Coldrex HotRem powder for oral solution with 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 lemon flavour

Units in package:

(10) sachets 5g

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2017-05-04

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 lemon flavour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The short term symptomatic relief of cold & flu symptoms including
headache, sore throat,
nasal congestion, sinusitis and its associated pain, body aches and
pains, and fever.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration. Empty the contents of the sachet into a
beaker and fill with very hot
water. Stir well. 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, except on
medical advice.
Maximum duration of use without medical advice: 7 days.
If symptoms persist, consult a doctor.
Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used.
4.3
CONTRAINDICATIONS
This product is contraindicated in following cases:
• Hypersensitivity to paracetamol, phenylephrine, ascorbic acid or
any of the excipients;
•
Patiens, 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
•
Patients, taking beta-blockers and tricyclic antidepressants .
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 products containing
paracetamol may lead to
an overd