CILOPAM-S escitalopram (as oxalate) 5 mg tablet blister

Main information

  • Trade name:
  • CILOPAM-S escitalopram (as oxalate) 5 mg tablet blister
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CILOPAM-S escitalopram (as oxalate) 5 mg tablet blister
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 191871
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

191871

CILOPAM-S escitalopram (as oxalate) 5 mg tablet blister

ARTG entry for

Medicine Registered

Sponsor

Eris Pharmaceuticals (Australia) Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088

Australia

ARTG Start Date

25/09/2012

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. CILOPAM-S escitalopram (as oxalate) 5 mg tablet blister

Product Type

Single Medicine Product

Effective date

16/09/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of major depression.,Treatment of social anxiety disorder (social phobia).,Treatment of generalised anxiety disorder.,Treatment of

obsessive-compulsive disorder.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

36 Months

Store below 30

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. CILOPAM-S escitalopram (as oxalate) 5 mg tablet blister

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, circular, biconvex, film-coated tablet with 'C5' embossed

on one side and plain on the other side.

Active Ingredients

escitalopram oxalate

6.37 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 28.11.2017 at 09:45:02 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

CILOPAM-S™

Consumer Medicine Information

Escitalopram oxalate, 5 mg, 10 mg & 20 mg tablets

What is in this leaflet

This leaflet answers some of the common questions people ask about CILOPAM-S. It does not

contain all the information that is known about CILOPAM-S.

It does not take the place of talking to your doctor and pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you taking this

medicine against the benefits they expect it will 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 CILOPAM-S is for

CILOPAM-S is used to treat depression.

It belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). They are

thought to work by their actions on brain chemicals called amines which are involved in controlling

mood.

Depression is longer lasting or more severe than the "low moods" everyone has from time to time

due to the stress of everyday life. It is thought to be caused by a chemical imbalance in parts of the

brain. This imbalance affects your whole body and can cause emotional and physical symptoms

such as feeling low in spirit, loss of interest in activities, being unable to enjoy life, poor appetite or

overeating, disturbed sleep, often waking up early, loss of sex drive, lack of energy and feeling

guilty over nothing.

CILOPAM-S corrects this chemical imbalance and may help relieve the symptoms of depression.

CILOPAM-S may also be used to treat patients who may avoid and/or are fearful of social

situations.

CILOPAM-S may also be used to treat patients who have excessive anxiety and worry.

CILOPAM-S may also be used to treat irrational fears or obsessional behaviour (obsessive-

compulsive disorder). Obsessive-compulsive disorder involves having both obsessions and

compulsions. Obsessions are unwanted thoughts that occur over and over again. Compulsions are

the ongoing need to repeat certain actions as a result of these thoughts.

Your doctor, however, may prescribe this medicine for another purpose.

Ask your doctor if you have any questions about why it has been prescribed for you.

This medicine is only available with a doctor’s prescription.

CILOPAM-S is not addictive. However, if you suddenly stop taking it, you may get side effects.

Tell your doctor if you get any side effects after stopping CILOPAM-S.

Before you take CILOPAM-S

When you must not take it

Do not take CILOPAM-S if you are allergic to it, to any medicine containing citalopram, 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 or other parts of the body, or rash, itching or hives on the skin.

Do not take CILOPAM-S at the same time as the following other medicines:

pimozide, a medicine used to treat mental disorders

monoamine oxidase inhibitors (MAOIs), such as phenelzine, tranylcypromine and moclobemide

which are also used for the treatment of depression.

One day must elapse after you have finished taking moclobemide before you start taking

CILOPAM-S. If you have taken any other MAOI you will need to wait 14 days. After stopping

CILOPAM-S you must allow 14 days before taking any MAOI including moclobemide.

Taking CILOPAM-S with MAOIs may cause a serious reaction with a sudden increase in body

temperature, extremely high blood pressure and severe convulsions. Your doctor will know

when it is safe to start CILOPAM-S after the MAOI has been stopped.

Do not take it after the use by (expiry) date printed on the pack.

If you take it after the expiry date has passed, it may not work as well. The expiry date refers to the

last day of the month.

Do not take it if the packaging is torn or shows signs of tampering.

Do not use it to treat any other complaints unless your doctor tells you to. Do not give this

medicine to anyone else.

Before you start to take it

You must tell your doctor if:

1. you have allergies to any other substances such as foods, preservatives or dyes.

2. you are pregnant or intend to become pregnant.

Do not take CILOPAM-S if you are pregnant unless you and your doctor have discussed the risks

and benefits involved.

Make sure your doctor and/or midwife know you are on CILOPAM-S.

When taken during pregnancy, particularly in the last three months of pregnancy, medicines like

CILOPAM-S may affect the general condition of your newborn baby and 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 doctor and/or

midwife immediately.

If used during pregnancy CILOPAM-S should never be stopped abruptly.

Ask your doctor or pharmacist for advice before taking any medicine.

3. you are breast-feeding or planning to breast-feed.

Do not take CILOPAM-S if you are breast-feeding unless you and your doctor have discussed the

risks and benefits involved. It is not recommended that you breastfeed while taking CILOPAM-S

as it is excreted in breast milk.

4. you have, or have had, the following medical conditions:

a tendency to bleed or bruise easily

diabetes

heart disease

kidney disease

liver disease

bipolar disorder (manic depression)

a history of seizures or fits

restlessness and/or a need to move often.

5. you are receiving electroconvulsive therapy.

Do not give CILOPAM-S to a child or adolescent.

There is no experience with its use in children or adolescents under 18 years old.

CILOPAM-S can be given to elderly patients over 65 years of age with a reduced dose.

The effects of CILOPAM-S in elderly patients are similar to that in other patients.

If you have not told your doctor about any of the above, tell them before you use CILOPAM-

S.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a

prescription from your pharmacy, supermarket or health food shop.

Some medicines and CILOPAM-S may interfere with each other. These include:

bupropion, a medicine helping to treat nicotine dependence

medicines used to treat reflux and ulcers, such as cimetidine, omeprazole, esomeprazole and

lansoprazole

medicines known to prolong bleeding, e.g. aspirin or other non-steroidal anti-inflammatory drugs

(NSAIDs)

ticlopidine and warfarin, medicines used to prevent blood clots

mefloquine, an anti-malaria medicine

sumatriptan, used to treat migraines

tramadol, used to relieve pain

medicines affecting the chemicals in the brain

some heart medications, e.g. flecainide, propafenone, metoprolol

tryptophan, an amino-acid

lithium, used to treat mood swings and some types of depression

antipsychotics, a class of medicines used to treat certain mental and emotional conditions, e.g.

risperidone, thioridazine and haloperidol

tricyclic antidepressants, e.g. imipramine, desipramine

St John's Wort (Hypericum perforatum), a herbal remedy

any other medicines for depression, anxiety, obsessive compulsive disorder or premenstrual

dysphoric disorder.

These medicines may be affected by CILOPAM-S, or may affect how well it works. You may need

to use different amounts of your medicines, or take different medicines. Your doctor will advise

you.

Some combinations of medicines may increase the risk of serious side effects and are potentially

life threatening.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while

taking CILOPAM-S.

How to take it

How much to take

Your doctor will decide what dose you will receive.

The standard dose for this medicine is 10 mg per day. This may be increased by your doctor to 20

mg per day.

The recommended maximum dose in elderly patients is 10 mg per day.

It is recommended that patients with liver disease receive an initial dose of 5 mg daily for the first

two weeks. Your doctor may increase the dose to 10 mg daily.

Your doctor may have prescribed a different dose.

Ask your doctor or pharmacist if you are unsure of the correct dose for you.

They will tell you exactly how much to take.

Follow the instructions they give you.

If you take the wrong dose, CILOPAM-S may not work as well and your condition may not improve.

How to take it

Swallow the tablets whole with a full glass of water.

Do not chew them.

When to take it

Take CILOPAM-S as a single dose either in the morning or in the evening.

Take CILOPAM-S with or without food.

How long to take it

Continue to take CILOPAM-S even if it takes some time before you feel any improvement in

your condition.

As with other medicines for the treatment of these conditions it may take a few weeks before you

feel any improvement.

Individuals will vary greatly in their response to CILOPAM-S. Your doctor will check your progress

at regular intervals.

The duration of treatment may vary for each individual, but is usually at least 6 months.

In some cases the doctor may decide that longer treatment is necessary.

Continue taking your medicine for as long as your doctor tells you, even if you begin to feel

better.

The underlying illness may persist for a long time and if you stop your treatment too soon, your

symptoms may return.

Do not stop taking this medicine suddenly.

If CILOPAM-S is stopped suddenly you may experience mild, but usually temporary, symptoms

such as dizziness, pins and needles, electric shock sensations, sleep disturbances (vivid dreams,

inability to sleep), feeling anxious or agitated, headaches, feeling sick (nausea), vomiting,

sweating, tremor (shaking), feeling confused, feeling emotional or irritable, diarrhoea, visual

disturbances, or fast or irregular heart beats.

When you have completed your course of treatment, the dose of CILOPAM-S is gradually reduced

over a couple of weeks rather than stopped abruptly.

Your doctor will tell you how to reduce the dosage so that you do not get these unwanted effects.

If you forget to take it

If you miss a dose and remember in less than 12 hours, take it straight away, and then go

back to taking it as you would normally.

Otherwise, if it is almost time for your next dose, skip the dose you missed and take the

next dose when you are meant to.

Do not take a double 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 when to take your medicine, ask your pharmacist for hints.

If you take too much (Overdose)

Telephone your doctor or the Poisons Information Centre (Australia: 13 11 26), or go to

Accident and Emergency at your nearest hospital immediately if you think that you or

anyone else may have taken too much CILOPAM-S, even if there are no signs of discomfort

or poisoning.

You may need urgent medical attention.

Symptoms of an overdose may include dizziness, low blood pressure, nausea (feeling sick),

vomiting, agitation, tremor (shaking) and rarely convulsions and coma.

While you are taking CILOPAM-S

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that

you are taking CILOPAM-S.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this

medicine.

If you become pregnant while taking CILOPAM-S, tell your doctor immediately.

Persons taking CILOPAM-S may be more likely to think about killing themselves or actually

trying to do so, especially when CILOPAM-S is first started or the dose is changed. Tell your

doctor immediately if you have thoughts about killing yourself or if you are close to or care

for someone using CILOPAM-S who talks about or shows signs of killing him or herself.

All mentions of suicide or violence must be taken seriously.

Occasionally, the symptoms of depression may include thoughts of suicide or self-harm. It is

possible that these symptoms continue or get worse until the full antidepressant effect of the

medicine becomes apparent. This is more likely to occur if you are a young adult, i.e. 18 to 24

years of age, and you have not used antidepressant medicines before.

Patients and care givers should pay attention for any of the following warning signs of

suicide-related behaviour while taking CILOPAM-S. Tell your doctor immediately, or even go

to the nearest hospital for treatment:

thoughts or talk of death or suicide

thoughts or talk of self-harm or harm to others

any recent attempts of self-harm

increase in aggressive behaviour, irritability or agitation.

Do not stop taking this medicine or change the dose without consulting your doctor, even if

you experience increased anxiety at the beginning of treatment.

At the beginning of treatment, some patients may experience increased anxiety which will

disappear during continued treatment.

Tell your doctor immediately if you experience symptoms such as restlessness or difficulty

in sitting or standing still.

These symptoms can occur during the first weeks of treatment.

Contact your doctor as soon as possible if you suddenly experience an episode of mania.

Some patients with bipolar disorder (manic depression) may enter into a manic phase. This is

characterised by profuse and rapidly changing ideas, exaggerated gaiety and excessive physical

activity.

Sometimes you may be unaware of the above-mentioned symptoms and therefore you may find it

helpful to ask a friend or relative to help you to observe the possible signs of change in your

behaviour.

Things you must not do

Do not give the tablets to anyone else, even if they have the same condition as you.

Do not take CILOPAM-S to treat any other complaints unless your doctor tells you to.

Do not stop taking CILOPAM-S, or lower the dosage, without checking with your doctor.

Do not let yourself run out of medicine over the weekend or on holidays.

Suddenly stopping CILOPAM-S may cause unwanted discontinuation symptoms such as

dizziness, headache and nausea. Your doctor will tell you when and how CILOPAM-S should be

discontinued. Your doctor will gradually reduce the amount you are using, usually over a period of

one to two weeks, before stopping completely.

Things to be careful of

Be careful driving or operating machinery until you know how CILOPAM-S affects you.

It may cause nausea, fatigue and dizziness in some people, especially early in the treatment. If you

have any of these symptoms, do not drive, operate machinery, or do anything else that could be

dangerous.

Avoid alcohol while you are taking this medicine.

It is not advisable to drink alcohol while you are being treated for depression.

Side effects

All medicines may have some unwanted side effects. Sometimes they are serious, but most of the

time they are not. Your doctor has weighed the risks of using this medicine against the benefits

he/she expects it will have for you.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are

taking CILOPAM-S.

It helps most people with depression, social anxiety disorder (social phobia), generalised anxiety

disorder and obsessive-compulsive disorder, but it may have unwanted side effects in a few

people.

The side effects of CILOPAM-S are, in general, mild and disappear after a short period of time.

Tell your doctor if you notice any of the following and they worry you:

decreased appetite or loss of appetite

dry mouth

diarrhoea

nausea (feeling sick)

sleeplessness

fatigue, sleepiness or drowsiness, yawning

increased sweating

sexual disturbances (decreased sexual drive; problems with ejaculation or erection; women may

experience difficulties achieving orgasm).

Tell your doctor as soon as possible if you notice any of the following:

agitation, confusion, panic attacks*, anxiety, restlessness*

dizziness

dizziness when you stand up due to low blood pressure*

low sodium levels in the blood (the symptoms are feeling sick and unwell with weak muscles or

feeling confused)*

abnormal liver function tests (increased amounts of liver enzymes in the blood)*

difficulties urinating*

unusual secretion of breast milk*

Bleeding disorders including skin and mucous bleeding (e.g. bruising*) and a low level of blood

platelets.*

rash, itching, patches of circumscribed swellings.

An increased risk of bone fractures has been observed in patients taking this type of medicine.*

These may be serious side effects of CILOPAM-S. You may need urgent medical attention.

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital, if

you notice any of the following:

Thoughts of harming yourself or thoughts of suicide, see also section "Things you must do"*.

serious allergic reaction (symptoms of an allergic reaction may include swelling of the face, lips,

mouth or throat which may cause difficulty in swallowing or breathing, or hives)

high fever, agitation, confusion, trembling and abrupt contractions of muscles (these symptoms

may be signs of a rare condition called serotonin syndrome)*

mania (i.e.: elevated mood and associated symptoms)*

hallucinations

seizures, tremors, movement disorders (involuntary movements of the muscles)*.

These are very serious side effects. You may need urgent medical attention or hospitalisation.

*The side effects marked with an asterisk (*) are a number of rare side effects that are known to

occur with medicines that work in a similar way to CILOPAM-S.

Tell your doctor if you notice anything else that is making you feel unwell.

Other side effects not listed above may occur in some people.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

After taking CILOPAM-S

Storage

Keep your tablets in the blister pack until it is time to take them.

If you take CILOPAM-S out of the blister pack it will not keep well.

Keep it in a cool dry place where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom or near a sink.

Heat and dampness can destroy some medicines.

Keep it 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.

Do not leave it in the car on hot days.

Disposal

Ask your pharmacist what to do with any CILOPAM-S tablets you have left over if your

doctor tells you to stop taking them, or you find that the expiry date has passed.

Product description

What CILOPAM-S looks like:

CILOPAM-S 5 mg tablets are white to off-white, circular, biconvex film-coated tablets with ‘C5’

embossed on one side and plain on other side in blister packs of 14*, 28*, 56* and 98* tablets.

CILOPAM-S 10 mg tablets are white to off-white, oval, biconvex film-coated tablets with ‘C4’

embossed on one side and notch break-line on other side in blister packs of 14*, 28*, 56* and 98*

tablets.

CILOPAM-S 20 mg tablets are white to off-white, oval, biconvex film-coated tablets with ‘C3’

embossed on one side and notch break-line on other side in blister packs of 14*, 28*, 56* and 98*

tablets.

* Some pack sizes and presentations may not be marketed.

Ingredients:

CILOPAM-S contains escitalopram oxalate as the active ingredient, equivalent to escitalopram 5

mg, 10 mg and 20 mg.

The tablets also contain the following in-active ingredients:

Microcrystalline cellulose;

Colloidal anhydrous silica;

Croscarmellose sodium;

Purified talc;

Magnesium stearate;

Hypromellose;

Macrogol 400; and

Titanium dioxide.

Distributor

Eris Pharmaceuticals (Australia) Pty Ltd

6 Eastern Road,

South Melbourne Vic. 3205

www.eris-pharma.com.au

This leaflet was prepared in October 2013.

5 mg

AUST R 191871

10 mg

AUST R 191884

20 mg

AUST R 191878

Version 2