Lemsip Cold & Flu Blackcurrant

Riik: Malta

keel: inglise

Allikas: Malta Medicines Authority

Toimeaine:

PHENYLEPHRINE HYDROCHLORIDE, ASCORBIC ACID, PARACETAMOL

Saadav alates:

Reckitt Benckiser Healthcare (UK) Limited 103-105 Bath Road Slough SL1 3UH, United Kingdom

ATC kood:

N02BE51

INN (Rahvusvaheline Nimetus):

PHENYLEPHRINE HYDROCHLORIDE 10 mg ASCORBIC ACID 50 mg PARACETAMOL 650 mg

Ravimvorm:

POWDER FOR ORAL SOLUTION

Koostis:

PHENYLEPHRINE HYDROCHLORIDE 10 mg ASCORBIC ACID 50 mg PARACETAMOL 650 mg

Retsepti tüüp:

OTC

Terapeutiline ala:

ANALGESICS

Volitamisolek:

Withdrawn

Loa andmise kuupäev:

2006-04-24

Toote omadused

Page 1 of 5 
SUMMARY  OF  PRODUCT  CHARACTERISTICS 

1. 
TRADE NAME OF MEDICINAL PRODUCT 

LEMSIP COLD & FLU BLACKCURRANT. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

 ACTIVE 
INGREDIENTS 
  MG/SACHET  
SPECIFICATION 

 Paracetamol 
650 
Ph 
Eur 
 Phenylephrine 
hydrochloride 
*10 
BP 

Ascorbic acid 
50 
Ph Eur 

*Equivalent to phenylephrine base 8.21 mg. 

3. PHARMACEUTICAL 
FORM 

Powder for oral solution. 

4. CLINICAL 
PARTICULARS 

 4.1. 
THERAPEUTIC 
INDICATIONS 

For relief of the symptoms of colds and influenza, including
relief of aches and pains 
and nasal congestion, and lowering of temperature. 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

Oral, after dissolution in water. 

Adults and children over 12:  Contents of one sachet dissolved by
stirring in hot water 
and sweetened to taste.  The dose may be repeated after 4 hours.  No
more than four 
doses should be taken in 24 hours. 

There is no indication that dosage need be modified for the
elderly. 

Not to be given to children under 12. 

 4.3. 
CONTRAINDICATIONS 

Severe coronary heart disease, hypertension, hypersensitivity to
paracetamol, 
phenylephrine or any other ingredient. 

Page 2 of 5 

4.4. 
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 

Care is advised in the administration of paracetamol to patients with
severe renal or 
hepatic impairment.  The hazard of overdose is greater in those
with non-cirrhotic 
alcoholic liver disease.  Patients should be advised not to take
other paracetamol-
containing products concurrently. 

Use with caution in patients with Raynaud’s phenomenon or diabetes.
 Each sachet 
contains approximately 3.2 g of carbohydrate.  Due to its aspartame
content this product 
should not be given to patients with phenylketonuria. 

Label warnings:  Do not exceed the stated dose.  Keep out of the
reach