Opiate Squill Linctus

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Opium tincture 1.369%{relative} (1% as 1.608%w/v = anhydrous morphine 0.0165%w/v);  ; Squill oxymel 3.78%{relative} (SFM Squill Oxymel BP 125:1000 =Squill 1.67%w/v)

Available from:

PSM Healthcare Ltd trading as API Consumer Brands

INN (International Name):

Opium tincture 1.369% w/w (1% as 1.608%w/v = anhydrous morphine 0.0165%w/v)

Pharmaceutical form:

Linctus

Composition:

Active: Opium tincture 1.369%{relative} (1% as 1.608%w/v = anhydrous morphine 0.0165%w/v)   Squill oxymel 3.78%{relative} (SFM Squill Oxymel BP 125:1000 =Squill 1.67%w/v) Excipient: Benzoic acid Camphor Ethanol Honey Methyl hydroxybenzoate Purified water Star anise oil Sugar premium liquid Tolu syrup

Units in package:

Bottle, plastic, Dispensing pack, 2 L

Class:

Pharmacy only

Prescription type:

Prescription

Manufactured by:

Temad Company, Active Pharmaceutical Ingredients

Therapeutic indications:

Demulcent expectorant and cough suppressant (label claim).

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, Dispensing pack - 2 L - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 2.5 L - 12 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 100 mL - 12 months from date of manufacture stored at or below 30°C

Authorization date:

1980-05-29

Patient Information leaflet

NEW ZEALAND CONSUMER MEDICINE INFORMATION
1
OPIATE SQUILL LINCTUS
Anhydrous Morphine 0.0165% w/v
Squill 1.67% w/v
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Opiate
Squill Linctus.
This leaflet answers some common questions about Opiate Squill
Linctus.
It does not contain all the available information. It does not take
the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
Opiate Squill Linctus against the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT OPIATE SQUILL LINCTUS IS USED FOR
The active ingredients are Anhydrous Morphine and Squill.
Opiate Squill Linctus is used to provide relief of a wet, productive
and irritating
cough.
This medicine belongs to a group of medicines called narcotic cough
suppressants.
Your doctor may have prescribed Opiate Squill Linctus for another
reason.
Ask your doctor if you have any questions about why Opiate Squill
Linctus has been
prescribed for you.
This medicine is available only with a doctor's prescription.
This medicine will add to the habit-forming effects (causing mental
and physical
dependence) of some central nervous system depressants (medicines that
slow
down the nervous system, possibly by causing drowsiness).
BEFORE YOU USE OPIATE SQUILL LINCTUS_ _
_ _
_WHEN YOU MUST NOT USE IT _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
2
Do not use Opiate Squill Linctus if:
•
You are allergic to any other the ingredients contained in this
product, including
honey.
•
You suffer from asthma, bronchitis or any other chronic lung disorder
causing
breathing difficulty.
•
You have heart, liver or kidney disease.
•
You suffer from alcoholism or raised pressure in the head.
•
You are pregnant, trying to become pregnant or are breast-feeding.
Do not suddenly stop taking this medicine. You may need to reduce the

Summary of Product characteristics

NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 1 of 6
1.
PRODUCT NAME
Opiate Squill Linctus
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Anhydrous Morphine 0.0165% w/v
Squill 1.67% w/v
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
Contains 20% v/v alcohol.
Contains honey.
3.
PHARMACEUTICAL FORM
Linctus
Presentation
A straw coloured to light brown opalescent liquid.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
For relief from a wet, productive and irritating cough.
4.2
Dose and method of administration
Adults and children over 12 years: Take 5 mL sipped slowly or added to
10 mL of warm
water and sipped slowly.
To be taken up to 3 to 4 times daily as required.
If symptoms persist for more than 7 days consult a doctor.
Children under 12 years: Not recommended.
The elderly: Use with care, not exceeding the recommended adult dose.
4.3
Contraindications
Contraindicated in patients with known hypersensitivity to any of the
ingredients. Also
contraindicated in patients with cardiac disorders and in impaired
hepatic or renal
function.
NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 2 of 6
Contraindicated in cases of moderate to severe respiratory depression,
alcoholism, head
injuries and conditions in which intracranial pressure is raised, also
in acute asthma, and
heart failure secondary to chronic lung disease.
Contraindicated in patients receiving treatment with monoamine oxidase
inhibitors or within 14 days of stopping such treatment.
4.4
Special warnings and precautions for use
The linctus should be given with caution to patients with:
hypothyroidism,
adrenocortical insufficiency, inflammatory or obstructive bowel
disorders,
prostatic hypertrophy, shock, myasthenia gravis, hypotension, the
elderly and
patients with general debilitation. Reduced doses may be required in
these
conditions.
Patients with rare hereditary problems of fructose intolerance,
glucose-galactose
malabsorption or sucrase-isomaltase insufficiency should not take this
medicine.
This product is not rec