TACROLIMUS

Main information

  • Trade name:
  • TACROLIMUS APOTEX tacrolimus 5 mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TACROLIMUS APOTEX tacrolimus 5 mg capsule blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209269
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209269

TACROLIMUS APOTEX tacrolimus 5 mg capsule 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

29/04/2014

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. TACROLIMUS APOTEX tacrolimus 5 mg capsule blister pack

Product Type

Single Medicine Product

Effective date

11/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Tacrolimus is indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.

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

50's [5x(1x10's)]

(S4) Prescription Only Medicine

50's [1x(5x10's)]

(S4) Prescription Only Medicine

Components

1. TACROLIMUS APOTEX tacrolimus 5 mg capsule blister pack

Dosage Form

Capsule

Route of Administration

Oral

Visual Identification

White to off white powder filled in size '4' greyish red cap/body HGC printed

with '5 mg' on cap and 'Tacro' on body with white ink

Active Ingredients

tacrolimus monohydrate

5.1 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 27.11.2017 at 10:34:56 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

Tacrolimus APOTEX Capsules - v02-0517

Tacrolimus APOTEX

Contains

the

active

ingredient

tacrolimus

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

Tacrolimus

APOTEX

Capsules. It does not contain all the

doctor

regularly

that

your

liver,

kidney, lung or heart will not be attacked or

rejected.

If you have been taking other medicines for

this purpose, but

are still

feeling unwell,

your doctor may change your treatment and

begin giving you Tacrolimus APOTEX

Tacrolimus

APOTEX

contains

active

ingredient

tacrolimus,

which

immunosuppressive agent.

Your

doctor

have

prescribed

Tacrolimus

APOTEX

another

reason.

Ask your doctor if you have any questions

about why this medicine has been prescribed

for you.

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

Tacrolimus APOTEX against

the benefits

this medicine is expected to have for you.

have

concerns

about

using

Tacrolimus

APOTEX

your

doctor

pharmacist.

Keep this leaflet with your medicine. You

may need to read it again.

What this medicine is used for

You have been given a new transplanted

liver or kidney, lung or heart from another

person

because

your

longer

healthy. Your body recognises that this new

organ is different from your organs and will

try to reject it by attacking it in the same

way that it would attack germs that enter

your body. This could make you become ill

again.

Tacrolimus

APOTEX

stops

this

attack;

very

important

take

Tacrolimus APOTEX given to you by your

Before you take this medicine

When you must not use it

Do not use Tacrolimus APOTEX if

you have an allergy

to tacrolimus,

other

macrolides

(these

antibiotics

erythromycin

family – trade names are Eryc, EES,

Klacid,

Zithromax,

Rulide

Biaxsig) or

any of

ingredients

contained

capsules.

Product Description at the end of this

leaflet for a list of ingredients.

Tacrolimus

APOTEX

packaging

torn

shows

signs

tampering.

Do not use Tacrolimus APOTEX beyond the

expiry date (month and year) printed on the

pack.

Before you start to use it

You must tell your doctor if

you are pregnant or planning to become

pregnant

you are using oral contraceptives

you are breast feeding

receiving

cyclosporin

immunosuppressive therapy

Tacrolimus APOTEX Capsules - v02-0517

If you have not told your doctor or pharmacist

about any of the above, tell them before you

start taking or are given

Tacrolimus APOTEX

Your doctor will advise you whether or not to

take

Tacrolimus APOTEX

or if you need to

adjust the dose or adapt your treatment.

Taking other medicines:

Tell your doctor or pharmacist if you are taking

any other medicines, including medicines you

can buy without a prescription from a pharmacy,

supermarket or health food shop.

This

is particularly

important for

Tacrolimus

APOTEX

because

there

some

specific

medicines

that

could

alter

Tacrolimus

APOTEX

effectiveness and safety.

Among these medicines is the herbal preparation

St John’s Wort (Hypericum perforatum) which

is capable of decreasing tacrolimus blood levels.

Your doctor or pharmacist can tell you what to

do if you are taking any of these medicines.

Effects on driving and operating machinery

Tacrolimus APOTEX

may cause visual or

nervous

disturbances.

affected,

drive or operate machinery.

Effects of food and alcohol

Food reduces the absorption of

Tacrolimus

APOTEX

so the capsules should be taken

at least 1 hour before a meal.

How to take this medicine

How much to take:

You can only get

Tacrolimus APOTEX

from

your

doctor.

Your

dose

will

calculated

according

your

weight,

age,

medical

condition. As your health and the function of

your new liver or kidney, lung or heart can be

affected by how much medicine you take, it is

normal

that

your

doctor

collects

samples

blood and urine at regular intervals. This is in

order

test

whether

your

medicine

requires

adjustment.

Tacrolimus APOTEX

should be taken in two

doses

(e.g.

morning

evening).

Take

capsule from the blister pack and swallow it

whole

with

plenty

water.

grapefruit

juice,

grapefruit

juice

contains

substances

that

interfere

with

action

Tacrolimus APOTEX

How to take it:

Tacrolimus APOTEX

capsules should be

taken at least 1 hour before a meal.

You must never change the dose yourself

even if you are feeling better. It is very

important that you keep taking this medicine

so that your body will not reject your new

liver kidney, lung or heart.

If you accidentally take a larger dose than

recommended, tell your doctor immediately.

If you do not understand the instructions

provided with this medicine, ask your doctor

or pharmacist for help.

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.

Do not take a double dose to make up

for the dose you missed.

If you have missed more than one dose, or are

not sure what to do, check with your doctor or

pharmacist.

If you have trouble remembering when to take

your medicine, ask your pharmacist for some

hints.

If you have taken too much (overdose)

Immediately telephone your doctor or the

Poisons Information Centre for advice, or go

to Accident and Emergency at your nearest

hospital.

Do

this

even

if

there

are

no

signs

of

discomfort

or

poisoning.

You

may

need

urgent medical attention.

Poisons

Information

Centre

telephone

numbers:

Australia: 13 11 26

Tacrolimus APOTEX Capsules - v02-0517

Keep these telephone numbers handy.

While you are taking this medicine

Things you must do

Always

follow

your

doctor’s

instructions carefully

Tell your doctor if you become pregnant

while taking

Tacrolimus APOTEX

If you are about to start taking a new

medicine,

tell

your

doctor

pharmacist

that

taking

Tacrolimus APOTEX

Tacrolimus

APOTEX

suppress

your

immune system by lowering your body's

immune defence system. This increases

your

risk

skin

cancer

other

cancers

while

taking

Tacrolimus

APOTEX

Always

protect

yourself

from the sun, wear sunscreen, a hat and

protective clothing.

Things you must not do

Do not take

Tacrolimus APOTEX

treat any other complaint unless your

doctor says so.

Do not give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Possible Side Effects

All medicines can have side effects. Sometimes

they are serious, most of the time they are not.

need

medical

treatment

some 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 experience any of the

following:

tiredness, lack of energy

stomach upset, including nausea (feeling

sick), vomiting, loss of appetite,

diarrhoea, stomach cramps

tremor (shaking)

headache

feeling depressed (sad)

sleeping difficulties

blurred vision or sensitive to light

muscle cramps, tenderness or weakness

Tell your doctor immediately if you notice

any of the following as you may need urgent

medical care:

signs of allergy such as rash, itching or

hives on the skin; swelling of the face,

lips, tongue or other part of the body;

shortness of breath, wheezing or

troubled breathing

fever

diabetes / increased blood sugar

swelling, numbness or tingling (pins and

needles) in your hands and feet

constant "flu-like" symptoms such as

chills, sore throat, aching joints, swollen

glands, or any other signs of infection

unusual bleeding or bruising

high blood pressure

palpitations, abnormal heart rhythms,

chest pain

new lumps or moles, or changes to

existing moles, anywhere on the body

swelling of the eyelids, hands or feet due

to excess fluid

a change in the amount of urine passed

or in the number of times you urinate,

pain on urinating, or other kidney

problems.

yellowing of the skin and/or eyes

(jaundice) often accompanied by

generally feeling unwell (for example,

tiredness, lack of energy, loss of

appetite, nausea and vomiting, pain in

the abdomen)

symptoms of anaemia, such as shortness

of breath, tiredness or dizziness

seizures (fits)

buzzing or ringing in the ears, difficulty

hearing

Tacrolimus APOTEX Capsules - v02-0517

Other side effects not listed above may also

occur in some people. Tell your doctor if you

notice any other effects.

Storage and disposal

Storage

Use all the capsules within 12 months of

opening the aluminium wrapper.

Keep

Tacrolimus APOTEX

Capsules in the

blisters until it is time to take them.

Keep

Tacrolimus APOTEX

Capsules in a cool

dry place where the temperature is below 25

degrees C.

Keep your medicines where children cannot

reach them. A locked cupboard at least one-and-

a-half metres (1.5 m) above the ground is a good

place to store medicines.

Do not store

Tacrolimus APOTEX

, or any

other medicine, in the bathroom or near a sink.

Do not leave medicines in the car or on window

sills. Heat and dampness can destroy some

medicines.

Disposal

If your doctor tells you to stop taking

Tacrolimus APOTEX

Capsules, or your

medicine has passed its expiry date, ask your

pharmacist what to do with any medicine which

may be left over.

Product Description

What Tacrolimus APOTEX Capsules look

like

Tacrolimus APOTEX 0.5 mg

capsules:

White to off white powder filled in size ‘5’

yellow coloured cap/yellow coloured body

hard gelatin capsule printed with “0.5 mg”

on cap and “Tacro” on body with red ink.

Packed in blister sheets of ten capsules and

sealed in an aluminium wrapper (Pack size 100

capsules).

Tacrolimus APOTEX

1 mg capsules:

White to off white powder filled in size ‘5’

white coloured cap/white coloured body hard

gelatin capsule printed with “1 mg” on cap and

“Tacro” on body with red ink.

Packed in blister sheets of ten capsules and sealed in an

aluminium wrapper (Pack size 100 capsules).

Tacrolimus APOTEX

5 mg capsules:

White to off white powder filled in size ‘4’

greyish red coloured cap/ greyish red coloured body

hard gelatin capsule printed with “5 mg” on cap and

“Tacro” on body with white ink.

Packed in blister sheets of ten capsules and sealed in

an aluminium wrapper (Pack size 50 capsules).

Ingredients

Each capsule contains 0.5 mg, 1 mg or 5 mg of

tacrolimus as the active ingredient.

It also contains the following inactive

ingredients: hypromellose, croscarmellose

sodium, lactose anhydrous, and magnesium

stearate.

The 0.5 mg and 1 mg capsules are printed with

TekPrint SB-1033 Red Ink, the 5 mg capsules

with TekPrint SW-0012 White ink.

The capsule shells contain gelatin, water,

titanium dioxide, sodium lauryl sulfate, iron

oxide yellow (0.5 mg capsules), and iron oxide

red (5 mg capsules).

This medicine is gluten-free, sucrose-free,

tartrazine-free and free of other azo dyes.

Sponsor

PHARMACOR PTY LIMITED

Suite 501, 7 Oaks Avenue

Dee Why NSW 2099

Australia

Distributor

Apotex Pty. Ltd.

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered trademarks of

Apotex Inc.

Australian Registration Numbers:

0.5 mg capsules:

ARTG No. 209273 blister pack

1 mg capsules

ARTG No. 209275 blister pack

Tacrolimus APOTEX Capsules - v02-0517

5 mg capsules

ARTG No. 209269 blister pack

This leaflet was last updated in May 2017.

1-11-2018

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