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RIVOTRIL 1 MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION OR INFUSION

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10140667 GB FY 1206.1078

Patient Information Leaflet

Rivotril©

1 mg/mI
Concentrate for solution for injection or infusion
Clonazepam

Please read all of this leaflet carefully
before you start taking this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask
your doctor or nurse.
• If any of the side effects become serious or
troublesome, or if you notice any
side effects not listed in this leaflet, please
tell your doctor or nurse.
In this leaflet:
I. What Rivotril is and what it is used for
2. Before you arc given Rivotril
3. How Rivotril will be given
4. Possible side effects
5. [-low to store Rivotril
6. Further information

1. What Rivotril is and what it is
used for
Rivotril I mg/mi sterile concentrate
contains a medicine called clonazepam.
This belongs to a group of medicines
called ‘bcnzodiazepines’.
• Rivotril sterile concentrate is used to treat
severe epilepsy (status epilepticus) in
infants, children and adults.
• It lowers the number and length of fits
(seizures) that you have.

2. Before you are given Rivotril
You must not be given Rivotril if you
are allergic (hypersensitive) to:
• Clonazepam or any of the other
ingredients of Rivotril (listed in Section 6:
Further information).
• Other ‘benzodiazepine’ medicines. These
include diazepam, flurazepam and
tcmazepam.

You must not be given Rivotril if any of
the above apply to you. if you are not
sure, talk to your doctor or nurse before
having Rivotril.

Rivotril must not be given if:
• You have breathing problems or lung
disease.
• You have severe liver problems.
• You have a condition called
‘rnyasthen i a gravis’ (where your
muscles become weak and get tired easily).
• You have a condition called ‘sleep apnoca
syndrome’ (where your breathing stops
when you are asleep).
• The patient is a premature or newborn
baby (less than I month old).
• You have problems with alcohol or drug
(prescription or recreational) use.
Rivotril must not be given if any of the above
apply to you. If you are not sure, talk to your
doctor or nurse before having Rivotril.
Take special care with Rivotril
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 nurse before
having Rivotril 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 slulTed speech or rapid eye
movements).

• You have a rare, inherited blood probleiu
called ‘porphyria’.
• You are elderly or debilitated (weak);
your doctor may adjust your dose.
If any of the above apply to you, or if you are
not sure, talk to your doctor or nurse before
you are given Rivotril.

Taking other medicines
Please tell your doctor or nurse 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 Rivotril can affect
the way some other medicines work. Also
some other medicines can affect the way
Rivotril works.
In particular, tell your doctor or nurse if you
are taking any of the following medicines:
• Other medicines to treat epilepsy, such as
carbamazcpine, hydantoins. phenobarbital,
phenytoin, prirnidone 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
(tranqui lliscrs).
• 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 being given Rivotril.

Pregnancy and breast-feeding
You must not take Rivotril if you are
pregnant, might become pregnant or arc
breast-feeding, unless your doctor tells you to.
Rivotril 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 having
Rivotril. This is because it can slow down
your reactions. If you are in any doubt about
whether you can do a particular activity, talk
to your doctor.
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.
Important information about some of
the ingredients of Rivotril
Rivotril sterile concentrate contains 20% v/v
of ethanol. Each ampoule contains tip to
0.16 g of alcohol. If you stiffer from liver
disease, alcoholism, brain injury or disease,
or are pregnant, Rivotril sterile concentrate
may be harmful.
Rivotril sterile concentrate contains benzyl
alcohol. Each ampoule contains 30 mg of
benzyl alcohol, which may cause toxic
reactions and allergic reactions in infants
and children tip to 3 years old.
[f you are in any doubt about whether you
should have this medicine, talk to your
doctor.

Taking Rivotril with Alcohol
Do not drink alcohol while you are being
given Rivotril. This is because it may cause
side effects or cause your fits to return.
Please run? one,

This information is intended for medical or healthcare professionals only:
The tear-off portion above is intended for the patient.
INFORMATION FOR HEALTHCARE PROFESSIONALS

Rivotril® 1 mg/mI
concentrate for solution for injection or infusion
Clonazepam
Please refer to the Summary of Product Characteristics for full prescribing
information.

Therapeutic indications
Adm i ni stered intravenously, Rivotril quickly
controls status epilepticus in all clinical
forms.
Presentation
Amber glass anipoules containing I nil
clonazepam solution supplied with amber
glass ampoules containing 1 ml solvent
(water for injections). The clonazepam
solution is clear, colourless to slightly green
yellow. Excipients are ethanol absolute,
glacial acetic acid, benzyl alcohol, propylene
glycol and nitrogen pure. Cartons of 5 or
10 clonazepam ampoules (with 5 or
10 solvent ampoules). Not all pack sizes may
be marketed.

Important information about the
excipients in Rivotril sterile concentrate
1 mg/in!.
Each ampoule (1 ing clonazepam) contains
30 mg benzyl alcohol, 159 mg (equivalent to
0.2 ml) ethanol absolute and 802 mg
propylene glycol.

and method of administration
Rivotril sterile concentrate is for intravenous
administration. Either slow intravenous
injection or intravenous infusion.

Posology

A diilts
i mg (one ampoule of active substance mixed
with one ampoule of solvent for parenteral
use) by slow intravenous injection.

Elderly
Care should be taken with the elderly.

Mode of adi,,inistration
Rivotril must be diluted prior to
in order to avoid irritation
of the veins, see Instructions for use.
administration

Children
0.5 mg (equivalent to half an ampoule
(0.5 ml) of active substance mixed with
half an ampoule of solvent (0.5 ml) for
parenteral use) by slow intravenous injection.
Special dosage instructions

Rivotril can be administered with one or
several other antiepileptic agents, in which
case the dosage of each drug must be
adjusted to achieve optimum effect.

Intravenous injection of Rivotril should be
into a large vein of the antecubital fossa.
The injection should be given slowly in
adults, the rate of injection must not exceed
0.25 mg 0.5 mg (0.5 1.0 ml of the
prepared solution) per minute and should
be administered with continuous monitoring
of EEG, respiration and blood pressure.
This will greatly diminish the rare possibility
of hypotension or apnoea occurring.
Nevertheless, facilities for resuscitation
should always be available. A total dose of
20 mg should not be exceeded.








Please

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3. How Rivotril will be given
Rivotril will be given to you by a doctor or
nurse in one of two ways.
• Slow injection into one of your veins.
This may take between 2 and 4 minutes.
• Through a small tube into one of your
veins (called an intravenous infusion’).
The dose of Rivotril varies from one patient to
another. It depends on your age and how well
you respond to the medicine. The doctor will
work out how much to give you. The dose you
are given should be less than 20 mg.

If you are given more Rivotril than you
should
Because Rivotril is given by a doctor or
nurse, it is unlikely that you or your child
will be given too much or that you or your
child will miss a dose. However, if you are
worried talk to your doctor or nurse.
Stopping Rivotril
If you receive long term treatment with Rivotril
(are given the medicine for a long time) you
may become dependent upon this medicine and
get withdrawal symptoms (see Section 4).
• Treatment with Rivotril must not be stopped
suddenly. If this happens, your fits may
return and you may get withdrawal
symptoms (see Section 4: Possible side
effects).
• If the dose of Rivotril you are being given
has to be reduced, or stopped, this must be
done gradually. Your doctor will explain how
this will be done.
If you have any further questions on the use of
this medicine, ask your doctor or nurse.

4. Possible side effects
Like all medicines Rivotril can cause side effects,
although not everybody will get 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 Rivotril. 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 beibre.
Infants and children
• If an infant or small child is being
given Rivotril, watch them carefully. This
is because they could develop breathing
problems, coughing or choking. This can be
caused by too much saliva being made.
• Early puberty in children. This is
reversible after stopping treatment
with Rivotril.
Elderly patients
Older patients taking benzodiazepine
medicines have a higher risk of falling
and breaking bones.

Other possible side effects
When you start being given Rivotril
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.
[C 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 Rivotril and then
increasing it slowly.
The following may occur at any time
during your treatment
Injection site
• Pain and inflammation of the vein into
which Rivotril was given, which may lead
to blood clots.
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.
• Diculty getting or keeping an erection
(erectile dysfunction).

Withdrawal symptoms
Using benzodiazepines like Rivotril may
make you dependent on the medicine.
This means that if treatment is stopped
quickly. or the dose reduces 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.

5. How to store Rivotril
• Your doctor or pharmacist is responsible for
storing Rivotril sterile concentrate. They are
also responsible for disposing of any unused
Rivotril correctly.

• Keep out of the reach and sight of children.
• Do not use Rivotril sterile concentrate
after the expiry date printed on the pack.
• Keep the ampoules of Rivotril sterile
concentrate in the original packaging
to protect them from light.
• Rivotril sterile concentrate should not
be stored above a temperature of 30°C.

6. Further information
What Rivotril contains
The active substance in Rivotril 1 mg/mI
sterile concentrate is clonazepam. Each 1 ml
of liquid medicine contains I ing (milligram)
of clonazepam.
The other ingredients in Rivotril sterile
concentrate are ethanol absolute, glacial
acetic acid, benzyl alcohol, propylene glycol
and pure nitrogen.

What Rivotril Sterile concentrate looks
like and contents of the pack
• The medicine in Rivotril sterile concentrate
is a clear, colourless to slightly greenyellow liquid
(‘concentrate for solution for injection
or infusion’). This liquid will be diluted with
‘water for injections’ before it is given to you.
• Rivotril is supplied in amber coloured
glass ampoules with separate amber
coloured glass ampoules of ‘water for
injections’ to dilute it with. They are
supplied in packs of 5 or 10 medicine
ampoules (with 5 or 10 ampoules of water).
Not all packs may be marketed.
Marketing Authorisation Holder
Roche Products Limited

6 Falcon Way
Shire Park
Welwyn Garden City, AL7 1TW

Less common withdrawal symptoms include:

United Kingdom

• 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.

Manufacturer (UK only)
Roche Products Limited
6 Falcon Way
Shire Park
Weiwyn Garden City, AL7 ITW

If any of the side effects become serious or
troublesome, or if you notice any side effects
not listed in this leaflet, please tell your
doctor or nurse.

United Kingdom

Manufacturer (Ireland only)
Roche Pharma AG
Emil-Barell-Str. I
D-79639 Greuzach-Wyhlen
Gerniany
This Leaflet was last revised in
January 2013

Rivotri I sterile concentrate solution may
be diluted when given in intravenous
infusions of saline or glucose, such as arc
customary in the treatment of status
epilepticus, sec Instructions jir use.

The active ingredient clonazepam can be
absorbed on PVC. It is therefore
recommended either glass containers be used
or, if PVC infusion bags are used, that the
mixture be infused straight-away over a
period of no longer than 2 hours.

Incompatibilities
Do not prepare Rivotril infusions using
sodium bicarbonate solution, as precipitation
of the solution may occur.

DO NOT prepare Rivotril infusions
using sodium bicarbonate solution, as
precipitation of the solution may occur.

Instriictioizs for use
Preparation of Rivotril
injection:

Shelflife
intravenous

The contents of the solvent ampoule, which
contains 1 ml Water for Injection, must be
added to the contents of the other ampoule,
which contains 1 mg clonazepam in I ml.
immediately before injection.

Preparation of Rivotril intraveno us
iiifusion:
Up to 3 mg (3 ampoules) in 250 ml of the
following solutions is permissible:

Sodium chloride intravenous infusion 0.9% w/v
Glucose intravenous infusion 5% and 10%
Sodium chloride and glucose intravenous
infusion (0.45% sodium chloride and 2.5%

Unopened: 4 years.
Shelf-life of diluted product: From a chemical
and physical stability point of view the
diluted product is stable for up
to 12 hours. However, it should be used
immediately after dilution in order to reduce
the possibility of microbial contamination
unless it is diluted under validated aseptic
conditions.

Special precautions Jr storage
Do not store above 30°C. Keep the ampoules
the outer carton to protect from light.

in

This leaflet was last revised in
January 2013

glucose)
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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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