ASARTAN

Main information

  • Trade name:
  • ASARTAN HCT 32/12.5 candesartan cilexetil/hydrochlorothiazide 32 mg/12.5 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ASARTAN HCT 32/12.5 candesartan cilexetil/hydrochlorothiazide 32 mg/12.5 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218423
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218423

ASARTAN HCT 32/12.5 candesartan cilexetil/hydrochlorothiazide 32 mg/12.5 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Aurobindo Pharma Australia Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088

Australia

ARTG Start Date

18/12/2013

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. ASARTAN HCT 32/12.5 candesartan cilexetil/hydrochlorothiazide 32 mg/12.5 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

19/10/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

The treatment of hypertension. Treatment should not be initiated with these fixed dose combinations.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. ASARTAN HCT 32/12.5 candesartan cilexetil/hydrochlorothiazide 32 mg/12.5 mg tablet blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

Yellow, uncoated oval shaped tablets debossed with J and 07 separated by

score line on one side and plain with score line on the other side

Active Ingredients

Candesartan cilexetil

32 mg

Hydrochlorothiazide

12.5 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:51:25 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

ASARTAN HCT™ 16/12.5, 32/12.5 & 32/25

Consumer Medicine Information

Candesartan cilexetil and hydrochlorothiazide tablets

What is in this leaflet

This leaflet answers some of the common questions people ask about ASARTAN HCT.

It does not contain all the information that is known about ASARTAN HCT. 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 ASARTAN

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 ASARTAN HCT is used for

ASARTAN HCT is used to treat high blood pressure.

Candesartan cilexetil is a type of medicine called an angiotensin II - receptor antagonist (or blocker).

It mainly works by causing relaxation of blood vessels.

Hydrochlorothiazide is a type of medicine called a diuretic. It works by reducing the amount of excess

fluid in the body.

Using these two medicines together will lower your blood pressure more than using either one on its

own.

Your doctor will have explained why you are being treated with ASARTAN HCT and told you what

dose to take.

You must follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

Your doctor may prescribe this medicine for another use.

Ask your doctor if you want more information.

ASARTAN HCT is not known to be addictive.

ASARTAN HCT is only available with a doctor’s prescription.

Before you take it

When you must not take it

Do not take ASARTAN HCT if you have an allergy to:

any medicine containing candesartan cilexetil or hydrochlorothiazide;

any of the ingredients listed at the end of the leaflet;

any medicine containing an angiotensin II receptor antagonist (or blocker); or

any sulphur drugs (sulphonamides) such as some antibiotics or some medicines to treat

diabetes.

Some of the 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; or

rash, itching or hives on the skin.

Do not take ASARTAN HCT if you have:

severe kidney or liver disease;

conditions associated with impaired bile flow (cholestasis); or

gout.

Do not use ASARTAN HCT if you are taking blood pressure medicine containing aliskiren,

especially if you have diabetes mellitus or have kidney problems.

Do not take ASARTAN HCT if you are pregnant or are planning to become pregnant.

It may affect your baby if you take it during pregnancy.

Do not take ASARTAN HCT if you are breastfeeding.

Your baby can take in components of ASARTAN HCT from breast milk if you are breastfeeding.

Do not give ASARTAN HCT to children.

There is no information about its use in children.

Do not take ASARTAN HCT after the use by (expiry) date printed on the pack has passed. It

may have no effect at all or an unexpected effect if you take it after the expiry date.

Do not take ASARTAN HCT if the packaging is torn or shows signs of tampering.

If you are not sure whether you should start taking this medicine, talk to your doctor or

pharmacist.

Do not use it to treat any other complaints unless your doctor tells you to.

Do not give this medicine to anyone else.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

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

kidney problems;

liver problems;

heart problems;

diabetes;

recent excessive vomiting or diarrhoea;

Systemic Lupus Erythematosus (SLE), a disease affecting the skin, joints and kidneys;

a salt restricted diet;

a condition called primary hyperaldosteronism; or

a past operation known as sympathectomy.

If you have not told your doctor or pharmacist about any of the above, tell them before you

start taking ASARTAN 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 ASARTAN HCT may interfere with each other. These include:

other blood pressure lowering medicines;

medicines containing potassium, including salt substitutes;

digoxin, a medicine used to treat heart failure;

non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to relieve pain, swelling and

other symptoms of inflammation, including arthritis;

colestipol and cholestyramine, medicines used to treat high blood cholesterol levels;

lithium, a medicine used to treat mood swings and some types of depression;

alcohol;

strong pain killers such as codeine, morphine, dextropropoxyphene;

barbiturates, used to treat epilepsy, such as phenobarbitone;

medicines like insulin that are used to treat diabetes;

calcium supplements, or medicines containing calcium;

medicines to treat irregular heartbeats;

corticosteroids such as prednisone, cortisone, dexamethasone;

laxatives;

medicines used to treat cancer such as cyclophosphamide;

methotrexate a medicine used to treat arthritis and some cancers; or

amantadine, a medicine used to treat Parkinson's disease.

These medicines may be affected by ASARTAN HCT or may affect how it works. You may need

different amounts of your medicines, or may need to take different medicines.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines. If you

have not told your doctor about any of these things, tell them before you take any ASARTAN HCT.

How to take it

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from

the information contained in this leaflet.

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

How much to take

The usual dose is one tablet once daily, taken whole with a glass of water.

How and when to take it

Take ASARTAN HCT once a day, at about the same time each day.

Keeping a regular time for taking ASARTAN HCT will help to remind you to take it.

It does not matter whether you take ASARTAN HCT with food or on an empty stomach.

How long to take it

ASARTAN HCT helps control your condition, but does not cure it. Therefore you must take

ASARTAN HCT every day. Continue taking the tablets for as long as your doctor tells you to.

If you forget to take it

If you miss a dose take it as soon as you remember, as long as it is 12 hours before the next

dose is due.

Then go back to taking it as you would normally.

If it is less than 12 hours to the next dose do not take the dose you have missed.

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

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

If you have trouble remembering when 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)

for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or

anyone else may have taken too much ASARTAN HCT. Do this even if there are no signs of

discomfort or poisoning.

If you take too many ASARTAN HCT tablets you may get a headache, feel sick (nausea), dizzy,

thirsty and very tired.

While you are taking it

Things you must do

Take ASARTAN HCT exactly as your doctor has told you to.

Your blood pressure will not be well controlled if you do not.

If you are about to be started on any new medicine, tell your doctor, dentist and pharmacist

that you are taking ASARTAN HCT.

Tell your doctor if you have excessive vomiting or diarrhoea while taking ASARTAN HCT.

You may lose too much water and your blood pressure may become too low.

Tell all other doctors, dentists and pharmacists who are treating you that you are taking

ASARTAN HCT.

If you go into hospital, please let the medical staff know you are taking ASARTAN HCT.

Tell your doctor immediately if you become pregnant or plan to become pregnant while you

are taking ASARTAN HCT.

You should not use ASARTAN HCT if you are pregnant or thinking about becoming pregnant. Your

doctor can discuss different treatment options with you.

If you plan to have surgery (even at the dentist) that needs a general anaesthetic, tell your

doctor or dentist that you are taking ASARTAN HCT.

Tell your doctor if you plan to have an examination such as an X ray or a scan requiring an

injection of iodinated contrast (dye) that you are taking ASARTAN HCT.

Be sure to keep all of your doctor's appointments so that your progress can be checked.

Your doctor will check your progress and may want to take some tests (eg blood tests, blood

pressure) from time to time. These tests may help to prevent side effects.

Things you must not do

Do not use it to treat any other complaints unless your doctor says to.

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

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

Things to be careful of

Move slowly when getting out of bed or standing up if you feel faint, dizzy or light-headed.

Be careful driving or operating machinery until you know how ASARTAN HCT affects you.

You may feel dizzy when you start taking ASARTAN HCT due to the drop in your blood pressure.

Drink plenty of water while you are using ASARTAN HCT, especially if you sweat a lot.

Please talk to your doctor or pharmacist about these possibilities if you think they may bother

you.

Side effects

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

ASARTAN HCT.

ASARTAN 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.

Do not be alarmed by the following list of side effects. You may not experience any of them.

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

Tell your doctor or pharmacist if you notice any of the following and they worry you:

headache or dizziness;

flu-like symptoms or infections;

chest, throat or sinus infections;

feeling sick (nausea) or vomiting;

back pain;

urinary tract infection;

feeling tired; or

stomach ache.

These side effects are usually mild.

following

side

effects

have

been

reported

very

rarely

patients

taking

candesartan:

palpitations, agitation, anxiety, depression, trouble sleeping (insomnia), drowsiness (somnolence),

nervousness, nightmare and sleep disorder. It is not known if these side effects are caused by

candesartan.

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

rapid hearbeats; or

aching muscles, tenderness or weakness in the muscles.

The above list includes serious side effects that may require medical attention. Serious side effects

are rare.

If any of the following happen, stop taking ASARTAN HCT and tell your doctor immediately

or go to Accident and Emergency at your nearest hospital:

swelling of the face, lips, tongue or throat;

swelling of the hands, feet or ankles.;

harsh sounds when breathing;

rash, itching or hives;

easy bruising or bleeding more easily than normal;

feel extremely tired;

yellowing of the skin and eyes;

signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers;

worsening of the kidney function including passing little or no urine, drowsiness, nausea, vomiting,

breathlessness, loss of appetite and weakness (especially in patients with existing kidney

problems or heart failure);

changes in your potassium, sodium and red or white blood cell levels may occur. Such changes

are usually detected by a blood test; or

symptoms that may indicate high potassium levels in the blood include nausea, diarrhoea, muscle

weakness and changes in heart rhythm.

These are very serious side effects. If you have them, you may have had a serious reaction to

ASARTAN HCT. You may need urgent medical attention or hospitalisation.

These side effects are very rare.

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

Some people may get other side effects while taking ASARTAN HCT.

After taking it

Storage

Keep your tablets in the blister foil until it is time to take them.

If you take ASARTAN HCT out of the blister foil, it will not keep well.

Keep it in a cool, dry place where the temperature stays below 25°C.

Do not store it 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 young 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

Ask your pharmacist what to do with any tablets you have left over if your doctor tells you to

stop taking them, or you find that the expiry date has passed.

Product description

What ASARTAN HCT looks like

ASARTAN HCT 16/12.5*, 32/12.5* & 32/25* mg tablets are supplied in blister packs containing 7*

(1x7) or 30* (3x10) tablets.

ASARTAN HCT 16/12.5

Pink, uncoated capsule shaped tablets debossed with ‘J’ and ‘05’ separated by score line on one

side and plain with score line on the other side.

ASARTAN HCT 32/12.5

Yellow, uncoated oval shaped tablets debossed with ‘J’ and ‘07’ separated by score line on one side

and plain with score line on the other side.

ASARTAN HCT 32/25

Pink, uncoated oval shaped tablets debossed with ‘J’ and ‘15’ separated by score line on one side

and plain with score line on the other side.

*Some of these presentations and pack sizes may not be marketed.

Ingredients

Active ingredients:

Candesartan cilexetil and hydrochlorothiazide.

Other ingredients:

carmellose calcium;

hydroxypropylcellulose;

lactose;

magnesium stearate;

aluminium magnesium silicate;

propylene glycol;

iron oxide red; and

iron oxide yellow (16/12.5 mg & 32/25 mg tablets only).

Sponsor/Marketing Authorisation Holder

Aurobindo Pharma Australia Pty Ltd

6 Eastern Road

South Melbourne

Victoria 3205

Australia

Distributed by Eris Pharmaceuticals (Australia) Pty Ltd

www.eris-pharma.com.au

Toll free telephone (Australia): 1800 233 588

The leaflet was prepared in October 2015

ASARTAN HCT

16/12.5 blister pack: AUST R 199103

ASARTAN HCT

32/12.5 blister pack: AUST R 218423

ASARTAN HCT

32/25 blister pack: AUST R 199095

Version 2.0

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

30-10-2018

Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide

Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide

There is a small increased risk of developing basal cell carcinoma and squamous cell carcinoma in long-term use of blood pressure medicine containing hydrochlorothiazide. This follows from a review of new studies and available data undertaken by the European Medicines Agency, EMA.

Danish Medicines Agency

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

8-3-2012

Review concluded regarding general reimbursement for Valsartan/Hydrochlorothiazide "Actavis"

Review concluded regarding general reimbursement for Valsartan/Hydrochlorothiazide "Actavis"

We have completed our review of an application for general reimbursement for Valsartan/Hydrochlorothiazide "Actavis". The product is neither eligible for general nor general conditional reimbursement.

Danish Medicines Agency

22-10-2018

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018) 6974 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

CoAprovel (Sanofi Clir SNC)

CoAprovel (Sanofi Clir SNC)

CoAprovel (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)6465 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

24-9-2018

Karvezide (Sanofi-Aventis groupe)

Karvezide (Sanofi-Aventis groupe)

Karvezide (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)6222 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

4-7-2018

Ifirmacombi (Krka d. d., Novo mesto)

Ifirmacombi (Krka d. d., Novo mesto)

Ifirmacombi (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)4340 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

27-6-2018

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4082 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1159/T/67

Europe -DG Health and Food Safety

27-6-2018

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4084 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1160/T/68

Europe -DG Health and Food Safety

11-6-2018

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3752 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1068/T/66

Europe -DG Health and Food Safety