BLOOMS THE CHEMIST VENLAFAXINE XR venlafaxine (as hydrochloride) 150mg modified release capsule blister pack

Main information

  • Trade name:
  • BLOOMS THE CHEMIST VENLAFAXINE XR venlafaxine (as hydrochloride) 150mg modified release capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BLOOMS THE CHEMIST VENLAFAXINE XR venlafaxine (as hydrochloride) 150mg modified release capsule blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 177457
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

177457

BLOOMS THE CHEMIST VENLAFAXINE XR venlafaxine (as hydrochloride) 150mg modified release

capsule 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

25/03/2011

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. BLOOMS THE CHEMIST VENLAFAXINE XR venlafaxine (as hydrochloride) 150mg modified release capsule

blister pack

Product Type

Single Medicine Product

Effective date

11/01/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of major depression, including prevention of relapse and recurrence where appropriate.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. venlafaxine (as hydrochloride) 150mg modified release capsule blister pack

Dosage Form

Capsule, modified release

Route of Administration

Oral

Visual Identification

Size No 00 hard gelatin capsule with opaque scarlet body and lid,

containing three round biconvex film coated tablets.

Active Ingredients

Venlafaxine hydrochloride

169.71 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 11:26:17 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

Blooms the Chemist

Venlafaxine XR

Capsules

Contains the active ingredient venlafaxine (as venlafaxine hydrochloride)

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 venlafaxine. 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

Blooms the Chemist Venlafaxine XR

Capsules. It contains the active

ingredient venlafaxine (as

venlafaxine hydrochloride).

It is used to treat major depression,

and to prevent it coming back. It is

also used in the treatment of panic

attacks and anxiety, including

avoidance or fear of social situations.

How it works

Depression can affect your whole

body and may cause emotional and

physical symptoms such as feeling

low in spirit, being unable to enjoy

life, poor appetite or overeating,

disturbed sleep, loss of sex drive,

lack of energy and feeling guilty over

nothing.

Excessive anxiety is a condition in

which you feel constantly and

uncontrollably worried and

distressed. It may also make you feel

irritable, and cause difficulty in

thinking and sleeping. Other

common symptoms associated with

anxiety may include a dry mouth, a

lump in the throat, cold clammy

hands, diarrhoea and nausea.

Depression and anxiety are treatable

illnesses. Anxiety or tension

associated with the normal stress of

everyday life usually does not require

treatment with medicines.

Venlafaxine belongs to a class of

medications for depression, called

Serotonin-Noradrenaline Reuptake

Inhibitors (SNRIs).

Serotonin and noradrenaline are

chemical messengers that allow

certain nerves in the brain to work.

Venlafaxine increases the level of

these two messengers. Experts think

this is how it helps to restore your

feeling of wellness.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed

Venlafaxine XR for another reason.

This medicine is available only with

a doctor's prescription.

There is no evidence that this

medicine is addictive.

Use in children

Do not give venlafaxine to children

or adolescents under 18 years of

age.

The safety and effectiveness of

venlafaxine in this age group have

not been established.

BLOOMS THE CHEMIST VENLAFAXINE XR CAPSULES

Before you take this

medicine

When you must not take it

Do not take this medicine if you

are taking other medicines called

Monoamine Oxidase Inhibitors

(MAOIs). These may be used for

the treatment of depression

(phenelzine, tranylcypromine,

moclobemide), Parkinson's disease

(selegiline) or infections (linezolid)

or diagnosis of certain conditions/

treatment of certain blood

disorders (methylene blue).

There may be others so check with

your doctor or pharmacist.

Do not take venlafaxine until 14

days after stopping most MAOIs,

and do not take any MAOIs until

more than one week after stopping

venlafaxine (see also point 7 in

"Before You Start to Take it").

(However you may take venlafaxine

24 hours after stopping the reversible

MAOI called moclobemide.)

Taking venlafaxine with a MAOI

may cause a serious reaction with a

sudden increase in body temperature,

extremely high blood pressure and

severe convulsions.

Do not take this medicine if:

The expiry date (EXP) printed on

the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

You have had an allergic

reaction to venlafaxine or any

of the ingredients listed at the

end of this leaflet.

Symptoms of an allergic reaction

may include 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 hayfever-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.

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:

epilepsy or fits (seizures or

convulsions)

a personal or family history of

bipolar disorder

aggression

drug abuse or misuse

blood pressure problems

diabetes

acute angle glaucoma or

increased pressure in the eye

a tendency to bleed more than

normal

other blood disorders

raised cholesterol levels

problems with your kidneys or

liver

low sodium levels in your blood,

or a condition called SIADH

(Syndrome of Inappropriate

Antidiuretic Hormone Secretion)

thoughts or actions relating to

self-harm or suicide

problems with your heart

Your doctor may wish to do some

heart tests such as an

electrocardiogram (ECG) or

blood tests during treatment with

venlafaxine.

any other medical conditions.

You are currently pregnant or you

plan to become pregnant. There

have been reports that babies

exposed to venlafaxine and other

antidepressants during the third

trimester of pregnancy may

develop complications after birth.

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 breastfeed.

Venlafaxine passes into breast

milk and there is a possibility that

the breastfed baby may be

affected. For this reason, the use

of venlafaxine is not

recommended if you are

breastfeeding. 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 any medical tests or

treatments.

You are currently receiving or are

planning to receive dental

treatment.

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

venlafaxine. These include:

Medicines called Monoamine

Oxidase Inhibitors (MAOIs).

MAOIs may be used for the

treatment of depression

(phenelzine, tranylcypromine,

moclobemide), Parkinson's

disease (selegiline), infections

(linezolid) and diagnosing

certain conditions/treating

certain blood disorders

(methylene blue). Do not take

venlafaxine until 14 days after

stopping most MAOIs, and do

not take any MAOIs until more

than one week after stopping

venlafaxine. For moclobemide,

do not take venlafaxine until at

least 24 hours after stopping

moclobemide, and do not take

moclobemide until more than

BLOOMS THE CHEMIST VENLAFAXINE XR CAPSULES

one week after stopping

venlafaxine.

St John's wort (Hypericum

perforatum) or tryptophan,

contained in some multivitamin

and herbal preparations, which

can be bought without a

prescription

Medicines used to treat

Parkinson's disease, called

dopamine agonists

Any other medications for

depression, anxiety, obsessive-

compulsive disorder or

premenstrual dysphoric disorder

Haloperidol, risperidone, lithium

or clozapine (used to treat

conditions which affect the way

you think, feel or act)

Tramadol (a strong pain killer)

Any other medicine which may

have an effect on the brain

Cimetidine (used to treat reflux

and stomach ulcers)

Medicines called triptans (used to

treat migraine)

Amiodarone or quinidine (used to

treat irregular heartbeats)

Medicines used to prevent blood

clots - e.g. warfarin and

clopidogrel

Medicines called diuretics, used

for reducing water in your body

and treating high blood pressure

Medicines used to treat diabetes.

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Your doctor may also wish to do

some heart tests such as an

electrocardiogram (ECG) or blood

tests if you are using any of the

following whilst taking venlafaxine:

Warfarin (used to prevent blood

clotting)

Indinavir (an antiviral)

Erythromycin (used to treat

infections)

Ketoconazole or fluconazole

(used as antifungal medicines)

Medications for weight loss,

including phentermine and

sibutramine

Metoprolol (used to treat high

blood pressure or angina)

Any medications that can affect

your heart beat

Grapefruit juice.

Other interactions not listed above

may also occur.

How to take this

medicine

Follow carefully all directions given

to you by your doctor or pharmacist.

Their instructions may be different to

the information in this leaflet.

How much to take

Your doctor or pharmacist 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.

The usual starting dose is 75 mg

taken once daily.

If necessary, after two weeks, your

doctor may increase your dose. The

maximum you should take in one day

is 225 mg.

The dose may be much lower if you

have liver or kidney problems.

If you have kidney or liver problems,

you may need a lower dose of

venlafaxine.

If you have heart problems and your

doctor wishes to increase your dose

of venlafaxine, your doctor may first

do some blood tests or heart tests

such as an electrocardiogram (ECG).

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

How to take it

Swallow the capsules whole with a

glass of water or other non-

alcoholic liquid. Do not divide,

crush, chew or place the capsules

in water.

Inside Venlafaxine XR capsules are

tablets that contain the venlafaxine

active ingredient. As the medicine

travels the length of your

gastrointestinal tract, venlafaxine is

slowly released.

When to take it

Take venlafaxine once daily with

food, either in the morning or in the

evening.

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.

Avoid drinking alcohol while you

are taking venlafaxine.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

Although you may begin to feel

better after two weeks, it may take

several weeks before you feel much

better. It is important to give

venlafaxine time to work.

Even when you feel well again, you

may need to keep taking venlafaxine

for several months to make sure the

benefits last. Discuss this with your

doctor and do not stop taking

venlafaxine until gaining your

doctor's agreement.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If it is less than 12 hours until your

next dose, skip the missed dose and

take your next dose at the usual time.

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 missed doses.

This may increase the chance of you

experiencing side effects.

Contact your doctor if you have

missed more than two doses in a row.

BLOOMS THE CHEMIST VENLAFAXINE XR CAPSULES

Always finish the capsules you are

taking in the current pack before you

start a new pack.

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.

If you take too much venlafaxine,

you may:

Feel sleepy

Vomit

Have an increased heart rate or

changes in heart rhythm

Have a seizure (fits)

Have breathing difficulties

Become unconscious

Have dilated pupils.

While you are taking

this medicine

Things you must do

Watch carefully for signs that your

depression is getting worse,

especially in the first few weeks of

treatment or if your dose has

changed.

Tell your doctor immediately if

you experience any of the following

symptoms, especially if they are

severe, you have not had these

symptoms before or they happen

very suddenly:

anxiety or agitation

panic attacks

difficulty sleeping

irritability

aggressiveness

hostility or impulsiveness

restlessness

overactivity or uninhibited

behaviour

other unusual changes in

behaviour

thoughts of suicide.

Tell your doctor immediately if

you have any thoughts about

suicide or doing harm to yourself.

Warning signs of suicide:

All thoughts or talk about suicide or

violence are serious. If you or

someone you know is showing the

following warning signs, either

contact your doctor or a mental

health advisor right away or go to the

nearest hospital for treatment.

thoughts or talk about death or

suicide.

thoughts or talk about self-harm

or doing harm to others.

any recent attempts of self-harm.

an increase in aggressive

behaviour, irritability or agitation.

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

you become pregnant.

Make sure your midwife and/or

doctor know immediately that

you are pregnant and taking

venlafaxine, as there is a

possibility of problems

developing in unborn children.

Symptoms such as feeding

difficulty, vomiting, tremor,

irritability and constant crying

have been reported rarely in

newborn babies after mothers

have taken venlafaxine in the last

3 months of pregnancy. In

addition, when taken particularly

in the last 3 months of pregnancy,

medicines like venlafaxine may

increase the risk of a serious

condition in babies, called

persistent pulmonary

hypertension of the newborn

(PPHN), making the baby breathe

faster and appear bluish. These

symptoms usually begin during

the first 24 hours after the baby is

born. If this happens to your baby

you should contact your midwife

and/or doctor immediately.

you are breastfeeding or are

planning to breastfeed

you are about to have any blood

tests

you are going to have surgery 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.

Some people (especially older people

and/or those taking diuretics/water

tablets) may experience a lack of

sodium in the blood when taking this

medicine. Tell your doctor if you get

a headache or start to feel dizzy,

confused, forgetful, weak, unsteady

or unable to concentrate. Make sure

to drink plenty of fluids.

If you are being treated for

depression, be sure to discuss with

your doctor any problems you may

have and how you feel, especially

any feelings of severe sadness,

thoughts of suicide, bursts of unusual

energy, anger or aggression, or if you

become particularly agitated or

restless.

This will help your doctor to

determine the best treatment for you.

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 or pharmacist tells you to

BLOOMS THE CHEMIST VENLAFAXINE XR CAPSULES

Stop taking your medicine, or

change the dosage, without first

checking with your doctor

Suddenly stop taking these

capsules if you have been taking

them for some time.

Check with your doctor for the best

way to slowly reduce the amount of

venlafaxine you are taking before

stopping completely.

Side effects from stopping treatment

with venlafaxine may include:

headache

nausea and vomiting

dizziness

insomnia

nervousness

anxiety

confusion and agitation

diarrhoea

sweating

loss of appetite

tremor

flu-like symptoms

impaired coordination and

balance

tingling or numbness of the hands

and feet.

Slowly reducing the amount of

venlafaxine being taken reduces the

possibility of these effects occurring.

Things to be careful of

Venlafaxine may make you feel

drowsy. Be careful when driving or

operating machinery until you know

how this medicine affects you.

Possible side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Venlafaxine XR 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 or pharmacist if

you notice any of the following.

This list includes the more common

side effects. Mostly, these are mild:

Stomach or bowel problems such

as:

nausea or vomiting

loss of appetite

diarrhoea

constipation

wind

Changes in your behaviour such

as:

difficulty sleeping or abnormal

dreams

sexual function problems such as

delayed ejaculation, problems

with erection, decreased sex drive

or difficulties achieving orgasm

nervousness

teeth grinding

a feeling of apathy or not caring

about things or not being part of

your body

excessive enthusiasm or desire,

delusions (mania).

Difficulty thinking or working

because of:

yawning

feeling sedated or drowsy

fainting or dizziness after

standing up

changes in muscle tone

muscle weakness or fatigue

restlessness, agitation or

difficulty sitting still

headache

heavy or irregular menstrual

periods.

Changes in your appearance such

as:

sweating (including night sweats)

hot flushes

rash

hair loss

itchiness

weight loss or weight gain

unusual milk production

Changes in your sight, hearing,

taste or touch such as:

dilated pupils

sensitivity to sunlight

ringing in the ears

altered taste

dry mouth

sore throat

numbness or pins and needles.

Tell your doctor as soon as possible

if you notice any of the following.

These may be serious side effects.

You may need medical attention.

Most of these side effects are rare.

blurred vision

cloudy urine, problems passing

urine, passing urine more

frequently, or being unable to

control urination

muscle tremors, spasms,

twitching, jerky movements or

sustained muscle contractions

impaired coordination and

balance

increase in bone fractures

abnormal facial movements such

as tongue thrusting, repetitive

chewing, jaw swinging, or

grimacing

hallucinations

confusion

excessively overactive

rapid heart beat

problems with breathing

bleeding or bruising more easily

than normal.

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 are usually very rare. You may

need urgent medical attention or

hospitalisation.

BLOOMS THE CHEMIST VENLAFAXINE XR CAPSULES

fits or seizures, which may be

accompanied by a sudden fever

symptoms of sudden fever with

sweating, rapid heartbeat and

muscle stiffness, which may lead

to loss of consciousness

palpitations, fainting, shortness of

breath or chest pain

dark, red or cola coloured urine,

muscle weakness and tenderness,

stiffness or aching

stomach pain, yellowing of the

skin, nausea, fever, clammy skin

and sweating

yellowing of the skin or eyeballs,

fever, fatigue, loss of appetite,

dark coloured urine or light

coloured bowel movements

a severe skin reaction with

painful red areas and large

blisters, accompanied by fever

and chills, aching muscles and

generally feeling unwell.

symptoms of a high fever,

agitation, confusion, trembling

and abrupt contractions of

muscles

signs of an infection such as

severe chills, fever, sore throat

and mouth ulcers

black sticky bowel motions or

bloody diarrhoea.

Other changes you may not be

aware of which can be identified by

blood tests:

increased blood pressure

increase in blood cholesterol

levels.

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to Venlafaxine

XR, 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:

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

hayfever-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 or pharmacist 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 Blooms The Chemist

Venlafaxine XR looks like

75 mg capsules

The capsules have an opaque flesh-

coloured cap and body.

Blister pack of 28 capsules.

150 mg capsules

The capsules have an opaque scarlet-

coloured cap and body.

Blister pack of 28 capsules.

Not all strengths, pack types and/or

pack sizes may be available.

Ingredients

Each capsule contains 75 or 150 mg

of venlafaxine (as venlafaxine

hydrochloride) as the active

ingredient.

It also contains the following inactive

ingredients:

Hypromellose

Sodium lauryl sulfate

Magnesium stearate

Ammonio methacrylate

copolymer

Basic butylated methacrylate

copolymer

Titanium dioxide (E171, CI

77891)

Gelatin

Red iron oxide (E172, C177491)

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

Blooms The Chemist Venlafaxine

XR 75 mg capsules (blisters)

AUST R: 177456

Blooms The Chemist Venlafaxine

XR 150 mg capsules (blisters)

AUST R: 177457

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park, NSW 2113

This leaflet was last updated in

January 2017

BLOOMS THE CHEMIST VENLAFAXINE XR CAPSULES