Sintuss drops oral (solution)

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

butamirate (butamirate citrate)

Disponibil de la:

Vetprom AD

Codul ATC:

R05DB13

INN (nume internaţional):

butamirate (butamirate citrate)

Dozare:

5mg/ml

Forma farmaceutică:

drops oral (solution)

Unități în pachet:

glass bottle-dropper 20ml

Tip de prescriptie medicala:

OTC

Statutul autorizaţiei:

Registered

Data de autorizare:

2020-05-12

Prospect

1
LEAFLET: INFORMATION FOR THE PATIENT
SINTUSS
0,5% PERORAL DROPS, SOLUTION
Butamirate citrate
READ CAREFULLY THE ENTIRE LEAFLET, BEFORE STARTING TO USE THIS
PRODUCT, SINCE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this product exactly the way it has been described in this
leaflet or as your physician or
pharmacist has told you.
-
Keep this leaflet. It may become necessary to read it again.
-
In case you need additional information or advice, ask your
pharmacist.
-
In case you have some undesired drug effects, notify your physician or
pharmacist. This includes
also all possible undesired effects not described in this leaflet. See
point 4.
- If after 5 - 7 days you don't feel better or your condition gets
worse, you have to seek medical help.
WHAT DOES THIS LEAFLET CONTAIN
1.
What is SINTUSS 0.5 % oral drops, solution and what is it used for
2.
What you should know before taking SINTUSS 0.5 % oral drops, solution
3.
How to take SINTUSS 0.5 % oral drops, solution
4.
Possible undesired effects
5.
How to store SINTUSS 0.5 % oral drops, solution
6.
Content of the packaging and additional information
1.
WHAT IS SINTUSS 0.5 % ORAL DROPS, SOLUTION AND WHAT IS IT USED FOR
SINTUSS 0.5 % oral drops, solution is a medicinal product containing
butamirate citrate which is an
antitussive medicine suppressing the centre of the coughing.
SINTUSS 0.5 % oral drops, solution is used for short-term treatment of
dry coughing from different
origin.
2.
WHAT YOU SHOULD KNOW BEFORE TAKING SINTUSS 0.5 % ORAL DROPS, SOLUTION
YOU SHOULD NOT TAKE SINTUSS 0.5 % ORAL DROPS, SOLUTION IF YOU are
allergic to butamirate citrate or
to some of the other components of this medicinal product (listed in
point 6).
WARNINGS AND PRECAUTIONS
It is necessary to have the following in mind:

This product should not be administered at children below 2 months,
except when it is
prescribed by a doctor.

If the coughing continues for more than 7 days, the body temperature
of your child increases,
your breathing becomes difficult and/or you feel

Caracteristicilor produsului

1
1.
NAME OF THE DRUG PRODUCT
SINTUSS 0.5 % oral drops, solution
2.
QUALITATIVE AND QUANTITATIVE CONTENT
1 ml (28 drops) solution contains 5 mg butamirate citrate.
Excipients with known effect:
1 ml solution contains 283.5 mg sorbitol.
1 ml solution contains 2.81 mg ethanol.
1 ml solution contains 246.0 mg glycerol.
For the full list of the excipients, see point 6.1.
3.
PHARMACEUTICAL FORM
Peroral drops, solution.
Appearance – clear, colourless solution with aroma of raspberry.
4.
CLINICAL DATA
4.1.
THERAPEUTIC INDICATIONS
Sintuss solution is indicated for symptomatic treatment of dry
non-productive coughing with different origin.
At children aged below 2 years, the product is administered solely
following doctor’s prescription.
4.2.
DOSAGE AND MODE OF APPLICATION
Dosage
AGE GROUP
DAILY DOSE
Children below 2 months
Only following a doctor’s prescription
See p. 4.4
Children from 2 months to 1 year
4 times a day х 2.5 mg (14 drops)
Children from 1 year to 3 years
4 times a day х 3.75 mg (21 drops)
Children above 3 years
4 times a day х 6.25 mg (35 drops)
Maximal duration of the treatment without doctor’s consultation –
not more than 7 days (see p. 4.4).
Patients with renal and/or hepatic insufficiency
There is no data available regarding the administration of the product
with these groups of patients.
Paediatric population:
At children aged below 2 years, the product is administered solely
following doctor’s prescription.
2
Mode of administration
Sintuss solution is intended for oral application. It may be mixed
with some water beforehand.
4.3.
CONTRAINDICATIONS
Hypersensitivity towards the active substance or one of the excipients
listed in p. 6.1.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Butamirate suppresses the coughing reflex. The simultaneous
application of mucolytics and expectorants
should be avoided due to the possibility of stagnation of mucus in the
respiratory ways resulting from the
suppressed coughing reflex which increases the risk of bronchospasm
and infections of the respiratory