LYSOPADOL 17.86 Mg/Ml Oromucosal Spray
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Taarifa za kipeperushi
(PIL)
04-06-2016
Tabia za bidhaa
(SPC)
15-06-2016
Viambatanisho vya kazi:
AMBROXOL HYDROCHLORIDE
Inapatikana kutoka:
Boehringer Ingelheim Limited
ATC kanuni:
R02AD
INN (Jina la Kimataifa):
AMBROXOL HYDROCHLORIDE
Kipimo:
17.86 Mg/Ml
Dawa fomu:
Oromucosal Spray
Dawa ya aina:
Product not subject to medical prescription
Eneo la matibabu:
ANESTHETICS, LOCAL
Idhini hali ya:
Authorised
Idhini ya tarehe:
2014-02-14
Taarifa za kipeperushi
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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Tabia za bidhaa
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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