Gerax 250 microgram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Alprazolam

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

N05BA; N05BA12

INN (International Name):

Alprazolam

Dosage:

250 microgram(s)

Pharmaceutical form:

Tablet

Prescription type:

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

Therapeutic area:

Benzodiazepine derivatives; alprazolam

Authorization status:

Marketed

Authorization date:

1996-01-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GERAX 250 MICROGRAM TABLETS
GERAX 500 MICROGRAM TABLETS
GERAX 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 illness 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 Gerax is and what it is used for
2.
What you need to know before you take Gerax
3.
How to take Gerax
4.
Possible side effects
5.
How to store Gerax
6.
Contents of the pack and other information
1.
WHAT GERAX IS AND WHAT IT IS USED FOR
Gerax 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.
Gerax tablets are only used to treat severe anxiety and severe anxiety
associated with depression. Gerax is
not recommended for the treatment of depression.
Gerax 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’).
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 GERAX
DO NOT TAKE GERAX:

if you are allergic to alprazolam or other similar benzodiazepine
medicines, or to any of the other
ingredients of this medicine (listed in section 6).

if you suffer from a disease called ‘myasthenia gravis’ where you
suffer from very weak and tired
muscles.

if you have severe chest problems or breathing d

Summary of Product characteristics

Health Products Regulatory Authority
30 March 2020
CRN009DFT
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gerax 250 microgram Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
250 micrograms:
Each tablet contains 250 micrograms alprazolam.
Excipients with known effect:
Each tablet contains 92.77 mg lactose monohydrate.
Each tablet contains 0.10 mg sodium benzoate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
250 micrograms:
White, oval tablets scored and marked "AL 0.25" on one side and "G" on
the other.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anxiety
Benzodiazepines are only indicated when the disorder is severe,
disabling or subjecting the individual to extreme distress.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Anxiety_
Treatment should be as short as possible. The overall duration of
treatment generally should not be more than 8 - 12 weeks,
including a tapering off process. The patient should be reassessed
regularly and the need for continued treatment should be
evaluated, especially in case the patient is symptom free.
The recommended starting dose is 500 micrograms to 1 mg daily in
divided doses, with increments (no greater than 1 mg
every 3 - 4 days), to the level of optimal control usually 3 to 4 mg
daily.
To discontinue alprazolam treatment, the dosage should be reduced
slowly in keeping with good medical practice. It is
suggested that the daily dosage of alprazolam be decreased by no more
than 0. 5 mg every 3 days. Some patients may require
an even slower dosage reduction. The risk of dependence may increase
with dose and duration of treatment, therefore, the
lowest possible effective dose and duration should be used and the
need for continued treatment reassessed frequently (see
section 4.4).
_Elderly _
In elderly or debilitated patients, a regimen of 250 micrograms twice
daily should be used initially wit