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CLONAZEPAM LIME 0.5MG TABLETS

Active substance(s): CLONAZEPAM

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ARTWORK INFORMATION:
PRODUCT:

Clonazepam Lime 0.5 / 2mg Tablets

LICENCE:

PL 20620/0090-91

APPROVED FOR
SUBMISSION:

ITEM / SIZE: Generic package leaflet / 220 mm (h) x 180 mm (w) [flat]
ID CODE:

L1000028/3

VERSION:

2; 12/2/2015

INK:

Black

APPROVED BY
HEALTH AUTHORITY:

CLONAZEPAM LIMETM 0.5MG & 2MG TABLETS
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING 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 gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

• rifampicin (an antibiotic).
• anaesthetics,
• hypnotics (sleep inducing drugs),
• tranquillisers,
• analgesics (drugs that relieve pain)
• baclofen, tizanidine (muscle relaxants).

THE LEAFLET CONTAINS INFORMATION ON:
1. What Clonazepam Tablets are and what they are used for.
2. Before you take Clonazepam Tablets
3. How to take Clonazepam Tablets
4. Possible side effects
5. How to store Clonazepam Tablets
6. Further Information

If you are not sure if any of the above applies to you, talk to your doctor
or pharmacist before taking Clonazepam tablets.

1. WHAT CLONAZEPAM TABLETS ARE AND WHAT THEY ARE
USED FOR?

Pregnancy or breast-feeding
Do not take this medicine if you are pregnant, might become pregnant
unless your doctor tells you to. Contact your doctor if you think you may
be pregnant, or are intending to become pregnant. If advised to take this
medicine during late pregnancy or during labour, your baby might have a
low body temperature, floppiness, breathing and feeding difficulties, an
irregular heart beat. The baby may have become dependent on
clonazepam and could suffer withdrawal symptoms.

The name of your medicine is Clonazepam LIMETM 0.5mg or 2mg Tablets
(called Clonazepam tablets throughout this leaflet). Clonazepam tablets
belongs to a group of medicines called ‘benzodiazepines’. They are used
to treat an illness called epilepsy. Clonazepam works by preventing
seizures or fits.
2. BEFORE YOU TAKE CLONAZEPAM TABLETS
You should not take Clonazepam tablets until you are sure it is safe for
you to do so.
Do not take this medicine and tell your doctor:
• If you are allergic (hypersensitive) to clonazepam or any of the other
ingredients of Clonazepam tablets (listed in Section 6 below) or to
other benzodiazepines (such as diazepam, chlordiazepoxide,
bromazepam, or flurazepam).
• If you are allergic to any of the ingredients it contains.
• If you suffer from lung disease.
• If you suffer from myasthenia gravis (severe muscle tiredness).
• If you suffer from sleeping disorders, such as difficulty breathing while
asleep.
• If you have a severe liver condition.
Take special care with Clonazepam Tablets and check with your
doctor or pharmacist before taking your medicine if you:
• have a lung, liver or kidney condition
• regularly drink alcohol or use recreational drugs.
• suffer from a form of inco-ordination of the muscles called cerebellar
ataxia.
• have a history of depression and/or suicide attempts.
• suffer from the disease which affects the skin and/or nervous system
called porphyria.
• have recently suffered a death of a near friend or relative.
If you are not sure if any of the above applies to you, talk to your doctor
or pharmacist before taking Clonazepam tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines you buy without a
prescription, including herbal medicines. This is because Clonazepam
tablets affect the way some other medicines work. Also some medicines
can affect the way Clonazepam tablets work.
Tell your doctor if you are taking any of the following medicines;
• hydantoins, phenobarbital, sodium valproate or carbamazepine
(medicines used to treat epilepsy). The effect of Clonazepam tablets
may be increased by these drugs.
• cimetidine (medicine used to treat stomach problems).

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Taking phenytoin or primidone with Clonazepam tablets may affect the
amount of drug in your blood.

Taking Clonazepam tablets with food or drink
Clonazepam tablets should be taken with a drink that does not contain
alcohol. Do not drink alcohol while you are taking clonazepam tablets as
it may cause fits (epileptic seizures) and increase the risk of having side
effects.

Do not take this medicine if you are breast-feeding or planning to
breast-feed as clonazepam passes into breast milk.
Driving and using machines:
Clonazepam may affect your ability to drive, operate machinery and
carry out other hazardous activities and should therefore be avoided
altogether or at least during the first few days of treatment. This may be
made worse if you take alcoholic drinks. If you increase your dose or
change the timings of when you take your medication this may also
modify your reactions.
You must not drink alcohol whilst taking Clonazepam tablets as this may
provoke epileptic seizures.
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.
Important information about some of the ingredients of
Clonazepam tablets
Clonazepam Tablets contains lactose. If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
3. HOW TO TAKE CLONAZEPAM TABLETS
Always take Clonazepam tablets exactly as your doctor has told you.
You should check with your doctor if you are not sure.
How much to take
The dose your doctor prescribes will depend on your illness. Follow your
doctor’s instructions carefully. Clonazepam tablets are taken 3 – 4 times
a day. They are started at a low dose and increased over 2 – 4 weeks

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until the right dose for you is reached (the maintenance dose). The
maximum dose is 20mg in a 24 hour period. The tablets should be
swallowed with water and can be broken in half to give a smaller dose.
Adults
• The starting dose should be no more than 1.0mg in a 24 hour period.
• The maintenance dose is usually a total of 4 to 8mg in a 24 hour period
however your doctor may tell you to take more.
Elderly
• The starting dose should be no more than 0.5mg in a 24 hour period,
as elderly people are particularly sensitive to the effects of
clonazepam and may become confused to begin with.
• The maintenance dose is usually a total of 4 to 8mg in a 24 hour period
however your doctor may tell you to take more.
Children and Infants
Infants: The starting dose should be no more than 0.25mg in a 24 hour
period (half a 0.5mg Tablet) and the maintenance dose is usually a total
of 0.5 – 1mg in a 24 hour period.
Children 1 – 5 years: The starting dose should be no more than 0.25mg
in a 24 hour period (half a 0.5mg Tablet) and the maintenance dose is
usually a total of 1 – 3mg in a 24 hour period.
Children 5 – 12 years: The starting dose should be no more than 0.5mg
in a 24 hour period and the maintenance dose is usually a total of 3 –
6mg in a 24 hour period.
If you take more Clonazepam tablets than you should
It is important to stick to the dose on the label of the medicine. If you or
someone else takes too much medicine, contact your doctor or nearest
hospital emergency department immediately. Always take any medicine
left over with you and also the box, as this will allow easier identification
of the medicine.
If you forget to take Clonazepam tablets
If you forget to take a dose, simply take the next dose when it is due.
Never take a extra dose to make up for a forgotten dose.
If you stop taking Clonazepam tablets
Keep taking Clonazepam tablets until your doctor tells you to stop.
Treatment with clonazepam may last all your life, therefore you must
always tell your doctor if you want to stop taking clonazepam, as sudden
discontinuation of treatment can cause the reappearance of seizures as
well as withdrawal symptoms.
After a period of usage it is advisable to reduce dosage gradually.
Sometimes withdrawal effects occur if the medicine is stopped suddenly
and these may include sleep disturbances, muscle pain, extreme anxiety,
tension, restlessness, confusion, mood changes, irritability, sweating,
tremor, headaches and agitation. In serious cases, withdrawal effects
can also include being oversensitive to light, noise and physical contact,
hallucinations, tingling and numbness and a feeling of being unreal.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Clonazepam Tablets can cause side effects although
not everybody gets them.
Tell your doctor immediately if you experience any of the
following as he/she may want you to stop taking this medicine:
- Rarely, changes in behaviour may occur including aggression,
excitement, irritability, nervousness, hostility, agitation, anxiety, sleep
disturbances, nightmares, vivid dreams, psychotic disorders, severe
behavioural disturbances, and new types of seizure may arise.
The following side effects have been reported:
- allergic reactions including severe hypersensitivity and shock.
- seizures as a result of long-term treatment (only with certain forms of
epilepsy), slowing or slurring of speech, reduced co-ordination of
movements or changes in vision (e.g. double vision, involuntary jerky
movements of the eye).
- depression, but it may also be associated with the underlying disease.

- r arely, changes in your blood and liver may occur and your doctor will
monitor for these.
- convulsions in patients with a metabolic disorder called porphyria.
- development of physical and psychological dependence may make it
difficult to come off or stop treatment if taken for too long.
- feeling drowsy or tired, especially at the start of treatment, muscle
weakness, dizziness, light-headedness, floppiness of the muscles or
bad co-ordination and unsteadiness when walking. In rare cases
breathing difficulties may occur. Your doctor can help to avoid most of
these effects by adjusting the dose. The effects are temporary and
disappear over the course of treatment.
- poor concentration, restlessness, confusion, disorientation and
memory loss
- increased salivation and secretion from the lungs in infants and small
children. Children should therefore be watched carefully as this might
cause difficulties in breathing and/or severe choking and coughing.
- hives or itching, swelling of the soft tissue, especially around the eyes,
lips and hands, hairloss, changes in your colouring (i.e. skin), nausea,
headache, loss of sexual desire, impotence, urinary incontinence,
early sexual development in children (this is reversible), abdominal
problems
- increased risk of falls and consequent injury, especially if you are
elderly as benzodiazepines have a muscle relaxing effect.
If any of the side effects get serious or lasts longer than a few days, or if
you notice other unwanted effects, tell your doctor or pharmacist.
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 (Tel: Freephone 0808 100
3352 or Website: www.mhra.gov.uk/yellowcard). By reporting side
effects you can help provide more information on the safety of this
medicine.
5. HOW TO STORE CLONAZEPAM TABLETS
• Keep out of the reach and sight of children.
• Do not use Clonazepam tablets after the expiry date, which is stated
on the end of the carton. The expiry date refers to the last day of the
month.
• Do not store above 25°C. Store in the original packaging.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Clonazepam Tablets contains?
The name of this medicine is Clonazepam LIMETM 0.5mg or 2mg Tablets.
The active substance in your tablet is clonazepam. Each Tablet contains
0.5mg or 2mg of clonazepam respectively. Other ingredients include
anhydrous lactose, pregelatinized starch, microcrystalline cellulose,
magnesium stearate. Clonazepam LIMETM 0.5mg Tablets also contain
ferric oxide yellow (E172) and ferric oxide red (E172).
What Clonazepam looks like and contents of the pack
Clonazepam LIMETM 0.5mg Tablets are peach coloured flat circular
bevelled tablets with cross scoring on one side and plain on the other
side. The tablets can be divided in to equal quarters.
Clonazepam LIMETM 2mg Tablets are white to off white flat circular
bevelled tablets with cross scoring on one side and plain on the other
side. The tablets can be divided in to equal quarters.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder of this medicine is LIME Pharma
Limited, Mckenzie House, Bury Street, Rusilip, Middlesex, HA4 7TL, UK.
Manufactured by Auden Mckenzie (Pharma Division) Ltd., Mckenzie
House, Bury Street, Rusilip, Middlesex, HA4 7TL, UK.
This leaflet was prepared in 02/2015
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12/02/2015 15:59

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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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