Synarel 200 micrograms/dose Nasal Spray Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nafarelin

Available from:

Pfizer Healthcare Ireland

ATC code:

H01CA; H01CA02

INN (International Name):

Nafarelin

Dosage:

200 Mcg/Dose

Pharmaceutical form:

Nasal spray, solution

Prescription type:

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

Therapeutic area:

Gonadotropin-releasing hormones; nafarelin

Authorization status:

Marketed

Authorization date:

1997-03-07

Patient Information leaflet

Component Code
Version/Proof
Project Number
Date:
KALAMAZOO
Time:
PAR Number
GS
SKU/FERT
Additional Info/Comments
Component Type
Site/CMO
Market
Layout
Size
Description
15:34
30 Nov 2022
PAA201687
Print Colors
01
18088
PAR-2022-0009476
J. Wood
F063508807
N/A
Leaflet
Kalamazoo
Ireland
SYNAREL/NAFARELIN ACETATE:NON-STERILE LIQUID:SPRAY,
NASAL:BOTTLE, PLASTIC (SPRAY):2MG/8ML(1x1x8ML)
DWG-102692-00
15” x 9” (3” x 1.5” folded)
Non-Print Colors
Dieline
Black
SYNAREL
®
NASAL SPRAY SOLUTION
NAFARELIN
PACKAGE LEAFLET: INFORMATION FOR THE USER
_Synarel_
®
_200 micrograms / dose_
_Nasal Spray Solution_
nafarelin
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 Synarel is and what it is used for
2.
What you need to know before you use Synarel
3.
How to use Synarel
4.
Possible side effects
5.
How to store Synarel
6.
Contents of the pack and other information
IMPORTANT THINGS THAT YOU SHOULD KNOW ABOUT YOUR
MEDICINE:
•
Synarel is for the treatment of endometriosis,
uterine fibroids, or as part of a supervised fertility
programme and is for use by women only.
•
You should use Synarel regularly as instructed by
your doctor or nurse, in order for it to be effective.
•
Most people do not have serious problems when
using Synarel but side effects can occur – see
Section 4 for details.
•
Taking other medicines may sometimes cause
problems. Check with your doctor or pharmacist
before taking this or any other medicines.
Please read the rest of this leaflet. It includes other
important infor

Summary of Product characteristics

Health Products Regulatory Authority
21 November 2022
CRN009Z7Z
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Synarel 200 micrograms/dose Nasal Spray Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Solution containing 2mg/ml of nafarelin (as acetate) supplied in
bottles fitted with a metered spray pump that delivers 200
micrograms of nafarelin base per spray.
This medicine contains 0.01 mg benzalkonium chloride in each spray
(0.1 mL per spray) which is equivalent to 0.1 mg/mL.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Nasal spray, solution
A clear, colourless to slightly yellow, aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Synarel is indicated for the hormonal management of endometriosis,
including pain relief and reduction of endometriotic
lesions.
Synarel may also be used in the hormonal management of symptomatic
uterine fibroids prior to a planned myomectomy or
hysterectomy, including the relief of clinical symptoms and the
reduction of uterine and fibroid volume.
Synarel may be used in controlled ovarian stimulation programmes prior
to _in vitro_ fertilisation, under the supervision of an
infertility specialist.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Synarel is for administration by the intranasal route only
_Endometriosis and uterine fibroids:_
Treatment should be started between days 2 and 4 of the menstrual
cycle.
The recommended daily dose of Synarel is 200mcg taken twice daily
(400mcg/day) as one spray to one nostril in the morning
and one spray into the other nostril in the evening.
The recommended duration of therapy is six months for the management
of endometriosis and three months for the
management of uterine fibroids.
_Controlled ovarian stimulation prior to in vitro fertilisation:_
In the use of Synarel associated with controlled ovarian stimulation
prior to _in vitro_ fertilisation, the long protocol should be
employed, whereby Synarelis continued through a period of transient
gonadotrophin stimulation lastin