LYSOPADOL BLACKCURRANT 20 Milligram Lozenges

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AMBROXOL HYDROCHLORIDE

Available from:

Boehringer Ingelheim Limited

ATC code:

R05CB06

INN (International Name):

AMBROXOL HYDROCHLORIDE

Dosage:

20 Milligram

Pharmaceutical form:

Lozenges

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Mucolytics

Authorization status:

Authorised

Authorization date:

2012-06-01

Patient Information leaflet

_LYSOPADOL_
_®_
_ BLACKCURRANT_
_20 MG LOZENGES_
ABCD
1.  WHAT LYSOPADOL BLACKCURRANT IS AND WHAT IT IS
USED FOR
Lysopadol Blackcurrant contains the active substance ambroxol 
hydrochloride.  The active substance is the part of the lozenges that
gives 
the therapeutic effect you need.
Lysopadol Blackcurrant has a local anaesthetic effect which relieves
the 
pain in acute sore throat.
Lysopadol Blackcurrant is used to  relieve the pain in acute sore
throat.
2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LYSOPADOL BLACKCURRANT
DO NOT TAKE LYSOPADOL BLACKCURRANT
–  If you are allergic to ambroxol hydrochloride or any of the
other    
ingredients of this medicine (listed in section 6)
–  If you suffer from the rare hereditary conditions
of fructose intolerance
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Lysopadol
Blackcurrant.
–  You should not use Lysopadol Blackcurrant 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 been told by your doctor that you have an
intolerance to 
some types of sugar, contact your doctor before taking this medicinal
product.  See also “Important information about some of the
ingredients
of Lysopadol Blackcurrant”
–  If you have liver or kidney problems, ask your doctor before
using
Lysopadol Blackcurrant
–  Lysopadol Blackcurrant is not suitable for the treatment of
painful
lesions in the mouth (e.g. ulcers or sores).  If you have mouth
ulcers
please consult a doctor
–  Shortness of breath (dyspnoea) may be observed due to an
underlying
condition (e.g. swollen throat).  Another reason could be
a feeling of 
tightness in the throat due to the local anaesthetic effect
of Lysopadol
Blackcurrant.  A further cause could be an allergic reaction which
may 
also cause your mouth and throat to swell
–  Your throat and mouth may feel less sensitive than usual
(numb)
–  There have been repor

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lysopadol Blackcurrant 20 mg Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One lozenge contains 20 mg of ambroxol hydrochloride.
Excipient(s) with known effect:
Each lozenge contains 1.381g sorbitol (E420).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lozenge.
Round, white tablet, both sides flat with bevelled edges.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pain relief in acute sore throat.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children over 12 years of age: up to 6 lozenges to be sucked per day, with a maximum of 1 lozenge per
dose.
Lysopadol Blackcurrant 20 mg Lozenges 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 Blackcurrant 20 mg Lozenges should not be used in children under 12 years of age.
Method of administration
Oromucosal use.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients with fructose intolerance should not receive Lysopadol Blackcurrant 20 mg Lozenges since they contain
significant amounts of sorbitol.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Lysopadol Blackcurrant 20 mg Lozenges can be used for up to 3 days. If symptoms worsen or still persist after 3 days
or if the patient has a high fever, a doctor should be consulted.
There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic
epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP) associated with the administration
HEALTH PRODUCTS REGULATORY AUTHORITY
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