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ZACCO 10MG/5ML ORAL SUSPENSION

Active substance(s): CLOBAZAM / CLOBAZAM

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Package Leaflet: Information for the user

Zacco 5mg/5ml Oral Suspension
Zacco 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.

The name of your medicine is Zacco
5mg/5ml or 10mg/5ml Oral
Suspension but will be referred to as
Zacco throughout this leaflet.
What is in this leaflet:
1. What Zacco is and what it is
used for
2. What you need to know before you
take Zacco
3. How to take Zacco
4. Possible side effects
5. How to store Zacco
6. Contents of the pack and other
information

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 Zacco.



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
• You have taken it according to the
children.
instructions given by the prescriber or
Other medicines and Zacco
in the information provided with the
Please tell your doctor or
medicine and
pharmacist if you are taking or
• It was not affecting your ability to
have recently taken or might take any other
drive safely.
medicines. This includes medicines you buy
Talk to your doctor or pharmacist if you are
without a prescription, including herbal
not sure whether it is safe for you to drive
medicines. This is because Zacco can
while taking this medicine.
affect the way some other medicines work.
Also some medicines can affect the way
Zacco contains:
Zacco works.
This medicine contains methyl

In particular, tell your doctor if you are
taking any of the following:
 Medicines for epilepsy (such as phenytoin,
1. What Zacco is and what it is
carbamazepine, stiripentol or valproic
used for
acid).
 Medicines for depression (Monoamine
Zacco contains the active substance
Oxidase Inhibitors (MAOIs) such as
clobazam which belongs to a group of
phenelzine and isocarboxazid or tricyclic
medicines called benzodiazepines.
anti-depressants - such as trazodone) or
It works by having a calming effect on the
Selective Serotonin Re-uptake Inhibitors
brain.
(SSRIs) such as fluvoxamine or
paroxetine.
Zacco can be used for:
 Medicines for severe mental illness called
 Severe anxiety over a short time.
‘antipsychotics’ (such as chlorpromazine,
 Epilepsy (fits) over a longer time.
haloperidol, clozapine and pimozide).
 Mental illness such as schizophrenia
 Painkillers (such as medicines containing
(in combination with other treatments).
codeine, dihydrocodeine or morphine).
 Sleeping tablets (such as zolpidem).
2. What you need to know before you  Tranquilisers (such as diazepam,
temazepam or lorazepam).
take Zacco
 Muscle relaxants (such as baclofen).
 Antihistamines that make you sleepy
(such as chlorphenamine, promethazine
Do not take Zacco if:
or diphenenhydramine).
 You are allergic (hypersensitive) to
 Lithium - used for a mental illness called
clobazam, other benzodiazepine
‘manic-depressive illness’ (mood changes
medicines or any of the other ingredients
between a state of high excitability or
of Zacco (see section 6). Signs of an
exaggerated emotions and depression).
allergic reaction include: a rash,
 Cimetidine - used to treat ulcers and
swallowing or breathing problems,
heartburn.
swelling of your lips, face, throat or
 Omeprazole – used to treat the symptoms
tongue.
of acid reflux such as heartburn or acid
 You are in the first three months of
regurgitation.
pregnancy or think you might be
 Ticlopidine – an antiplatelet medication
pregnant (see below under ‘Pregnancy
used in patients with an increased risk of
and breast-feeding’ for more information).
stroke.
 You are breast-feeding.
 Fluconazole – used in the treatment of
 You have ever had problems with drugs
fungal conditions.
or alcohol dependence in the past.
 Dextromethorphan – used to relieve dry,
 You suffer from an illness that causes
irritating coughs.
muscle weakness (called ‘myasthenia
 Nebivolol – medicine used to treat high
gravis’).
blood pressure.
 You have liver problems.
 You have breathing problems.
If you are not sure if any of the above apply
to you talk to your doctor or pharmacist.
 You stop breathing for short periods
during sleep (called ‘sleep apnoea
Anaesthetics
syndrome’).
If you are going to have an anaesthetic, tell
 The patient is under 6 years old.
your doctor or anesthetist that you are
taking Zacco. This is because your doctor
Do not take if any of the above apply to
may need to change the amount of
you. If you are not sure, talk to your doctor anaesthetic or muscle relaxants to give you.
or pharmacist before taking Zacco.
Zacco with food, drink and alcohol
Do not drink alcohol while taking Zacco.
Warnings and Precautions
This is because there is an increased risk of
Talk to your doctor or pharmacist before
sleepiness and other side effects.
taking your medicine if:
 You have problems with controlling your
Pregnancy, breast-feeding
movements (called ‘spinal or cerebellar
and fertility
ataxia’).
Do not take Zacco if you are:
 You have depression, irrational fears and
 In the first three months of pregnancy
obsessions.
 Breast-feeding. This is because it may
 You have delusions (believing things
pass into the mother’s milk
which are not true) or hallucinations
Talk
to your doctor before taking this
(sensing things which are not there).
medicine if you are pregnant, plan to get
 You have kidney problems.
pregnant or think you may be pregnant.
 You have ever become dependent upon
This is because Zacco is not recommended
another drug or alcohol. Alcohol should
for use in pregnant women.
not be taken during treatment with



Zacco 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/MFG013/06-07/v3

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.

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.

parahydroxybenzoate (E218), which may
cause allergic reactions (possibly delayed).

This medicine also contains sucralose
(E955). If you have been told by your
doctor that you have an intolerance to
some sugars, contact your doctor before
taking this medicinal product.
This medicinal product also contains
0.097mmol (2.24mg) of sodium per dose of
Zacco (5ml). To be taken into
consideration by patients on a controlled
sodium diet.

3. How to take Zacco
Always take this medicine exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not
sure.
Taking this medicine





If you feel the effect of your medicine is
too weak or too strong, do not change
the dose yourself, but ask your doctor.
Keep taking Zacco until your doctor
tells you to stop.
Zacco is usually given for 2 to 4 weeks.
After that, your doctor will decide whether
you should keep taking this medicine.

The recommended doses are:

Adults

The usual
dose is 2030ml (2030mg)
each day.
This can
be taken
as two
separate
doses or
as a single
dose at
night. Your
doctor
may
increase
your dose
up to 60ml
(60mg)
each day.
Your
doctor
may lower
the dose
to suit
you.

5mg/5ml

10mg/5ml

Children
(over 6
years)

The usual
starting
dose is 5ml
(5mg) each
day.

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

Older
people

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

The usual
dose is
10ml-15ml
(20-30mg)
each day.
This can
be taken
as two
separate
doses or
as a single
dose at
night.
Your
doctor
may
increase
your dose
up to 30ml
(60mg)
each day.
Your
doctor
may lower
the dose
to suit
you.

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
Zacco 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.



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.

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
suspension 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).

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.
4. Turn the bottle the right way up
(figure 6A). Remove the syringe from
the adaptor (figure 6B).

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




5. Put the end of the syringe into the
mouth and push the plunger slowly
back in to deliver the medicine into the
mouth (figure 7).
7

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 Zacco than you
should
If you take more Zacco 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 Zacco
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 Zacco
Keep taking this medicine until your doctor
tells you to stop. Do not stop taking
Zacco just because you feel better.
 When your doctor says that you can stop
taking Zacco, you need to do this
gradually. Your doctor will help you to do
this.


PIL/UK/MFG013/06-07/v3



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

Other side effects include:
 Headache
 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.
By reporting side effects you can help
provide more information on the safety of
this medicine.

5. How to store Zacco



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.
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 Zacco 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 Zacco looks like and contents
of the pack
Zacco 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.
Zacco is supplied in bottles containing
100ml and 150ml suspension.
Not all pack sizes may be marketed.
POM
Marketing Authorisation Holder and
Manufacturer:
Thame Laboratories
Unit 4, Bradfield Road,
Ruislip, Middlesex,
HA4 0NU, UK
If this leaflet is hard to see or read,
please call +44 (0) 208 515 3700
for help.
This leaflet was last revised in 12/2016.

Expand Transcript

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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