Alprazolam 0.25 mg Tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Alprazolam

Dostupno od:

Rowex Ltd

ATC koda:

N05BA; N05BA12

INN (International ime):

Alprazolam

Doziranje:

0.25 milligram(s)

Farmaceutski oblik:

Tablet

Tip recepta:

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

Područje terapije:

Benzodiazepine derivatives; alprazolam

Status autorizacije:

Marketed

Datum autorizacije:

2008-10-17

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALPRAZOLAM 0.25 MG TABLETS
ALPRAZOLAM 0.5 MG TABLETS
ALPRAZOLAM 1 MG TABLETS
alprazolam
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 or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illnes are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Alprazolam is and what it is used for
2.
What you need to know before you take Alprazolam
3.
How to take Alprazolam
4.
Possible side effects
5.
How to store Alprazolam
6.
Content of the pack and other information
1.
WHAT ALPRAZOLAM IS AND WHAT IT IS USED FOR
Alprazolam is a tranquilliser containing the active substance
alprazolam. Alprazolam belongs to one of a
group of medicines called benzodiazepines. Benzodiazepines affect
chemical activity in the brain to promote
sleep and to reduce anxiety and worry.
Alprazolam is used to TREAT ANXIETY that is severe, disabling or
causing the sufferer great distress.
Alprazolam tablets should only be used for short-term treatment of
anxiety. The overall duration of treatment
should not be more than 12 weeks including a period where the dose is
gradually reduced (this is called dose
‘tapering’).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALPRAZOLAM
DO NOT TAKE ALPRAZOLAM IF YOU

are allergic to alprazolam or any of the other ingredients of this
medicine (listed in section 6), or
previously had an allergic reaction to another benzodiazepine.

suffer from myasthenia gravis (severe muscle weakness)

have a severe lung disease e.g. bronchitis, emphysema

have "sleep apnoea", where breathing temporarily stops during sleep

have a severe liver disease.
WARNINGS A

Svojstava lijeka

Health Products Regulatory Authority
14 July 2020
CRN009MQ5
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alprazolam 0.25 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.25 mg of alprazolam.
Excipient(s) with known effect:
Each tablet contains 92.2 mg of lactose and 0.12 of sodium benzoate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, oblong tablet with a score line and debossed APZM 0.25.
The tablets can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of anxiety.
Alprazolam should only be used if the disorder is severe or is causing
invalidity, or if the patient is experiencing inordinate
suffering as a result of the disorder.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The treatment period should be as short as possible. The patient
should be reassessed regularly and the need for continued
treatment should be evaluated, especially in case the patient is
symptom free. The total length of treatment should not exceed
8-12 weeks, including the period of gradual dose reduction. Prolonged
treatment may be necessary in certain circumstances,
but this should not be done until the patient's condition has been
reassessed.
As with all benzodiazepines, physicians should be aware that long-term
use might lead to dependence in certain patients.
The optimal dose of alprazolam should be individually determined in
accordance with the severity of the symptoms and the
patient's response. The lowest dose which can control symptoms should
be used. Dose should be reassessed at intervals of no
more than 4 weeks. The usual dose is stated below. In the few patients
who require higher doses, the dose should be increased
cautiously to avoid adverse reactions. When higher dose is required,
the evening dose should be increased before the daytime
doses.
Patients who have never previously taken psychotropic medicinal
products generally require lower doses than patients who
have