Olbas Blackcurrant pastilles

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Eucalyptus oil; Peppermint oil; Levomenthol; Juniper berry oil; Methyl salicylate; Clove oil

Доступно од:

G.R. Lane Health Products Ltd

АТЦ код:

R05X

INN (Међународно име):

Eucalyptus oil; Peppermint oil; Levomenthol; Juniper berry oil; Methyl salicylate; Clove oil

Дозирање:

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

Фармацеутски облик:

Pastille

Пут администрације:

Oromucosal

Класа:

No Controlled Drug Status

Тип рецептора:

Never Valid To Prescribe As A VMP

Резиме производа:

BNF: 12030400; GTIN: 5000477242014

Информативни летак

SUGAR FREE
Manufactured by
Ernest Jackson & Co. Ltd.,
Crediton, Devon, EX17 3AP, UK,
for the Marketing
Authorisation holder
G. R. Lane Health Products Ltd.,
Sisson Road, Gloucester,
GL2 0GR, UK, to whom any letters
should be addressed.
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:
Maltitol Solution, Gelatin,
Blackcurrant Flavour,
Anthocyanin Extract,
Flavouring, Malic Acid,
Vegetable Oil/Carnauba wax,
Aspartame, Acesulfame
Potassium, Silicone Antifoam.
Minimum 21 pastilles
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 Blackcurrant 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
Blackcurrant Pastilles Contains a source of phenylalanine. May
be harmful for people with phenylketonuria. If you have been told
by your doctor that you have an intolerance to Maltitol, contact
your doctor before taking this medicinal product.
How to take Olbas Blackcurrant 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 yo

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Olbas Blackcurrant 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: Aspartame, Maltitol.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Pastille
Purple, oval, ribbed, oiled 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, the elderly 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 Blackcurrant Pastilles should not be used in children and
adolescents under the
age of 16.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Aspartame
is
a
source
of
phenylalanine.
May
be
harmful
for
people
with
phenylketonuria.
Patients with rare hereditary problems of fructose intolerance 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
Blackcurrant
Pastilles in pregnant women. Animal studies are insufficient with
respect to
reproductive toxicity. Olbas Blackcurrant Pastilles should not be used
during
pregnancy unless potential benefits outweigh any risks.
It is unknown whether Olbas Blackcurrant Pastilles/metabolites are
excreted in
human or animal milk. However, at therapeutic doses of Olbas
Blackcurrant
Pastilles
no