Centrax 10mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Prazepam

Available from:

Pfizer Healthcare Ireland

ATC code:

N05BA; N05BA11

INN (International Name):

Prazepam

Dosage:

10 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

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

Therapeutic area:

Benzodiazepine derivatives; prazepam

Authorization status:

Marketed

Authorization date:

1975-07-07

Patient Information leaflet

Page 1 of 7
2022-0075701
PACKAGE LEAFLET: INFORMATION FOR THE USER
CENTRAX® 10MG TABLETS
prazepam
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 Centrax is and what it is used for
2.
What you need to know before you take Centrax
3.
How to take Centrax
4.
Possible side effects
5.
How to store Centrax
6.
Contents of the pack and other information
1.
WHAT CENTRAX IS AND WHAT IT IS USED FOR
Centrax is a tranquilliser containing the active ingredient prazepam.
It belongs to a group of
medicines called benzodiazepines. Benzodiazepines affect chemical
activity in the brain and may
help to reduce anxiety and stress.
It is used for short term relief of severe or disabling anxiety or
when anxiety is causing great
distress.
The overall length of your treatment should not be more than 4 to 6
weeks including a period
where the dose is gradually reduced.
IT IS NOT SUITABLE FOR CHILDREN AND ADOLESCENTS UNDER 18 YEARS.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CENTRAX
DO NOT TAKE CENTRAX:
•
If you are allergic to prazepam or other similar benzodiazepine
medicines, or any of the other
ingredients of this medicine (listed in section 6)
•
If you suffer from an autoimmune disease called ‘myasthenia
gravis’ where you suffer from
very weak and tired muscles
•
If you have severe breathing difficulties
•
If you have severe liver problems
•
If you have ‘sleep apnoea’- this is a condition where your
breathing becomes irregular, even
stopping for short periods, while you are asleep

Summary of Product characteristics

Health Products Regulatory Authority
25 May 2023
CRN00D4DP
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Centrax 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg prazepam.
Excipient with known effect:
This medicine contains 93.73mg lactose monohydrate in each tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
The tablet can be divided 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
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 prazepam 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 prazepam or reduce the
dosage (see section 4.4).
Duration of treatment
Treatment should be as short as possible.
Posology
Anxiety:
The patient should be reassessed regularly and the need for continued
treatment should be evaluated, especially in case the
patient is symptom free. The overall duration of treatment generally
should not be more than 4-6 weeks, including a tapering
off process.
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 with special expertise.
Adults (18 years and over):
The usual dose is 30 mg daily in single or divided doses. The dose
should be adjusted within the range 10 mg to 60 mg daily in
accordance with response of the patient.
The lowest dose which can control symptoms should be used. It should
not be usually continued beyond four weeks.
Health Products Regulatory Authorit