SUMMARY CMI
OLMETEC®
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 OLMETEC?
OLMETEC contains the active ingredient olmesartan medoxomil. OLMETEC is used to treat high blood pressure.
For more information, see Section 1. Why am I using OLMETEC? in the full CMI.
2. What should I know before I use OLMETEC?
Do not use if you have ever had an allergic reaction to OLMETEC 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 OLMETEC? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with OLMETEC 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 OLMETEC?
- Follow all directions given to you by your doctor or pharmacist carefully. Your doctor will tell you which OLMETEC tablet or how much OLMETEC suspension you will need to take each day. Take OLMETEC at the same time each day.
- Swallow OLMETEC tablets whole with a full glass of water.
- Shake the OLMETEC suspension bottle and then use either a medicine measure or a dosing syringe to give the required volume to your child.
More instructions can be found in Section 4. How do I use OLMETEC? in the full CMI.
5. What should I know while using OLMETEC?
Things you should do |
|
Things you should not do |
|
Driving or using machines |
|
Drinking alcohol |
|
Looking after your medicine |
|
For more information, see Section 5. What should I know while using OLMETEC? in the full CMI.
6. Are there any side effects?
Common side effects may include dizziness, feeling light-headed, cough, headache, feeling nauseous or vomiting, diarrhoea, tiredness, 'flu-like' symptoms, sore throat and difficulty swallowing, back pain, swelling of the face or body and urinary infection. Serious side effects may include swelling of the face, lips tongue or throat which causes difficulty swallowing or breathing, muscle or joint pain, fast heartbeat and chest pain. 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.
FULL CMI
OLMETEC®
Active ingredient(s): olmesartan medoxomil
Consumer Medicine Information (CMI)
This leaflet provides important information about using OLMETEC. 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 OLMETEC.
Where to find information in this leaflet:
1. Why am I using OLMETEC?
2. What should I know before I use OLMETEC?
3. What if I am taking other medicines?
4. How do I use OLMETEC?
5. What should I know while using OLMETEC?
6. Are there any side effects?
7. Product details
1. Why am I using OLMETEC?
OLMETEC contains the active ingredient olmesartan medoxomil. OLMETEC contains olmesartan medoxomil, which belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which causes blood vessels to tighten. OLMETEC blocks the action of angiotensin-II and therefore relaxes your blood vessels. This helps lower your blood pressure.
OLMETEC is used to treat high blood pressure which is sometimes called hypertension.
Everyone has blood pressure. This pressure helps push blood all around your body. Your blood pressure changes at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed.
There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems, including stroke, heart disease and kidney failure.
OLMETEC is not addictive.
2. What should I know before I use OLMETEC?
Warnings
Do not use OLMETEC if:
- you have an allergy to OLMETEC or any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction to OLMETEC may include skin rash, itchiness, shortness of breath, swelling of the face, lips or tongue, muscle pain or tenderness or joint pain.
- you have serious problems with your kidneys
- you have serious problems with your liver
- you have diabetes and are taking a medicine called aliskiren to reduce blood pressure
- you are pregnant or breast-feeding
- the expiry date on the pack has passed or if the packaging is torn or shows signs of tampering
Tell your doctor if:
- you have allergies to any other medicines, or any other substances, such as foods, preservatives or dyes.
- you have or have had any other medical conditions, especially the following:
- Kidney problems
- liver problems
- heart problems
- excessive vomiting or diarrhoea recently
- high levels of potassium in your blood.
- Problems with your adrenal glands (small glands above the kidneys) - you are following a very low salt diet
- you are or intend to become pregnant or plan to breastfeed.
- you are taking potassium supplements, potassium-sparing agents, potassium-containing salt substitutes or other medicines that may increase serum potassium (e.g., trimethoprim-containing products)
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 OLMETEC if you are pregnant or breastfeeding.
OLMETEC may enter your womb or it may pass into the breast milk and there is the possibility that your baby may be affected.
If pregnancy is discovered OLMETEC should be discontinued as soon as possible.
Use in children
The safety and effectiveness of OLMETEC in children aged less than 1 year has not been established.
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.
Some medicines and OLMETEC may interfere with each other. These include:
- other medicines to treat high blood pressure
- other diuretics, also known as fluid or water tablets
- non-steroid anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors, medicines used to relieve pain, swelling and other symptoms of inflammation including arthritis
- potassium supplements or potassium-containing salt substitutes
- other medicines that may increase serum potassium (e.g., trimethoprim-containing products)
- lithium, a medicine used to treat mood swings and some types of depression
- any medicines that contain colesevelam
- any medicines that contain aliskiren
These medicines may be affected by OLMETEC, 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 will advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect OLMETEC.
4. How do I use OLMETEC?
How much to take
Tablets:
- For most adult patients, the usual starting dose of OLMETEC is 20 mg once a day. The dose may need to be increased to OLMETEC 40 mg once a day if necessary.
Suspension:
- If you have been prescribed OLMETEC suspension, your pharmacist will prepare this for you.
- Follow the instructions given by your doctor or pharmacist.
- Do not give OLMETEC suspension to children under 1 year of age.
- For children 6-18 years (weighing 35 kg or more):
- One OLMETEC 20 mg tablet once daily, or 10 mL of the 2 mg/mL suspension - For children 6-18 years (weighing less than 35 kg):
- 5 mL of the 2mg/ mL suspension - For children 1-5 years (weighing 5 kg or more):
- The dose will vary depending on your child's weight.
How to take OLMETEC
Tablets
- Swallow OLMETEC whole with a full glass of water.
- Do not chew the tablets.
Suspension
- Shake the bottle and then using either a medicine measure or a dosing syringe give the required volume to your child.
When to take OLMETEC
- Take OLMETEC at about the same time each day.
Taking OLMETEC at the same time each day will have the best effect. It will also help you remember when to take OLMETEC. - It does not matter whether you take it with or without food.
OLMETEC helps control your condition, but does not cure it. Therefore you must take OLMETEC every day. Continue taking your medicine for as long as your doctor tells you.
If you forget to take OLMETEC
OLMETEC 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 your medicine 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.
This may increase the chance of you getting an unwanted side effect.
If you take too much OLMETEC (overdose)
If you think that you have used too much OLMETEC, 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.
Keep telephone numbers for these places handy.
If you take too much OLMETEC, you may feel light-headed, dizzy, or you may faint. You may also have a fast heartbeat.
5. What should I know while using OLMETEC?
Things you should do
- If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking OLMETEC.
- Have your blood pressure checked when your doctor says, to make sure OLMETEC is working.
- Go to your doctor regularly for a check-up.
Your doctor may occasionally do a blood test to check your potassium levels and see how your kidneys are working. - If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.
Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor. - If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking OLMETEC.
Your blood pressure may suddenly drop. - If you are about to have any blood tests, tell your doctor that you are taking OLMETEC.
OLMETEC may interfere with the results of some tests. - Make sure you drink enough water during exercise and hot weather when you take OLMETEC, especially if you sweat a lot.
If you do not drink enough water while taking OLMETEC, you may feel faint, light-headed or sick. This is because your blood pressure is dropping suddenly. If you continue to feel unwell, tell your doctor.
Call your doctor straight away if you:
- have excess vomiting and/or diarrhoea while taking OLMETEC.
You may lose too much water and salt and your blood pressure may drop too much. - feel light-headed or dizzy after taking your first dose of OLMETEC, or when your dose is increased.
- become pregnant while taking OLMETEC.
Remind any doctor, dentist or pharmacist you visit that you are using OLMETEC.
Things you should not do
- Do not give OLMETEC to anyone else, even if they have the same condition as you.
- Do not take OLMETEC to treat any other complaints unless your doctor or pharmacist tells you to.
- Do not stop taking OLMETEC, or lower the dosage, without checking with your doctor.
Things that would be helpful for your blood pressure
Some self-help measures suggested below may help your condition. Talk to your doctor or pharmacist about these measures and for more information.
- Alcohol - your doctor may advise you to limit your alcohol intake.
- Weight - your doctor may suggest losing some weight to help lower your blood pressure and help lessen the amount of work your heart has to do. Some people may need a dietician's help to lose weight.
- Diet - eat a healthy diet which includes plenty of fresh vegetables, fruit, bread (preferably wholegrain), cereals and fish. Also eat less sugar and fat (especially saturated fat) which includes sausages, fatty meats, full cream dairy products, biscuits, cakes, pastries, chocolates, chips and coconut. Monounsaturated and polyunsaturated fats from olive oil, canola oil, avocado and nuts are beneficial in small quantities.
- Salt - your doctor may advise you to watch the amount of salt in your diet. To reduce your salt intake you should avoid using salt in cooking or at the table and avoid cooked or processed foods containing high sodium (salt) levels.
- Exercise - regular exercise, maintained over the long term, helps to reduce blood pressure and helps get the heart fitter. Regular exercise also improves your blood cholesterol levels, helps reduce your weight and stress levels, and improves your sleep, mood and ability to concentrate. However, it is important not to overdo it. Walking is good exercise, but try to find a route that is reasonably flat. Before starting any exercise, ask your doctor about the best kind of programme for you.
- Smoking - your doctor may advise you to stop smoking or at least cut down. There are enormous benefits to be gained from giving up smoking. There are many professionals, organisations and strategies to help you quit. Ask your doctor or pharmacist for further information and advice.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how OLMETEC affects you.
As with other medicines in this class, OLMETEC may cause dizziness, light-headedness or tiredness in some people. Make sure you know how you react to OLMETEC before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs do not drive.
Drinking alcohol
Tell your doctor if you drink alcohol.
If you drink alcohol, dizziness or light-headedness may be worse.
Your doctor may advise you to limit your alcohol intake.
Looking after your medicine
Tablets:
- Keep your tablets in the box until it is time to take them.
If you take the tablets out of the box they will not keep well. - Keep your tablets in a cool dry place where the temperature stays below 25°C.
Suspension:
- Keep the suspension in the bottle until it is time to take it
- Keep the suspension in the refrigerator where the temperature stays between 2 to 8°C.
Do not store your medicine:
- in the bathroom or near a sink, or
- in the car or on window sills.
Heat and dampness can destroy some medicines.
Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking OLMETEC 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.
If you are over 65 years of age you may have an increased chance of getting side effects.
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 |
Head and nervous system-related:
| These are common side effects and are generally mild. 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 |
| Call your doctor as soon as possible, if you notice any of these serious side effects. You may need medical attention. |
| Stop taking OLMETEC and call your doctor immediately, or go straight to the Emergency Department at your nearest hospital if you notice any of these very serious side effects. |
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Serious side effects are rare.
Other side effects not listed here may occur in some people.
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 OLMETEC contains
Active ingredient (main ingredient) | OLMETEC tablets
|
Other ingredients (inactive ingredients) | OLMETEC tablets
|
Allergens |
|
Do not take this medicine if you are allergic to any of these ingredients.
What OLMETEC looks like
- OLMETEC 10 mg - white, circular film-coated tablet with C13 embossed on one side. (AUST R 102134)*
- OLMETEC 20 mg - white, circular film-coated tablet with characteristic odour, approximately 8.5 mm in diameter with C14 embossed on one side. (AUST R 102138)
- OLMETEC 40 mg - white, oval film-coated tablet with characteristic odour, approximately 15 mm x 7 mm in size, with C15 embossed on one side. (AUST R 102139)
- OLMETEC suspension - Pale, reddish-white suspension
The tablets are supplied in blister packs of 10* or 30 film-coated tablets.
*Not currently available in Australia
Who distributes OLMETEC
Organon Pharma Pty Ltd
Level 5, 66 King St
Sydney NSW 2000
Australia.
This leaflet was prepared in January 2025.
® Registered trademark of Daiichi Sankyo Company Ltd
Published by MIMS April 2025