BISOLVON DRY dextromethorphan hydrobromide monohydrate 2mg/mL oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dextromethorphan hydrobromide monohydrate, Quantity: 2 mg/mL

Available from:

Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

INN (International Name):

dextromethorphan hydrobromide monohydrate

Pharmaceutical form:

Oral Liquid

Composition:

Excipient Ingredients: propylene glycol; purified water; maltitol solution; methyl hydroxybenzoate; saccharin sodium; Flavour; Fragrance (perfume)

Administration route:

Oral

Units in package:

125mL, 200mL

Prescription type:

(S2) Pharmacy Medicine

Therapeutic indications:

Cough suppressant

Product summary:

Visual Identification: Syrupy, clear, colourless liquid with odour of apricot and vanilla; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

1999-03-19

Patient Information leaflet

BISOLVON
® DRY ORAL LIQUID
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ACTIVE INGREDIENT(S): Dextromethorphan hydrobromide monohydrate
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
Bisolvon Dry Oral Liquid. YOU SHOULD ALSO SPEAK TO
YOUR DOCTOR OR PHARMACIST IF YOU WOULD LIKE FURTHER
INFORMATION OR IF YOU HAVE ANY CONCERNS OR QUESTIONS
ABOUT USING BISOLVON DRY ORAL LIQUID.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using Bisolvon Dry Oral Liquid?
2. What should I know before I use Bisolvon Dry Oral Liquid
3. What if I am taking other medicines?
4. How do I use Bisolvon Dry Oral Liquid?
5. What should I know while using Bisolvon Dry Oral Liquid?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING BISOLVON DRY ORAL LIQUID?
BISOLVON DRY ORAL LIQUID CONTAINS THE ACTIVE INGREDIENT
DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE.
Dextromethorphan hydrobromide monohydrate is a cough
suppressant that acts on the cough centre in the brain to
suppress a dry cough
BISOLVON DRY ORAL LIQUID IS USED FOR THE TREATMENT OF DRY,
IRRITATING COUGHS.
Bisolvon Dry Oral Liquid does not have any pain-relieving
(analgesic) properties.
2.
WHAT SHOULD I KNOW BEFORE I USE BISOLVON
DRY ORAL LIQUID
WARNINGS
TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO ANY OTHER
MEDICINES, FOODS, PRESERVATIVES OR DYES.
DO NOT USE BISOLVON DRY ORAL LIQUID IF:
YOU ARE ALLERGIC TO:
•
ANY MEDICINE CONTAINING DEXTROMETHORPHAN
HYDROBROMIDE MONOHYDRATE (ACTIVE INGREDIENT)
•
ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET
Some of the symptoms of an allergic reaction may
include:
o
shortness of breath
o
wheezing or difficulty breathing
o
swelling of the face, lips, tongue or other parts of the
body
o
rash, itching or hives on the skin.
•
YOU HAVE THE FOLLOWING MEDICAL CONDITIONS:
o
Asthma
o
a lung condition called chronic obstructive airways
disease (COAD or COPD)
o
respiratory failure
o
pneumonia
o
shallow breathing (respiratory depression)
o
fructose intolerance
o
mastocytosis.
•
YOU A

Summary of Product characteristics

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1
AUSTRALIAN PRODUCT INFORMATION – BISOLVON
® DRY
(DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE)
1
NAME OF THE MEDICINE
Dextromethorphan hydrobromide monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL of Bisolvon Dry Oral Liquid contains dextromethorphan
hydrobromide
monohydrate 10 mg.
Excipients with known effect: methyl hydroxybenzoate, maltitol,
saccharin sodium
Each Bisolvon Dry Pastille contains dextromethorphan hydrobromide
monohydrate 10.5 mg
(equivalent to dextromethorphan hydrobromide anhydrous 10 mg).
Excipients with known effect: maltitol, saccharin sodium
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Bisolvon Dry Oral Liquid is a clear, colourless, syrupy liquid with an
aroma of apricot and
vanilla.
Bisolvon Dry Pastille is a yellow, round pastilles with a honey lime
flavour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bisolvon Dry Oral Liquid and Bisolvon Dry Pastilles are used for the
symptomatic treatment
of dry, irritant, unproductive coughs. Bisolvon Dry Pastilles also
helps soothe the throat.
4.2
DOSE AND METHOD OF ADMINISTRATION
Bisolvon Dry Oral Liquid and Bisolvon Dry Pastilles are preparations
for oral administration.
The following dosage regimen is recommended:
In the case of self treatment, the maximum duration of treatment is 5
days.
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2
BISOLVON DRY ORAL LIQUID
_ADULTS AND CHILDREN 12 YEARS AND OVER: _
5 – 15 mL of Bisolvon Dry Oral Liquid, every 4 – 6 hours when
necessary.
The maximum total daily dose is 60 mL of Bisolvon Dry Oral Liquid
(equivalent to 120 mg
dextromethorphan hydrobromide). Do not exceed 4 doses in a 24 hour
period.
_CHILDREN 6 – 11 YEARS: _
2.5 – 7.5 mL of Bisolvon Dry Oral Liquid, every 4 – 6 hours when
necessary.
The maximum total daily dose is 30 mL of Bisolvon Dry Oral Liquid
(equivalent to 60 mg of
dextromethorphan hydrobromide). Do not exceed 4 doses in a 24 hour
period.
BISOLVON DRY PASTILLES
_ADULTS AND CHILDREN 12 YEARS AND OVER: _
Slowly