NITROLINGUAL 400 Mcg/Dose Sublingual Spray

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

GLYCERYL TRINITRATE

可用日期:

LTT Pharma Limited

ATC代码:

C01DA02

INN（国际名称）:

GLYCERYL TRINITRATE

剂量:

400 Mcg/Dose

药物剂型:

Sublingual Spray

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Organic nitrates

授权状态:

Authorised

授权日期:

2011-08-26

资料单张

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING 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 or nurse.
- 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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
What Nitrolingual is and what it is used for
What you need to know before you take
Nitrolingual
How to take Nitrolingual
Possible side effects
How to store Nitrolingual
Contents of the pack and other information
WHAT NITROLINGUAL IS AND WHAT IT IS USED
FOR
Nitrolingual is a sublingual spray which you use
under your tongue. The active ingredient is called
glyceryl trinitrate or GTN for short. GTN is one of a
group of medicines called ‘nitrates’. These relax the
muscles around the blood vessels and make it
easier for the heart to do its work.
Nitrolingual helps stop the pain of angina (pain in
your chest, arms or neck especially when you exert
yourself). You can also use the medicine
immediately before doing things which you know will
cause you angina pain.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
NITROLINGUAL
DO NOT TAKE NITROLINGUAL
•
if you are ALLERGIC (hypersensitive) to NITRATES or
ANY OF THE OTHER INGREDIENTS of Nitrolingual
(see list of ingredients in Section 6). An allergic
reaction may include rash, itching, difficulty
breathing or swelling of the face, lips, throat or
tongue.
•
if you are VERY ILL BECAUSE of VERY LOW BLOOD
PRESSURE, SEVERE BLOOD LOSS, A STROKE, bleeding
in the brain, A SEVERE HEAD INJURY OR SEVERE
ANAEMIA
•
if you have certain UNUSUAL HEART CONDITIONS
(such as acute circulatory shock, including
hypovolaemic shock, uncontrolled cardiogenic
shock, (‘shock’ in these cases is where insufficient
blood flow r

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nitrolingual Pumpspray 400 micrograms per metered dose, sublingual
spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 400 micrograms glyceryl trinitrate.
Excipients: contains 9.6 mg anhydrous ethanol per metered dose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Sublingual spray.
_Product imported from the UK:_
A clear colourless to slightly yellow solution.
4 CLINICAL PARTICULARS
As per PA2243/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA2243/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Coconut oil
Anhydrous ethanol (alcohol)
Medium-chain partial glycerides
Peppermint oil.
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the bottle and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_0_
_4_
_/_
_0_
_5_
_/_
_2_
_0_
_1_
_8_
_C_
_R_
_N_
_ _
_2_
_2_
_0_
_2_
_8_
_7_
_4_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
6.5 NATURE AND CONTENTS OF CONTAINER
Red plastic-coated glass bottle (colourless type III glass) fitted
with metering pump. Each bottle contains 11.2g solution
(equivalent to about 200 doses).
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING