NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
ROCRIVOT11120
Contains the active ingredient clonazepam
Consumer Medicine Information
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 you taking Rivotril against the benefits they expect it will have 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 (prolonged or repeated fits or seizures without any recovery between attacks).
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 reason.
Ask your doctor if you have any questions why Rivotril has been prescribed for you.
This medicine may be addictive. 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.
This medicine is available only with a doctor’s prescription.
Before you take Rivotril
Do not take Rivotril if:
1.you have had an allergic reaction to Rivotril, any other benzodiazepine medicine or any ingredients listed at the end of this leaflet
Some symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty in breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
2.you have severe and chronic lung disease
3.you have severe liver disease
4.you have an addiction to drugs or alcohol
5.the package is torn or shows signs of tampering
6.the expiry date (EXP) printed on the pack has passed.
If you take this medicine after the expiry date has passed it may not work as well.
Rivotril injection contains benzyl alcohol and must not be given to newborn babies, especially premature babies.
WARNING: Rivotril Oral liquid must be administered as DROPS only. Refer to section below for more information on ‘How to take Rivotril’.
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.
1.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.
2.if you are breastfeeding or plan to breastfeed
Rivotril may pass into the breast milk and cause drowsiness and/or feeding difficulties in the baby. Rivotril is not recommended for use while breastfeeding.
3.if you have any other health problems including:
liver, kidney or lung disease
high or low blood pressure
myasthenia gravis (severe muscle weakness)
sleep apnoea (a condition where you have temporary stops in breathing during sleep)
glaucoma (a condition where you have high pressure in the eye)
depression, psychosis or schizophrenia and /or you have had depression or suicidal thoughts in the past.
porphyria (a rare blood pigment disorder)
a history of alcohol or drug abuse
4.if you drink alcohol
You should not drink alcohol while taking Rivotril. Alcohol may increase the effects of Rivotril and lead to serious side effects.
5.if you are lactose intolerant
6.if you are allergic to any other medicines, foods, dyes or preservatives.
Taking other medicines
Tell your doctor if you are taking any other medicines including any that you have bought without a prescription from a pharmacy, supermarket or health-food shop.
Some medicines may interfere with Rivotril. These medicines include:
sleeping tablets, sedatives or tranquillisers
some medicines for depression
other medicines to control epilepsy
medicines for allergies or colds such as antihistamines
pain relievers
muscle relaxants
anaesthetics
cimetidine – a medicine used to treat ulcers
disulfiram – a medicine used in alcohol abuse
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 about any of the above, tell them before you start taking Rivotril.
How to take Rivotril
WARNING-Rivotril Oral liquid
Measure the prescribed dose of Rivotril Oral liquid as DROPS ONLY. Refer to ‘Oral Drops’ under the heading ‘How to take it’ below for more information.
How much to take
Take Rivotril exactly as your doctor has prescribed.
Your doctor will tell you how much Rivotril to take each day.
The dose varies from person to person depending on age and the condition being treated. Infants and children may need a lower dosage and the use of Rivotril drops is recommended
How to take it
Tablets
Swallow the Rivotril tablets whole with a glass of water.
Oral Drops
Measure the prescribed dose of Rivotril Oral liquid as DROPS ONLY.
Do not administer drops directly into the mouth from the bottle. After each administration, ensure that the dropper is secure in the neck of the bottle. Drops should be given with a spoon. After each opening, make sure the dropper is secured within the neck of the bottle. Rivotril is compatible with water, tea or fruit juice.
Injections
Rivotril injections will be prepared and given by a doctor or nurse.
When to take it
Take Rivotril as directed by your doctor.
Rivotril may be taken with or without food.
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 take a 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.
If you take too much Rivotril (overdose)
If you think that you or anyone else may have taken too much Rivotril, immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice or go to Accident and Emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you have taken too much Rivotril, you may feel drowsy, tired, confused, dizzy, have difficulty breathing, feel weak or become unconscious.
Keep telephone numbers for these places handy.
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.
Your doctor may want do some blood and other tests from time to time to check on your progress and detect any unwanted side effects.
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 may 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
Be careful if you are elderly, unwell, drinking alcohol 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. Your doctor may suggest that you avoid alcohol while you are taking Rivotril.
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 people. 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
muscle weakness
tremor
loss of memory, inattentiveness, confusion, lack of concentration
headache, hangover feeling in the morning
slurred speech
unpleasant dreams
palpitations
vomiting
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
difficulties in breathing
sudden anxiety or excitation
hallucinations or delusions
severe sleep disturbances
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 your tablets in the bottle to protect from light until it is time to take them.
If you take the tablets out of the bottle they may not keep well.
Keep Rivotril tablets in a cool dry place where the temperature stays below 30 °C.
Keep Rivotril drops in a cool dry place where the temperature stays below 25 °C.
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 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.
Rivotril injection will be stored appropriately by the health care facility where you are treated.
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 tablets that are left over.
Product Description
What Rivotril looks like
Rivotril 0.5 mg Tablets are round, pale orange with a score break on one side and ROCHE 0.5 on the other, and come in blister packs of 50.
Rivotril Tablets are gluten free.
Rivotril drops are a clear blue liquid supplied in a 10mL amber glass bottle with a dropper in the neck of the bottle.
Rivotril injection is a clear, colourless to greenish yellow liquid. It is supplied as a pack of 5 amber glass ampoules (1 mL) with 5 diluent ampoules (1 mL).
Ingredients
Active ingredient – clonazepam
each 0.5 mg tablet contains 0.5 mg clonazepam
each 1 mL drops contains 2.5 mg clonazepam
each 1mL ampoule for injection contains 1 mg clonazepam
Inactive ingredients
0.5 mg tablets contain lactose monohydrate, pregelatinised maize starch, magnesium stearate (470), pregelatinised potato starch, talc (553) and the colourings iron oxide red, CI 77491 (172) and iron oxide yellow, CI 77492 (172)
Rivotril drops contain saccharin sodium (954), propylene glycol (1520), glacial acetic acid (260) peach flavour PHL-014725 and brilliant blue FCF (E133, CI42090).
Rivotril injection contains ethanol, benzyl alcohol, propylene glycol (1520) and glacial acetic acid (260).
Manufacturer
Rivotril is distributed in Australia by:
Roche Products Pty Limited
ABN 70 000 132 865
Level 8, 30-34 Hickson Road
Sydney NSW 2000
Medical enquiries: 1 800 233 950
Please check with your pharmacist for the latest Consumer Medicine Information.
Australian Registration Numbers:
Rivotril 0.5 mg Tablets (blister) AUST R 285708
Rivotril 2.5 mg/mL Drops
AUST R 13758
Rivotril 1 mg/1 mL Injection
AUST R 13757
This leaflet was prepared on 1 November 2020.
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