APO-Valsartan

Main information

  • Trade name:
  • APO-Valsartan HCTZ 80/12.5 valsartan 80 mg and hydrochlorothiazide 12.5 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-Valsartan HCTZ 80/12.5 valsartan 80 mg and hydrochlorothiazide 12.5 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222296
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222296

APO-Valsartan HCTZ 80/12.5 valsartan 80 mg and hydrochlorothiazide 12.5 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

29/03/2016

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. APO-Valsartan HCTZ 80/12.5 valsartan 80 mg and hydrochlorothiazide 12.5 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

1/11/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Valsartan HCTZ is indicated for the treatment of hypertension. Treatment should not be initiated with these 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

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. APO-Valsartan HCTZ 80/12.5 valsartan 80 mg and hydrochlorothiazide 12.5 mg tablet blister pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

Orange, modified, capsule shaped, film-coated tablets, engraved 'APO' on

one side and '80/12.5' on the other side.

Active Ingredients

Hydrochlorothiazide

12.5 mg

Valsartan

80 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 11:44:57 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

APO-Valsartan HCTZ

Tablets

Contains the active ingredients valsartan 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 valsartan 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.

You can also download the most up

to date leaflet from

www.apotex.com.au.

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 APO-

Valsartan HCTZ. It contains the

active ingredients valsartan and

hydrochlorothiazide.

It is used to treat hypertension (high

blood pressure).

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.

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

Valsartan HCTZ reduces blood

pressure in two different ways.

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.

Hydrochlorothiazide helps reduce

the amount of excess fluid in the

body by increasing the amount of

urine produced. This helps lower

your blood pressure.

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be used in

children. Safety and effectiveness in

children have not been established.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You have or have had any of

the following:

severe kidney or liver disease,

including biliary cirrhosis

cholestasis, a condition where the

flow of bile is blocked or reduced

anuria, a condition where you are

unable to urinate

symptomatic hyperuricaemia, a

condition where you have a high

level of uric acid in your blood,

which can be present as gout,

stones or kidney disease

refractory hypokalaemia, a

condition where you have a low

level of potassium in your blood

APO-VALSARTAN HCTZ TABLETS

hyponatraemia, a condition where

you have a low level of sodium in

your blood

hypercalcaemia, a condition

where you have a high level of

calcium in your blood.

diabetes and taking a medication

containing aliskiren,

You are pregnant.

Valsartan HCTZ may affect your

developing baby if you take it

during pregnancy.

You have had a severe allergic

reaction to sulphonamide-

derived medicines, such as some

antibiotics, e.g., trimethoprim

and sulfamethoxazole.

You are hypersensitive to, or

have had an allergic reaction to,

valsartan, hydrochlorothiazide

or sulphonamide-derived

medicines any of the

ingredients listed at the end of

this leaflet.

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:

sulphonamide or penicillin

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

systemic lupus erythematosus, a

disease affecting the skin, joints

and kidneys

high cholesterol levels

diabetes swelling, mainly of the

face and throat, while taking

other medicines (including an

ACE - inhibitor or aliskiren)

primary hyperaldosteronism

(Conn's syndrome), a hormone

disorder causing fluid retention

obstructed blood flow through the

heart from narrowing of valves

(stenosis) or enlarged septum of

the heart (HOCM)

recent excessive vomiting or

diarrhoea

salt restricted diet

asthma.

acute angle closure glaucoma, a

condition where you have

reduced vision

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 5. 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.

Taking other medicines

Some medicines may interact with

valsartan HCTZ. These include:

medicines used to treat high

blood pressure, including ACE

inhibitors, any other angiotensin

receptor agonists, beta-blockers,

calcium channel blockers,

methyldopa and renin inhibitors

(e.g. aliskiren)

medicines used to treat other

heart conditions, including

digitalis glycosides (e.g.,

digoxin), antiarrhythmics (used to

treat irregular heart rhythms) and

pressor amines (e.g.,

noradrenaline)

anti-inflammatory medicines,

including NSAIDs and COX-2

inhibitors, medicines used to

relieve pain, swelling and other

symptoms of inflammation,

including arthritis

diuretic medicines, also known

water / fluid tablets.

medicines or supplements which

contain potassium

some antibiotics, such as

penicillin, tetracyclines and

rifamycin.

anti-rejection drugs (cyclosporin),

medicines or supplements

containing calcium

vitamin D

other medicines that raise blood

pressure

medicines used to relax muscles

before or during surgery

steroid medicines such as

cortisone, prednisone and

adrenocorticotropic

hormone(ACTH)

antidepressant and antipsychotic

medicines, including lithium,

medicines used to treat mood

swings and some types of

depression cytotoxic medicines,

such as cyclophosphamide or

methotrexate

products containing salicylic acid

amphotericin, a medicine used to

treat fungal infections

APO-VALSARTAN HCTZ TABLETS

medicines used to treat diabetes,

such as oral tablets or insulin

medicines used to treat gout

including allopurinol and

uricosuric agents (e.g.,

probenecid and sulfinpyrazone)

antiepileptic medicines, including

carbamazepine medicines used to

lower cholesterol,such as

cholestyramine and colestipol

amantadine, a medicine used to

treat Parkinson's disease or to

prevent influenza

anticholinergic medicines (e.g.

atropine), used to treat

Parkinson's disease, relieve

stomach cramps, spasms and

prevent travel sickness

carbenoxolone, a medicine used

to treat stomach ulcers

alcohol, anaesthetics and

sedatives

high doses of iodine,

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 valsartan

HCTZ.

How to take this

medicine

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much to take

Your doctor 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.

The usual dose is one tablet of either

80/12.5mg, 160/12.5mg or

320/12.5mg per day.

If your blood pressure is still too high

after 4 weeks, your doctor may

increase the dose to one tablet of

either 160/25mg or 320/25mg per

day.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

How to take it

Swallow the tablet with a full 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.

Always take this medicine in the

same way in relation to food. It does

not matter if you take it before, with

or after food, as long as you take it

the same way each day.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If it is almost time to take your next

dose, skip the missed dose and take

your next dose at the usual time.

Otherwise take it as soon as you

remember and then go back to taking

your medicine as you would

normally.

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.

Too much valsartan HCTZ 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.

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 should

not take this medicine whilst

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.

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 or pharmacist tells you to

APO-VALSARTAN HCTZ TABLETS

stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Things to be careful of

Be careful when driving or operating

machinery until you know how this

medicine 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.

When you are outdoors, wear

protective clothing and use at least

a 15+ 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.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking valsartan HCTZ 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.

This list includes the more common

side effects. Mostly, they are mild:

headache

dizziness, spinning sensation,

blurred vision

dizziness on standing up,

especially when getting up from a

sitting or lying position

sleepiness, tiredness or weakness

pain in the back or joints

runny nose or congested sinuses

dry cough, sore throat or hoarse

voice

dry mouth

diarrhoea, constipation or wind

nausea (feeling sick), vomiting,

loss of appetite, stomach upset or

indigestion

muscle pain, muscle tenderness or

weakness, cramps or joint pain

tingling or numbness in hands or

feet

symptoms of sunburn which

happen more quickly than normal

difficulty sleeping

feeling anxious or sad

problems with sexual function

pain when passing urine, frequent

urge to urinate

hair loss

facial pain.

anaemia

If you experience any of the

following, stop taking your

medicine and contact your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

These are very serious side effects

and are usually rare. You may need

urgent medical attention or

hospitalisation.

feeling of fast or irregular heart

beat (pounding, racing, skipping

beats)

chest pain

tiredness or lack of energy, being

short of breath when exercising,

dizziness and looking pale

constant "flu-like" symptoms

such as chills, fever, sore throat,

aching joints, sores in mouth,

swollen glands

pain in the stomach, often

accompanied by nausea and

vomiting

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

severe dizziness or fainting

passing less urine than normal

signs of liver disease such as

nausea, vomiting, loss of appetite,

feeling generally unwell, fever,

itching, yellowing of the skin and

eyes and dark coloured urine

decrease in vision or pain in your

eyes.

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to valsartan

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,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hayfever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

APO-VALSARTAN HCTZ TABLETS

Keep your medicine in a cool dry

place where the temperature will

stay below 25°C. Protect from

moisture.

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 APO-Valsartan HCTZ

looks like

160/12.5 mg

Dark red, modified, capsule shaped,

film-coated tablets, engraved "APO"

on one side and "160/12.5" on the

other side.

320/12.5 mg

Pink, oval shaped, film-coated

tablets, engraved "APO" on one side

and "320/12.5" on the other side.

320/25 mg

Yellow, oval shaped, film-coated

tablets, engraved "APO" on one side

and "320/25" on the other side

80/12.5 mg

Orange, modified, capsule shaped,

film-coated tablets, engraved "APO"

on one side and "80/12.5" on the

other side.

160/25 mg

Brown, modified capsule shaped,

film-coated tablets, engraved "APO"

on one side and "160/25" on the other

side.

Available in blisters packs of 28

tablets.

* Not all strengths may be available.

Ingredients

Each tablet contains the following

amount of valsartan and

hydrochlorothiazide respectively:

160/12.5mg, 320/12.5mg, 320/25mg,

80/12.5mg and 160/25mg.

Each tablet also contains the

following inactive ingredients:

powdered cellulose

calcium hydrogen phosphate

colloidal anhydrous silica

croscarmellose sodium

magnesium stearate

hypromellose

hydroxypropyl cellulose

titanium dioxide

iron oxide red (80/12.5mg,

160/12.5mg, 320/12.5mg &

160/25mg tablets)

iron oxide yellow (80/12.5mg,

320/25mg & 160/25mg tablets)

iron oxide black (160/25mg &

320/12.5mg tablets).

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

APO-Valsartan HCTZ 160/12.5

tablets (blisters): AUST R 202354.

APO-Valsartan HCTZ 320/12.5

tablets (blisters): AUST R 202344.

APO-Valsartan HCTZ 320/25 tablets

(blisters): AUST R 202345

APO-Valsartan HCTZ 80/12.5 mg

tablets (blisters): AUST R 222296.

APO-Valsartan HCTZ 160/25 mg

tablets (blisters): AUST R 222295.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was last updated in:

May 2016.

APO-VALSARTAN HCTZ TABLETS

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Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

19-7-2018

Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products

Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products

The investigation into valsartan-containing products is ongoing and there are currently three voluntary recalls related to the NDMA impurity detected in the valsartan

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

16-7-2018

Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen (NDMA)

Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen (NDMA)

As a precautionary measure, the distribution firm, Major Pharmaceuticals, is issuing a nationwide voluntary recall of all lots within expiry of Valsartan which were supplied by Teva Pharmaceuticals and labeled as Major Pharmaceuticals.

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

13-7-2018

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

FDA is alerting the public about a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure

FDA - U.S. Food and Drug Administration

9-7-2018

Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

Several drugs containing the ingredient valsartan are being recalled by their manufacturers. An impurity, N-nitrosodimethylamine (NDMA), was found in the valsartan used in these products. The valsartan was supplied by Zhejiang Huahai Pharmaceuticals. NDMA is a potential human carcinogen, which means that it could cause cancer with long-term exposure. Five companies have affected products, which are being recalled (identified in table below).

Health Canada

5-7-2018

Recall of valsartan blood pressure medicine

Recall of valsartan blood pressure medicine

Impurities that could potentially be harmful to health have been found in variants of medicines containing the active substance valsartan. The medicine is used to treat hypertension and heart failure. Patients treated with these medicines are therefore advised to contact their doctor as soon as possible to be switched to another type of medicine.

Danish Medicines Agency

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

18-3-2008

Warning about Power 1 Walnut

Warning about Power 1 Walnut

The Danish Medicines Agency has been made aware that the Health Sciences Authority in Singapore has confiscated large quantities of the illegal medicinal product Power 1 Walnut, which has been marketed as a potency-enhancing product containing only herbs.

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

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 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

Exforge (Novartis Europharm Limited)

Exforge (Novartis Europharm Limited)

Exforge (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4085 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/716/T/96

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

11-6-2018

Dafiro (Novartis Europharm Limited)

Dafiro (Novartis Europharm Limited)

Dafiro (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3753 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/776/T/99

Europe -DG Health and Food Safety

6-6-2018

Copalia (Novartis Europharm Limited)

Copalia (Novartis Europharm Limited)

Copalia (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3695 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/774/T/97

Europe -DG Health and Food Safety

3-5-2018

Entresto (Novartis Europharm Limited)

Entresto (Novartis Europharm Limited)

Entresto (Active substance: sacubitril / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2779 of Thu, 03 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4062/T/18

Europe -DG Health and Food Safety