LYSOPADOL 17.86 Mg/Ml Oromucosal Spray
Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Информативни летак
(PIL)
04-06-2016
Карактеристике производа
(SPC)
15-06-2016
Активни састојак:
AMBROXOL HYDROCHLORIDE
Доступно од:
Boehringer Ingelheim Limited
АТЦ код:
R02AD
INN (Међународно име):
AMBROXOL HYDROCHLORIDE
Дозирање:
17.86 Mg/Ml
Фармацеутски облик:
Oromucosal Spray
Тип рецептора:
Product not subject to medical prescription
Терапеутска област:
ANESTHETICS, LOCAL
Статус ауторизације:
Authorised
Датум одобрења:
2014-02-14
Информативни летак
1. WHAT LYSOPADOL SPRAY IS AND WHAT IT IS
USED FOR
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2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LYSOPADOL SPRAY
DO NOT TAKE LYSOPADOL SPRAY:
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WARNINGS AND PRECAUTIONS
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OTHER MEDICINES AND LYSOPADOL SPRAY
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Карактеристике производа
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lysopadol 17.86 mg/ml Oromucosal Spray, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One actuation of the spray contains 2.5 mg of ambroxol hydrochloride.
One ml of the spray contains 17.86 mg of ambroxol hydrochloride.
Excipient(s) with known effect:
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose (4 actuations) and very
small amounts of propylene glycol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal spray, solution
Clear and almost colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pain relief in acute sore throat for adults and children over 12 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children over 12 years of age: one dose of 10 mg (4 actuations) to be sprayed into the back of the throat up
to 6 times per day.
Lysopadol 17.86 mg/ml Oromucosal Spray can be used for up to 3 days. In case of persistent symptoms or high fever,
the patient should consult a doctor.
_Paediatric population_
Lysopadol 17.86 mg/ml Oromucosal Spray should not be used in children under 12 years of age (see section 4.4).
Method of administration
Oromucosal use
Prior to use, the pump should be actuated 5 times so that an even spray mist is released. After not having used the spray
for a long time, the pump should be actuated once before applying the product again. For application the spray bottle
should be used in an upright position with the nozzle targeted at the back of the throat whilst pushing down the pump
head completely.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance (ambroxol) or to any of the excipients listed in section 6.1.
HEALTH PRODUCTS REGULATORY A
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