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What is Omeprazol Accord and what it is used
Omeprazol Accord contains the active ingredient omeprazole. It belongs to a group of medicines called 'proton pump inhibitors'. They work by reducing the amount of acid your stomach produces.
Accord Omeprazol is used to treat the following conditions:
"Gastroesophageal reflux disease" (GERD). This is a condition in which acid from the stomach into the gullet ("tube" connecting the throat to the stomach) causing pain, inflammation and heartburn;
Ulcers in the upper intestine (duodenal) or stomach (gastric ulcer);
Ulcers due to infection by bacteria called "Helicobacter pylori". If you have this condition, your doctor may prescribe antibiotics to treat the infection and allow the ulcer to heal;
Ulcers caused by medicines called NSAIDs (nonsteroidal anti-inflammatory drugs). If taking NSAIDs Accord Omeprazol may also be used to prevent the development of ulcers;
Devoting too much acid in the stomach caused by a growth in the pancreas (syndrome Zoninger-Ellison).
Children older than 1 year and weighing> = 10 kg:
"Gastroesophageal reflux disease" (GERD). This is a condition in which acid from the stomach into the gullet ("tube" connecting the throat to the stomach) causing pain, inflammation and heartburn.
In children, the symptoms of this condition can include the return of stomach contents into the mouth (regurgitation), nausea, and poor weight gain.
Adolescents and children aged 4 years
Ulcers due to infection by bacteria called "Helicobacter pylori". If your child has this condition, your doctor may prescribe antibiotics to treat the infection and allow the ulcer to heal.
2. What you need to know before taking Omeprazol Accord
Do not take Omeprazol Accord:
if you are allergic to omeprazole or any 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 infection with HIV).
If you are unsure, before taking Omeprazol Accord, talk to your doctor or pharmacist.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking Omeprazol Accord.
Accord Omeprazol may mask the symptoms of other diseases. Therefore, if any of the following happened to you before you start taking Omeprazol Accord or while taking it, 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;
You begin 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 slightly increased incidence of infectious diarrhea;
If you have severe liver problems.
In the long omeprazole Accord (over 1 year), probably your doctor will monitor your condition. When you meet him, you should report any new and unusual symptom or circumstance.
Taking proton pump inhibitors such as Omeprazol Accord, especially over a period of one year, may slightly increase the risk of fractures of the hip, wrist and spine. Tell your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
Other medicines and Omeprazol Accord
Tell your doctor or pharmacist if you are taking, have recently taken or take any other medicines. The reason for this is that Omeprazol Accord may affect some medicines, as well as some drugs can affect the action of Omeprazol Accord.
Do not take Omeprazol Accord if you are taking a medicine containing nelfinavir (used to treat infection with HIV).
Tell your doctor or pharmacist if you are taking any of the following medicines:
Ketoconazole, itraconazole or voriconazole (used to treat fungal infections);
Digoxin (used to treat diseases of the heart);
Diazepam (used to treat anxiety, relax muscles or in epilepsy);
Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor you during initiation or discontinuation of Omeprazol Accord;
Medicines used to thin your blood - such as warfarin and other vitamin K blockers may be necessary for your doctor to monitor you during initiation or discontinuation of Omeprazol Accord;
Rifampicin (used to treat tuberculosis);
Atazanavir (used for the treatment of infection by HIV);
Tacrolimus (used in organ transplantation);
St. John's Wort (Hypericum perforatum) (used to treat mild depression);
Cilostazol (used to treat intermittent claudication);
Saquinavir (used for the treatment of infection by HIV);
Clopidogrel (used to prevent the development of a blood clot - thrombus);
Erlotinib (used to treat cancer);
Methotrexate (chemotherapeutic drug, which is used in high doses to treat cancer) - if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Omeprazol Accord.
If your doctor has prescribed antibiotics amoxicillin and clarithromycin concomitantly with Omeprazol Accord to treat ulcers caused by infection with Helicobacter pylori, is very important to know if you are taking any other medicines.
Omeprazol Accord with food, beverages and alcohol
You can take the gastro-resistant capsules both with food and on an empty stomach.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
If you are breastfeeding, your doctor will decide whether you can take Omeprazol Accord.
Driving and using machines
Omeprazol is not expected Accord will affect your ability to drive or operate any tools or machines. May have side effects such as dizziness and visual disturbances (see section 4). If you experience such reactions, you should not drive or operate machinery.
Omeprazol Accord contains lactose and sucrose.
If your doctor has told you that you have an intolerance to some sugars, contact before taking this medicine.
3. How to take Omeprazol Accord
Always take this medicine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Your doctor will tell you how gastro-resistant capsules to take and how long to take them. This depends on your condition and your age. The recommended dosages are provided below.
For the treatment of the symptoms of gastroesophageal reflux disease, such as heartburn and regurgitation of gastric acid:
If your doctor has determined that your esophagus is affected slightly, the usual dose is 20 mg once daily for 4-8 weeks. Your doctor may tell you to take a dose of 40 mg for a further 8 weeks if your gullet has not healed completely.
Once the esophagus healed, the usual dose is 10 mg once daily.
If your esophagus is not damaged, the usual dose is 10 mg once daily.
For the treatment of ulcers in the upper intestine (duodenal):
The usual dose is 20 mg once a day for 2 weeks. Your doctor may tell you to continue taking the same dose for a further 2 weeks if your ulcer has not healed.
If the ulcer does not heal completely, the dosage may be increased to 40 mg once daily for 4 weeks.
To treat ulcers in the stomach (gastric ulcer):
The usual dose is 20 mg once daily for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your ulcer has not healed.
If the ulcer does not heal completely, the dosage may be increased to 40 mg once daily for 8 weeks.
To prevent the recurrence of duodenal ulcers and stomach:
The usual dose is 10 mg and 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 a day for 4-8 weeks.
To prevent the development of duodenal ulcers and stomach, if taking NSAIDs:
The usual dose is 20 mg once daily.
For the treatment of ulcers caused by Helicobacter pylori infection and prevent them coming:
The usual dose is 20 mg Omeprazol Accord twice a day for one week.
Your doctor will prescribe a dose of two antibiotics: amoxicillin, clarithromycin and metronidazole.
Removal of too much acid in the stomach caused by a growth in the pancreas (syndrome Zollinger-Ellison):
The usual dose is 60 mg daily.
Your doctor will adjust your dose depending on your needs and will also decide how long you should take the drug.
Use in children and adolescents:
For the treatment of the symptoms of gastroesophageal reflux disease, such as heartburn and regurgitation of gastric acid:
Omeprazol Accord can accept children aged 1 year and weighing over 10 kg.
The dosage for children is determined based on body weight, so your doctor will decide the correct dose.
For the treatment of ulcers caused by Helicobacter pylori infection and prevent their development:
Omeprazol Accord can accept children over the age of 4 years. The dosage for children is determined based on body weight, so your doctor will decide the correct dose.
Your doctor will prescribe your child's intake of two of the following antibiotics: amoxicillin, clarithromycin and metronidazole.
How to take this medicine
It is recommended to take gastro-resistant capsules in the morning.
You can take the gastro-resistant capsules with food or on an empty stomach.
Swallow gastro-resistant capsules whole with half a glass of water. Do not chew or crush the capsules. The reason for this is that the gastro-resistant capsules contain coated pellets which stop gastric acid to decompose the drug. It is important that the integrity of the granules can not be impaired.
What to do if you or your child have trouble swallowing gastro-resistant capsules
If you or your child have trouble swallowing gastro-resistant capsules:
Open the capsule and swallow the contents directly or half a cup of water or pouring water (non-carbonated), acidic fruit juice (eg. Apple, orange or pineapple) or applesauce;
Always stir the mixture before drinking it (the mixture will be clear). Drink the mixture 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. Do not use milk or soda. Solids contain medicine - do not chew or crush.
If you take more than the amount of Omeprazol Accord
If you take more than prescribed by your doctor Omeprazol Accord, immediately contact your doctor or pharmacist.
If you forget to take Omeprazol Accord
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed.
Do not take a double dose to make up for a missed dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of these rare but serious side effects, stop taking Omeprazol Accord and immediately call your doctor:
Sudden wheezing, swelling of the lips, tongue, throat, or your entire body, rash, fainting or difficulty swallowing (severe allergic reaction);
Skin redness, blistering or peeling. Can also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This can be "Stevens-Johnson 'or' toxic epidermal necrolysis';
Yellow skin, dark urine and fatigue, which may be signs of liver problems.
Side effects may occur with certain frequencies, which are defined as follows:
Very common: affects more than 1 in 10 patients;
Common: affects 1 to 10 of 100 patients;
Uncommon: affects 1 to 10 users in 1,000 patients;
Rare: affects 1 to 10 users in 10,000 patients;
Very rare: affects less than 1 in 10,000 patients;
Not known: frequency can not be estimated from the available data.
Other side effects include:
Common side effects:
Effects on the stomach or intestines, diarrhea, abdominal pain, constipation, wind (flatulence);
Nausea or vomiting.
Uncommon side effects:
Swelling of the feet and ankles;
Sleep disorders (insomnia);
Dizziness, numbness, "pins and needles", feeling sleepy;
Changes in blood tests that check how the liver;
Skin rash, lumpy rash (hives) and itchy skin;
Malaise and lack of energy;
Fracture of the hip, wrist or spine.
Rare side effects:
Blood problems such as low white blood cells or platelets. This can cause weakness, bruising or increased risk of infection;
Allergic reactions, sometimes severe, including swelling of the lips, tongue and throat, fever, wheezing;
Low levels of sodium in the blood. This can cause weakness, vomiting and cramps;
Anxiety, confusion, or depression;
Change in taste;
Vision problems - such as blurred vision;
Sudden onset of wheezing or shortness of breath (bronchospasm);
Inflammation in the mouth;
Infection called "candidiasis" which may affect the gut and is caused by a fungus;
Liver problems, including jaundice - yellowing of the skin, dark urine and fatigue;
Hair loss (alopecia);
Skin rash when exposed to sunlight;
Joint pain (arthralgia) or muscles (myalgia)
Severe kidney problems (interstitial nephritis);
Inflammatory bowel disease (causing diarrhea).
Very rare side effects:
Changes in blood count including agranulocytosis (lack of white blood cells);
Seeing, feeling or hearing things (hallucinations);
Severe liver problems leading to liver failure and inflammation of the brain;
Sudden development of severe rash or peeling skin. This may be associated with fever and arthralgia (erythema multiforme, Stevens-Johnson, toxic epidermal necrolysis);
Breast enlargement in men.
Not known (frequency can not be estimated from the available data):
Inflammatory bowel disease (causing diarrhea);
If you are taking Omeprazol Accord for more than three months, it is possible values of magnesium in your blood decrease. Low levels of magnesium may occur, such as fatigue, uncontrollable muscle spasms, disorientation, convulsions, dizziness, increase in heart rate. If you experience any of these symptoms, please inform your doctor immediately. Low levels of magnesium can also lead to a reduction in the levels of potassium or calcium in the blood. Your doctor may order regular blood tests to monitor the values of magnesium.
In very rare cases Omeprazol Accord may affect the white blood cells that cause immunodeficiency. If you have an infection with symptoms such as fever with a severely reduced general condition, or fever with local infection symptoms such as pain in the neck, throat, or mouth, or difficulty urinating, it is necessary to consult a doctor as soon as possible to can a blood test decrease the number of white blood cells (agranulocytosis) be dismissed as possible. In this case it is important to give information about your medicine.
Listed possible side effects should not worry you. You can not get any of them.
Adverse event reporting
If you get any side effects, tell your doctor, pharmacist or nurse.
5. How to store Omeprazol Accord
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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