Olbas pastilles

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Peppermint oil; Eucalyptus oil; Juniper berry oil; Clove oil; Menthol; Wintergreen oil

Available from:

G.R. Lane Health Products Ltd

ATC code:

R05X

INN (International Name):

Peppermint oil; Eucalyptus oil; Juniper berry oil; Clove oil; Menthol; Wintergreen oil

Dosage:

11.2mg/1gram ; 11.6mg/1gram ; 670microgram/1gram ; 20microgram/1gram ; 1mg/1gram ; 470microgram/1gram

Pharmaceutical form:

Pastille

Administration route:

Oromucosal

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 12030400; GTIN: 0000050477029

Patient Information leaflet

DO NOT USE IF SEALED INNER
POUCH IS CUT OR TORN.
Active ingredients
per pastille:
Eucalyptus Oil........ 19.7mg
Peppermint Oil....... 19.0mg
Levomenthol ............ 1.7mg
Juniper Oil ............. 1.14mg
Methyl Salicylate ..... 0.8mg
Clove Oil................. 0.03mg
Other ingredients:
Modified Starch, Sucrose,
Glucose, Sodium Copper
Chlorophyllin (E141).
You can help to make
medicines safer by reporting
any side-effects to the
Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
Alternatively you can get a
paper Yellow Card form from
your surgery or pharmacy, or
call freephone 0808 100 3352
(available 10am-2pm
Monday – Friday)
Before you take Olbas Pastilles
Do not take if you are allergic to any of the ingredients.
Taking other medicines Please tell your doctor or pharmacist
if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Pregnancy and breast-feeding It is best not to take any
non-essential medication when pregnant or breast-feeding. Ask
your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients of Olbas
Pastilles If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicinal product. This product contains 677mg of sucrose
per pastille. This should be taken into account in people with
diabetes mellitus.
How to take Olbas Pastilles
Adults and children aged 16 and over: Dissolve 1 pastille slowly
in the mouth when required. Do not take more than 8 pastilles in
any 24 hour period. Not recommended for children under 16 years
old. You must contact a doctor if symptoms worsen or do not
improve after 7 days.
If you take more Olbas Pastilles than you should, talk to a
doctor or pharmacist immediately.
Possible side effects
Like all medicines, Olbas Pastilles can cause side effects, although
not everybody gets them. Tell your doctor if you notice any of the
following mild side effects: Heartburn, wheezing, worsening of
asthma or s

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Olbas Pastilles
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ingredients
%w/w
mg per pastille
Eucalyptus Oil
1.160
19.70
Peppermint Oil
1.120
19.00
Levomenthol
0.100
1.70
Juniper Oil
0.067
1.14
Methyl Salicylate
0.047
0.80
Clove Oil
0.002
0.03
Excipients: Glucose, Sucrose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Pastille.
Dull green, oval ribbed, sugar-coated pastille.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of colds, coughs, catarrh, sore throats,
influenza,
catarrhal headache and nasal congestion.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oropharyngeal use.
Adults and children aged 16 and over: Dissolve 1 pastille slowly in
the mouth
when required.
Do not take more than 8 pastilles in any 24 hour period.
Not recommended for children under 16 years old.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients.
Olbas Pastilles should not be used in children and adolescents under
the age of
16.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients
with
rare
hereditary
problems
of
fructose
intolerance,
glucose-
galactose malabsorption or sucrase-isomaltase insufficiency should not
take
this medicine.
If symptoms worsen or do not improve after 7 days, a doctor should be
contacted.
Do not exceed the stated dose.
4.5
INTERACTION 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 Pastilles
in
pregnant women. Animal studies are insufficient with respect to
reproductive
toxicity. Olbas Pastilles should not be used during pregnancy unless
potential
benefits outweigh any risks.
It is unknown whether Olbas Pastilles/metabolites are excreted in
human or
animal milk. However, at therapeutic doses of Olbas Pastilles no
effects on the
breastfed
newborns/infants
are
anticipated.
Nevertheless
it
is
not
recom-
mended that