdose
Limited information is available regarding overdose with omeprazole in humans. Doses up to 560 mg are 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, and apathy, depression and confusion have also been observed in single cases.
The symptoms related to omeprazole overdose described have been transient and no serious consequences have been 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: A02B C 01
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 over 24 hours 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 appearance of gastric glandular cysts has been observed, representing the physiological consequence of the pronounced inhibition of acid secretion. These formations are benign and reversible in nature.
The decrease in 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-reducing drugs may cause a slightly increased risk of gastrointestinal infections Salmonella And Campylobacter.
During treatment with antisecretory medicinal products, serum gastrin increases in response to decreased acid secretion. CgA also increases due to decreased gastric acidity. The increased level of CgA can interfere with tests for neuroendocrine tumors. The literature indicates that proton pump inhibitor treatment should be stopped at least 5 days before CgA measurement. If CgA and gastrin levels have not normalized after 5 days, measurements should be repeated 14 days after stopping omeprazole treatment.
Pediatric population
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 years 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 is sensitive to the acidic environment, and is therefore administered orally in the form of gastro-resistant granules contained in capsules. Absorption of omeprazole is rapid, with maximum plasma levels visible approximately 1-2 hours after administration of the dose. Absorption of omeprazole occurs in the small intestine and is usually completed within 3-6 hours. Concomitant food intake does not affect drug bioavailability. Systemic availability (bioavailability) after a single oral dose of omeprazole is approximately 40%. After repeated daily dosing the bioavailability increases to approximately 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.
Biotransformation
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 plasma metabolite. 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 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.
Elimination
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 population
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 trials 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.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Contents of the capsules:
Sugar balls (made from corn starch and sucrose)
Sodium lauryl sulfate
Anhydrous disodium phosphate
Mannitol
Hypromellose 6 cP
Macrogol 6000
Talc
Polysorbate 80
Titanium dioxide (E171)
Copolymer of Methacrylic Acid-Ethyl Acrylate (1: 1)
Capsule body:
Jelly
Quinoline yellow (E104)
Titanium dioxide (E171)
06.2 Incompatibility
Not relevant
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Do not store above 25 ° C.
OPA-Al-PVC / Al blisters: Store in the original container to protect from moisture.
HDPE bottle: Keep the bottle tightly closed to protect the medicine from moisture.
06.5 Nature of the immediate packaging and contents of the package
Aluminum / Aluminum blister:
7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 140, 280 and 500 capsules
HDPE bottle with desiccant silica gel contained in the polypropylene cap:
5, 7, 14, 15, 28, 30, 50, 56, 60, 90, 100 and 500 capsules
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
DOC Generici Srl
Via Turati 40
20121 Milan
08.0 MARKETING AUTHORIZATION NUMBER
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09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
October 2007
Renewal: April 2012
10.0 DATE OF REVISION OF THE TEXT
October 2014
