Levodropropizine ELC 30mg/5ml Syrup

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LEVODROPROPIZINE

Available from:

ELC GROUP s.r.o. Pobrezni 394/12, Karlin 186 00 Prague 8, Czech Republic

ATC code:

R05DB27

INN (International Name):

LEVODROPROPIZINE 30 ml/5ml

Pharmaceutical form:

SYRUP

Composition:

LEVODROPROPIZINE 30 ml/5ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Authorised

Authorization date:

2019-06-10

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVODROPROPIZINE ELC 30 MG/5 ML SYRUP
Levodropropizine
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.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
WHAT IS IN THIS LEAFLET
1.
What Levodropropizine ELC is and what it is used for
2.
What you need to know before you take Levodropropizine ELC
3.
How to take Levodropropizine ELC
4.
Possible side effects
5.
How to store Levodropropizine ELC
6.
Contents of the pack and other information
1.
WHAT LEVODROPROPIZINE ELC IS AND WHAT IT IS USED FOR
Levodropropizine ELC contains the active substance levodropropizine,
with an antitussive action and
suppressing bronchospasm.
This medicine is used for the symptomatic treatment of non-productive
(dry) cough.
Many data demonstrate the efficacy in reducing the cough of different
etiology, such as cough associated
with bronchopulmonary carcinoma, cough associated with infections of
the upper and lower airways and
pertussis.
You must talk to your doctor if you do not feel better or if you feel
worse after 7 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVODROPROPIZINE ELC
DO NOT TAKE LEVODROPROPIZINE ELC:
-
if you are allergic to levodropropizine or any of the other
ingredients in this medicine (listed in
section 6);
-
if you suffer from bronchorrhea (bronchial hypersecretion), a
condition characterized by a high
production of mucus (phlegm);
-
if you suffer from certain respiratory disorders characterized by
reduced ability to expel mucus
(Kartagener's syndrome, ciliary dyskinesia);
-
if you are pregnant or

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levodropropizine ELC 30 mg/5 ml syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml of solution contain:
Active ingredient: levodropropizine 30 mg
Excipient(s) with known effect:
5 ml of solution contain:
Sucrose – 3g
Sodium- less than 23mg
Ethanol – 1.2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Syrup
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of non-productive cough.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The medicinal product is used 3 times daily at intervals of at least 6
hours.
Children under 2 years old
Levodropropizine ELC should not be used in children under the age of 2
years.
Children over 2 years old:
10-20 kg- 3 ml of syrup 3 times daily;
20-30 kg- 5 ml of syrup 3 times daily.
_Adults _
10 ml of syrup up to 3 times daily.
The maximum duration of treatment without medical consultation is 7
days.
If the cough persists after seven days of Levodropropizine ELC, the
patient should contact a doctor.
Indeed, cough is a symptom and its causal pathology should be studied
and treated.
Method of administration
Levodropropizine ELC should be used orally. The bottle with syrup is
accompanied by a measuring cup
that allows measuring 3 ml, 5 ml, and 10 ml.
2
To open the bottle hardly press the cap and turn anticlockwise.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Do not use the medicinal product in people with bronchorrhea and
reduced mucociliary function
(Kartagener syndrome, ciliary dyskinesia). Pregnancy and lactation
(see section 4.6).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Elderly patients
The observed lack of significant changes in the pharmacokinetic
profile of levodropropizine with age
suggests that modification of doses or intervals between successive
doses in the elderly probably not
necessary. In any case, in the face of evidence of changes in
sensitivity to many medicines in th