Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
1. Why am I using Probitor?
Probitor contains the active ingredient omeprazole. Probitor is used to treat: the symptoms of reflux oesophagitis or reflux disease; peptic ulcers; peptic ulcers associated with helicobacter pylori infection; peptic ulcers associated with non-steroidal anti-inflammatory drugs (NSAIDs); and a rare condition called Zollinger-Ellison syndrome.
For more information, see Section 1. Why am I using Probitor? in the full CMI.
2. What should I know before I use Probitor?
Do not use if you have ever had an allergic reaction to omeprazole or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Probitor? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Probitor and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How do I use Probitor?
- Take one Probitor capsule each day, unless your doctor has told you otherwise.
- Swallow Probitor whole with a glass of water. Do not crush or chew the pellets or granules.
More instructions can be found in Section 4. How do I use Probitor? in the full CMI.
5. What should I know while using Probitor?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Drinking alcohol |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using Probitor? in the full CMI.
6. Are there any side effects?
Mild side effects include: constipation, nausea or vomiting, diarrhoea, wind, stomach pain, headache, dizziness, skin rash, itchy skin, dry or sore mouth.
Serious side effects (Call your doctor straight away, or go straight to the Emergency Department) include: swelling of the face, lips, mouth, tongue or throat, shortness of breath or difficulty in breathing, skin reaction (which may include rash, itching, redness, blistering or peeling of the skin) especially in sun-exposed areas with joint pain, ulcers, blisters or bleeding of the lips, eyes, mouth, nose and genitals, blood in the urine, swelling of hands, feet or ankles, yellowing of the skin or eyes, feeling generally unwell, nausea, vomiting, loss of appetite. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
Probitor®
Active ingredient(s): omeprazole
Consumer Medicine Information (CMI)
This leaflet provides important information about using Probitor. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Probitor.
Where to find information in this leaflet:
1. Why am I using Probitor?
2. What should I know before I use Probitor?
3. What if I am taking other medicines?
4. How do I use Probitor?
5. What should I know while using Probitor?
6. Are there any side effects?
7. Product details
1. Why am I using Probitor?
Probitor contains the active ingredient omeprazole. Probitor 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.
Reflux Oesophagitis
Probitor 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.
Probitor is also taken to help stop reflux oesophagitis coming back or relapsing.
Peptic Ulcers
Probitor 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.
Probitor is also used to help stop gastric or duodenal ulcers coming back.
Peptic Ulcers Associated with Helicobacter pylori Infection
Probitor is used to treat 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 Probitor 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)
Probitor is used to treat 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.
Probitor is also used to heal and prevent ulcers associated with NSAIDs.
Zollinger-Ellison Syndrome
Probitor is also used to treat a rare condition called Zollinger-Ellison syndrome.
This syndrome is where the stomach produces large amounts of acid, much more than in ulcers or reflux disease.
There is no evidence that Probitor is addictive.
2. What should I know before I use Probitor?
Warnings
Do not use Probitor if:
- you are allergic to omeprazole, or any of the ingredients listed at the end of this leaflet.
- you are allergic to any medicine containing a proton pump inhibitor.
- Always check the ingredients to make sure you can use this medicine.
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; rash, itching or hives on the skin. - you are also taking cilostazol.
Please check with your doctor or pharmacist if you are taking cilostazol. This medicine will be affected by Probitor. - the use by (expiry) date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
Check with your doctor if you:
- allergies to any other medicines, foods, dyes or preservatives.
- take any medicines for any other condition.
- any problems with your liver.
- any other medical conditions
- been diagnosed with osteoporosis.
- ever had a skin reaction after treatment with a medicine similar to Probitor that reduces stomach acid.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Do not take Probitor if you are pregnant or breastfeeding unless your doctor says so. Ask your doctor about the risks and benefits involved.
Check with your doctor if you are pregnant or intend to become pregnant.
It is not known if it is safe for you to take Probitor while you are pregnant. It may affect your baby.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known if your baby can take in Probitor from breast milk if you are breastfeeding.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Do not take Probitor if you are taking the following medicine:
- cilostazol – a medicine used to treat intermittent claudication.
Some medicines may interfere with Probitor and affect how it works.
- phenytoin – a medicine used to treat epilepsy or fits.
- warfarin and clopidogrel – medicines used to prevent blood clots.
- digoxin – a medicine used to treat heart conditions.
- diazepam – a medicine used to treat anxiety and some other conditions.
- St John’s wort – a herbal remedy used to treat mood disorders.
- ketoconazole, itraconazole, voriconazole – medicines used to treat fungal infection.
- clarithromycin or rifampicin – medicines used to treat infections.
- atazanavir and nelfinavir – medicines used to treat viral infections such as HIV.
- tacrolimus and mycophenolate mofetil – medicines used to assist in organ transplants.
- methotrexate – a medicine used to treat arthritis and some types of cancer.
- erlotinib or related medicines used to treat cancer.
These medicines may be affected by Probitor 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.
If you have not told your doctor about any of these things, tell them before you take Probitor.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Probitor.
4. How do I use Probitor?
How much to take
- Take one Probitor capsule each day, unless your doctor has told you otherwise.
- Adults: The dose of Probitor is usually 20 mg a day.
The dose for Probitor varies from patient to patient.
Your doctor will decide the right dose for you.
When to take Probitor
- Take Probitor at about the same time each day.
- Keeping a regular time for taking Probitor will help to remind you to take it.
- Probitor can be taken with food or on an empty stomach.
How to take Probitor
- Swallow Probitor whole with a glass of water. If the granules or pellets contained in the capsules are crushed or chewed, they will not work properly.
- Keep taking Probitor for as long as your doctor recommends.
- In most patients, Probitor relieves symptoms rapidly and healing is usually complete within 4 weeks.
Continue taking Probitor for as long as your doctor tells you to.
If you forget to use Probitor
Probitor should be used regularly at the same time each day. If you miss your dose at the usual time, 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 you missed.
If you use too much Probitor
If you think that you have used too much Probitor, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), or - contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Probitor?
Things you should do
Take Probitor exactly as your doctor has prescribed.
If you are about to start any new medicine, remind your doctor and pharmacist that you are taking Probitor.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Probitor.
Tell your doctor if you become pregnant while you are taking Probitor.
Tell your doctor if your symptoms return.
Although Probitor can heal ulcers successfully, it may not prevent them recurring at a later date.
If you need to have any medical tests while you are taking Probitor, tell your doctor.
It may affect the results of some tests.
Remind any doctor, dentist or pharmacist you visit that you are using Probitor.
Things you should not do
- Do not take Probitor 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.
- 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 unwantedside effects.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Probitor affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
- Keep your Probitor in the original container until it is time to take them.
If you take Probitor out of the original container they will not keep well. - Do not use after the printed expiry date. Keep the container tightly closed.
- Keep it in a cool, dry place where the temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
- in the bathroom or near a sink, or
- in the car or on window sills.
Keep it where young children cannot reach it.
When to discard your medicine
If your doctor tells you to stop taking Probitor or the capsules have passed their expiry date, ask your pharmacist what to do with any capsules you have left over.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
Less serious side effects | What to do |
These side effects are usually mild. Gut or Gastrointestinal related:
General Disorders:
Skin related:
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Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
These are serious side effects that may require medical attention. Serious side effects are rare. Muscle-Joint Related:
Bleeding related:
Electrolytes related:
Gut or Gastro-intestinal related:
Mood and brain related:
Eye related:
Others:
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Tell your doctor immediately if you notice any of these serious side effects. |
These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare. Allergy related:
Skin related:
Liver Related:
Others:
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Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Occasionally, Probitor may be associated with changes in your liver or blood, which may require your doctor to do certain blood tests.
When taking Probitor, inflammation in your kidney may occur. Signs and symptoms may include decreased volume of urine or blood in your urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report such signs to the treating physician.
Other problems are more likely to arise from the ulcer itself rather than the treatment.
Tell your doctor if your reflux symptoms return after you stop taking Probitor.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
7. Product details
This medicine is only available with a doctor’s prescription.
What Probitor contains
Active ingredient (main ingredient) |
Omeprazole |
Other ingredients (inactive ingredients) |
Pellets
Capsule
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Potential allergens |
This medicine does not contain lactose, gluten, tartrazine or any other azo dyes. |
Do not take this medicine if you are allergic to any of these ingredients.
What Probitor looks like
Probitor 20 mg capsules – opaque yellow cap and body enteric capsule containing off-white to cream-white spherical pellets.
Available in bottles of 5, 30 and 100 enteric capsules and in blister packs of 6, 7, 28, 30 and 35 enteric capsules.
Not all presentations are available in Australia.
Australian Registration Numbers:
20 mg capsules: AUST R 82757 (blister packs)
20 mg capsules: AUST R 78186 (bottles)
Who distributes Probitor
Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park
NSW, Australia 2113
Tel: 1800 726 369
This leaflet was prepared in August 2023.
Published by MIMS October 2023