LYSOPADOL LEMON 20 Milligram Lozenges

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

AMBROXOL HYDROCHLORIDE

Inapatikana kutoka:

Boehringer Ingelheim Limited

ATC kanuni:

R02AD

INN (Jina la Kimataifa):

AMBROXOL HYDROCHLORIDE

Kipimo:

20 Milligram

Dawa fomu:

Lozenges

Dawa ya aina:

Product not subject to medical prescription

Eneo la matibabu:

ANESTHETICS, LOCAL

Idhini hali ya:

Transfer Pending

Idhini ya tarehe:

2012-06-01

Taarifa za kipeperushi

ABCD
1. WHAT LYSOPADOL LEMON IS AND WHAT IT IS USED FOR
Lysopadol Lemon contains
the active substance ambroxol hydrochloride.
The active substance is the part of the lozenges that gives the
therapeutic
effect you need.
Lysopadol Lemon has a local anaesthetic effect which relieves the pain
in
acute sore throat.
Lysopadol Lemon is used to relieve the pain in acute sore throat.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LYSOPADOL LEMON
DO NOT TAKE LYSOPADOL LEMON
– 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 Lemon
– You should not use Lysopadol Lemon 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 “Lysopadol Lemon contains sorbitol and sucrose
”
– If you have liver or kidney problems, ask your doctor before using
Lysopadol Lemon
– Lysopadol Lemon 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 Lemon. 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 reports of severe skin reactions associated with
the
administration of ambroxol hydrochloride. If you develop a skin rash
(including lesions of the mucous membranes such as mouth, throat,
nose, eyes, genitals), stop using Lysopadol Lemon and contact your
doctor immediately
C

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lysopadol Lemon 20 mg Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One lozenge contains 20 mg of ambroxol hydrochloride.
Excipient(s) with known effect:
Each lozenge contains 1.37 g sorbitol (E420) and 6.3 mg sucrose.
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 Lemon 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 Lemon 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 Lemon
20 mg Lozenges since they contain significant
amounts of sorbitol.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Lysopadol Lemon 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
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