Toularynx thym Syrup 6,5g/100ml

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

THYMUS VULGARIS, AMMONIA EXTRACTION, SOLVENT, GLYCEROL, ETHANOL

Tilgængelig fra:

Laboratoria Qualiphar N.V/S.A Rijksweg 9 2880 Bornem, Belgium

ATC-kode:

R05X

INN (International Name):

THYMUS VULGARIS AMMONIA EXTRACTION SOLVENT 10 % GLYCEROL 85 % ETHANOL 90 %

Lægemiddelform:

SYRUP

Sammensætning:

THYMUS VULGARIS AMMONIA EXTRACTION SOLVENT 10 % GLYCEROL 85 % ETHANOL 90 %

Recept type:

OTC

Terapeutisk område:

COUGH AND COLD PREPARATIONS

Autorisation status:

Authorised

Autorisation dato:

2018-11-07

Indlægsseddel

1/3
TOULARYNX THYM, SYRUP
THYMUS VULGARIS L. LIQUID EXTRACT [1:2-3], EXTRACTION SOLVENT AMMONIA
10% (M/M) : GLYCEROL 85% (M/M) :
ETHANOL 90% (V/V) : WATER (1:20:70:109)
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 have told you.
WHAT IS IN THIS LEAFLET
1.
What Toularynx thym is and what it is used for.
2.
What you need to know before you take Toularynx thym.
3.
How to take Toularynx thym.
4.
Possible side effects.
5.
How to store Toularynx thym.
6.
Contents of the pack and other information.
1. WHAT TOULARYNX THYM IS AND WHAT IT IS USED FOR.
Toularynx thym is a traditional herbal medicinal product used as an
aid to facilitate coughing up phlegm
(expectorant) in productive cough associated with cold.
It is a traditional herbal medicinal product for use in the specified
indication exclusively based upon long-standing
use.
The indication should be rephrased as shown above
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOULARYNX THYM.
DO NOT TAKE TOULARYNX THYM
-
If you are allergic to the active substance or any of the other
ingredients of this medicine (listed in
section 6).
-
If you are allergic to plants belonging to the mint or deadnettle
family (Lamiaceae family).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Toularynx thym.
-
The use in children younger than 2 years old is not recommended
because medical advice should be
sought.
-
Consult your doctor when shortness of breath (dyspnoea), fever or
phlegm containing pus (purulent
sputum) occurs.
-
Consult your doctor if the symptoms worsen during the use of this
medicine.
-
Toularynx thym contains alcohol and maltitol. Please also read the
section “Toularynx thym contains
alcohol and maltitol”.
-
If you are using other medicines. Please also read the section
“Other medicines and Toularynx thym”.
Consult your doctor if one of the above warnings applies to you, or i

Produktets egenskaber

Page
1
of
4
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Toularynx Thym 6.5 g/100 ml, syrup
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Thymus vulgaris L. liquid extract [1:2-3],
extraction solvent ammonia 10% (m/m):
glycerol 85% (m/m): ethanol 90% (v/v): water (1:20:70:109)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Syrup
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Traditional herbal medicinal product used for the relief of a
productive cough associated with a cold. It
is a traditional herbal medicinal product for use in the specified
indication exclusively based upon long-
standing use.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
This syrup is sugar-free and can therefore be used without any
problems by diabetics.
The packaging contains a cup that can measure up to 30 ml. The bottle
is sealed with a child-resistant
closure that should be opened as followed: push the closure system
down while turning counter-
clockwise.
Posology
Children from 2 to 4 years old: 4 x 5 ml per day.
Children from 4 to 12 years old: 4 x 10 ml per day.
Children over 12 years of age and adults: 4 x 15 ml per day.
The interval between two intakes should be at least 4 hours.
The use in children under 2 years of age is not recommended (see 4.4:
Special warnings and
precautions for use).
Consult your doctor if your symptoms do not improve after 7 days.
Method of administration
Oral use.
Page
2
of
4
4.3. CONTRAINDICATIONS
Hypersensitivity to the active substance or to other members of the
Lamiaceae family, or to any of the
excipients listed in section 6.1.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE_ _
When dyspnoea, fever or purulent sputum occurs, a doctor should be
consulted.
If the symptoms worsen during the use of this medicine, a doctor
should be consulted.
This medicinal product contains 2.2 vol % ethanol (alcohol) in the
syrup, i.e. up to 260 mg per dose (15
ml), equivalent to 6.6 ml beer or 2.8 ml wine per dose. This may be
harmful to people suffering f