Levotuss 60mg/ml oral drops, solution

Country: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

LEVODROPROPIZINE

Доступно од:

Dompe Farmaceutici SpA Via San Martino 12, 20122, Milan, Italy

АТЦ код:

R05DB27

INN (Међународно име):

LEVODROPROPIZINE 6 % (W/V)

Фармацеутски облик:

ORAL DROPS, SOLUTION

Састав:

LEVODROPROPIZINE 6 % (W/V)

Тип рецептора:

POM

Терапеутска област:

COUGH AND COLD PREPARATIONS

Статус ауторизације:

Withdrawn

Датум одобрења:

2009-01-30

Информативни летак

1
PACKAGE LEAFLET
LEVOTUSS 60 MG/ML ORAL DROPS, SOLUTION
R05DB27
LEVODROPROPIZINE
COMPOSITION
100 ml of solution contain :
Active ingredient : Levodropropizin 6 g
Excipients:
propylene
glycol,
xylitol,
sodium
saccharate,
methyl-para-hydroxybenzoate,
forest fruits aroma, anise aroma, anhydrous citric acid, purified
water
PHARMACEUTICAL FORM AND CONTENT
Oral drops, solution
LEVOTUSS 60 mg/ml oral drops, solution – 30 ml bottle (1 ml contains
20 drops)
PHARMACOTHERAPEUTIC CLASS
Preparations for cough and cold: sedatives of cough.
MARKETING AUTHORIZATION HOLDER
Dompé farmaceutici S.p.A. – Via San Martino, 12, 20122 Milano
(Italy)
MANUFACTURER OF THE FINISHED PRODUCT
Dompé farmaceutici S.p.A.., Via Campo di Pile, 67100 L’Aquila
(Italy)
RESPONSIBLE FOR BATCH RELEASE
Dompé farmaceutici S.p.A., Via Campo di Pile, 67100 L’Aquila
(Italy)
THERAPEUTIC INDICATIONS
Symptomatic therapy of cough
CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any excipient. Avoid
the administration of the
drug in patients with bronchial hypersecretion and reduced mucociliary
function (Kartagener
syndrome, ciliary dyskinesia).
Pregnancy and lactation (see “Special warnings”).
PRECAUTIONS FOR USE
The effect of the administration of the specialty to children younger
than 24 months has not
been studied completely and in any case the drug should be used with
caution in such
patients.
2
Caution is recommended in patients with severe renal failure
(creatinine clearance < 35
ml/min).
It being evident that the sensitivity to several drugs is altered in
old patients, special caution
is necessary when administering Levodropropizin to old patients.
Caution is also recommended for the concomitant intake of sedative
drugs in particularly
sensitive subjects (see “Interactions”).
INTERACTIONS
Animal pharmacology studies have demonstrated that Levodropropizin
does not potentiate
the effect of substances acting on the nervous system (eg.
benzodiazepines, alcohol,
phenytoin, imipramine). In animals, Levodropropizin does not mod

Карактеристике производа

1 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 
Levotuss 60 mg/ml oral drops, solution 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
100 ml of solution contain : 
Active ingredient : Levodropropizin 6 g 
Excipients: see 6.1 

3. PHARMACEUTICAL FORM 
Oral drops, solution 

4. CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS 
Symptomatic therapy of cough 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 
Adults: 20 drops (corresponding to 60 mg) up to 3 times daily with at least 6-hour-intervals, 
unless differently prescribed from the physician. 
Children:  up  to  3  daily  administrations  with  at  least  6-hour-intervals,  according  to  the 
following scheme: 

WEIGHT (KG) 
NO. 
OF 
DROPS/ 
ADMINISTRATION 
WEIGHT (KG) 
NO. 
OF 
DROPS/ 
ADMINISTRATION 
7-10 
3 
29-31 
10 
11-13 
4 
32-34 
11 
14-16 
5 
35-37 
12 
17-19 
6 
38-40 
13 
20-22 
7 
41-43 
14 
23-25 
8 
44-46 
15 
26-28 
9 
more than  46 
20 

According  to  the  opinion  of  the  physician,  the  above  dosages  may  be  doubled  up  to  a 
maximum of 20 drops 3 times daily. 
Drops must preferably be diluted in a half glass water. 
Treatment  should  be  continued  until  cough  disappears  or  according  to  the  physician’s 
prescription. In any case, if after 2 weeks of therapy, cough is still present, it is advisable to 
discontinue  treatment  and ask  for  the physician’s advice. Indeed, cough is a symptom and 
its causal pathology should be studied and treated. 

4.3 CONTRAINDICATIONS 
Hypersensitivity  to  the  active  ingredient  or  to  any  excipient.  Avoid  the  administration  of  the 
drug in patients with bronchorrhea and reduced mucociliary function (Ka