RIVOTRIL 2MG TABLETS

Active substance: CLONAZEPAM

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Patient Information Leaflet

10139688 GB 1206.1072

Rivotril

®

0.5 mg and 2 mg Tablets
Clonazepam

 Pain-killers (analgesics) and
medicines to relax your muscles
(muscle relaxants).

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 pharmacist.
 This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them even if their symptoms
are the same as yours.
 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 pharmacist.

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 Rivotril.
Taking Rivotril with Alcohol
Do not drink alcohol while you are taking
Rivotril. This is because it may cause
side effects or cause your fits to return.
Pregnancy and breast-feeding
You must not take Rivotril if you are
pregnant, might become pregnant or are
breast-feeding, unless your doctor tells
you to. Rivotril is known to have harmful
effects on the unborn child.

In this leaflet:
1. What Rivotril is and what it is used for
2. Before you take Rivotril
3. How to take Rivotril
4. Possible side effects
5. How to store Rivotril
6. Further information

Driving and using machines
Talk to your doctor about driving and
using machines or tools, whilst you are
taking Rivotril. 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.

1. What Rivotril is and what it is
used for
Rivotril contains a medicine called
clonazepam. This belongs to a group of
medicines called ‘benzodiazepines’.
Rivotril is used to treat epilepsy in
infants, children and adults.
 It lowers the number of fits (seizures)
that you have.
 Any fits that you do have will be less
serious.

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.

2. Before you take Rivotril

Important information about some
of the ingredients of Rivotril
This medicine contains lactose, which
is a type of sugar. If you have been told by
your doctor that you cannot tolerate or
digest some sugars (have an intolerance
to some sugars), talk to your doctor
before taking this medicine.

Do not take 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 temazepam.
Do not take Rivotril if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist
before taking Rivotril.

3. How to take Rivotril
Always take Rivotril exactly as your
doctor has told you. You should check with
your doctor if you are not sure.

Do not take Rivotril if:
 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 Rivotril if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist
before taking Rivotril.

 Your doctor will start you on a low dose
of Rivotril 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 three equal amounts which you will
take at evenly spaced times throughout
the day.
 If the daily dose cannot be split equally,
take the largest dose at bedtime.
 Once your doctor has found the right
dose for you, they may tell you to take
Rivotril as a single dose in the evening.
Adults and children over 12 years
 The usual starting dose is 1 mg a day,
or less.
 This will be increased gradually
(usually to between 4 mg and 8 mg
a day). The maximum dose is
20 mg a day.

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 pharmacist
before taking 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 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.
If any of the above apply to you, or if
you are not sure, talk to your doctor or
pharmacist before you take Rivotril.

The elderly
 The usual starting dose is 0.5 mg a day,
or less.
 This will be increased gradually
(usually to between 4 mg and 8 mg
a day). The maximum dose is 20 mg
a day.
Infants (aged 0 to 1 year)
 The usual starting dose is 0.25 mg
a day, or less.
 This will be increased gradually
(usually to between 0.5 mg and 1 mg
a day).
Small children (aged 1 to 5 years)
 The usual starting dose is 0.25 mg
a day, or less.
 This will be increased gradually
(usually to between 1 mg and 3 mg
a day).
Older children (aged 5 to 12 years)
 The usual starting dose is 0.5 mg a day,
or less.
 This will be increased gradually
(usually to between 3 mg and 6 mg
a day).

Taking other medicines
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 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
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).
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If you take more Rivotril than you
should
 If you take more Rivotril than
you should, talk to a doctor or go to
a hospital straight away. Take the
medicine pack with you.
 If you take too many tablets, you may
feel drowsy, sleepy, light-headed,
have a lack of co-ordination or be less
responsive than normal.
If you forget to take Rivotril
 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.
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Breathing
 Breathing problems (respiratory
depression). Early signs include
suddenly noisy, difficult and uneven
breathing. Your skin may become blue.

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).
 Do not stop taking your tablets 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 Rivotril you take has to be
reduced, or stopped, this must be
done gradually. Your doctor will let you
know how to do this.

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).

If someone else takes your Rivotril
tablets by mistake, they should talk to a
doctor or go to a hospital straight away.

Withdrawal symptoms
Using benzodiazepines like Rivotril 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.

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

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.

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.

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 pharmacist.
5. How to store Rivotril
 Keep Rivotril tablets in their original
bottle and in the outer carton to protect
from light.
 Rivotril tablets do not need special
storage conditions.
 Keep out of the reach and sight of
children.
 Do not use Rivotril after the expiry date
printed on the pack.
 Do not throw away any left over tablets.
Instead, return them to your
pharmacist so that they can be disposed
of carefully. Only keep them if your
doctor tells you to.

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 before.

6. Further
information
What Rivotril contains
The active substance in Rivotril is
clonazepam. There are two different sizes
of tablets:
 Rivotril 0.5 mg Tablets. Each tablet
contains 0.5 mg (half a milligram)
clonazepam.
 Rivotril 2 mg Tablets. Each tablet
contains 2 mg clonazepam.

Infants and children
 If an infant or small child is taking
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.

The other ingredients in Rivotril 0.5 mg
Tablets are lactose monohydrate, maize
starch, pregelatinised potato starch, talc,
magnesium stearate, yellow iron oxide
(E172) and red iron oxide (E172).

Elderly patients
Older patients taking benzodiazepine
medicines have a higher risk of falling
and breaking bones.

The other ingredients in Rivotril 2 mg
Tablets are lactose anhydrous,
pregelatinised maize starch,
microcrystalline cellulose and magnesium
stearate.

Other possible side effects

When you start taking 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.
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 Rivotril and then increasing it slowly.

What Rivotril looks like and contents of
the pack
 Rivotril 0.5 mg Tablets are round,
pinkish-buff in colour, marked
‘ROCHE 0,5’ on one side and a single
break mark on the other.
 Rivotril 2 mg Tablets are round, white
in colour, marked ‘ROCHE ·2·’ on one
side and cross break marks on the
other.
 Rivotril 0.5 mg Tablets are scored so
that they can easily be broken into
halves. This can allow you to take lower
doses at the start of your treatment.
 Rivotril 2 mg Tablets are cross scored
so that they can easily be broken into
halves or quarters. This can allow you
to take lower doses at the start of your
treatment.
 Rivotril 0.5 mg Tablets are supplied
in glass bottles which contain 50, 100 or
150 tablets. Not all packs may be
marketed.
 Rivotril 2 mg Tablets are supplied
in glass bottles which contain 30 or
100 tablets. Not all packs may be
marketed.

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.

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and Manufacturer
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6 Falcon Way
Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom

Stomach and gut
 Feeling sick (nausea).
 Stomach upset.
Eyes
 Double vision.
 Jerky movements of the eyes
(nystagmus).
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This leaflet was last revised in
November 2012

2

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20.12.2012 15:53:03

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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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