Korold-Asteria tablets film-coated

Land: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

paracetamol, pseudoephedrine (pseudoephedrine hydrochloride), chlorphenamine (chlorphenamine maleate)

Fáanlegur frá:

Hankook Korus Pharm Co.

ATC númer:

N02BE51

INN (Alþjóðlegt nafn):

paracetamol, pseudoephedrine (pseudoephedrine hydrochloride), chlorphenamine (chlorphenamine maleate)

Skammtar:

500mg+ 30mg+ 2mg

Lyfjaform:

tablets film-coated

Einingar í pakka:

(20/2x10/) and (100/10x10/) in blister

Gerð lyfseðils:

OTC

Leyfisstaða:

Registered

Leyfisdagur:

2016-02-03

Upplýsingar fylgiseðill

leaflet (120X260)mm
[COMPOSITION]
Each film- coated tablet contains
Paracetamol…………………………………………………………………500mg
Pseudoephedrine
hydrochloride………………………………………….30mg
Chlorpheniramine
maleat…………………………………………………..2mg
Excipients:
Lowsubstituted
Hydroxypropyl
cellulose,
Microcrystalline
cellulose,
Polyethylene
glycol
6000,
Hydroxypropylmethylcellulose2910, Magnesium stearate, Carboxymethyl
starch, Titanium oxide, Hydroxypropylcellulose
[INDICATION AND USAGE]
For the treatment of nasal mucus, snuffle, sneezing, throat pain,
fever, headache, muscle pain.
[DOSAGE AND ADMIISTRATION]
Adult & over 12 years old: It is administrated 2 tablets per 6 hour,
not exceeded more than 8 tablets the maximum.
[CONTRAINDICATION]
1) The patient who have been experienced its high sensitive symptoms
such as eruption, rube faction, itch, edema,
eyelid lip) and etc.
2) The patients who have been experienced asthma by administering this
medicine or other cold agents, anti
inflammatory agents.
[PRECAUTION]
The patients should consult with doctor or pharmacist before
administering this medicine.
1)Patients, parents, brothers who have physical constitution on the
allergic reactions easily such ascontact
dermatitis, bronchial asthma, allergic coryza, migraine, food allergy.
2) The patients who have been experienced its allergic symptoms (ex:
high fever, eruption, joint pain, asthma,
itching) by this medicine.
3) The patients who are infected by chicken in pox or influenza or
infants, young children, children under 12 years
suspected by those disease.
4) The patients who have the Liver, kidney, thyroid disease, diabetes,
and hypertension, as well as have weak body
condition or a high -fever.
5) The patients who have glaucoma (ex: pains on eyes, bleary) ,
urinary tract difficulty.
6) Women who are pregnant women or breast feeding, possibility on
pregnancy.
7) The persons who are treated by doctors or dentists.
8) Children under 12years

Vara einkenni

_Summary of Product Characteristics_
1.
NAME OF THE MEDICINAL PRODUCT
Korold-Asteria
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION Active ingredient
No.
Chemical Name
Specification
Quantity/ Tab.
Use
1
Paracetamol
USP
500.0 mg
Active
(Acetaminophen)
ingredient
2
Pseudoephedrin
USP
30.0mg
Active
hydrochloride
ingredient
3
Chlorpheniramine
USP
2.0mg
Active
maleate
ingredient
Excipient(s)
No.
Chemical Name
Specification
Quantity/Tab.
Use
1
Low-substituted Hydroxypropyl
KP
15.0 mg
Inactive
cellulose
ingredient
2
Microcrystalline cellulose
KP
60.0 mg
Inactive
ingredient
3
Polyethylene glycol 6000
KP
2.0 mg
Plasticizer
4
Hydroxypropylmethylcellulose
KP
20.0 mg
Coating agent
2910
Magnesium stearate
KP
8.0 mg
Lubricant
5
6
Carboxymethyl starch
KP
25.0 mg
Dissolvent
7
Titanium oxide
KP
1.5 mg
Sunscreen
agent
8
Hydroxypropylcellulose
KP
25.0 mg
Binder
3. PHARMACEUTICAL FORM
Film-coated tablets
_Summary of Product Characteristics_
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of nasal mucus, snuffle, sneezing, throat pain,
fever, headache, muscle pain
4.2 Posology and method of administration
Adult & over 12years old: It is administered 2 tablets per 6 hours,
not exceeded more than 8
tablets the maximum.
4.3
Contraindications
1)
The patients who have been experienced its high sensitive symptoms
such as eruption, rube
faction, itch, edema, eyelid, lip) and etc.
2)
The patients who have been experienced asthma by administering this
medicine or other
cold agents, anti-inflammatory agents.
4.4
Precautions
The patients should consult with doctor or pharmacist before
administering this medicine.
1)
Patients, parents, brothers who have physical constitution on the
allergic reactions easily
such as contact dermatitis, bronchial asthma, allergic coryza,
migraine, food allergy.
2)
The patients who have been experienced its allergic symptoms (ex: high
fever, eruption, joint
pain, asthma, itching) by this medicine.
3)
The patients who are infected by chicken in pox or influenza or
infants, young children,
children