LIBRIUM Capsule (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Librium 5mg Capsules.
2. Qualitative and quantitative composition
Each 5mg capsule contains 5mg of the active ingredient chlordiazepoxide hydrochloride BP. Each capsule contains 105.9 mg lactose. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Librium Capsules 5 mg.
4.1. Therapeutic indications
Short-term (2-4 weeks) symptomatic treatment of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, ...
4.2. Posology and method of administration
Posology Anxiety states Usual dose 10 mg, 2–3 times a day and up to 30 mg daily in divided doses. For severe symptoms 20 mg, 2–4 times a day. Maximun dose up to 100 mg daily in divided doses. Adjusted ...
4.3. Contraindications
Librium is contraindicated for patients with: hypersensitivity to the active substance chlordiazepoxide or to any of the excipients listed in section 6.1 myasthenia gravis severe pulmonary insufficiency ...
4.4. Special warnings and precautions for use
Tolerance Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks. Dependence and withdrawal The dependent potential of the benzodiazepines is low, ...
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, anaesthetics, and sedative antihistamines the central depressive effects ...
4.6. Pregnancy and lactation
Pregnancy Chlordiazepoxide crosses the placenta. There is a limited amount of data from the use of chlordiazepoxide in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). ...
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 ...
4.8. Undesirable effects
Common adverse effects include drowsiness, sedation, dizziness, somnolence, fatigue, balance disorder, unsteadiness and ataxia; these are dose-related and may persist into the following day even after ...
4.9. Overdose
When taken alone in overdosage, Librium presents few problems in management. When taken with centrally-acting drugs, especially alcohol, the effects of overdose are likely to be more severe and in the ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeiutic group:</b> Psycholeptica, anxiolytics, benzodiazepine derivatives <b>ATC code:</b> N05BA02 Chlordiazepoxide is a psychotropic substance from the class of 1,4-benzodiazepines with ...
5.2. Pharmacokinetic properties
Absorption Librium is well absorbed, with peak blood levels being achieved one or two hours after administration. Steady-state levels are usually reached within three days. Distribution Chlordiazepoxide ...
5.3. Preclinical safety data
Mutagenic and tumourigenic potential In <em>in-vivo</em> and <em>in-vitro</em> studies with chlordiazepoxide, there are indications for a mutagenic effect. Nevertheless, in similar test systems results ...
6.1. List of excipients
<u>5mg capsules contain the following excipients:</u> Gelatine Starch maize white Talc purified Lactose Yellow iron oxide E172 Indigo carmine E132 Titanium dioxide E171 Quinoline yellow E104 Erythrosine ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
PVDC blister pack 36 months. HDPE bottle 24 months. Plastic bottle 24 months. Amber glass bottle 24 months.
6.4. Special precautions for storage
Librium capsules should not be stored above 30°C.
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 ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordence with local requirements.
7. Marketing authorization holder
Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
8. Marketing authorization number(s)
PL 46302/0175
9. Date of first authorization / renewal of the authorization
1 March 1998 / 18 March 2003
10. Date of revision of the text
August 2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
