Actacode Codeine Linctus (Chloroform-free) codeine phosphate hemihydrate 5 mg/mL oral liquid bottle

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

codeine phosphate hemihydrate, Quantity: 5 mg/mL

Dostupné s:

Arrotex Pharmaceuticals Pty Ltd

INN (Mezinárodní Name):

codeine phosphate hemihydrate

Léková forma:

Oral Liquid, solution

Složení:

Excipient Ingredients: glycerol; propylene glycol; sucrose; purified water; potassium sorbate; hydrochloric acid; sodium hydroxide; methyl hydroxybenzoate; propyl hydroxybenzoate; ethyl hydroxybenzoate; butyl hydroxybenzoate; isobutyl hydroxybenzoate

Podání:

Oral

Jednotky v balení:

100mL

Třída:

Medicine Registered

Druh předpisu:

(S8) Controlled Drug

Terapeutické indikace:

Relief of unproductive, dry and intractable coughs associated with colds and flu.

Přehled produktů:

Visual Identification: A clear, almost colourless syrup. Almost odourless. Free from visible contamination.; Container Type: Bottle; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Stav Autorizace:

Licence status A

Datum autorizace:

2006-03-15

Informace pro uživatele

ACTACODE – Consumer Medicine Information
Page 1 of 4
ACTACODE LINCTUS (ORAL LIQUID)
_codeine phosphate hemihydrate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
ACTACODE. 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 taking
ACTACODE against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT ACTACODE IS
USED FOR
ACTACODE contains codeine
phosphate as the active
ingredient. It belongs to a group
of medicines called cough
suppressants.
ACTACODE is used for the
relief of unproductive, dry and
intractable coughs associated
with colds and flu.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
ACTACODE HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed
it for another purpose.
ACTACODE is available only
with a doctor’s prescription.
BEFORE YOU TAKE
IT
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ACTACODE IF YOU
HAVE EVER HAD AN ALLERGIC
REACTION TO:
•
codeine
•
morphine
•
oxycodone
•
any of the ingredients listed at
the end of this leaflet.
Symptoms of an allergic reaction
may include red, itchy skin
rashes, difficulty breathing, hay
fever, swelling of the face or
throat or faintness.
DO NOT TAKE ACTACODE IF YOU
ARE EXPERIENCING BREATHING
DIFFICULTIES SUCH AS ASTHMA,
BRONCHITIS, EMPHYSEMA OR OTHER
SEVERE/ACUTE RESPIRATORY
DISEASES.
DO NOT TAKE IT IF YOU ARE
WARNINGS
_HAZARDOUS AND HARMFUL USE _
Actacode contains codeine and poses risks of hazardous and harmful use
which can lead to
overdose and death. Assess the patient’s risk of hazardous and
harmful use before prescribing and
monitor the patient regularly during treatment
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious, life-threatening or fatal respiratory depression may occur
with the use of Actacode. Be
aware of situations

Charakteristika produktu

1
AUSTRALIAN PRODUCT INFORMATION – ACTACODE (CODEINE
PHOSPHATE HEMIHYDRATE) ORAL LIQUID
1
NAME OF THE MEDICINE
Codeine phosphate hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTACODE ORAL LIQUID contains codeine phosphate hemihydrate 5 mg/mL.
Excipients with known effect: Sucrose, potassium sorbate,
hydroxybenzoic acid esters (present in
Nipastat ARTG No 10363)
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
The oral liquid is a clear, almost colourless syrup, almost odourless
and free from visible
contamination.
WARNINGS
_HAZARDOUS AND HARMFUL USE _
Actacode contains codeine and poses risks of hazardous and harmful use
which can
lead to overdose and death. Assess the patient’s risk of hazardous
and harmful use
before prescribing and monitor the patient regularly during treatment
(see _section 4.4. _
_Special Warnings and Precautions for Use_).
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious, life-threatening or fatal respiratory depression may occur
with the use of
Actacode. Be aware of situations which increase the risk of
respiratory depression,
modify dosing in patients at risk and monitor patients closely,
especially on initiation or
following a dose increase (see _section 4.4 Special Warnings and
Precautions for Use_).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) _
_DEPRESSANTS, INCLUDING ALCOHOL _
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines,
tricyclic antidepressants, antipsychotics, cannabis or other central
nervous system
(CNS) depressants, including alcohol, may result in profound sedation,
respiratory
depression, coma, and death. Limit dosages and durations to the
minimum required
and monitor patients for signs and symptoms of respiratory depression
and sedation.
Caution patients not to drink alcohol while taking Actacode.
2
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Relief of unproductive, dry and intractable coughs associated with
colds and flu.
4.2
D
OSE AND METHOD O