Diazepam RecTubes 5mg Rectal Solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIAZEPAM

Available from:

Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

ATC code:

N05BA01

INN (International Name):

DIAZEPAM 2 mg/ml

Pharmaceutical form:

RECTAL SOLUTION

Composition:

DIAZEPAM 2 mg/ml

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Withdrawn

Authorization date:

2006-08-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIAZEPAM RECTUBES® 2.5MG RECTAL SOLUTION
DIAZEPAM RECTUBES® 5MG RECTAL SOLUTION
DIAZEPAM RECTUBES® 10MG RECTAL SOLUTION
(REFERRED TO AS DIAZEPAM RECTUBES® IN THIS LEAFLET)
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 Diazepam RecTubes® are and what they are used for
2. What you need to know before you use Diazepam RecTubes®
3. How to use Diazepam RecTubes®
4. Possible side effects
5. How to store Diazepam RecTubes®
6. Contents of the pack and other information
1. WHAT DIAZEPAM RECTUBES® ARE AND WHAT THEY ARE USED FOR
Diazepam RecTubes® contain diazepam which belongs to a group of
medicines called
benzodiazepines. Diazepam is used to treat:
_• _severe anxiety and agitation
_• _muscle spasms
_• _epilepsy or febrile convulsions
_• _symptoms of alcohol withdrawal
Diazepam RecTubes® can also be used to provide sedation before
operations
(premedication).
Your doctor may prescribe Diazepam RecTubes® for other uses. Please
follow your doctor’s
instructions.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE_ _DIAZEPAM RECTUBES®
DO NOT USE DIAZEPAM RECTUBES® IF YOU:
• are ALLERGIC to diazepam or to other benzodiazepine medicines or
to any of the other
ingredients of this medicine (listed in section 6).
• have ACUTE RESPIRATORY DEPRESSION (slow and/or shallow breathing)
• SUFFER FROM DEPRESSION (with or without anxiety) or HYPERACTIVITY
• have a PHOBIA (a fear of a particular object or situation) or
other mental illness
• have a conditio

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diazepam RecTubes 5mg Rectal Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diazepam 5mg in 2.5ml
(2mg/ml)
Excipients with known effect:
Each 5mg tube contains
Benzoic acid (E210) - 2.5 mg
Sodium benzoate (E211) - 122.5 mg
Propylene glycol - 1000 mg
Benzyl alcohol - 37.5 mg
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Rectal solution
A clear, colourless or almost yellow solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Diazepam has anticonvulsant, sedative, and muscle relaxant properties.
It is
used in the treatment of severe anxiety and tension states, as a
sedative and
premedication, in the control of muscle spasm, and in the management
of
alcohol withdrawal symptoms.
Diazepam rectal tubes may be used in acute severe anxiety and
agitation,epileptic
and febrile convulsions, tetanus,as a sedative in minor surgical and
dental
procedures, or in other circumstances in which a rapid effect is
required but where
intravenous injection is impracticable or undesirable.
Diazepam rectal tubes may be of particular value for the immediate
treatment of
convulsions in infants and children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Sensitivity to diazepam varies with age.
_Adults: _
_Elderly patients: _
_0.5 mg/kg body weight _
_0.25 mg/kg body weight _
_ _
_ _
A maximum dose of 30 mg diazepam is recommended, unless adequate
medical
supervision and monitoring are available.
Paediatric population
_Children above 1 year of age: _
_0.5 mg/kg body weight _
_ _
If convulsions are not controlled other anticonvulsive measures should
be
instituted.
The dose can be repeated every 12 hours.
Method of administration
The solution is administered rectally. Adults should be in the lateral
position;
children should be in the prone or lateral position.
a)
Tear open the foil pack. Remove the cap.
b)
Insert the tube nozzle completely into the rectum. For children under
15kg,
insert only half way. Hold the tube with the spout downw