Stesolid 5mg 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:

2mg/1ml

Pharmaceutical form:

Enema

Administration route:

Rectal

Class:

Schedule 4 (CD Benz)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04010200; GTIN: 5029801000014

Patient Information leaflet

BBBB4216
STESOLID® RECTAL TUBES
5 MG AND 10 MG
diazepam
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 STESOLID RECTAL TUBES ARE AND
WHAT THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU
USE STESOLID RECTAL TUBES
3 HOW TO USE STESOLID RECTAL TUBES
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE STESOLID RECTAL TUBES
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT STESOLID RECTAL TUBES ARE AND
WHAT THEY ARE USED FOR
Stesolid 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
Stesolid
rectal tubes can also be used to provide
sedation before operations (premedication).
Your doctor may prescribe Stesolid rectal tubes
for other uses. Please follow your doctor’s
instructions.
2
WHAT YOU NEED TO KNOW BEFORE YOU
USE STESOLID RECTAL TUBES
DO NOT USE Stesolid
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Stesolid
®
rectal tubes 5 mg.
Diazepam 5mg Rectal Tubes
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diazepam 2 mg/ml.
Excipients with known effect:
Each 5mg tube contains:
Benzoic acid (E210) - 2.50mg
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 exacerbated)
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