Use in adults

To treat symptoms of GORD such as heartburn and acid regurgitation:

• If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is 20 mg once a day 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 yet healed.
• The recommended dose once the gullet has healed is 10 mg once a day.
• If your gullet has not been damaged, the usual dose is 10 mg once a day.

To treat ulcers in the upper part of the intestine (duodenal ulcer):

• The recommended dose is 20 mg once a day for 2 weeks. Your doctor may tell you to take the same dose for a further 2 weeks if your ulcer has not yet healed.
• If the ulcers do not fully heal, the dose can be increased to 40 mg once a day for 4 weeks.

To treat ulcers in the stomach (gastric ulcer):

• The recommended dose is 20 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your ulcer has not yet healed.
• If the ulcers do not fully heal, the dose can be increased to 40 mg once a day for 8 weeks.

To prevent the duodenal and stomach ulcers from coming back:

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

To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is 20 mg once a day for 4–8 weeks.

To prevent duodenal and stomach ulcers if you are taking NSAIDs:

• The recommended dose is 20 mg once a day.

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:

• The recommended dose is 20 mg Omeprazole twice a day for one week.
• Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.

Use in children and adolescents

To treat symptoms of GORD such as heartburn and acid regurgitation:

• Children over 1 month of age may take Omeprazole. The dose for children is based on the child’s weight and the doctor will decide the correct dose based on the following:

Age: 1 month to 1 year of age, posology: 1 mg/kg once daily. Doses above 1.5 mg/kg/day have not been studied.

Age: ≥ 1 year of age, weight: 10-20 kg, posology: 10 mg once daily. The dose can be increased to 20 mg once daily if needed.

Age: ≥ 2 years of age, weight: > 20 kg, posology: 20 mg once daily. The dose can be increased to 40 mg once daily if needed.

* Individual dose measurements ≤ 2ml are not indicated

** The 2 mg/ml and 4 mg/ml strengths are equivalent with respect to buffering capacity (same amount of buffer on a ml basis).

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:

• Children aged over 4 years may take Omeprazole. 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

• This medicine contains 10mg (Omeprazole 2mg/ml Oral Suspension) in each 5 millilitre (5ml) of suspension.
• Take this medicine by mouth.
• It is recommended that you take your dose of medicine in the morning.
• This medicine should be taken on an empty stomach, at least 30 minutes before a meal.
• Use the dosing device provided to measure the correct dose (see Measuring your dose).
• A glass of water may be taken after taking the dose.
• This medicine can also be administered via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes.
• Instructions for use via NG or PEG tube:
  • Ensure that the enteral feeding tube is free from obstruction before administration.
  • Flush the enteral tube with 5mL of water
  • Administer the required dose of Omeprazole Oral Suspension with a suitable measuring device.
  • Flush the enteral tube with 5mL of water

This product can be used with Polyurethane and PVC nasogastric (NG) and percutaneous endoscopic gastrostomy (PEG) tubes of size 6 Fr to 16 Fr. For the smallest diameter tubes (6 Fr) a smaller flush volume of 2ml may be used in very young children

Preparing and taking the suspension

The container is two compartment system containing powder both in the cap and in the bottle. The two powders first need to be combined and are then to be constituted in water. A red mixing disk will drop into the medicine to help mix the powders and also mix the constituted suspension after addition of the water. It should remain in the bottle. The red cap is replaced by a grey cap after constitution. It is recommended that a pharmacist constitutes Omeprazole Oral Suspension prior to its dispensing to the patient.

Instructions for initial constitution.

Combination of powder in cap and bottle

• Shake the bottle for 10 seconds to loosen the powder.
• Twist the red cap anti-clockwise (see arrow on cap) until the seal is broken to release the powder in the red cap into the bottle.
• Twist the red cap back to the original position, securely fastening the red cap onto the bottle.

Constitution of the powder

• Shake the bottle vigorously for ten seconds to mix the powders.
• Tap the base of the bottle three times on a hard horizontal surface to make sure all powder is in the bottle and not in the cap.
• Remove the red cap from the bottle.
• Add 64ml of water by using a suitable measuring device up to the line on the label.
• Securely fasten the red cap onto the bottle and shake vigorously for 30 seconds.

Placement of syringe adaptor

• Remove the red cap and red ring and throw away.
• Insert the colourless, transparent Bottle Adaptor and replace the red cap with the grey plastic screw-cap.
• Leave for fifteen minutes for product to reach final consistency.

Measuring your dose

Instructions for use of the syringe

1. Shake for 20 seconds immediately prior to each use
2. To open the bottle, press the grey cap down and turn it anti-clockwise (Figure 1). Do not remove the white cap portion.
3. Take the syringe and put it into the adaptor opening (Figure 2).
4. Turn the bottle upside down (Figure 3).
5. Fill the syringe with a small amount of suspension by pulling the plunger down (Figure 4A). Then push the plunger upward in order to remove any possible bubbles (Figure 4B). Finally, pull the plunger down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor. The top flat edge of the piston should be in line with the graduation mark you are measuring to (Figure 4C).
6. Turn the bottle the right way up (Figure 5A).
7. Remove the syringe from the adaptor (Figure 5B).
8. Put the end of the syringe into the mouth of the patient and push the plunger slowly back in to take the medicine. The suspension will be released slowly while the last portion will be released faster due to reduced resistance in the tip of the syringe.
9. Wash the syringe with water and let it dry before you use it again (Figure 6).
10. Close the bottle with the grey plastic screw cap – leave the bottle adaptor in the bottle.

Note: It is normal to have the red plastic disc in the suspension during use; do not attempt to remove it.

If you take more Omeprazole Oral Suspension than you should

If you take more of this medicine than prescribed by your doctor, talk to your doctor or pharmacist straight away.

If you forget to take Omeprazole Oral Suspension

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 stop taking Omeprazole Oral Suspension

Do not stop taking Omeprazole without first talking to your doctor or pharmacist.