GALANTAMINE AN SR galantamine (as hydrobromide) 24mg modified release capsules blister pack

Main information

  • Trade name:
  • GALANTAMINE AN SR galantamine (as hydrobromide) 24mg modified release capsules blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GALANTAMINE AN SR galantamine (as hydrobromide) 24mg modified release capsules blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 182036
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

182036

GALANTAMINE AN SR galantamine (as hydrobromide) 24mg modified release capsules blister pack

ARTG entry for

Medicine Registered

Sponsor

Southern Cross Pharma Pty Ltd

Postal Address

PO Box 2037,MALUA BAY, NSW, 2536

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. GALANTAMINE AN SR galantamine (as hydrobromide) 24mg modified release capsules blister pack

Product Type

Single Medicine Product

Effective date

13/01/2016

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. GALANTAMINE AN SR galantamine (as hydrobromide) 24mg modified release capsules blister pack

Dosage Form

Capsule, modified release

Route of Administration

Oral

Visual Identification

opaque orange-orange size 2 hard gelatin capsule containing three round

biconvex tablets

Active Ingredients

Galantamine hydrobromide

30.756 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 07:23:59 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

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Galantamine AN SR Capsules

Galantamine hydrobromide

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Galantamine AN SR

modified release capsules. It does not

contain all the available information. It

does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and benefits.

Your doctor has weighed the risks of

you taking Galantamine AN SR against

the benefits this medicine is expected

to have for you.

If you have any concerns about taking

Galantamine AN SR, ask your doctor

or pharmacist.

Keep this leaflet with your medicine.

You may need to read it again.

What Galantamine AN

SR is used for

Galantamine AN SR 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.

The symptoms of Alzheimer’s disease

are thought to be due to a lack of

acetylcholine, a substance which

transmits messages between brain

cells. Galantamine AN SR increases

the amount of this substance to help

improve or stabilise the symptoms and

therefore slow the progress of

Alzheimer’s disease.

Your doctor may have prescribed

Galantamine AN SR for another

reason. Ask your doctor if you have

any questions about why this medicine

has been prescribed for you.

Before you take

Galantamine AN SR

When you must not take it

Do not take Galantamine AN SR if you

have:

an allergy to Galantamine AN SR

or any of the ingredients. See

Product Description at the end of

this leaflet for a list of ingredients.

severe liver and/or kidney disease.

Do not take Galantamine AN SR if the

packaging is torn or shows signs of

tampering. Do not use Galantamine

AN SR beyond the expiry date (month

and year) printed on the pack.

Before you start to take it

You must tell your doctor if you are:

pregnant, or planning to become

pregnant

breastfeeding, or planning to

breastfeed

planning to undergo surgery which

will require anaesthesia.

You must also tell your doctor if you

have, or have had any of the following

health problems:

liver and/or kidney disease

heart problems

stomach ulcers

brain disorders, such as

Parkinson’s disease, fits

breathing disorders, such as

asthma, pneumonia

recent gut or bladder surgery

difficulties in passing urine

attacks of sudden abdominal pain

If you have not told your doctor or

pharmacist about any of the above, tell

them before you start taking or are

given Galantamine AN SR.

Your doctor will advise you whether or

not to take Galantamine AN SR or if

you need to adjust the dose or alter

your treatment. Since there may be

other related conditions that

Galantamine AN SR is not intended to

treat, you should verify with your

doctor that you are taking

Galantamine AN SR for the treatment

of mild to moderate Alzheimer’s

disease.

Initial results from clinical trials in

patients with mild cognitive

impairment of various causes have

shown a slightly higher mortality rate

(higher death rate) in those taking

Galantamine AN SR than those taking

placebo (a pill without an active

ingredient which is commonly used in

clinical trials as a reference for

comparison). The reason for this

difference is currently not known

and may just be due to chance. There is

no evidence of increased risk of death

in those with mild to moderately severe

Alzheimer's disease taking

Galantamine AN SR.

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.

In particular, tell your doctor or

pharmacist if you are

taking any of the following:

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)

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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).

These medicines may be affected by

Galantamine AN SR or may affect how

well Galantamine AN SR works. Your

doctor or pharmacist can tell you what

to do if you are taking any of these

medicines.

Effects on driving and operating

machinery

Alzheimer’s disease may reduce

your ability to drive or operate

machines.

Galantamine AN SR may cause

dizziness or drowsiness in some

people, especially during initial

treatment.

Discuss with your doctor whether

it is safe for you to drive or

operate machinery.

Taking Galantamine AN

Galantamine AN SR modified release

capsules should be taken once a day,

preferably with food. Be sure to drink

plenty of liquids during your treatment

with Galantamine AN SR to keep

yourself hydrated. The capsule must be

swallowed whole. The contents should

not be crushed and sprinkled on food.

Adults

The dose of Galantamine AN SR 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.

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.

Children

Galantamine AN SR is not

recommended for children.

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.

Otherwise, take it as soon as you

remember, and then go back to

taking it as you would normally.

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

New Zealand: 0800 764 766 or

0800 POISON

Keep these telephone numbers handy.

If you take too much Galantamine AN

SR, you may experience vomiting or a

feeling that you want to vomit, nausea,

stomach cramps, excessive production

of saliva, tears or sweat, dry mouth,

loss of control of your bladder or

bowels, a slow or fast heart beat, low

blood pressure, dizziness, light-

headedness, muscle weakness or

twitching, fits, breathing difficulties,

chest pain, hallucinations or you may

collapse.

While you are taking

Galantamine AN SR

Things you must do

Always follow your doctor’s

instructions carefully.

Tell your doctor if you become

pregnant while taking

Galantamine AN SR.

If you are about to start taking a

new medicine, tell your doctor and

pharmacist that you are taking

Galantamine AN SR.

Things you must not do

Do not use Galantamine AN SR 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 and they worry

you:

nausea, vomiting, diarrhoea,

stomach pain or discomfort,

indigestion, difficulty swallowing

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low potassium levels in the blood

– weakness, muscle cramps,

numbness and tingling that begins

in the lower extremities.

leg cramps, tingling in the hands

or feet

ringing in the ears

dehydration (sometimes severe) -

thirst , lack of fluids

hallucinations (seeing, feeling or

hearing things that are not there)

mood changes such as agitation or

aggressive feelings

feeling depressed or having

thoughts of harming yourself

low blood pressure – dizziness,

light-headedness

slow, fast or irregular heart beat

increased sweating

fever

skin rashes

trembling or shakiness

loss of appetite, weight loss

drowsiness, tiredness, weakness,

feeling unwell, confusion, trouble

sleeping, headache

falling (sometimes resulting in

injury)

runny or blocked nose

urinary tract infection

high blood pressure

elevated liver enzymes

yellowing of the skin and eyes

light coloured bowel motions

dark coloured urine.

Some of these side effects occur

mainly during the early stages of

treatment, or when the dose of

Galantamine AN SR is increased. They

usually disappear gradually over time.

For example, nausea and vomiting tend

to pass after a few days.

Some of these effects may be due to

the Alzheimer’s disease but always

inform your doctor about any

unwanted effect that has occurred

while taking Galantamine AN SR.

Tell your doctor immediately, or go

to Accident and Emergency at your

nearest hospital if you notice any of

the following:

signs of allergy such as rash or

hives on the skin; swelling of the

face, lips, tongue or other parts of

the body; wheezing or difficulty

breathing.

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

widespread severe rash with

peeling skin which may be

accompanied by fever, flu-like

symptoms, blisters in the mouth,

eyes and/or genitals (Stevens

Johnson syndrome)

fits (seizures)

pain or tightness in the chest

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

These may be serious side effects. You

may need urgent medical attention.

These are rare side effects.

Other side effects not listed above may

also occur in some people. Tell your

doctor if you notice any other effects.

After taking Galantamine

AN SR

Storage

Keep Galantamine AN SR in the pack

until it is time to take them.

Keep Galantamine AN SR in a cool

dry place where the temperature is

below 25

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 Galantamine AN SR, or

any other medicine, in the bathroom or

near a sink. Do not leave medicines in

the car or on windowsills. Heat and

dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking

Galantamine AN SR, 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

There are 3 different types of

Galantamine AN SR modified

release capsules:

Galantamine AN SR 8 mg modified

release capsules

White opaque capsules containing one

round biconvex tablet.

Galantamine AN SR 16 mg

modified release capsules

Flesh opaque capsules containing two

round biconvex tablets.

Galantamine AN SR 24 mg

modified release capsules

Orange opaque capsules containing

three round biconvex tablets.

Galantamine AN SR modified release

capsules are available in blister packs

of 28 capsules.

Ingredients

The active ingredient of Galantamine

AN SR is galantamine

hydrobromide.

Galantamine AN SR modified release

capsules contain either 8 mg, 16 mg or

24 mg of galantamine (as

hydrobromide).

All capsules also contain

microcrystalline cellulose,

hypromellose, ethylcellulose, and

magnesium stearate, titanium dioxide

and gelatine. In addition, the 16 mg

capsules contain iron oxide red and the

24 mg capsules contain indogo

carmine, erythrosine, iron oxide red

and iron oxide yellow.

Sponsor

Southern Cross Pharma Pty Ltd

56 Illabunda Drive

Malua Bay NSW 2536

ABN 47 094 447 677

This leaflet was prepared in February

2015.

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Australian Registration Numbers:

Galantamine AN SR 8mg 182042

Galantamine AN SR 16mg 182032

Galantamine AN SR 24mg 182036