Coldrex tablets

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

paracetamol, caffeine, phenylephrine (phenylephrine hydrochloride), terpin hydrate, ascorbic acid

Доступна с:

SmithKline Beecham S.A. Ctra. de Ajalvir

код АТС:

N02BE51

ИНН (Международная Имя):

paracetamol, caffeine, phenylephrine (phenylephrine hydrochloride), terpin hydrate, ascorbic acid

дозировка:

500mg+ 25mg+ 5mg+ 20mg+ 30mg

Фармацевтическая форма:

tablets

Штук в упаковке:

(12/1x12/) in blister

Тип рецепта:

OTC

Статус Авторизация:

Registered

Дата Авторизация:

2019-10-21

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Coldrex
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE CONSTITUENTS:
Paracetamol 500 mg
Caffeine 25 mg
Phenylephrine hydrochloride 5 mg
Terpin hydrate 20 mg
Ascorbic acid (ethylcellulose coated) 30 mg
3.
PHARMACEUTICAL FORM
Tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of the symptoms of colds and influenza: fever,
headache, sore throat,
runny nose, nasal congestion, sinus pain and muscle ache.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration only.
Adults (including the elderly) and children aged 12 years and over:
One to two tablets every 4 to 6 hours as required.
Maximum daily dose – eight tablets in any 24 hour period.
Minimum dosing interval: 4 hours.
Maximum duration of use without medical advice: 7 days.
Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used for the
shortest duration
of treatment.
Children below 12 years: Not recommended for children under the age of
12 years.
If symptoms persist, consult a doctor.
4.3
CONTRAINDICATIONS
This product is contraindicated in patients with:
• Hypersensitivity to paracetamol, caffeine, phenylephrine
hydrochloride, terpin hydrate,
ascorbic acid or any of the excipients;
•
Who
are
taking,
or
have
taken,
within
the
last
two
weeks,
monoamine
oxidase
inhibitors,(see “Interaction with other medicinal products”).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Contains paracetamol. Do not use with any other paracetamol-containing
products. The
concomitant use with other products containing paracetamol may lead to
an overdose.
Do not exceed the stated dose. Paracetamol overdose may cause liver
failure which may
require liver transplant or lead to death.
Cases of hepatic dysfunctions/failure have been reported in patients
with depleted
glutathione levels, such as those who are severely malnourished,
anorexic, have a low
body mass index, are chronic heavy users of alcohol, or have
sepsis.Concomitant use of
other