Bisolvon Dry

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dextromethorphan hydrobromide monohydrate 0.2%{relative}

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Dextromethorphan hydrobromide monohydrate 0.2% w/v

Dosage:

2 mg/mL

Pharmaceutical form:

Oral solution

Composition:

Active: Dextromethorphan hydrobromide monohydrate 0.2%{relative} Excipient: Apricot Flavour 653460 Maltitol Methyl hydroxybenzoate Propylene glycol Purified water Saccharin sodium Vanilla Flavour 33P080

Prescription type:

Restricted

Manufactured by:

Divi's Laboratories Limited

Therapeutic indications:

For the treatment of dry irritating coughs

Product summary:

Package - Contents - Shelf Life: Bottle, glass, amber with PE CRC screw cap - 200 mL - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2014-12-16

Patient Information leaflet

BISOLVON® DRY ORAL LIQUID
1
BISOLVON® DRY ORAL LIQUID
ACTIVE INGREDIENT: 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.
Bisolvon Dry Oral Liquid 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
This medicine can lead to dependence. Therefore, the
treatment should be of short duration.
DO NOT USE BISOLVON DRY ORAL LIQUID IF:
•
you are allergic to any medicine containing
dextromethorphan hydrobromide monohydrate
(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.
•
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 are taking, or have taken in the previo

Summary of Product characteristics

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NEW ZEALAND DATA SHEET
1
BISOLVON DRY
BISOLVON DRY Oral Liquid
BISOLVON DRY Pastilles
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
Oral solution
BISOLVON DRY Oral Liquid is a clear, colourless, syrupy liquid with an
aroma of apricot and
vanilla.
Pastille
BISOLVON DRY Pastille is a yellow, round pastille with a honey lime
flavor.
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.
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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.
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 (equivalent to
120 mg
dextromethorphan hydrobromide monohydrate). 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 monohydrate). Do not exceed 4 doses in a
24 hour period.
BISOLVON DRY Pastilles:
Adults and children 12 years and over:
Slowly suck 1 - 3 pastilles