Stesolid rectal solution 10mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diazepam

Available from:

Accord Healthcare Limited

ATC code:

N05BA; N05BA01

INN (International Name):

Diazepam

Dosage:

10 milligram(s)

Pharmaceutical form:

Rectal solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Benzodiazepine derivatives; diazepam

Authorization status:

Marketed

Authorization date:

1992-10-14

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 of the 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.
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 MYASTHENIA GRAVIS (a condition
which causes muscle weakness)
•
have SEVERE LIVER disorders
•
have PORPHYRIA (an inherited condition
causing skin blisters, abdominal pain and
brain or nervous system disorders)
•
planning a PREGNANCY or are PREGNANT
(see below ‘Pregnancy, breast-feeding and
fertility’)
• SUFFER FROM S

Summary of Product characteristics

Health Products Regulatory Authority
25 March 2019
CRN008THP
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Stesolid rectal solution 10mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Diazepam 4 mg/ml
Each tube contains 10 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
Stesolid rectal tubes 10mg 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
The dosage depends on age, weight, individual reactions, the
indications and the severity of the conditions.
Children 1 to 3 years of age:
5
mg
Children above 3 years of age:
10
mg
Adults:
10
mg
Elderly patients:
5
mg
If the patient does not respond within 5 minutes, the dose may be
repeated. Further doses of Stesolid rectal tubes should be
administered only after consultation with a physician. If convulsions
have not been brought adequately under control with
diazepam, other measures should be instituted.
4.3 CONTRAINDICATIONS
Stesolid is contraindicated for patients with:
● Hypersensitivity to benzodiazepines or to one or more of the
excipients (see section 6.1)
● Myasthenia gravis
● Sleep apnoea syndrome
● Severe respiratory insufficiency
● Severe hepatic insufficiency
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Concomitant use of alcohol/CNS depressants
The concomitant use of diazepam with alcohol and/or CNS depressants
should be avoided. Such concomitant use has the
potential to increase the clinical effects of diazepam possibly
including severe sedation, clinically relevant respiratory and/or
cardio-vascular depression (see section 4.5)
H