TERRY

Main information

  • Trade name:
  • TERRY WHITE CHEMISTS CANDESARTAN HCTZ 32/25 candesartan cilexetil 32 mg & hydrochlorothiazide 25 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TERRY WHITE CHEMISTS CANDESARTAN HCTZ 32/25 candesartan cilexetil 32 mg & hydrochlorothiazide 25 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210573
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210573

TERRY WHITE CHEMISTS CANDESARTAN HCTZ 32/25 candesartan cilexetil 32 mg &

hydrochlorothiazide 25 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

16/07/2013

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. TERRY WHITE CHEMISTS CANDESARTAN HCTZ 32/25 candesartan cilexetil 32 mg & hydrochlorothiazide

25 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

26/07/2017

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

Al/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. TERRY WHITE CHEMISTS CANDESARTAN HCTZ 32/25 candesartan cilexetil 32 mg & hydrochlorothiazide 25 mg tablet blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

Light pink, oval biconvex uncoated mottled tablets debossed with 'L3' & '04'

on either side of break line on one side & break line on one other side

Active Ingredients

Candesartan cilexetil

32 mg

Hydrochlorothiazide

25 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 27.11.2017 at 09:25:03 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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Terry White Chemists

Candesartan HCTZ

Tablets

Contains the active ingredient candesartan cilexetil and hydrochlorothiazide

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about candesartan cilexetil

and hydrochlorothiazide (HCTZ). 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

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is Terry

White Chemists Candesartan HCTZ

tablets. It contains the active

ingredients candesartan cilexetil and

hydrochlorothiazide.

It is used to treat:

high blood pressure, also called

hypertension.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

How it works

Candesartan cilexetil is a type of

medicine called an angiotensin II

receptor inhibitor (or antagonist). 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

effectively than using either one on

its own.

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be used in

children. The safety and

effectiveness of this medicine in

children under 18 years of age have

not been established.

Before you use this

medicine

When you must not use it

Do not use this medicine if:

You have or have had any of

the following:

severe kidney disease

gout

severe liver disease and/or

cholestasis.

taking blood pressure medicine

containing aliskiren, especially if

you have diabetes mellitus or

kidney problems.

You are pregnant or planning

to become pregnant.

This medicine may affect your

developing baby if you take it

during pregnancy.

You are breast-feeding or

planning to breast-feed.

This medicine may pass into

human breast milk.

You are hypersensitive to, or

have had an allergic reaction to,

TERRY WHITE CHEMISTS CANDESARTAN HCTZ TABLETS

candesartan cilexetil,

hydrochlorothiazide or any of

the ingredients listed at the end

of this leaflet.

You are hypersensitive to, or

have had an allergic reaction to,

any sulphur drugs

(sulphonamides) such as

antibiotics or some medicines

used to treat diabetes.

Symptoms of an allergic reaction

may include cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting or hayfever-

like symptoms.

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

Department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

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

a past operation known as

sympathectomy

you are hypersensitive to, or have

had an allergic reaction to,

penicillin.

You are currently pregnant or you

plan to become pregnant. Do not

take this medicine whilst

pregnant.

You are currently breast-feeding

or you plan to breast-feed. Do not

take this medicine whilst breast-

feeding.

You have recently been

vaccinated or plan to get a

vaccination.

You are planning to have surgery

or an anaesthetic.

You are currently receiving or are

planning to receive dental

treatment.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines may interact with

Candesartan HCTZ.. These include:

other medicines that lower blood

pressure such as ACE inhibitors,

angiotensin II receptor blockers

and aliskiren, especially if you

have diabetes-related kidney

problems

medicines used to raise blood

pressure.

other medicines associated with

potassium loss, such as other

diuretics and laxatives.

medicines containing potassium,

including salt substitutes.

cardiac glycosides, medicines

used to treat heart failure and

irregular heartbeat, such as

Digoxin.

other medicines used to treat

irregular heartbeat.

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.

Vitamin D supplements

corticosteroids such as

prednisone, cortisone,

dexamethasone.

non-depolarizing muscle

relaxants such as tubocurarine.

iodinated contrast media, a

radiographic die used for imaging

techniques such as CT scans.

amantadine, an antiviral and an

antiparkinsonian medicine.

anticholinergic agents, medicines

that act on the nervous system,

such as atropine.

cytotoxic medicines, such as

medicines used for

chemotherapy.

cyclosporine, an

immunosuppressant used to

prevent organ transplant

rejection.

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with candesartan

HCTZ.

TERRY WHITE CHEMISTS CANDESARTAN HCTZ TABLETS

How to take this

medicine

Follow carefully all directions given

to you by your doctor carefully.

Their instructions may be different to

the information in this leaflet.

If you are not sure how to take this

medicine, ask your doctor or

pharmacist for help.

How much to take

Your doctor or pharmacist will tell

you how much of this medicine you

should take. This will depend on

your condition and whether you are

taking any other medicines.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

The usual dose is one tablet once

daily.

How to take it

Swallow the tablets whole with a

glass of water.

When to take it

Take this medicine at the same time

each day. Taking it at the same time

each day will have the best effect and

will also help you remember when to

take it.

It does not matter if you take it

before, with or after food.

How long to take it

Continue taking this medicine for as

long as your doctor tells you.

This medicine controls your

condition, but does not cure it. It is

important to keep taking your

medicine even if you feel well.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If you forget to take a dose, take it as

soon as you remember, as long as it

is at least 12 hours before your next

dose is due.

Then go back to taking it as you

would normally.

If it is less than 12 hours to your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

Do not take a double dose to make

up for missed doses. This may

increase the chance of you

experiencing side effects.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints to help you

remember.

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively go to the Accident

and Emergency Department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

If you take too many candesartan

HCTZ tablets, you may get a

headache, feel sick (nausea), dizzy,

thirsty and very tired.

While you are taking

this medicine

Things you must do

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breast-feeding or are

planning to breast-feed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital

you experience excessive

vomiting or diarrhoea.

You may lose too much water

and your blood pressure may

become too low.

Your doctor may occasionally do

tests to make sure the medicine is

working and to prevent side effects.

Go to your doctor regularly for a

check-up.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Things you must not do

Do not:

Give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Take your medicine to treat any

other condition unless your

doctor tells you to.

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

candesartan HCTZ affects you.

You may feel dizzy when you start

taking candesartan HCTZ due to the

drop in your blood pressure.

Move slowly when getting out of

bed or standing up if you feel faint,

dizzy or light-headed.

Drink plenty of water while you

are using this medicine, especially

if you sweat a lot.

Please talk to your doctor or

pharmacist about these

possibilities if you think they may

be a problem for you.

TERRY WHITE CHEMISTS CANDESARTAN HCTZ TABLETS

Possible side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking this

medicine or if you have any

questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but

most of the time they are not.

Tell your doctor if you notice any

of the following:

headache or dizziness

flu-like symptoms or infections

chest, throat or sinus infections

feeling sick (nausea)

back pain

urinary tract infection

rapid heartbeats

feeling tired

stomach ache.

Tell your doctor as soon as possible

if you notice any of the following:

aching muscles, tenderness or

weakness in the muscle.

The above list includes serious side

effects and are usually rare. They

may require medical attention.

If you experience any of the

following, stop taking your

medicine and contact your doctor

immediately or go to Accident and

Emergency at your nearest

hospital:

easy bruising or bleeding more

easily than normal

feeling 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

symptoms that may indicate high

potassium levels in the blood

include nausea, diarrhoea, muscle

weakness and changes in heart

rhythm

blurred vision or eye pain.

These are very serious side effects

and are usually very rare. You may

need urgent medical attention or

hospitalisation.

Other side effects not listed above

may above may occur in some

patients. Tell your doctor if you

notice any other side effects.

Allergic reactions

If you think you are having an

allergic reaction to candesartan

HCTZ, do not take any more of

this medicine and tell your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, 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

fainting

hayfever-like symptoms.

Storage and disposal

Storage

Keep your tablets in the blister

pack until it is time to take them.

If you take candesartan out of the

blister pack it will not keep well.

Keep your tablets in a cool dry place

where the temperature will stay

below 25°C.

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink. Do not leave it on a

window sill or in the car. Heat and

dampness can destroy some

medicines.

Keep this medicine 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 or pharmacist tells you

to stop taking this medicine or it has

passed its expiry date, your

pharmacist can dispose of the

remaining medicine safely.

Product description

What Terry White Chemists

Candesartan HCTZ looks

like

Terry White Chemists Candesartan

HCTZ 16/12.5 mg tablets: light pink,

oval shape, biconvex, uncoated,

mottled tablet debossed with 'L3' and

'02' on either side of breakline on one

side and break line on other side

Terry White Chemists Candesartan

HCTZ 32/12.5 mg tablets: light

yellow, oval, biconvex, uncoated,

mottled tablet debossed with 'L3' &

'04' on either side of breakline on one

side and break line on other side

Terry White Chemists Candesartan

HCTZ 32/25 mg tablets: light pink,

oval, biconvex, uncoated, mottled

tablet debossed with 'L3' & '04' on

either side of break line on one side

& break line on one other side

Ingredients

Terry White Chemists Candesartan

HCTZ Tablets 16/12.5 mg contains

16 mg candesartan cilexetil and 12.5

mg of hydrochlorothiazide.

Terry White Chemists Candesartan

HCTZ Tablets 32/12.5 mg contains

TERRY WHITE CHEMISTS CANDESARTAN HCTZ TABLETS

32 mg candesartan cilexetil and 12.5

mg of hydrochlorothiazide.

Terry White Chemists Candesartan

HCTZ Tablets 32/25 mg contains 32

mg candesartan cilexetil and 25 mg

of hydrochlorothiazide.

Terry White Chemists Candesartan

HCTZ is available in:

Blister packs of 7 and 30 tablets.

Not all strengths, and/or pack sizes

may be available.

Ingredients

Each tablet contains 16 mg or 32mg

of candesartan and 12.5mg or 25mg

of HCTZ as the active ingredient.

It also contain the following inactive

ingredients:

lactose

carmellose calcium

starch - maize

macrogol 8000

hydroxypropylcellulose

magnesium stearate

Pigment Blend PB-24880 Pink

(16/12.5 mg and 32/25 tablet

only)

(iron oxide yellow) (32/12.5 mg

tablet only).

This medicine is gluten-free, sucrose-

free, tartrazine-free and free of other

azo dyes.

Australian Registration

Numbers

Terry White Chemists Candesartan

HCTZ 16/12.5 mg blister pack:

AUST R 210571

Terry White Chemists Candesartan

HCTZ 32/12.5 mg blister pack:

AUST R 210572

Terry White Chemists Candesartan

HCTZ 32/25 mg blister pack:

AUST R 210573

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park, NSW 2113

Australia

This leaflet was prepared in

November 2016.

TERRY WHITE CHEMISTS CANDESARTAN HCTZ TABLETS

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

27-11-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carc...

FDA - U.S. Food and Drug Administration

23-11-2018

ACT-Candesartan 4mg tablets (2018-11-23)

ACT-Candesartan 4mg tablets (2018-11-23)

Health Canada

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

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

12-11-2018

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7555 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

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