Menthol and Eucalyptus inhalation

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Magnesium carbonate light; Menthol; Eucalyptus oil

Dostupno od:

Alliance Healthcare (Distribution) Ltd

INN (International ime):

Magnesium carbonate light; Menthol; Eucalyptus oil

Doziranje:

70mg/1ml ; 20mg/1ml ; 100microlitre/1ml

Farmaceutski oblik:

Inhalation vapour

Administracija rute:

Inhalation

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 03080000

Uputa o lijeku

_Data Matrix:_
_ _
21511009 VERIFIED
FRONT FACE
FRONT FACE REVERSE
CARRIER
PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
A
gill.kennedy
557448
11939
Addition of reporting of side
effects statement
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Landscape peelable label
100ml
21511009
42 x 150mm
1
11.02.2015
Process Cyan
Process Magenta
Process Yellow
Process Black
Keyline (Non-printing)
Braille
Text free area (non-printing)
Menthol & Eucalyptus Inhalation
Braille BQ
Helvetica
Helvetica Neue
OCRB
Optima
_MENTHOL &_
_EUCALYPTUS_
_INHALATION_
RELIEVES COUGHS, COLDS
& BLOCKED NOSES
For symptomatic relief of coughs, colds and
blocked noses. Inhale the steamy vapour
through the mouth and nose. SHAKE WELL
BEFORE USE. ADULTS, THE ELDERLY AND
CHILDREN OVER 3 MONTHS: Add 1 x 5ml
spoonful to 568ml (1 pint) of hot (not boiling)
water. Inhale the vapour. Repeat after 4 hours
if required. DO NOT GIVE TO CHILDREN UNDER 3
MONTHS OLD unless your doctor tells you to.
FOR EXTERNAL USE ONLY.
PEEL WHERE SHOWN FOR FURTHER
PRECAUTIONS.
ACTIVE INGREDIENTS:
menthol 2% w/v,
eucalyptus oil 10% v/v.
ALSO CONTAINS:
magnesium carbonate, benzalkonium chloride
and purified water. Do not store above 25°C.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Manufactured by the licence holder L.C.M.
Ltd., Huddersfield, HD7 5QH, UK for
Thornton and Ross Ltd., Huddersfield,
HD7 5QH, UK.
PL 12965/0027 21511009
100ML
This medicine contains menthol and eucalyptus oil which
are decongestants and help ease breathing difficulties.
1. BEFORE YOU USE THIS MEDICINE
DO NOT USE THE MEDICINE IF YOU OR YOUR
CHILD HAVE….
• An ALLERGY to any of the ingredients listed on the front.
• Or your child is UNDER 3 MONTHS old.
PREGNANT OR BREASTFEEDING….
Using Menthol & Eucalyptus Inhalation during pregnancy
and breastfeeding is unlikely to have any ill effects when
used as directed. If unsure, talk to your doctor or
pharmacis

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Menthol and Eucalyptus Inhalation BP 1980
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Menthol BP 2.0% w/v
Eucalyptus Oil BP 10.0% v/v
3
PHARMACEUTICAL FORM
Suspension
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For relief of the symptoms of coughs, colds and blocked noses
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Inhaled via the mouth and nasal passages.
Adults, children over 3 months of age and the elderly:
Add one 5ml spoonful to a pint of hot, but not boiling water.
The dose may be repeated after 4 hours if required.
4.3
CONTRAINDICATIONS
Not suitable for children under 3 months.
Contra-indicated in patients with hypersensitivity to menthol,
eucalyptus or any of the
other ingredients
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not suitable for children under 3 months.
For external use only
Keep all medicines away from children.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known
4.6
FERTILITY, PREGNANCY AND LACTATION
Use of this product in the above conditions is not considered likely
to cause any
harmful effects.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known
4.8
UNDESIRABLE EFFECTS
Menthol may give rise to hypersensitivity reactions including contact
dermatitis.
There have been reports of apnoea and instant collapse in infants
following the local
application of menthol to their nostrils.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medicinal product is
important. It allows continued monitoring of the benefit/risk balance
of the medicinal
product. Healthcare professionals are asked to report any suspected
adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9
OVERDOSE
Symptoms of poisoning with swallowed menthol and eucalyptus inhalation
include
epigastric burning, severe abdominal pain, central nervous system
depression,
pulmonary damage, nausea and vomiting, drowsiness, dizziness and
muscular
weakness