Pholcodine 5mg/5ml linctus

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Pholcodine

Commercializzato da:

Thornton & Ross Ltd

Codice ATC:

R05DA08

INN (Nome Internazionale):

Pholcodine

Dosaggio:

1mg/1ml

Forma farmaceutica:

Oral solution

Via di somministrazione:

Oral

Classe:

Schedule 5 (CD Inv)

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 03090100; GTIN: 5011309025118

Foglio illustrativo

PHOLCODINE LINCTUS 200ML
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Scheda tecnica

OBJECT 1
PHOLCODINE LINCTUS BP
Summary of Product Characteristics Updated 09-Nov-2017 | Thornton &
Ross Ltd
1. Name of the medicinal product
Pholcodine Linctus
2. Qualitative and quantitative composition
Pholcodine monohydrate 5.0mg/5ml.
Each 5ml of syrup contains 4g of sucrose
Each 5ml of syrup contains 3.3 vol% of ethanol (alcohol)
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
ORAL SOLUTION.
A deep orange/ red viscous liquid with a characteristic odour.
4. Clinical particulars
4.1 Therapeutic indications
Cough suppressant for the relief of acute non-productive cough
associated with upper respiratory tract
infections.
4.2 Posology and method of administration
Oral use
Recommended Doses
Adults and children over 12 years: 5-10ml.
The elderly: Adult dose is appropriate.
Dosage Schedule
The dosage may be repeated after 4 hours if required but not more than
4 doses in any 24 hours.
4.3 Contraindications
Contraindicated in patients with hypersensitivity to the active
substance or to any of the excipients; and in
cases of liver failure.
It should not be administered to patients in or at risk of developing
respiratory failure or during an attack
of asthma.
Patients with chronic bronchitis, chronic obstructive pulmonary
disease (COPD), bronchiolitis or
bronchiectasis due to sputum retention.
Pholcodine monohydrate should be avoided in patients being treated
with monoamine oxidase inhibitors
or within 2 weeks of cessation of their use (see section 4.5).
Children under 12 years of age.
4.4 Special warnings and precautions for use
Pholcodine Linctus should be used with caution in patients with renal,
hepatic or respiratory disease,
including a history of asthma.
Pholcodine Linctus and other cough suppressants may cause sputum
retention and this may be harmful in
patients with chronic bronchitis and bronchiectasis.
Ask a doctor before use if you suffer from a chronic or persistent
cough, if you have asthma, are suffering
from an acute asthma attack or where cough is accompanied by excessive
secretion