Consumer medicine information

OLMEKAR

Olmesartan medoxomil and amlodipine besilate

Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about OLMEKAR. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using OLMEKAR against the benefits it is expected to have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

WHAT OLMEKAR IS USED FOR

OLMEKAR 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.

How OLMEKAR works

OLMEKAR 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. OLMEKAR blocks the action of angiotensin-II and therefore relaxes your blood vessels. This helps lower your blood pressure.

OLMEKAR also contains amlodipine besilate, a calcium channel blocker. This reduces the movement of calcium into the cells of the heart and blood vessels. This also helps to lower blood pressure as it relaxes the blood vessels and increases the supply of blood and oxygen to the heart.

Your doctor may have prescribed OLMEKAR for another reason. Ask your doctor if you have any questions about why OLMEKAR has been prescribed for you.

OLMEKAR is not addictive.

This medicine is available only with a doctor’s prescription.

BEFORE YOU USE OLMEKAR

When you must not use it

Do not take OLMEKAR if you have an allergy to:

olmesartan,
amlodipine besilate, medicines belonging to a group of chemicals called dihydropyridines used to treat blood pressure and other heart problems,
or any of the ingredients listed at the end of this leaflet

Symptoms of an allergic reaction to OLMEKAR may include skin rash, itchiness, shortness of breath, swelling of the face, lips or tongue, muscle pain or tenderness or joint pain.

Do not take OLMEKAR if:

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 have had recent serious heart problems
you have low potassium or sodium levels in the blood

Do not take OLMEKAR if you are pregnant or breastfeeding. OLMEKAR 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 OLMEKAR should be discontinued as soon as possible.

Do not take OLMEKAR after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If you are not sure whether you should start taking OLMEKAR, talk to your doctor.

Before you start to use it

Tell your doctor if you have allergies to:

any other medicines
any other substances, such as foods, preservatives or dyes.

Tell your doctor if you have or have had any medical conditions, especially the following:

kidney problems
liver problems
heart problems
diabetes
excessive vomiting or diarrhoea recently
high levels of potassium in your blood
problems with your adrenal glands (small glands above the kidneys)

You must also tell your doctor if 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)
you have skin cancer or if you develop a new skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of some types of skin and lip cancer (nonmelanoma skin cancer). Discuss with your doctor how to protect your skin from sun exposure, and avoid artificial tanning

If you have not told your doctor about any of the above, tell him/ her before you start taking OLMEKAR.

Taking other medicines

Tell your doctor or pharmacist 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 and OLMEKAR may interfere with each other. These include:

other medicines to treat high blood pressure
any medicines that contain aliskiren
medicines used to treat angina, such as diltiazem
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 or antidepressant medicines
some antibiotics, such as erythromycin or rifampicin
some antifungals, such as ketoconazole or itraconazole
anti-proteases, medicines used to treat HIV infection such as ritonavir
medicines which lower your immune system, such as ciclosporin and tacrolimus
St John’s Wort
grapefruit or grapefruit juice
any medicines that contain colesevelam.

These medicines may be affected by OLMEKAR or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Other medicines not listed above may also interfere with OLMEKAR.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

Use in children

The safety and effectiveness of OLMEKAR in children have not been established.

HOW TO USE OLMEKAR

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

Your doctor or pharmacist will tell you which OLMEKAR tablet you will need to take each day. This depends on your condition and whether or not you are taking any other medicines.

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

How much to use

Take one tablet once a day.

How to use it

Swallow whole tablet with a full glass of water.

Do not chew the tablets.

When to take it

Take OLMEKAR at about the same time each day, with or without food. Taking your tablets at the same time each day will have the best effect. It will also help you remember when to take the tablets. It does not matter whether you take it with or without food.

How long to use it for

OLMEKAR helps control your condition but does not cure it. Therefore, you must take OLMEKAR every day. Continue taking your medicine for as long as your doctor tells you.

If you forget to use 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 to take your medicine, ask your pharmacist for some hints.

If you use too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) or go to Accident and Emergency at the nearest hospital if you think that you or anyone else may have taken too much OLMEKAR. Do this even if there are no signs of discomfort or poisoning. Keep telephone numbers for these places handy.

If you take too much OLMEKAR, you may feel light-headed, dizzy or you may faint. You may also have a fast heartbeat.

WHILE YOU ARE USING OLMEKAR

Things you must do

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking OLMEKAR.

If you have excess vomiting and/or diarrhoea while taking OLMEKAR, tell your doctor. You may lose too much water and salt and your blood pressure may drop too much.

If you feel light-headed or dizzy after taking your first dose of OLMEKAR, or when your dose is increased, tell your doctor immediately.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking OLMEKAR. Your blood pressure may drop suddenly.

If you become pregnant while taking OLMEKAR, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking OLMEKAR. OLMEKAR may interfere with the results of some tests.

Have your blood pressure checked when your doctor says, to make sure OLMEKAR 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.

Things you must not do

Do not give OLMEKAR to anyone else, even if they have the same condition as you.

Do not take OLMEKAR to treat any other complaints unless your doctor or pharmacist tells you to.

Do not stop taking OLMEKAR, or lower the dosage, without checking with your doctor.

Things to be careful of

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.

Be careful driving or operating machinery until you know how OLMEKAR affects you. As with other medicines in this class, OLMEKAR may cause dizziness, light-headedness or tiredness in some people. Make sure you know how you react to OLMEKAR 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. If you drink alcohol, dizziness or light-headedness may be worse.

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 must 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.

SIDE EFFECTS

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

OLMEKAR helps most people with high blood pressure, 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.

If you are over 65 years of age you may have an increased chance of getting side effects.

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

The 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 or pharmacist if you notice any of the following and they worry you:

feeling light-headed, dizzy or faint
cough
headache
feeling sick (nausea) or vomiting
diarrhoea
unusual tiredness or weakness, fatigue
‘flu-like’ symptoms
bronchitis
sore throat and discomfort when swallowing (pharyngitis)
back pain
urinary tract infection
swelling of the face, hands, feet or ankles.

These are common side effects. They are generally mild.

Tell your doctor as soon as possible if you notice any of the following:

skin rash or itchiness
aching, tender or weak muscles not caused by exercise
painful joints
fast heartbeat
shortness of breath or tightness in the chest
swelling of the face, hands, feet or ankles
yellowing of the whites of the eyes, dark urine and itching of the skin
symptoms that may indicate high potassium levels in the blood, such as nausea, diarrhoea, muscle weakness, change in heart rhythm.

These may be serious side effects. You may need medical attention. Serious side effects are rare.

If any of the following happen, stop taking OLMEKAR and either 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 swallowing or breathing

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

Other side effects not listed above may occur in some patients.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

AFTER USING OLMEKAR

Storage

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.

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

Do not leave it on a windowsill or in the car on hot days. Heat and dampness can destroy some medicines.

Keep it where 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 OLMEKAR or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

PRODUCT DESCRIPTION

What it looks like

OLMEKAR tablets come in four strengths and each has a different appearance:

OLMEKAR 20/5
White, round, biconvex, film-coated tablet debossed with “L75” on one side and plain on other side. AUST R 290077

OLMEKAR 20/10
Grayish-orange, round, biconvex, film-coated tablet debossed with “L76” on one side and plain on other side. AUST R 290079

OLMEKAR 40/5
Light yellow, round, biconvex, film-coated tablet debossed with “L77” on one side and plain on other side. AUST R 290090

OLMEKAR 40/10
Red (brownish red), round, biconvex, film-coated tablet debossed with “L78” on one side and plain on other side. AUST R 290078

Supplied in blister packs of 30 tablets.

Ingredients

OLMEKAR 20/5 –
20 mg olmesartan medoxomil and 5mg amlodipine besilate

OLMEKAR 20/10 –
20 mg olmesartan medoxomil and 10 mg amlodipine as besilate.

OLMEKAR 40/5 –
40 mg olmesartan medoxomil and 5mg amlodipine besilate

OLMEKAR 40/10 –
40 mg olmesartan medoxomil and 10mg amlodipine besilate

Other ingredients:

silicified microcrystalline cellulose
colloidal anhydrous silica
pregelatinised maize starch
croscarmellose sodium
magnesium stearate
20/5 mg: Opadry II White
20/10 mg: Opadry II Beige
40/5 mg: Opadry II Yellow
40/10mg: Opadry II Brown

OLMEKAR does not contain sucrose, tartrazine, or any other azo dyes.

SUPPLIER

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121

This leaflet was prepared: December 2022

Published by MIMS February 2023