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SPC, Ireland: HALCION Tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Halcion 125 micrograms Tablets.

Qualitative and quantitative composition

Each tablet contains 125 micrograms of Triazolam. Excipients with known effect: Each tablet contains Lactose Monohydrate 72.0mg. For the full list of excipients, see section 6.1.

Pharmaceutical form

Tablet. Lavender elliptical tablet with Upjohn10 on one side, plain on the other side.

Therapeutic indications

Insomnia: Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.

Posology and method of administration

Insomnia Treatment should be as short as possible. Generally the duration of treatment varies from a few days to two weeks with a maximum, including tapering-off process, of four weeks. Halcion should ...

Contraindications

Triazolam is contraindicated: In patients with a known hypersensitivity to benzodiazepines, triazolam or to any component of this medicine,listed in section 6.1. In patients with myasthenia gravis, severe ...

Special warnings and precautions for use

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimum required. Caution must be used in treating ...

Interaction with other medicinal products and other forms of interaction

Pharmacokinetic interactions can occur when triazolam is administered along with drugs that interfere with its metabolism. Compounds which inhibit certain hepatic enzymes (particularly cytochrome P4503A4) ...

Pregnancy and lactation

The data concerning teratogenicity and effects on postnatal development and behavior following benzodiazepine treatment are inconsistent. There is evidence from some early studies with other members of ...

Effects on ability to drive and use machines

Triazolam can have a major influence on the ability to drive and operate machines. Patients should be advised not to drive or operate machinery during treatment until it has been established that they ...

Undesirable effects

Table 1. Adverse Reactions: Frequency of adverse reactions observed from placebo-controlled clinical trials and post-marketing experience frequency 'Not known. Very Common (≥1/10) Common (≥1/100 to <1/10) ...

Overdose

Symptoms of overdose with triazolam are extensions of its pharmacological action and include drowsiness, slurred speech, motor in coordination, coma, and respiratory depression. Serious sequelae are rare ...

Pharmacodynamic properties

Pharmacotherapeutic group: Benzodiazepine derivatives ATC code: NO5CD05 Triazolam is a short-acting benzodiazepine with anticonvulsant anxiolytic, sedative, muscle relaxant and amnesic properties. It is ...

Pharmacokinetic properties

Triazolam is rapidly and nearly completely absorbed from the gastro-intestinal tract; peak plasma concentrations being achieved within 2 hours of administration by mouth. Triazolam has a short plasma elimination ...

Preclinical safety data

Carcinogenesis No evidence of carcinogenic potential was observed in rats or mice during 24-month studies with triazolam at doses greater than or equal to 800 times the maximum human daily dose of 0.5 ...

List of excipients

Maize starch Lactose monohydrate Microcrystalline cellulose Colloidal anhydrous silica Docusate sodium Sodium benzoate Magnesium stearate Erythrosine (E127 aluminium lake) Indigo carmine (E132 aluminium ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 4 years.

Special precautions for storage

Do not store above 25°C. Keep the blister in the outer carton. Store in the original package.

Nature and contents of container

PVC/Al foil blister strips: Pack sizes: 7, 10 and 30 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24

Marketing authorization number(s)

PA 0822/129/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 13 November 1984 Date of last renewal: 13 November 2009

Date of revision of the text

03/2019

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