Olbas Oil

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

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Pakuotės lapelis Pakuotės lapelis (PIL)
24-01-2024
Prekės savybės Prekės savybės (SPC)
22-12-2023

Veiklioji medžiaga:

Cajuput oil; Clove oil; Eucalyptus oil; Juniper oil; Levomenthol; Mint oil, partly dementholised ; Methyl salicylate

Prieinama:

LanesHealth (Ireland) Limited

ATC kodas:

R05X

INN (Tarptautinis Pavadinimas):

Cajuput oil; Clove oil; Eucalyptus oil; Juniper oil; Levomenthol; Mint oil, partly dementholised ; Methyl salicylate

Vaisto forma:

Inhalation vapour, liquid

Gydymo sritis:

OTHER COLD PREPARATIONS

Autorizacija statusas:

Marketed

Leidimo data:

1988-09-01

Pakuotės lapelis

                                READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
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.
•
You must talk to a doctor if you do not feel better or if you
feel worse.
In this leaflet:
1. What Olbas Oil is and what it is used for
2. What you need to know before you use Olbas Oil
3. How to use Olbas Oil
4. Possible side effects
5. How to store Olbas Oil
6. Contents of the pack and other information
5. HOW TO STORE OLBAS OIL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton and the bottle label, as “EXP” and refers to the last day
of the
stated month.
Do not store above 25ºC.
Store in the original container with the cap tightly closed.
Do not use if cap seal is broken or missing.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Olbas Oil contains
The active substances (w/w) are:
Cajuput Oil
..................................................................18.5%
Clove Oil
.........................................................................0.1%
Eucalyptus Oil
.........................................................35.45%
Juniper Oil
.......................................................................2.7%
Levomenthol
.................................................................4.1%
Mint Oil, Partly Dementholised ....................35.45%
Methyl Salicylate
..........................................................3.7%
                                
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Prekės savybės

                                Health Products Regulatory Authority
22 December 2023
CRN00DQXY
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olbas Oil
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances
% w/w
Cajuput Oil
18.50
Clove Oil
0.10
Eucalyptus Oil
35.45
Juniper Oil
2.70
Menthol
4.10
Mint Oil, Partly Dementholised
35.45
Methyl Salicylate
3.70
3 PHARMACEUTICAL FORM
Inhalation vapour, liquid
Cutaneous liquid
A pale green transparent liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an antiseptic, decongestant and analgesic for topical use in relief
of nasal congestion and oropharyngeal inflammation and
of pain due to muscular trauma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Inhalation:
Adults and children over 5 years: Sprinkle 2/3 drops on a
handkerchief, or add to hot water and inhale the vapour.
Topical:
Apply lightly to the painful area 3 times daily.
4.3 CONTRAINDICATIONS
(i) Hypersensitivity to the active substances.
(ii) Use on broken skin.
(iii) Use in infants or young children under 5 years.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If there is no improvement or there is an aggravation of the condition
consult the doctor.
Incorrect use or accidental exposure to Olbas Oil may be harmful. If
the product is accidentally put into the nose or swallowed,
or gets into the eye(s) the patient should seek immediate medical
advice.
If the product comes into direct contact with the surface of the
eye(s) the patient should wash the eye(s) thoroughly.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No interaction studies have been performed.
4.6 FERTILITY, PREGNANCY AND LACTATION
Health Products Regulatory Authority
22 December 2023
CRN00DQXY
Page 2 of 3
There are no reports of adverse effects when used during pregnancy and
lactation. Hence the product may be used.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Olbas Oil has no influence on the ability to drive and use machines.
4.8 UNDESIRABLE EFFECTS
Burns at application site, frequency: not known.
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