Olbas Inhaler Nasal Stick

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

PEPPERMINT OIL, CAJUPUT OIL, EUCALYPTUS OIL, LEVOMENTHOL

Dostupné z:

LanesHealth (Ireland) Limited Suite 7, The Courtyard, Carmanhall Road, Sandyford, Dublin 18, D18 NW62, Ireland

ATC kód:

R01AX

INN (Medzinárodný Name):

PEPPERMINT OIL 20 % (W/W) CAJUPUT OIL 20 % (W/W) EUCALYPTUS OIL 20 % (W/W) LEVOMENTHOL 40 % (W/W)

Forma lieku:

NASAL STICK

Zloženie:

PEPPERMINT OIL 20 % (W/W) CAJUPUT OIL 20 % (W/W) EUCALYPTUS OIL 20 % (W/W) LEVOMENTHOL 40 % (W/W)

Typ predpisu:

OTC

Terapeutické oblasti:

NASAL PREPARATIONS

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2005-12-23

Príbalový leták

NASAL STICK
_inhaler_
_inhaler_
_Olbas_
_Olbas_
The pure plant remedy for symptomatic relief of
coughs, colds and catarrh.
Olbas Inhaler contains essential oils which have
decongestant properties.
Before you use Olbas Inhaler
Do not use if you are allergic to any of the ingredients.
How to use Olbas Inhaler
Adults and children aged 7 and over: Unscrew outer cover from
stick, close one nostril, place inhaler in other nostril, and inhale
deeply. After use, wipe stick with a tissue and replace cover.
Not recommended for children under 7 years old.
Do not use more than 4 times an hour.
If symptoms persist, talk to your doctor.
Possible side effects
Like all medicines, Olbas Inhaler can cause side effects although not
everybody gets them. If you notice any side effect, please tell your
doctor or pharmacist.
How to store Olbas Inhaler
Keep out of the reach and sight of children. Do not use after the
expiry date below. Do not store above 25°C. Keep the container
tightly closed.
Further information
Active ingredients w/w: Cajuput Oil 20%, Eucalyptus Oil 20%,
Levomenthol 40%, Peppermint Oil 20%.
Marketing authorisation holder:
LanesHealth (Ireland) Limited, Suite 7, The Courtyard, Carmanhall
Road,
Sandyford, Dublin 18, D18 NW62, Ireland.
Manufacturer (EU QP Release Site):
Elara Pharmaservices Europe Limited,
239 Blanchardstown Corporate Park,
Ballycoolin, Dublin, D15 KV21, Ireland.
NASAL STICK
335
Cutter
Nasal stick containing
695mg
Approved: Mar 2019
PA 22702/2/3
1006-01
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NASAL STICK
_inhaler_
_inhaler_
Immediate relief
for stuffy noses
_Olbas_
_Olbas_
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1006-01 BREXIT EIRE inhaler card
Date:05/03/19
Amends author: GW
Brief Description:
Licence Change
Size: 150mm x 210mm
Colours:
Pantone 335
Pantone 353

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Olbas Inhaler Nasal Stick
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ingredients
%w/w
Cajuput Oil
20
Levomenthol
40
Peppermint Oil
20
Eucalyptus Oil
20
3.
PHARMACEUTICAL FORM
Nasal stick.
White tube closed with a white cap and containing a wad dosed with
Olbas
Inhaler oil.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the symptomatic relief of blocked up sinuses, catarrh, hay fever,
colds and
influenza.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For nasal use.
Adults and children aged 6 and over: Insert into each nostril in turn
and inhale
whilst keeping the other nostril closed. Do not use more than four
times per
hour.
Not recommended for children under 6 years old.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substances.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms worsen or do not improve after 7 days, a doctor should be
contacted.
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No interaction studies have been performed.
4.6.
PREGNANCY AND LACTATION
There are no or limited amount of data from the use of Olbas Inhaler
in
pregnant women. Animal studies are insufficient with respect to
reproductive
toxicity. Olbas Inhaler should not be used during pregnancy unless
potential
benefits outweigh any risks.
It is unknown whether Olbas Inhaler/metabolites are excreted in human
or
animal milk. However, at therapeutic doses of Olbas Inhaler no effects
on the
breastfed
newborns/infants
are
anticipated.
Nevertheless
it
is
not
recommended that Olbas Inhaler be used during breast feeding.
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Olbas Inhaler has no influence on the ability to drive and use
machines.
4.8.
UNDESIRABLE EFFECTS
No
undesirable
effects
are
likely
with
this
product
because
of
the
low
concentrations
of
the
active
ingredients.
However,
local
hypersensitivity,
contact
dermatitis
and
irritant
effects
of
Levomenthol
are
listed
in
the
literature.
4.9.
OVERDOSE
Reports of an over