PHARMACOR

Main information

  • Trade name:
  • PHARMACOR TACROLIMUS tacrolimus 1 mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PHARMACOR TACROLIMUS tacrolimus 1 mg capsule blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209266
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209266

PHARMACOR TACROLIMUS tacrolimus 1 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. PHARMACOR TACROLIMUS tacrolimus 1 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

100's [2x(5x10's)]

(S4) Prescription Only Medicine

100's [10x(1x10's)]

(S4) Prescription Only Medicine

Components

1. PHARMACOR TACROLIMUS tacrolimus 1 mg capsule blister pack

Dosage Form

Capsule

Route of Administration

Oral

Visual Identification

White to off white powder filled in size '5' white cap/white body HGC printed

with '1 mg' on cap and 'Tacro' on body with red ink

Active Ingredients

tacrolimus monohydrate

1.02 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 10:36:50 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

________________________________________________________________________________________________

Pharmacor Tacrolimus CMI v0316

PHARMACOR TACROLIMUS

Tacrolimus

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

PHARMACOR

TACROLIMUS

Capsules. It does not contain

all the available information. It does not take

place

talking

your

doctor

pharmacist.

All medicines have risks and benefits. Your

doctor has weighed the risks of you taking

PHARMACOR

TACROLIMUS

against

benefits this medicine is expected to have

for you.

have

concerns

about

using

PHARMACOR

TACROLIMUS

your

doctor or pharmacist.

Keep this leaflet with your medicine. You

may need to read it again.

What PHARMACOR

TACROLIMUS 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.

PHARMACOR

TACROLIMUS

stops

this

attack;

very

important

take

PHARMACOR TACROLIMUS

given to you

by your doctor regularly so that your new

liver,

kidney,

lung

heart

will

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

PHARMACOR

TACROLIMUS.

PHARMACOR

TACROLIMUS

contains the

active

ingredient

tacrolimus,

which

immunosuppressive agent.

Your

doctor

have

prescribed

PHARMACOR

TACROLIMUS

another

reason. Ask your doctor if you have any

questions about why this medicine has been

prescribed for you.

Before you use PHARMACOR

TACROLIMUS

When you must not use it

Do not use

PHARMACOR TACROLIMUS

you have an allergy to tacrolimus,

other

macrolides

(these

antibiotics

erythromycin

family – trade names are Eryc, EES,

Klacid,

Zithromax,

Rulide

Biaxsig) or any of the ingredients

contained

capsules.

Product Description at the end of this

leaflet for a list of ingredients.

Do not use

PHARMACOR TACROLIMUS

packaging

torn

shows

signs

tampering.

PHARMACOR

TACROLIMUS

beyond

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

________________________________________________________________________________________________

Pharmacor Tacrolimus CMI v0316

If you have not told your doctor or pharmacist

about any of the above, tell them before you

start

taking

given

PHARMACOR

TACROLIMUS.

Your doctor will advise you whether or not to

take PHARMACOR TACROLIMUS 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

particularly

important

PHARMACOR TACROLIMUS because there

some

specific

medicines

that

could

alter

PHARMACOR

TACROLIMUS

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

PHARMACOR TACROLIMUS

may cause

visual or nervous disturbances. If affected,

do not drive or operate machinery.

Effects of food and alcohol

Food

reduces

absorption

PHARMACOR

TACROLIMUS

capsules should be taken at least 1 hour

before a meal.

Using PHARMACOR

TACROLIMUS

How much to take:

only

PHARMACOR

TACROLIMUS

from your doctor. Your dose

will be calculated according to your weight, age,

and 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 of blood and urine at regular intervals.

This is in order to test whether your medicine

requires adjustment.

PHARMACOR TACROLIMUS should be taken

in two doses (e.g. morning and evening). Take

the capsule from the blister pack and swallow it

whole

with

plenty

water.

grapefruit

juice,

grapefruit

juice

contains

substances

that

interfere

with

action

PHARMACOR TACROLIMUS.

How to take it:

PHARMACOR

TACROLIMUS

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

Poisons Information Centre for advice, or go to

Accident

Emergency

your

nearest

hospital.

Do this even if there are no signs of discomfort

poisoning.

need

urgent

medical

attention.

Poisons Information Centre telephone numbers:

________________________________________________________________________________________________

Pharmacor Tacrolimus CMI v0316

Australia: 13 11 26

Keep these telephone numbers handy.

While you are taking

PHARMACOR TACROLIMUS

Things you must do

Always

follow

your

doctor’s

instructions carefully

Tell your doctor if you become pregnant

while taking PHARMACOR TACROLIMUS

If you are about to start taking a new

medicine, tell your doctor and pharmacist that

you are taking PHARMACOR TACROLIMUS.

PHARMACOR

TACROLIMUS

suppress your immune system by lowering your

body's immune defence system. This increases

your risk of skin cancer and other cancers while

taking PHARMACOR TACROLIMUS. Always

protect yourself from the

sun, wear sunscreen,

a hat and protective clothing.

Things you must not do

Do not take PHARMACOR

TACROLIMUS to 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.

Side Effects

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 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

________________________________________________________________________________________________

Pharmacor Tacrolimus CMI v0316

Other side effects not listed above may also

occur in some people. Tell your doctor if you

notice any other effects.

After using PHARMACOR

TACROLIMUS

Storage

Use all the capsules within 12 months of

opening the aluminium wrapper.

Keep PHARMACOR TACROLIMUS

Capsules

in the blisters until it is time to take them.

Keep PHARMACOR TACROLIMUS

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 PHARMACOR TACROLIMUS, 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

PHARMACOR TACROLIMUS 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 it looks like

PHARMACOR TACROLIMUS

PHARMACOR TACROLIMUS

capsules

0.5 mg are yellow, packed in blister sheets of

ten capsules and sealed in an aluminium wrapper

(Pack size 100 capsules) and 100 capsules in

HDPE bottle.

PHARMACOR TACROLIMUS

1 mg

capsules are white, packed in blister sheets of

ten capsules and sealed in an aluminium wrapper

(Pack size 100 capsules) and 100 capsules in

HDPE bottle.

PHARMACOR TACROLIMUS

5 mg

capsules are greyish-red, packed in blister sheets

of ten capsules and sealed in an aluminium

wrapper (Pack size 50 capsules) and 100

capsules in HDPE bottle.

Ingredients

PHARMACOR TACROLIMUS Capsules

contain

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 5mg 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).

Sponsor

PHARMACOR PTY LIMITED

Suite 501, 7 oaks Avenue

Dee Why NSW 2099

Australia

Australian Registration Number:

0.5 mg capsules:

ARTG No. 209272 blister pack

ARTG No. 209274 bottle pack

1 mg capsules:

ARTG No. 209266 blister pack

ARTG No. 209268 bottle pack

5 mg capsules:

ARTG No. 209267 blister pack

ARTG No. 209270 bottle pack

The CMI was last updated in March 2016.

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