BISOLVON DRY HONEY LIME FLAVOUR dextromethorphan hydrobromide monohydrate 10.5 mg pastille blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dextromethorphan hydrobromide monohydrate, Quantity: 10.5 mg

Available from:

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

INN (International Name):

dextromethorphan hydrobromide monohydrate

Pharmaceutical form:

Pastille

Composition:

Excipient Ingredients: menthol; Acacia; saccharin sodium; white beeswax; betadex; quinoline yellow; sodium cyclamate; light liquid paraffin; maltitol solution; citric acid; Flavour

Administration route:

Oral

Units in package:

30, 10, 40, 20

Prescription type:

(S2) Pharmacy Medicine

Therapeutic indications:

BISOLVON DRY Pastilles are used for the symptomatic treatment of dry, irritant, unproductive coughs and helps soothe the throat.

Product summary:

Visual Identification: Yellow, round pastilles with a citrus like flavour.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-11-03

Patient Information leaflet

BISOLVON
® DRY PASTILLES
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ACTIVE INGREDIENT: Dextromethorphan hydrobromide monohydrate
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
Bisolvon Dry Pastilles. 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 PASTILLES.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using Bisolvon Dry Pastilles?
2. What should I know before I use Bisolvon Dry Pastilles?
3. What if I am taking other medicines?
4. How do I use Bisolvon Dry Pastilles?
5. What should I know while using Bisolvon Dry Pastilles?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING BISOLVON DRY PASTILLES?
Bisolvon Dry Pastilles are used for the treatment of dry,
irritating coughs.
Bisolvon Dry Pastilles contains the active ingredient
dextromethorphan hydrobromide, a cough suppressant
that acts on the cough centre in the brain to suppress a dry
cough.
Bisolvon Dry Pastilles also helps soothe sore throats.
Bisolvon Dry Pastilles does not have any pain-relieving
(analgesic) properties.
2.
WHAT SHOULD I KNOW BEFORE I USE BISOLVON
DRY PASTILLES?
WARNINGS
DO NOT USE BISOLVON DRY PASTILLES IF:
YOU ARE ALLERGIC TO DEXTROMETHORPHAN HYDROBROMIDE
(ACTIVE INGREDIENT), OR 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
•
DO NOT TAKE BISOLVON DRY PASTILLES IF 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
•
DO NOT TAKE THIS MEDICINE IF YOU ARE TAKING, OR
HAVE TAKEN IN THE PREVIOUS 14 DAYS A MONOAMINE
OXIDASE INHIBITOR (MAOI) USED TO

Summary of Product characteristics

bis-ccdsv5-piv10-25mar21
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.
bis-ccdsv5-piv10-25mar21
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