Fluifort 90mg/ml syrup

Страна: Мальта

мова: англійська

Джерело: Medicines Authority

Активний інгредієнт:

CARBOCISTEINE

Доступна з:

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

Код атс:

R05CB03

ІПН (Міжнародна Ім'я):

CARBOCISTEINE 9 % (W/V)

Фармацевтична форма:

SYRUP

Склад:

CARBOCISTEINE 9 % (W/V)

Тип рецепту:

OTC

Терапевтична области:

COUGH AND COLD PREPARATIONS

Статус Авторизація:

Authorised

Дата Авторизація:

2007-01-03

інформаційний буклет

Page 1 of 3
Package insert
FLUIFORT 90 mg/ml syrup
Carbocysteine lysine salt monohydrate
COMPOSITION
100 ml solution contain:
Active ingredient: carbocysteine lysine salt monohydrate equal to 9 g
carbocysteine lysine salt;
Excipients: saccharose, natural cherry aroma,
methyl-p-parahydroxybenzoate, caramel, purified
water.
PHARMACEUTICAL FORM AND CONTENT:
Fluifort 90 mg/ml syrup – 1 bottle to 200 ml
PHARMACOTHERAPEUTIC CLASS
Cough and cold preparation. Mucolytics
MARKETING AUTHORIZATION HOLDER
Dompé farmaceutici S.p.A - Via San Martino, 12, 20122 Milano (Italy)
MANUFACTURER AND FINAL CONTROL
Dompé farmaceutici S.p.A. – Via Campo di Pile, L’Aquila (Italy)
INDICATIONS
Mucolytic drug, fluidifying agent in the acute and chronic diseases of
the respiratory system.
CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the excipients.
Gastric-duodenal ulcer.
Pregnancy and lactation (see “Special warnings”). Children aged
less than 2 years.
PRECAUTIONS FOR USE
No tolerance or addiction effects are known.
INTERACTIONS
Controlled clinical trials did not point out any interaction with the
most common medicines used for
the treatment of upper airways disorders or with food and laboratory
tests.
SPECIAL WARNINGS
Mucolytic agents could induce bronchial obstruction in children below
2 years. Indeed bronchial
mucus drainage capability is limited in this year, because of the
physiologic features of the
respiratory tract.
They should not be used in children below 2 years.
Each dose to 15 ml provides 6 g saccharose. This must be considered
when treating patients with
diabetes mellitus.
The medicine contains methyl-para-hydroxybenzoate, known for the
possibility of causing urticaria.
Para-hydroxybenzoates may generally cause delayed reactions, such as
contact dermatitis, and
rarely immediate reactions with urticaria and bronchospasm.
Fluifort 90 mg/ml syrup does not contain gluten; therefore, it may be
administered to patients
suffering from celiac disease.
Fluifort 90 mg/ml syrup does not contain aspar

Характеристики продукта

Page 1 of 4
SUMMARY OF PRODUCT’S CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fluifort 90 mg/ml syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml syrup contain:
active ingredient: carbocysteine lysine salt monohydrate equivalent to
9 g carbocysteine
lysine salt
Excipients: Saccharose, methyl-p-hydroxybenzoate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Syrup
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mucolytic drug, fluidifying agent in the acute and chronic diseases of
the respiratory
system.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
A graduated cup is enclosed in the package.
To open the bottle hardly press the cap and turn anticlockwise.
Adults:15 ml 2-3 times daily or as directed by a health care
professional
Children: older than 5 years: 5 ml 2-3 times daily or as directed by a
health care professional
from 2 to 5 years: 2,5 ml 2-3 times daily or as directed by a health
care professional
In consideration of the pharmacokinetic properties and of the high
tolerability, the
recommended posology may be kept in patients with renal and liver
failure, too.
DURATION OF TREATMENT: Carbocysteine monohydrate lysine salt may be
used for longer
periods of time; in this case, please follow the recommendations of
the physician.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the excipients.
Gastric-duodenal ulcer.
Pregnancy and lactation. Children aged less than 2 years.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Mucolytics can cause bronchial obstruction in children aged less than
2 years.
Due to the physiological characteristics of the airways, the ability
to drain bronchial mucus
is limited in this age group.
For this reason, mucolytic agents should not be used in children under
2 years of age (see
paragraph 4.3).
No tolerance or addiction phenomena are known.
Patients
with
rare
inherited
problems
of
glucose
intolerance,
glucose-galactose
malabsorption or lack of the saccharose-isomaltase enzyme should not
take this medicines.
The medicine