LIBRIUM 10MG CAPSULES

Active substance: CHLORDIAZEPOXIDE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

Librium 5 mg and 10 mg Capsules
Chlordiazepoxide hydrochloride
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.
■  you experience any side effect and this becomes serious, tell
If
your doctor or pharmacist.
In this leaflet:
1. What Librium is and what it is used for
2. Before you take Librium Capsules
3. How to take Librium Capsules
4. Possible side effects
5. How to store Librium Capsules
6. Further information
1. WHAT LIBRIUM IS AND WHAT IT IS USED FOR
Librium belongs to a group of medicines known as benzodiazepines,
which are tranquillisers (medicines that have a calming effect).
Librium capsules are used for the short-term treatment of severe
anxiety, which may occur alone or in association with sleeplessness
(insomnia) or personality/behavioural disorders. Librium capsules
may also be used to treat muscle spasms, and to relieve symptoms of
sudden alcohol withdrawal.
2. BEFORE YOU TAKE LIBRIUM CAPSULES
Do not take Librium if you:
■ re allergic (hypersensitive) to chlordiazepoxide or any of the
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ingredients of Librium Capsules (these are listed in section 6,
“Further Information”).
■  re allergic (hypersensitive) to any medicine known as a benzo­
a
diazepine (e.g. nitrazepam, diazepam, flurazepam, or temazepam).
■ 
suffer from lung disease.
■ suffer with breathing difficulties while awake or asleep.
■ uffer from myasthenia gravis (a condition in which the muscles
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become weak and tire easily).
■  re suffering from a psychiatric illness or a personality disorder
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(severe mental problems).
■ have a severe liver condition.
Librium Capsules are not to be used in anyone under 18 years of age.
Take special care with Librium
Tell your doctor before you take these capsules if you:
■ 
have a long-term lung, liver or kidney disease.
■ 
suffer from depression or have recently suffered the death of a close
friend or relative.
■ are suffering or have suffered from a mental illness.
■ 
have abused alcohol or drugs.
■  pregnant or breast feeding.
are
■ ave a decrease in mental function as you should receive a lower dose.
h
Librium capsules relax the muscles, therefore elderly patients should
take extra care when they get up at night as there is a risk of falls and
consequently of injuries including hip fractures.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription. This is extremely important, as using more than one
medicine at the same time can strengthen or weaken the effect of the
medicines involved. In particular, tell your doctor if you are taking
any of the following medicines:
■ 
Antidepressants, sleeping tablets, neuroleptics, hypnotics, tranquillisers or other such medicines which act on the brain and
nerves.
■ 
Medicines used to relieve pain or anaesthetics.
■ 
Antihistamines (used for treating allergies) that cause drowsiness
(e.g. chlorphenamine).
■ 
Medicines for treating epilepsy (e.g. phenytoin and phenobarbital).
■  edicines that affect the liver (e.g. the antibiotic rifampicin and
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cimetidine, omeprazole; medicines used to treat stomach problems,
disulfiram and contraceptive agents).
■  edicines used to treat viral infections (e.g. ritonavir) as these
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medicines can potentiate the actions of benzodiazepines.
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■  rugs to treat high blood pressure (e.g. beta
D
blockers, anticoagulants, cardiac glycosides,
moxonidine).
■ 
Drugs known as dopaminergics (e.g. levodopa,
for Parkinson’s disease).
■ Sodium oxybate used in patients with narcolepsy
■ 
Theophylline; drug to make breathing easier
Taking Librium with food and drink
Take the medicine before or with your meals.
Do not drink alcohol for as long as you are taking Librium Capsules.
Alcohol will increase the effects of the capsules and this can be
dangerous.
Pregnancy and breast-feeding
Tell your doctor before taking Librium Capsules if you are pregnant,
think that you are pregnant or intend to become pregnant during
treatment.Your doctor will then decide whether you should take this
medicine.
Tell your doctor before taking Librium Capsules if you are breastfeeding. Avoid use of Librium if you are breast-feeding, as Librium
passes into breast-milk.
If your doctor has decided that you should receive this medicine
during late pregnancy or during labour, your baby might have a low
body temperature, floppiness and breathing and feeding difficulties.
Also, your unborn baby may be at risk of developing dependency
to this medicine and after birth may be at some risk of developing
withdrawal symptoms.
Driving and using machines
Librium Capsules may cause side effects such as drowsiness, tiredness,
dizziness, confusion, poor muscle co-ordination and problems with
your eyesight. This may affect your ability to drive and operate
machinery. Do not drive or operate machinery if you experience any
of these side effects.
The medicine can affect your ability to drive. Do not drive while
taking this medicine until you know how it affects you.
It may be an offence to drive if your ability to drive safely is affected.
However, you would not be committing an offence if:
The medicine has been prescribed to treat a medical or dental problem
and
■ ou have taken it according to the instructions given by the
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prescriber or in the information provided with the medicine and
■  t was not affecting your ability to drive safely
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Talk to your doctor or pharmacist if you are not sure whether it is safe
for you to drive while taking this medicine.
There is further information for patients who are intending to drive in
Great Britain – go to https://www.gov.uk/drug-driving-law
Important information about some of the ingredients of Librium
Librium Capsules contain lactose. Therefore, 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 LIBRIUM CAPSULES
Your doctor will find the lowest dose to control your symptoms. The
dose that your doctor prescribes will depend on the nature of your
illness, your reaction to the medicine, your age and bodyweight.
Always take Librium exactly as your doctor has told you. Do not
change the prescribed dose yourself. You should check with your
doctor or pharmacist if you are not sure how to take this medicine. If
you think that the effect of your medicine is too weak or too strong,
talk to your doctor.
Swallow the capsule(s) whole with a glass of water.

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Dosage
For the treatment of:
Anxiety

Usual dosage:
Up to 30 mg per day. The maximum
dose is 100 mg per day, taken in divided
doses throughout the day
Sleeplessness (Insomnia) 10 to 30 mg before going to sleep.
associated with anxiety
Symptoms of sudden
25 to 100 mg. This can be repeated 2 to
alcohol withdrawal
4 hours after the initial dose, if necessary
Muscle spasms
10 to 30 mg per day, taken in divided
doses throughout the day.
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.
Librium Capsules are not for use in children.
You will normally see an improvement in your symptoms after 10 to
15 days of taking Librium regularly.
Treatment will not normally be continued for more than 4 weeks. This
is because Librium Capsules may become less effective if you take
them for more than four weeks. If you think that your medicine is no
longer working, you should consult your doctor.
Also, you may become dependent on the capsules if you use them at
high doses and for long periods. Therefore, Librium Capsules are not
suitable for long-term use and after a few weeks it is worth trying to
get by without these capsules. This will help to prevent you becoming
used to Librium and reduce the risk of dependence.
Do not stop taking Librium Capsules without discussing with your
doctor (refer to “When you stop taking Librium” below.)
If you take more Librium than you should
If you take too many capsules or someone else accidentally takes your
medicine, contact your doctor, pharmacist or nearest hospital straight
away.
If you forget to take Librium
Do not take a double dose to make up for a forgotten dose. Instead
you should simply continue with the next dose when it is due.
When you stop taking Librium
Your doctor will advise you when to stop taking the capsules. Do not
stop taking Librium Capsules abruptly. You may experience withdrawal
effects if your treatment is stopped suddenly. This is less likely if your
dose is gradually reduced towards the end of your treatment.
Withdrawal symptoms may include:
■  recurrence of sleep problems ■ diarrhoea
a
■ confusion
■ depression
■ restlessness
■ nervousness
■ incontinence
■ irritability
■ headaches
■ sweating
■ muscle pain
■ extreme anxiety
In severe cases the following symptoms may occur:
■ 
changes in behaviour or the way you are feeling
■ 
numbness and tingling of the extremities
■ 
over-sensitivity to light, noise and touch
■ hallucinations
■ fits
If you are woken up soon after taking the medicine your memory may
be temporarily affected.
If you have taken benzodiazepines for a long time, the reduction in
your dosage will be over a longer period of time than would normally
be required when you stop taking this medicine.You may need
additional help. Your doctor will be able to discuss this with you.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Librium can cause side effects, although not everybody
gets them.
It is very important that you immediately seek medical advice if you
develop any of the following symptoms:
A severe allergic (anaphylaxis) or serious allergic reaction which causes
swelling of your face or throat (angioedema), difficulty breathing, thoughts
of self-harm, 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.

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Tell your doctor or pharmacist if you develop any
of the following side effects:
Common:
■ drowsiness and
■ unsteadiness
lightheadedness
and clumsiness
the next day
■ poor muscle
■ tiredness
co-ordination
■ sedation and dizziness
■ confusional states
■ loss of balance
■ speech disorder
Rare:
■ headache
■ double vision
■ vertigo
■ 
changes in the
■ low blood pressure
level of sexual desire
■ stomach upsets
■ inability to pass urine
■ skin rashes
■ incontinence
■ problems with your eyesight ■ impotence
■ emotional disturbances
■ menstrual disorder
The following side effects have also been reported
(Frequency unknown):
■ 
Forgetfulness, memory loss, hallucinations, dependence,
depression, restlessness, agitation, irritability, aggression,
delusion, nightmares, 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
By reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE LIBRIUM CAPSULES
■ 
Store Librium Capsules out of the sight and reach of children.
■ 
Store Librium Capsules below 30 °C.
■  not use Librium Capsules after the expiry date which is stated
Do
on the bottle and outer carton after “EXP”. The expiry date refers to
the last day of that month.
■  edicines must not be disposed of via wastewater or household
M
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Librium contains
Active substance: 
Chlordiazepoxide hydrochloride. Each capsule
contains 5 mg or 10 mg of chlordiazepoxide
hydrochloride.
Other ingredients: Starch maize white, talc purified, lactose, gelatine
and the colouring agents yellow iron oxide
(E172), indigo carmine (E132) and titanium
dioxide (E171). In addition, the 5 mg capsules
also contain the colouring agents quinoline
yellow (E104) and erythrosine (E127).
What Librium looks like and contents of the pack
■ 
Librium 5 mg Capsules are green and yellow with “LIB 5” printed
on them.
■ 
Librium 10 mg Capsules are black and green with “LIB 10” printed
on them.
■ 
Librium Capsules are available in pack sizes of 100.
Marketing Authorisation Holder
Meda Pharmaceuticals Ltd., Skyway House, Parsonage Road, Takeley,
Bishop’s Stortford, CM22 6PU, UK
Manufacturer
Labiana Pharmaceuticals S.L.U., Casanova 27-31
08757- Corbera de Llobregat (Barcelona), Spain
For any information about this medicine, please contact the
Marketing Authorisation Holder.
This leaflet was last revised in 03/2014
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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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