Adult Meltus Dry Coughs with Congestion
Riik: Malta
keel: inglise
Allikas: Medicines Authority
Infovoldik
(PIL)
25-05-2024
Toote omadused
(SPC)
25-05-2024
Toimeaine:
DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Saadav alates:
Cupal Limited 103 - 105 Bath Road Slough, SL1 3UK, United Kingdom
ATC kood:
R05D
INN (Rahvusvaheline Nimetus):
DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5ml PSEUDOEPHEDRINE HYDROCHLORIDE 10 mg/5ml
Ravimvorm:
ORAL LIQUID
Koostis:
DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5ml PSEUDOEPHEDRINE HYDROCHLORIDE 10 mg/5ml
Retsepti tüüp:
OTC
Terapeutiline ala:
COUGH AND COLD PREPARATIONS
Volitamisolek:
Withdrawn
Loa andmise kuupäev:
2007-06-12
Toote omadused
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Adult Meltus Dry Coughs with Congestion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dextromethorphan hydrobromide BP
10.00 mg /5ml
Pseudoephedrine hydrochloride BP
10.00 mg /5ml
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Oral liquid.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The symptomatic relief of dry painful tickly coughs and catarrh.
4.2 POSOLOGY AND ROUTE OF ADMINISTRATION
Oral Use.
ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS OF AGE:
One or two 5ml spoonfuls to be taken four times a day.
Not to be given to children under 12 years of age.
4.3 CONTRAINDICATIONS
Patients with cardiovascular disease, hypertension,
hyperthyroidism, hyperexcitability,
phaeochromocytoma, closed angle glaucoma. Use with caution in
patients with liver disease
and asthma. May increase the difficulty of micturation in
patients with prostatic
enlargements.
Hypersensitivity to any of the ingredients. If
also taking monoamine oxidase inhibitors.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not exceed the stated dose.
If symptoms persist or worsen, seek medical advice.
Keep out of the reach of children.
If pregnant or taking regular medication, consult your doctor
before taking this product.
Page 2 of 4
4.5 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS
OF INTERACTION
Mono-amine oxidase inhibitors.
The activity of the pseudoephedrine content is diminished by
guanethidine, reserpine and methyldopa and may be diminished
or enhanced by tricyclic
antidepressants; it may diminish the effects of
guanethidine and may increase the possibility
of arrhythmias in digitalised patients.
Use with caution in patients with diabetes.
4.6 PREGNANCY AND LACTA
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