Family Meltus Chesty Coughs Honey & Lemon Flavour

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

GUAIFENESIN

Предлага се от:

Cupal Limited 103 - 105 Bath Road Slough, SL1 3UK, United Kingdom

АТС код:

R05CA03

INN (Международно Name):

GUAIFENESIN 50 mg/5ml

Лекарствена форма:

SYRUP

Композиция:

GUAIFENESIN 50 mg/5ml

Вид предписание :

OTC

Терапевтична област:

COUGH AND COLD PREPARATIONS

Статус Оторизация:

Withdrawn

Дата Оторизация:

2007-07-12

Данни за продукта

 
         Page 1 of 3 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAME OF MEDICINAL PRODUCT 

Family Meltus Chesty Coughs Honey & Lemon Flavour 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

 Guaiphenesin 
50mg 

3. PHARMACEUTICAL 
FORM 

 Syrup. 

4. CLINICAL 
PARTICULARS 

 4.1 
Therapeutic 
Indications 

Symptomatic relief of deep chesty cough and to soothe the throat. 

4.2 
Posology and Method of Administration 

Route of administration: Oral. 

Dosage may be repeated 3 - 4 times daily. 

Adults and children over 12 years 
: 
Two to four 5ml spoonsful 

Children 6 - 12 years   

: 
Two 5ml spoonsful 

Children 2 - 6 years   

: 
One 5ml spoonful 

Children under 2 years 

: 
On medical advice only. 

 4.3 
Contraindications 

 None 
known. 

 4.4 
Special 
Warnings 

 None. 

4.5 
Interaction with Other Medicaments and Other Forms of Interaction 

 None 
known. 

4.6 
Pregnancy and Lactation 

May be used. 

4.7 
Effects on Ability to Drive and use Machines 

 None 
known. 

         Page 2 of 3 
 4.8 
Undesirable 
Effects 

Some gastro-intestinal discomfort. Very large doses may cause nausea
and vomiting. 

 4.9 
Overdose 

Very large doses may cause nausea and vomiting. The drug is however,
rapidly 
metabolised and excreted in the urine.   

 Treatment 

Patient should be kept under observation and
treated symptomatically. 

5. PHARMACOLOGICAL 
PROPERTIES 

 5.1 
Pharmacodynamic 
Properties 

The Guaiphenesin is an expectorant. 

The sugar, honey and glycerin have a demulcent effect. 

 5.2 
Pharmacokinetic 
Properties 

Guaiphenesin is absorbed from the gastrointestinal tract.  It is
metabolised and 
excreted in the urine. 

5.3 
Pre-clinical Safety Data 

There are no preclinical data of relevance to the prescriber wh