Fluifort 1.35 g powder for oral solution

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

CARBOCISTEINE

Предлага се от:

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

АТС код:

R05CB03

INN (Международно Name):

CARBOCISTEINE 1.35 g

Лекарствена форма:

POWDER FOR ORAL SOLUTION

Композиция:

CARBOCISTEINE 1.35 g

Вид предписание :

OTC

Терапевтична област:

COUGH AND COLD PREPARATIONS

Статус Оторизация:

Authorised

Дата Оторизация:

2018-06-04

Листовка

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUIFORT 1.35 G POWDER FOR ORAL SOLUTION
Carbocisteine lysine salt
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your pharmacist.
-
If you develop any side effects, talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. See paragraph 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Fluifort is and what it is used for
2.
What you need to know before you take Fluifort
3.
How to take Fluifort
4.
Possible side effects
5.
How to store Fluifort
6.
Contents of the package and other information
1.
WHAT FLUIFORT IS AND WHAT IT IS USED FOR
Fluifort contains the active ingredient carbocisteine lysine salt
monohydrate which belongs to a group of
medicinal products for coughs and colds called mucolytics which are
used to facilitate the elimination of mucus
from the airways.
This medicine is indicated for the treatment of coughs and acute and
chronic diseases of the respiratory system.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUIFORT
DO NOT TAKE FLUIFORT
-
if you are allergic to carbocisteine lysine salt monohydrate or to any
of the other
components of this medicine (listed in paragraph 6);
-
if you suffer from a gastroduodenal ulcer, a problem that may affect
the stomach or the first part of the
bowel;
-
if you are pregnant or breastfeeding (see paragraph “Pregnancy and
breastfeeding”).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Fluifort if:
-
you are elderly or debilitated
-
you have serious respiratory problems
-
you have asthma or a history of asthma
-
you have a history of stomac

Данни за продукта

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fluifort 1.35 g powder for oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains:
active ingredient: carbocisteine lysine salt monohydrate equivalent to
1.35 g carbocisteine
lysine salt
Excipients with known effect: sucrose, aspartame.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral solution
Powder that rapidly dissolves in hot water and gives rise to an amber
solution that releases a
characteristic balsamic flavour of menthol, eucalyptus and honey.
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
Posology
Adults and adolescents above 15 years: one sachet 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.
Method of administration
For oral use only.
Dissolve the content of the sachet according to the instructions
presented in section 6.6.
Can be taken either with or without food.
Duration of treatment
Page 2 of 6
Carbocisteine monohydrate lysine salt may be used for longer periods
of time. However, if
after 2 weeks of therapy the symptoms are not resolved, it is
advisable to seek medical advice
4.3
CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the excipients.
Gastric-duodenal ulcer.
Pregnancy and lactation.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Severe respiratory failure, asthma and debilitating conditions
Special precautions should be taken in patients with severe
respiratory failure, in patients with
asthma and with a history of bronchospasm, as well as in patients with
debilitating conditions.
The use of carbocisteine causes a decrease in mucus viscosity and an
increase in mucus
removal, both through the ciliary activity of