BASIMGLURANT to a child under 18 years. The effect

BASIMGLURANT

Basimglurant
tablets

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Consumer Medicine Information (CMI)

 

What this leaflet contains

 

This
leaflet contains information that can help you use Basimglurant safely and
effectively.  

 

Your
doctor may have more information about Basimglurant, therefore this leaflet
should not act as a substitute for a conversation with your doctor or pharmacist.

 

For any further concerns about using
Basimglurant, ask your doctor.

 

This leaflet should be kept with the
medicine.  

 

What it is used for

 

Basimglurant
is available in mild release capsules or hard gelatin capsules for immediate
release of 1.5 mg.1

 

Basimglurant
is used to treat:

•    
Major Depressive Disorder, more
commonly known as depression2

•    
Anxiety 2

•    
Fragile X syndrome, also known as
FXS or Martin-Bell Syndrome2

 

Basimglurant
is one of a group of medicines called metabotropic glutamate receptor
modulators.3

 

Basimglurant
works by regulating a chemical in the brain known as glutamate, which is
involved in controlling mood.3

 

If you are unsure why you have been
prescribed Basimglurant, contact your doctor.

 

Note
that you may have been prescribed Basimglurant to treat a different condition
or illness. Contact your doctor if you are still unsure.

 

There
is not enough information available to advise the use of Basimglurant for
children under 18 years old.

 

Before you take it

 

When
you must not take it

Do not take Basimglurant if you are
taking another medicine called fluvoxamine to treat obsessive compulsive
disorder (OCD) or depression. Taking fluvoxamine with Basimglurant may alter
how long it takes for the drugs to leave your body, which will affect how often
you should be taking the drug.4

 

Do not take Basimglurant if you are
allergic to:

·   
any other medicine that also contains
Basimglurant

·   
any of the ingredients listed on the
last page of this leaflet.

 

Some
of the symptoms of an allergic reaction may include:

·   
watery or itchy eyes

·   
runny nose, blocked nose

·   
sore throat

·   
difficulty breathing

·   
swelling of any parts of the body

·   
itchy skin and/or a rash

 

Do not take Basimglurant if you are
pregnant.

Current
research has not yet revealed whether there are harmful effects of taking
Basimglurant while pregnant. Therefore, as a precaution, Basimglurant should
not be taken when pregnant.

 

Do not give Basimglurant to a child
under 18 years.

The
effect of Basimglurant on children younger than 18 years has not been
established yet.

 

Do not take Basimglurant after it
has expired or if the packaging is torn or tampered with

If
the packaging is damaged or the tablets have expired, return the tablets to the
pharmacist. See the packaging for an expiry date.

 

If you aren’t sure about the expiry
date or other information printed on the packaging, consult your doctor or
pharmacist. 

 

Before you
start to take it

Let your doctor know if you have, or
currently suffer from any of the following:

·   
Manic episodes1

·   
Meniere’s disease3

·   
Bipolar disorder5

·   
Mood disorders due to other medical conditions,
substance or drug abuse3

·   
or other conditions that could cause vertigo or
dizziness3

 

Based on
clinical trial results, Basimglurant may worsen these conditions.

 

Let your doctor know if you are allergic to any
preservatives or dyes that may be used in Basimglurant tablets.

 

Let your doctor know if you are or
plan to become pregnant or if you are breast feeding.

Current
research has not established the risks of taking Basimglurant whilst pregnant
or breast feeding, therefore it is best not to take Basimglurant if you are
pregnant or breastfeeding.

 

Risks
of taking basimglurant whilst breastfeeding or pregnant are unknown as of now.

 

Ensure you let your doctor know
about any of the above information before taking Basimglurant. 

 

Taking
other medicines

Let your doctor know if you are
taking any other medicines, even medicines that you can get without a
prescription.

Taking
Basimglurant can interfere with other medicines, including:

·   
Medicines used to treat Obsessive
Compulsive Disorder (E.g. Fluvoxamine)4

·   
Medicines used to treat epilepsy
(E.g. Carbamazepine)4

·   
Medicines used to treat anxiety
(E.g. Diazepam)4

·   
Medicines used to treat migraine
(E.g. Triptans, NSAIDs)4

·   
Medicines used to treat vertigo
(E.g. Ondansetron)3

·   
Medicines used to treat depression (E.g. SSRIs, tricyclic
antidepressants4

 

There may
be more medicines that can interfere with Basimglurant that haven’t been
confirmed yet. The above list is based off clinical trial results. 

 

Basimglurant
might affect how these medicines work. Alternatively, these medicines might
affect how basimglurant works.

 

Your
doctor may need to change how much of each medicine you take.

 

How to take it

 

Carefully follow all instructions given
to you by your doctor. Your doctor might give you different
instructions compared to this leaflet. Follow your doctor’s instructions.

 

If you do not understand the
instructions, let your doctor know and they will be able to help.

 

How much to
take

The
usual dose is one capsule once per day.1 Your doctor might change
this dose depending on your condition.

 

How to take
it

No specific method of taking the
tablet has been proven to be better, therefore taking with a glass of water is
recommended.

 

When to
take it

Take
Basimglurant in the morning when you wake up. It is best taken on an empty
stomach.1

 

(The
above information is based on clinical trials where patients took basimglurant
on an empty stomach.)

 

It is recommended to take  Baasimglurant at the same time each day   

Having
a repetitive routine will help you remember to take your medicine at the right
time.   

 

(Current
research has yet to confirm whether taking the drug fasted or unfasted has a significant
difference. Phase II trials showed promising results when subjects took the
drug fasted)1

 

How long to
take it

Take Basimglurant for as long as
your doctor has told you to

Keep
taking Basimglurant even if you feel better.

 

Don’t
worry if you do not feel better as soon as you take Basimglurant. An
improvement might only be felt a week after taking the medicine.3  

 

(This
information is an estimate from data from Phase II studies)

 

Continue taking Basimglurant  until the pack is finished

 

 

If you
forget to take it

Information about skipping doses of
basimglurant is unknown at the moment.

 

(Speculative)Do not take two doses
at once to make up for the dose that you missed.

You
may experience worsened side effects if you take too much Basimglurant at once.

 

For further questions about missing
a dose or for tips on how to remember to take your medicine, ask your doctor.

 

If you take
too much Basimglurant (overdose)

Call your doctor and contact the  Poisons Information Centre (13 11 26) as soon
as possible, or go to your nearest hospital. Do this if you think you, or
anyone else has overdosed on Basimglurant. Do this even if you feel fine after
overdosing.

You
may still need medical attention even if you feel fine immediately after
overdosing.  

 

Symptoms
of an overdose may include dizziness, feeling very excited and restlessness.1

 

While you are taking it

 

Things you
must do

If your doctor prescribes another
medicine for another condition, make sure you let them know that you are taking
Basimglurant.

 

If any other doctor or dentist or
pharmacist is treating you, let them know that you are taking Basimglurant.

 

If you are going to have surgery, let
the surgeon know that you are taking Basimglurant.

In
case basimglurant affects other medicines used during surgery. (Clinical trials
have not established this yet)

 

If you become pregnant while taking
this medicine, tell your doctor immediately.

 

Things you
must NOT do

Do not take Basimglurant to treat
anything other than what the doctor has prescribed it for.

 

Do not operate machinery or drive
until you know how basimglurant affects you

This
medicine may cause dizziness, sleepiness and attention disturbances in some people.1 If you have any of
these symptoms, do not drive, operate machinery or do anything else that requires
close attention.  

 

This
information is also unconfirmed and based off results from published Phase II
trials.

 

Do not give Basimglurant to other
people, even though they may have the same condition as you

 

Do not stop taking Basimglurant and
do not change the dose without consulting your doctor.

If
you stop taking it suddenly, your condition may worsen or you may have unwanted
side effects such as anxiety, nausea, dizziness.1

 

This
is based on side effects of the drug found in Phase II.

 

Things to
be careful of

Be careful when drinking alcohol when
taking Basimglurant.

Research
has not clarified how much alcohol you can drink if you take this drug.

 

Side Effects

 

If you do not feel well while you
are taking Basimglurant, let your doctor know as soon as you can

This
medicine helps most people with depression,
but it may have unwanted side effects
in a few people. You may need medical attention if you experience some of these
side effects. How bad the side effects are changes from person to person.

 

Note that it is normal not to experience
any of the following side effects. Side effects vary from person to person.

 

If any of the following side effects
are persistent or cause you concern, let your doctor know:

·   
Persistent dizziness, nausea,
vertigo1

·   
Drowsiness1

·   
Overexcitement, mania1

·   
Inability to concentrate1

·   
More side effects unconfirmed

 

The
above is a list of the common side effects of Basimglurant observed during
research. Research shows they are tolerable and short lived.1 Let
your doctor know if you experience side effects that worry you.

 

Do not hesitate to tell your doctor
if you experience anything that make you feel unwell

It
is possible that other side effects not listed above may appear.

 

After using basimglurant

 

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

If
you take them out, they may not keep well

 

Store at ____ to ____ (temperature)

Tests
have shown that if not stored correctly, ______ (consequence unknown at the
moment)

 

Do not store Basimglurant at extreme
temperatures or in areas that may get wet easily, such as the bathroom sink.

Basimglurant
tablets might be destroyed or degraded by high temperatures or moisture.

 

Keep Basimglurant out of reach of
children

A
good place to store it would be a cupboard located high above ground.

 

 

 

Disposal

If your doctor tells you to stop
taking Basimglurant, or if the pack has expired, ask the pharmacist to confirm
the best way to dispose of the medicine.

 

Product Description

 

What it
looks like

1.5
mg Basimglurant is a hard capsule

 

Colour,
markings on the drug have yet to be specified.

 

Ingredients

Basimglurant
contains 1.5 mg of basimglurant as
the active ingredient.

 

It
also contains:

·   
Other ingredients not yet confirmed

·   
Probably a preservative and maybe a
colouring dye

 

Manufacturer/distributor

Basimglurant is made or distributed
in Australia by:

Address of Roche Australia

 

End
of Leaflet.