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CLONAZEPAM THAME 2MG/5ML ORAL SOLUTION

Active substance(s): CLONAZEPAM / CLONAZEPAM

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Package Leaflet: Information for the user
Clonazepam Thame 0.5mg/5ml Oral Solution
Clonazepam Thame 2mg/5ml Oral Solution
(clonazepam)







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
Clonazepam Thame 0.5mg/5ml or
2mg/5ml Oral Solution but will be
referred to as Clonazepam throughout
this leaflet.
What is in this leaflet:
1. What Clonazepam is and what it
is used for
2. What you need to know before
you take Clonazepam
3. How to take Clonazepam
4. Possible side effects
5. How to store Clonazepam
6. Contents of the pack and other
information
1. What Clonazepam is and what it
is used for
Clonazepam belongs to a group of
medicines called benzodiazepine.
It is used to treat epilepsy in adults and
elderly.
 It lowers the number of fits
(seizures) that you have.
 Any fits that you do have will be less
serious.
2.











What you need to know before
you take Clonazepam
Do not take this medicine if:
You are allergic (hypersensitive) to
Clonazepam or any of the other
ingredients of this medicine (listed in
Section 6) or to other
‘benzodiazepine’ medicines. These
include diazepam, flurazepam and
temazepam.
You have breathing problems or lung
disease.
You have severe liver problems.
You have a condition called
‘myasthenia gravis’ (where your
muscles become weak and get tired
easily).
You have a condition called ‘sleep
apnoea syndrome’ (where your
breathing stops when you are
asleep).
You have problems with alcohol or
drug (prescription or recreational)
use.

Do not take this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist before
taking Clonazepam.
Take special care with this medicine
A small number of people being treated
with anti-epileptics such as clonazepam
have had thoughts of harming or killing
themselves. If at any time you have
these thoughts, immediately contact
your doctor.
Check with your doctor or pharmacist
before taking this medicine if:
 You have liver, kidney or lung
problems.
 You have ever had depression.
 You have ever tried to kill yourself.
 A close friend or relative has recently
died.
 You regularly drink alcohol or take
recreational drugs or you have had
problems with alcohol or drug use in
the past.
 You have spinal or cerebellar ataxia
(where you may become shaky and
unsteady, have slurred speech or
rapid eye movements).
 You have a rare, inherited blood
problem called ‘porphyria’.
 You are elderly or debilitated (weak);
your doctor may adjust your dose.

PIL/UK/MFG103/05-06/v5

If any of the above apply to you, or if
you are not sure, talk to your doctor or
pharmacist before you take
Clonazepam.
Other medicines and
Clonazepam
Please tell your doctor or
pharmacist if you are taking or have
recently taken any other medicines. This
includes medicines that you buy without
a prescription and herbal medicines. This
is because clonazepam can affect the way
some other medicines work. Also some
other medicines can affect the way
clonazepam works.
In particular, tell your doctor or
pharmacist if you are taking any of the
following medicines:
 Other medicines to treat epilepsy,
such as carbamazepine, hydantoins,
phenobarbital, phenytoin, primidone
or sodium valproate.
 Cimetidine (used to treat stomach
problems and heartburn).
 Rifampicin (an antibiotic used to
treat infections).
 Medicines used to make you sleep
(hypnotics).
 Medicines that help with anxiety
(tranquillisers).
 Pain-killers (analgesics) and
medicines to relax your muscles
(muscle relaxants).
Operations
If you are going to have an anaesthetic
for an operation or for dental treatment,
it is important to tell your doctor or
dentist that you are taking Clonazepam.
Taking Clonazepam with Alcohol
Do not drink alcohol while you are
taking Clonazepam. This is because it
may cause side effects or cause your fits
to return.
Pregnancy and
breast-feeding
You must not take
Clonazepam if you are pregnant, might
become pregnant or are breast-feeding,
unless your doctor tells you to.
Clonazepam is known to have harmful
effects on the unborn child.
Driving and using machines
Talk to your doctor about driving and
using machines or tools, whilst you are
taking Clonazepam. This is because it
can slow down your reactions,
particularly when you start taking it. If
you are in any doubt about whether you
can do a particular activity, talk to your
doctor.
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.
 However, you would not be
committing an offence if:
- The medicine has been
prescribed to treat a medical
or dental problem and
- You have taken it according to
the instructions given by the
prescriber or in the
information provided with the
medicine and
- It was not affecting your
ability to drive safely.
Talk to your doctor or pharmacist if you
are not sure whether it is safe for you to
drive while taking this medicine.
Dependence
When taking this medicine there is a risk
of dependence which increases with the
dose and duration of treatment and also
in patients with a history of alcohol
and/or drug abuse.
Clonazepam contains:
This medicine also contains ethanol
(96%). This means that each 5ml
contains 64.68mg of alcohol. This is
same as 1.6ml of beer or 0.66ml of wine
per 5ml dose.

3.

How to take Clonazepam

Always take Clonazepam exactly as your
doctor has told you. You should check
with your doctor if you are not sure.






Your doctor will start you on a low
dose of Clonazepam and gradually
increase it over 2 to 4 weeks until
the right dose has been found for
you.
Your doctor will usually tell you to
split your daily dose into four equal
amounts which you will take at
evenly spaced times throughout the
day.
Once your doctor has found the right
dose for you, they may tell you to
take Clonazepam as a single dose in
the evening.

Starting dose:
Clonazepam Thame 0.5mg/5ml Oral
Solution is recommended for starting
dose.
Adults: The usual starting dose is 10ml
(1mg) a day, or less.
Elderly: The usual starting dose is 5ml
(0.5mg) a day, or less.
Maintenance dose:
Clonazepam Thame 2mg/5ml Oral
Solution is recommended for
maintenance dose.
Adults and elderly: The starting dose
will be increased gradually as
maintenance dose (usually to between
10ml (4mg) and 20ml (8mg) a day).
The maximum dose is 50ml (20mg) a
day.
Route and method of
administration
This medicinal product must be taken
orally.
Use the 10ml oral syringe with 1ml
measurement markings (0.25ml
intermediate graduation).
Instructions for the use of syringe:
a) Open the bottle: press the cap and
turn it anticlockwise (figure 1).
b) Separate the adaptor from the
syringe (figure 2). Insert the
adaptor into the bottle neck (figure
3). Ensure it is properly fixed. Take
the syringe and put it in the adaptor
opening (figure 4).

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

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

e) Empty the contents of the syringe
into the patient’s mouth by pushing
the piston to the bottom of the
syringe (figure 7). Close the bottle
with the plastic screw cap. Wash the
syringe with water (figure 8).

7

If you take more Clonazepam than
you should
 If you take more Clonazepam than
you should, talk to a doctor or go to
a hospital straight away. Take the
medicine pack with you.
 If you take more Clonazepam, you
may feel drowsy, sleepy, lightheaded, have a lack of co-ordination
or be less responsive than normal.
If you forget to take Clonazepam
 If you forget to take a dose, skip the
missed dose. Then take the next
dose when it is due.
 Do not take a double dose (two
doses at the same time) to make up
for a forgotten dose.
If you stop taking Clonazepam
If you receive long term treatment with
Clonazepam (are given the medicine for
a long time) you may become
dependent upon this medicine and get
withdrawal symptoms (see Section 4).
 Do not stop taking your medicine
without talking to your doctor. If you
do, your fits may return and you
may get withdrawal symptoms (see
Section 4: Possible side effects).
 If the dose of Clonazepam you take
has to be reduced, or stopped, this
must be done gradually. Your doctor
will let you know how to do this.
If someone else takes your Clonazepam
by mistake, they should talk to a doctor
or go to a hospital straight away.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, Clonazepam can
cause side effects, although not
everybody gets them.
Important side effects to look out
for:
Allergic reactions
If you get an allergic reaction, see a
doctor straight away.
The signs may include:
 Sudden swelling of the throat, face,
lips and mouth. This may make it
difficult to breathe or swallow.
 Sudden swelling of the hands, feet
and ankles.
 Skin rash or itching.
Effects on the heart
If you notice any of the following effects,
see a doctor straight away.
The signs may include:
 Breathlessness, swelling of the
ankles, cough, tiredness and a racing
heart.
 Chest pain which may spread to your
neck and shoulders and down your
left arm.
Effects on behaviour
If you notice any of the following effects,
talk to your doctor as they may want
you to stop taking Clonazepam. The
signs may include:
 Being aggressive, excited, irritable,
nervous, agitated, hostile or anxious.
 Problems sleeping, nightmares and
vivid dreams.
 Mental problems such as seeing or
hearing things that are not really
there (hallucinations), delusions
(believing in things that are not real)
and problems with your speech.
 Types of fits (seizures) that you have
not had before.
Other possible side effects:
When you start taking Clonazepam you
may notice the following effects:
 Feeling drowsy and tired.
 Feeling dizzy and light-headed.
 Weak or floppy muscles or jerky
movements (poor co-ordination).
 Feeling unsteady when walking.

PIL/UK/MFG103/05-06/v5

If you notice any of these effects, talk to
your doctor. Your doctor may be able to
help you by giving you a lower dose of
Clonazepam and then increasing it
slowly.
The following may occur at any time
during your treatment
Mind and nervous system
 Poor concentration, confusion and a
feeling of being lost (disorientation).
 Feeling restless.
 Difficulty remembering new things.
 Headache.
 Depression.
 Slowing or slurring of speech.
 Poor co-ordination, including feeling
unsteady when walking.
 An increase in how often you have
fits.
Liver, kidney and blood
 Changes in how well your liver is
working (shown by blood tests).
 Loss of bladder control.
 Blood problems. The signs include
feeling tired, bruising easily, being
short of breath and nose bleeds.
Your doctor may want you to have
blood tests from time to time.
Stomach and gut
 Feeling sick (nausea).
 Stomach upset.
Eyes
 Double vision.
 Jerky movements of the eyes
(nystagmus).
Breathing
 Breathing problems (respiratory
depression). Early signs include
suddenly noisy, difficult and uneven
breathing. Your skin may become
blue.
Skin and hair
 Skin rashes, hives (lumpy rash) and
itchy skin.
 Changes to the colour of your skin.
 Hair loss (the hair usually grows
back).
Sexual
 Loss of sex drive.
 Difficulty getting or keeping an
erection (erectile dysfunction).
Withdrawal symptoms
Using benzodiazepines like Clonazepam
may make you dependent on the
medicine. This means that if you stop
treatment quickly, or reduce the dose
too quickly, you may get withdrawal
symptoms. The symptoms can include:
 Problems sleeping.
 Muscle pain, shaking (tremor) and
feeling restless.
 Feeling very anxious, tense,
confused, irritable or agitated, or
changes in your mood.
 Increased sweating.
 Headache.
Less common withdrawal symptoms
include:
 Feeling sensitive to light, noise and
physical contact.
 Seeing or hearing things that are not
really there (hallucinations).
 Tingling and feeling numb in your
arms and legs.
 A feeling of losing contact with
reality.
Injury
 Patients taking benzodiazepine
medicines are at risk of falling and
breaking bones. This risk is
increased in the elderly and those
taking other sedative (including
alcohol).
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 Clonazepam
Keep this medicine out of the sight
and reach of children.
 Do not use this medicine after the
expiry date which is stated on the
carton or bottle label after ‘Exp’. The
expiry date refers to the last day of that
month.
 This medicinal product does not require
any special temperature storage
conditions.
 Keep the bottle tightly closed.
 Keep the bottle in the outer carton in
order to protect from light.
 Discard 30 days after first opening.
 Do not use this medicine if you notice
that the solution becomes discoloured or
shows any signs of deterioration. Seek
the advice of your pharmacist.
 Do not throw away any medicine via
waste water 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 Clonazepam contains
The active substance is Clonazepam.
Each 5ml Solution contains 0.5mg
Clonazepam.
Each 5ml Solution contains 2mg
Clonazepam.
The other ingredients are ethanol (96%)
and medium chain triglycerides.
What Clonazepam looks like and
contents of the pack
Clonazepam is clear, colourless to pale
yellow colour oral solution supplied in an
amber glass bottle with tamper-evident,
child resistant plastic screw cap and a 10ml
oral syringe with 0.25ml graduation for
measuring the required dose and a syringe
adaptor.
Clonazepam oral solution is supplied in
bottles containing 150ml solution.
Marketing Authorisation Holder and
Manufacturer:
Thame Laboratories,
Unit 4, Bradfield Road,
Ruislip, Middlesex,
HA4 0NU, UK
POM
If this leaflet is hard to see or read,
please call +44 (0) 208 515 3700
for help.
This leaflet was last revised in 06/2017.

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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