Diazepam 10mg RecTubes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diazepam

Available from:

Wockhardt UK Ltd

ATC code:

N05BA01

INN (International Name):

Diazepam

Dosage:

4mg/1ml

Pharmaceutical form:

Enema

Administration route:

Rectal

Class:

Schedule 4 (CD Benz)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04010200; GTIN: 5012727901527

Patient Information leaflet

Process Black
Text Free Area (non-printing)
Keyline (non-printing)
Wockhardt UK Limited
Diazepam Rectube solution common leaflet
106002/3
See uploaded pdf
420mm x 160mm
MPI
4
28/03/2017
835142
N/A
8pt (Main Body) / 8pt (Variables)
UK
English
MEASURE BAR SHOULD BE 150MM AT 100% SCALE
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WARNING! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.
[e-mail]
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. P

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diazepam RecTubes 10mg Rectal Solution
2
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Diazepam 10mg in 2.5ml
(4mg/ml)
Excipients with known effect:
Each 10mg tube contains:
Benzoic acid (E210) - 2.5mg
Sodium benzoate (E211) - 122.5mg
Propylene glycol - 1000mg
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 spou