CLONAZEPAM 0.5MG TABLETS

Active substance: CLONAZEPAM

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Rivotril 0.5mg Tablets/
Clonazepam 0.5mg Tablets
(clonazepam)
Your medicine is available using any of the above names, but will be
referred to as Rivotril throughout this:
Patient Information Leaflet
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.
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

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.

2) Before you take Rivotril
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.
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.
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.
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).
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 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 breastfeeding, 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 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.
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
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.

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.
 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.
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).
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.

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).RESSINFORMATION

 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.

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.

Eyes
 Double vision.
 Jerky movements of the eyes (nystagmus).

If someone else takes your Rivotril tablets by mistake, they should talk to a
doctor or go to a hospital straight away.
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.
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 before.
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.
Elderly patients
Older patients taking benzodiazepine medicines have a higher risk of falling
and breaking bones.
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.
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.

Stomach and gut
 Feeling sick (nausea).
 Stomach upset.

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.
 Difficulty getting or keeping an erection (erectile dysfunction).
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.
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.
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
 Store in the original blister and outer carton in order to protect from light.
 Keep out of the sight and reach 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. If the tablets become
discoloured or show any other signs of deterioration, you should seek the
advice of your pharmacist who will tell you what to do.

6) Further information
What Rivotril contains
The active substance in Rivotril is clonazepam.
 Rivotril 0.5 mg Tablets. Each tablet contains 0.5 mg clonazepam.
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).
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 break line on the other.
 Rivotril tablets have break lines so that they can easily be broken into
halves or quarters so that you can take low doses at the start of your
treatment.
 Rivotril tablets are supplied in blisters packs of 60 tablets.
Marketing Authorisation Holder and Manufacturer
Rivotril 0.5mg Tablets

PL 10383/1943

POM

Rivotril tablets are manufactured by Roche Farma, S.A. C/Severo Ochoa,
13. Pol. Industrial. Leganes 28914 Madrid, Spain and is procured from
within the EU and repackaged by the Product Licence Holder: Primecrown
Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5
5QS.

Leaflet Date: 16.05.2013

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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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