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CLONAZEPAM NRIM 2MG TABLETS

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NRIM Clonazepam NRIM 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.

THE LEAFLET CONTAINS INFORMATION ON:
1.
2.
3.
4.
5.
6.

What Clonazepam Tablets are and what they are used for
Before you take Clonazepam Tablets
How to take Clonazepam Tablets
Possible side effects
How to store Clonazepam Tablets
Further Information

1. WHAT CLONAZEPAM TABLETS ARE AND WHAT THEY ARE
USED FOR?
The name of your medicine is Clonazepam NRIM 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:




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

Taking phenytoin or primidone with Clonazepam tablets may affect the amount
of drug in your blood.
If you are not sure if any of the above applies to you, talk to your doctor or
pharmacist before taking Clonazepam tablets.
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.
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.
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.

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.

Important information about some of the ingredients of
Clonazepam tablets

Taking other medicines

How much to take

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.

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 until the right dose for you is reached (the
maintenance dose). The maximum dose is 20mg in a 24 hour period. The

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.

Client: NRIM

PL Number: 41830/0018 - 19

Size: 180mm x 220mm

Product: Clonazepam Tablets PIL Page 1

Date: 28.11.13

Colours: I Black

Strength: 0.5mg / 2mg

Version: 5

Fonts: Vectora

Arta Creative Solutions Ltd
Suite 1, Interlinks House
81c Church Road
London NW4 4DP

t
f
e
w

020 8203 5976
020 8203 2357
info@artacreative.co.uk
www.artacreative.co.uk

tablets should be swallowed with water and can be broken in half to give a
smaller dose.

The following side effects have been reported:


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
an 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.









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 or
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.
Rarely, 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.
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.
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 NRIM 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 NRIM 0.5mg Tablets also contain ferric oxide yellow (E172) and
ferric oxide red (E172).
What Clonazepam looks like and contents of the pack
Clonazepam NRIM 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 NRIM 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 and manufacturer of this medicine is NRIM
Limited, Unit 15 Moorcroft, Harlington Road, Hillingdon, UB8 3HD, United
Kingdom.
This leaflet was prepared in 11/2013

Client: NRIM

PL Number: 41830/0018 - 19

Size: 180mm x 220mm

Product: Clonazepam Tablets PIL Page 2

Date: 28.11.13

Colours: I Black

Strength: 0.5mg / 2mg

Version: 5

Fonts: Vectora

Arta Creative Solutions Ltd
Suite 1, Interlinks House
81c Church Road
London NW4 4DP

t
f
e
w

020 8203 5976
020 8203 2357
info@artacreative.co.uk
www.artacreative.co.uk

Expand Transcript

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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