RIVOTRIL®
clonazepam tablets 0.5mg and 2.0mg; oral drops 2.5mg/ml; injection 1mg.
What is in this leaflet
This leaflet answers some common questions about RIVOTRIL.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of
your taking RIVOTRIL against the benefits expected for you.
If you have any concerns about taking this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What RIVOTRIL is used for
RIVOTRIL drops and tablets are used for the treatment of epilepsy in infants,
children and adults.
RIVOTRIL Injection is also used to treat status epilepticus.
RIVOTRIL belongs to a group of medicines called benzodiazepines. They are
thought to work by their action on brain chemicals.
Your doctor, however, may have prescribed RIVOTRIL for another purpose.
Ask your doctor if you have any questions why RIVOTRIL has been prescribed for
you.
This medicine is available only with a doctor's prescription.
Before you take RIVOTRIL
Do not take RIVOTRIL if:
- you have had an allergic reaction to RIVOTRIL, any other benzodiazepine
medicine or any ingredients listed at the end of this leaflet - you have severe and chronic lung disease
- RIVOTRIL injection contains benzyl alcohol and must not be given to new
born babies, especially premature babies - the package is torn or shows signs of tampering
- the expiry date printed on the pack has passed.
If you take this medicine after the expiry date has passed it may not work as
well. If the pharmacist has repacked the medicine for you, there may not be an
expiry date on the pack.
If you are not sure if you should be taking RIVOTRIL, talk to your doctor.
Before you start to take it
Your doctor must know about all the following before you start to take
RIVOTRIL:
- if you are pregnant or plan to become pregnant
It is not known whether RIVOTRIL is harmful to an unborn baby when taken by a
pregnant woman. If there is a need to take RIVOTRIL when you are pregnant your
doctor will discuss the risks and benefits to you and the unborn baby. - if you are breastfeeding or plan to breastfeed
RIVOTRIL may pass into the breastmilk and cause drowsiness and/or feeding
difficulties in the baby. RIVOTRIL is not recommended for use while
breastfeeding. - if you have any other health problems including:
- liver, kidney or lung disease
- high or low blood pressure
- balance and/or co-ordination difficulties
- depression, psychosis or schizophrenia
- alcohol or drug abuse.
- if you drink alcohol
You should not take alcohol with RIVOTRIL. Alcohol can change the way this
medicine works. - if you are allergic to any other medicines, foods, dyes or preservatives.
Dependence
RIVOTRIL can cause dependency. The risks are greater for patients on higher
doses or on long term treatment, or patients who have a history of alcohol or
drug abuse.
Tell your doctor or pharmacist before you take RIVOTRIL if you are
concerned about becoming dependent on this medicine.
Taking other medicines
Tell your doctor if you are taking any other medicines including any that
you have bought from a pharmacy, supermarket or healthfood shop.
Some medicines may interfere with RIVOTRIL. These medicines include:
- sleeping tablets, sedatives or tranquillisers
- medicines for depression
- other medicines to control fits such as phenytoin (Dilantin®),
carbamazepine (Tegretol®, Teril®) and valproic acid
(Epilim®) - pain relievers
- muscle relaxants
- flumazenil (Anexate®).
These medicines may be affected by RIVOTRIL or may affect how well RIVOTRIL
works. Your doctor or pharmacist can tell you what to do if you are taking any
of these medicines. They also have a more complete list of medicines to be
careful with or avoid while taking RIVOTRIL.
If you have not told your doctor or pharmacist about any of the above,
tell them before you start taking RIVOTRIL.
How to take RIVOTRIL
How much to take
Take RIVOTRIL exactly as your doctor has prescribed. Your doctor will
tell you how much RIVOTRIL to take each day.
Tablets and Drops
The dose varies from person to person depending on the age and the condition
being treated. The initial dose for adults should not exceed 1.5mg/day (three
0.5mg tablets) divided into three doses. The dose can then be increased, if
necessary, by 0.5mg every third day. The usual long term adult dose is between
3mg and 6mg per day, and should not exceed 20mg per day.
The starting dose for infants and children up to the age of 10 years (or up
to 30kg bodyweight) is 0.01 to 0.03 mg per kilogram daily, given in two to three
divided doses. The dose may be increased by the doctor by no more than
0.25-0.5mg every third day until either a daily maintenance dose of
approximately 0.1mg/kg of bodyweight daily has been reached or seizures are
controlled. The maximum daily dose in children is 0.2mg per kilogram of
bodyweight and should not be exceeded.
The starting dose for children between 10 and 16 years is 1 to 1.5mg per day,
divided into two or three doses. The dose may be increased by the doctor by
0.25-0.5 mg every third day until the maintenance dose (usually 3 to 6 mg/day)
is reached.
Tablets should be swallowed whole with a glass of water. If using the drops,
your doctor or pharmacist will tell you how many drops should be given.
Drops should never be administered directly from the neck of the bottle
into the mouth in case the dropper dislodges. The drops should be given with a
spoon and may be mixed with water, tea or fruit juice.
Injections
The RIVOTRIL injection is used to treat severe epileptic attacks (fits) and
should only be administered by a doctor. The injection should always be diluted
before use. For infants and children usually half an ampoule (0.5 mg) is given.
Adults are usually given 1 ampoule (1mg). The doctor may administer more
RIVOTRIL if the fits do not stop.
When to take it
The medicine should be taken morning and evening, with or without food. If
RIVOTRIL is to be taken three times per day then a dose should also be taken at
lunchtime.
How long to take RIVOTRIL
Continue taking RIVOTRIL until your doctor tells you to stop.
If you forget to take RIVOTRIL
If it is almost time for your next dose, skip the dose you missed and take
your next dose when you are meant to. Otherwise, take it as soon as you remember
and then go back to taking it as you would normally.
Do not double a dose to make up for one you have missed.
If you are not sure whether to skip the dose, talk to your doctor or
pharmacist.
In case of an overdose
If you or anyone else has taken too much RIVOTRIL, immediately telephone
your doctor or National Poisons Information Centre (telephone 0800 POISON or
0800 764 766) for advice or go to Accident and Emergency at your nearest
hospital, even if there are no signs of discomfort or poisoning. Keep telephone
numbers for these places handy.
If you have taken too much RIVOTRIL, you may feel drowsy, tired, confused,
dizzy, have difficulty breathing, feel weak or become unconscious.
If you are not sure what to do, contact your doctor or pharmacist.
While you are taking RIVOTRIL
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you
are taking RIVOTRIL.
Do not take any other medicines whether they require a prescription or not
without first telling your doctor.
Tell your doctor if you become pregnant while taking RIVOTRIL.
Tell your doctor if, for any reason, you have not taken your medicine
exactly as prescribed. Otherwise, your doctor may think that it was not
effective and change your treatment unnecessarily.
Tell your doctor if you feel RIVOTRIL is not helping your condition.
Be sure to keep all of your appointments with your doctor so that your
progress can be checked.
Things you must not do
Do not drive or operate machinery until you know how RIVOTRIL affects you.
RIVOTRIL may cause drowsiness or dizziness in some people and therefore may
affect alertness. Make sure you know how you react to RIVOTRIL before you drive
a car or operate machinery or do anything else that could be dangerous if you
are drowsy, dizzy or not alert.
Do not take RIVOTRIL for a longer time than your doctor has prescribed.
Do not stop taking RIVOTRIL or lower the dose without first checking with
your doctor. Stopping this medicine suddenly could make your epilepsy worse or
cause some unwanted effects. Your doctor will explain how you should slowly
reduce your dose of RIVOTRIL before you can stop taking it completely.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give RIVOTRIL to anyone else even if they have the same condition
as you.
Do not use RIVOTRIL to treat other complaints unless your doctor says to.
Things to be careful of
Drinking alcohol while taking RIVOTRIL. Alcohol can change the way the
medicine works. You should not drink alcohol while taking RIVOTRIL.
If you are elderly, unwell or taking other medicines. Some people may
experience side effects such as drowsiness, confusion, dizziness and
unsteadiness which may increase the risk of a fall.
Side Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking RIVOTRIL.
RIVOTRIL helps most people with epilepsy but it may have unwanted side
effects in a few. All medicines can have side effects. Sometimes they are
serious, most of the time they are not. You may need medical treatment if you
get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- drowsiness, tiredness
- dizziness, unsteadiness
- loss of memory, inattentiveness, confusion, lack of concentration
- headache, hangover feeling in the morning
- slurred speech
- unpleasant dreams
- reduced muscle tone
- depressed mood.
Tell your doctor immediately or go to casualty at your nearest hospital if
you notice any of the following:
- sudden anxiety or excitation
- hallucinations or delusions
- severe sleep disturbances
- difficulty breathing.
These are serious side effects. You may need urgent medical attention.
Serious side effects are rare.
This is not a complete list of all possible side effects. Others may occur in
some people and there may be some side effects not yet known.
Tell your doctor if you notice anything else that is making you feel
unwell, even if it is not on this list.
Ask your doctor or pharmacist if you don't understand anything in this
list.
Do not be alarmed by this list of possible side effects. You may not
experience any of them.
After taking RIVOTRIL
Storage
Keep RIVOTRIL in a cool dry place where the temperature stays below 25°C
for the drops or 30°C for the tablets or injection. Do not store it, or any
other medicine, in a bathroom or near a sink.
Do not leave it in the car or on window sills. Heat and dampness can
destroy some medicines.
Keep the tablets in the bottle until it is time to take them. If you
take the tablets out of the bottle they may not keep well.
Keep RIVOTRIL where young children cannot reach it. A locked cupboard
at least one-and-a-half metres above the ground is a good place to store
medicines.
Disposal
If your doctor tells you to stop taking RIVOTRIL, or the medicine has passed
its expiry date, ask your pharmacist what to do with any medicine that may be
left over.
Product Description
What RIVOTRIL looks like
RIVOTRIL 0.5 mg tablets are round, pale orange with a double score break on
one side and ROCHE 0.5 on the other.
RIVOTRIL 2 mg tablets are round, whitish, with a double score break on one
side and ROCHE .2. on the other.
RIVOTRIL drops are a colourless to slightly greenish-yellow clear liquid with
an odour like peaches.
RIVOTRIL injection contains a clear colourless to slightly green-yellow
solution in amber ampoules.
Ingredients
Active ingredient - clonazepam
- each 0.5 mg tablet contains 0.5 mg clonazepam
- each 2 mg tablet contains 2 mg clonazepam
- each 1 mL drops contains 2.5 mg clonazepam
- each ampoule contains 1mg clonazepam.
Inactive ingredients -
- both 0.5 mg and 2 mg tablets contain lactose, maize starch and magnesium
stearate (470). - the 0.5 mg tablets also contain potato starch , talc (553) and the
colourings iron oxide red, CI 77491 (172) and iron oxide yellow, CI 77492
(172) - the 2 mg tablets also contain microcrystalline cellulose (460)
- the drops contain saccharin sodium (954), propylene glycol (1520), glacial
acetic acid (260) and peach flavour 85 502 - the injection contains ethanol, benzyl alcohol, propylene glycol (1520)
and glacial acetic acid (260).
RIVOTRIL tablets are gluten free.