Olmesartan HCT

Main information

  • Trade name:
  • Olmesartan/HCT Sandoz 20/12.5 olmesartan medoxomil/hydrochlorothiazide 20/12.5 mg film coated tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Olmesartan/HCT Sandoz 20/12.5 olmesartan medoxomil/hydrochlorothiazide 20/12.5 mg film coated tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221119
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221119

Olmesartan/HCT Sandoz 20/12.5 olmesartan medoxomil/hydrochlorothiazide 20/12.5 mg film coated

tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

5/02/2015

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. Olmesartan/HCT Sandoz 20/12.5 olmesartan medoxomil/hydrochlorothiazide 20/12.5 mg film coated tablets

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

Indicated for the treatment of hypertension.,Treatment should not be initiated with this fixed dose combination.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

2 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Blister Pack

PVC/PVDC/Al

2 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. Olmesartan/HCT Sandoz 20/12.5 olmesartan medoxomil/hydrochlorothiazide 20/12.5 mg film coated tablets blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

20/12.5 mg film coated tablets are yellow film coated, round, biconvex

tablets debossed with 346 on one side and L on other side.

Active Ingredients

Hydrochlorothiazide

12.5 mg

Olmesartan medoxomil

20 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 01:25:00 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

OLMESARTAN/HCT SANDOZ

Olmesartan/HCT

Sandoz

®

Olmesartan medoxomil and hydrochlorothiazide

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

This leaflet answers some common

questions about Olmesartan/HCT

Sandoz.

It does not contain all the available

information.

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

Olmesartan/HCT Sandoz against the

benefits he/she expects it will have

for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with your

Olmesartan/HCT Sandoz Tablets.

You may need to read it again.

What Olmesartan/HCT

Sandoz is used for

Olmesartan/HCT Sandoz is used to

treat high blood pressure which is

sometimes called hypertension.

Everyone has blood pressure. This

pressure helps push blood all around

your body. Your blood pressure

changes at different times of the day,

depending on how busy or worried

you are. You have hypertension (high

blood pressure) when your blood

pressure stays higher than is needed,

even when you are calm and relaxed.

There are usually no symptoms of

hypertension. The only way of

knowing that you have hypertension

is to have your blood pressure

checked on a regular basis. If high

blood pressure is not treated it can

lead to serious health problems,

including stroke, heart disease and

kidney failure.

How Olmesartan/HCT

Sandoz works

Olmesartan/HCT Sandoz belongs to

a group of medicines known as

angiotensin-II receptor antagonists.

Angiotensin-II is a substance

produced in the body which causes

blood vessels to tighten.

Olmesartan/HCT Sandoz blocks the

action of angiotensin-II and therefore

relaxes your blood vessels. This

helps lower your blood pressure.

Olmesartan/HCT Sandoz also

contains a diuretic which reduces the

amount of fluid in the body. This also

helps to lower blood pressure.

Your doctor may have prescribed

Olmesartan/HCT Sandoz for another

reason. Ask your doctor if you have

any questions about why

Olmesartan/HCT Sandoz has been

prescribed for you.

Olmesartan/HCT Sandoz is not

addictive.

This medicine is available only with

a doctor's prescription.

Before you take

Olmesartan/HCT

Sandoz

When you must not take it

Do not take Olmesartan/HCT

Sandoz if:

you have an allergy to

olmesartan, sulfonamide

derived medicines (e.g. thiazide

diuretics), or any of the

ingredients listed at the end of

this leaflet

Symptoms of an allergic reaction to

Olmesartan/HCT Sandoz may

include skin rash, itchiness, shortness

of breath, swelling of the face, lips or

tongue, muscle pain or tenderness or

joint pain.

you have serious problems with

your kidneys

you have serious problems with

your liver

you have low potassium or

sodium levels in the blood

you have high calcium or uric

acid levels in the blood.

you have diabetes and are

taking a medicine called

aliskiren to reduce blood

pressure.

Do not take Olmesartan/HCT

Sandoz if you are pregnant or

breastfeeding.

Olmesartan/HCT Sandoz may enter

your womb or it may pass into the

OLMESARTAN/HCT SANDOZ

breast milk and there is the

possibility that your baby may be

affected.

If pregnancy is discovered

Olmesartan/HCT Sandoz should be

discontinued as soon as possible.

Do not take Olmesartan/HCT

Sandoz after the expiry date

printed on the pack or if the

packaging is torn or shows signs of

tampering.

If you are not sure whether you

should start taking

Olmesartan/HCT Sandoz, talk to

your doctor.

Before you start to take it

Tell your doctor if you have

allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

Tell your doctor if you have or

have had any medical conditions,

especially the following:

kidney problems

liver problems

heart problems

diabetes

excessive vomiting or diarrhoea

recently

gout

Systemic Lupus Erythematosus

(SLE)

high levels of potassium in your

blood.

problems with your adrenal

glands (small glands above the

kidneys)

You must also tell your doctor if

you:

are following a very low salt diet

you are or intend to become

pregnant or plan to breastfeed.

If you have not told your doctor

about any of the above, tell him/

her before you start taking

Olmesartan/HCT Sandoz.

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

Olmesartan/HCT Sandoz may

interfere with each other. These

include:

other medicines used to treat high

blood pressure

other diuretics, also known as

fluid or water tablets

non-steroidal anti-inflammatory

drugs (NSAIDs) or COX-2

inhibitors, medicines used to

relieve pain, swelling and other

symptoms of inflammation,

including arthritis

potassium supplements or

potassium-containing salt

substitutes

lithium or antidepressant

medicines

insulin and tablets used to treat

diabetes

antacids, medicines used to treat

heartburn and indigestion

medicines which lower your

immune system, such as

corticosteroids and cytotoxic

medicines used to treat cancer

(including radiation therapy)

alcohol

laxatives, medicines used to treat

constipation

medicines used to relieve pain

medicines used to treat epilepsy

antiarrhythmics which treat

irregular heart beats

muscle relaxants

cholestyramine and colestipol,

used to treat high cholesterol.

any medicine that contains

aliskiren

any medicines that contain

colesevelam.

These medicines may be affected by

Olmesartan/HCT Sandoz, or may

affect how well it works. You may

need different amounts of your

medicine, or you may need to take

different medicines.

Other medicines not listed above

may also interfere with

Olmesartan/HCT Sandoz. Your

doctor and pharmacist have more

information on medicines to be

careful with or avoid while taking

this medicine.

Use in children

The safety and effectiveness of

Olmesartan/HCT Sandoz in children

has not been established.

How to take

Olmesartan/HCT

Sandoz

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

Your doctor or pharmacist will tell

you which Olmesartan/HCT Sandoz

tablet you will need to take each day.

This depends on your condition and

whether or not you are taking any

other medicines.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

The dose of Olmesartan/HCT Sandoz

is one tablet to be taken once a day.

How to take it

Swallow Olmesartan/HCT Sandoz

whole with a full glass of water.

Do not chew the tablets.

OLMESARTAN/HCT SANDOZ

When to take it

Take Olmesartan/HCT Sandoz at

about the same time each day, with

or without food.

Taking your tablets at the same time

each day will have the best effect.

It will also help you remember when

to take the tablets. It does not matter

whether you take it with or without

food.

How long to take it

Olmesartan/HCT Sandoz helps

control your condition, but does not

cure it. Therefore you must take

Olmesartan/HCT Sandoz every day.

Continue taking your medicine for as

long as your doctor tells you.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

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 the dose that you missed.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or the Australian Poisons

Information Centre (telephone 13

11 26) or go to Accident and

Emergency at the nearest hospital,

if you think that you or anyone else

may have taken too much

Olmesartan/HCT Sandoz. Do this

even if there are no signs of

discomfort or poisoning.

Keep telephone numbers for these

places handy.

If you take too much

Olmesartan/HCT Sandoz, you may

feel light-headed, dizzy or you may

faint. You may also have a fast heart

beat.

While you are using

Olmesartan/HCT

Sandoz

Things you must do

If you are about to be started on

any new medicine, tell your doctor,

dentist or pharmacist that you are

taking Olmesartan/HCT Sandoz.

Make sure you drink enough water

during exercise and hot weather

when you are taking

Olmesartan/HCT Sandoz,

especially if you sweat a lot.

If you do not drink enough water

while taking Olmesartan/HCT

Sandoz, you may feel faint, light-

headed or sick. This is because your

blood pressure is dropping suddenly.

If you continue to feel unwell, tell

your doctor.

If you have excess vomiting and/or

diarrhoea, while taking

Olmesartan/HCT Sandoz, tell your

doctor.

You may lose too much water and

salt and your blood pressure may

drop too much.

If you feel light-headed or dizzy

after taking your first dose of

Olmesartan/HCT Sandoz, or when

your dose is increased, tell your

doctor immediately.

If you plan to have surgery that

needs a general anaesthetic, tell

your doctor or dentist that you are

taking Olmesartan/HCT Sandoz.

Your blood pressure may drop

suddenly.

If you become pregnant while

taking Olmesartan/HCT Sandoz,

tell your doctor immediately.

If you are about to have any blood

tests, tell your doctor that you are

taking Olmesartan/HCT Sandoz.

Olmesartan/HCT Sandoz may

interfere with the results of some

tests.

Tell your doctor if photosensitivity

reaction occurs during your

treatment.

Tell your doctor immediately in

case of acute onset of decreased

visual acuity or ocular pain.

Have your blood pressure checked

when your doctor says, to make

sure Olmesartan/HCT Sandoz is

working.

Go to your doctor regularly for a

check-up.

Your doctor may occasionally do a

blood test to check your potassium

levels and see how your kidneys are

working.

Things you must not do

Do not give Olmesartan/HCT

Sandoz to anyone else, even if they

have the same condition as you.

Do not take Olmesartan/HCT

Sandoz to treat any other

complaints unless your doctor or

pharmacist tells you to.

Do not stop taking

Olmesartan/HCT Sandoz, or lower

the dosage, without checking with

your doctor.

Things to be careful of

If you feel light-headed, dizzy or

faint when getting out of bed or

standing up, get up slowly.

Standing up slowly, especially when

you get up from bed or chairs, will

help your body get used to the

change in position and blood

pressure. If this problem continues or

gets worse, talk to your doctor.

Be careful driving or operating

machinery until you know how

OLMESARTAN/HCT SANDOZ

Olmesartan/HCT Sandoz affects

you.

As with other medicines in this class,

Olmesartan/HCT Sandoz may cause

dizziness, light-headedness or

tiredness in some people. Make sure

you know how you react to

Olmesartan/HCT Sandoz before you

drive a car, operate machinery, or do

anything else that could be dangerous

if you are dizzy or light-headed. If

this occurs do not drive. If you drink

alcohol, dizziness or light-

headedness may be worse.

Things that would be helpful

for your blood pressure

Some self help measures suggested

below may help your condition. Talk

to your doctor or pharmacist about

these measures and for more

information.

Alcohol - your doctor may advise

you to limit your alcohol intake.

Weight - your doctor may suggest

losing some weight to help lower

your blood pressure and help

lessen the amount of work your

heart has to do. Some people may

need a dietician's help to lose

weight.

Diet - eat a healthy diet which

includes plenty of fresh

vegetables, fruit, bread

(preferably wholegrain), cereals

and fish. Also eat less sugar and

fat (especially saturated fat)

which includes sausages, fatty

meats, full cream dairy products,

biscuits, cakes, pastries,

chocolates, chips and coconut.

Monounsaturated and

polyunsaturated fats from olive

oil, canola oil, avocado and nuts

are beneficial in small quantities.

Salt - your doctor may advise you

to watch the amount of salt in

your diet. To reduce your salt

intake you should avoid using salt

in cooking or at the table and

avoid cooked or processed foods

containing high sodium (salt)

levels.

Exercise - regular exercise,

maintained over the long term,

helps to reduce blood pressure

and helps get the heart fitter.

Regular exercise also improves

your blood cholesterol levels,

helps reduce your weight and

stress levels, and improves your

sleep, mood and ability to

concentrate. However, it is

important not to overdo it.

Walking is good exercise, but try

to find a route that is reasonably

flat. Before starting any exercise,

ask your doctor about the best

kind of programme for you.

Smoking - your doctor may

advise you to stop smoking or at

least cut down. There are

enormous benefits to be gained

from giving up smoking. There

are many professionals,

organisations and strategies to

help you quit. Ask your doctor or

pharmacist for further

information and advice.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Olmesartan/HCT Sandoz.

Olmesartan/HCT Sandoz 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.

If you are over 65 years of age you

may have an increased chance of

getting side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

The following is a list of possible

side effects. Do not be alarmed by

this list. You may not experience any

of them.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

feeling light-headed, dizzy or

faint

cough

headache

feeling sick (nausea) or vomiting

stomach pain

diarrhoea or constipation

an uncomfortable feeling in the

stomach

unusual tiredness or weakness,

fatigue

'flu-like' symptoms

runny or blocked nose, or

sneezing

bronchitis

sore throat and discomfort when

swallowing (pharyngitis)

swelling of the hands, feet or

ankles

back pain

urinary tract infection

jaundice

blurred vision

skin rashes or eczema

sleep disturbance

depression.

These are common side effects. They

are generally mild.

Tell your doctor as soon as possible

if you notice any of the following:

skin rash or itchiness

aching, tender or weak muscles

not caused by exercise

painful joints

fast heart beat

shortness of breath or tightness in

the chest

swelling of the hands, feet or

ankles

symptoms that may indicate high

potassium levels in the blood,

such as nausea, diarrhoea, muscle

weakness, change in heart

rhythm.

OLMESARTAN/HCT SANDOZ

These may be serious side effects.

You may need medical attention.

Serious side effects are rare.

If any of the following happen, stop

taking Olmesartan/HCT Sandoz

and either tell your doctor

immediately or go to Accident and

Emergency at your nearest

hospital:

swelling of the face, lips, mouth,

tongue or throat which may cause

difficulty in swallowing or

breathing

chest pain.

These are very serious side effects.

You may need urgent medical

attention or hospitalisation. These

side effects are very rare.

Other side effects not listed above

may occur in some patients. Tell

your doctor or pharmacist if you

notice anything that is making you

feel unwell.

After using

Olmesartan/HCT

Sandoz

Storage

Keep your tablets in the box until

it is time to take them.

If you take the tablets out of the box

they will not keep well.

Keep your tablets in a cool dry

place where the temperature stays

below 25°C.

Do not store Olmesartan/HCT

Sandoz 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 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 tells you to stop

taking Olmesartan/HCT Sandoz or

the tablets have passed their expiry

date, ask your pharmacist what to

do with any that are left over.

Product description

What it looks like

Olmesartan/HCT Sandoz tablets

come in three strengths and each has

a different appearance:

Olmesartan/HCT Sandoz 20/12.5mg

is a yellow film coated, round,

biconvex tablet debossed with '346'

on one side and 'L' on other side

Olmesartan/HCT Sandoz 40/12.5mg

is a yellow film coated, oval shape,

biconvex tablets debossed with

'L347' on one side and plain on other

side

Olmesartan/HCT Sandoz 40/25mg is

a yellow film coated, oval shape,

biconvex tablets debossed with

'L348' on one side and plain on other

side

The product is presented in blister

packs of 30 film-coated tablets.

Ingredients

Active ingredients:

Olmesartan/HCT Sandoz 20/12.5 -

20mg olmesartan medoxomil and

12.5mg hydrochlorothiazide

Olmesartan/HCT Sandoz 40/12.5 -

40mg olmesartan medoxomil and

12.5mg hydrochlorothiazide

Olmesartan/HCT Sandoz 40/25 -

40mg olmesartan medoxomil and

25mg hydrochlorothiazide

Other ingredients:

lactose monohydrate

microcrystalline cellulose

hydroxypropylcellulose

magnesium stearate

Opadry Yellow 03F82788

Olmesartan/HCT Sandoz does not

contain sucrose, tartrazine or any

other azo dyes.

Supplier

Olmesartan/HCT Sandoz is supplied

in Australia by:

Sandoz Pty Ltd

ABN 60 075 449 553

54 Waterloo Road

Macquarie Park, NSW 2113

Australia

Tel: 1800 634 500

Australian Registration

Numbers

Olmesartan/HCT Sandoz 20/12.5

AUST R 221119

Olmesartan/HCT Sandoz 40/12.5

AUST R 221124

Olmesartan/HCT Sandoz 40/25

AUST R 221130

This leaflet was prepared in January

2017.

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

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

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.)

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Europe -DG Health and Food Safety

2-10-2018

CoAprovel (Sanofi Clir SNC)

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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

25-5-2018

Webinar: Changes to the regulation of autologous human cells and tissue products

Webinar: Changes to the regulation of autologous human cells and tissue products

Webinar providing an overview of the changes to the regulation of autologous HCT

Therapeutic Goods Administration - Australia