Active ingredient
- omeprazole
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 34111/0002.
Omeprazole 2 mg/ml, Powder for Oral Suspension
Package leaflet: information for the patient
Omeprazole 2mg/ml, Powder for Oral Suspension
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Omeprazole Oral Suspension is and what it is used for
2. What you need to know before you take Omeprazole Oral Suspension
3. How to take Omeprazole Oral Suspension
4. Possible side effects
5. How to store Omeprazole Oral Suspension
6. Contents of the pack and other information
1. What Omeprazole Oral Suspension is and what it is used for
The name of your medicine is Omeprazole 2mg/ml, Powder for Oral Suspension (called Omeprazole Oral Suspension in this leaflet).
Omeprazole Oral Suspension contains the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.
Omeprazole is commonly used to treat the following conditions:
In adults:
In children:
Children over 1 month of age:
Children over 4 years of age and adolescents:
Your doctor will tell you why you have been given this medicine.
2. What you need to know before you take Omeprazole Oral Suspension
Do not take Omeprazole Oral Suspension
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Omeprazole Oral Suspension.
Warnings and precautions
Talk to your doctor or pharmacist before taking Omeprazole.
Omeprazole may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Omeprazole Oral Suspension or while you are taking it, talk to your doctor straight away:
If you take Omeprazole on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.
Taking a proton pump inhibitor like Omeprazole, especially over a period of more than one year, may slightly increase your risk of fracture in 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).
If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Omeprazole. Remember to also mention any other ill-effects like pain in your joints.
Children
Some children with chronic illnesses may require long-term treatment although it is not recommended. Do not give this medicine to children under 1 month of age.
Other medicines and Omeprazole Oral Suspension
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription. This is because Omeprazole can affect the way some medicines work and some medicines can have an effect on Omeprazole.
Do not take Omeprazole 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 medicines:
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Omeprazole to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.
Omeprazole Oral Suspension with food and drink
You should take Omeprazole Oral Suspension without food on an empty stomach.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used. Your doctor will decide whether you can take Omeprazole if you are breastfeeding.
Driving and using machines
Omeprazole is not likely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances may occur (see section 4). If affected, you should not drive or operate machinery.
Omeprazole Oral Suspension contains maltitol, potassium, sodium, sodium methyl parahydroxybenzoate and sodium benzoate.
3. How to take Omeprazole Oral Suspension
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how much medicine to take and how long to take it for. This will depend on your condition and how old you are.
For doses of ≤ 15mg, the 2 mg/ml strength is recommended. For doses of 20mg or 40mg, the 4mg/ml strength is suitable.
The recommended dose is given below.
Use in adults
To treat symptoms of GORD such as heartburn and acid regurgitation:
To treat ulcers in the upper part of the intestine (duodenal ulcer):
To treat ulcers in the stomach (gastric ulcer):
To prevent the duodenal and stomach ulcers from coming back:
To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):
To prevent duodenal and stomach ulcers if you are taking NSAIDs:
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
Use in children and adolescents
To treat symptoms of GORD such as heartburn and acid regurgitation:
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:
Taking this medicine
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
Constitution of the powder
Placement of syringe adaptor
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.
If you have further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following rare but serious side effects, stop taking Omeprazole Oral Suspension and contact a doctor immediately:
Other side effects include:
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
Omeprazole Oral Suspension may in very rare cases affect the white blood cells leading to immune deficiency. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medicine at this time.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Omeprazole Oral Suspension
6. Contents of the pack and other information
What Omeprazole Oral Suspension contains
What Omeprazole Oral Suspension looks like and contents of the pack
Before constitution: White / off-white / slightly yellow powder in a cap attached to a bottle containing white / off-white / slightly yellow powder, which may contain dark specks due to sweetener.
After constitution: White / off-white / brownish oral suspension. May contain dark specks due to sweetener.
Pack: Amber plastic (PET) bottle with powder fitted with a red Polypropylene (PP) closure cap containing powder, all enclosed in an aluminium foil pouch.
Each bottle contains 47 g of powder for oral suspension. Once constituted the bottle contains 90 ml of oral suspension, of which 75 ml is intended for dosing and administration.
Each pack also contains an opaque PP oral dosing syringe (5 ml, graduated at each 1ml and intermediate marks every 0.1ml) with white HDPE plunger, colourless, transparent LDPE press-in bottle adaptor and grey PP replacement cap.
Pack: 1 or 2 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Distributor:
Other sources of information
This leaflet is also available in other formats for blind and partially-sighted patients.
For large print and Braille, please go to www.medicines.org.uk
This leaflet was last revised in August 2019.
L5VG7RBJ1
610354
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
+44 (0)113 244 1400
+44 (0)800 919 312
+44 (0)113 245 3567
+44 (0)7836 557 879