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CHLORDIAZEPOXIDE 10MG FILM-COATED TABLETS

Active substance(s): CHLORDIAZEPOXIDE HYDROCHLORIDE

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Package Leaflet: Information for the User
Chlordiazepoxide 5mg & 10mg film-coated Tablets
Read all of this leaflet carefully before you starts taking this
medicine because it contains important information for you.
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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 for you only. Do not pass it on to
others. It may harm them even if their signs of illness are the same as
yours.
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:
1.
2.

3.
4.
5.
6.

What are Chlordiazepoxide film-coated Tablets and what they are used for
What you need to know before you take Chlordiazepoxide
film-coated Tablets
How to take Chlordiazepoxide film-coated Tablets
Possible side effects
How to store Chlordiazepoxide film-coated Tablets
Contents of the pack and other information

1. What Chlordiazepoxide film-coated Tablets are and what they are
used for
The active ingredient (which makes the tablets work) is chlordiazepoxide
hydrochloride. It belongs to a group of drugs known as benzodiazepines and has a
calming effect. Chlordiazepoxide film-coated Tablets are used for the short-term
relief (2-4 weeks only) of severe or disabling anxiety occurring alone or along with
sleeping problems, muscle spasm of varied causes and for the relief of symptoms
of sudden alcohol withdrawal.

2. What you need to know before you take Chlordiazepoxide
film-coated Tablets
Do not take Chlordiazepoxide Tablets if you:
• have had any unusual or allergic

reactions to chlordiazepoxide,
other benzodiazepine medicines or
to any of the other ingredients in

the tablets (see Section 6).
• have a disorder known as

myasthenia gravis a condition
where muscles become easily tired
and weak leading to difficulty

breathing
• have severe liver disease
• suffer from lung disease or
breathing difficulties

have a condition called sleep
apnoea where you have difficulty
breathing while asleep
suffer from phobias or obsessive
behaviour
are suffering from a psychiatric
illness or personality disorder
(severe mental problems)
are pregnant, planning a
pregnancy or breast-feeding
unless it is under the supervision
of your doctor (see Pregnancy
and breast-feeding below)

Warnings and precautions
Talk to your doctor or pharmacist before taking Chlordiazepoxide Tablets if you
• have a long term lung, liver or
• are suffering or have suffered from
kidney disease
a mental illness
• have a history of alcohol or drug
• are pregnant or breast feeding
abuse
• have a decrease in mental
• suffer from depression or have
function as you should receive a
lower dose.
recently suffered the death of a
close friend or relative (because
there is a risk of suicide in such
patients)
Chlordiazepoxide Tablets relax the muscles, therefore elderly patients should take
extra care when they get up in the night as there is a risk of falls and consequently of
injuries including hip fractures.
Dependence
There is a risk of becoming reliant on this type of medicine (dependence) which
increases with high doses, duration of treatment and in patients with a history of
alcoholism and drug abuse. If dependence has developed, withdrawal symptoms will
occur if you suddenly stop treatment. Treatment should therefore be gradually
withdrawn. See Section 3, ‘If you stop taking Chlordiazepoxide Tablets’.
Tolerance
Chlordiazepoxide may not work as well in promoting sleep after repeated use for a
few weeks. If after a few weeks you notice that the tablets are not working as well as
when you first started treatment, you should speak to your doctor.
Sleep and Memory problems
Chlordiazepoxide Tablets may make you feel sleepy or forgetful. Chlordiazepoxide
Tablets may also cause partial loss of memory (anterograde amnesia); this happens
most often several hours after taking the product. Therefore to reduce the risk of
these, you should take your medicine at bedtime and ensure that you will be able to
have 7 to 8 hours of uninterrupted sleep.
Children and adolescents
Chlordiazepoxide Tablets are not to be used in anyone under 18 years of age.
Other medicines and Chlordiazepoxide Tablets
Some medicines can increase the sedative effects or other side effects of
Chlordiazepoxide Tablets. Tell your doctor if you are taking, have recently taken
or might take any other medicines, especially:

drugs for mental disturbances

medicines that affect the liver
such as chlorpromazine
(e.g. the antibiotic rifampicin and
cimetidine, omeprazole;

tranquillisers (to relieve
medicines used to treat stomach
anxiety), antidepressants (for
problems e.g. cisapride,
depression) and medicines for
disulfiram and contraceptive
sleep
agents

medicines used to treat viral

baclofen and tizanidine (muscle
infections (e.g. ritonavir)
relaxants)

pain relieving medicines

lofexidine (for opiate drug

sedative antihistamines (for
withdrawal)
allergies) such as

nabilone (for nausea and
chlorphenamine
vomiting after chemotherapy)

barbiturates (for anxiety and

anaesthetics (to remove sensation
difficulty sleeping)
or cause unconsciousness for

medicines for epilepsy (e.g.
surgical procedures)
phenytoin and phenobarbital)

sodium oxybate (to treat sudden

medicines for high blood
muscular weakness in people
pressure (e.g. beta blockers,
who have a sleep disorder known
anticoagulants, cardiac
as narcolepsy)
glycosides, moxonidine)

drugs known as dopaminergics

Theophylline; drug to make
(e.g. levodopa for Parkinson’s
breathing easier
disease).
If you go to a doctor, dentist or hospital for any reason, tell them you are taking
Chlordiazepoxide film-coated Tablets.
Chlordiazepoxide Tablets with food, drink and alcohol
Take the medicine before or with your meals.
Do not take alcohol with this medicine. Alcohol is likely to increase the effects of
chlordiazepoxide and this can be dangerous.
If you have a history of alcohol or drug abuse, you must tell your doctor before taking
this medicine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will then decide whether you should take this medicine.
Tell your doctor before taking Chlordiazepoxide Tablets if you are breast-feeding.
Avoid use of Chlordiazepoxide if you are breast-feeding as this medicine passes into
breast milk.
If your doctor has decided that you should receive this medicine during late
pregnancy or during labour, your baby may have a low body temperature, floppiness,
and breathing and feeding difficulties and may be at risk of developing withdrawal
symptoms in the first few days.

Driving and using machines
Chlordiazepoxide Tablets can cause reduced alertness, drowsiness, blurred vision and
dizziness, especially after a change in dose. If you are affected in this way, do not
drive , use machines or take part in activities that may put you or others at risk.
Chlordiazepoxide Tablets contain the excipient 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 Chlordiazepoxide film-coated Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
You will be prescribed the lowest dose needed to control your symptoms. Long term
use of Chlordiazepoxide Tablets is not recommended and treatment will be as short
as possible. Take the medicine by mouth and only in the doses prescribed.
Anxiety:
Adults : Starting dose 5 mg daily
increased if needed up to 30mg per
day. The maximum dose is 100 mg per
day taken in divided doses throughout
the day.

Difficulty
sleeping
(insomnia)
associated with anxiety:
Adults : 10 mg to 30 mg before going to
sleep for a maximum of 4 weeks including
a 2 week tapering off period.

Muscle spasm:
Adults : A total of 10 mg to 30 mg
daily in separate doses.

Relief of symptoms of acute alcohol
withdrawal:
Adults : 25 to 100 mg, repeated if needed
in 2 to 4hrs after initial dose.

If you are elderly or suffer from a lung, liver or kidney condition, or are
generally unwell, your doctor will usually prescribe a lower dose.
If you take more Chlordiazepoxide Tablets than you should
If you accidentally take more tablets than prescribed, you may have difficulty walking
and speaking, and you must contact your doctor or nearest hospital casualty
department at once. Take any remaining tablets with you, so that they can be
identified.
If you forget to take Chlordiazepoxide Tablets
If you miss a dose, skip the missed dose and take the next one when it is due. Do not
take a double dose to make up for a forgotten dose.
If you stop taking Chlordiazepoxide Tablets
If you stop treatment suddenly, withdrawal symptoms can occur. These include
headache, muscle pain, extreme anxiety, tension, difficulty sleeping, restlessness,
confusion, irritability and in severe cases mental disturbances, numbness and tingling
of the hands and feet, extreme sensitivity to light, noise and touch or fits. To avoid
this there will be a tapering off period, during which the dose will be gradually
decreased. Do not stop taking Chlordiazepoxide Tablets without talking to your
doctor. Treatment will not normally last more than 4 weeks. This is because
Chlordiazepoxide Tablets may become less effective if you take them for more than
four weeks. If you think your medicine is no longer working you should consult your
doctor.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines Chlordiazepoxide can cause side effects. Do not be alarmed by
this list of adverse side effects. Most people take Chlordiazepoxide without any
problems. Tell your doctor at once if you notice any of the following effects:
A severe allergic reaction (anaphylaxis) or serious allergic reaction which causes
swelling of your face or throat (angioedema), difficulty breathing, thoughts of selfharm, yellowing of the eyes and skin (jaundice), abnormality in the blood (blood
dyscrasias) with symptoms such as weakness, pale skin, bleeding problems, sore
throat and frequent infections.
Changes in behaviour may occur rarely. These changes may include aggression,
excitement, confusion and depression.
If these behavioural symptoms occur, you must inform your doctor. He/she
may want you to stop taking this medicine.
Tell your doctor or pharmacist if you develop any of the following side effects:


Common: light-headedness, drowsiness, sleepiness, sedation and dizziness,
unsteadiness, loss of balance and walking difficulties, poor muscle coordination, confusional states, speech disorder.

Rare: headache, dizziness, muscle weakness, vertigo (spinning sensation), low
blood pressure, stomach upsets, skin rashes, blurred vision, double vision,
emotional disturbances, changes in the level of sexual desire, impotence,
menstrual disorders, incontinence and difficulty passing urine.

The following side effects have also been reported (Frequency unknown):
forgetfulness, memory loss, dependence, restlessness, agitation, irritability,
aggressive outbursts, delusions (being suspicious or believing things that are not
true), nightmares, hallucinations (seeing or hearing things that are not there),
changes in salivation, increased liver enzymes, changes in the way you walk and
muscle weakness, paradoxical reactions (e.g. anxiety, sleep disorders, insomnia,
suicide attempt, suicidal ideation), tremor, stiffness and slow movement.
If you are woken up soon after taking the medicine your memory may be
temporarily affected.
If you are an elderly patient, you may be more susceptible to side effects and
may suffer from confusion. If this happens, tell your doctor and he/she may
decide to change your dose.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

5. How to store Chlordiazepoxide Tablets
Keep this medicine out of the sight and reach of children. Do not store above 25ºC.
Keep blister in the outer carton. If your doctor tells you to stop the treatment, return
any unused tablets to the pharmacist for safe disposal. Do not use after the expiry
date stated on the blister and carton. The expiry date refers to the last day of that
month. Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These measures
will help protect the environment.

6. Contents of the pack and other information
What Chlordiazepoxide Tablets contain
The active substance (which makes the medicine work) is chlordiazepoxide
hydrochloride. Each tablet contains 5mg or 10mg of
chlordiazepoxide hydrochloride. The other ingredients are: magnesium stearate,
lactose monohydrate, pregelatinised maize starch, hydroxypropylmethylcellulose,
ethylcellulose, diethyl phthalate, Brilliant Blue (E133), Indigo Carmine (E132).
What Chlordiazepoxide Tablets look like and contents of the pack
The tablets are round, green, film-coated tablets. Available in containers and blister
packs of 28, 30, 50, 56, 60, 84, 100, 250, 500, 1000.
Not all pack sizes may be marketed.
Marketing authorisation holder
Dr. Reddy’s Laboratories (UK) Ltd.,
6 Riverview Road, Beverley, HU17 0LD, UK.
Date leaflet revised April 2015

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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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