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What is Omeprazol Genericon and what it is used
Omeprazol Genericon are hard capsules, which contain the active substance omeprazol in the form of granules coated with a shell, protecting the drug from the dissolution of the acid in the stomach. It belongs to a group of medicines called "proton pump inhibitors" that work by reducing the amount of acid your stomach produces.
Omeprazol Genericon used for the following conditions:
Gastro-oesophageal reflux disease (GERD). This is a condition in which fluid from the stomach back into the esophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn;
Ulcers in the upper part of the small intestine (duodenal ulcer) or stomach (gastric ulcer);
Ulcers due to infection with bacteria called Helicobacter pylori (H. pylori). If your situation is such, the doctor may prescribe antibiotics to cure the infection and heal the ulcer;
Ulcers caused by taking medicines called NSAIDs (nonsteroidal anti-inflammatory drugs). Omeprazol Genericon also can be taken to prevent the development of ulcers if you are taking NSAIDs;
Devoting too much acid in the stomach caused by a growth in the pancreas (pancreatic) (Syndrome Tsolingen-Ellison).
Children over 1 year and weighing> 10 kg:
Gastro-oesophageal reflux disease (GERD). A condition in which acid from the stomach enters the esophagus (the tube that connects the throat to the stomach) causing pain, inflammation and heartburn.
In children, the symptoms of the condition can include the return of stomach contents into the mouth (regurgitation), vomiting and poor weight gain.
Adolescents and children over 4 years
Ulcers attributable to infections with bacteria called Helicobacter pylori. Where if your suffering from this condition, the doctor may also prescribe antibiotics to cure the infection and heal the ulcer.
2. Before you take Omeprazol Genericon
Do not take Omeprazole Genericon:
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).
Warnings and Precautions
Talk to your doctor or pharmacist before taking Omeprazole Genericon.
Omeprazole Genericon may hide the symptoms of other diseases. Therefore, if any of the following happened to you before you start taking Omeprazole Genericon or while taking him, immediately contact your doctor:
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 to vomit food or blood;
If your stools become black (blood);
if you develop severe or persistent diarrhea, as omeprazole has been associated with a slight increase in the incidence of infectious diarrhea;
If you have severe liver problems.
Taking proton pump inhibitors such as omeprazole Genericon, especially when using more than 1 year may moderately increase the risk of fractures of the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking
corticosteroids (which can increase the risk of osteoporosis).
Other medicines and Omeprazol Genericon
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 the Omeprazole Genericon may affect the way some medicines and also some medicines can affect the way Omeprazole Genericon.
Do not take Omeprazole Genericon if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Tell your doctor or pharmacist if you are taking any of the following medicinal products:
ketoconazole, itraconazole or voriconazole (used to treat infections caused by fungi);
digoxin (to treat heart problems);
diazepam (for the treatment of anxiety, muscle relaxation or for epilepsy);
phenytoin (for epilepsy). If you are taking phenytoin, your doctor will monitor your condition during initiation and discontinuation of Omeprazole Genericon;
drugs that are administered blood thinners such as warfarin and other vitamin K antagonists may need your doctor to monitor your condition during initiation and discontinuation of Loprilin;
rifampicin (to treat tuberculosis);
atazanavir (to treat HIV infection);
tacrolimus (in cases of organ transplantation);
herbal products containing St. John's wort. (St John's wort, Hypericum perforatum), (for the treatment of mild depression);
cilostazol (for the treatment of claudication (intermittent claudication));
saquinavir (used to treat HIV infection);
clopidogrel (to prevent blood clots (thrombi)).
It is important to tell your doctor if you are taking other medications if the treatment of ulcers caused by H. pylori infection with Omeprazole Genericon prescribe antibiotics amoxicillin and clarithromycin.
Omeprazol Genericon food, beverages and alcohol
You can take the capsules with food and fasting.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Driving and using machines
Omeprazol is not expected Genericon to affect your ability to drive or operate machinery. Can occur side effects such as dizziness and visual disturbances (see section 4). If this happens, you should not drive or operate machinery.
Genericon omeprazole gastro-resistant capsules contain sucrose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.
3. How to take Omeprazol Genericon
Always take this medicine exactly as you have been told your doctor or pharmacist. If you're 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 your age.
Typical doses are given below:
To treat symptoms of GERD such as heartburn and return acids from the stomach into the esophagus:
If your doctor has determined that your esophagus is slightly damaged, the usual dose is 20 mg once daily for a period of 4-8 weeks. The doctor may prescribe a dose of 40 mg for 8 weeks if your gullet has not completely healed;
The usual dose after reorganization occurs in the esophagus is 10 mg once daily;
If your gullet has not been damaged, the usual dose is 10 mg once daily.
For the treatment of ulcers of the upper part of the small intestine (duodenal ulcer):
The usual dose is 20 mg once daily for a period of 2 weeks. If your ulcer has not healed, the physician may continue your treatment with the same dose for another two weeks;
If the ulcer does not fully heal, the dose can be increased to 40 mg once a day for 4 weeks.
To treat stomach ulcers (gastric ulcer):
The usual dose is 20 mg once a day for four weeks. If your ulcer has not healed, the physician may continue your treatment with the same dose for another 4 weeks;
If the ulcer is not healed completely, the dose can be increased to 40 mg once a day for 8 weeks.
To prevent recurrence of gastric ulcer and duodenal:
The usual dose is 10 mg or 20 mg once daily. Your doctor may increase the dose to 40 mg once daily.
For the treatment of ulcers of the stomach and the duodenum caused by NSAIDs (nonsteroidal anti-inflammatory drugs):
The usual dose is 20 mg once daily for four to eight weeks.
To prevent development of duodenal ulcers and stomach if you are taking NSAIDs:
The usual dose is 20 mg once daily.
For the treatment of ulcers caused by Helicobacter pylori infection and to prevent recurrence:
The usual dose is 20 mg Omeprazol Genericon twice daily for a period of one week;
Your doctor will also prescribe intake of two of the following antibiotics: amoxicillin, clarithromycin and metronidazole.
For the treatment of increased expression of heartburn caused by a tumor of the pancreas (pancreas) (Syndrome-Ellison Tsyolingen):
The usual dose is 60 mg once daily;
Your doctor will decide the dose according to your individual needs and will decide how long you should take the drug.
Use in children and adolescents:
To treat symptoms of GERD such as heartburn and regurgitation of gastric contents into the mouth:
Children over 1 year and weighing over 10 kg can take Omeprazole Genericon. The dose for children is determined by the child's weight, your doctor will determine the correct dose.
For the treatment of ulcers caused by Helicobacter pylori infection and to prevent recurrence:
Children over 4 years may take Omeprazole Genericon. The dose for children is determined by the child's weight, your doctor will determine the exact dose;
Your child's doctor will prescribe taking two of the following antibiotics: amoxicillin, clarithromycin and metronidazole.
Specific patient groups:
Elderly (over 65 years):
There is no need dose adjustment in elderly patients.
Patients with renal impairment:
No need dose adjustment in patients with impaired renal function.
Patients with impaired hepatic function:
The maximum daily dose should be limited to 10 mg, 20 mg.
How to take this medicine
It is recommended to take the capsules morning.
You can take the capsules with food or on an empty stomach.
Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules. This is because the capsules contain coated granules that protect the drug from dissolving of heartburn. It is important that the integrity of the granules can not be compromised.
What to do if you or your child is experiencing difficulty in swallowing the capsules
Open capsules and drank half a glass of water or mix the contents with a small amount of milk with some sour fruit juice (apple, orange or pineapple) or applesauce.
Always stir the mixture just before drinking. Drink the solution immediately or within 30 minutes.
To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink. The solids contain the active substance - do not chew or crush.
If you take more dose Omeprazol Genericon
If you take more than your prescribed dose Omaprazol Genericon, tell your doctor or visit the nearest hospital.
If you forget to take Omeprazol Genericon
If you forget to take a dose, take it as soon as you remember, if rather then should not take the next dose. Take the next capsule normal for this time. Do not take a double dose to make up the missed dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may occur with certain frequency and depending on it can be:
Very common: occur in more than 1 patient out of 10 patients;
Common: occur in less than 1 in 10 but more than 1 in 100 patients;
Relatively rare: There are less than 1 in 100 but less than 1 in 1000 patients;
Rare: There are less than 1 in 100 but less than 1 in 10,000 patients;
Very rare: occur in less than 1 out of 10,000 patients;
Not known: From the available data can not be estimated.
If you notice any of the below listed rare but serious side effects, stop taking Omeprazole Genericon and immediately inform your doctor:
Sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction);
Redness of the skin with the formation of bubbles or peeling. Also there may be blisters and bleeding lips, eyes, mouth, nose or genitals. This may be due to Stevens-Johnson or toxic epidermal necrolysis;
Yellow skin, dark urine and tiredness which can be symptoms of liver problems.
Other side effects include:
Common side effects:
effects on the stomach or gut: diarrhea, stomach pain, constipation, flatulence (flatulence);
nausea or vomiting.
Uncommon side effects:
swelling of feet and ankles;
sleep disorders (insomnia);
dizziness, tingling like pins and needles and punctures the skin, drowsiness;
feeling dizzy and dizziness (vertigo);
changes in blood liver function test;
skin rash, hives (urticaria) and itching of the skin;
malaise and lack of energy;
fractures (hip, wrist or spine) (see section 2 "Warnings and Precautions").
Rare side effects:
blood disorders such as reducing the number of white blood cells or platelets. This can cause weakness, bruising body or frequent infections;
Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing;
low sodium levels in the blood. This can lead to weakness, vomiting and cramps;
agitation, confusion or depression;
visual disturbances such as blurred vision;
sudden onset of shortness of breath or wheezing (bronchospasm);
inflammation of the inside of the mouth;
infection, which is called "thrush", is caused by the fungus, and can affect the gut;
liver problems, incl. jaundice, which can lead to yellowing of the skin, dark urine, and fatigue;
hair loss (alopecia);
skin rash when exposed to the sun;
joint pain (arthralgia) or muscle pains (myalgia);
severe kidney problems (intestinal nephritis);
Very rare side effects:
changes in the blood picture incl. agranulocytosis (decrease in the number of white blood cells);
hearing sounds, sensations and experience of seeing images that are not real (hallucinations);
severe liver problems leading to liver failure and inflammation of the brain;
sudden onset of severe rash or blistering or peeling of the skin. They may be accompanied by fever or joint pain (erythema multiforme, Stevens-Johnson, toxic epidermal necrolysis);
breast enlargement in men;
If you are Omeprazol Genericon for more than three months, the levels of magnesium in your blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, abnormal heart rhythm. If you experience any of these symptoms, please contact your doctor immediately. Low levels of magnesium can also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor levels of magnesium you.
In very rare cases Omeprazole Genericon can affect the white blood cells leading to immune deficiency. If you have an infection with symptoms such as fever with severe malaise or fever with local infection symptoms such as pain in the neck, throat or mouth or difficulty urinating, you should as soon as possible to consult your doctor in order to establish a possible reduction in number of white blood cells (agranulocytosis) by blood tests. In this case it is important to give information about your medicine.
Do not be alarmed by this list of possible side effects. You can not get any of them. If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet.
5. How to store Omeprazol Genericon
No special storage conditions.
Keep out of reach of children!
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Plastic containers should always be tightly closed.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Omeprazole Genericon
Each gastro-resistant capsule, hard contain:
Active substance: 20 mg of omeprazole.
Other ingredients are:
content of the capsule: hypromellose, disodium phosphate dihydrate (E-339 ii), talc, titanium dioxide (E-171), a copolymer of methacrylic acid-ethyl acrylate copolymer (1: 1), triethyl citrate, sugar spheres (consisting of sucrose and corn starch );
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