Stesolid rectal solution 5mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diazepam

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N05BA; N05BA01

INN (International Name):

Diazepam

Dosage:

5 milligram(s)

Pharmaceutical form:

Rectal solution

Therapeutic area:

Benzodiazepine derivatives; diazepam

Authorization status:

Marketed

Authorization date:

2017-12-22

Patient Information leaflet

STESOLID® RECTAL SOLUTION
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 this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT STESOLID IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE STESOLID
3.
HOW TO USE STESOLID
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE STESOLID
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT STESOLID IS AND WHAT IT IS USED FOR
Stesolid rectal solution contains diazepam which belongs to a group of
medicines called
benzodiazepines. Diazepam is used to treat:

severe anxiety and agitation

epilepsy or febrile convulsions

tetanus
Stesolid rectal solution may also be used to cause relaxation and
sleepiness before an operation or
dental procedure, or in other circumstances where a rapid effect is
required but where intravenous
injection is impracticable or undesirable.
Your doctor may prescribe Stesolid for other uses. Please follow your
doctor’s instructions.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE STESOLID
DO NOT USE
Stesolid rectal tubes and
TELL
your doctor if you:

are
ALLERGIC
to diazepam, to other benzodiazepine or to any of the other
ingredients of this
medicine (listed in section 6)

HAVE SEVERE BREATHING PROBLEMS OR HAVE DIFFICULTY 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
MYASTHENIA GRAVIS
(a condition which causes muscle weakness)

have
SEVERE LIVER
disorders

have
PORPHYRIA
(an inherited condition causing sk

Summary of Product characteristics

Health Products Regulatory Authority
21 December 2020
CRN00C0T4
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Stesolid rectal solution 5mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Diazepam 2 mg/ml
Each tube contains 5 mg of diazepam
Excipients with known effect: Benzoic acid 1 mg/ml and Propylene
Glycol 400 mg/ml
For the full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Rectal Solution.
Clear, colourless to yellowish 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.
Stesolid rectal tubes 5 mg 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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
Stesolid is contraindicated for patients with:

Hypersensitivity to benzodiazepines or to one or more of the
excipients (see section 6.1)Phobic or obsessional
states; chronic psychosis, hyperkinesis (paradoxical reactions may
occur)

Myasthenia gravis (condition may be exacerbated)Sleep apnoea syndrome
(condition may be exacerbated)Acute
pulmonary insufficiency; respiratory depression, acute or chronic
severe respiratory insufficiency (ventilator failure
may be exacerbated)Severe hepatic insufficiency (elimination half-life
of diazepam may be prolonged)

Acute porphyria

Diaz