CLONAZEPAM 0.5MG/5ML ORAL SOLUTION

Active substance: CLONAZEPAM

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Liver, kidney and blood
n changes in how well your liver is working (shown by blood tests)
n loss of bladder control
n blood problems - the signs may include feeling tired, bruising easily, being short of breath and nose bleeds. Your
doctor may want to give you blood tests from time to time.
Stomach and gut
n feeling sick (nausea)
n stomach upset.
Eyes
n double vision
n jerky movements of the eyes (nystagmus).
Skin and hair
n skin rashes and itchy skin
n changes to the colour of your skin
n hair loss (the hair usually grows back).
Sexual
n loss of sex drive
n difficulty getting or keeping an erection (erectile dysfunction).
Withdrawal symptoms
Using benzodiazepines like Clonazepam 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 most common symptoms
can include:
n problems sleeping
n muscle pain, shaking (tremor) or feeling restless
n feeling very anxious, tense, confused, irritable or agitated, or changes in your mood
n increased sweating
n headache.
Less common withdrawal symptoms can include:
n feeling sensitive to light, noise or physical contact
n seeing or hearing things that are not really there (hallucinations)
n tingling and feeling numb in your arms and legs
n a feeling of losing contact with reality.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor
or pharmacist.

5. How to store Clonazepam 0.5mg/5ml Oral Solution
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Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package in order to protect from light.
Do not use 1 month after you first open it. Take it back to the pharmacy.
Do not use after the expiry date (month, year) stated on the label and carton after EXP. The expiry date refers to the
last day of that month.
n If it is out of date or you no longer want it, take it back to the pharmacy.
n Do not use Clonazepam if you notice anything wrong with the medicine. Talk to your pharmacist.

6. Further information
What Clonazepam 0.5mg/5ml Oral Solution contains
The active substance is clonazepam. Each 5ml contains 0.5mg clonazepam.
The other ingredients are ethanol, saccharin, levomenthol and medium chain triglycerides.
What Clonazepam 0.5mg/5ml Oral Solution looks like and contents of the pack
Clonazepam 0.5mg/5ml Oral Solution is a clear, pale straw coloured liquid which smells of menthol. It comes in a brown
glass bottle holding 150ml of solution and with a 2.5ml/5ml double ended spoon with 1.25ml measuring line.
The Marketing Authorisation Holder and Manufacturer is
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
Tel: + 44 (0) 113 244 1400.
This leaflet was last revised in 11/2011.



Patient Information Leaflet
Clonazepam 0.5mg/5ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine.
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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 only for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours
n If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet
1. What Clonazepam 0.5mg/5ml Oral Solution is and what it is used for
2. Before you take Clonazepam 0.5mg/5ml Oral Solution
3. How to take Clonazepam 0.5mg/5ml Oral Solution
4. Possible side effects
5. How to store Clonazepam 0.5mg/5ml Oral Solution
6. Further information

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1. What Clonazepam 0.5mg/5ml Oral Solution is and what it is used for

The name of your medicine is Clonazepam 0.5mg/5ml Oral Solution (called Clonazepam in this leaflet). Clonazepam
belongs to a group of medicines called benzodiazepines.
It is used to treat epilepsy in adults.
n It lowers the number of fits (seizures) that you have.
n Any fits that you do have will be less serious.

2. Before you take Clonazepam 0.5mg/5ml Oral Solution
Do not take this medicine if you are allergic (hypersensitive) to:
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clonazepam or any of the other ingredients listed in Section 6
other benzodiazepine medicines. These include diazepam, flurazepam and temazepam.
An allergic reaction can include a rash, itching or shortness of breath.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before
taking Clonazepam.
Do not take this medicine if:
n you have breathing problems or lung disease
n your breathing stops when you are asleep (sleep apnoea)
n you have severe liver problems
n your muscles become weak and get tired easily (myasthenia gravis).
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before
taking Clonazepam.
Take special care with this medicine
A small number of people being treated with epilepsy medicines such as Clonazepam have had thoughts of harming or
killing themselves. If at any time you have these thoughts, contact your doctor immediately.
Check with your doctor or pharmacist before taking this medicine if:
n you have any liver, kidney or lung problems
n you have ever had depression
n you have ever tried to harm or kill yourself
n a close friend or relative has recently died
n you regularly drink alcohol or take recreational drugs or you have had problems with alcohol or drug use in the past.
This is because you should not drink alcohol or take recreational drugs while you are taking Clonazepam
n you are shaky and unsteady, have slurred speech or have rapid eye movements (spinal or cerebellar ataxia)
n you have a rare, inherited blood problem called porphyria.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Clonazepam.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes
medicines obtained without a prescription, including herbal medicines. This is because clonazepam can affect the way
some other medicines work. Also some other medicines can affect the way clonazepam works.
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In particular tell your doctor or pharmacist if you are taking any of the following medicines:
n other medicines to treat epilepsy, such as carbamazepine, hydantoins, phenobarbital, phenytoin, primidone or
sodium valproate
n medicines used to make you sleep (hypnotics)
n medicines that help with anxiety (tranquillisers)
n pain killers or medicines to relax your muscles (muscle relaxants)
n cimetidine – for stomach problems and heartburn
n rifampicin – an antibiotic used to treat infections.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Clonazepam.
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 Clonazepam.
Taking Clonazepam with alcohol
Do not drink alcohol while you are taking Clonazepam. This is
because it may cause side effects or cause your fits to return.
Pregnancy and breast-feeding
Do not take Clonazepam if you are pregnant, planning to become pregnant or are breast-feeding, unless your doctor tells
you to. This is because Clonazepam may affect your baby.
Driving and using machines
Talk to your doctor about driving or using machines or tools while you are taking Clonazepam. This is because the
medicine 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.
Important information about some of the ingredients of Clonazepam 0.5mg/5ml Oral Solution
This medicine contains 2.6% v/v ethanol (alcohol). This means that each 5ml contains 0.1g of alcohol. This is the same as
2.6ml of beer or 1.1ml of wine per 5ml dose. It is harmful if you have a drinking problem (alcoholism). You should be
aware the medicine has alcohol in it if:
n you are pregnant or breast-feeding
n you have liver problems.

3. How to take Clonazepam 0.5mg/5ml Oral Solution
Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you
are not sure.
n Clonazepam 0.5mg/5ml Oral Solution contains 0.5mg of clonazepam in one 5ml spoonful.
n Always use the 2.5ml/ 5ml double ended spoon with a 1.25ml dosing line within the 2.5ml end that is provided with
the pack.
n Do not use a different spoon as it may be made of polystyrene or PVC and may react with the medicine.
n If a pharmacist gives you a different device such as an oral syringe or pipette, you may find that the plunger of the
syringe may stop moving smoothly or the markings may fade over time. If this happens, take it back to your
pharmacy and swap for a new one.
How to take
n Take this medicine by mouth only.
n Make sure that everything you are using is dry. This is because the medicine should not be mixed with water before
you take it. You can drink water after taking the medicine if you want, this will not affect the medicine.
How much to take
n Your doctor will start you on a low dose of Clonazepam and gradually increase it over 2 to 4 weeks until the right
dose has been found for you.
n Your doctor will usually tell you to split your daily dose into four equal amounts which you will take at evenly
spaced times throughout the day.
n If your daily dose cannot be split equally, take the largest dose at bedtime.
n Once your doctor has found the right dose for you, they may tell you to take Clonazepam as a single dose in the
evening.
Adults
n The usual starting dose is 1mg a day (10ml) or less.
n This will be increased gradually, usually to between 4mg and 8mg a day (40 to 80ml).
n The maximum dose is 20mg a day (200ml).
The elderly
n The usual starting dose is 0.5mg a day (5ml) or less.
n This will be increased gradually, usually to between 4mg and 8mg a day (40 to 80ml).
n The maximum dose is 20mg a day (200ml).



If you take more Clonazepam than you should (overdose)
n Talk to a doctor or go to your nearest hospital straight away. Take the medicine pack with you.
n If you take too much Clonazepam you may feel drowsy, sleepy, light-headed, have a lack of coordination or be less
responsive than normal.
If you forget to take this medicine
n If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed
dose.
n Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
Stopping Clonazepam
n Do not stop taking Clonazepam without talking to your doctor.
If you do your fits may return and you may get withdrawal
symptoms (listed in Section 4: Possible side effects).
n If the dose of Clonazepam you take has to be lowered, or
stopped, this must be done gradually. Your doctor will let
you know how to do this.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Clonazepam can cause side effects, although not everybody gets them. The side effects below may

sometimes happen.
Important side effects to look out for
See a doctor straight away if you notice any of the following serious side effects – you may need urgent medical
treatment:
n thoughts of harming or killing yourself
n allergic reactions – the signs may include skin rash, flaking skin, boils, sore lips and mouth, swelling of the face, fever,
sudden wheezing, fluttering or tightness of the chest or collapse.
Effects on behaviour
If you notice any of the following effects, talk to your doctor as they may want you to stop taking Clonazepam. The signs
may include:
n being aggressive, excited, irritable, nervous, agitated or anxious
n problems sleeping, nightmares or vivid dreams
n mental problems such as seeing or hearing things that are not really there (hallucinations), believing in things that
are not real (delusions) or problems with your speech
n types of fits (seizures) that you have not had before.
Elderly patients
Older patients taking benzodiazepine medicines have a higher risk of falling and breaking bones.
Other possible side effects
When you start taking Clonazepam you may notice the following effects:
n feeling drowsy and tired
n feeling dizzy and light-headed
n weak or floppy muscles or jerky movements (poor coordination)
n 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
Clonazepam and then increasing it slowly.
The following may occur at any time during your treatment:
Mind and nervous system
n poor concentration, confusion or a feeling of being lost (disorientation)
n feeling restless
n difficulty remembering new things
n headache
n depression
n slowing or slurring of speech
n poor coordination, including feeling unsteady when walking
n an increase in how often you have fits.

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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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