Halcion 250 microgram Tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Triazolam

제공처:

Pfizer Healthcare Ireland

ATC 코드:

N05CD; N05CD05

INN (국제 이름):

Triazolam

복용량:

250 microgram(s)

약제 형태:

Tablet

처방전 유형:

Product subject to prescription which may not be renewed (A)

치료 영역:

Benzodiazepine derivatives; triazolam

승인 상태:

Marketed

승인 날짜:

1977-09-30

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor,
pharmacist or nurse.
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Halcion is and what it is used for
2. What you need to know before you take Halcion
3. How to take Halcion
4. Possible side effects
5. How to store Halcion
6. Contents of the pack and other information
1. What Halcion is and what it is used for
Halcion contains the active ingredient triazolam.
Triazolam belongs to a group of medicines called
benzodiazepines.
Halcion is used for the short-term treatment of severe
insomnia (difficulty in falling asleep or sleeping properly).
You must talk to a doctor if you do not feel better or
if you feel worse.
2. What you need to know before you take Halcion
Do not take Halcion if you:
•
are allergic to triazolam or other similar benzodiazepine
medicines or any of the other ingredients of this
medicine (listed in section 6)
•
suffer from an autoimmune disease called ‘myasthenia
gravis’ where you suffer from very weak and tired
muscles
• have severe breathing difficulties
• have ‘sleep apnea’- this is a condition where your
breathing becomes irregular, even stopping for short
periods, while you are asleep
• have severe liver problems
• are taking simultaneously
• medicines for fungal infections containing
ketoconazole or itraconazole,
• medicines for depression containing nefazodone,
• medicines for HIV infections containing efavirenz
or HIV protease inhibitors (e.g. ritonavir),
• or other medicines that strongly reduce the

제품 특성 요약

Health Products Regulatory Authority
14 November 2023
CRN00DWYN
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Halcion 250 microgram Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 micrograms of Triazolam.
Excipients with known effect:
This medicinal product contains 72 mg of lactose monohydrate and 0.15
mg of sodium benzoate in each tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Powder blue, elliptical, flat bevelled-edge tablet with the
‘UPJOHN’ logo and ‘17’ on one face and a single score on the
other
face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Insomnia
Benzodiazepines are only indicated when the disorder is severe,
disabling or subjecting the individual to extreme distress.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage of triazolam should be individualised for a maximum
beneficial effect and to help avoid significant adverse effects.
It is recommended to find the lowest effective dose, particularly in
geriatric or debilitated patients.
The risk of dependence may increase with dose and duration of
treatment; therefore, the lowest effective dose and duration
should be used and the need for continued treatment reassessed
frequently (see section 4.4.).
Abrupt discontinuation or rapid dosage reduction of triazolam after
continued use may precipitate withdrawal reactions, which
can be life threatening. To reduce the risk of withdrawal reactions,
use a gradual taper to discontinue triazolam or reduce the
dosage (see section 4.4.).
Duration of Treatment
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. In certain
cases extension beyond the maximum treatment period
may be necessary; if so, it should not take place without
re-evaluation of the patient's status.
Method of Administration
Halcion should be taken just before going to bed.
Posology
Insomnia:
The usual dose