Coldrex HotRem powder for oral solution with honey and lemon flavour

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

paracetamol, phenylephrine (phenylephrine hydrochloride), ascorbic acid

Available from:

SmithKline Beecham S.A. Ctra. de Ajalvir

ATC code:

N02BE51

INN (International Name):

paracetamol, phenylephrine (phenylephrine hydrochloride), ascorbic acid

Dosage:

750mg+ 10mg+ 60mg

Pharmaceutical form:

powder for oral solution with honey and lemon flavour

Units in package:

(10) sachets 5g

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2021-03-17

Summary of Product characteristics

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 honey and lemon flavor.
Sachet content: heterogeneous powder from off-white with beige shade
to bright – brown, with
white, bright-brown and dark-brown inclusions.
Solution in hot water: opaque, from bright-yellow to bright-brown,
with non-dissolving white
inclusions and characteristic honey and 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 5 sachets in any 24hour 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