TELMISARTAN

Main information

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

Documents

Localization

  • Available in:
  • TELMISARTAN HCTZ AN 40/12.5 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:
  • 221179
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221179

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

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

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

Product Type

Single Medicine Product

Effective date

23/11/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

TELMISARTAN HCTZ AN 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 Light

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. TELMISARTAN HCTZ AN 40/12.5 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 18.10.2017 at 07:36:58 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

Telmisartan HCTZ AN tablets – Consumer Medicine Information

Telmisartan HCTZ AN CMI v2.0

Page 1

TELMISARTAN HCTZ AN

Tablets

Telmisartan and Hydrochlorothiazide

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about

TELMISARTAN HCTZ AN.

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 TELMISARTAN HCTZ AN

is used for

TELMISARTAN HCTZ AN 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 TELMISARTAN HCTZ AN works

TELMISARTAN HCTZ AN 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 TELMISARTAN

HCTZ AN for another reason. Ask your doctor if

you have any questions about why

Telmisartan HCTZ AN tablets – Consumer Medicine Information

Telmisartan HCTZ AN CMI v2.0

Page 2

TELMISARTAN HCTZ AN has been

prescribed for you.

TELMISARTAN HCTZ AN is not addictive. This

medicine is available only with a doctor’s

prescription.

Use in Children

The safety and effectiveness of TELMISARTAN

HCTZ AN in children and teenagers up to 18 years

of age have not been established.

Before you take

TELMISARTAN HCTZ AN

When you must not take it

Do not take TELMISARTAN HCTZ AN if you

have ever had an allergic reaction after taking:

Telmisartan or hydrochlorothiazide (the

two active ingredients in TELMISARTAN

HCTZ AN ),

Other sulfonamide-derived medicines

Any of the other ingredients listed at the

end of this leaflet.

Symptoms of an allergic reaction to

TELMISARTAN HCTZ AN may include skin

rash, itchiness, shortness of breath, swelling of the

face, lips or tongue, muscle pain or tenderness or

joint pain.

Do not take TELMISARTAN HCTZ AN if you

have a rare hereditary condition of galactose

intolerance.

The maximum recommended daily dose of

TELMISARTAN HCTZ AN contains 112 mg of

lactose (in the 40/12.5 mg and 80/12.5 mg tablets)

and 99 mg of lactose (in the 80/25 mg tablets).

Do not take TELMISARTAN HCTZ AN if you

are pregnant or intend to become pregnant.

TELMISARTAN HCTZ AN is not recommended

for use in pregnancy. Like other similar medicines,

it could affect your unborn baby if you take it

during pregnancy.

Do not breast-feed if you are taking

TELMISARTAN HCTZ AN.

It is not known if telmisartan or

hydrochlorothiazide, the active ingredients in

TELMISARTAN HCTZ AN, pass into breast milk

and there is a possibility that your baby may be

affected.

Do not take TELMISARTAN HCTZ AN 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 TELMISARTAN HCTZ AN after

the expiry date printed on the pack or 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 TELMISARTAN HCTZ AN, 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

galactose intolerance

recent severe diarrhoea or vomiting

asthma

systemic lupus erythematosus (a disease

affecting the skin, joints and kidney)

eye problems

Telmisartan HCTZ AN tablets – Consumer Medicine Information

Telmisartan HCTZ AN CMI v2.0

Page 3

Tell your doctor if you are following a very low

salt diet.

Tell your doctor if you plan to become pregnant

or breastfeed.

If you have not told your doctor about any of the

above, tell your doctor before you take

TELMISARTAN HCTZ AN.

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 TELMISARTAN HCTZ AN

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 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, 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

TELMISARTAN HCTZ AN, or may affect the

way it works. Also, other medicines used to treat

high blood pressure may have an additive effect

with TELMISARTAN HCTZ AN in lowering your

blood pressure. Therefore, you may need different

amounts of your medicines.

Your doctor or pharmacist may have more

information on medicines to be careful with or

avoid while taking TELMISARTAN HCTZ AN.

How to take TELMISARTAN

HCTZ AN

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 TELMISARTAN

HCTZ AN 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 TELMISARTAN HCTZ AN 80/12.5

mg tablet once a day.

Telmisartan HCTZ AN tablets – Consumer Medicine Information

Telmisartan HCTZ AN CMI v2.0

Page 4

If your blood pressure is still not satisfactorily

controlled with TELMISARTAN HCTZ AN

80/12.5 mg, your doctor may increase your dose to

one TELMISARTAN HCTZ AN 80/25 mg tablet

once a day.

It is important to take TELMISARTAN HCTZ

AN exactly as your doctor or pharmacist has

told you.

When to take it

Take TELMISARTAN HCTZ AN 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 TELMISARTAN

HCTZ AN before or after food.

How to take it

Swallow the tablet whole with a full glass of

water.

You can take TELMISARTAN HCTZ AN with or

without food.

How long to take it

Take TELMISARTAN HCTZ AN every day

until your doctor tells you to stop.

TELMISARTAN HCTZ AN helps control your

high blood pressure but does not cure it. It is

important to keep taking TELMISARTAN HCTZ

AN 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 have trouble remembering when to take

your medicine, ask your pharmacist for some

hints.

If you take too much (overdose)

Immediately telephone your doctor or 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 TELMISARTAN

HCTZ AN.

Do this even if there are no signs of discomfort

or poisoning.

You may need urgent medical attention. If you take

too much TELMISARTAN HCTZ AN 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

TELMISARTAN HCTZ AN

Things you must do

Tell any other doctors, dentists and pharmacists

who are treating you that you are taking

TELMISARTAN HCTZ AN.

If you are about to be started on any new

medicine, tell your doctor or pharmacist that

you are taking TELMISARTAN HCTZ AN.

If you feel that TELMISARTAN HCTZ AN is

not helping your condition, tell your doctor or

pharmacist.

Tell your doctor if, for any reason, you have not

used TELMISARTAN HCTZ AN exactly as

prescribed.

Telmisartan HCTZ AN tablets – Consumer Medicine Information

Telmisartan HCTZ AN CMI v2.0

Page 5

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 TELMISARTAN HCTZ

AN.

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

TELMISARTAN HCTZ AN.

TELMISARTAN HCTZ AN may affect some

medicines you receive during surgery.

Things you must not do

Do not use TELMISARTAN HCTZ AN 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.

Things to be careful of

Be careful when driving or operating machinery

until you know how TELMISARTAN HCTZ

AN affects you.

Like other medicines used to treat high blood

pressure, TELMISARTAN HCTZ AN may cause

sleepiness, dizziness or lightheadedness 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 TELMISARTAN HCTZ AN ,

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 TELMISARTAN HCTZ AN 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

transient abnormal or blurred vision

back pain

changes in heart rhythm or increased heart

rate

rash or redness or itchiness of skin

increased sweating

dizziness or lightheadedness when you

stand up (postural hypotension)

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

Telmisartan HCTZ AN tablets – Consumer Medicine Information

Telmisartan HCTZ AN CMI v2.0

Page 6

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 TELMISARTAN HCTZ AN, 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

TELMISARTAN HCTZ AN is having an excessive

effect.

You should tell your doctor if you experience

any of these symptoms. Tell your doctor

immediately or go to the Emergency

Department 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

sudden loss of vision or eye pain.

These are serious side effects. You may need

urgent medical attention or hospitalisation. These

side effects are rare.

Tell your doctor if you notice anything else that

is making you unwell.

Other side effects not listed above may also occur

in some people.

After taking TELMISARTAN

HCTZ AN

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 TELMISARTAN HCTZ AN in a cool, dry

place where the temperature stays below 25

C.

Do not store TELMISARTAN HCTZ AN or any

other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep TELMISARTAN HCTZ AN where young

children cannot reach it.

Disposal

If your doctor tells you to stop using

TELMISARTAN HCTZ AN 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

TELMISARTAN HCTZ AN is the brand name of

your medicine. TELMISARTAN HCTZ AN tablets

are available in three strengths: 40/12.5 mg,

80/12.5 mg and 80/25 mg tablets.

TELMISARTAN HCTZ AN 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 TELMISARTAN HCTZ

AN 40/12.5 mg tablets are marked with L199. The

pink mottled face of TELMISARTAN HCTZ AN

80/12.5 mg tablets are marked with L200.

Telmisartan HCTZ AN tablets – Consumer Medicine Information

Telmisartan HCTZ AN CMI v2.0

Page 7

TELMISARTAN HCTZ AN 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

TELMISARTAN HCTZ AN 80/25 mg tablets are

marked with L201TELMISARTAN HCTZ AN

tablets are available in blister packs of 28 tablets.

The following Australian Registration Numbers

appear on the carton:

AUST R 221179 for TELMISARTAN HCTZ AN

40/12.5 mg tablets

AUST R 221180 for TELMISARTAN HCTZ AN

80/12.5 mg tablets

AUST R 221181 for TELMISARTAN HCTZ AN

80/25 mg tablets

Ingredients

Each TELMISARTAN HCTZ AN 40/12.5 mg

tablet contains 40 mg telmisartan and 12.5 mg

hydrochlorothiazide.

Each TELMISARTAN HCTZ AN 80/12.5 mg

tablet contains 80 mg telmisartan and 12.5 mg

hydrochlorothiazide.

Each TELMISARTAN HCTZ AN 80/25 mg tablet

contains 80 mg telmisartan and 25 mg

hydrochlorothiazide.

The other ingredients found in the tablets are:

povidone (K25)

lactose

magnesium stearate

meglumine

sodium hydroxide

sodium stearyl fumarate

mannitol

TELMISARTAN HCTZ AN 40/12.5 mg and

80/12.5 mg tablets also contain Pigment Blend PB-

24880 Pink and TELMISARTAN HCTZ AN 80/25

mg tablets also contain Pigment Blend PB-52290

Yellow, as colouring agent.

Sponsor

Amneal Pharma Australia Pty Ltd

12 River Street

South Yarra VIC 3141

Australia

This leaflet was last updated in

May 2015

9-11-2018

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FDA - U.S. Food and Drug Administration

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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

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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.

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8-3-2012

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

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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