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CLOBAZAM THAME 5MG/5ML ORAL SUSPENSION

Active substance(s): CLOBAZAM

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Package Leaflet: Information for the user

Clobazam Thame 5mg/5ml Oral Suspension
Clobazam Thame 10mg/5ml Oral Suspension
(clobazam)




Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
Keep this leaflet. You may need to read
it again.
If you have any further questions, ask
your doctor, or pharmacist.
This medicine has been prescribed for
you only. Do not pass it on to others.
It may harm them, even if their signs of
illness are the same as yours.
If you get any of the side effects, talk to
your doctor or pharmacist. This includes
any possible side effects not listed in this
leaflet. See section 4.

You have difficulty digesting medicines.
In some patients liver may not metabolise
(break down) medicines adequately.
In these patients the medicine may
remain in the body for a longer period of
time. This may result in side effects. If
you are known to poorly metabolise
certain medicines please speak to your
doctor.
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before taking Clobazam.

Driving and using machines
You may feel sleepy or have
concentration or memory problems
after taking this medicine. You may also
experience double vision or you may react
more slowly to things. If this happens, do
not drive or use any tools or machines.

Do not drink alcohol while taking Clobazam.
This is because there is an increased risk of
sleepiness and other side effects.

up to 60ml
(60mg)
each day.
Your
doctor
may lower
the dose
to suit
you.



The medicine can affect your ability to drive
as it may make you sleepy or dizzy.
 Do not drive while taking this medicine
until you know how it affects you.
 It is an offence to drive if this medicine

affects your ability to drive.
Children
 However, you would not be committing
 Not recommended for children under
an offence if:
6 years of age.
 Careful assessment of the use must be
• The medicine has been prescribed to
treat a medical or dental problem and
made before using benzodiazepines in
The name of your medicine is Clobazam
• You have taken it according to the
children.
Thame 5mg/5ml or 10mg/5ml Oral
instructions given by the prescriber or
Suspension but will be referred to as
Other medicines and Clobazam
in the information provided with the
Clobazam throughout this leaflet.
Please tell your doctor or
medicine and
pharmacist
if
you
are
taking
or
What is in this leaflet:
• It was not affecting your ability to
have recently taken or might take any other
1. What Clobazam is and what it is
drive safely.
medicines. This includes medicines you buy
used for
Talk to your doctor or pharmacist if you are
without a prescription, including herbal
2. What you need to know before you
not sure whether it is safe for you to drive
medicines. This is because Clobazam can
take Clobazam
while taking this medicine.
affect
the
way
some
other
medicines
work.
3. How to take Clobazam
Also some medicines can affect the way
4. Possible side effects
Clobazam contains:
Clobazam works.
5. How to store Clobazam
This medicine contains methyl
In particular, tell your doctor if you are
6. Contents of the pack and other
parahydroxybenzoate (E218), which may
taking any of the following:
information
cause allergic reactions (possibly delayed).
 Medicines for epilepsy (such as phenytoin,
This medicine also contains sucralose
carbamazepine, stiripentol or valproic
1. What Clobazam is and what it is
(E955). If you have been told by your
acid).
used for
doctor that you have an intolerance to
 Medicines for depression (Monoamine
some sugars, contact your doctor before
Oxidase Inhibitors (MAOIs) such as
This medicine contains the active substance
taking this medicinal product.
phenelzine and isocarboxazid or tricyclic
clobazam which belongs to a group of
This medicinal product also contains
anti-depressants - such as trazodone) or
medicines called benzodiazepines.
0.097mmol (2.24mg) of sodium per dose of
Selective Serotonin Re-uptake Inhibitors
It works by having a calming effect on the
clobazam (5ml). To be taken into
(SSRIs) such as fluvoxamine or
brain.
consideration by patients on a controlled
paroxetine.
sodium diet.
 Medicines for severe mental illness called
Clobazam can be used for:
‘antipsychotics’
(such
as
chlorpromazine,
 Severe anxiety over a short time.
haloperidol, clozapine and pimozide).
 Epilepsy (fits) over a longer time.
3. How to take Clobazam
 Painkillers (such as medicines containing
 Mental illness such as schizophrenia
codeine, dihydrocodeine or morphine).
(in combination with other treatments).
Always take this medicine exactly as your
 Sleeping tablets (such as zolpidem).
doctor has told you. You should check with
Tranquilisers (such as diazepam,
your doctor or pharmacist if you are not
temazepam
or
lorazepam).
2. What you need to know before you
sure.
 Muscle relaxants (such as baclofen).
take Clobazam
Taking this medicine
Antihistamines that make you sleepy
 If you feel the effect of your medicine is
(such as chlorphenamine, promethazine
Do not take Clobazam if:
or diphenenhydramine).
too weak or too strong, do not change
 Lithium - used for a mental illness called
the dose yourself, but ask your doctor.
 You are allergic (hypersensitive) to
‘manic-depressive illness’ (mood changes  Keep taking Clobazam until your doctor
clobazam, other benzodiazepine
between a state of high excitability or
tells you to stop.
medicines or any of the other ingredients
exaggerated emotions and depression).
of Clobazam (see section 6). Signs of an
Clobazam is usually given for 2 to 4 weeks.
 Cimetidine - used to treat ulcers and
allergic reaction include: a rash,
After that, your doctor will decide whether
heartburn.
swallowing or breathing problems,
you should keep taking this medicine.
 Omeprazole – used to treat the symptoms
swelling of your lips, face, throat or
The recommended doses are:
of acid reflux such as heartburn or acid
tongue.
5mg/5ml
10mg/5ml
regurgitation.
 You are in the first three months of
 Ticlopidine – an antiplatelet medication
The usual
Adults
The usual
pregnancy or think you might be
used in patients with an increased risk of
pregnant (see below under ‘Pregnancy
dose is 20- dose is
stroke.
and breast-feeding’ for more information).
10ml-15ml
30ml (20 Fluconazole – used in the treatment of
 You are breast-feeding.
(20-30mg)
30mg)
fungal conditions.
 You have ever had problems with drugs
each day.
each day.
 Dextromethorphan – used to relieve dry,
or alcohol dependence in the past.
This can
This can
irritating coughs.
 You suffer from an illness that causes
be
taken
be
taken
 Nebivolol – medicine used to treat high
muscle weakness (called ‘myasthenia
as
two
as
two
blood pressure.
gravis’).
separate
separate
 You have liver problems.
If you are not sure if any of the above apply
doses or
doses or
 You have breathing problems.
to you talk to your doctor or pharmacist.
as a single
as
a
single
 You stop breathing for short periods
Anaesthetics
dose at
dose at
during sleep (called ‘sleep apnoea
If you are going to have an anaesthetic, tell
night. Your night.
syndrome’).
your doctor or anesthetist that you are
 The patient is under 6 years old.
Your
doctor
taking Clobazam. This is because your
doctor
may
doctor may need to change the amount of
Do not take if any of the above apply to
may
increase
you. If you are not sure, talk to your doctor anaesthetic or muscle relaxants to give you.
or pharmacist before taking Clobazam.
increase
your dose
Clobazam with food, drink and alcohol


Warnings and Precautions
Talk to your doctor or pharmacist before
taking your medicine if:
 You have problems with controlling your
movements (called ‘spinal or cerebellar
ataxia’).
 You have depression, irrational fears and
obsessions.
 You have delusions (believing things
which are not true) or hallucinations
(sensing things which are not there)
 You have kidney problems.
 You have ever become dependent upon
another drug or alcohol. Alcohol should
not be taken during treatment with
Clobazam as there is an increased risk of
experiencing side effects.
 You are over 65. This is due to increased
sensitivity to adverse reactions in the
elderly such as drowsiness, dizziness and
muscle weakness. There is also an
increased risk of fall that may result in
serious injury.

PIL/UK/MFG013/04-05/v2

Pregnancy,breast-feeding
and fertility
Do not take Clobazam if you
are:
 In the first three months of pregnancy
 Breast-feeding. This is because it may
pass into the mother’s milk
Talk to your doctor before taking this
medicine if you are pregnant, plan to get
pregnant or think you may be pregnant.
This is because Clobazam is not
recommended for use in pregnant women.
However, your doctor may give you this
medicine during late pregnancy or during
labour.
 If this happens, there is a risk of having a
baby with a low body temperature,
floppiness, breathing or feeding problems
 If this medicine is taken regularly in late
pregnancy, your baby may get withdrawal
symptoms. In this case the newborn
should be closely monitored during the
postnatal period.

Children
(over 6
years)

Older
people

The usual
starting
dose is 5ml
(5mg) each
day.
The usual
dose for
anxiety is
10ml -20ml
(10-20mg)
each day.

your dose
up to 30ml
(60mg)
each day.
Your
doctor
may lower
the dose
to suit
you.

The usual
starting
dose is
2.5ml
(5mg) each
day.
The usual
dose for
anxiety is
5ml- 10ml
(10-20mg)
each day.

TURN OVER

Method of administration
This product may settle during storage.
Shake the bottle well before use.
Use the measuring syringe provided in the
pack to deliver the required dose.
When you are taking medicines like
Clobazam you should not use a different
clobazam containing medicine except under
your doctor’s supervision.
Instructions for the use of syringe:
1. Open the bottle: press the cap down
and turn it anticlockwise (Figure 1).
2. Seperate the adaptor from the syringe
(figure 2). Insert the adaptor into the
bottle neck (figure 3). Ensure it is fixed
well.

If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them. You may feel ill after taking this
medicine, or notice unusual or unexpected
symptoms. If this happens, tell your doctor.
Tell your doctor straight away if you
have any of the following side effects:







Take the syringe and put it in the
adaptor opening (figure 4). Turn the
bottle upside down (figure 5).

3. Fill the syringe with a small amount of
solution by pulling the piston down
(figure 5A), then push the piston up in
order to remove any possible air bubbles
(figure 5B). Pull the piston down to the
graduation mark corresponding to the
quantity in millilitres (ml) prescribed by
your doctor (figure 5C).

4. Turn the bottle the right way up
(figure 6A). Remove the syringe from
the adaptor (figure 6B). Empty the
contents of the syringe in a glass of
water or baby’s bottle by pushing the
piston to the bottom of the syringe
(figure 7).

5. Drink the whole contents of the
glass/baby’s bottle immediately.
6. Close the bottle with the plastic screw
cap. Wash the syringe with water
(figure 8) and store in a clean place.

If you take more Clobazam than you
should
If you take more Clobazam than you
should, tell your doctor or go to your
nearest hospital casualty department
straight away. Do not drive yourself,
because you may start to feel sleepy.
Remember to take the medicine pack with
you. This is so that the doctor knows what
you have taken.
If you forget to take Clobazam
 If you forget to take a dose, take it as
soon as you remember.
 However, if it is nearly time for the next
dose, skip the missed dose.
 Do not take a double dose to make up
for a forgotten dose.
If you stop taking Clobazam
Keep taking this medicine until your doctor
tells you to stop. Do not stop taking
Clobazam just because you feel better.
 When your doctor says that you can stop
taking Clobazam, you need to do this
gradually. Your doctor will help you to do
this.
 Stopping the medicine can make you feel
stressed (anxiety), confused or
depressed. You may also lose your
appetite and have difficulty sleeping.
Tell your doctor if this happens.

PIL/UK/MFG013/04-05/v2



Feeling restless, have difficulty sleeping
or nightmares
Feeling irritable or anxious
Believing things which are not true
(delusions)
Sensing things which are not there
(hallucinations)
Feeling suicidal
Increased possibility of tripping or falling
especially in elderly patients.
Blistering or bleeding of the skin around
the lips, eyes, mouth, nose and genitals.
Also, flu-like symptoms and fever. This
may be something called ‘Stevens
Johnson Syndrome’ which is a severe
blistering rash where layers of the skin
may peel off to leave large areas of raw
exposed skin over the body. Also, a
feeling of being generally unwell, fever,
chills and aching muscles. This is
something called ‘Toxic epidermal
necrolysis’.

If you get any of the above side effects,
your doctor may decide that your treatment
needs to be stopped. These side-effects are
more likely to happen in elderly people and
children.




For 10mg/5ml: Discard 60 days after first
opening.
Do not throw away any medicine via
wastewater or household waste. Ask
your pharmacist how to dispose of
medicines you no longer use. These
measures will help protect the
environment.

6. Contents of the pack and other
information

What Clobazam contains
The active substance is clobazam.
Each 5ml of oral suspension contains 5mg
clobazam.
Each 5ml of oral suspension contains 10mg
clobazam.
The other ingredients are methyl
parahydroxybenzoate (E218), citric acid
monohydrate (E330), sodium citrate
(E331), sucralose (E955), xanthan gum
(E415) and purified water.
What Clobazam looks like and contents
of the pack
Clobazam is white to off-white viscous liquid
supplied in an amber glass bottle with
tamper-evident child resistant plastic screw
cap and a 5ml polypropylene oral syringe with
0.1ml graduation mark and an adaptor for the
syringe. Where higher doses are to be
administered, dosing cups should be
considered.
Clobazam is supplied in bottles containing
100ml and 150ml suspension.
Not all pack sizes may be marketed.
POM

Tell your doctor or pharmacist if any of
the following side effects get serious or
lasts longer than a few days, or if you
notice any side effects not listed in this
leaflet.

Marketing Authorisation Holder and
Manufacturer:
Syri Limited t/a Thame Laboratories
Unit 4, Bradfield Road,
Ruislip, Middlesex,
HA4 0NU, UK

The following side effects are more likely to
happen at the start of treatment. They
usually last for a short time:

This medicinal product is authorised in
the Member State of the EEA under the
following names:






Feeling sleepy or dizzy
Dry mouth, constipation
Loss of appetite, feeling sick
Shaking fingers.

UK and IE:
Clobazam Thame 5mg/5ml
Oral Suspension
Clobazam Thame 10mg/5ml
Oral Suspension

Other side effects include:
 Headache
This leaflet was last revised in 12/2015.
 Breathing problems
 Loss of memory, confusion
 skin rash
 Muscle weakness
 Problems walking or other movement
problems
 Being aggressive
 Reacting to things more slowly than usual
 Eye problems such as double vision and
rapid uncontrolled movement of the eyes
 Difficulty in staying awake or alert
 Becoming dependent on Clobazam (also
called ‘physical or mental dependence’)
 Weight gain
 Loss of sexual drive.
If you take this medicine for a long time,
you are more likely to get the following side
effects:
 Anxiety
 Confusion, depression
 Loss of appetite
 Difficulty sleeping
 Dependence
Reporting of side effects
If you get any side effects talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via
the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard in UK.
By reporting side effects you can help
provide more information on the safety of
this medicine.

5. How to store Clobazam






Keep this medicine out of the sight and
reach of children.
Do not use after the expiry date which is
stated on the carton or bottle after ‘Exp’.
The expiry date refers to the last day of
that month.
This medicinal product does not require
any special storage conditions.
For 5mg/5ml: Discard 30 days after first
opening.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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