TARKA® 2/180, TARKA® 4/240trandolapril and verapamil hydrochloride (sustained release)

Consumer Medicine Information

TARKA® 2/180, TARKA® 4/240 Published by MIMS/myDr October 2010 1

What is in this leaflet

This leaflet answers some commonquestions about Tarka.

It does not contain all the availableinformation.

It does not take the place of talking toyour doctor or pharmacist.

All medicines have risks andbenefits. Your doctor has weighedthe risks of you taking Tarka againstthe benefits they expect it will havefor you.

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

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

What Tarka is used for

Tarka lowers high blood pressure,which doctors call hypertension.

Tarka modified-release tabletsbelong to the group of blood-pressurelowering medicines (also calledantihypertensives).

Tarka contains two different types ofmedicines:

• a calcium channel blocker(verapamil)

• an Angiotensin ConvertingEnzyme (ACE) inhibitor(trandolapril)

Everyone has blood pressure. Thispressure helps get your blood allaround your body.

Your blood pressure may be differentat different times of the day,depending on how busy or worriedyou are. You have hypertension (highblood pressure) when your bloodpressure stays higher than is needed,even when you are calm and relaxed.

There are usually no symptoms ofhypertension.

The only way of knowing that youhave hypertension is to have yourblood pressure checked on a regularbasis. You may feel fine and have nosymptoms, but if high blood pressureis not treated, it can lead to serioushealth problems. Tarka helps tolower your blood pressure.

Your doctor may have prescribedTarka for another reason. Ask yourdoctor if you have any questionsabout why Tarka has been prescribedfor you.

Tarka is not recommended for use inchildren under the age of 18, as therehave been no studies of its effects inchildren.

This medicine is available only witha doctor's prescription.

There is no evidence that Tarka isaddictive.

Before you take Tarka

When you must not take it

Do not take Tarka if you have hadan allergic reaction to medicinescontaining verapamilhydrochloride or trandolapril orany other ACE inhibitors.

Some of the symptoms of an allergicreaction may include severe blisters,skin rash, itching or flaking skin.

Do not take Tarka if you have hadan allergic reaction to any of theingredients listed at the end of thisleaflet.

Do not take Tarka if you arepregnant or plan to becomepregnant.

Tarka is not recommended for useduring pregnancy.

Do not take Tarka if you arebreastfeeding or plan tobreastfeed.

Tarka is not recommended while youare breastfeeding.

Do not take Tarka if you have everexperienced excessive swelling ofthe face, lips or the throat, whichhas made it difficult to breathe.

Taking Tarka could cause thisproblem to happen again.

Do not take Tarka if you have:

•••• Certain other heart conditions(such as heart failure, a veryslow heart rate, somearrhythmias or disease of theheart muscle).

•••• Low blood pressure also calledhypotension.

•••• Severe liver problemsassociated with fluid swelling ofthe abdomen.

•••• Problems with your adrenalglands (i.e. Conn's Syndrome)

Do not take Tarka after the expirydate (EXP) printed on the pack.

Do not take Tarka if the packagingis torn or shows signs oftampering.

TARKA® 2/180, TARKA® 4/240 Published by MIMS/myDr October 2010 2

If you are not sure whether youshould start taking Tarka contactyour doctor.

Before you start to take it:

Tell your doctor if you haveallergies to:

•••• any other medicines•••• any other substances, such as

foods, dyes or preservatives.

Tell your doctor if you have orhave had any medical conditionsespecially the following:

• any other heart problem• blood vessel (circulatory) disease

or a stroke• liver or kidney problems• muscle conditions such as

Duchenne's muscular dystrophy,myasthenia gravis or Lambert-Eaton syndrome

• regular dialysis, blood filtrationor similar procedures

• high levels of potassium in yourblood

• dizzy spells• diabetes• collagen disease• are about to have surgery or a

general anaestheticIf you have not told your doctorabout any of the above, tell thembefore you start taking Tarka.

Taking other medicines

Several medicines can causeunwanted reactions if used withTarka. Ask your doctor or pharmacistfor advice before taking thismedicine.

In particular tell your doctor if youare taking any of the followingmedicines:

Medicines to treat heart problemsor high blood pressure:

• Diuretics (also called fluidtablets) or potassiumsupplements.

• Any medicines used to controlyour heart beat (such as betablockers, or other medicines usedto control irregular heart beats) oryour blood pressure. They maycause your blood pressure tobecome too low or may slow yourheart beat too much.

Medicines to treat or preventorgan transplant rejection:

• Such as cyclosporine, everolimus,sirolimus and tacrolimus

Medicines to treat epilepsy orseizures:

• Such as phenytoin,carbamazepine and phenobarbital.

Medicines used to treat infectionsor tuberculosis:

• Such as erythromycin,clarithromycin, telithromycin orrifampicin

Medicines used to treat asthma:

• Such as theophylline

Medicines used to treat diabetes:

• Such as insulin and some oraldiabetes medicines

Medicines used to treat pain orreduce swelling such as:

• Steroids e.g. cortisone orprednisone

• Certain anti-inflammatorymedicines or pain-killers e.g.naproxen, ibuprofen or aspirin

Medicines to treat indigestion orstomach ulcers:

• Such as antacids and cimetidine

Medicines used to lowercholesterol:

• Such as atorvastatin orsimvastatin

Medicines used in surgicalprocedures such as:

• General anaesthetics used forinducing sleep

• Muscle relaxants e.g. dantrolene

Medicines used to treat or preventgout:

• Such as allopurinol or colchicine

Medicines used to treatpsychological problems:

• Any medicines to treatdepression, or psychosis. Such asimipramine, midazolam orlithium

Medicines to treat cancer:

• Such as doxorubicin.Avoid alcohol while using Tarka.You may experience greater bloodpressure lowering effects than usual.

Avoid grapefruit juice, as this mayincrease the blood levels ofverapamil.

These medicines may be affected byTarka, or may affect how well itworks. You may need differentamounts of your medicines or youmay need to take different medicines.Your doctor will advise you.

This is not a complete list ofmedicines which may interfere withTarka.

Tell your doctor or pharmacist if youare taking or have recently taken anyother medicines or herbal remedies,including those obtained without aprescription from a pharmacy,supermarket or health food shop.

Your doctor and pharmacist mayhave more information on medicinesto be careful with or to avoid whiletaking Tarka.

How to take Tarka

How much to take

The usual dose of Tarka is one tableta day, with or after food.

Follow all directions given to youby your doctor carefully.

These directions may differ from theinformation contained in this leaflet.

If you do not understand theinstructions on the pharmacist'slabel fixed on the box, ask yourdoctor or pharmacist for help.

TARKA® 2/180, TARKA® 4/240 Published by MIMS/myDr October 2010 3

How to take it

Swallow the Tarka tablet whole witha glass of water.

Avoid grapefruit and its juice whileyou are using Tarka. Grapefruit juicemay increase the amount ofverapamil which your body absorbs.This may increase your risk of sideeffects from Tarka.

When to take it

Take Tarka at about the same timeeach day. It should be taken withor after food, not includinggrapefruit.

Taking your tablet at the same timeeach day will have the best effect. Itwill also help you to remember whento take the tablet.

How long to take it

Tarka is usually taken long term.Keep taking Tarka for as long asyour doctor recommends.

If you forget to take it

If it is almost time for your nextdose, skip the dose you missed andtake your next dose when you aremeant to. Otherwise, if it is thesame day, take it as soon as youremember, and then go back totaking you medicine at the sametime you would normally.

Do not take a double dose to makeup for the dose that you missed.

This may increase the chance of yougetting an unwanted side effect.

If you are not sure what to do, askyour doctor or pharmacist.

If you take too much(overdose)

Immediately telephone your doctoror the Poisons Information Centre(telephone 13 11 26) for advice, orgo to Accident and Emergency atyour nearest hospital, if you thinkthat you or anyone else may havetaken too much Tarka. Do thiseven if there are no signs ofdiscomfort or poisoning.

You may need urgent medicalattention.

If you take too much Tarka, you mayhave severe dizziness,lightheadedness, weakness, irregularheartbeat, chest pain, feel very faintor collapse.

While you are takingTarka

Things you must do

If you become pregnant whiletaking Tarka, tell your doctorimmediately.

If you are about to be started onany new medicine, tell your doctoror pharmacist that you are takingTarka.

Tell all doctors, dentists andpharmacists who are treating youthat you are taking Tarka.

If you are going to have surgeryincluding dental surgery, tell yourdoctor or dentist that you aretaking Tarka.

Consult your doctor if you havesevere vomiting or diarrhoea whiletaking Tarka.

This may lead to dehydration, whichinterferes with the way Tarka works.

If you have conditions affectingyour kidneys or blood vessels andyou have been taking Tarka formany months or more, ask yourdoctor about having periodic bloodtests.

If you are taking medicines otherthan Tarka, which can affect yourkidneys or immune system, askyour doctor about having periodicblood tests.

Things you must not do

Do not take Tarka with grapefruitor its juice.

Do not give Tarka to anyone else,even if they have the samecondition as you.

Do not take Tarka to treat anyother complaints unless you doctortells you to.

Do not stop taking Tarka, or lowerthe dosage without checking withyour doctor.

Things to be careful of

Be careful getting up from a sittingposition.

Dizziness, lightheadedness orfainting may occur, especially whenyou get up quickly. Getting upslowly may help.

Be careful driving or operatingmachinery until you know howTarka affects you.

As with other medicines, Tarka maycause dizziness, lightheadedness ortiredness in some people. If thisoccurs do not drive, operatemachinery or do anything else thatcould be dangerous if you are tired,dizzy or lightheaded.

If you drink alcohol while takingTarka, dizziness or light-headednessmay be worse.

Side effects

Tell your doctor or pharmacist assoon as possible if you do not feelwell while you are using Tarka.

Like all other medicines, Tarka mayhave unwanted side effects in somepeople. Sometimes they are serious,most of the time they are not. Youmay need medical treatment if youget some of the side effects.

As with most medicines, if you areover 65 years of age you may havean increased change of getting sideeffects. Report any side effects toyour doctor promptly.

Ask your doctor or pharmacist anyquestions you may have. Tell yourdoctor if you notice any of thefollowing more common sideeffects and they worry you:

• constipation• dizziness, spinning sensation

TARKA® 2/180, TARKA® 4/240 Published by MIMS/myDr October 2010 4

• headache• feeling sick, also known as

nausea• abdominal pain• unusual tiredness or weakness• dry cough• hot flushesThese side effects are usually mild.

Tell your doctor immediately or goto Accident and Emergency at thenearest hospital if you notice any ofthe following:

• slow, fast, or irregular heart beat• shortness of breath (sometimes

with tiredness, weakness andreduced ability to exercise

• palpitations• yellowing of the skin or eyes, a

fever or tenderness around themiddle

These may be serious side effects.You may need urgent medicalattention. Serious side effects arerare.

If any of the following happen, stoptaking Tarka and either tell youdoctor immediately or go toAccident and Emergency at yournearest hospital:

• swelling of the face, lips mouth,tongue or throat which may causedifficulty in swallowing orbreathing

• chest pain, fainting, collapse• symptoms of allergy such as

severe blisters, skin rash, itchingor flaking skin - sometimes withfever.

These are very serious side effects.You may need urgent medicalattention or hospitalisation.

Other side effects not listed abovemay also occur in some patients. Askyour doctor or pharmacist for moreinformation about side effects, asthey have a more complete list ofside effects. Inform your doctorpromptly about these or any othersymptoms. If the condition persists orworsens, seek medical attention.

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

Tell your doctor if you noticeanything that is making you feelunwell.

After using Tarka

Storage

Keep your tablets in the pack untilit is time to take them.

Keep Tarka in a cool dry placewhere the temperature stays below25°C.

Do not keep Tarka or any othermedicine in the bathroom or near asink. Do not leave it in the car onhot days or on window sills.Heat and dampness can destroy somemedicines.

Keep you tablets where childrencannot reach them.

Disposal

Medicines should not be disposed ofvia wastewater or household waste.

If your doctor tells you to stoptaking Tarka, or the tablets havepassed their expiry date, ask yourpharmacist what to do with anytablets left over.

Product description

What it looks like

Tarka tablets come in two strengths:

• Tarka 2/180: pink film coatedtablets

• Tarka 4/240: red-brown filmcoated tablets

Tarka tablets are presented in ablister pack of 28 tablets.

Ingredients

The active substances are verapamilhydrochloride and trandolapril.

Tarka 2/180 tablets containtrandolapril 2mg and verapamilhydrochloride (sustained release)180mg.

Tarka 4/240 tablets containtrandolapril 4mg and verapamilhydrochloride (sustained release)240mg.

Tarka tablets also contain:

• starch-maize• povidone• sodium stearylfumarate• lactose• cellulose - microcrystalline• sodium alginate• magnesium stearate• hypromellose• hydroxypropylcellulose• Macrogol 400• Macrogol 6000• Docusate sodium• Talc - purified• Silica-colloidal anhydrous• Titanium dioxide• Iron oxide yellow CI 77492• Iron oxide red CI77491• Iron oxide black CI 77499Tarka tablets are gluten free.

Supplier

Tarka tablets are supplied by:Abbott Australasia Pty LtdABN 95 000 180 38932-34 Lord StreetBotany NSW 2019

Australian registration numbers:Tarka 2/180 - AUST R 104663Tarka 4/240 - AUST R 104664

This leaflet was updated on:07 June 2010

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