Junior Meltus Dry Cough with Congestion

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE

Tersedia dari:

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

Kode ATC:

R05DA09

INN (Nama Internasional):

DEXTROMETHORPHAN HYDROBROMIDE 3.5 mg/5ml PSEUDOEPHEDRINE HYDROCHLORIDE 10 mg/5ml

Bentuk farmasi:

ORAL SOLUTION

Komposisi:

DEXTROMETHORPHAN HYDROBROMIDE 3.5 mg/5ml PSEUDOEPHEDRINE HYDROCHLORIDE 10 mg/5ml

Jenis Resep:

OTC

Area terapi:

COUGH AND COLD PREPARATIONS

Status otorisasi:

Withdrawn

Tanggal Otorisasi:

2007-07-17

Karakteristik produk

 
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SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Junior Meltus Dry Coughs with Congestion   
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Dextromethorphan hydrobromide 3.5mg/5ml 
Pseudoephedrine hydrochloride 10mg/5ml 
3 PHARMACEUTICAL 
FORM 
Oral solution 
4 CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 
An oral solution for the symptomatic relief of
unproductive coughs accompanied by 
congestion of the upper respiratory tract. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
To be given four times a day.  Do not repeat dosage more
frequently 

than every four hours. 
Children 6-12 years: Two 5ml spoonfuls 
Children 2-5 years: One 5ml spoonful 
Adults, the elderly and children over 12 years are recommended
to take Adult Meltus Dry 
Coughs with Congestion.  Not to be given to children under
two years of age. 
4.3 CONTRA-INDICATIONS 
Junior Meltus Dry Coughs with Congestion is contraindicated in 
patients with a known 
hypersensitivity to pseudoephedrine or dextromethorphan.
 Contraindicated in persons under 
treatment with monoamine oxidase inhibitors or within 2 weeks
of stopping such treatment.  
Contraindicated in patients with severe hypertension or
severe coronary artery disease. 
Junior Meltus Dry Coughs with Congestion should
not be administered to patients where the 
cough is associated with asthma or where the cough is
accompanied by excessive secretions. 
Dextromethorphan,
in common with other centrally acting antitussive
agents, should not be 
given in or at risk of developing respiratory failure.
 Although pseudoephedrine has virtually 
no pressor effect in patients with normal blood pressure,
Junior Meltus Dry Coughs with 
Congestion should be used with caution in patients taking
hypertensive agents, tricyclic 
antidepressants, other sympathomimetic agents, such
as decongestants, appetite suppres