ALKEM

Main information

  • Trade name:
  • ALKEM AMLODIPINE amlodipine (as besilate) 5 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALKEM AMLODIPINE amlodipine (as besilate) 5 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215708
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215708

ALKEM AMLODIPINE amlodipine (as besilate) 5 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Pharmacor Pty Ltd

Postal Address

Suite 501,7 Oaks Ave,Dee Why, NSW, 2099

Australia

ARTG Start Date

25/07/2014

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. ALKEM AMLODIPINE amlodipine (as besilate) 5 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

10/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Hypertension

ALKEM AMLODIPINE is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority

of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of ALKEM AMLODIPINE, which has been

used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin-converting enzyme inhibitor

Angina

ALKEM AMLODIPINE is indicated for the first line treatment of chronic stable angina. ALKEM AMLODIPINE may be used alone, as monotherapy or in

combination with other antianginal drugs.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

7 tablets - sample pack

(S4) Prescription Only Medicine

10 tablets - sample pack

(S4) Prescription Only Medicine

Components

1. ALKEM AMLODIPINE amlodipine (as besilate) 5 mg tablet blister pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White to off-white, octagonal, flat faced, bevelled edged scored tablet

debossed with "210" and "5" on one side and plain on other side.

Active Ingredients

amlodipine besilate

6.93 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 08:14:54 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

Alkem Amlodipine

Page 1 of 4

Alkem Amlodipine

Amlodipine <

am-load-i-peen>

Besilate

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions about Alkem Amlodipine.

It does not contain all the available

information. It does not take the place

talking

your

doctor

pharmacist.

All medicines have risks and benefits.

Your doctor has weighed the risks of

you taking Alkem Amlodipine against

the benefits it is expected to have for

you.

If

you

have

any

concerns

about

taking

this

medicine,

ask

your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Alkem Amlodipine

is used for

What it does

Alkem Amlodipine is used to:

lower

high

blood

pressure

(hypertension).

There are usually no symptoms of

hypertension.

only

knowing that you have hypertension

have

your

blood

pressure

checked on a regular basis. If high

blood pressure is not treated it can

lead to serious health problems.

● treat angina pectoris.

Angina is a pain or uncomfortable

feeling in the chest, often spreading

to the arms or neck, and sometimes

to the shoulders and back. The pain

of angina is due

to a shortage of

oxygen to the heart.

Alkem

Amlodipine

relief of a sudden attack of angina.

Your

doctor

will

give

other

medication to treat this.

How it works

Alkem Amlodipine belongs to a group of

medicines

called

calcium

channel

blockers

calcium

ion

antagonists.

They

work

widening

your

blood

vessels, m a k i n g it e a s i e r fo r y o u r

heart to pump blood around the body

and help increase the supply of blood

oxygen

your

heart.

Calcium

channel

blockers

change

amount

calcium

your

blood

bones.

Ask

your

doctor

if

you

have

any

questions

about

why

Alkem

Amlodipine

has

been prescribed for

you.

Your doctor may have prescribed it for

another reason.

This medicine is available only with a

doctor's prescription.

Use in Children

There

enough

information

recommend the use of this medicine in

children.

Before you take

Alkem Amlodipine

When you must not take it

Do not take Alkem Amlodipine if you

have an allergy to:

Alkem

Amlodipine,

other

medicine containing

amlodipine

other

calcium

channel

blockers

such

medicines

with

active

ingredient felodipine, nifedipine or

lercandipine.

Check with your doctor or pharmacist

if you are unsure.

any of the ingredients listed at

the end of this leaflet.

Some of the symptoms of an allergic

reaction may include:

shortness 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 this medicine 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

this

medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies

to

any

other

medicines,

foods,

preservatives or dyes.

Tell your doctor if you have or

have

had

any

of

the

following

medical conditions:

heart

p r o b l e m s

i n c l u d i n g

heart failure

liver problems

Tell your doctor if you are pregnant

or plan to become pregnant.

This

medicine

affect

your

developing baby if you take it during

pregnancy.

Your

doctor

discuss

with

risks

benefits

involved.

Do not breast-feed if you are taking

this medicine.

It is not known if the active ingredients

Alkem

Amlodipine

passes

into

breast milk or if your baby may be

affected.

If

you

have

not

told

your

doctor

about any of the above, tell him/her

before

you

start

taking

Alkem

Amlodipine.

If you have not told your doctor

about

any

of

the

above,

tell

him/her

before

you

start

taking

Alkem Amlodipine.

Taking other medicines

Tell your doctor or pharmacist if you

are

taking

any

other

medicines,

including:

Alkem Amlodipine

Page 2 of 4

all prescription medicines

medicines,

vitamins,

herbal

supplements or natural therapies you

without

prescription

from

pharmacy, supermarket, naturopath or

health food shop.

Some medicines may be affected by

Alkem Amlodipine or may affect how

well it works. You may need different

amounts of your medicines, or you may

need to take different medicines. Your

doctor will advise you.

Tell your doctor or pharmacist if

you are taking any of the following:

other m e d i c i n e s used to treat

angina, such as diltiazem

some antibiotics,

such

erythromycin,

clarythromycin

rifampicin

some antifungals,

such

ketoconazole or itraconazole

anti-proteases,

medicines

used

treat HIV infection, such as ritonavir

Simvastatin,

medicine

used

lower cholesterol

cyclosporine or tacrolimus, medicine

used to suppress the immune system

St John’s Wort

Your

doctor

pharmacist

have

more information on medicines to be

careful

with

avoid

while

taking

Alkem Amlodipine.

How

to

take

Alkem

Amlodipine

Take

Alkem

Amlodipine

exactly

as

your doctor has prescribed.

Follow all directions given to you by

your doctor or pharmacist carefully.

They

may differ from the information

contained in this leaflet.

If

you

do

not

understand

the

instructions

on

the

box,

ask

your

doctor or pharmacist for help.

How much to take

usual

dose

Alkem Amlodipine

5 mg each day.

Your doctor may

increase this to 10 mg each day.

Your

doctor

prescribe

another

dose of Alkem Amlodipine depending

your

condition

respond to this medicine.

How to take it

Swallow the tablet whole with a full

glass of water.

When to take it

Take your medicine at about the same

time

each

day,

either

morning

or

evening.

Taking

same

time

each

will have the best effect.

It will also

help you remember when to take it.

Alkem Amlodipine can be taken with or

without food.

How long to take it

You

must

take

Alkem

Amlodipine

every

day.

Continue

taking

your

medicine for as long as your doctor

tells you.

This medicine helps to control your

condition, but does not cure it.

It is

important

keep

taking

your

medicine even if you feel well.

If you forget to take it

If it is less than 12 hours before

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 Poisons Information Centre – the

telephone

number

in

Australia

is

131 126 and in New Zealand is

0800

POISON

or

0800

764

766

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

Alkem

Amlodipine.

Do this even if there are no signs of

discomfort or poisoning.

You may

need urgent medical attention.

If you take too many tablets, you may

feel

dizzy,

lightheaded

faint

have an irregular heartbeat.

While you are taking

Alkem

Things you must do

Tell any other doctors, dentists and

pharmacists

who

are

treating

you

that

you

are

taking

Alkem

Amlodipine.

If you are about to start any new

medicine,

tell

your

doctor

or

pharmacist

that

you

are

taking

Alkem Amlodipine.

If you become pregnant while taking

Alkem

Amlodipine, tell

your

doctor

immediately.

Keep

all

of

your

doctor’s

appointments

so

that

your

progress

can be checked.

Your

doctor

some

tests

from

time to time to make sure the medicine is

working and to prevent unwanted side

effects.

Alkem Amlodipine

Page 3 of 4

Things you must not do

Do

not

take

Alkem

Amlodipine

to

treat any other conditions unless your

doctor tells you to.

Do not give this medicine to anyone

else,

even

if

they

have

the

same

condition as you.

Things to be careful of

Avoid

eating

large

quantities

of

grapefruit

or

drinking

large

quantities of grapefruit juice.

Grapefruit juice contains one or more

components that alter the metabolism os

some

medicines,

including

Alkem

Amlodipine.

Drinking very large quantities (over 1.2

liters) of grapefruit juice each day while

taking Alkem Amlodipine may increase

the effects of this medicine.

Be

careful

driving

or

operating

machinery until you know how Alkem

Amlodipine affects you.

Alkem Amlodipine may cause dizziness

or drowsiness in some people.

If you have any of these symptoms, do

not

drive,

operate

machinery

or

do

anything else that could be dangerous.

Things

that

would

be

helpful

for your high blood pressure or

angina.

Some

self-help

measures

suggested

below may

assist

your

condition.

Your doctor or pharmacist can give you

more information about these measures.

Weight:

Your doctor

suggest

losing

some

weight.

Somepeople

may need

dietician to plan a

suitable diet to

help with weight loss.

Exercise:

Regular

exercise

helps

lower blood pressure and

strengthen the heart. It is important

not to overdo it. Before

commencing regular exercise you

should consult your doctor who will

suggest the most suitable exercise for

you.

feel

uncomfortable

when

exercising

experience

symptoms

such

unusual

chest

pain

breathlessness

your

doctor.

Alcohol: Your doctor

advise

limit

your

alcohol

intake.

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 at the table

or in cooking.

Smoking: Your doctor may

advise

stop

smoking

least cut down.

Side effects

Tell

your

doctor

or

pharmacist

as

soon

as

possible

if

you

do

not

feel

well

while

you

are

taking

Alkem

Amlodipine.

Alkem

Amlodipine

helps

most

people

have

some

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 attention if you

get some of the side effects.

It can be difficult to tell whether side

effects are the result of taking Alkem

Amlodipine, effects of your condition

or side effects of other medicines you

may be taking. For this reason it is

important to tell your doctor of any

change in your condition.

Do

not

be

alarmed

by

the

list

of

possible side effects.

You may not experience any of them.

Tell your doctor if

Ask your doctor

or pharmacist for advice if you

experience any of the following and

they worry you:

headache

dizziness

flushing

tiredness

drowsiness or sleepiness

stomach pain or nausea

These

more

common

side

effects of Alkem Amlodipine. All side

effects should be reported to a health

professional.

Tell your doctor or pharmacist if you

experience any of the following and

they worry you:

indigestion

sexual problems

These

Alkem Amlodipine but you should tell

your doctor if they worry you.

Tell your doctor as soon as

possible if...

Tell your doctor immediately if you

notice any of the following:

changes in heart beat either fast or

slow

swelling of the ankles, feet, face or

hands

tingling or numbness of the hands or

feet

dizziness

lightheadedness

standing up from a sitting or

lying position

unusual tiredness or weakness

muscle cramps or aches

joint pain

eye pain or change in vision

changes in mood, feeling anxious or

nervous

symptoms of

liver disease such as

itching,

yellowing of

skin and

eyes, and dark coloured urine

unusual

movements,

including

trembling and shaking of the hands

and fingers, twisting movements of

body,

shuffling

walk

stiffness of the arms and legs.

These may be serious side effects that

may need urgent medical attention.

Alkem Amlodipine

Page 4 of 4

Go to hospital if...

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital, if you notice

any of the following:

fast or irregular heart beats

chest pain

chest pain associated with exertion

(angina) that lasts longer, is more

severe or occurs more often

shortness of breath

symptoms of allergy such as skin

rash and/or itching

severe

upper

stomach

pain,

often

with nausea and vomiting.

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

Ask your

doctor or

pharmacist to

answer any questions y o u may

have.

If you are 65 years or older, you

should

be

especially

careful

while

taking

Alkem

Amlodipine.

Report

any

side

effects

promptly

to

your

doctor.

Some people in this age group may

more

likely

experience

side

effects

such

swelling

feet

ankles,

muscle

cramps

dizziness.

Tell

your

doctor

or

pharmacist

if

you

notice

anything

else

that

is

making you feel unwell

Other side effects not listed above may

also occur in some people

After

taking

Alkem

Amlodipine

Storage

Keep your tablets in the pack until it

is time to take them.

If you take your tablets out of the pack

they may not keep as well.

Keep your tablets in a cool dry place

where the temperature stays below

25

C.

Do not store Alkem Amlodipine or

any other medicine in the bathroom

or near a sink. Do not leave your

medicines on a window sill or in the

car.

Heat and dampness can destroy some

medicines.

Keep

Alkem

Amlodipine

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

Alkem

Amlodipine,

or

the

tablets have passed their expiry date,

ask your pharmacist what to do with

any medicine that is left over.

Product Description

What it looks like

Alkem Amlodipine tablets are available

in two strengths:

Alkem Amlodipine 5 mg tablets -

white to off-white, octagonal, flat-

faced, bevelled edged scored

tablet, plain on one side and “210”

& “5” on other side.

Alkem Amlodipine 10 mg tablets -

white to off-white, octagonal,

flat-faced, bevelled edged tablet,

plain on one side and “209” &

“10” on other side.

The 5 mg and 10 tablets are supplied in

packs of 7, 10 and 30 tablets of blister

pack; and 30 and 100 tablets of HDPE

bottle pack.

Ingredients

Active ingredients

Alkem

Amlodipine

tablets

contain

amlodipine

besilate

equivalent to amlodipine 5 mg.

Alkem

Amlodipine

tablets

contain

amlodipine

besilate

equivalent to amlodipine 10 mg.

Other ingredients

Microcrystalline cellulose

calcium phosphate

sodium starch glycollate (Type A)

magnesium stearate

silicon dioxide

Alkem

Amlodipine

does

contain

gluten, sugar or lactose.

Supplier

Alkem

Amlodipine

supplied

Australia by:

Pharmacor Pty Limited

Suite 501, 7 Oaks Avenue

Dee Why, NSW, 2099

Australia

Australian Registration

Numbers:

Alkem Amlodipine 5 mg-AUST R

215708 (Blister Pack)

Alkem Amlodipine 10 mg - AUST R

215705 (Blister Pack)

Alkem Amlodipine 5 mg-AUST R

281107 (Bottle Pack)

Alkem Amlodipine 10 mg-AUST R

281108 (Bottle Pack)

This leaflet was prepared on 01/09/2017

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...

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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...

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Copalia HCT (Novartis Europharm Limited)

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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

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Exforge (Novartis Europharm Limited)

Exforge (Novartis Europharm Limited)

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

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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

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Dafiro (Novartis Europharm Limited)

Dafiro (Novartis Europharm Limited)

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

Europe -DG Health and Food Safety

6-6-2018

Copalia (Novartis Europharm Limited)

Copalia (Novartis Europharm Limited)

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

Europe -DG Health and Food Safety

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Twynsta (Boehringer Ingelheim International GmbH)

Twynsta (Boehringer Ingelheim International GmbH)

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