Coldrex HotRem powder for oral solution with lemon flavour

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

paracetamol, phenylephrine (phenylephrine hydrochloride), ascorbic acid

Доступна с:

SmithKline Beecham S.A. Ctra. de Ajalvir

код АТС:

N02BE51

ИНН (Международная Имя):

paracetamol, phenylephrine (phenylephrine hydrochloride), ascorbic acid

дозировка:

750mg+ 10mg+ 60mg

Фармацевтическая форма:

powder for oral solution with lemon flavour

Штук в упаковке:

(10) sachets 5g

Тип рецепта:

OTC

Статус Авторизация:

Registered

Дата Авторизация:

2021-02-27

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Coldrex HotRem
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE CONSTITUENTS:
Paracetamol 750.00 mg
Phenylephrine Hydrochloride 10.00 mg
Ascorbic acid 60.00 mg
3.
PHARMACEUTICAL FORM
Powder for oral solution with lemon flavor.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the short-term relief of the symptoms of cold & influenza, such
as;

Increased body temperature

nasal and sinus congestion

minor aches and pains, such as sore throat, headache, muscle ache and
sinus pain
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration only. Empty the contents of the sachet into a
glass, fill with hot
water, stir until dissolved. Add cold water as necessary.
Adults (including the elderly) and children aged 12 years and over:
One sachet to be taken every four to six hours as required.
Maximum daily dose - five sachets in any 24 hour period.
Minimum dosing interval: 4 hours.
Not recommended for children under the age of 12 years.
Maximum duration of use without medical advice: 7 days.
Do not exceed the stated dose.
The lowest effective dose and shortest duration of treatment should be
considered.
4.3
CONTRAINDICATIONS
This product is contraindicated in patients with:
• Hypersensitivity to paracetamol, phenylephrine, ascorbic acid or
any of the excipients;
• Who are taking, or have taken, within the last two weeks,
monoamine oxidase inhibitors,
which typically are used to treat depression;
• Pheochromocytoma;
• Closed-angle glaucoma;
• Hepatic or severe renal insufficiency;
• Hypertension;
• Hyperthyroidism;
• Diabetes
• Heart disease
• Taking beta-blockers and tricyclic antidepressants.
Do not take simultaneously with other sympathomimetic decongestants.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Contains
paracetamol.
Do
not
use
with
any
other
paracetamol-containing
products,
decongestants
(medicines
for
the
relief
congestion
or
blocked
nose)
or
cold
and
flu
medicines. The concomitant use with other pr