APO-TELMISARTAN

Main information

  • Trade name:
  • APO-TELMISARTAN HCTZ 40/12.5mg telmisartan 40mg and hydrochlorothiazide 12.5mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-TELMISARTAN HCTZ 40/12.5mg telmisartan 40mg and hydrochlorothiazide 12.5mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 208064
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

208064

APO-TELMISARTAN HCTZ 40/12.5mg telmisartan 40mg and hydrochlorothiazide 12.5mg tablet blister

pack

ARTG entry for

Medicine Registered

Sponsor

Alembic Pharmaceuticals Australia Pty Ltd

Postal Address

Level 2 108 Power Street,HAWTHORN, VIC, 3122

Australia

ARTG Start Date

8/04/2014

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-TELMISARTAN HCTZ 40/12.5mg telmisartan 40mg and hydrochlorothiazide 12.5mg tablet blister pack

Product Type

Single Medicine Product

Effective date

19/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

APO TELMISARTAN 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

36 Months

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. APO-TELMISARTAN HCTZ 40/12.5mg telmisartan 40mg and hydrochlorothiazide 12.5mg tablet blister pack

Dosage Form

Tablet, multilayer

Route of Administration

Oral

Visual Identification

Oblong biconvex bilayered uncoated tablets with one white/off white color

layer and one pink colour mottled layer debossed with L199

Active Ingredients

Hydrochlorothiazide

12.5 mg

Telmisartan

40 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 20.10.2017 at 02:05:18 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

APO-TELMISARTAN

HCTZ Tablets

Telmisartan and Hydrochlorothiazide

Consumer Medicine Information

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

What is in this leaflet

This leaflet answers some common

questions about APO-

TELMISARTAN HCTZ .

It does not contain all available

information. It does not take the

place of talking to your doctor or

pharmacist.

This leaflet was last updated on the

date at the end of this leaflet. More

recent information may be available.

The latest Consumer Medicine

Information is available from your

pharmacist, doctor, or from

www.medicines.org.au and may

contain important information about

the medicine and its use of which

you should be aware.

All medicines have benefits and

risks. Your doctor has weighed the

risks of you taking this medicine

against the benefits it is expected to

have for you.

If you have any concerns about this

medicine, ask your doctor or

pharmacist. Keep this leaflet with

the medicine.

You may need to read it again.

What APO-

TELMISARTAN HCTZ

is used for

APO-TELMISARTAN HCTZ is

used to lower high blood pressure

(hypertension).

Everyone has blood pressure. This

pressure helps your blood move

around your body. Your blood

pressure may be different 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 or relaxed. There

are usually no signs 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 APO-

TELMISARTAN HCTZ

works

APO-TELMISARTAN HCTZ

contains telmisartan and

hydrochlorothiazide in one single

tablet. These two active ingredients

help to reduce blood pressure in

different ways:

Telmisartan belongs to a group of

medicines called angiotensin II

receptor antagonists. Angiotensin

II is a substance in the body

which causes blood vessels to

narrow, thus increasing blood

pressure. Telmisartan works by

blocking the effect of angiotensin

II. When the effect of angiotensin

II is blocked, your blood vessels

relax and your blood pressure

goes down.

Hydrochlorothiazide belongs to

the group of medicines called

diuretics. Diuretics help to reduce

the amount of excess fluid in the

body by increasing the amount of

urine produced. They help with

lowering blood pressure

particularly when used with other

blood pressure lowering

medicines. Your doctor may have

prescribed APO-

TELMISARTAN HCTZ for

another reason.

Ask your doctor if you have any

questions about why APO-

TELMISARTAN HCTZ has been

prescribed for you.

APO-TELMISARTAN HCTZ is not

addictive. This medicine is available

only with a doctor’s prescription.

Use in children

The safety and effectiveness of APO-

TELMISARTAN HCTZ in children

and teenagers up to 18 years of age

have not been established.

Before you take APO-

TELMISARTAN HCTZ

When you must not take it

Do not take APO-TELMISARTAN

HCTZ if you have ever had an

allergic reaction after taking:

Telmisartan or

hydrochlorothiazide (the two

active ingredients in APO-

TELMISARTAN HCTZ),

Other sulfonamide-derived

medicines

any of the other ingredients listed

at the end of this leaflet.

Symptoms of an allergic reaction to

APO-TELMISARTAN HCTZ may

includeshortness 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.

Do not take APO-TELMISARTAN

HCTZ if you have a rare

hereditary condition of fructose

intolerance.

The maximum recommended daily

dose of APO-TELMISARTAN

HCTZ contains 170 mg of mannitol

(in the 40/12.5 mg tablets) and

approximately 340 mg of mannitol

(in the 80/12.5 mg and 80/25 mg

tablets).

Do not take APO-TELMISARTAN

HCTZ if you have a rare

hereditary condition of galactose

intolerance.

The maximum recommended daily

dose of APO-TELMISARTAN

HCTZ contains 84 mg of lactose

monohydrate (in the 40/12.5 mg) and

180.5mg of lactose monohydrate (in

the 80/12.5 mg tablets) and 169.4 mg

of lactose monohydrate (in the 80/25

mg tablets).

Do not take APO-TELMISARTAN

HCTZ if you are pregnant or

intend to become pregnant.

APO-TELMISARTAN HCTZ is not

recommended for use in pregnancy.

Like other similar medicines, it may

affect your developing baby if you

take it during pregnancy.

Do not breast-feed if you are

taking APO-TELMISARTAN

HCTZ.

It is not known if telmisartan or

hydrochlorothiazide, the active

ingredients in APO-TELMISARTAN

HCTZ, pass into breast milk and

there is a possibility that your baby

may be affected.

Do not take APO-TELMISARTAN

HCTZ if you have any of the

following medical conditions:

severe liver disease

severe kidney disease

cholestasis or biliary obstructive

disorders (problem with the flow

of bile from the gall bladder)

low potassium levels in the blood

high calcium levels in the blood.

diabetes or kidney problems and

you are taking aliskiren (a

medicine used to treat high blood

pressure).

Do not take APO-TELMISARTAN

HCTZ after the expiry date

printed on the pack.

Do not take APO-TELMISARTAN

HCTZ if the packaging is torn or

shows signs of tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

If you are not sure whether you

should start taking APO-

TELMISARTAN HCTZ, 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

a condition known as primary

hyperaldosteronism (raised

aldosterone levels, also known as

Conn's syndrome)

diabetes

gout

fructose intolerance

galactose intolerance

recent severe diarrhoea or

vomiting

asthma

systemic lupus erythematosus (a

disease affecting the skin, joints

and kidney)

eye problems

Tell your doctor if you are

following a very low salt diet.

Tell your doctor if you are

pregnant or plan to become

pregnant or breastfeed.

If you have not told your doctor

about any of the above, tell your

doctor before you take APO-

TELMISARTAN HCTZ.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and APO-

TELMISARTAN HCTZ may

interfere with each other. These

include:

any other medicines used to treat

high blood pressure such as beta-

blockers

heart medicines such as digoxin,

a medicine used to treat heart

Apo-Telmisartan HCTZ

failure or antiarrhythmic

medicines

lithium, a medicine used to treat

certain mental illnesses

other diuretics or fluid tablets

medicines used to help the

kidneys get rid of salt and water

by increasing the amount of urine

produced

laxatives

potassium supplements or

potassium-containing salt

substitutes

medicines or salt substitutes

which may increase your

potassium levels

amphotericin B, a medicine used

to treat fungal infections

penicillin antibiotics used to treat

bacterial infections

alcohol

sleeping tablets

strong pain killing medicines

medicines for diabetes (oral

tablets or capsules or insulin)

powder or granules used to help

reduce cholesterol

corticosteroid medicines such as

prednisolone, cortisone or ACTH

aspirin

nonsteroidal anti-inflammatory

agents (medicines used to relieve

pain, swelling and other

symptoms of inflammation

including arthritis)

medicines used to treat gout

calcium supplements or

medicines containing calcium

anticholinergic medicines, which

can be used to treat Parkinson's

disease, relieve stomach cramps

or prevent travel sickness

amantadine, a medicine used to

treat Parkinson's disease or to

prevent influenza

medicines used to treat cancer

(cytotoxic medicines)

These medicines may be affected by

APO-TELMISARTAN HCTZ, or

may affect the way it works. Also,

other medicines used to treat high

blood pressure may have an additive

effect with APO-TELMISARTAN

HCTZ in lowering your blood

pressure. Therefore, you may need

different amounts of your medicines,

or you may need to take different

medicines.

Your doctor or pharmacist may have

more information on medicines to be

careful with or avoid while taking

APO-TELMISARTAN HCTZ.

How to take APO-

TELMISARTAN HCTZ

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 how many tablets 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 label, ask your

doctor or pharmacist for help.

How much to take

The usual dose for adults is one

APO-TELMISARTAN HCTZ

40/12.5 mg tablet once a day. If your

blood pressure is still too high after

4-8 weeks of starting treatment, your

doctor may increase your dose to one

APO-TELMISARTAN HCTZ

80/12.5 mg tablet once a day.

If your blood pressure is still not

satisfactorily controlled with APO-

TELMISARTAN HCTZ 80/12.5 mg,

your doctor may increase your dose

to one APO-TELMISARTAN HCTZ

80/25 mg tablet once a day.

It is important to take APO-

TELMISARTAN HCTZ exactly as

your doctor or pharmacist has told

you.

When to take it

Take APO-TELMISARTAN

HCTZ at about the same time each

day, either morning or evening.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take it.

It does not matter if you take APO-

TELMISARTAN HCTZ before or

after food.

How to take it

Swallow the tablet whole with a

full glass of water.

You can take APO-TELMISARTAN

HCTZ with or without food.

How long to take it

Take APO-TELMISARTAN

HCTZ every day until your doctor

tells you to stop.

APO-TELMISARTAN HCTZ helps

control your high blood pressure but

does not cure it. It is important to

keep taking APO-TELMISARTAN

HCTZ every day even if you feel

well.

People who have high blood pressure

often feel well and do not notice any

signs of this problem.

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 the dose

as soon as you remember, and then

go back to taking it 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 unwanted side effects.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

when to take your medicine, ask

your pharmacist for some hints.

Apo-Telmisartan HCTZ

If you take too much

(overdose)

Immediately telephone your

doctor or Poisons Information

Centre (telephone 13 11 26) for

advice or go to Accident and

Emergency at your nearest

hospital, if you think that you or

anyone else may have taken too

much APO-TELMISARTAN

HCTZ.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention. If you take too much APO-

TELMISARTAN HCTZ you may

feel dizzy, light-headed or faint.

Your heartbeat may be faster or

lower than usual. You may

experience dehydration, nausea,

drowsiness and muscle spasm.

While you are taking

APO-TELMISARTAN

HCTZ

Things you must do

Tell any other doctors, dentists and

pharmacists who are treating you

that you are taking APO-

TELMISARTAN HCTZ.

If you are about to be started on

any new medicine, tell your doctor

or pharmacist that you are taking

APO-TELMISARTAN HCTZ.

If you feel that APO-

TELMISARTAN HCTZ is not

helping your condition, tell your

doctor or pharmacist.

Tell your doctor if, for any reason,

you have not used APO-

TELMISARTAN HCTZ exactly as

prescribed.

Otherwise, your doctor may think

that it was not effective and change

your treatment unnecessarily.

Tell your doctor immediately if

you become pregnant while taking

APO-TELMISARTAN HCTZ.

You should not take this medicine

while you are pregnant.

If you are going to have surgery,

tell your doctor and anaesthetist

that you are taking APO-

TELMISARTAN HCTZ.

APO-TELMISARTAN HCTZ may

affect some medicines you receive

during surgery.

Things you must not do

Do not use APO-TELMISARTAN

HCTZ to treat other complaints

unless your doctor or pharmacist

tells you to.

Do not give this medicine to anyone

else, even if they have the same

symptoms as you.

Do not stop taking APO-

TELMISARTAN HCTZ or lower

the dosage without checking with

your doctor.

Things to be careful of

Be careful when driving or

operating machinery until you

know how APO-TELMISARTAN

HCTZ affects you.

Like other medicines used to treat

high blood pressure, APO-

TELMISARTAN HCTZ may cause

sleepiness, dizziness or light-

headedness in some people.

If you have any of these symptoms,

do not drive, operate machinery or

do anything else that could be

dangerous.

You may feel dizzy or light-headed

when you begin to take APO-

TELMISARTAN HCTZ, especially

if you are also taking a diuretic (or

fluid tablet) or if you are dehydrated.

If this medicine makes you feel

dizzy or light-headed, be careful

when getting up from a sitting or

lying position.

Standing up slowly, especially when

you get up from a bed or chair, 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.

If you exercise, or if you sweat, or

if the weather is hot, you should

drink plenty of water.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking APO-

TELMISARTAN HCTZ even if

you do not think it is connected

with the medicine.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have. Tell your doctor if you notice

any of the following and they

worry you:

'flu-like' symptoms

fainting, dizziness or spinning

sensation

a feeling of tension or fullness in

the nose, cheeks and behind the

eyes, sometimes with a throbbing

ache (sinusitis)

infections of the air passages

shortness of breath or difficulty

breathing

abnormal or blurred vision

eye pain

back pain

changes in heart rhythm or

increased heart rate

rash or redness or itchiness of

skin

increased sweating

dizziness or light-headedness

when you stand up (postural

hypotension)

Apo-Telmisartan HCTZ

stomach pain or discomfort

(abdominal pain, dyspepsia,

gastritis)

wind or excessive gas in the

stomach or bowel

vomiting

diarrhoea or constipation

dry mouth

pins and needles

sleep disturbances or trouble

sleeping

feeling anxious

depression

impotence

leg pain or cramps in legs

aching muscles or aching joints

not caused by exercise or muscle

spasms

chest pain

pain

liver problems

changes in the levels of potassium

or sodium or uric acid in your

blood (such changes are usually

detected by a blood test)

Tell your doctor as soon as possible

if you experience any side effects

during or after taking APO-

TELMISARTAN HCTZ, so that

these may be properly treated.

Symptoms such as feeling very

thirsty, sleepy, sick or vomiting, a

dry mouth, general weakness, muscle

pain or cramps, a very fast heart rate,

may mean that the

hydrochlorothiazide part of APO-

TELMISARTAN HCTZ is having an

excessive effect.

You should tell your doctor if you

experience any of these symptoms.

Tell your doctor immediately or go

to casualty at your nearest hospital

if you notice any of the following:

swelling of the face, lips, mouth,

tongue or throat which may cause

difficulty in swallowing or

breathing

severe and sudden onset of

pinkish, itchy swellings on the

skin, also called hives or nettle

rash

developing or worsening of a

disease called systemic lupus

erythematosus which affects the

skin, joints and kidney

These are serious side effects. You

may need urgent medical attention or

hospitalisation. These side effects are

rare.

Tell your doctor or pharmacist if

you notice anything else that is

making you unwell.

Other side effects not listed above

may also occur in some people.

After taking APO-

TELMISARTAN HCTZ

Storage

Leave the tablets in the blister strip

until it is time to take a dose.

The blister pack protects the tablets

from light and moisture.

Keep APO-TELMISARTAN

HCTZ in a cool, dry place where

the temperature stays below 25°C.

Do not store APO-

TELMISARTAN HCTZ or any

other medicine in the bathroom or

near a sink. Do not leave it in the

car or on window sill.

Heat and dampness can destroy some

medicines.

Keep APO-TELMISARTAN

HCTZ where children cannot

reach it.

Disposal

If your doctor tells you to stop

using APO-TELMISARTAN

HCTZ or it has passed its expiry

date, ask your pharmacist what to

do with any that is left over.

Product description

What it looks like

APO-TELMISARTAN HCTZ is the

brand name of your medicine. APO-

TELMISARTAN HCTZ tablets are

available in three strengths: 40/12.5

mg, 80/12.5 mg and 80/25 mg

tablets.

APO-TELMISARTAN HCTZ

40/12.5 mg and 80/12.5 mg tablets

are pink mottled and white to off-

white biconvex, oval shaped, two

layer tablets. The white to off-white

layer may contain pink specks. Each

tablet contains either 40 mg or 80 mg

of telmisartan and 12.5 mg of

hydrochlorothiazide. The pink

mottled face of APO-

TELMISARTAN HCTZ 40/12.5 mg

tablets are marked with L199. The

pink mottled face of APO-

TELMISARTAN HCTZ 80/12.5

mg tablets are marked with L200.

APO-TELMISARTAN HCTZ 80/25

mg tablets are yellow mottled and

white to off-white biconvex, oval

shaped, two layer tablets. The white

to off-white layer may contain

yellow specks. Each tablet contains

80 mg of telmisartan and 25 mg of

hydrochlorothiazide. The white face

of APO-TELMISARTAN HCTZ

80/25 mg tablets are marked with

L201.

APO-TELMISARTAN HCTZ tablets

are available in blister packs of 28

tablets.

The following Australian

Registration Numbers appear on the

carton:

AUST R 208064 for APO-

TELMISARTAN HCTZ 40/12.5 mg

tablets

AUST R 208069 for APO-

TELMISARTAN HCTZ 80/12.5 mg

tablets

AUST R 208063 for APO-

TELMISARTAN HCTZ 80/25 mg

tablets

Ingredients

Each APO-TELMISARTAN HCTZ

40/12.5 mg tablet contains 40 mg

Apo-Telmisartan HCTZ

telmisartan and 12.5 mg

hydrochlorothiazide.

Each APO-TELMISARTAN HCTZ

80/12.5 mg tablet contains 80 mg

telmisartan and 12.5 mg

hydrochlorothiazide.

Each APO-TELMISARTAN HCTZ

80/25 mg tablet contains 80 mg

telmisartan and 25 mg

hydrochlorothiazide.

The other ingredients found in the

tablets are:

povidone (K25)

lactose monohydrate

magnesium stearate

meglumine

sodium hydroxide

sodium stearyl fumarate

mannitol

APO-TELMISARTAN HCTZ

40/12.5 mg and 80/12.5 mg tablets

also contain Pigment Blend PB-

24880 Pink and APO-

TELMISARTAN HCTZ 80/25 mg

tablets also contain Pigment Blend

PB-52290 Yellow, as colouring

agent.

Sponsor

ALEMBIC PHARMACEUTICALS

AUSTRALIA PTY LIMITED

Level 2, 108 Power Street

Hawthorn VIC 3122

Distributor

Apotex Pty Ltd

Level 3,

16 Giffnock Avenue

Macquarie Park

NSW 2113

Australia

This leaflet was last updated in

June 2017

Apo-Telmisartan HCTZ

4-12-2018

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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

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

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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

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. ...

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10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

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

9-6-2018

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods is voluntarily recalling fresh cut watermelon, honeydew melon, cantaloupe and fresh-cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis, because these products have the potential to be contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

24-5-2018

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

The FDA has approved Semintra (telmisartan oral solution), the first FDA-approved animal drug to control systemic hypertension in cats. Semintra is an oral solution administered either directly into the cat’s mouth or on top of a small amount of food.

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

25-10-2018

Micardis (Boehringer Ingelheim International GmbH)

Micardis (Boehringer Ingelheim International GmbH)

Micardis (Active substance: telmisartan) - Centralised - Yearly update - Commission Decision (2018)7136 of Thu, 25 Oct 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

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

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

4-6-2018

Twynsta (Boehringer Ingelheim International GmbH)

Twynsta (Boehringer Ingelheim International GmbH)

Twynsta (Active substance: telmisartan / amlodipine) - Centralised - Yearly update - Commission Decision (2018)3625 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

16-5-2018

Semintra (Boehringer Ingelheim Vetmedica GmbH)

Semintra (Boehringer Ingelheim Vetmedica GmbH)

Semintra (Active substance: Telmisartan) - Centralised - Variation - Commission Decision (2018)3020 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2436/X/8

Europe -DG Health and Food Safety

16-3-2018

Pending EC decision:  Semintra, telmisartan, Opinion date: 15-Mar-2018

Pending EC decision: Semintra, telmisartan, Opinion date: 15-Mar-2018

Europe - EMA - European Medicines Agency