Lysopadol 17.86 mg/ml oromucosal spray, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AMBROXOL HYDROCHLORIDE

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

R02AD

INN (International Name):

AMBROXOL HYDROCHLORIDE

Dosage:

17.86 milligram(s)/millilitre

Pharmaceutical form:

Oromucosal spray, solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anesthetics, local

Authorization status:

Marketed

Authorization date:

2014-02-14

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LYSOPADOL
®
17.86 MG/ML OROMUCOSAL SPRAY, SOLUTION
ambroxol hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFLET
1. What Lysopadol Spray is and what it is used for
2. What you need to know before you take Lysopadol Spray
3. How to take Lysopadol Spray
4. Possible side effects
5. How to store Lysopadol Spray
6. Contents of the pack and other information
1.
WHAT LYSOPADOL SPRAY IS AND WHAT IT IS USED FOR
• Lysopadol Spray contains the active substance Ambroxol
hydrochloride. The active substance is the part of
the spray that gives the therapeutic effect you need.
• Lysopadol Spray has a local anaesthetic effect which relieves the
pain in acute sore throat.
• Lysopadol Spray is used to relieve the pain in acute sore throat
for adults and children over 12 years of age.
• You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LYSOPADOL SPRAY
DO NOT TAKE LYSOPADOL SPRAY

If you are allergic to ambroxol hydrochloride or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Lysopadol Spray.
• You should not use Lysopadol Spray for more than 3 days. If you
still have symptoms after 3 days or if you
have a high fever, please consult a doctor.
• If you have liver or kidney problems, ask your doctor before using
Lysopadol Spray.
• Lysopad

Summary of Product characteristics

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.
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