Stesolid 10mg rectal tube

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diazepam

Available from:

Accord-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: 5029801000021

Patient Information leaflet

BBBB4148
DIAZEPAM 5 MG AND 10 MG
RECTAL TUBES
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING 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 the leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1 WHAT DIAZEPAM RECTAL TUBES ARE
AND WHAT THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE
YOU USE DIAZEPAM RECTAL TUBES
3 HOW TO USE DIAZEPAM RECTAL TUBES
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE DIAZEPAM RECTAL
TUBES
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT DIAZEPAM RECTAL TUBES ARE
AND WHAT THEY ARE USED FOR
Diazepam rectal tubes 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
rectal tubes can also be used
to provide sedation before operations
(premedication).
Your doctor may prescribe Diazepam rectal
tubes for other uses. Please follow your doctor’s
instructions.
2 WHAT YOU NEED TO KNOW BEFORE
YOU USE DIAZEPAM RECTAL TUBES
DO NOT USE Diazepam
rectal tubes 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 condition called MYASTHENIA GRAVIS
which causes muscles to weaken and tire
easily
• suffer from SLEEP APNOEA (a sleep disorder
where you have abnormal pauses in breathing
d

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Stesolid
®
rectal tubes 10 mg.
Diazepam 10mg Rectal Tubes
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diazepam 4 mg/ml.
Excipients with known effect:
Each 10mg tube contains:
Benzoic acid (E210) - 2.5mg
Sodium benzoate (E211) - 122.50mg
Benzyl alcohol – 37.50mg
Propylene glycol (E 1520) - 1.00g
Ethanol – 250mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Enema
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.
This medicine may be used for 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.
This medicine 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: _
_ _
_ _
_ _
_ _
_0.5 mg/kg body weight _
_ _
_Elderly patients: _
_ _
_ _
_0.25 mg/kg body weight _
A maximum dose of 30mg 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 _
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance, benzodiazepines or any of
the
excipients listed in section 6.1
•
Phobic or obsessional states; chronic psychosis, hyperkinesis
(paradoxical
reactions may occur)
•
Acute pulmonary insufficiency; respiratory depression, acute or
chronic
severe respiratory insufficiency (ventilatory failure may be
exacerbated)
•
Myasthenia gravis (condition may be exacerbated)
•
Sleep apnoea (condition may be exacerbat