APO-GALANTAMINE MR galantamine (as hydrobromide) 16mg modified release capsules blister pack

Main information

  • Trade name:
  • APO-GALANTAMINE MR galantamine (as hydrobromide) 16mg modified release capsules blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-GALANTAMINE MR galantamine (as hydrobromide) 16mg modified release capsules blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 182041
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

182041

APO-GALANTAMINE MR galantamine (as hydrobromide) 16mg modified release capsules blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

20/01/2012

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. APO-GALANTAMINE MR galantamine (as hydrobromide) 16mg modified release capsules blister pack

Product Type

Single Medicine Product

Effective date

22/06/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Galantamine is indicated for the treatment of mild to moderately severe dementia of the Alzheimer type

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. APO-GALANTAMINE MR galantamine (as hydrobromide) 16mg modified release capsules blister

Dosage Form

Capsule, modified release

Route of Administration

Oral

Visual Identification

opaque flesh-flesh size 2 hard gelatin capsule containing two round

biconvex tablets

Active Ingredients

Galantamine hydrobromide

20.504 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 07:22:01 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

APO-Galantamine MR

Capsules

Contains the active ingredient galantamine (as galantamine hydrobromide)

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about galantamine. It does

not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au .

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is APO-

Galantamine MR. It contains the

active ingredient galantamine

hydrobromide.

It is used to treat mild to moderately

severe dementia of the Alzheimer's

type.

The symptoms of Alzheimer's

disease include confusion, memory

loss or other changes in behaviour.

As the disease progresses, patients

find it more and more difficult to

carry out their normal daily activities.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

How it works

The symptoms of Alzheimer's

disease are thought to be due to a

lack of acetylcholine, a substance

which transmits messages between

brain cells. APO-Galantamine MR

increases the amount of this

substance, to help improve or

stabilise the symptoms and therefore

slow the progress of Alzheimer's

disease.

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be used in

children.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You have or have had any of

the following:

severe liver disease

severe kidney disease.

You are hypersensitive to, or

have had an allergic reaction to,

galantamine or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed on

the pack has passed.

APO-GALANTAMINE MR CAPSULES

The packaging is torn, shows

signs of tampering or it does not

look quite right.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

liver and/or kidney disease

heart problems

stomach ulcers

brain disorders, such as

Parkinson's disease, fits (seizures)

breathing disorders, such as

asthma, pneumonia

recent gut or bladder surgery

difficulties in passing urine

attacks of sudden abdominal pain.

You are currently pregnant or you

plan to become pregnant. Do not

take this medicine whilst

pregnant until you and your

doctor have discussed the risks

and benefits involved.

You are currently breastfeeding

or you plan to breast-feed. Do not

take this medicine whilst

breastfeeding until you and your

doctor have discussed the risks

and benefits involved.

You are planning to have surgery

or an anaesthetic.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines may interact with

galantamine. These include:

anticholinergic medicines (used

to prevent travel sickness, relieve

stomach cramps, spasms or

diarrhoea)

cholinergic medicines (e.g.

bethanecol and certain medicines

used during surgery)

medicines used to treat

Parkinson's disease

medicines for certain heart

problems (such as digoxin,

quinidine) or to help lower blood

pressure (such as a class of

medicine called beta blockers)

medicines used for breathing

problems

certain medicines used to treat

fungal infections (such as

ketoconazole) or bacterial

infections (such as erythromycin)

certain medicines used to relieve

pain, swelling and other

symptoms of inflammation,

including arthritis

certain medicines used to treat

depression (such as paroxetine,

fluoxetine, fluvoxamine).

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with galantamine.

How to take this

medicine

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much to take

Your doctor will tell you how much

of this medicine you should take.

This will depend on your condition

and whether you are taking any other

medicines.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

The dose of APO-Galantamine MR

is gradually increased to the most

suitable dose. The necessary dosage

steps should be determined by your

doctor to suit your needs.

The following scheme is an example

of how your doctor may increase the

dose:

Start with 8 mg a day.

After four weeks of treatment,

raise the dose to 16 mg a day.

After at least another four weeks

of treatment, raise the dose to 24

mg a day.

For long-term treatment, up to 24 mg

a day is usually suitable but your

doctor will determine the dose that is

best for you.

How to take it

APO-Galantamine MR capsules

should be taken once a day,

preferably with food.

The capsule must be swallowed

whole. The contents should not be

crushed and sprinkled on food.

Be sure to drink plenty of liquids

during your treatment with APO-

Galantamine MR to keep yourself

hydrated.

When to take it

Take this medicine at the same time

each day. Taking it at the same time

each day will have the best effect and

will also help you remember when to

take it.

It is preferable to take this medicine

with food.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

Make sure you have enough to last

over weekends and holidays.

If treatment is discontinued for more

than several days, tell your doctor.

Your doctor will need to restart your

treatment at the lowest dose. This

will minimise the chance of

experiencing side effects.

If you forget to take it

If it is almost time to take your next

dose, skip the missed dose and take

your next dose at the usual time.

Otherwise, take it as soon as you

APO-GALANTAMINE MR CAPSULES

remember and then go back to taking

your medicine as you would

normally.

Do not take a double dose to make

up for missed doses.

This may increase the chance of you

experiencing side effects.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints to help you

remember.

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively, go to the Accident

and Emergency department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

Symptoms of overdose can include:

muscle weakness or twitches

severe nausea, vomiting,

gastrointestinal cramping,

salivation, teary eyes, urination,

defecation, sweating, slow heart

rate, low blood pressure, collapse

and convulsions

difficulty breathing.

While you are taking

this medicine

Things you must do

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breast-feed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

Your doctor may occasionally do

tests to make sure the medicine is

working and to prevent side effects.

Go to your doctor regularly for a

check-up.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Things you must not do

Do not:

Give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Take your medicine to treat any

other condition unless your

doctor tells you to.

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Things to be careful of

APO-Galantamine MR may cause

dizziness or drowsiness in some

people, especially during initial

treatment.

Be careful when driving or operating

machinery until you know how this

medicine affects you.

Alzheimer's disease may reduce your

ability to drive or operate machines.

Weight loss is associated with this

medicine and is common for people

with Alzheimer's. Therefore, you and

your doctor should monitor your

weight while taking this medication.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking galantamine or if you have

any questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor if you notice any

of the following:

nausea, vomiting, diarrhoea,

stomach pain or discomfort,

indigestion

tiredness, weakness

muscle cramps, trembling,

numbness and tingling or burning

sensation

headache

ringing in the ears

dehydration (sometimes severe) -

thirst, lack of fluids

hallucinations (seeing, feeling or

hearing things that are not there)

feeling depressed or having

thoughts of harming yourself

dizziness, light-headedness

slow, fast or irregular heart beat

increased sweating

changes in taste

loss of appetite, weight loss

fainting or falling (sometimes

resulting in injury)

high blood pressure

abnormal liver test results

If you experience any of the

following, stop taking your

medicine and contact your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

These are very serious side effects

and you may need urgent medical

attention or hospitalisation:

yellowing of the skin and eyes

light coloured bowel motions,

dark coloured urine.

vomiting blood or material that

looks like coffee grounds

bleeding from the back passage,

black sticky bowel motions

(stools) or bloody diarrhoea

fainting, especially if you have a

slow or irregular heart beat

fits (seizures)

pain or tightness in the chest

APO-GALANTAMINE MR CAPSULES

flu-like symptoms, followed by a

painful red or purplish rash that

spreads and blisters

flu-like symptoms with a red,

pustule rash

symptoms of stroke which can

include collapsing, numbness or

weakness of arms or legs,

headache, dizziness and

confusion, visual disturbance,

difficulty swallowing, slurred

speech and loss of speech.

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to galantamine, do

not take any more of this medicine

and tell your doctor immediately

or go to the Accident and

Emergency department at your

nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will

stay below 25°C.

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink. Do not leave it on a

window sill or in the car. Heat and

dampness can destroy some

medicines.

Keep this medicine 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

this medicine or it has passed its

expiry date, your pharmacist can

dispose of the remaining medicine

safely.

Product description

What APO-Galantamine

looks like

APO-Galantamine MR modified

release capsules are available in

blister packs of 28 capsules.

8 mg modified release capsules

White opaque capsules containing

one round biconvex tablet.

16 mg modified release capsules

Flesh opaque capsules containing

two round biconvex tablets.

24 mg modified release capsules

Orange opaque capsules containing

three round biconvex tablets.

* Not all strengths, pack types and/or

pack sizes may be available.

Ingredients

Each capsule contains 8, 16 or 24 mg

of galantamine hydrobromide as the

active ingredient.

It also contains the following inactive

ingredients:

microcrystalline cellulose

hypromellose

ethylcellulose

magnesium stearate

titanium dioxide

gelatine

In addition, the 16 mg capsules

contain:

iron oxide red

And the 24 mg capsules contain:

iron oxide red

indigo carmine

erythrosine

iron oxide yellow.

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

APO-Galantamine MR 8 mg

capsules (blister packs): AUST R

182030.

APO-Galantamine MR 16 mg

capsules (blister packs): AUST R

182041.

APO-Galantamine MR 24 mg

capsules (blister packs): AUST R

182034.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was last updated in

March 2015

APO-GALANTAMINE MR CAPSULES