Olmesartan medoxomil, amlodipine (as besilate) and hydrochlorothiazide
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about OLAMLO HCT. 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 taking
OLAMLO HCT against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What OLAMLO HCT is used for
OLAMLO HCT 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 OLAMLO HCT works
OLAMLO HCT 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. OLAMLO HCT blocks the action of angiotensin-II
and therefore relaxes your blood vessels. This helps lower your blood pressure.
OLAMLO HCT 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.
OLAMLO HCT also contains hydrochlorothiazide, a diuretic which reduces the amount
of fluid in the body. This also helps to lower blood pressure.
Your doctor may have prescribed OLAMLO HCT for another reason. Ask your doctor if
you have any questions about why OLAMLO HCT has been prescribed for you.
This medicine is available only with a doctor's prescription.
The safety and effectiveness of OLAMLO HCT in children and teenagers under the age
of 18 years have not been established.
OLAMLO HCT is not addictive.
Before you take OLAMLO HCT
When you must not take it
Do not take OLAMLO HCT 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,
hydrochlorothiazide, a diuretic
or any of the ingredients listed at the end of this leaflet or other sulfonamide-derived
drugs
Symptoms of an allergic reaction to OLAMLO HCT 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 OLAMLO HCT if:
you have serious problems with your kidneys
you have serious problems with your liver
you have had recent serious heart problems
you have low potassium or sodium levels in the blood
you have high calcium or uric acid levels in the blood.
you have diabetes and are taking a medicine called aliskiren to reduce blood pressure.
Do not take OLAMLO HCT if you are pregnant or breastfeeding.
OLAMLO HCT 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 OLAMLO HCT should be discontinued as soon as possible.
Do not take OLAMLO HCT 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 OLAMLO HCT, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies:
any other medicines
any other substances, such as foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
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)
systemic lupus erythematosus, a disease affecting the skin, joints and kidneys
gout
You must also tell your doctor if you:
are following a very low salt diet
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 (non- melanoma 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 OLAMLO HCT.
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 OLAMLO HCT may interfere with each other.
These include:
other medicines to treat high blood pressure
digitalis glycosides, medicines used to treat heart problems
medicines used to treat angina, such as diltiazem
antiarrhythmics which treat irregular heartbeats
non-steroid anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors, medicines used to
relieve pain, swelling and other symptoms of inflammation including arthritis
antacids, medicines used to treat heartburn and indigestion
simvastatin, a medicine used to help lower cholesterol levels
potassium supplements or potassium-containing salt substitutes
other medicines that may increase serum potassium (e.g., trimethoprim-containing products)
calcium containing supplements
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
other diuretics, also known as fluid or water tablets
insulin and tablets used to treat diabetes
medicines which lower your immune system, such as corticosteroids, ciclosporin, tacrolimus
and cytotoxic medicines used to treat cancer (including radiation therapy)
alcohol
laxatives, medicines used to treat constipation
medicines used to relieve pain
medicines used to treat epilepsy
muscle relaxants
cholestyramine and colestipol, used to treat high cholesterol
St John's Wort
grapefruit or grapefruit juice
medicines used to treat gout, such as allopurinol
medicines used to treat Parkinson's Disease, such as amantadine
any medicines that contain aliskiren
any medicines that contain colesevelam.
These medicines may be affected by OLAMLO HCT, 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 OLAMLO HCT. 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 OLAMLO HCT in children have not been established.
How to take OLAMLO HCT
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 OLAMLO HCT 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 take
The dose of OLAMLO HCT is one tablet to be taken once a day.
How to take it
Swallow OLAMLO HCT whole with a full glass of water.
Do not chew the tablets.
When to take it
Take OLAMLO HCT 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 take it
OLAMLO HCT helps control your condition, but does not cure it.
Therefore you must take OLAMLO HCT every day. Continue taking your tells you.
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 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 (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 OLAMLO HCT. Do this even if there are no
signs of discomfort or poisoning.
Keep telephone numbers for these places handy.
If you take too much OLAMLO HCT, you may feel light-headed, dizzy or you may faint.
You may also have nausea, drowsiness, muscle spasm and a fast heartbeat.
While you are using OLAMLO HCT
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 OLAMLO HCT.
Make sure you drink enough water during exercise and hot weather when you are taking
OLAMLO HCT, especially if you sweat a lot.
If you do not drink enough water while taking OLAMLO HCT, you may feel light-headed
or sick. This is because your blood pressure is dropping suddenly. If you continue
to feel unwell, tell your doctor.
If you have excess vomiting and/or diarrhoea while taking OLAMLO HCT, tell your doctor.
You may lose too much water and salt and your blood pressure may drop too much. You
may also have dry mouth, weakness, drowsiness, confusion, muscle pain or cramps and
seizures. Tell your doctor immediately if you experience any of these symptoms.
If you feel light-headed or dizzy after taking your first dose of OLAMLO HCT, 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 OLAMLO HCT.
Your blood pressure may drop suddenly.
If you become pregnant while taking OLAMLO HCT, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking OLAMLO
HCT.
OLAMLO HCT may interfere with the results of some tests.
Tell your doctor if photosensitivity reaction occurs during your treatment.
Tell your doctor immediately in case of acute onset of decreased visual acuity or
ocular pain.
Have your blood pressure checked when your doctor says, to make sure OLAMLO HCT 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 OLAMLO HCT to anyone else, even if they have the same condition as you.
Do not take OLAMLO HCT to treat any other complaints unless your doctor or pharmacist
tells you to.
Do not stop taking OLAMLO HCT, 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 OLAMLO HCT affects you.
As with other medicines in this class, OLAMLO HCT may cause dizziness, light-headedness
or tiredness in some people. Make sure you know how you react to OLAMLO HCT 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.
The following subheading and text may be added as needed.
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.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking OLAMLO HCT.
OLAMLO HCT 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.
Hydrochlorothiazide, a component of this medicine, increases sensitivity of the skin
to the sun and may increase the risk of some types of skin and lip cancer (non-melanoma
skin cancer).
Hydrochlorothiazide, a component of this medicine, may cause a decrease in vision
or pain in your eyes due to high pressure (possible signs of fluid accumulation in
the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma.
Hydrochlorothiazide, a component of this medicine, may cause fever, severe shortness
of breath, breathing faster than normal, difficulty breathing, slightly blue fingertips
and lips.
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
stomach pain or discomfort
diarrhoea
unusual tiredness or weakness, fatigue
'flu-like' symptoms
runny or blocked nose, or sneezing
bronchitis
sore throat and discomfort when swallowing (pharyngitis)
back pain
urinary tract infection
jaundice
blurred vision
skin rashes or eczema
sleep disturbance
depression
swelling of the ankles, feet, face or hands
flushing
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 heart beat
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 high potassium
levels in the blood, such as nausea, diarrhoea, muscle weakness, change in heart rhythm
symptoms that may indicate water and salt imbalance such as dry mouth, weakness, drowsiness,
confusion, muscle pain or cramps and seizures.
These may be serious side effects. You may need medical attention. Serious side effects
are rare.
If any of the following happen, stop taking OLAMLO HCT 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
chest pain
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 OLAMLO HCT
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 OLAMLO HCT 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 OLAMLO HCT 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
OLAMLO HCT tablets come in five strengths and each has a different appearance:
OLAMLO HCT 20/5/12.5 mg is an off white to peach, round, bevel-edged, film-coated
tablets debossed with “OC1” on one side and plain on other side.
OLAMLO HCT 40/5/12.5 mg is a light yellow, round, bevel-edged, film- coated tablets
debossed with “OC2” on one side and plain on other side.
OLAMLO HCT 40/5/25 mg is a light yellow, oval, bevel-edged, film- coated tablets debossed
with “OC3” on one side and plain on other side.
OLAMLO HCT 40/10/12.5 mg is a
brick red, round, bevel-edged, film-
coated tablets debossed with “OC4” on one side and plain on other side.
OLAMLO HCT 40/10/25 mg is a brick red, oval, bevel-edged, film- coated tablets debossed
with “OC5” on one side and plain on other side.
The product is presented in Alu/Alu blister packs of 10 or 30 film-coated tablets.
Ingredients
Active ingredients:
OLAMLO HCT 20/5/12.5 mg contains 20 mg olmesartan medoxomil, 5 mg amlodipine as besilate
and 12.5 mg hydrochlorothiazide.
OLAMLO HCT 40/5/12.5 mg contains 40 mg of olmesartan medoxomil, 5 mg amlodipine as
besilate and 12.5 mg hydrochlorothiazide.
OLAMLO HCT 40/5/25 mg contains 40 mg of olmesartan medoxomil, 5 mg amlodipine as besilate
and 25 mg hydrochlorothiazide.
OLAMLO HCT 40/10/12.5 mg contains 40 mg of olmesartan medoxomil 10 mg amlodipine as
besilate and 12.5 mg hydrochlorothiazide.
OLAMLO HCT 40/10/25 mg contains 40 mg of olmesartan medoxomil, 10 mg amlodipine as
besilate and 25 mg hydrochlorothiazide.
Other ingredients:
povidone
pregelatinised maize starch
silicified microcrystalline cellulose
lactose monohydrate
magnesium stearate
opadry II complete film coating system 85F570046 TAN (20/5/12.5mg)
opadry II complete film coating system 85F520133 YELLOW
(40/5/12.5mg and 40/5/25mg)
opadry II complete film coating system 85F540170 PINK (40/10/12.5mg and 40/10/25mg)
OLAMLO HCT does not contain sucrose, tartrazine or any other azo dyes.
Sponsor
Accord Healthcare Pty Limited Level 24, 570 Bourke Street Melbourne VIC 3000
Phone: 1800 134 988
Supplier
OLAMLO HCT is distributed in Australia by:
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276
Australian Registration Number
OLAMLO HCT 20/5/12.5 AUST R 312006
OLAMLO HCT 40/10/12.5 AUST R 312009
OLAMLO HCT 40/5/12.5 AUST R 312003
OLAMLO HCT 40/5/25 AUST R 312005
OLAMLO HCT 40/10/25 AUST R 312008
This leaflet was prepared in February 2023