|Information for patients
OMEPRAZOLE is used to treat the symptoms of reflux oesophagitis or reflux disease in adults and in children. This can be caused by "washing back" (reflux) of food and acid from the stomach into the food pipe (oesophagus).
Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn, which
usually occurs after eating or at night and which worsens when bending over.
OMEPRAZOLEis also used to help stop reflux oesophagitis coming back or relapsing.
OMEPRAZOLE is used to treat acid-related dyspepsia. Dyspepsia is an uncomfortable feeling in the stomach or belching after eating. It is also known as indigestion.
OMEPRAZOLE is used to treat peptic ulcers. Depending on the position of the ulcer it is called a gastric
or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out from the stomach. These ulcers can be caused by too much acid being made in the stomach. They can cause pain and discomfort (indigestion) which is felt between the naval and the breast bone.
OMEPRAZOLEis also used to help stop gastric or duodenal ulcers coming back.
Peptic Ulcers Associated with Helicobacter pylori Infection
Most people who have a peptic ulcer also have a bacteria called Helicobacter pylori in their stomach. When OMEPRAZOLEis taken with antibiotics, they will kill Helicobacter pylori and let your peptic ulcer heal.
When OMEPRAZOLEis taken together with two antibiotics, they are more effective than taken one or
two at a time. It is possible that the antibiotics may not always kill Helicobacter pylori. You may need furthertreatment.
Peptic Ulcers Associated with Non-steroidal Anti-Inflammatory Drugs
Some peptic ulcers are caused by taking medicines called non-steroidal anti-inflammatory drugs. These
medicines are commonly taken to relieve pain, swelling and other symptoms of inflammation, including
arthritis. OMEPRAZOLE is also used to heal and prevent ulcers associated with NSAIDs.
OMEPRAZOLE is also used to treat a rare condition called Zollinger-Ellison syndrome, where the
stomach produces large amounts of acid, much more than in ulcers or reflux disease.
OMEPRAZOLEis a type of medicine called a proton-pump inhibitor. It works by decreasing the amount of acid made by the stomach, to give relief of symptoms and allow healing to take place. This does not stop food being digested in the normal way.
Your doctor will have explained why you are being treated with OMEPRAZOLE and told you what dose
Follow all instructions given to you by your doctor carefully.
Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.
|Before Consuming the Medicine
||Do not use OMEPRAZOLE if:
??you have an allergy to omeprazole or any of the ingredients in the contents
??the packaging shows signs of tampering
??the expiry date on the pack has passed.
Do not use OMEPRAZOLEto treat any other complaints unless your doctor says to.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
|Drug Special Care
||Before you start to use it
Tell your doctor if:
??you are pregnant or planning to become pregnant
??you are breastfeeding or planning to breastfeed
??you have or have had liver disease or liver problems
??you have or have had any medical conditions
??you have any allergies to any other medicines or any other substances, such as foods, preservatives
You must use OMEPRAZOLE exactly as your doctor has prescribed.
Tell all doctors, dentists and pharmacists who are treating you that you are taking OMEPRAZOLE.
|Drug Drug Interactions
||Tell your doctor if you are taking any other medicines, including:
??warfarin or other vitamin K antagonists
??other medicines that you buy at the chemist, supermarket or health food shop
These medicines may be affected by OMEPRAZOLE or may affect how well it works.
Your doctor or pharmacist can tell you what to do if you are taking any other medicines.
There is no evidence that OMEPRAZOLE is addictive.
|Drug Pregnancy Interaction
|Drug Breast feeding Interaction
|Drug Machinery Interaction
||OMEPRAZOLEis not likely to affect your ability to drive or use machines.
|Drug More Information
|How to take the Medicine
||Take OMEPRAZOLE capsules as instructed by your doctor. Take one OMEPRAZOLE capsule each
day, unless your doctor has told you otherwise.
The dose of OMEPRAZOLE is usually 20 mg a day, but may vary depending on what condition you are
being treated for and how severe it is.
The recommended dose in children with reflux oesophagitis is 10 mg once a day in children weighing 10-20kg and 20 mg in children weighing more than 20 kg.
||Swallow OMEPRAZOLE capsules whole with a glass of water. Do not crush or chew.
If you have trouble swallowing OMEPRAZOLE, open the capsule over an empty glass or cup and swallow the pellets with half a glass of liquid, or mix the pellets in a slightly acidic fluid e.g. fruit juice, yoghurt or non carbonated water and take within 30 minutes. Or, suck the capsule until it opens (1-2 minutes) and swallow the pellets with liquid. Do not crush or chew the capsules or the pellets. If the pellets in the capsules are chewed or crushed they will not work properly.
Take OMEPRAZOLE at the same time each day, preferably in the morning. Keeping a regular time for taking OMEPRAZOLE will help remind you to take it. In most patients, OMEPRAZOLE relieves symptoms rapidly and healing is usually complete within 4 weeks.
Although OMEPRAZOLE heals ulcers very successfully, it may not prevent them coming back at a later date. OMEPRAZOLE can be taken to prevent these relapses. If you are taking OMEPRAZOLE with
antibiotics, it is possible that the antibiotics may not kill Helicobacter pylori. You may need further treatment with antibiotics.
Tell your doctor if your symptoms return.
It does not matter whether you take OMEPRAZOLE with food or on an empty stomach.
|Excess Drug Consumption
||If you or anyone else has taken too much OMEPRAZOLE, immediately contact a doctor or Poisons
Information Centre or go to the nearest Accident & Emergency department or clinic. It is important to do this even if there are no signs of discomfort or poisoning.
Keep the telephone numbers for these places handy.
|Forgot Drug Consumption
||If you forget to take a dose, take it as soon as you remember, and then go back to taking it as you would normally. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose that you missed.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
|Stop Drug Consumption
|Possible Side Effects
||Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking OMEPRAZOLE.
OMEPRAZOLE helps most people with stomach or duodenal ulcers or reflux disease, but it may have
unwanted side effects in a few people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may
need medical treatment if you get some of the side effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you think you have any of these effects or notice anything else that is making you feel unwell.
Some people may get other side effects while taking OMEPRAZOLE.
Other problems are more likely to arise from the ulcer itself rather than the treatment.
For this reason, contact your doctor immediately if you notice any of the following:
??pain or indigestion occurs during treatment with OMEPRAZOLE
??you begin to vomit blood or food
??you pass black (blood-stained) motions.
Important: This leaflet alerts you to some of the situations when you should call your doctor. Other
situations, which cannot be predicted, may arise. Nothing in this leaflet should stop you from calling your
doctor or pharmacist with any questions or concerns you have about using OMEPRAZOLE capsules.
|Common Drug Side Effects
||Tell your doctor if you notice any of the following and they worry you:
??diarrhoea, wind (flatulence) or constipation
??nausea and/or vomiting
??stomach pain or discomfort
??skin rash, itching
??headache and/or dizziness
??breast enlargement in men
??unusual hair loss or thinning
These side effects are usually mild.
|Rare Drug Side Effects
||Tell your doctor as soon as possible if you notice any of the following:
??muscle pain or weakness, joint pain
??"pins and needles" (tingling or numbness of the hands and feet)
??changes in sleep patterns
??changes in mood
??hallucinations or confusion
??bleeding or bruising more easily than normal, nose bleeds
??frequent infections such as fever, severe chills, sore throat or mouth ulcers
|Very Rare Drug Side Effects
||Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:
??severe skin reaction which may include redness, blistering and peeling of the skin, accompanied with
fever and chills, aching muscles
??ulcers, blisters or bleeding of the lips, eyes, mouth, nose and genitals
??swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
These side effects are very rare.
|Drug Side Effects Symptoms
|How to Store the Medicine
|How to Store the Medicine
Keep your OMEPRAZOLE capsules in the bottle with the lid tightly closed until it is time to take them. If
you leave OMEPRAZOLE capsules out of the original bottle they will not keep well.
Keep it in a cool, dry place where the temperature stays below 25°C.
Use capsules within 3 months of first opening the bottle.
Do not store it or any other medicine in the bathroom or near a sink.
Heat and dampness can destroy medicines.
Do not use OMEPRAZOLE after the expiry date printed on the label and carton.
Keep out of the reach and sight of children. Do not leave OMEPRAZOLE in the car on hot days.
If your doctor tells you to stop taking OMEPRAZOLE or the capsules have passed their expiry date, ask
your pharmacist what to do with any capsules you have left over.