Coldrex HotRem powder for oral solution with honey and lemon flavour

Pays: Arménie

Langue: anglais

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingrédients actifs:

paracetamol, phenylephrine (phenylephrine hydrochloride), ascorbic acid

Disponible depuis:

SmithKline Beecham S.A. Ctra. de Ajalvir

Code ATC:

N02BE51

DCI (Dénomination commune internationale):

paracetamol, phenylephrine (phenylephrine hydrochloride), ascorbic acid

Dosage:

750mg+ 10mg+ 60mg

forme pharmaceutique:

powder for oral solution with honey and lemon flavour

Unités en paquet:

(10) sachets 5g

Type d'ordonnance:

OTC

Statut de autorisation:

Registered

Date de l'autorisation:

2017-06-27

Résumé des caractéristiques du produit

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 flavour
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 flavour.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The short term symptomatic relief of cold & flu symptoms including
fever, headache, body
aches and pains, nasal congestion, sore throat, sinusitis and its
associated 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 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 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 ta