1. Name Of The Medicinal Product
Librium 10mg Capsules
2. Qualitative And Quantitative Composition
Each 10mg capsule contains 10mg of the active ingredient chlordiazepoxide hydrochloride BP.
3. Pharmaceutical Form
Librium Capsules 10mg
4. Clinical Particulars
4.1 Therapeutic Indications
Short-term (2
Muscle spasm of varied aetiology.
Symptomatic relief of acute alcohol withdrawal.
4.2 Posology And Method Of Administration
Adults
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Elderly
Elderly or debilitated patients: doses should not exceed half those normally recommended.
Children
Librium is not for paediatric use.
The lowest dose which can control symptoms should be used. Treatment should not be continued at the full dose beyond four weeks.
Long-term chronic use is not recommended.
Treatment should always be tapered off gradually. Patients who have taken benzodiazepines for a prolonged time may require a longer period during which doses are reduced. Specialist help may be appropriate.
Librium capsules and tablets are for oral administration.
Treatment should be kept to a minimum and given only under close medical supervision. Little is known regarding the efficacy or safety of benzodiazepines in long-term use.
4.3 Contraindications
Patients with known sensitivity to benzodiazepines; acute pulmonary insufficiency; respiratory depression; phobic or obsessional states; chronic psychosis.
4.4 Special Warnings And Precautions For Use
In patients with chronic pulmonary insufficiency, and in patients with chronic renal or hepatic disease, dosage may need to be reduced.
Librium should not be used alone to treat depression or anxiety associated with depression, since suicide may be precipitated in such patients.
Amnesia may occur.
In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines.
The dependent potential of the benzodiazepines is low, particularly when limited to short-term use, but this increases when high doses are used, especially when given over long periods. This is particularly so in patients with a history of alcoholism or drug abuse or in patients with marked personality disorders. Regular monitoring in such patients is essential, routine repeat prescriptions should be avoided and treatment should be withdrawn gradually. Symptoms such as depression, nervousness, rebound insomnia, irritability, sweating, and diarrhoea have been reported following abrupt cessation of treatment in patients receiving even normal therapeutic doses for short periods of time.
In rare instances, withdrawal following excessive dosages may produce confusional states, psychotic manifestations and convulsions.
Abnormal psychological reactions to benzodiazepines have been reported. Rare behavioural effects include paradoxical aggressive outbursts, excitement, confusion, and the uncovering of depression with suicidal tendencies. Extreme caution should therefore be used in prescribing benzodiazepines to patients with personality disorders.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
If Librium is combined with centrally-acting drugs such as neuroleptics, tranquilisers, antidepressants, hypnotics, analgesics and anaesthetics, the sedative effects are likely to be intensified. The elderly require special supervision.
When Librium is used in conjunction with anti-epileptic drugs, side-effects and toxicity may be more evident, particularly with hydantoins or barbiturates or combinations including them. This requires extra care in adjusting dosage in the initial stages of treatment.
Known inhibitors of hepatic enzymes, eg cimetidine, have been shown to reduce the clearance of benzodiazepines and may potentiate their action and known inducers of hepatic enzymes, eg rifampicin, may increase the clearance of benzodiazepines.
Concomitant intake with alcohol should be avoided. The sedative effect may be enhanced when the product is used in combination with alcohol. This adversely affects the ability to drive or use machines.
4.6 Pregnancy And Lactation
There is no evidence as to drug safety in human pregnancy, nor is there evidence from animal work that it is free from hazard. Do not use during pregnancy, especially during the first and last trimesters, unless there are compelling reasons.
If the product is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuance of the product if she intends to become or suspects that she is pregnant.
The administration of high doses or prolonged administration of low doses of benzodiazepines in the last trimester of pregnancy has been reported to produce irregularities in the foetal heart rate, and hypotonia, poor sucking and hypothermia in the neonate.
Moreover, infants born to mothers who took benzodiazepines chronically during the later stages of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period.
Chlordiazepoxide may appear in breast milk. If possible the use of Librium should be avoided during lactation.
4.7 Effects On Ability To Drive And Use Machines
Patients should be advised that, like all medicaments of this type, Librium may modify patients' performance at skilled tasks. Sedation, amnesia, impaired concentration and impaired muscle function may adversely affect the ability to drive or use machinery. If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased. Patients should further be advised that alcohol may intensify any impairment, and should, therefore, be avoided during treatment.
4.8 Undesirable Effects
Common adverse effects include drowsiness, sedation, unsteadiness and ataxia; these are dose-related and may persist into the following day even after a single dose. The elderly are particularly sensitive to the effects of centrally-depressant drugs and may experience confusion, especially if organic brain changes are present; the dosage of Librium should not exceed one-half that recommended for other adults.
Other adverse effects are rare and include headache, vertigo, hypotension, gastro-intestinal upsets, skin rashes, visual disturbances, changes in libido, and urinary retention. Isolated cases of blood dyscrasias and jaundice have also been reported.
4.9 Overdose
When taken alone in overdosage Librium presents few problems in management. Signs may include drowsiness, ataxia and dysarthria, with coma in severe cases. Treatment is symptomatic. Gastric lavage is useful only if performed soon after ingestion.
The value of dialysis has not been determined. Anexate is a specific IV antidote for use in emergency situation. Patients requiring such intervention should be monitored closely in hospital (see separate prescribing information).
If excitation occurs, barbiturates should not be used.
When taken with centrally-acting drugs, especially alcohol, the effects of overdosage are likely to be more severe and, in the absence of supportive measures, may prove fatal.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Librium has anxiolytic and central muscle relaxant properties. It has little autonomic activity.
5.2 Pharmacokinetic Properties
Librium is well absorbed, with peak blood levels being achieved one or two hours after administration. The drug has a half-life of 6
Chlordiazepoxide is metabolised to desmethylchlordiazepoxide. Demoxepam and desmethyldiazepam are also found in the plasma of patients on continuous treatment. The active metabolite desmethylchloriazepoxide has an accumulation half-life of 10
Steady-state levels of these active metabolites are reached after 10
No clear correlation has been demonstrated between the blood levels of Librium and its clinical effects.
5.3 Preclinical Safety Data
None stated
6. Pharmaceutical Particulars
6.1 List Of Excipients
10mg capsules contain the following excipients: gelatine, starch maize white, talc purified, lactose, black iron oxide E172, titanium dioxide E171, yellow iron oxide E172 and indigo carmine E132.
6.2 Incompatibilities
None
6.3 Shelf Life
PVDC blister pack 36 months
HDPE bottle 60 months
Plastic bottle 60 months
Amber glass bottle 60 months
6.4 Special Precautions For Storage
Librium capsules should not be stored above 30ºC.
6.5 Nature And Contents Of Container
PVDC Blister pack container 10 capsules
HDPE bottle with jay-cap (snap-fit) closure containing 100 capsules
Plastic bottle with screw cap containing 100 capsules
Amber glass bottle with screw cap containing 100 capsules
6.6 Special Precautions For Disposal And Other Handling
None
7. Marketing Authorisation Holder
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop's Stortford
CM22 6PU
United Kingdom
8. Marketing Authorisation Number(S)
PL 15142/0005
9. Date Of First Authorisation/Renewal Of The Authorisation
1 March 1998
10. Date Of Revision Of The Text
June 2009
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