Suprecur 150 micrograms/ metered dose Nasal Spray, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Buserelin

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

L02AE; L02AE01

INN (International Name):

Buserelin

Dosage:

150 microgram(s)

Pharmaceutical form:

Nasal spray, solution

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Gonadotropin releasing hormone analogues; buserelin

Authorization status:

Marketed

Authorization date:

1991-02-27

Patient Information leaflet

536006
536006
SAP-NR. (DMC): 536006
CODE: 1559
SCHRIFTGRÖSSE: 8 PUNKT
DRUCKFARBEN: PANTONE REFLEX BLUE
FORMAT 420 X 148 MM
ERSTELLT AM: 11. JANUAR 2017 / VERSION: 2 / MAC
536006
WHAT IS IN THIS LEAFLET
1. What Suprecur Nasal Spray is and what it is used
for
2. What you need to know before you use
Suprecur Nasal Spray
3. How to use Suprecur Nasal Spray
4. Possible side effects
5. How to store Suprecur Nasal Spray
6. Contents of the pack and other information
1. WHAT SUPRECUR NASAL SPRAY IS
AND WHAT IT IS USED FOR
The name of your medicine is Suprecur
150 micrograms/metered dose Nasal Spray,
solution (called Suprecur Nasal Spray throughout
this leaflet). It contains a medicine called
buserelin acetate. This belongs to a group of
medicines called gonadotropin releasing hormone
analogues. This is a synthetic version of a
hormone that occurs naturally in the body. It
works by lowering the production of sex
hormones.
It can be used for the following:
• Treatment of endometriosis – an illness where
some of the tissues that line the womb are
found elsewhere in the body
• As part of a treatment for infertility – it works
by stopping the natural production of
hormones that control ovulation. Synthetic
hormones are then used to artificially stimulate
ovulation. Your doctor should give you more
information about how your treatment works
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
SUPRECUR NASAL SPRAY
DO NOT USE THIS MEDICINE AND TELL YOUR
DOCTOR IF:
× You are allergic (hypersensitive) to buserelin or
other similar medicines such as goserelin,
benzalkonium chloride or any of the other
ingredients of Suprecur Nasal Spray (listed in
Section 6 below). Signs of an allergic reaction
include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or
tongue
× You have abnormal menstrual bleeding where
the cause is not endometriosis
× You have a tumour that is affected by hormones
× You are pregnant or breast-feeding
This medicine is for use in women only. Do not
use if any of the above apply

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Suprecur 150 micrograms/ metered dose Nasal Spray, solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (100mg) contains 150 micrograms buserelin, as
buserelin acetate.
150 micrograms buserelin is equivalent to 157.5 micrograms buserelin
acetate.
Excipients: Suprecur nasal spray contains 10 micrograms of
Benzalkonium chloride per metered dose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal Spray, Solution
Clear, colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment of endometriosis, unless the disease primarily requires
surgical treatment.
Pituitary desensitisation in preparation for ovulation induction, as
an adjunct to gonadotropin administration.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
To ensure the desired effect it is very important that individual
doses be administered at approximately equal intervals.
Patients must adhere to these intervals conscientiously.
_Adult females (over the age of 18 years)_
_Endometriosis:_ Regardless of body weight, the usual dose is 300
micrograms, thrice daily (given as a spray to each
nostril). The product may be used before or after meals or at other
times, provided that uniform intervals are maintained
between doses.
The usual duration of treatment is 6 months since there is no
experience of longer use, only limited experience of
retreatment.
It is recommende that the duration of treatment does not exceed 9
months.
In the case of transfer of patients from danazol to Suprecur, it might
be preferable on theoretical grounds to consider an
overlap of 2 – 3 days.
_For adjunctive use in ovulation induction:_ The total daily
intranasal dose for this indication is 600 micrograms
buserelin, given in four divided dosages of 150 micrograms (one spray
in one nostril) spread over the waking hours.
Treatment should start in the early follicular phase (day 1) or,
provided the existence of an early pregnancy has been
excluded in