DILTIAZEM AN diltiazem hydrochloride 60mg tablet blister pack

Main information

  • Trade name:
  • DILTIAZEM AN diltiazem hydrochloride 60mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DILTIAZEM AN diltiazem hydrochloride 60mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 184100
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

184100

DILTIAZEM AN diltiazem hydrochloride 60mg 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

20/07/2012

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. DILTIAZEM AN diltiazem hydrochloride 60mg tablet blister pack

Product Type

Single Medicine Product

Effective date

18/08/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Moderate to severe angina pectoris due to atherosclerotic coronary artery disease or coronary artery spasm (vasospastic angina).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

4 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

90 tablets

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, film coated, capsule shaped, scored tablet with one face embossed

DL/60

Active Ingredients

diltiazem hydrochloride

60 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 29.11.2017 at 05:11:48 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

Diltiazem AN tablets – Consumer Medicine Information

Diltiazem AN tablets

Diltiazem hydrochloride

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

DILTIAZEM

does

contain

available

information.

does

take

place

talking

your

doctor

pharmacist.

medicines

have

risks

benefits.

Your

doctor

weighed the risks of you taking

DILTIAZEM

against

benefits they expect it will have

for you.

If

you

have

any

concerns

about

taking

this

medicine,

ask

your

doctor

or

pharmacist.

Keep

this

leaflet

with

the

medicine.

need

read it again.

What DILTIAZEM AN

is used for

The name of your medicine is

DILTIAZEM AN. It contains the

active ingredient called diltiazem

hydrochloride.

DILTIAZEM

belongs

group

medicines

called

calcium

channel

blockers

calcium antagonists. They work

opening

blood

vessels,

which lowers blood pressure and

lets

more

blood

oxygen

reach

heart.

They

change the amount of calcium in

your blood or bones.

DILTIAZEM

used

prevent angina.

Angina

pain

uncomfortable sensation in the

chest,

often

spreading

arms or neck and sometimes to

shoulders

back.

pain

angina

shortage of oxygen to the heart.

Your

doctor

have

prescribed

DILTIAZEM

another reason. Ask your doctor

if you have any questions about

why DILTIAZEM AN has been

prescribed for you.

There

evidence

that

DILTIAZEM AN is addictive.

This medicine is available only

with a doctor’s prescription.

Before You Take

DILTIAZEM AN

When you must not take

it

Do not use DILTIAZEM AN if:

1.

you

have

an

allergy

to

diltiazem hydrochloride

or

any

of

the

ingredients

listed

at

the

end

of

this

leaflet

Symptoms of an allergic reaction

to these medicines may include:

asthma,

wheezing

shortness of breath

swelling of the face, lips or

tongue

which

cause

difficulty

swallowing

breathing

hives, itching or skin rash

fainting

you are pregnant, or intend

to

become

pregnant.

DILTIAZEM

affect

your developing baby if you

take it during pregnancy.

you

are

breast-feeding

or

intend

to

breast-feed.

DILTIAZEM AN passes into

breast

milk

affect

your baby.

Do not use DILTIAZEM AN if

the

packaging

is

torn

or

shows signs of tampering.

Do not use DILTIAZEM AN if

the expiry date (EXP) printed

on the pack has passed. If you

take

this

medicine

after

expiry date has passed, it may

not work (as well).

If

you

are

not

sure

whether

you

should

start

using

DILTIAZEM AN, contact your

doctor.

Do not give these medicines

to a child.

The safety and effectiveness of

these medicines have not been

established in children.

Before you start to use it

Tell your doctor if:

1.

you have allergies to

any other medicines

any other substances such

as foods, preservatives or

dyes.

you

are

pregnant

or

intend

to

become

pregnant.

DILTIAZEM AN should not

be used during pregnancy.

you are breast-feeding or

planning to breast-feed.

Your doctor will discuss the

risks and benefits of using

DILTIAZEM

during

breastfeeding.

decision

will

have

made

whether

discontinue

breastfeeding

discontinue

therapy

taking

into

consideration

importance of the medicine.

4.

you

have,

or

have

had,

the

following

medical

conditions:

Abnormal heart beat rhythm

hypotension

(low

blood

pressure)

Heart attack or other heart-

Diltiazem AN CMI v3.0

Page 1

Diltiazem AN tablets – Consumer Medicine Information

related complications

Impaired

renal

(kidney)

hepatic (liver) function

Diabetes

Taking other medicines

Tell

your

doctor

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 may interfere

with

DILTIAZEM

AN.

These

include:

Dantrolene

muscle

relaxant)

Some

other

medicines

your

heart

high

blood

pressure (eg. beta blockers,

digoxin, amiodarone, nitrates)

Cyclosporin, which you may

have

been

given

after

operation

because

rheumatoid arthritis

Rifampicin (an antibiotic)

Cimetidine

ranitidine

(for

ulcers or reflux)

Diazepam

(for

depression,

alcohol withdrawal or anxiety)

Carbamazepine

(for

bipolar

disorder or epilepsy)

Lithium (for bipolar disorder)

Theophylline (for asthma and

other breathing problems)

Certain drugs used to treat

prostate problems

Inhaled

anaesthetic

agents

such

halothane,

isoflurane,

enflurane

(for

surgery)

Drugs

used

lower

your

blood

cholesterol

(including

simvastatin, lovastatin)

Benzodiazepines

medicines used as sedatives

or to treat anxiety such as

midazolam, triazolam

Corticosteroids

such

methylprednisolone,

prednisone, cortisone

Antiarrhythmics or medicines

used to treat irregular heart

beats

These

medicines

affected by DILTIAZEM AN, or

affect

well

works.

You may need to take different

amounts

your

medicine,

you may need to take different

medicines.

Your

doctor

will

advise you.

Your doctor and pharmacist may

have

more

information

medicines to be careful with or

avoid

while

taking

DILTIAZEM

How to take

DILTIAZEM AN

How much to take

DILTIAZEM AN is usually taken

times

day.

Take

prescribed dose as directed by

your doctor.

A lower dosage may be required

in elderly patients (over 65 years

old).

Follow all directions given to you

by your doctor and pharmacist

carefully. They may differ from

the information contained in this

leaflet.

understand

instructions on the box, ask your

doctor or pharmacist for help.

How to take it

Swallow the tablets whole with

a glass of water.

When to take it

Take DILTIAZEM AN tablets at

same

time

each

directed by your doctor.

How long to take it

Take

DILTIAZEM

AN

for

as

long as your doctor tells you

to.

Do not stop taking DILTIAZEM

AN suddenly because this can

bring on an attack of angina.

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 tablets as

you would normally.

Do not take a double dose to

make

up

for

the

dose

you

have missed.

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 hints.

If you take too much

(overdose)

Immediately

telephone

your

doctor or Poisons Information

Centre (telephone 13 11 26), or

go to casualty at your nearest

hospital, if you think that you

or

anyone

else

may

have

taken

too

much

DILTIAZEM

AN. Do this even if there are

no

signs

of

discomfort

or

poisoning.

You

may

need

urgent medical attention.

If

you

take

too

much

DILTIAZEM AN, you may feel

dizzy

and

light-headed,

feel

pain in your left arm or chest

or notice your heart beating

very

slowly.

If

any

of

these

occur you should get medical

attention immediately.

While you are taking

DILTIAZEM AN

Things you must do

Use DILTIAZEM AN exactly as

your doctor has prescribed.

If you do not follow your doctor's

instructions,

relief

from

your

attacks

angina.

Tell

your

doctor

if

you

continue

to

have

angina

attacks

or

if

they

become

more frequent while you are

using DILTIAZEM AN.

Diltiazem AN CMI v3.0

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Diltiazem AN tablets – Consumer Medicine Information

Tell all doctors, dentists and

pharmacists who are treating

you

that

you

are

taking

DILTIAZEM AN.

Tell your doctor or pharmacist

that you are taking DILTIAZEM

AN

if

you

are

about

to

be

started on any new medicines.

Things you must not do

Do not use it to treat any other

complaints unless your doctor

says to.

Do not give this medicine to

anyone

else,

even

if

their

symptoms

seem

similar

to

yours.

As mentioned previously, do

not suddenly stop taking your

medicine since this can cause

severe

angina

for

a

day

or

two.

Things to be careful of

Be careful driving or operating

machinery until you know how

DILTIAZEM AN affects you.

DILTIAZEM

cause

dizziness and fainting in some

patients,

especially

when

first start to use it. Make sure

know

react

DILTIAZEM AN before you drive

a car, operate machinery, or do

anything

else

that

could

dangerous

this

happens

you.

Be

careful

not

to

overdo

physical

activities

when

you

first

start

using

DILTIAZEM

AN.

You may feel better when you

start taking it, but you will need

time

improve

your

physical

fitness.

Get

up

slowly

when

getting

out of bed or standing up if

you feel light-headed, dizzy or

faint.

If this is a problem and it gets

worse or continues, talk to your

doctor.

Side Effects

Tell your doctor or pharmacist

as soon as possible if you do

not

feel

well

while

you

are

using DILTIAZEM AN.

DILTIAZEM

helps

most

people with angina, but it may

have unwanted effects in a few

people.

medicines

have

side

effects.

Sometimes

they

serious, most of the time they

are not. You may need medical

treatment if you get some of the

side effects.

Ask your doctor or pharmacist

any questions you may have.

Tell your doctor if you notice any

of the following and they worry

you:

swelling

flushing

(feeling

hot suddenly)

headache

nausea,

vomiting,

constipation,

diarrhoea,

indigestion, gastric pain

dizziness

confusion,

hallucinations,

abnormal

dreams,

mental

depression or mood changes

trouble sleeping

nervousness, tremor

ringing

other

persistent

noise in the ears

loss of memory

dry mouth

loss of appetite

weight increase

increased

sensitivity

unusual

movements

uncontrollable movements

rash or an itchy, burning or

prickly sensation

small

round,

raised

itchy

areas on the skin

weakness or tiredness

These

more

common

side effects of DILTIAZEM AN.

These side effects are usually

mild.

If any of the following happen,

stop

taking

DILTIAZEM

AN

and

tell

your

doctor

immediately or go to casualty

at your nearest hospital:

feel

continuously

light

headed or dizzy

you notice your heart beating

irregularly,

slowly

very

quickly

you feel pain, which may be

severe, in your left arm and

chest

have

blisters

bleeding

lips,

eyes,

mouth, nose or genitals

you have skin reactions such

as red, painful or itchy spots,

blisters or peeling of the skin.

These

very

serious

side

effects.

need

urgent

medical

attention

hospitalisation.

These

side

effects are rare.

Other

side

effects

not

listed

above may also occur in some

patients.

Tell

your

doctor

if

you notice anything else that

is making you feel unwell.

Ask your doctor or pharmacist

if

you

don’t

understand

anything in this list.

Do not be alarmed by this list of

possible side effects. You may

not experience any of them.

After taking

DILTIAZEM AN

Storage

Keep

your

tablets

in

their

blister pack until it is time to

take

them.

take

tablets out of their blister pack

they may not keep well.

Keep DILTIAZEM AN in a cool,

dry place where it stays below

25°C. Do not store it, or any

other medicine, in a bathroom

or near a sink. Do not leave it

in the car or on window sills.

Heat and dampness can destroy

some medicines.

Keep

this

medicine

where

young children cannot reach

it. A locked cupboard at least

one-and-a half metres above the

Diltiazem AN CMI v3.0

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Diltiazem AN tablets – Consumer Medicine Information

ground is a good place to store

medicines.

Disposal

If your doctor tells you to stop

taking DILTIAZEM AN, or the

tablets

have

passed

their

expiry

date,

ask

your

pharmacist

what

to

do

with

any tablets left over.

Product description

What it looks like

DILTIAZEM

tablets

are white, film coated, capsule

shaped

scored

with

face embossed DL/60.

DILTIAZEM

tablets

available

blister

packs

(AUST

184100)

bottle

packs (AUST R 184098) of 90

tablets.

Ingredients

DILTIAZEM AN tablets contain

60 mg of the active ingredient

diltiazem hydrochloride.

Other Ingredients:

dried aluminium hydroxide

hydrogenated castor oil

lactose

magnesium stearate

methacrylic acid copolymer

Opadry

white

Y-1-7000B

(hypromellose,

titanium

dioxide,

macrogol

400,

indigo carmine CI73015)

purified talc

DILTIAZEM AN does not contain

sucrose, gluten, tartrazine or any

other azo dyes.

Name and Address of the

Sponsor

Amneal

Pharma

Australia

12 River St

South Yarra, Vic, 3141

Australia

Date of Preparation

May 2015

Doc ID: 56.AN.M.2.0

Diltiazem AN CMI v3.0

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