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TRIENTINE DIHYDROCHLORIDE CAPSULES 300MG

Active substance(s): TRIENTINE DIHYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Trientine dihydrochloride capsules 300mg

2

3

QUALITATIVE AND QUANTITATIVE COMPOSITION
Trientine dihydrochloride

300 mg

Equivalent to

200 mg base

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 therapeutic dose.

4.5

Interaction with other medicinal products and other forms of interaction
Trientine has been found to reduce serum iron levels.

4.6

Fertility, Pregnancy and lactation
The product should be used in pregnancy only after careful consideration of
the benefits compared with the risks of treatment in the individual patient.
Factors which need to be borne in mind include the risks associated with the
disease itself, the risk of those alternative treatments which are available and
the possible teratogenic effects of trientine.
The pregnancy should be monitored in order to detect possible foetal
abnormality and to assess maternal serum copper levels throughout the
pregnancy.
The dose of trientine used should be adjusted in order to maintain serum
copper levels within the normal range. Babies born to mothers being treated
with trientine should be monitored for serum copper and ceruloplasmin levels
where appropriate.

4.7

Effects on ability to drive and use machines
None stated

4.8

Undesirable effects
Nausea on initial treatment and occasionally skin rash can occur. Duodenitis and
severe colitis have been reported. Very rarely anaemia.
There have been reports of neurological deterioration in Wilson’s Disease patients
treated with copper chelators including trientine, with symptoms of, for example,
dystonia, rigidity, tremor and dysarthria.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via: https://yellowcard.mhra.gov.uk/.

4.9

Overdose
In one reported case an overdose of 30 capsules did not produce any apparent
adverse effect.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Trientine dihydrochloride is a copper-chelating agent which aids the
elimination of copper from the body by forming a stable soluble complex that
is readily excreted from the kidney.

5.2

Pharmacokinetic properties
None stated.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Capsule content:
Magnesium stearate

Colloidal anhydrous silica
Capsule shell:
Gelatin
Titanium dioxide (E171)
Grey printing ink containing:
Shellac
Titanium dioxide (E171)
Iron oxide black (E172)
Iron oxide yellow (E172)
Propylene glycol

6.2

Incompatibilities
Not known.

6.3

Shelf life
36 months.
3 months after first opening.

6.4

Special precautions for storage
Store in a refrigerator (2°C - 8˚C). Do not freeze. Store in the original
container and retain the silica gel sachet in the bottle in order to protect from
moisture.

6.5

Nature and contents of container
100 capsules in an amber glass bottle with a polypropylene cap with induction
heat seal liner, also containing a sachet of dried silica gel as desiccant.

6.6

Special precautions for disposal
None stated.

7

MARKETING AUTHORISATION HOLDER
Univar BV
Schouwburgplein 30-34
3012 CL Rotterdam
The Netherlands

8

MARKETING AUTHORISATION NUMBER(S)
PL 41626/0001

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
8 August 1985 / 16 April 1996.

10

DATE OF REVISION OF THE TEXT
20/06/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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