Exforge HCT

amlodipine besilate/valsartan/hydrochlorothiazide

Consumer Medicine Information

This leaflet answers some common questions about Exforge HCT.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine. You can also download the most up to date leaflet from www.novartis.com.au.

Those updates may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine 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.

Exforge HCT is used to control high blood pressure, also called hypertension.

Everybody has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different 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.

High blood pressure increases the workload of the heart and blood vessels. If it continues for a long time, it can damage the blood vessels in the brain, heart and kidneys. This can lead to stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure reduces the chance of these disorders happening.

Exforge HCT contains amlodipine besilate, valsartan and hydrochlorothiazide. These medicines reduce blood pressure in three different ways.

1.Amlodipine besilate blocks the movement of calcium into the cells of the heart and blood vessels. As a result, they relax blood vessels and increase the supply of blood and oxygen to the heart while reducing its workload.

2.Valsartan blocks the effect of angiotensin II, which is a substance in the body that tightens blood vessels and makes your blood pressure rise. When the effect of angiotensin II is blocked, your blood vessels relax and your blood pressure goes down.

3.Hydrochlorothiazide helps reduce the amount of excess fluid in the body by increasing the amount of urine produced. This helps lower your blood pressure.

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

Your doctor may have prescribed it for another purpose.

There is not enough information to recommend the use of Exforge HCT in children.

This medicine is only available with a doctor’s prescription. It is not addictive.

Do not take Exforge HCT if you have ever had an allergic reaction after taking:

amlodipine besilate, valsartan or hydrochlorothiazide (the active ingredients in Exforge HCT)

medicines belonging to a group of chemicals called dihydropyridines, used to treat blood pressure and other heart problems

medicines belonging to a group of chemicals called sulfonamide-derived (such as some antibiotics e.g. Bactrim trimethoprim and sulfamethoxazole)

any of the other ingredients listed at the end of this leaflet.

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.

Do not take Exforge HCT if you are pregnant or intend to become pregnant.

Exforge HCT is not recommended for use in pregnancy. Like other similar medicines, it could affect your unborn baby.

Do not take Exforge HCT if you have any of the following medical conditions:

severe kidney disease or are having dialysis

severe liver disease including biliary cirrhosis

cholestasis, which is reduced or stopped bile flow

anuria, which is a condition where you are unable to urinate

high uric acid levels in the blood, which may cause gout

low level of potassium or sodium, or high level of calcium in your blood.

Check with your doctor if you are unsure if you have any of the above conditions.

Do not take Exforge HCT if you are also taking other blood pressure medicines containing aliskiren and have type 2 diabetes.

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

In that case, return it to your pharmacist.

Tell your doctor if you have/have had any of the following health problems/medical conditions:

kidney problems or received a kidney transplant

liver problems

systemic lupus erythematosus, a disease affecting the skin, joints and kidneys

heart problems, including obstructed blood flow from narrowing of valves (stenosis) or enlarged septum (HOCM)

swelling, mainly of the face and throat, while taking other medicines (including an ACE inhibitor or aliskiren)

a hormone disorder causing fluid retention known as primary hyperaldosteronism (Conn’s syndrome)

passing less urine than is normal for you or difficulty passing urine

salt restricted diet

suffering from several episodes of vomiting or diarrhoea.

skin cancer

Your doctor may want to take special precautions if you have any of the above conditions.

Tell your doctor if you are breast-feeding a baby. Ask your doctor about the risks and benefits of taking Exforge HCT in this case.

Hydrochlorothiazide and amlodipine are known to pass into the breast milk, however it is not known if valsartan, the other active ingredient of Exforge HCT, passes into the breast milk and could affect your baby. Therefore, Exforge HCT is not recommended if you are breast-feeding.

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Your doctor will want to know if you are prone to allergies.

If you have not told your doctor about any of these things, tell him/her before you take Exforge HCT.

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

Some medicines and Exforge HCT may interfere with each other. These include:

medicines used to treat high blood pressure and some other heart conditions including fluid tablets or diuretic medicines, ACE-inhibitors, aliskiren and beta blockers

simvastatin (a medicine used to help lower cholesterol levels), since the dose may have to be reduced when taken with Exforge HCT

intravenous dantrolene used to treat malignant hyperthermia

some antibiotics (rifampicin), anti-rejection drugs (cyclosporin), antiretrovirals (ritonavir) which may increase the effect of valsartan

tablets, preparations or supplements which increase the potassium levels in your blood (such as certain types of diuretics, potassium supplements, salt substitutes etc.)

non-steroidal anti-inflammatory drugs (NSAIDs) and selective Cyclooxygenase-2 Inhibitors (Cox-2 inhibitors), medicines used to relieve swelling and other symptoms of inflammation, including arthritis (Your doctor may also check your kidney function)

medicines or supplements containing calcium

vitamin D

medicines used to relax muscles before or during surgery

steroid medicines such as cortisone, prednisone and ACTH

lithium, antidepressants, antipsychotics, medicines used to treat mood swings and some types of depression

cyclophosphamide or methotrexate

penicillin

amphotericin, a medicine used to treat fungal infections

insulin and tablets used to treat diabetes

medicines used to treat gout

cyclosporine

carbamazepine, an anticonvulsant and mood stabilising drug used primarily in the treatment of epilepsy and bipolar disorder

digoxin or other digitalis glycosides (medicines used to treat heart problems)

antiarrhythmics (medicines used to treat heart problems)

medicines used for oesophageal ulceration and inflammation

amantadine, and anti-Parkinson therapy also used to treat or prevent certain illnesses caused by viruses

cytotoxic drugs used in cancer therapy

medicine used to treat gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson’s disease and as aid to anaesthesia from a class called anticholinergic agents

cholestyramine, colestipol, and other resins (medicines used mainly to treat high levels of lipids in the blood)

pressor amines, such as noradrenaline (substances that raise blood pressure)

barbiturates, narcotics (medicines with sleep-inducing properties) and alcohol.

radioactive iodine, used as a medical tracer or diagnosis.

Your doctor and pharmacist have a more complete list of medicines to be careful of while taking Exforge HCT.

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

These instructions may differ from the information contained in this leaflet.

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

Your doctor will tell you how many tablets to take each day. The usual dose is one tablet a day.

Take your Exforge HCT dose at the same time each day.

This also helps you remember to take it, especially if you take it as part of your usual routine (e.g. at breakfast time). This medicine will keep working for the whole 24 hours until the next dose is due.

Swallow the tablet with a full glass of water.

Always take Exforge HCT in the same way, with or without food.

You can take it with or without food but it will work best if you always take it in the same way every day.

Take this medicine until your doctor tells you to stop even if you feel quite well.

People who have high blood pressure often feel well and do not notice any signs of this problem.

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

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

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

This may increase the chance of side effects.

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

Immediately telephone your doctor or the Poisons Information Centre (telephone number: 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much Exforge HCT. Do this even if there are no signs of discomfort or poisoning.

Keep the telephone numbers for these places handy.

Too much Exforge HCT may make you feel dizzy, light headed or faint. You may experience rapid, shallow breathing or cold, clammy skin. Your heartbeat may be faster than usual. This is because your blood pressure is too low.

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

You should not take this medicine while you are pregnant.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

Otherwise your doctor may think that it was not effective and change your treatment unnecessarily.

Be sure to keep all of your doctor’s appointments so that your progress can be checked. Do this even if you feel well.

People with high blood pressure often do not notice any signs of this problem. But it is important to keep track of your progress. Your doctor will want to check your blood pressure and your kidney and liver function from time to time.

If you are going to have surgery, tell your doctor and anaesthetist that you are taking Exforge HCT.

Exforge HCT may affect some medicines you receive during surgery.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Exforge HCT.

Tell any other doctor, dentist or pharmacist who treats you that you are taking Exforge HCT.

Do not take Exforge HCT to treat any other complaints unless your doctor says you can.

Do not give this medicine to anyone else, even if their condition seems to be similar to yours.

Avoid eating grapefruit or drinking grapefruit juice.

Grapefruit juice can affect the metabolism of some medicines, including amlodipine.

Be careful driving, operating machinery or doing jobs that require you to be alert while you are taking Exforge HCT until you know how it affects you.

This medicine can cause tiredness, sleepiness or dizziness in some people. If you have these symptoms, do not drive or do anything else that could be dangerous.

If this medicine makes you feel dizzy or light-headed, be careful when getting up from a sitting or lying position.

Dizziness can usually be prevented by getting up slowly and flexing leg muscles and toes to get the blood flowing. When getting out of bed, dangle your legs over the side for a minute or two before standing up.

When you are outdoors, wear protective clothing and use a factor 30 (or higher), water resistant sunscreen.

Do not use a sunlamp.

This medicine may cause your skin to be much more sensitive to sunlight than it normally is.

Exposure to sunlight may cause a skin rash, itching, redness or severe sunburn. If your skin does appear to be burning, tell your doctor.

Treatment with Exforge HCT, particularly long-term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer).

Protect your skin from sun exposure and UV rays while taking Exforge HCT. Regularly check your skin for any new lesions and promptly report any suspicious skin lesions to your doctor.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Exforge HCT, even if you do not think it is connected with the medicine.

All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you get some of the side effects.

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

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

Tell your doctor if you notice any of these side effects and they worry you:

headache

buzzing, whistling, ringing or other persistent noise in the ears

dizziness, spinning sensation, changes in vision, uncoordinated movements

dizziness on standing up, especially when getting up from a sitting or lying position

sleepiness, tiredness, weakness or difficulty sleeping

pain in the back or joints

muscle pain, muscle tenderness or weakness, cramps

runny nose or congested sinuses

dry cough, sore throat or hoarse voice

dry mouth

bleeding, tender or enlarged gums

indigestion, loss of appetite, stomach upset, pain, diarrhoea, constipation or wind

nausea (feeling sick) or vomiting

tingling or numbness in hands or feet

rash, redness, blistering or peeling of skin, itching

appearance of a lump or discoloured patch on the skin

lip cancer; the signs and symptoms include:

a sore that doesn’t heal or comes back after healing

pale white or yellow flat areas that look like scars

raised and scaly red patches

small, smooth and shiny lumps that are pearly white, pink or red

a pink growth with raised edges and indents in the centre

a growth that has small blood vessels on the surface.

excessive sweating

feeling anxious or sad

problems with sexual function

breast enlargement in men

unusual hair loss or thinning

pain when passing urine, passing more urine than normal or frequent urge to urinate

redness and warm feeling of the face and/or neck

swelling of the ankles, feet, face or hands

flushing

palpitations

unusual tiredness or weakness

weight gain

feeling nervous, depressed or moody

distorted sense of taste

sensitivity to light

symptoms of sunburn which happens more quickly than normal

facial pain.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

signs of allergy such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other parts of the body; shortness of breath, wheezing or troubled breathing

feeling of fast or irregular heart beat (pounding, racing, skipping beats)

chest pain

tiredness or lack of energy, being short of breath when exercising

bleeding or bruising more easily than normal

constant “flu-like” symptoms such as chills, fever, sore throat, aching joints, sores in mouth, swollen glands

severe dizziness or fainting

stomach pain with nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine

signs of a serious skin reaction such as painful red areas, large blisters, peeling of layers of skin, bleeding in the lips, eyes, mouth, nose or genitals. These signs may be accompanied by fever and chills, aching muscles and feeling generally unwell

unusual bleeding or bruising under the skin

passing less urine than normal

decrease in vision or pain in your eyes due to high pressure.

Tell your doctor immediately if you notice any new skin or lip lesions during or after treatment or if an existing lesion changes its appearance.

The above list includes serious side effects which may require medical attention. These side effects do not occur frequently.

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

Other side effects not listed above may also occur in some people.

Keep your tablets in the original container until it is time to take them.

Store them in a cool dry place below 30°C (room temperature).

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

Do not leave Exforge HCT in the car or on window sills.

Heat and dampness can destroy some medicines. Exforge HCT will keep well if it is cool and dry.

Keep medicines where children cannot reach them.

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

If your doctor tells you to stop taking Exforge HCT, or it has passed its expiry date, ask your pharmacist what to do with any tablets that are left over.

Exforge HCT 5/160/12.5 (5 mg amlodipine, 160 mg valsartan and 12.5 mg hydrochlorothiazide) tablets are white, ovaloid, biconvex with bevelled edge and imprinted with NVR on one side and VCL on the other. Packs of 7’s and 28’s.

Exforge HCT 10/160/12.5 (10 mg amlodipine, 160 mg valsartan and 12.5 mg hydrochlorothiazide) tablets are pale yellow, ovaloid, biconvex with bevelled edge and imprinted with NVR on one side and VDL on the other. Packs of 7’s and 28’s.

Exforge HCT 5/160/25 (5 mg amlodipine, 160 mg valsartan and 25 mg hydrochlorothiazide) tablets are yellow, ovaloid, biconvex with bevelled edge and imprinted with NVR on one side and VEL on the other. Packs of 7’s and 28’s.

Exforge HCT 10/160/25 (10 mg amlodipine, 160 mg valsartan and 25 mg hydrochlorothiazide) tablets are brown yellow, ovaloid, biconvex with bevelled edge and imprinted with NVR on one side and VHL on the other. Packs of 7’s and 28’s.

Exforge HCT 10/320/25 (10 mg amlodipine, 320 mg valsartan and 25 mg hydrochlorothiazide) tablets are brown yellow, ovaloid, biconvex with bevelled edge and imprinted with NVR on one side and VFL on the other. Packs of 7’s and 28’s.

Exforge HCT tablets are non-divisible and cannot be divided into equal doses.

Exforge HCT tablets contain amlodipine besilate (5 mg or 10 mg), valsartan (160 mg or 320 mg) and hydrochlorothiazide (12.5 mg or 25 mg) as the active ingredients.

The tablets contain the following inactive ingredients:

cellulose – microcrystalline

crospovidone

silica – colloidal anhydrous

magnesium stearate

hypromellose

macrogol 4000

talc – purified

Exforge HCT 5/160/12.5 tablets also contain:

titanium dioxide.

Exforge HCT 5/160/25 and also contain:

titanium dioxide

iron oxide yellow.

Exforge HCT 10/160/12.5 tablets also contain:

titanium dioxide

iron oxide yellow

iron oxide red.

Exforge HCT 10/160/25 and 10/320/25 tablets also contain:

iron oxide yellow.

Exforge HCT is supplied in Australia by:

ABN 18 004 244 160

54 Waterloo Road

Macquarie Park NSW 2113

Telephone: 1 800 671 203.

Australian Registration Numbers:

Exforge HCT 5/160/12.5: AUST R 157954

Exforge HCT 5/160/25: AUST R 158162

Exforge HCT 10/160/12.5: AUST R 158164

Exforge HCT 10/160/25: AUST R 158166

Exforge HCT 10/320/25: AUST R 158168.

This leaflet was prepared in August 2019.

© Copyright 2019.

® = Registered Trademark.

Internal document code: exh130819c based on PI exh130819i