SPRAY-TISH MENTHOL tramazoline hydrochloride 82mcg spray solution pump actuated metered dose

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

tramazoline hydrochloride, Quantity: 1.184 mg/mL

Dostopno od:

Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

INN (mednarodno ime):

tramazoline hydrochloride

Farmacevtska oblika:

Spray, solution

Sestava:

Excipient Ingredients: purified water; glycerol; sodium chloride; hypromellose; sodium bicarbonate; magnesium sulfate heptahydrate; magnesium chloride hexahydrate; sodium hydroxide; camphor; cineole; povidone; calcium chloride dihydrate; benzalkonium chloride; menthol; citric acid monohydrate

Pot uporabe:

Nasal

Enote v paketu:

15mL, 10mL

Tip zastaranja:

(S2) Pharmacy Medicine

Terapevtske indikacije:

For the symptomatic relief of nasal congestion associated with common cold, hayfever and rhinitis.

Povzetek izdelek:

Visual Identification: Clear, faintly yellowish solution.; Container Type: Aerosol - Pump Actuated Metered Dose; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

1999-12-07

Navodilo za uporabo

SPRAY-TISH
® MENTHOL
S
p
r
a
y
-
T
i
s
h
®
M
e
n
t
h
o
l
ACTIVE INGREDIENT: _tramazoline hydrochloride_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using Spray-
Tish Menthol. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR
PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU
HAVE ANY CONCERNS OR QUESTIONS ABOUT USING SPRAY-TISH
MENTHOL.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using Spray-Tish Menthol?
2. What should I know before I use Spray-Tish Menthol?
3. What if I am taking other medicines?
4. How do I use Spray-Tish Menthol?
5. What should I know while using Spray-Tish Menthol?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING SPRAY-TISH MENTHOL?
SPRAY-TISH MENTHOL CONTAINS THE ACTIVE INGREDIENT
TRAMAZOLINE HYDROCHLORIDE. Spray-Tish Menthol is a nasal
decongestant. It clears a stuffy or blocked nose by shrinking
the inflamed and swollen blood vessels in the lining of the
nose.
SPRAY-TISH MENTHOL IS USED TO RELIEVE A STUFFY OR
BLOCKED NOSE (NASAL CONGESTION) ASSOCIATED WITH THE
COMMON COLD, HAYFEVER AND RHINITIS. A RUNNY NOSE, NASAL
CONGESTION, ITCHING AND SNEEZING, ARE TYPICAL SYMPTOMS
OF A CONDITION KNOWN AS RHINITIS.
2.
WHAT SHOULD I KNOW BEFORE I USE SPRAY-
TISH MENTHOL?
WARNINGS
DO NOT USE SPRAY-TISH MENTHOL IF:
•
you are allergic to tramazoline hydrochloride, or any of
the ingredients listed at the end of this leaflet. Always
check the ingredients to make sure you can use this
medicine.
•
the lining of your nose is dry and has formed crusts or
scabs. For example, a condition called “rhinitis sicca”
•
you have had brain surgery via the nasal cavity
•
you have an eye problem called “narrow-angle
glaucoma”
CHECK WITH YOUR DOCTOR OR PHARMACIST IF YOU:
•
have any other medical conditions, including those listed
below:
o
arterial hypertension
o
heart disease
o
an enlarged prostate
o
a rare condition called “porphyria” (a disorder of
blood pigment metabolism)
o
phaechromocytoma (a tumour on the adrenal gland
near t

Lastnosti izdelka

Property of the Sanofi group -
spraytishmenth-ccds0159-03-piv7-10mar21
1
AUSTRALIAN PRODUCT INFORMATION – SPRAY-TISH MENTHOL
(TRAMAZOLINE HYDROCHLORIDE) SPRAY SOLUTION
1
NAME OF THE MEDICINE
Tramazoline hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Spray-Tish Menthol contains the active ingredient, tramazoline
hydrochloride in a strength of
1.184 mg/mL.
Benzalkonium chloride 0.202 mg/mL is used as a preservative.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Spray-Tish Menthol is a nasal spray.
Spray-Tish Menthol is a Clear, faintly yellowish solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of nasal congestion associated with common
cold, hayfever and
rhinitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
Adults and children six years of age and over:
The recommended dose is 1 to 2 sprays into each nostril up to 4 times
a day as required.
Administration should not be continued longer than 3 days without
medical advice.
Directions for Use
Patients should be advised not to pierce the nozzle or attempt to
enlarge the hole, as the
existing hole is designed to deliver the correct dose of Spray-Tish
Menthol.
To use:
1.
Remove protective cap.
2.
Before using the spray pump for the first time, rapidly depress the
spray pump 5 to 7
times until an even spray mist is released. Spray-Tish Menthol is now
primed and ready
Property of the Sanofi group -
spraytishmenth-ccds0159-03-piv7-10mar21
2
for use. With subsequent use, the spray pump is immediately
functional. However, if
used infrequently, it may require repriming.
3.
Blow nose thoroughly before using Spray-Tish Menthol.
4.
Insert the spray adaptor into the nostril and depress the spray pump
while breathing in
gently through the nose. Administer 1 to 2 sprays and then repeat in
the other nostril.
5.
Replace the protective cap after use.
It is recommended that the spray adaptor be cleaned after use.
4.3
CONTRAINDICATIONS
Spray-Tish Menthol should not be used in:
•
Patients with dry