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CHLORDIAZEPOXIDE 10MG TABLETS

Active substance(s): CHLORDIAZEPOXIDE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CHLORDIAZEPOXIDE
5 mg & 10 mg TABLETS

Read all of this leaflet carefully before you start
taking 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 become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

THIS LEAFLET CONTAINS
1. What Chlordiazepoxide is for
2. Before you take Chlordiazepoxide
3. How to take Chlordiazepoxide
4. Possible side effects
5. How to store Chlordiazepoxide
6. Further information

1. WHAT CHLORDIAZEPOXIDE IS FOR
Chlordiazepoxide belongs to a group of medicines called
benzodiazepines. It can be used in the short-term (2-4
weeks only) treatment of:
In adults:
 severe anxiety, occurring alone or in association with
insomnia (difficulty in sleeping), stress or a loss of
control with reality (psychosis)
 muscle spasms
 the symptoms of alcohol withdrawal.
Chlordiazepoxide tablets are not for use in children.
If you are not sure why you have been prescribed this
medicine then please ask your doctor.

2. BEFORE YOU TAKE CHLORDIAZEPOXIDE
Do not take Chlordiazepoxide and tell your doctor if
you:
 are allergic to Chlordiazepoxide, any of the other
ingredients in the tablets (listed in section 6 of this
leaflet) or to other benzodiazepines
 have severe liver, lung or breathing problems
 have muscle weakness sometimes causing difficulty
breathing (myasthenia gravis)
 suffer from breathing problems whilst asleep (sleep
apnoea)
 suffer from depression, mental health problems,
irrational fears (phobias) or obsessions
 are pregnant, planning to become pregnant or are
breast-feeding, (see ‘Pregnancy and breast-feeding’
below)
Take special care with Chlordiazepoxide
Tell your doctor before you take this medicine if you:
 have a history of alcohol or drug abuse
 suffer from a personality disorder
 have recently suffered a loss or bereavement
 are elderly or have problems with your liver or lungs
Medicines such as Chlordiazepoxide may lead to:
 addiction. You may become dependent on these
capsules. Any risk is more likely with high doses,
prolonged treatment or if you have a history of alcohol
or drug abuse.
 tolerance. Chlordiazepoxide tablets may become
less effective after a few weeks. if you think that the
tablets are not working as well as they did, you should
consult your doctor.
 withdrawal. You may experience withdrawal effects if
your treatment is stopped suddenly. Withdrawal
symptoms can occur with Chlordiazepoxide tablets
even when normal doses are given for short periods
of time, (see section 3; ‘If you suddenly stop taking
Chlordiazepoxide’).
Taking other medicines
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, even medicines
bought without a prescription.

In particular, tell your doctor or pharmacist if you are
taking any of the following medicines, as they may affect
how Chlordiazepoxide tablets work:
 Medicines to treat depression such as Fluvoxamine or
Mirtazapine
 Medicines to treat mental health problems such as
Olanzapine or Prochlorperazine
 Medicines to calm you down or to help you sleep
 Sodium oxybate to reduce daytime sleepiness or
sudden loss of muscle strength
 Disulfiram or Lofexidine for drug dependence
 Strong pain killers or general anaesthetics
 Nabilone to treat sickness caused by chemotherapy
 Medicines to treat epilepsy such as Phenytoin or
barbiturates
 Levodopa to treat Parkinson’s disease
 Medicines to treat high blood pressure such as
Captopril, Enalapril (ACE inhibitors), Doxazosin,
Prazosin (alpha-blockers), Candesartan, Losartan
(angiotensin-II receptor antagonists), Guanethidine,
Hydralazine, Minoxidil, Moxonidine or Sodium
nitroprusside
 Medicines to treat high blood pressure or chest pain
such as Propranolol, Atenolol (beta-blockers),
Amlodipine, Felodipine (calcium-channel blockers),
Glyceryl trinitrate, Isosorbide mononitrate (nitrates)
 Medicines to increase urine production such as
Diuretics
 Muscle relaxants such as Baclofen or Tizanidine
 Rifampicin to treat bacterial infections
 Cimetidine to treat ulcers
 Antihistamines for allergies
If you go into hospital or have treatment for other
conditions, tell the doctor that you are taking
Chlordiazepoxide.
Taking Chlordiazepoxide with food and drink
Alcohol may increase the sedative effects of
Chlordiazepoxide and make you feel very sleepy. Do not
drink alcohol whilst taking Chlordiazepoxide.
Grapefruit juice contains one or more components that
alter how the body uses some medicinal products,
including benzodiazepines. Do not drink grapefruit
juice whilst taking Chlordiazepoxide.
Pregnancy and breast-feeding
Do not take Chlordiazepoxide if you are pregnant,
planning to become pregnant or you are breast-feeding,
unless your doctor has told you to.
If you take this medicine late in your pregnancy or during
labour your baby might have an irregular heart rate, a low
body temperature, floppiness, and breathing and feeding
difficulties.
If you take this medicine regularly during late pregnancy,
your baby may become dependent on Chlordiazepoxide
and may develop withdrawal symptoms after birth.
Make sure you follow your doctor’s advice.
Driving and using machines
Chlordiazepoxide may make you feel sleepy, cause loss
of concentration or memory or muscle weakness. Do not
drive or operate machinery if you are affected in this way.
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 Chlordiazepoxide
Chlordiazepoxide 5 mg and 10 mg tablets contain
lactose (a type of sugar). If you know you have an
intolerance to some sugars contact your doctor before
taking this medicine.
Chlordiazepoxide 5 mg and 10 mg tablets also contain
sunset yellow (E110), which may cause allergic
reactions.

3. HOW TO TAKE CHLORDIAZEPOXIDE
Always take Chlordiazepoxide tablets exactly as your
doctor has told you. Swallow the tablets whole.
When taking this medicine try to make sure you sleep well
for 7-8 hours per night.
Dosage
You will be prescribed the lowest effective dose for the
shortest time necessary to treat your symptoms. This will
reduce the risk of addiction.
Adults:
Anxiety:
The usual dose is 30 mg a day in divided doses. This can
be increased to a maximum of 100 mg a day in divided
doses.
Insomnia in association with anxiety:
The usual dose is 10-30 mg at bedtime.
Muscle spasms:
The usual dose is 10-30 mg a day in divided doses.
Alcohol withdrawal symptoms:
The usual dose is 25-100 mg, which may be repeated
after two to four hours if necessary.
Elderly or debilitated (those that are weak or feeble):
Usually require half the adult dose, as you are likely to be
more sensitive to the effects of Chlordiazepoxide. Follow
your doctor’s advice.
If you have kidney or mild liver problems you may also be
given a lower dose, this should not be more than half the
usual adult dose.
Children: Not recommended.
If you take more Chlordiazepoxide than you should
Contact your doctor or go to a hospital immediately. Show
them the package or container. Symptoms of an overdose
may include drowsiness, confusion, tiredness, breathing
problems, difficulty in controlling movements, low blood
pressure or falling into a coma.
If you forget to take Chlordiazepoxide
Don’t worry, just take your next scheduled dose at the
correct time. Do not take a double dose to make up for the
one you have missed.
If you suddenly stop taking Chlordiazepoxide
The risk of withdrawal symptoms is greater. Your doctor
will gradually reduce your dose to reduce the possibility of
withdrawal effects.
Withdrawal symptoms may include headache, sweating,
diarrhoea, muscle pain, tension, extreme anxiety, mood
changes, sleep disturbances, depression or irritability and
occasionally hallucinations, fits, unusual behaviour,
numbness and tingling of the hands and feet or sensitivity
to light, noise or touch.
Treatment should be gradually withdrawn otherwise the
symptoms you are being treated for may return more
intensely than before (rebound sleeplessness and
anxiety). The risk of this happening is greater when you
stop taking Chlordiazepoxide suddenly.
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, although not everybody gets them.
If you get any of the following side effects, STOP
TAKING this medicine and see your doctor at once:
 feeling restless, agitated irritated or depressed
 nightmares or hallucinations (feeling or seeing things
that are not there)
 aggressive outbursts or rages
 unusual behaviour or false beliefs (delusions).
Other side effects include:
The most common side effects are:
 feeling sleepy, light-headed
 unsteadiness
 clumsiness and loss of co-ordination.
You could notice the above common side effects even
after a single dose and they may continue for more than
24 hours. If you are elderly you are more likely to suffer
from side effects, especially confusion.

Side effects that occur less often are:
 loss of memory
 headache
 dizziness or a feeling of spinning (vertigo)
 reduced alertness and tiredness
 low blood pressure
 stomach upsets
 skin rashes
 muscle weakness
 problems with your vision
 changes in sex drive
 difficulty passing urine
 numbed emotions
Other side effects are:
 dependence (addiction)
 shaking (tremor)
 difficulty in speaking
 making more saliva than usual
 loss of control of your bladder or bowels
(incontinence)
A few cases of unusual bleeding or bruising of the skin,
feeling feverish or yellowing of the skin and whites of the
eyes (jaundice) have been known to occur.
If any of the side effects become serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk your doctor or 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.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE CHLORDIAZEPOXIDE
Keep out of the sight and reach of children.
Store below 25°C and away from light. Store in the
original package or container and keep the container
tightly closed.
Do not use the tablets after the expiry date, which is
stated on the package or container. The expiry date refers
to the day, month and year.
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 Chlordiazepoxide contains
The active ingredient in Chlordiazepoxide 5 mg and 10
mg tablets is chlordiazepoxide hydrochloride.
The other ingredients are lactose, maize starch,
pregelatinised starch, magnesium stearate,
hypromellose, ethylcellulose, diethyl phthalate,
hydroxypropyl cellulose, quinoline yellow (E104), titanium
dioxide (E171), sunset yellow (E110) and patent blue V
(E131).
What Chlordiazepoxide looks like and contents of the
pack
Chlordiazepoxide 5 mg tablets are round green
film-coated tablets with the marking MP3 on one side.
Chlordiazepoxide 10 mg tablets are round green
film-coated tablets with the marking MP4 on one side.
The tablets come in blister packs and containers of 28,
30, 50, 56, 60, 84, 100, 250, 500 and 1000.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Genethics (UK) Limited,
Boumpoulinas 11, Nicosia. P.C. 1060, Cyprus
Manufacturer
Custom Pharmaceuticals Limited,
Conway Street, Hove, East Sussex BN3 3LW
For more information about this product, please contact
the Marketing Authorisation Holder.
This leaflet was last revised in 01/2015
U0003-0004/O/PIL/U1

Product:

Chlordiazepoxide
5 & 10 mg Tablets

Printing Colours:

Non-Printing Colours:

Black

MA Holder:

Genethics UK

PL No.:

34109/0003 & 0004

Pack Size:

All Pack

Dimensions:

148 X 297 mm

Livery:

Genethics UK

Created By:

DTawde

Manufacturer:

-

Artwork Code:

U0003-0004/O/PIL/U1

Bar Code:

-

Font Type:
Font Size:

Arial Narrow
8.6 pt

Market:

UK

Component:

Leaflet

Final Preparation Date For Submission: 06/01/2015

Packing Site Technical Approval:

00/00/0000
Authority Approval Date:
Latest Implementation Deadline:
Print Proof Approval:

00/00/0000
00/00/0000
00/00/0000

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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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