EXFORGE®5/80; 5/160; 10/160; 5/320; 10/320Amlodipine besylate/Valsartan

Consumer Medicine Information

EXFORGE® Published by MIMS/myDr March 2014 1

What is in this leaflet

This leaflet answers some commonquestions about EXFORGE.

It does not contain all the availableinformation. It does not take theplace of talking to your doctor orpharmacist.

The information in this leaflet waslast updated on the date listed on thefinal page. More recent informationon the medicine may be available.

You should ensure that you speakto your pharmacist or doctor toobtain the most up to dateinformation on the medicine. Youcan also download the most up todate leaflet fromwww.novartis.com.au.Those updates may contain importantinformation about the medicine andits use of which you should be aware.

All medicines have risks andbenefits. Your doctor has weighedthe risks of you taking this medicineagainst the benefits they expect itwill have for you.

If you have any concerns abouttaking this medicine, ask yourdoctor or pharmacist.

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

What EXFORGE isused for

EXFORGE is used to control highblood pressure, also calledhypertension.

Everybody has blood pressure. Thispressure helps get your blood allaround your body. Your bloodpressure may be different at differenttimes of the day, depending on howbusy or worried you are. You havehypertension (high blood pressure)when your blood pressure stayshigher than is needed, even when youare calm and relaxed.

High blood pressure increases theworkload of the heart and bloodvessels. If it continues for a longtime, it can damage the blood vesselsin the brain, heart and kidneys. Thiscan lead to stroke, heart failure orkidney failure. High blood pressureincreases the risk of heart attacks.Lowering your blood pressurereduces the chance of these disordershappening.

EXFORGE contains valsartan andamlodipine besylate. Thesemedicines reduce blood pressure intwo different ways.

1. Valsartan blocks the effect ofangiotensin II, which is asubstance in the body thattightens blood vessels and makesyour blood pressure rise. Whenthe effect of angiotensin II isblocked, your blood vessels relaxand your blood pressure goesdown.

2. Amlodipine besylate blocks themovement of calcium into thecells of the heart and bloodvessels. As a result, they relaxblood vessels and increase thesupply of blood and oxygen to theheart while reducing its workload.

EXFORGE is used to treat highblood pressure in patients whoseblood pressure is not controlled

enough with either amlodipine orvalsartan on its own.

Ask your doctor if you have anyquestions about why this medicinehas been prescribed for you.Your doctor may have prescribed itfor another purpose.

There is not enough information torecommend the use of EXFORGE inchildren.

This medicine is only available witha doctor's prescription. It is notaddictive.

Before you takeEXFORGE

When you must not take it

Do not take EXFORGE if you haveever had an allergic reaction aftertaking:

• valsartan or amlodipine besylate(the active ingredients inEXFORGE)

• medicines belonging to a group ofchemicals calleddihydropyridines, used to treatblood pressure and other heartproblems.

• any of the other ingredients listedat the end of this leaflet

EXFORGE® Published by MIMS/myDr March 2014 2

Symptoms of an allergic reactionmay include shortness of breath,wheezing or difficulty breathing;swelling of the face, lips, tongue orother parts of the body; rash, itchingor hives on the skin.

Do not take EXFORGE if you arepregnant or intend to becomepregnant.EXFORGE is not recommended foruse in pregnancy. Like other similarmedicines, it could affect yourunborn baby.

Do not take EXFORGE if you haveany of the following medicalconditions:

• severe kidney disease or arehaving dialysis

• severe liver disease includingbiliary cirrhosis

• cholestasis, which is reduced orstopped bile flow

Do not take Exforge if you are alsotaking other blood pressurelowering medicines containingaliskiren and have type 2 diabetes.

Do not take EXFORGE after theexpiry date printed on the pack orif the packaging is torn or showssigns of tampering.In that case, return it to yourpharmacist.

Before you start to take it

Tell your doctor if you have/havehad any of the following healthproblems/medical conditions:

• severe kidney problems orreceived a kidney transplant

• liver problems• heart problems, including

obstructed blood flow fromnarrowing of valves (stenosis) orenlarged septum (HOCM)

• a condition known as primaryhyperaldosteronism (Conn'ssyndrome), a hormone disordercausing fluid retention

• swelling, mainly of the face andthroat, while taking othermedicines (including an ACEinhibitor or aliskiren)

• suffering from several episodes ofvomiting or diarrhoea or aretaking a diuretic (a drugincreasing the amount of urine).

Your doctor may want to take specialprecautions if you have any of theabove conditions.

Tell your doctor if you are breast-feeding a baby. Ask your doctorabout the risks and benefits oftaking EXFORGE in this case.It is not known if valsartan oramlodipine, the active ingredients ofEXFORGE, pass into the breast milkand could affect your baby.

Tell your doctor if you are allergicto any other medicines, foods, dyesor preservatives.Your doctor will want to know if youare prone to allergies.

If you have not told your doctorabout any of these things, tellhim/her before you takeEXFORGE.

Taking other medicines

Tell your doctor or pharmacist ifyou are taking any othermedicines, including medicinesthat you buy without aprescription from a pharmacy,supermarket or health food shop.Some medicines and EXFORGE mayinterfere with each other. Yourdoctor may need to change the doseor take other precautions. In somecases you may have to stop takingone of the medicines. This appliesespecially to the medicines listedbelow:

These include:

• medicines used to treat highblood pressure and some otherheart conditions including fluidtablets or diuretic medicines,ACE-inhibitors, aliskiren andbeta blockers

• simvastatin (a medicine used tohelp lower cholesterol levels),since the dose may have to bereduced when taken with Exforge

• some antibiotics (rifampicin),anti-rejection drugs (cyclosporin),antiretrovirals (ritonavir) whichmay increase the effect ofvalsartan

• tablets, preparations orsupplements which increase thepotassium levels in your blood(such as certain types of diuretics,potassium supplements, saltsubstitutes etc), lithium (amedicine used to treat some typesof depression)

• anticonvulsant agents (e.g.carbamazepine, phenobarbital,phenytoin, fosphenytoin,primidone), rifampicin, St. John'swort

• nitroglycerin and other nitrates, orother substances called"vasodilators"

• medicines used for HIV/AIDS(e.g. ritonavir) or for treatment offungal infections (e.g.ketoconazole)

• certain types of pain killers callednon-steroidal anti-inflammatorymedicines (NSAIDs) or SelectiveCyclooxygenase-2 Inhibitors(Cox-2 Inhibitors).

• intravenous dantrolene used totreat malignant hyperthermia

Your doctor may also check yourkidney function.

Your doctor and pharmacist have amore complete list of medicines to becareful of while taking EXFORGE.

How to take EXFORGE

Follow carefully all directionsgiven to you by your doctor andpharmacist.These instructions may differ fromthe information contained in thisleaflet.

If you do not understand theinstructions on the label, ask yourdoctor or pharmacist for help.

EXFORGE® Published by MIMS/myDr March 2014 3

How much to take

Your doctor will tell you how manytablets to take each day. The usualdose is one tablet a day.Depending on how you respond tothe treatment, your doctor maysuggest a higher or lower dose.

When to take it

Take your EXFORGE dose at thesame time each day.This also helps you remember to takeit, especially if you take it as part ofyour usual routine (e.g. at breakfasttime). This medicine will keepworking for the whole 24 hours untilthe next dose is due.

How to take it

Swallow the tablet with a full glassof water.

Always take EXFORGE in thesame way, with or without food.You can take it with or without foodbut it will work best if you alwaystake it in the same way every day.

How long to take it

Take this medicine until yourdoctor tells you to stop even if youfeel quite well.People who have high blood pressureoften feel well and do not notice anysigns of this problem.

If you forget to take it

If it is almost time for your nextdose, skip the missed dose and takethe next one when you are meantto.

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

Do not take a double dose to makeup for the one that you missed.This may increase the chance of sideeffects.

If you have trouble rememberingwhen to take your medicine, askyour pharmacist for some hints.

If you take too much(Overdose)

Immediately telephone your doctoror the Poisons Information Centre(telephone number: 13 11 26) foradvice, or go to Accident andEmergency at your nearesthospital if you think that you oranyone else may have taken toomuch EXFORGE. Do this even ifthere are no signs of discomfort orpoisoning. Keep the telephonenumbers for these places handy.Too much EXFORGE may make youfeel dizzy, light headed or faint. Youmay experience rapid, shallowbreathing or cold, clammy skin. Yourheartbeat may be faster than usual.This is because your blood pressureis too low.

While you are takingEXFORGE

Things you must do

If you become pregnant whiletaking EXFORGE, tell your doctorimmediately.You should not take this medicinewhile you are pregnant.

Tell your doctor if, for any reason,you have not taken your medicineexactly as prescribed.Otherwise your doctor may think thatit was not effective and change yourtreatment unnecessarily.

Be sure to keep all of your doctor'sappointments so that your progresscan be checked. Do this even if youfeel well.People with high blood pressureoften do not notice any signs of thisproblem. But it is important to keeptrack of your progress. Your doctorwill want to check your bloodpressure and your kidney and liverfunction from time to time.

If you are going to have surgery,tell your doctor and anaesthetistthat you are taking EXFORGE.EXFORGE may affect somemedicines you receive duringsurgery.

If you are about to be started onany new medicine, remind yourdoctor and pharmacist that youare taking EXFORGE.

Tell any other doctor, dentist orpharmacist who treats you thatyou are taking EXFORGE.

Things you must not do

Do not use EXFORGE to treat anyother complaints unless yourdoctor says you can.

Do not give this medicine to anyoneelse, even if their condition seemsto be similar to yours.

Things to be careful of

Avoid eating grapefruit ordrinking grapefruit juice.Grapefruit juice can affect themetabolism of some medicines,including amlodipine.

Be careful driving, operatingmachinery or doing jobs thatrequire you to be alert while youare taking EXFORGE until youknow how it affects you.This medicine can cause tiredness,sleepiness or dizziness in somepeople. If you have these symptoms,do not drive or do anything else thatcould be dangerous.

If this medicine makes you feeldizzy or light-headed, be carefulwhen getting up from a sitting orlying position.Dizziness can usually be preventedby getting up slowly and flexing legmuscles and toes to get the bloodflowing. When getting out of bed,dangle your legs over the side for aminute or two before standing up.

EXFORGE® Published by MIMS/myDr March 2014 4

Side effects

Tell your doctor or pharmacist assoon as possible if you do not feelwell while you are takingEXFORGE, even if you do notthink it is connected with themedicine.All medicines can have side effects.Sometimes they are serious, but mostof the time they are not. You mayneed medical treatment if you getsome of the side effects.

Do not be alarmed by this list ofpossible side effects. You may notexperience any of them.

Ask your doctor or pharmacist toanswer any questions you mayhave.

Tell your doctor if you notice anyof these side effects and they worryyou:

• headache• buzzing, whistling, ringing or

other persistent noise in the ears• dizziness, spinning sensation,

changes in vision, uncoordinatedmovements

• dizziness on standing up,especially when getting up from asitting or lying position

• sleepiness, tiredness, weakness ordifficulty 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• stomach upset, pain, diarrhoea or

constipation• nausea (feeling sick) or vomiting• tingling or numbness in hands or

feet• rash, redness, blistering or

peeling of skin, itching• excessive sweating• feeling anxious or sad• problems with sexual function• breast enlargement in men• unusual hair loss or thinning

• passing more urine than normalor frequent urge to urinate

• redness and warm feeling of theface and/or neck

• swelling of the ankles, feet, faceor hands

• flushing• palpitations• indigestion• unusual tiredness or weakness• weight gain• feeling nervous, depressed or

moody• distorted sense of taste• sensitivity to light

Tell your doctor immediately or goto Accident and Emergency atyour nearest hospital if you noticeany of the following:

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

• feeling of fast or irregular heartbeat (pounding, racing, skippingbeats)

• 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, feelinggenerally unwell, fever, itching,yellowing of the skin and eyes,and dark coloured urine

The above list includes serious sideeffects which may require medicalattention. These side effects do notoccur frequently.

Tell your doctor if you noticeanything else that is making youfeel unwell.Other side effects not listed abovemay also occur in some people.

After using EXFORGE

Storage

• Keep your tablets in the originalcontainer until it is time to takethem.

• Store them in a cool dry placebelow 30°C (room temperature).

• Do not store EXFORGE or anyother medicine in the bathroom ornear a sink.

• Do not leave EXFORGE in thecar or on window sills.Heat and dampness can destroysome medicines. EXFORGE willkeep well if it is cool and dry.

Keep medicines where childrencannot reach them.A locked cupboard at least one-and-a-half metres above the ground is agood place to store medicines.

Disposal

If your doctor tells you to stoptaking EXFORGE, or it has passedits expiry date, ask yourpharmacist what to do with anytablets that are left over.

Product description

What it looks like

• EXFORGE 5/80 (5 mg ofamlodipine and 80 mg valsartan)tablets are dark yellow, round andimprinted with NVR on one sideand NV on the other. Packs of 7and 28.

• EXFORGE 5/160 (5 mg ofamlodipine and 160 mg valsartan)tablets are dark yellow, oval andimprinted with NVR on one sideand ECE on the other. Packs of 7and 28.

• EXFORGE 10/160 (10 mg ofamlodipine and 160 mg valsartan)tablets are light yellow, oval andimprinted with NVR on one sideand UIC on the other. Packs of 7and 28.

EXFORGE® Published by MIMS/myDr March 2014 5

• EXFORGE 5/320 (5 mg ofamlodipine and 320 mg valsartan)tablets are very dark yellow, ovaland imprinted with NVR on oneside and CSF on the other. Packsof 7 and 28.

• EXFORGE 10/320 (10 mg ofamlodipine and 320 mg valsartan)tablets are dark yellow, oval andimprinted with NVR on one sideand LUF on the other. Packs of 7and 28.

Ingredients

EXFORGE tablets containamlodipine besylate (5 mg or 10 mg)and valsartan (80 mg,160 or 320 mg)as the active ingredient.

The tablets contain the following nonactive ingredients:

• Cellulose - microcrystalline• crospovidone• silica - colloidal anhydrous• magnesium stearate• hypromellose• macrogol 4000• titanium dioxide• iron oxide yellow• talc - purifiedEXFORGE 5/320 mg tablets do notcontain titanium dioxide.

EXFORGE 5/320 and 10/320 mgtablets also contain sodium starchglycollate.

EXFORGE 10/160 and 5/320 mgtablets also contain iron oxide red.

Sponsor

EXFORGE is supplied in Australiaby:NOVARTIS PharmaceuticalsAustralia Pty LimitedABN 18 004 244 16054 Waterloo RoadNorth Ryde NSW 2113Telephone: 1 800 671 203® = Registered Trademark

This leaflet was prepared inDecember 2013.

Australian Registration Numbers:

• EXFORGE 5/80 (5 mg ofamlodipine and 80 mg valsartan)tablets(AUST R 130787)

• EXFORGE 5/160 (5 mg ofamlodipine and 160 mg valsartan)tablets(AUST R 130834)

• EXFORGE 10/160 (10 mg ofamlodipine and 160 mg valsartan)tablets(AUST R 130841)

• EXFORGE 5/320 (5 mg ofamlodipine and 320 mg valsartan)tablets(AUST R 161820)

• EXFORGE 10/320 (10 mg ofamlodipine and 320 mg valsartan)tablets(AUST R 161824)

(Internal reference only:exf241213c.doc based on PIexf241213i.doc)