Trientine 200mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Trientine dihydrochloride

Available from:

Univar Solutions B.V.

ATC code:

A16AX12

INN (International Name):

Trientine dihydrochloride

Dosage:

200mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09080100; GTIN: 8719326233703

Patient Information leaflet

1
1000013006
TRIENTINE DIHYDROCHLORIDE
CAPSULES 300mg
_Content: _100 capsules
Active Ingredient: Trientine Dihydrochloride 300mg
equivalent to 200mg of Trientine base.
_Dosage:_ Up to 8 capsules per day, to be taken orally
as directed by your physician, divided up into 2-4 smaller
doses throughout the day. Take 30 mins to 1 hour before
food. lf taking iron supplements or antacid indigestion
remedies, these should be taken after food.
_Storage: _Store in original container in the fridge
between 2 and 8°C.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Use within 3 months of first opening
PL 41626/0001
_Marketing Authorisation Holder:_
Univar Solutions BV
Schouwburgplein 30-34,
3012 CL Rotterdam.
The Netherlands
POM
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TRIENTINE DIHYDROCHLORIDE
CAPSULES 300mg
1x100 capsules
Read all of this leaflet carefully before
you start taking this medicine.
•
Keep this leaflet. You might need to
read it again.
•
If you have any further questions, ask
your doctor or pharmacist.
•
This medicine has been prescribed
for you. Do not pass it on to others.
It may harm them, even if their
symptoms are the same as yours.
•
If any of the side effects get serious, or
if you notice any side effect not listed
in this leaflet please tell your doctor or
pharmacist.
In this leaflet
1. What Trientine Dihydrochloride is and
what it is used for
2. Before you take Trientine
Dihydrochloride
3. How to take Trientine Dihydrochloride
4. Possible side effects
5. How to store Trientine Dihydrochloride
6. Further information
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1. WHAT TRIENTINE
DIHYDROCHLORIDE IS
AND WHAT IT IS USED FOR
Trientine Dihydrochloride is used for the
treatment of Wilson’s disease which is
caused by having too much copper in your
body. It is used in patients who cannot
tolerate D-Penicillamine treatment.
Trientine Dihydrochloride is a chelating
agent. It controls the amount of copper in
the body by binding to it. The copper can
then be passed from the body.
2. BEFORE YOU TAKE
Trientine Dihydroc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trientine dihydrochloride capsules 300mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trientine dihydrochloride
300 mg
Equivalent to
200 mg base
3
PHARMACEUTICAL FORM
Hard capsules (capsules)
White capsules marked in grey ink with the company logo and
“Trientine 300mg”.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of Wilson’s disease in patients intolerant of
D-Penicillamine
therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
Adults (including elderly): 1.2-2.4 grams (4-8 capsules) daily in 2 to
4 divided
doses preferably 30 minutes to 1 hour before meals.
Children: The dose is lower than for adults and depends on age and
body
weight. The dose should be adjusted according to clinical response.
0.6-1.5
grams have been used at initiation of therapy.
4.3
CONTRAINDICATIONS
None stated
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Trientine is not indicated as an alternative to D-Penicillamine in the
treatment of
rheumatoid arthritis or cystinuria. Penicillamine-induced systemic
lupus
erythematosus may not resolve on transfer to trientine. Trientine is a
chelating agent
which has been found to reduce serum iron levels possibly reducing its
absorption.
Iron supplementation may be necessary in some cases and should be
administered at a
different time of the day to trientine.
There is no evidence that calcium or magnesium antacids alter the
efficacy of
trientine but it is good practice to separate their administration.
(i.e. antacids should
be taken after meals).
There is no advantage in using trientine and penicillamine in
combination.
There have been reports of neurological deterioration in Wilson’s
Disease patients
treated with copper chelators including trientine. It is possible this
effect may be
more evident in patient with pre-existing neurological symptoms. It is
recommended
to monitor patients closely for such signs and symptoms and to
consider a titrated
increase in dose to reach the recommended therapeu