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What Omeprazole is and what it is used for
Omeprazole contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors" that act to reduce the amount of acid formed in your stomach.
Omeprazole Genericon is used for the following conditions:
Gastroesophageal reflux disease (GERD). This is a condition in which fluid from the stomach returns to the esophagus (the organ that connects the throat to the stomach) causing pain, inflammation and burning behind the sternum;
Upper ulcer of the small intestine (duodenal ulcer) or stomach (gastric ulcer);
Ulcers due to an infection with a bacterium called Helicobacter pylori (H. pylori). If so, your doctor may also prescribe antibiotics to cure the infection and to heal the ulcer;
Ulcers caused by medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Omeprazole Genericone may also be taken to prevent the development of an ulcer if you are taking NSAIDs;
Too much acid in the stomach due to formation in the pancreas (Pancreas) (Zollingen-Allison Syndrome).
Children over 1 year and weighing> 10kg
Gastroesophageal reflux disease (GERD). A condition in which stomach acid enters the esophagus (the organ that connects the throat to the stomach) causing pain and inflammation behind the sternum.
In children, symptoms of this condition may include a return to the stomach contents (regurgitation), vomiting, and low weight gain.
Adolescents and children over 4 years
Ulcers due to infections with a bacterium called Helicobacter pylori. If your child is suffering from this condition, your doctor may also prescribe antibiotics to cure the infection and to heal the ulcer;
2. What you need to know before taking Omeprazole
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 (eg pantoprazole, lansoprazole, rabeprazole, esomeprazole);
if you are taking a medicine containing nelfinavir (used for HIV infection).
Do not take Omaprazole Genericon if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Omaprazole Genericon.
Warnings and precautions
Omeprazole Genericon may mask the symptoms of other diseases. Therefore, if any of the following has happened to you before you start taking Omeprazole Genericon or while taking it, contact your doctor immediately:
if you lose a lot of weight for no apparent reason or have difficulty swallowing;
if you have abdominal pain or indigestion;
if you start vomiting food or blood;
if your stools turn black (bloody);
if you develop severe or prolonged diarrhea because omeprazole is associated with a slight increase in the incidence of infectious diarrhea; if you have serious liver problems;
The use of proton pump inhibitors, such as omeprazole Genericon, especially when used for more than 1 year, can moderately increase the risk of hip, wrist or spine fractures.
Tell your doctor:
if you have osteoporosis
if you are taking corticosteroids (which may increase your risk of osteoporosis);
if you have ever had a skin reaction after treatment with a medicine similar to Omeprazole Genericon, which reduces gastric acidity;
If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as possible as you may need to stop treatment with Omeprazole Genericon. Be sure to also mention any other adverse effects, such as joint pain; - if you need to do a specific type of blood test (Chromogranin A).
With long-term administration of Omaprazole Genericon (over 1 year), it is likely that your doctor will regularly monitor your condition. When you meet him, you should tell him about any new or unusual symptom or circumstance.
Taking a proton pump inhibitor such as Omeprazole Genericon for more than 1 year may increase the risk of hip, wrist, or spine fractures. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase your risk of osteoporosis).
Some children with chronic illnesses may need long-term treatment, although it is not recommended. Do not give this medicine to children under 1 year of age or weighing more than 10 kg.
Other medicines and Omeprazole
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The reason for this is that Omeprazole may affect the effects of some medicines, as well as some
Omeprazole with food, drink and alcohol
You can take the capsules both after meals and on an empty stomach.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Your doctor will decide whether to take Omeprazole Genericon during this time.
Omeprazole is excreted in human milk, but is unlikely to affect the infant when used at therapeutic doses. Your doctor will decide if you can take Omeprazole Genericon while you are breast-feeding.
Driving and using machines
Omeprazole Genericon is not expected to affect the ability to drive or use machines. Adverse reactions such as dizziness and visual impairment may occur (see section 4). If this happens, you should not drive or operate machinery.
Omeprazole Generic gastro-resistant capsules contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.
3. How to take Omeprazole
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will tell you how many capsules to take and how long to take them. It depends on your condition and age.
The recommended doses are:
To treat the symptoms of GERD such as burning behind the sternum and returning acid from the stomach to the esophagus:
If your doctor has found that your esophagus is slightly impaired, the usual dose is 20 mg once a day for 4-8 weeks. Your doctor may prescribe a 40 mg dose for another 8 weeks if your esophagus is not fully healed. The usual dose after esophageal healing occurs is 10 mg once daily; If your esophagus is not damaged, the usual dose is 10 mg once a day;
To treat curvatures of the upper small intestine (duodenal ulcer):
The usual dose is 20 mg once a day for a period of 2 weeks. If your ulcer has not healed, your doctor may continue your treatment with the same dose for another 2 weeks; If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for a period of 4 weeks.
For the treatment of gastric ulcer (gastric ulcer):
The usual dose is 20 mg once daily for a period of four weeks. If your ulcer has not healed, your doctor may continue your treatment with the same dose for another 4 weeks; If the ulcer has not completely healed, the dose may be increased to 40 mg once daily for a period of 8 weeks.
To prevent recurrence of stomach and duodenal ulcer:
The usual dose is 10 mg or 20 mg once daily. Your doctor may increase the dose to 40 mg once a day.
For the treatment of stomach and duodenal ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):
The usual dose is 20 mg once daily for 4 to 8 weeks.
To prevent the development of ulcers of the duodenum and stomach if you are taking NSAIDs:
The usual dose is 20 mg once daily.
To treat ulcers caused by Helicobacter pylori infection and to prevent recurrence:
The usual dose is 20 mg omeprazole Genericon twice daily for one week; Your doctor will also prescribe you to take two of the following antibiotics: amoxicillin, clarithromycin and metronidazole.
For the treatment of increased acid secretion in the stomach caused by a tumor of the pancreas (Pancreas) (Zoelligen-Allison Syndrome):
The recommended dose is 60 mg once a day.
Your doctor will determine the dose according to your individual needs and will decide how long you should take the medicine.
Use in children and adolescents
For the treatment of GERD symptoms such as burning behind the sternum and returning the gastric contents to the mouth:
Children over 1 year of age and weighing over 10 kg may take Omeprazole Genericon. The dose in children is determined depending on the child's weight, your doctor will determine the exact dose.
To treat ulcers caused by Helicobacter pylori infection and to prevent recurrence:
Children over 4 years of age can take Omeprazole Genericon. The dose in children is determined depending on the child's weight, your doctor will determine the exact dose. Your child's doctor will also prescribe two antibiotics called amoxicillin and clarithromycin.
How to take this medicine
It is recommended that you take the capsules in the morning. You can take the capsules after meals or on an empty stomach.
Swallow the capsules whole with half a glass of water. Do not chew or break the capsules. This is necessary because the capsules contain coated granules that prevent the medicine from dissolving from the acids in the stomach. It is important that the integrity of the granules is not compromised.
What to do if you or your child has difficulty swallowing capsules:
Open the capsules and drink the contents with half a glass of water or stir the contents
Rare side effects (may affect up to 1 in 1,000 people)
blood disorders such as a decrease in white blood cells or platelets. This can cause weakness, bruising or more frequent infections; allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing;
low levels of sodium in the blood. This can lead to weakness, vomiting and cramps; agitation, confusion or depression; taste change;
impaired vision such as blurred vision; sudden onset of wheezing or shortness of breath (bronchospasm); dry mouth;
inflammation of the inside of the mouth;
an infection called "thrush" is caused by fungi and can affect the intestine;
liver problems, incl. jaundice, which can lead to yellowing of the skin, darkening of the urine and fatigue;
hair loss (alopecia);
skin rash when exposed to the sun;
joint pain (arthralgia) or muscle pain (myalgia);
severe kidney problems (intestinal nephritis);
Very rare side effects (may affect up to 1 in 10,000 people)
changes in the blood picture incl. agranulocytosis (reduction in white blood cell count); aggressive behavior; hearing sounds, experiencing sensations, and seeing images that are unrealistic (hallucinations);
severe liver problems leading to liver failure and brain inflammation;
sudden onset of severe rash or blistering or flaking of the skin. They may be accompanied by fever or joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
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In very rare cases, omeprazole Genericone can affect white blood cells, leading to immune deficiency. If you have an infection with symptoms such as fever with severe general fatigue or fever with symptoms of local infection such as neck, throat, or mouth pain or difficulty urinating, you should consult your doctor as soon as possible to determine possible reduction in the number of white blood cells (agranulocytosis) by blood tests. In this case, it is important that you provide information about your medicine.
Frequency not known (cannot be estimated from available data)
inflammation of the intestine (leading to diarrhea);
if you have been on Omeprazole Genericone for more than three months, your blood magnesium levels may drop. Low levels of magnesium can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, impaired heart rhythm. If you experience any of these symptoms, please tell your doctor immediately. Low levels of magnesium can also lead to decreased levels of potassium or calcium in the blood. Your doctor may decide to do regular blood tests to monitor your magnesium levels; a rash that may be accompanied by joint pain.
Don't worry about this list of possible side effects. You may not receive any of them.
Contents of the pack and additional information
What Omeprazole Genericon contains
The active substance is omeprazole. Omeprazole Genericonon contains 20 mg omeprazole.
The other ingredients are:
- capsule content: hypromellose, disodium phosphate dihydrate (E-339 I), talc, titanium dioxide (E-171), methacrylic acid-ethyl acrylate copolymer (1: 1), triethyl citrate, sugar spheres (consisting of sucrose and maize) starch);
- capsule shell: titanium dioxide (E-171), gelatin, purified water.
What Omeprazole Genericicon looks like and contents of the pack
Opaque white hard gelatin capsules (size 2) labeled OM-20 containing white to pink / light beige pellets.
Packaging: Polyethylene packaging, with screw cap containing dryer, with 7, 14 or 28 pieces of gastro-resistant capsules, solid, in carton, with leaflet: patient information.
Not all pack sizes may be marketed.
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