LYSOPADOL MINT 20 Milligram Lozenges

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

AMBROXOL HYDROCHLORIDE

Dostupné s:

Boehringer Ingelheim Limited

ATC kód:

R05CB06

INN (Mezinárodní Name):

AMBROXOL HYDROCHLORIDE

Dávkování:

20 Milligram

Léková forma:

Lozenges

Druh předpisu:

Product not subject to medical prescription

Terapeutické oblasti:

Mucolytics

Stav Autorizace:

Transfer Pending

Datum autorizace:

2004-02-10

Informace pro uživatele

ABCD
1.  WHAT LYSOPADOL MINT IS AND WHAT IT IS USED FOR
Lysopadol Mint contains the active substance ambroxol hydrochloride.
The active substance is the part of the lozenges that gives the
therapeutic effect you need.
Lysopadol Mint has a local anaesthetic effect which relieves the pain
in 
acute sore throat. 
Pain relief starts within 20 minutes in most sufferers and lasts for
at least 3 hours.
Lysopadol Mint is used to relieve the pain in mild to moderate
symptoms
of acute sore throat.
2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LYSOPADOL MINT
DO NOT TAKE LYSOPADOL MINT
–  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 Mint.
–  You should not use Lysopadol Mint 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 Mint”
–  If you have liver or kidney problems, ask your doctor before
using
Lysopadol Mint
–  Lysopadol Mint 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
Mint. 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 assoc

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lysopadol Mint 20mg Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One lozenge contains 20 mg of ambroxol hydrochloride.
Excipient(s) with known effect: Sorbitol (1.37 g per lozenge), lactose monohydrate (less than 1 mg per lozenge).
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 of mild to moderate symptoms of 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.
Lysopadol Mint 20 mg Lozenges should not be used for more than 3 days. In case of persistent symptoms or high
fever, the patient should consult a doctor.
_Paediatric population_
Lysopadol Mint 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 Mint 20 mg Lozenges since they contain significant amounts of sorbitol.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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
of ambroxol hydrochloride. If symptoms or signs of a progressive skin rash (sometimes associated with blisters or
mucosal lesions) are present, ambroxol hydrochloride treatment should be discontinued immediately and medical
advice should be sought.
Dyspnoea may be observed in the context o