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CLONAZEPAM AUDEN 500MCG TABLETS

Active substance(s): CLONAZEPAM

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Pregnancy and Breast Feeding
Do not start taking this medicine if you are pregnant, or think you may be, unless your doctor tells you to. Contact your doctor if
you think you may be pregnant, or are intending to become pregnant. If you are advised to take this medicine during late

Clonazepam Auden 500 microgram and 2 mg Tablets

an irregular heartbeat. The baby may have become dependent on clonazepam and so could suffer withdrawal symptoms.
If you have any questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you. It should not be given to anyone else. It may harm them, even if their symptoms are
similar to yours.
Tell your doctor or pharmacist if you experience side effects that get serious, or you notice side effects not listed in the

Driving
of treatment. This may be made worse if you drink alcohol. Increasing the dose of clonazepam or changing the time that you
take it may also slow your reactions. You should not drive unless your doctor says you can.

1. Why do you need to use this medicine?
2. How does this medicine work?
3. Before you take Clonazepam Auden Tablets
4. How to take Clonazepam Auden Tablets
5. Possible side effects
6. Storing Clonazepam Auden Tablets
7. What is in Clonazepam Auden Tablets
8. Addresses

The medicine can affect your ability to drive as it may make you sleepy or dizzy.
- Do not drive while taking this medicine until you know how it affects you.
- It is an offence to drive if this medicine affects your ability to drive.
- However, you would not be committing an offence if:
• The medicine has been prescribed to treat a medical or dental problem and
• You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
• It was not affecting your ability to drive safely.

Clonazepam 500 microgram and 2 mg Tablets

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

1. Why do you need to use this medicine?

Other medicines
Always tell your doctor if you are taking any other medicines because taking some medicines together can be harmful, including
medicines you have bought yourself.

Clonazepam is used to treat epilepsy.

2. How does this medicine work?

Some medicines may affect how your body uses clonazepam:
carbamazepine, phenobarbital, phenytoin, primidone (medicines used to treat epilepsy)
amprenavir, ritonavir (medicines used to treat HIV)
cimetidine (medicine used to treat stomach problems)
rifampicin (an antibiotic)
theophylline (used to treat asthma)
medicines that help with anxiety (tranquillisers).

3. Before you take Clonazepam Auden Tablets

Do not use Clonazepam Auden Tablets;
if you are allergic to any of the ingredients of this medicine (see section 7) or to other benzodiazepines (such as
-

You should not breast feed as clonazepam passes into breast milk.

if you have lung disease
if you have myasthenia gravis (severe muscle weakness)
if you have a severe liver condition
if you have problems with alcohol or drug (prescription or recreational) use
if patient is in a coma.

If any of the following apply to you, tell your doctor or nurse before taking the tablets:
if you are, may be or planning to become pregnant or are breast-feeding
if you have a lung, liver or kidney condition
if you regularly drink alcohol or use recreational drugs
if you suffer from cerebellar ataxia (you have a problem co-ordinating movement)
if you have a history of depression or have attempted suicide
if you have porphyria (a disease that affects the skin and/or nervous system)
if you have recently suffered a death of a near friend or relative
if you are taking any other medicines to treat epilepsy
if you have been told by your doctor that you have an intolerance to some sugars because the tablets contain lactose.
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.
Do not drink alcohol

fects.
AAAI3793

Low blood pressure may occur if clonazepam is taken with:
antihypertensives (medicines used to lower blood pressure) and medicines for the treatment of heart problems (such
as nitrates and beta-blockers).
alpha blockers (a group of medicines used to lower blood pressure and to treat urinary retention)
diuretics (water tablets).
You are likely to feel sleepy if clonazepam is taken with:
alcohol
general anaesthetics
tricyclic and tricyclic-related antidepressants
antihistamines (except those that are applied to the skin or inhaled through the nose; used to treat allergic reactions
such as hayfever)
antipsychotics (used to change behaviour and moods)
baclofen, tizanidine (muscle relaxants)
lofexidine (used to treat dependency to strong pain killers)
mirtazapine (an antidepressant)
nabilone (used to treat nausea and vertigo or dizziness)
opioid analgesics (strong medicines for pain relief).
AAAI3793

Clonazepam Auden All Strengths Tablet PIL - UK
item no:

approved for print/date

AAAI3793

dimensions: 210 x 300

print proof no: 2

pharmacode:

origination date: 19.10.15

min pt size: 7pt

originated by:

R.Paul

revision date:

27.10.15

Technical Approval

revised by:

R.Paul

date sent: 19.10.15

supplier:

Centaur
technically app. date: 26.10.15
Pharmaceuticals

colours/plates
1. black
2.
3.
4.
5.
6.
Non Printing Colours
1. Profile

Clonazepam can also affect other medicines that you may be taking:
phenytoin, primidone (medicines used to treat epilepsy)
levodopa ( a medicine used to treat Parkinson’s disease).








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.

4. How to take Clonazepam Auden Tablets



Always take the tablets exactly as your doctor tells you to. The dose your doctor tells you to take will depend on the nature of
your illness, your reaction to the medicine and your age.
Clonazepam is taken 3-4 times a day. It is started at a low dose and increased over 2-4 weeks until the right dose for you is
reached (the maintenance dose). The maximum dose is 20 mg in a 24 hour period. Swallow the tablets with water. The tablets
can be broken in half to give a smaller dose.






Elderly
The starting dose should be no more than 0.5 mg in a 24 hour period, as elderly people are sensitive to the effects of clonazepam
and may become confused to begin with. The maintenance dose is usually a total of 4 to 8 mg in a 24 hour period, but your
doctor may tell you to take more.

Dizziness, light-headedness, sleepiness, tiredness, lack of co-ordination, poor concentration, restlessness, confusion,
The effects are
usually short-lived and may disappear by adjusting the dose.
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.
Feeling unsteady when walking.
Platelet count bruising easily, being short of breath and nose bleeds.
Slurring of speech, lack of co-ordination of movement, double vision, rapid eye movements are all reversible effects that
may occur particularly if on long-term or high-dose treatment.
called porphyria.
Infants and small children may start to dribble or drool because of increased production of saliva and secretions from the
airways. Children should therefore be watched carefully as this might cause problems in breathing and/or severe choking
and coughing.
Rarely, nausea and stomach problems can occur.
Rarely there may be hives, rashes, short-term hair loss or change in skin colouring.
Rarely, urinary incontinence (not being able to control when to pass water) may occur.

There have been some isolated reports of:

changes to your blood or liver function (seen in test results).

early development of puberty in children. This effect is reversible.

Adults
The starting dose should be no more than 1.0 mg in a 24 hour period. The maintenance dose is usually a total of 4 to 8 mg in a
24 hour period, but your doctor may tell you to take more.

Stopping Clonazepam Auden Tablets suddenly may cause withdrawal symptoms. These include, shakes (tremors), sweating,
agitation, problems sleeping, anxiety (sometimes severe), headaches, muscle pain, tension, restlessness, confusion, irritability

Children and Infants
Infants: The starting dose should be no more than 0.25 mg in a 24 hour period (half a 0.5 mg tablet) and the maintenance dose is
usually a total of 0.5 - 1 mg in a 24 hour period.

light and touch, numbness and tingling of the hands and feet or hallucinations.
Gradual withdrawal of Clonazepam Auden Tablets will help to reduce these effects.

Children 1-5 years: The starting dose should be no more than 0.25 mg in a 24 hour period (half a 0.5 mg tablet) and the
maintenance dose is usually a total of 1 - 3 mg in a 24 hour period.

Reporting of side effects:

Children 5-12 years: The starting dose should be no more than 0.5 mg in a 24 hour period (one tablet) and the maintenance dose
is usually a total of 3 - 6 mg in a 24 hour period.

also report side effects directly via the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard). By reporting side effects you
can help provide more information on the safety of this medicine.

Do not suddenly stop taking Clonazepam Auden Tablets. If you need to stop taking Clonazepam Auden Tablets, your doctor
will tell you how to stop slowly to reduce any side effects as you can get withdrawal symptoms if you stop suddenly. These
symptoms may include problems with sleeping, muscle pain, anxiety (sometimes severe), tension, restlessness, confusion, severe
mood changes, irritability, sweating, shakes (tremor), headaches and agitation. In serious cases, withdrawal effects can also
include being oversensitive to light, noise and touch, hallucinations, tingling, numbness and a feeling of being unreal.
If you think the effect of Clonazepam Auden Tablets is too strong or too weak, talk to your doctor. Do NOT change the dose yourself.

Keep your Clonazepam Auden Tablets in a safe place where children cannot see or reach them.
Keep the blister in the outer carton to protect them from light. Do not put them into another container. Do not use Clonazepam
Auden Tablets after the expiry date printed on the carton and labels.

What to do if you miss a dose
If you forget to take a tablet, simply take the next dose when it is due. NEVER take an extra dose to make up for the forgotten dose.
What to do if you take too many tablets
If you take too many tablets or someone else accidentally takes your medicine, contact you doctor, pharmacist or nearest
hospital immediately.

All medicines sometimes cause side effects in some people. The following side effects have been reported:

Allergic reactions can occur (such as itching, swelling of the tongue, eyes, lips and hands). Rarely this can be severe.






7. What is in Clonazepam Auden Tablets?

The name of your medicine is Clonazepam Auden Tablets and its active ingredient is clonazepam.
There are two tablet strengths and they both come in packs of 100 tablets:
Clonazepam Auden 500 micrograms Tablets, which contain 500 micrograms of clonazepam in each tablet, are white
round tablets cross-scored and marked ‘CLN 0.5’.
Clonazepam Auden 2 mg Tablets, which contain 2 milligrams of clonazepam in each tablet, are white round tablets
cross-scored and marked ‘CLN 2’.
Other ingredients in the tablets are lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

5. Possible side effects



6. Storing Clonazepam Auden Tablets

8. Addresses

Marketing Authorisation holder: Auden Mckenzie (Pharma Division) Ltd., Whiddon Valley, Barnstaple, North Devon, EX32 8NS, UK

Changes in behaviour: aggressiveness, excitability, nervousness, hostility, anxiety, problems sleeping, nightmares, vivid
dreams, irritability, agitation, extreme mood changes and new types of seizures may occur. If they occur then tell your
doctor immediately so that your treatment can be changed.
Memory loss (amnesia) after a traumatic event which may be linked with some strange behaviour (more likely with higher
doses).
Depression.
Loss of sex drive, impotence.
Dependence on clonazepam – this is more of a risk when the dose is high or the treatment is for a long time, and is
especially likely to occur in patients with a history of alcoholism or drug abuse.

Manufacturer:Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, UK
October 2015

For information in large print, on tape, on CD or in Braille, phone 01271 385 257

AAAI3793

AAAI3793

Clonazepam Auden All Strengths Tablet PIL - UK
item no:

approved for print/date

AAAI3793

dimensions: 210 x 300

print proof no: 2

pharmacode:

origination date: 19.10.15

min pt size: 7pt

originated by:

R.Paul

revision date:

27.10.15

Technical Approval

revised by:

R.Paul

date sent: 19.10.15

supplier:

Centaur
technically app. date: 26.10.15
Pharmaceuticals

colours/plates
1. black
2.
3.
4.
5.
6.
Non Printing Colours
1. Profile

Pregnancy and Breast Feeding
Do not start taking this medicine if you are pregnant, or think you may be, unless your doctor tells you to. Contact your doctor if
you think you may be pregnant, or are intending to become pregnant. If you are advised to take this medicine during late

Clonazepam Auden 500 microgram and 2 mg Tablets

an irregular heartbeat. The baby may have become dependent on clonazepam and so could suffer withdrawal symptoms.
If you have any questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you. It should not be given to anyone else. It may harm them, even if their symptoms are
similar to yours.
Tell your doctor or pharmacist if you experience side effects that get serious, or you notice side effects not listed in the

Driving
of treatment. This may be made worse if you drink alcohol. Increasing the dose of clonazepam or changing the time that you
take it may also slow your reactions. You should not drive unless your doctor says you can.

1. Why do you need to use this medicine?
2. How does this medicine work?
3. Before you take Clonazepam Auden Tablets
4. How to take Clonazepam Auden Tablets
5. Possible side effects
6. Storing Clonazepam Auden Tablets
7. What is in Clonazepam Auden Tablets
8. Addresses

The medicine can affect your ability to drive as it may make you sleepy or dizzy.
- Do not drive while taking this medicine until you know how it affects you.
- It is an offence to drive if this medicine affects your ability to drive.
- However, you would not be committing an offence if:
• The medicine has been prescribed to treat a medical or dental problem and
• You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
• It was not affecting your ability to drive safely.

Clonazepam 500 microgram and 2 mg Tablets

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

1. Why do you need to use this medicine?

Other medicines
Always tell your doctor if you are taking any other medicines because taking some medicines together can be harmful, including
medicines you have bought yourself.

Clonazepam is used to treat epilepsy.

2. How does this medicine work?

Some medicines may affect how your body uses clonazepam:
carbamazepine, phenobarbital, phenytoin, primidone (medicines used to treat epilepsy)
amprenavir, ritonavir (medicines used to treat HIV)
cimetidine (medicine used to treat stomach problems)
rifampicin (an antibiotic)
theophylline (used to treat asthma)
medicines that help with anxiety (tranquillisers).

3. Before you take Clonazepam Auden Tablets

Do not use Clonazepam Auden Tablets;
if you are allergic to any of the ingredients of this medicine (see section 7) or to other benzodiazepines (such as
-

You should not breast feed as clonazepam passes into breast milk.

if you have lung disease
if you have myasthenia gravis (severe muscle weakness)
if you have a severe liver condition
if you have problems with alcohol or drug (prescription or recreational) use
if patient is in a coma.

If any of the following apply to you, tell your doctor or nurse before taking the tablets:
if you are, may be or planning to become pregnant or are breast-feeding
if you have a lung, liver or kidney condition
if you regularly drink alcohol or use recreational drugs
if you suffer from cerebellar ataxia (you have a problem co-ordinating movement)
if you have a history of depression or have attempted suicide
if you have porphyria (a disease that affects the skin and/or nervous system)
if you have recently suffered a death of a near friend or relative
if you are taking any other medicines to treat epilepsy
if you have been told by your doctor that you have an intolerance to some sugars because the tablets contain lactose.
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.
Do not drink alcohol

fects.
AAAI3790

Low blood pressure may occur if clonazepam is taken with:
antihypertensives (medicines used to lower blood pressure) and medicines for the treatment of heart problems (such
as nitrates and beta-blockers).
alpha blockers (a group of medicines used to lower blood pressure and to treat urinary retention)
diuretics (water tablets).
You are likely to feel sleepy if clonazepam is taken with:
alcohol
general anaesthetics
tricyclic and tricyclic-related antidepressants
antihistamines (except those that are applied to the skin or inhaled through the nose; used to treat allergic reactions
such as hayfever)
antipsychotics (used to change behaviour and moods)
baclofen, tizanidine (muscle relaxants)
lofexidine (used to treat dependency to strong pain killers)
mirtazapine (an antidepressant)
nabilone (used to treat nausea and vertigo or dizziness)
opioid analgesics (strong medicines for pain relief).
AAAI3790

Clonazepam Auden All Strengths Tablet PIL - UK
item no:

approved for print/date

AAAI3790

dimensions: 210 x 300

print proof no: 3

pharmacode:

origination date: 19.10.15

min pt size: 7pt

originated by:

R.Paul

revision date:

28.10.15

revised by:

date sent: 19.10.15
R.Paul
Centaur
technically app. date: 26.10.15
Pharmaceuticals

supplier:

colours/plates
1. black
2.
3.
4.
5.
6.

Technical Approval

Non Printing Colours
1. Profile

Clonazepam can also affect other medicines that you may be taking:
phenytoin, primidone (medicines used to treat epilepsy)
levodopa ( a medicine used to treat Parkinson’s disease).








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.

4. How to take Clonazepam Auden Tablets



Always take the tablets exactly as your doctor tells you to. The dose your doctor tells you to take will depend on the nature of
your illness, your reaction to the medicine and your age.
Clonazepam is taken 3-4 times a day. It is started at a low dose and increased over 2-4 weeks until the right dose for you is
reached (the maintenance dose). The maximum dose is 20 mg in a 24 hour period. Swallow the tablets with water. The tablets
can be broken in half to give a smaller dose.






Elderly
The starting dose should be no more than 0.5 mg in a 24 hour period, as elderly people are sensitive to the effects of clonazepam
and may become confused to begin with. The maintenance dose is usually a total of 4 to 8 mg in a 24 hour period, but your
doctor may tell you to take more.

Dizziness, light-headedness, sleepiness, tiredness, lack of co-ordination, poor concentration, restlessness, confusion,
The effects are
usually short-lived and may disappear by adjusting the dose.
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.
Feeling unsteady when walking.
Platelet count bruising easily, being short of breath and nose bleeds.
Slurring of speech, lack of co-ordination of movement, double vision, rapid eye movements are all reversible effects that
may occur particularly if on long-term or high-dose treatment.
called porphyria.
Infants and small children may start to dribble or drool because of increased production of saliva and secretions from the
airways. Children should therefore be watched carefully as this might cause problems in breathing and/or severe choking
and coughing.
Rarely, nausea and stomach problems can occur.
Rarely there may be hives, rashes, short-term hair loss or change in skin colouring.
Rarely, urinary incontinence (not being able to control when to pass water) may occur.

There have been some isolated reports of:

changes to your blood or liver function (seen in test results).

early development of puberty in children. This effect is reversible.

Adults
The starting dose should be no more than 1.0 mg in a 24 hour period. The maintenance dose is usually a total of 4 to 8 mg in a
24 hour period, but your doctor may tell you to take more.

Stopping Clonazepam Auden Tablets suddenly may cause withdrawal symptoms. These include, shakes (tremors), sweating,
agitation, problems sleeping, anxiety (sometimes severe), headaches, muscle pain, tension, restlessness, confusion, irritability

Children and Infants
Infants: The starting dose should be no more than 0.25 mg in a 24 hour period (half a 0.5 mg tablet) and the maintenance dose is
usually a total of 0.5 - 1 mg in a 24 hour period.

light and touch, numbness and tingling of the hands and feet or hallucinations.
Gradual withdrawal of Clonazepam Auden Tablets will help to reduce these effects.

Children 1-5 years: The starting dose should be no more than 0.25 mg in a 24 hour period (half a 0.5 mg tablet) and the
maintenance dose is usually a total of 1 - 3 mg in a 24 hour period.

Reporting of side effects:

Children 5-12 years: The starting dose should be no more than 0.5 mg in a 24 hour period (one tablet) and the maintenance dose
is usually a total of 3 - 6 mg in a 24 hour period.

also report side effects directly via the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard). By reporting side effects you
can help provide more information on the safety of this medicine.

Do not suddenly stop taking Clonazepam Auden Tablets. If you need to stop taking Clonazepam Auden Tablets, your doctor
will tell you how to stop slowly to reduce any side effects as you can get withdrawal symptoms if you stop suddenly. These
symptoms may include problems with sleeping, muscle pain, anxiety (sometimes severe), tension, restlessness, confusion, severe
mood changes, irritability, sweating, shakes (tremor), headaches and agitation. In serious cases, withdrawal effects can also
include being oversensitive to light, noise and touch, hallucinations, tingling, numbness and a feeling of being unreal.
If you think the effect of Clonazepam Auden Tablets is too strong or too weak, talk to your doctor. Do NOT change the dose yourself.

Keep your Clonazepam Auden Tablets in a safe place where children cannot see or reach them.
Keep the blister in the outer carton to protect them from light. Do not put them into another container. Do not use Clonazepam
Auden Tablets after the expiry date printed on the carton and labels.

What to do if you miss a dose
If you forget to take a tablet, simply take the next dose when it is due. NEVER take an extra dose to make up for the forgotten dose.
What to do if you take too many tablets
If you take too many tablets or someone else accidentally takes your medicine, contact you doctor, pharmacist or nearest
hospital immediately.

All medicines sometimes cause side effects in some people. The following side effects have been reported:

Allergic reactions can occur (such as itching, swelling of the tongue, eyes, lips and hands). Rarely this can be severe.






7. What is in Clonazepam Auden Tablets?

The name of your medicine is Clonazepam Auden Tablets and its active ingredient is clonazepam.
There are two tablet strengths and they both come in packs of 100 tablets:
Clonazepam Auden 500 micrograms Tablets, which contain 500 micrograms of clonazepam in each tablet, are white
round tablets cross-scored and marked ‘CLN 0.5’.
Clonazepam Auden 2 mg Tablets, which contain 2 milligrams of clonazepam in each tablet, are white round tablets
cross-scored and marked ‘CLN 2’.
Other ingredients in the tablets are lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

5. Possible side effects



6. Storing Clonazepam Auden Tablets

8. Addresses

Marketing Authorisation holder: Auden Mckenzie (Pharma Division) Ltd., Whiddon Valley, Barnstaple, North Devon, EX32 8NS, UK

Changes in behaviour: aggressiveness, excitability, nervousness, hostility, anxiety, problems sleeping, nightmares, vivid
dreams, irritability, agitation, extreme mood changes and new types of seizures may occur. If they occur then tell your
doctor immediately so that your treatment can be changed.
Memory loss (amnesia) after a traumatic event which may be linked with some strange behaviour (more likely with higher
doses).
Depression.
Loss of sex drive, impotence.
Dependence on clonazepam – this is more of a risk when the dose is high or the treatment is for a long time, and is
especially likely to occur in patients with a history of alcoholism or drug abuse.

Manufacturer: Auden Mckenzie (Pharma Division) Ltd, Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK
October 2015

For information in large print, on tape, on CD or in Braille, phone 01271 385 257

AAAI3790

AAAI3790

Clonazepam Auden All Strengths Tablet PIL - UK
item no:

approved for print/date

AAAI3790

dimensions: 210 x 300

print proof no: 3

pharmacode:

origination date: 19.10.15

min pt size: 7pt

originated by:

R.Paul

revision date:

28.10.15

revised by:

date sent: 19.10.15
R.Paul
Centaur
technically app. date: 26.10.15
Pharmaceuticals

supplier:

colours/plates
1. black
2.
3.
4.
5.
6.

Technical Approval

Non Printing Colours
1. Profile

Expand view ⇕

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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