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Rivotril

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Generic Name: (clonazepam)
Product Name: Rivotril

Indication: 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).

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.


Action: How Rivotril works

Clonazepam is an anticonvulsant which exhibits several pharmacological properties characteristic of the benzodiazepine class of medicines.

The exact site and mode of action of the anticonvulsant action of clonazepam is unknown.

Benzodiazepines enhance the polysynaptic inhibitory processes at all levels of the central nervous system. Clonazepam is more effective in blocking the spread of electrical activity in the lesion itself.

Each 0.5 mg tablet contains 0.5 mg of the active ingredient clonazepam. Each 2 mg tablet contains 2 mg of the active ingredient clonazepam. Each 1 mL drops contains 2.5 mg of the active ingredient clonazepam. Each 1mL ampoule for injection contains 1 mg of the active ingredient clonazepam.

0.5 mg and 2 mg tablets contain the inactive ingredients lactose monohydrate, pregelatinised maize starch and magnesium stearate (470). 0.5 mg tablets also contain the inactive ingredients pregelatinised potato starch, talc (553) and the colourings iron oxide red, CI 77491 (172) and iron oxide yellow, CI 77492 (172). 2 mg tablets also contain the inactive ingredient microcrystalline cellulose (460). Rivotril drops contain the inactive ingredients saccharin sodium (954), propylene glycol (1520), glacial acetic acid (260) peach flavour PHL-014725 and brilliant blue FCF (E133, CI42090). Rivotril injection contains the inactive ingredients ethanol, benzyl alcohol, propylene glycol (1520) and glacial acetic acid (260).

Dose advice: How to use Rivotril

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 here.
    • 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;
    • You have severe and chronic lung disease;
    • You have severe liver disease;
    • You have an addiction to drugs or alcohol;
    • The package is torn or shows signs of tampering;
    • 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.

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 breast milk 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:
  • 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;
  • If you are lactose intolerant;
  • 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

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

Rivotril drops should not be administered directly into the mouth. Drops should be given with a spoon. 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.

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-anda-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.

Schedule of Rivotril

Rivotril is an S4 – Prescription only medicine.

Side effects of Rivotril

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.

For further information talk to your doctor.

References

  1. Rivotril Consumer Medicine Information (CMI). Dee Why, NSW: Roche Products Pty Limited. June 2017. [PDF]
  2. Rivotril Product Information (PI). Dee Why, NSW: Roche Products Pty Limited. June 2017. [PDF]

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Dates

Posted On: 22 July, 2003
Modified On: 26 September, 2017
Reviewed On: 17 September, 2017


Created by: myVMC