Apotex Apo-Ome 20mg, 14 capsules

What APO-OME 20 is and what it is used for

APO-OME 20 gastro-resistant capsules contain the active substance omeprazole. Omeprazole belongs to a group of medicines called 'proton pump inhibitors'. They work by reducing the amount of acid that builds up in your stomach.

Without a doctor's recommendation (Dispensing without a prescription)

APO-OME 20 is used in adults to treat the symptoms of reflux (eg heartburn, acid regurgitation).
Reflux is the return of the acidic contents of the stomach back to the esophagus, which can become inflamed and painful. This can cause symptoms such as a painful burning sensation in the chest rising to the mouth (heartburn) and a sour feeling in the mouth (acid regurgitation).
You may need to take the capsules 2-3 days in a row to improve your symptoms.

Only on doctor's recommendation (Medicinal product subject to medical prescription)

APO-OME 20 is only used to treat the following conditions on the advice of a doctor:

In adults:

• Esophageal reflux disease. In this case, stomach acid returns to the esophagus (the tube that connects the mouth and stomach) and causes pain, inflammation and heartburn.
• Ulcers of the upper small intestine (duodenal ulcers) or stomach (stomach ulcers).
• Ulcers that are infected with a bacterium called "Helicobacter pylori". If you have this condition, your doctor may also prescribe antibiotics to treat the infection and heal the ulcer.
• Ulcers caused by the use of medicines called "non-steroidal anti-inflammatory drugs" (NSAIDs). APO-OME 20 can be used to prevent ulcers when taking NSAIDs.
• Excessive production of stomach acid caused by the growth of the pancreas (Zollinger-Ellison syndrome).

In children:

Children from 1 year and weighing> = 10 kg

• Esophageal reflux disease. In this case, stomach acid returns to the esophagus (the tube that connects the mouth and stomach) and causes pain, inflammation and heartburn.

In children, symptoms may include the return of stomach contents to the mouth (regurgitation), nausea (vomiting) and slow weight gain.

Children from 4 years and teenagers

• Ulcers that are infected with a bacterium called "Helicobacter pylori". If your child has this infection, your doctor may prescribe antibiotics to treat the infection and heal the ulcer.

How to use APO-OME 20

Treatment without a doctor's supervision (Dispensing without a prescription)

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.
Without a doctor's recommendation, APO-OME 20 is used in adults to treat the symptoms of reflux (eg heartburn, acid regurgitation).

The usual dose is one 20 mg capsule once a day for 14 days. See your doctor if the symptoms of the disease do not go away after this time. Sometimes it may be necessary to take the capsules for the next 2-3 days to improve the symptoms.

Treatment only after consultation with a doctor (Prescription only)

Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

Your doctor will tell you how many capsules to take and for how long. It depends on the disease and your age.
The usual doses are listed below:

Adults

Treatment of symptoms of esophageal reflux disease, eg heartburn and acid regurgitation:

• If your doctor finds that your esophagus is slightly damaged, the usual dose is 20 mg once a day for 4-8 weeks. If your esophagus does not heal, your doctor may advise you to take a dose of 40 mg for another 8 weeks.
• if the esophagus has healed, the usual starting dose is 10 mg once a day.
• if the esophagus is not damaged, the usual dose is 10 mg once a day.

Treatment of ulcers in the upper small intestine (duodenal ulcer):

• the usual dose is 20 mg once a day for 2 weeks. If the ulcer does not heal, your doctor may advise you to take the same dose for another 2 weeks.
• if the ulcer does not heal completely, the dose can be increased to 40 mg once a day for 4 weeks.

Treatment of gastric ulcers:

• the usual dose is 20 mg once a day for 4 weeks. If healing does not occur, your doctor may advise you to take the same dose for another 4 weeks.
• if the ulcer has not completely healed, the dose can be increased to 40 mg once a day for 8 weeks.

Prevention of the return of duodenal and gastric ulcers:

• the usual dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

Treatment of duodenal and gastric ulcers caused by the use of NSAIDs (non-steroidal anti-inflammatory drugs):

• the usual dose is 20 mg once a day for 4 to 8 weeks.

Prevention of duodenal and gastric ulcers if you are taking NSAIDs:

• the usual dose is 20 mg once a day.

Treatment of ulcers caused by Helicobacter pylori infections and prevention of their return:

• the usual dose is 20 mg twice a day for 1 week.
• Your doctor will prescribe two of the following antibiotics: amoxicillin, clarithromycin or metronidazole.

Treatment of excessive acid production in the stomach caused by the growth of the pancreas (Zollinger-Ellison syndrome):

• the usual dose is 60 mg daily.
• your doctor may increase the dose as needed and decide how long you will take the medicine.

Children

Treatment of symptoms of esophageal reflux disease, eg heartburn and acid regurgitation:

• children over 1 year of age and weighing more than 10 kg can take APO-OME 20. The dose for children is determined based on body weight and your doctor will decide on the correct dose.

Treatment of ulcers caused by Helicobacter pylori infections and prevention of their return:

• children over 4 years of age can take APO-OME 20. The dose for children is determined based on body weight and your doctor will decide on the correct dose.
• Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin to your child.

How to use this product

• It is recommended to take the capsules in the morning.
• You can take the capsules with or without food.
• Swallow the capsules whole with half a glass of water. Do not bite or crush the capsules. The capsules contain coated pellets which prevent the active substance from breaking down in the acidic environment of the stomach. It is important that the pellets are not damaged. These micropellets contain the active substance omeprazole and are coated with a layer that protects them from decomposition as they pass through the stomach. The pellets release the active substance in the small intestine, from where it enters the body at the site of action.

What to do if you or your child have difficulty swallowing capsules

• If you or your child have difficulty swallowing capsules:
  • open the capsule and swallow the contents and drink half a glass of water or pour the contents of the capsule into a glass with carbon dioxide-free water (still water), sour fruit juice (eg apple, orange or pineapple) or apple juice.
  • always stir before drinking (the mixture will not be completely clear). Drink the mixture immediately or within 30 minutes at the latest.
  • to drink all the medicine, rinse the glass well once more with water and drink the contents. Do not use milk or carbonated water. Solid particles contain the active substance - do not bite or crush them.

What APO-OME 20 contains

The active substance is omeprazole. Each capsule contains 20 mg of omeprazole.
The other ingredients are: magnesium hydroxide, mannitol, povidone, methacrylate copolymer type C, triethyl citrate, red iron oxide, titanium dioxide, black ink, gelatin.