Clonazepam Auden 2mg Tablets
Patient Information Leaflet
Clonazepam Auden 500 microgram and 2 mg Tablets
Read this leaflet carefully before you start taking this medicine. Keep this leaflet; you may want to read it again later.
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
leaflet.
In this leaflet:
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
Clonazepam 500 microgram and 2 mg Tablets
1. Why do you need to use this medicine?
Clonazepam is used to treat epilepsy.
2. How does this medicine work?
Clonazepam works by preventing epileptic seizures or fits. It belongs to a group of medicines called benzodiazepines.
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 diazepam, chlordiazepoxide, bromazepam, flurazepam)
if you have lung disease
if you have myasthenia gravis (severe muscle weakness)
if you suffer from sleeping disorders, such as difficulty breathing while asleep (sleep apnoea)
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 whilst taking clonazepam as it may cause fits (epileptic seizures) and increase the risk of having side effects.
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 pregnancy or during labour, at birth, your baby may have a low body temperature, floppiness, breathing and feeding difficulties,
an irregular heartbeat. The baby may have become dependent on clonazepam and so could suffer withdrawal symptoms.
You should not breast feed as clonazepam passes into breast milk.
Driving
Clonazepam may affect your ability to drive, operate machinery and other hazardous activities, particularly in the first few days
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.
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.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking 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.
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)
disulfiram (medicine used to treat alcohol dependence)
fluvoxamine (an antidepressant)
rifampicin (an antibiotic)
theophylline (used to treat asthma)
medicines that help with anxiety (tranquillisers).
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).
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.
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.
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.
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.
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.
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.
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.
5. Possible side effects
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.
Tell your doctor if you suddenly have difficulty in breathing, or if you think you have an allergic reaction.
• 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 histoiy of alcoholism or drug abuse.
_AAAI3793
• Dizziness, light-headedness, sleepiness, tiredness, lack of co-ordination, poor concentration, restlessness, confusion, disorientation, floppiness and weakness of the muscles, headache. Particularly at the start of treatment. 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.
Increase in number of fits (epileptic seizures) may occur during long-term treatment or in patients with a rare condition
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.
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 and fits (epileptic seizures). In severe cases the following effects may happen: a feeling of being unreal, oversensitivity to noise, 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.
Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can
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.
6. Storing Clonazepam Auden Tablets
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 expity date printed on the carton and labels.
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, microctystalline cellulose, sodium starch glycolate.
8. Addresses
Marketing Authorisation holder: Auden Mckenzie (Pharnia Division) Ltd, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, UK Manufacturer: Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, UK Date of preparation of this leaflet: October 2015
For information in large print, on tape, on CD or in Braille, phone 01271 385 257
u
Auden Mckenzit
AAAR7Q3_
Patient Information Leaflet
Clonazepam Auden 500 microgram and 2 mg Tablets
Read this leaflet carefully before you start taking this medicine. Keep this leaflet; you may want to read it again later.
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
leaflet.
In this leaflet:
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
Clonazepam 500 microgram and 2 mg Tablets
1. Why do you need to use this medicine?
Clonazepam is used to treat epilepsy.
2. How does this medicine work?
Clonazepam works by preventing epileptic seizures or fits. It belongs to a group of medicines called benzodiazepines.
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 diazepam, chlordiazepoxide, bromazepam, flurazepam)
if you have lung disease
if you have myasthenia gravis (severe muscle weakness)
if you suffer from sleeping disorders, such as difficulty breathing while asleep (sleep apnoea)
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 whilst taking clonazepam as it may cause fits (epileptic seizures) and increase the risk of having side effects.
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 pregnancy or during labour, at birth, your baby may have a low body temperature, floppiness, breathing and feeding difficulties,
an irregular heartbeat. The baby may have become dependent on clonazepam and so could suffer withdrawal symptoms.
You should not breast feed as clonazepam passes into breast milk.
Driving
Clonazepam may affect your ability to drive, operate machinery and other hazardous activities, particularly in the first few days
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.
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.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking 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.
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)
disulfiram (medicine used to treat alcohol dependence)
fluvoxamine (an antidepressant)
rifampicin (an antibiotic)
theophylline (used to treat asthma)
medicines that help with anxiety (tranquillisers).
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).
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.
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.
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.
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.
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.
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.
[f you think the effect of Clonazepam Auden Tablets is too strong or too weak, talk to your doctor. Do NOT change the dose yourself.
What to do if you miss a dose
[f 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
[f you take too many tablets or someone else accidentally takes your medicine, contact you doctor, pharmacist or nearest hospital immediately.
5. Possible side effects
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.
Tell your doctor if you suddenly have difficulty in breathing, or if you think you have an allergic reaction.
* 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.
_AAAI3790
* Dizziness, light-headedness, sleepiness, tiredness, lack of co-ordination, poor concentration, restlessness, confusion, disorientation, floppiness and weakness of the muscles, headache. Particularly at the start of treatment. 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.
* Increase in number of fits (epileptic seizures) may occur during long-term treatment or in patients with a rare condition
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.
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 and fits (epileptic seizures). In severe cases the following effects may happen: a feeling of being unreal, oversensitivity to noise, 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.
Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can
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.
6. Storing Clonazepam Auden Tablets
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 expity date printed on the carton and labels.
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.
8. Addresses
Marketing Authorisation holder: AudenMckenzie (Phanma Division) Ltd., Whiddon Valley, Barnstaple, North Devon, EX32 8NS, UK Manufacturer: AudenMckenzie (Phanua Division) Ltd, Mckenzie House, Bitty Street, Ruislip, Middlesex, HA4 7TL, UK Date of preparation of this leaflet: October 2015
For information in large print, on tape, on CD or in Braille, phone 01271 385 257
u
Auden Mckenzie
HAAR7Q0_