Sinecod drops oral

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

butamirate (butamirate citrate)

Available from:

GlaxoSmithKline Consumer Healthcare SARL

ATC code:

R05DB13

INN (International Name):

butamirate (butamirate citrate)

Dosage:

5mg/ml

Pharmaceutical form:

drops oral

Units in package:

glass vial 20ml with dropper

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2022-03-09

Summary of Product characteristics

Global Labelling & Compliance
SINECOD
Oral drops
Butamirate citrate
CORE SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
GDS01_Sinecod_10/2018+Nyon2 01.06.2021 Sinecod
1
NAME OF THE MEDICINAL PRODUCT
Sinecod
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Butamirate citrate (INN).
For a full list of excipients, see section 6.
3
PHARMACEUTICAL FORM
Sinecod oral drops: packs of 20 ml
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of dry cough of various origins
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use only.
For children under 2 years of age: only with a doctor’s prescription
(see 4.4. Special warnings
and precautions for use).
Children 2 months to 1 year old: 10 drops 4 times daily
1 to 3 years: 15 drops 4 times daily;
over 3 years: 25 drops 4 times daily.
The maximum duration of treatment without a doctor’s prescription is
1 week.
The smallest dose should be used to achieve necessary effect in the
shortest period of
treatment.
4.3
CONTRAINDICATIONS
Known hypersensitivity to any of the ingredients. Do not take Sinecod
if you have allergy to
butamirate citrate or any other ingredient.
GDS01_Sinecod_10/2018+Nyon2 01.06.2021 Sinecod
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Due to inhibition of the cough reflex by butamirate, the simultaneous
administration of
expectorants has to be avoided, because it may lead to the stagnation
of mucus in the
respiratory tract, which increases the risk of bronchospasm and
airways infection.
For patients whose symptoms worsen or do not improve within 7 days and
/ or develop a
fever, rash, or persistent headache, additional investigations of the
underlying cause should be
done.
The paediatric drops may only be used with a doctor’s prescription
in children aged less than
2 years.
Keep out of the reach of children.
5 drops of the drug contain 71 mg of sorbitol, which is a source of
fructose. DROPS SHOULD NOT
BE TAKEN TO PATIENTS WITH RARE HEREDITARY DISORDERS ASSOCIATED WITH
INTOLERANCE TO
FRUCTOSE.
This drug contains a small amou