APO-Omeprazole Capsule

What omeprazole is used for

The name of your medicine is APO-Omeprazole. It contains the active ingredient, omeprazole.

It is used to treat:

Reflux Oesophagitis:

Omeprazole is used to treat the symptoms of reflux oesophagitis or reflux disease. 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.

Omeprazole is also taken to help stop reflux oesophagitis coming back or relapsing.

Peptic Ulcers:

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.

Omeprazole is 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 bacterium called Helicobacter pylori in their stomach.

When omeprazole is taken with antibiotics, they work to kill the bacterium and let your ulcer heal. You may need further treatment with antibiotics.

Peptic Ulcers Associated with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):

Some peptic ulcers are caused by taking medicines called non-steroidal anti-inflammatory drugs (NSAIDs), a type of medicine used to treat pain or inflammation. Omeprazole is also used to heal and prevent ulcers associated with NSAIDs.

Zollinger-Ellison Syndrome:

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.

How it works

Omeprazole is 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.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may prescribe this medicine for another reason.

This medicine is only available on prescription.

There is no evidence that omeprazole is addictive.

Use in children

There is not enough information to recommend the use of this medicine in children.

Before you take omeprazole

When you must not take it

Do not take omeprazole if you have an allergy to:

omeprazole
any ingredient listed at the end of this leaflet
any medicine containing a proton-pump inhibitor.

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; muscle pain or tenderness or joint pain or rash, itching or hives on the skin.

Do not take this medicine after the expiry date (EXP) printed on the pack.

If you take this medicine after the expiry date has passed, it may not work as well.

Do not take this medicine if the packaging is torn, shows signs of tampering or if it does not look quite right.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should take this medicine, talk to your doctor or pharmacist.

Before you start to take it

You must tell your doctor if you have:

  • allergies to any other medicines, foods, dyes or preservatives
  • any problems with your liver
  • any other medical condition.

Do not take omeprazole if you are pregnant or breast-feeding unless your doctor says so. Ask your doctor about the risks and benefits involved. It is not known if it is safe for you to take omeprazole while you are pregnant. It may affect your baby.

It is not known if your baby can take in omeprazole from breast milk if you are breast-feeding.

Taking other medicines

Tell your doctor if you are taking any other medicines including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with omeprazole. These include:

  • phenytoin - a medicine used to treat epilepsy or fits
  • warfarin - a medicine used to prevent blood clots
  • diazepam - a medicine used to treat anxiety and some other conditions
  • ketoconazole, itraconazole, voriconazole - medicines used to treat fungal infection
  • antiretroviral drugs (for example atazanavir and nelfinavir) - medicines used to treat viral infections such as HIV
  • tacrolimus - a medicine used to assist in organ transplants
  • Clopidogrel - known as an antiplatelet medicine, which reduces the chances of blood clots forming.

These medicines may be affected by omeprazole or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor can tell you what to do if you are taking any other medicines.

How to take this medicine

Follow all directions given to you by your doctor and pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

How much to take

The dose for omeprazole varies from patient to patient. Your doctor will decide the right dose for you. This depends on your condition and whether or not you are taking any other medicines.

How to take it

Swallow the capsules with a glass of water.

Do not crush or chew the capsules.

If the granules or pellets contained in the capsules are crushed or chewed, they will not work properly.

When to take it

Take each dose of omeprazole at about the same time each day.

Taking each dose of omeprazole at the same time each day will help you remember when to take it.

Omeprazole can be taken with food or on an empty stomach.

How long to take it

Keep taking omeprazole for as long as your doctor recommends.

If you are taking omeprazole to heal an ulcer or to treat reflux disease, you will usually need to take omeprazole for 4 to 8 weeks.

It is very important that you take the full course of omeprazole as prescribed by your doctor so that your condition is properly treated.

If you are taking omeprazole to stop an ulcer from coming back or to treat other conditions, your doctor will tell you how long you need to take the capsules.

Make sure you have enough to last over weekends and holidays.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (13 11 26) for advice, or go to Accident and Emergency department at your nearest hospital, if you think that you or anyone else may have taken too much omeprazole.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are taking omeprazole

Things you must do

Take omeprazole exactly as your doctor has prescribed.

If you are about to start any new medicine, remind your doctor and pharmacist that you are taking omeprazole.

Tell all doctors, dentists and pharmacists who are treating you that you are taking omeprazole.

Tell your doctor immediately if you become pregnant while you are taking omeprazole.

Tell your doctor if your symptoms return. Although omeprazole can heal ulcers successfully, it may not prevent them recurring at a later date.

Things you must not do

Do not take omeprazole to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you or their symptoms seem similar to yours.

Do not stop taking your medicine or change the dosage without checking with your doctor. If you stop taking it suddenly or change the dose, your condition may worsen or you may have unwanted side effects.

Side effects of omeprazole

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking omeprazole.

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.

Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.

Ask your doctor or pharmacist to answer any questions you may have.

Following is a list of possible side effects. Do not be alarmed by this list. You may not experience any of them.

Tell your doctor if you notice any of the following and they worry you:

  • constipation
  • nausea
  • diarrhoea
  • headache
  • skin rash.

The above list includes the more common side effects. These side effects are usually mild.

Tell your doctor immediately if you notice any of the following:

muscle pain or weakness
dizziness
"pins and needles"
changes in sleep patterns
mood changes
increase in breast size (males)
fever
increased bruising
signs of liver inflammation including yellowing of the skin or eyes, feeling generally unwell, nausea, vomiting, loss of appetite.

These may be serious side effects that may require medical attention. Most of these side effects are rare.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing
shortness of breath or difficulty in breathing
skin reaction which may include rash, itching, redness, blistering or peeling of the skin
ulcers, blisters or bleeding of the lips, eyes, mouth, nose and genitals
swelling of feet, hands and ankles.

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Other side effects not listed above may occur in some patients.

Other problems may 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 that occurs during treatment with omeprazole
you begin to vomit blood or food
you pass black (blood-stained) motions.

After taking this medicine

Storage

Keep your medicine in its original packaging until it is time to take it.

If you take this medicine out of its original packaging, it may not keep well.

Keep your medicine in a cool, dry place where the temperature stays below 25°C, protected from moisture.

Do not store your medicine, or any other medicine, in the bathroom or near a sink.

Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine, or it has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.

Product description

What APO-Omeprazole looks like

APO-Omeprazole is an opaque yellow cap and body capsule, containing off-white to cream-white spherical pellets.

Each blister pack/bottle contains 30 capsules.

Ingredients

Active ingredient:

Each capsule contains omeprazole 20 mg.

Inactive ingredients:

Pellets:

  • sodium lauryl sulfate
  • dibasic anhydrous sodium phosphate
  • hypromellose
  • mannitol
  • macrogol 6000
  • purified talc
  • polysorbate-80
  • titanium dioxide
  • eudragit L30-D-55
  • maize starch
  • sucrose.

Capsule:

  • gelatin
  • titanium dioxide
  • quinoline yellow CI47005.

This medicine is gluten-free, lactose-free, tartrazine-free and free of other azo dyes.

Australian Registration Number

APO-Omeprazole 20 mg

(blister pack): AUST R 149518.

APO-Omeprazole 20 mg

(bottle): AUST R 167316.

Distributor

Apotex Pty Ltd

66 Waterloo Road

North Ryde NSW 2113

Australia

This leaflet was prepared in:

February 2010.