JONCIA

Main information

  • Trade name:
  • JONCIA
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • JONCIA
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 176515
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

176515

JONCIA milnacipran hydrochloride 100 mg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Pierre Fabre Australia Pty Ltd

Postal Address

PO Box 6493,North Sydney,Sydney, NSW, 2059

Australia

ARTG Start Date

17/11/2011

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. JONCIA

Product Type

Single Medicine Product

Effective date

17/11/2011

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Management of fibromyalgia

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PCTFE (Aclar)/Al

3 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

28 capsules

(S4) Prescription Only Medicine

14 capsules

(S4) Prescription Only Medicine

56 capsules

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

orange cap printed 'PFM', yellow body printed '100'

Active Ingredients

Milnacipran hydrochloride

100 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 12:49:50 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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

CONSUMER MEDICINE INFORMATION

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JONCIA

®

25, 50, 100 mg capsules

Milnacipran hydrochloride

What is in this leaflet

This leaflet answers some

common questions about

Joncia

It does not contain all the

available information.

It does not take the place

of talking to your doctor or

pharmacist.

All medicines have

benefits and risks. Your

doctor has weighed the

risks of you taking Joncia

against the benefits this

medicine is expected to

have for you.

If you have any

concerns about taking

this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the

medicine. You may need

to read it again.

What Joncia

®

is used

for

Joncia

is used to manage

fibromyalgia.

Fibromyalgia is a health

problem involving muscle

and joint pain, tenderness,

tiredness, sleep problems

and a number of

symptoms such as

morning stiffness,

mood disturbances and

cognition problems.

Joncia

is a kind of

medicine called a

serotonin-noradrenaline

reuptake inhibitor which

has the ability to increase

the levels of the

biochemicals, serotonin

and noradrenaline thereby

improving the problems

experienced with

fibromyalgia syndrome.

Your doctor may have

prescribed Joncia

another purpose.

Ask your doctor if you

have any questions about

why Joncia

has been

prescribed for you.

This medicine is available

only on a doctor’s

prescription.

Before you take

Joncia

®

When you must not

take it

You must not take

Joncia

®

if you are taking

medicine to treat

depression.

Joncia

is not used to

treat depression, but it

acts like medicines that

are used to treat

depression

(antidepressants) and

other psychiatric

disorders. If you are

taking medicine to treat

another psychiatric

disorder you should

discuss this with your

doctor before you take

Joncia

If you take Joncia

with

medicines to treat

depression, the potentially

life-threatening condition

of serotonin syndrome

may occur. Serotonin

syndrome may include

agitation, hallucinations,

coma, changes in blood

pressure, fast heart rate,

increased body

temperature,

incoordination, nausea

and vomiting.

Do not take Joncia

®

if

you have an allergy to

Joncia

®

or any of the

ingredients listed at the

end of this leaflet

Some of the symptoms of

an allergic reaction may

include:

shortness of breath

wheezing or difficulty

breathing

swelling of the face,

lips, tongue or other

parts of the body

rash, itching or hives

on the skin

Do not take Joncia

®

if

you have severe

problems with your

heart, a high risk of

serious arrhythmia

(changes in the rate or

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rhythm of your heart

beat), uncontrolled high

blood pressure or

severe or unstable heart

disease.

Joncia

can increase

blood pressure and heart

rate which may make your

condition worse.

Do not take Joncia

®

if

you have glaucoma.

Do not take Joncia

®

if

you are having

injections of adrenaline

or noradrenaline.

Taking milnacipran with

this kind of medicine may

cause high blood pressure

and possibly change the

rhythm or rate of your

heart beat.

Ask your doctor or

pharmacist if you are

not sure if you have

been taking or have

been given one of these

medicines.

Do not take Joncia

®

if

you are breastfeeding.

Small amounts of the

active ingredient in

Joncia

may pass into

breast milk and therefore

there is a possibility that

the breast-fed baby may

be affected.

Do not take Joncia

®

after

the expiry date printed

on the pack. The expiry

date refers to the last

day of that month.

If you take this medicine

after the expiry date has

passed, it may not work

as well.

Do not take Joncia

®

if

the packaging is torn or

shows signs of

tampering.

If your medicine has

expired or is damaged,

return it to your

pharmacist for disposal.

If you are not sure

whether you should

start taking Joncia

®

,

talk

to your doctor.

Before you start to

take it

Tell your doctor if you

have allergies to any

other medicines, foods,

preservatives or dyes.

Tell your doctor if you

have or have had any

medical conditions,

especially the following:

kidney disease;

liver disease;

glaucoma or high

pressure of the fluids

inside your eye;

an enlarged prostate

or difficulty urinating;

epilepsy (fits or

convulsions) or a

history of epilepsy;

high blood pressure or

heart disease;

bleeding problems;

Tell your doctor if you

suffer from depression

or have or have had

suicidal thoughts.

Symptoms of depression

may include thoughts of

harming yourself or

committing suicide. It is

the experience with

depression that these

suicidal thoughts or

actions may increase in

the early stages of

recovering from your

depression. Joncia

anti-depressant effects,

although it is not used to

treat depression.

Therefore, during the first

few weeks or more of

treatment with Joncia

thoughts of suicide may

get worse.

You should tell your

doctor if you suffer from

depression or have or

have had suicidal

thoughts so that you will

receive careful monitoring

during your treatment with

Joncia

Tell your doctor if you

are pregnant or intend

to become pregnant.

Taking Joncia

®

during

pregnancy is not

recommended. If you

discover that you are

pregnant during treatment,

tell your doctor. Your

doctor will discuss the

risks and benefits of using

Joncia

®

when pregnant

and decide whether or not

treatment should be

continued.

Tell your doctor if you

drink a lot of alcohol.

Taking other

medicines

Tell your doctor or

pharmacist if you are

taking any other

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medicines, including

any that you buy without

a prescription from your

pharmacy, supermarket

or health food shop.

Some medicines and

Joncia

®

may interfere with

each other. These

include:

MAO inhibitors,

medicines used to

treat depression;

serotonin reuptake

inhibitors, medicines

used to treat

depression;

St John’s wort, a

herbal product used to

treat depression;

injections of

adrenaline or

noradrenaline;

digoxin, a medicine

used to treat heart

failure;

clonidine, a medicine

used to treat high

blood pressure;

medicines used to

treat migraine

belonging to a group

known as triptans eg.

sumatriptan;

medicines which have

an effect on blood

clotting such as

NSAIDS and aspirin,

or other medicines that

may increase the risk

of bleeding;

some medicines used

to treat Parkinson’s

disease.

medicines which affect

the central nervous

system.

diuretics, medicines

used to treat swelling

of the ankles, feet or

legs or high blood

pressure.

lithium, a medicine

used to treat mood

swings and some

types of depression.

antipsychotic

medicines, used to

treat certain mental

and emotional

conditions.

dopamine agonists,

medicines typically

used for treating

Parkinson’s disease.

tryptophan, an amino

acid found in protein-

based foods which can

increase the levels of

serotonin in the brain.

These medicines may be

affected by Joncia

, or

may affect how well it

works. You may need to

take different amounts of

your medicine, or you may

need to take different

medicines. Your doctor or

pharmacist will advise

you.

Your doctor and

pharmacist have more

information on medicines

to be careful with or to

avoid while taking Joncia

Avoid drinking alcohol

or taking medicines

which contain alcohol

while taking Joncia

®

.

Alcohol may interfere with

the way Joncia

®

works or

how well it works.

If you are 65 years or

older, you should be

especially careful while

taking Joncia

®

. Report

any side effects

promptly to your doctor.

As people grow older,

they are more likely to get

side effects from

medicines.

The safety and

effectiveness of Joncia

®

in children and

adolescents under the

age of 18 years have not

been established. Use

in children and

adolescents aged under

18 years is not

recommended.

If you have not told your

doctor or pharmacist

about any of the above,

tell them before you

start taking Joncia

®

.

How to take Joncia

®

Take Joncia

®

exactly as

your doctor has

prescribed.

How much to take

Your doctor will decide

what dose you will

receive.

Your treatment with

Joncia

®

has to be started

gradually. Your doctor will

prescribe a dosage

schedule for the start of

your treatment.

After this initiation period,

the usual dose is one 50

mg capsule in the morning

and one 50 mg capsule in

the evening, preferably

during meals.

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Your doctor may prescribe

a different dosing

schedule and/or dose if

you have problems with

your kidneys.

If you feel that Joncia

®

not having enough of an

effect or is having too

strong an effect, talk to

your doctor or pharmacist.

Follow all directions

given to you by your

doctor and pharmacist

carefully.

They may differ from the

information contained in

this leaflet.

If you do not understand

the instructions on the box

or bottle, ask your doctor

or pharmacist for help.

How to take it

Swallow Joncia

®

with a

glass of water preferably

during meals.

How long to take it

Continue taking your

medicine for as long as

your doctor tells you.

Treatment will usually last

for several months.

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,

then go back to taking it

as you would normally.

Do not double a dose to

make up for the dose

you have missed.

If you are not sure what

to do, ask your doctor or

pharmacist.

If you have trouble

remembering to take your

medicine, ask your

pharmacist for some hints

If you take too much

(overdose)

Immediately contact

your doctor or the

Poisons Information

Centre (In Australia

telephone 131 126. In

New Zealand telephone

0800 764 766) for advice,

or go to Accident and

Emergency at the

nearest hospital, if you

think that you or anyone

else may have taken too

much Joncia

®

.

You may need urgent

medical attention.

If you stop taking it

Do not stop taking

Joncia

®

without the

advice of your doctor

even if you feel better.

If your doctor decides that

you no longer need to

take Joncia

, your doctor`

will reduce your dose

gradually over a period of

no less than two weeks

before stopping treatment

altogether. Suddenly

stopping Joncia

may lead

to headache, dizziness,

sleepiness, diarrhoea,

vomiting, anxiety

disorders and pain

(withdrawal symptoms).

While you are taking

Joncia

®

Things you must do

You must tell your

doctor if you are

experiencing any

distressing thoughts or

feelings at any time

while you are taking

Joncia

®

.

If you are suffering from

depression, you must

tell your doctor

immediately if you feel

that your depression is

getting worse or if you

are having suicidal

feelings or thoughts of

harming yourself while

you are taking Joncia

®

.

If you are about to be

started on any new

medicine, remind your

doctor and pharmacist

that you are taking

Joncia

®

.

Tell any other doctors,

dentists and

pharmacists who treat

you that you are taking

Joncia

®

.

If you are going to have

surgery, tell the surgeon

or anaesthetist that you

are taking Joncia

®

.

If you become pregnant

while taking Joncia

®

, tell

your doctor

immediately.

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Things you must not

do

Do not stop taking

Joncia

®

without the

advice of your doctor.

Suddenly stopping

Joncia

®

may cause

withdrawal symptoms.

Do not give this

medicine to anyone

else, even if their

symptoms seem similar

to yours or if they have

the same condition as

you.

Do not take Joncia

®

to

treat any other

complaints unless your

doctor tells you to.

Things to be careful of

Be careful driving or

operating machinery

until you know how

Joncia

®

affects you.

Joncia

may reduce

physical ability and

alertness in some people.

Side effects

Tell your doctor as soon

as possible if you do not

feel well while you are

taking Joncia

®

.

Like other medicines,

Joncia

can cause some

side effects. If they occur,

most are likely to be minor

and temporary. However,

some may be serious and

need medical attention.

Do not be alarmed by

the following 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

notice any of the

following and they worry

you:

headache

nausea

constipation

excessive sweating

hot flushes

loss of appetite

weight loss

agitation

anxiety

depression

problems sleeping

dizziness

migraine

shaking or tremor

change in taste

increase in skin

sensitivity

stomach pain or

discomfort

diarrhoea

dry mouth

indigestion

vomiting

itching, rash

muscle ache, pain or

tenderness

pain passing urine

problems with

erection, ejaculation or

pain in the testicles

fatigue

memory problems

palpitations (fast or

irregular heart beat)

fast heart rate

high blood pressure

chest pain

swelling

These are the more

common side effects of

Joncia

Tell your doctor

immediately if you have

any suicidal thoughts or

other mental/mood

changes.

Contact your doctor or

mental health

professional

immediately or go to the

nearest hospital for

treatment if you or

someone you know is

showing any of the

following warning signs

of suicide:

worsening of your

anxiety or

depression;

thoughts or talk of

death or suicide;

thoughts or talk of

self-harm or harm

to others;

any recent

attempts of self-

harm or suicide;

an extreme

increase in activity

and talking

(mania);

increase in

agitation or

restlessness;

panic attacks;

increase in

aggressive

behavior, irritability

or any other

unusual changes

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in behavior or

mood.

All mentions of suicide

or violence must be

taken seriously.

If any of the following

happen, tell your doctor

immediately or go to

Accident and

Emergency at your

nearest hospital:

difficulty breathing

chest pain

palpitations, fast or

irregular heart beat

rash, itching or hives

on the skin

swelling of the feet

and ankles, face, lips,

tongue or other parts

of the body.

severe agitation,

confusion,

hallucinations, inability

to walk, fainting or

seizure.

These are very serious

side effects. You may

need urgent medical

attention or

hospitalisation. Serious

side effects are rare.

Other side effects not

listed above may also

occur in some patients.

Tell your doctor if you

notice anything else that

is making you feel

unwell.

After using Joncia

®

Storage

Your Joncia

capsules

both in the blister pack or

in the bottle, should be

stored

in a dry place where the

temperature stays below

Keep your capsules in

their original

pack/container until it is

time to take them.

Do not store Joncia

®

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 young 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 Joncia

®

,

or the capsules have

passed their expiry date,

ask your pharmacist

what to do with any

capsules left over.

Product description

What it looks like

The 25 mg capsules are

yellow and white with

“PFM 25” imprinted in

black.

The 50 mg capsules are

orange and white with

“PFM 50” imprinted in

black.

The 100 mg capsules are

orange and yellow with

“PFM 100” imprinted in

black.

The 25, 50 and 100 mg

capsules are supplied in

blister packs of 14, 28, or

56 capsules.

Ingredients

Active ingredient:

milnacipran

hydrochloride

Other ingredients:

calcium hydrogen

phosphate

carmellose calcium

povidone K30

silica hydrophobic-

colloidal

magnesium stearate

talc-purified

The capsule shell for the

25 mg and 100 mg

strengths contain:

titanium dioxide

(E171)

quinoline yellow

(E104)

sunset yellow FCF

(E110)

gelatin

The capsule shell for the

50 mg strength contains:

titanium dioxide

(E171)

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sunset yellow FCF

(E110)

gelatin

The capsules are marked

with food grade ink.

Distributor

Joncia

®

is supplied in

Australia by:

Pierre Fabre Australia Pty

Limited

Suite 901, 1 Elizabeth

Plaza, North Sydney,

NSW 2060

Australian Registration

Number:

25 mg: AUST R 176508

50 mg: AUST R 176513

100 mg: AUST R 176515

This leaflet was prepared

in November 2011 and

updated in August 2018.

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