Bisolvon Dry

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dextromethorphan hydrobromide monohydrate 10.5mg

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Dextromethorphan hydrobromide monohydrate 10.5 mg

Dosage:

10.5 mg

Pharmaceutical form:

Pastille

Composition:

Active: Dextromethorphan hydrobromide monohydrate 10.5mg Excipient: Acacia Betadex Citric acid Limette flavour 18635/02 Honey Flavour 8366/001 Levomenthol Light liquid paraffin Maltitol Purified water Quinoline yellow Saccharin sodium Sodium cyclamate White beeswax

Prescription type:

Restricted

Manufactured by:

Divi's Laboratories Limited

Therapeutic indications:

Bisolvon Dry Pastilles are used for the symptomatic treatment of dry, irritant, unproductive coughs.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al - 20 pastilles - 36 months from date of manufacture stored below 25°C

Authorization date:

2015-02-23

Patient Information leaflet

BISOLVON®DRY PASTILLES ®
1
BISOLVON® DRY PASTILLES
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 CONTAINS THE ACTIVE INGREDIENT
DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE.
Bisolvon Dry Pastilles are a cough suppressant that acts on
the cough centre in the brain to suppress a dry cough.
BISOLVON DRY PASTILLES ARE USED FOR THE TREATMENT OF DRY,
IRRITATING COUGHS.
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
This medicine can lead to dependence. Therefore, the
treatment should be of short duration.
DO NOT USE BISOLVON DRY PASTILLES IF:
•
You are allergic to 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

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 pastill