Adult Meltus Chesty Coughs with Congestion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

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

ATC code:

R05CA10

INN (International Name):

GUAIFENESIN 100 mg/5ml PSEUDOEPHEDRINE HYDROCHLORIDE 300 mg/5ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

GUAIFENESIN 100 mg/5ml PSEUDOEPHEDRINE HYDROCHLORIDE 300 mg/5ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2007-06-12

Summary of Product characteristics

 
Page 1 of 4 
SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Adult Meltus Chesty Coughs with Congestion 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
 Guaiphenesin 
100mg/5ml 
Pseudoephedrine hydrochloride 30mg/5ml 
3 PHARMACEUTICAL 
FORM 
Oral solution. 
4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
The symptomatic relief of
upper respiratory tract disorders accompanied by productive 
cough which benefit from a combination of a nasal decongestant and
an expectorant. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
 Oral 

ADULTS AND CHILDREN AGED 12 YEARS
AND OVER: Two 5ml spoonsful three times a day. 
THE ELDERLY: No specific studies have been carried out on
the elderly, but similar products 
have been widely used in older
people. However it may be advisable to monitor renal and 
hepatic function, and if there is serious impairment then caution
should be exercised. 
4.3 CONTRA-INDICATIONS 

The product is contraindicated in patients who have
previously shown tolerance to 
pseudoephedrine or guaiphenesin. It is also contraindicated in
persons currently being 
treated with monoamine oxidase inhibitors, and also within two
weeks of stopping such 
treatment. It is also contraindicated in persons with severe
hypertension or severe coronary 
artery disease. 
4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

Although pseudoephedrine has virtually no presser effect in patients
with normal blood 
pressure, Adult Meltus Chesty Coughs with Congestion should be
used with caution in 
patients taking antihypertensive agents, tricyclic antidepressants,
other sympathomimetic 
agents such as decongestants, appetite suppressants and
amphetamine-like psychostimulants. 
The effects of a single dose of linctus on the blood pressure of
these patients should be 
observed before recommending repeated or unsupervised treatment. 
As with other sympathomimetic