Trientine Waymade

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Trientine dihydrochloride 250mg

Available from:

Clinect NZ Pty Limited

Dosage:

250 mg

Pharmaceutical form:

Capsule

Composition:

Active: Trientine dihydrochloride 250mg Excipient: Gelatin Stearic acid Sunset yellow FCF TekPrint black SW-9008 Titanium dioxide Water

Prescription type:

Prescription

Therapeutic indications:

Trientine Waymade is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, 150 cc HDPE with screw cap - 100 capsules - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 60 days opened stored at or below 30°C

Authorization date:

2020-03-06

Patient Information leaflet

Trientine Waymade
1
TRIENTINE WAYMADE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.

This medicine is new. Please report side effects. See the full CMI for
further details.
1.
WHY AM I USING TRIENTINE WAYMADE?
Trientine Waymade contains the active ingredient trientine
dihydrochloride. Trientine Waymade is used to treat Wilson’s disease
in people who can not take another medicine called penicillamine
because of side effects. For more information, see Section 1.
Why am I using Trientine Waymade? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TRIENTINE WAYMADE?
Do not use if you have ever had an allergic reaction to trientine
dihydrochloride or any of the ingredients listed at the end of the
CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS,
TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO
BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see
Section 2. What should I know before I use Trientine
Waymade? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Trientine Waymade and affect how it
works. A list of these medicines is in Section 3. What if I
am taking other medicines? in the full CMI.
4.
HOW DO I USE TRIENTINE WAYMADE?
•
Always take this medicine exactly as your doctor or pharmacist has
told you.
•
Adults: The usual dose is between 3 and 5 capsules per day in divided
doses.
•
Children: The dose will depend on age and weight.
•
The capsules should be swallowed whole with water and should not be
opened or chewed.
•
The capsules should be taken on an empty stomach, at least one hour
before meals or two hours after meals. The capsules
should be taken at least one hour apart from any other medicine, food,
or milk.
More instructions can be found in Section 4. How do I use Trientine
Waymade? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TRIENTINE WAYMADE?
THINGS YOU
SHOULD DO
•
Remind any doctor,

Summary of Product characteristics

Trientine dihydrochloride Data Sheet 19 September 2023
1
NEW ZEALAND DATA SHEET
1
TRIENTINE WAYMADE 250MG CAPSULES
Trientine Waymade 250 mg oral capsules.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg trientine dihydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Cylindrical size “1” hard gelatin capsule with opaque orange
colour cap printed with “NAV” in black ink and
opaque white colour body printed with “101” in black ink. Capsule
filled with white to off white colour powder.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Trientine Waymade is indicated in the treatment of patients with
Wilson’s disease who are intolerant of
penicillamine.
4.2 DOSE AND METHOD OF ADMINISTRATION
_DOSE _
ADULTS AND CHILDREN
The starting dose would usually correspond to the lowest recommended
dose and the dose should
subsequently be adapted according to the patient’s clinical response
(see section 4.4 Special Warnings and
Precautions for Use).
The recommended initial dose of Trientine Waymade is 500 -750 mg/day
for paediatric patients and 750 -1250
mg/day for adults given in divided doses two, three or four times
daily. This maybe increased to a maximum
of 2000 mg/day for adults or 1500 mg/day for paediatric patients age
12 or under.
The daily dose of Trientine Waymade should be increased only when the
clinical response is not adequate, or
the concentration of free serum copper is persistently above 20
mcg/dL. Optimal long-term maintenance
dosage should be determined at 6 to 12 month intervals.
PATIENTS PRIMARILY PRESENTING HEPATIC SYMPTOMS
The recommended dose in patients primarily presenting hepatic symptoms
is the same as the recommended
adult dose. It is advised, however, to monitor patients presenting
with hepatic symptoms every two to three
weeks after initiation of treatment with Trientine Waymade.
PATIENTS PRIMARILY PRESENTING NEUROLOGICAL SYMPTOMS
Dose recommendations are the same as for adults. However, up titration
should